10 minute read

In Australia, there are different options to challenge the validity of a patent application or granted patent.  This can be of significant interest from a freedom to operate perspective when a business is planning to launch or commercialise a product or process, regardless of whether the product or process is covered by its own intellectual property.

Challenging a patent application or patent

(i)           Third party submissions

A patent application can be challenged pre-acceptance (prior to being allowed by the examiner during prosecution) by filing third party submissions.  Any party may file third party submissions up to three months following the date of advertised acceptance of a patent application in Australia.  The Notice is filed with any documents relevant to the assertion that the invention claimed is not novel and/or does not involve an inventive step. 

(ii)          Re-examination

It is also possible to request re-examination between acceptance and grant which is at the Commissioner’s discretion. 

On the other hand, if a third party requests re-examination following grant, re-examination must be conducted and either an adverse or non-adverse report must be issued.

During re-examination, an examination report will issue which outlines the examiner’s findings.  In the case of an adverse report, the patentee will be given the opportunity to respond with its own written submissions and/or amendments.  If the patentee cannot resolve outstanding issues encountered during re-examination, the Commissioner will typically set the matter for a hearing prior to revoking the patent either wholly or in so far as it relates to a particular claim if the patentee is unsuccessful.  

Hearings are typically rare during re-examination as most outstanding issues can be resolved by a patentee by filing written submissions or amendments in reply to a re-examination report.  The most common grounds which are difficult to resolve as they are subjective are issues relating to inventive step (obviousness) and patentable subject matter (such as manner of manufacture for software patents).

(iii)         Opposition proceedings

The validity of a patent application can also be challenged by commencing (pre-grant) opposition proceedings.  This involves filing a notice of opposition, which must be filed within three months of the date on which acceptance of the (opposed) application is advertised.

Opposition proceedings typically involve the preparation of expert evidence.

(iv)         Revocation

If a patent application proceeds to grant, a third party has the option of challenging the validity of the patent claims by commencing revocation proceedings before an Australian court or, alternatively, seeking revocation of the claims during infringement proceedings commenced by the patentee. 

Ex-parte

Under Australian practice, third party submissions and re-examination requests are ex-parte.  That is the requestor is not a party to the process and there is no opportunity for further iterations of evidence.

Re-examination considerations and advantages

In this article, we will focus on the advantages of filing a request for re-examination as a cheaper and more time efficient route to challenge validity of patent claims. 

Compared to opposition and revocation proceedings, re-examination can be orders of magnitude cheaper and generally issues can be resolved in a matter of months rather than years.  This can provide more clarity for a party’s commercial objectives in a shorter time frame which would otherwise delay product launches and commercial activities.

Traditionally, re-examination was a less popular route because prior to the commencement of the new Patents Act (Raising the Bar) which came into effect on April 2013, re-examination was limited only to the grounds of novelty and inventive step.  Unless a party had “knock-out” prior art for novelty purposes, challenging inventive step was notoriously difficult as assessing inventive step in Australia requires expert evidence from expert witnesses as discussed above and is highly subjective. 

Accordingly, most Australian attorneys would not recommend re-examination if the main ground of challenge was inventive step.  This is highlighted by the Merck & Cie decision below.

However, as a result of the changes to our law, the grounds which could be considered during re-examination were expanded to include full description (including best method of performance), clarity and succinctness, patentable subject matter and fair basis/support.  Usefulness is also considered, but in context of whether the claimed invention achieves the promised benefit. 

Difficulty with inventive step – Merck & Cie [2020] APO 45

A recent Patent Office decision (Merck & Cie) highlights the high bar demanded of third parties to invalidate a granted patent when requesting re-examination in relation to the ground of inventive step.  The Delegate dismissed the ground of inventive step after oral hearing proceedings on the basis that the Delegate could not be practically certain that the granted patent was invalid in view of the evidence provided despite issuance of three re-examination reports maintaining lack of inventive step during re-examination proceedings.

This decision reinforces the already accepted notion of the difficulty third parties face when relying on re-examination at the Patent Office to invalidate a granted patent in respect of inventive step.

The claims of the Australian Patent 2012200512 filed in the name of Merck & Cie (the Patentee) are directed to formulations of a specific polymorph of the compound (6R)-L-erythro-tetrahydrobiopterin dihydro-chloride (referred to as Form B).  The formulations comprise one, or both, of the pharmaceutical excipients polyvinylpyrrolidone (PVP) and/or dicalcium phosphate (DCP).

On 23 October 2017, a third party (the Requestor) filed a request for re-examination.  Objections were raised by the Examiner under the ground of inventive step.  Three rounds of submissions were filed by the Patentee to address the lack of inventive step objection, however, the submissions were not considered to be persuasive.  

As a result, the Examiner assigned the matter to a hearings officer to consider revocation and that the Patentee could request a hearing to contest the decision.  A hearing was requested by the Patentee.

(i)           The Arguments

The Requestor raised the following grounds for re-examination:

a)            the claimed invention lacked novelty;

b)            the claimed invention lacked an inventive step; and

c)            the claims are not fairly based on the disclosure of the specification.

Nine prior art documents were filed with the request including expert evidence in the form of declarations by three expert witnesses. 

The only ground raised in the re-examination reports by the Examiner was inventive step and was the primary ground during hearing.  Additional documents had been cited by the Examiner to support lack of inventive step.

The Examiner asserted that the claims lacked an inventive step because the polymorph Form B was known from the cited documents, and that its outstanding properties make it “especially feasible” for pharmaceutical application. 

Similarly, the Examiner considered that the use of active pharmaceutical ingredients in combination with excipients PVP and DCP (either alone or in combination) was routine based on the teachings of the cited art.  Accordingly, a person of ordinary skill would be expected to simply substitute the active pharmaceutical ingredients described in the cited art with the improved polymorphic Form B in combination with the excipients disclosed.

The major issue in determining whether the claimed invention had an inventive step was that the Examiner asserted that the specification did not describe a problem to be solved (namely stability).  The Examiner noted that the “specification does not appear to suggest any particular problem when formulating compositions of the polymorphic Form B, nor does it indicate that there is any particular difficulty in formulating Form B” and that as a consequence “there are no proposed solutions which have a need for invention when preparing a pharmaceutical composition” and therefore the claimed invention is obvious.

Similar issues had been raised during prosecution that the selection of polymorph Form B in combination with excipients PVP and DCP were routine.  However, the Patentee had drawn analogies to the circumstances of Bristol Myers Squibb v Apotex and argued that these excipients (either alone or in combination) provided improved hygroscopicity (absorption of moisture from surrounding atmosphere) that could not have been predicted.  The application was accepted in view of this argument.  However, the Examiner considered that the supplementary material provided by the Requestor established that the use of these ingredients was obvious. 

(ii)          The Decision

Despite the arguments raised by the Requestor and the Examiner that a specific problem was not identified by the specification and particularly not by any reformulation development around Form B with any advantageous excipients, the Delegate was satisfied that the problem to be solved, as provided by the Patentee, is the provision of a formulation of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride that has high storage stability.

The evidence before the Delegate indicated that while (6R)-L-erythro-tetrahydrobiopterin dihydrochloride was known to exist as a white crystalline solid, this was the only crystal form described in the prior art.  The Delegate found that polymorphism requires at least two different crystal forms and it was only once the Patentee discovered different crystal forms that the white crystal of the prior art could be considered a polymorph (form B).  Polymorph forms was therefore not common general knowledge. 

No evidence was provided regarding the storage stability of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride and that tablets comprising (6R)-L-erythro-tetrahydrobiopterin dihydrochloride together with PVP and/or DCP were known or even common general knowledge.

The Delegate found that the problem in the present case is the provision of a formulation of (6R)-L-erythro-tetrahydrobiopterin dihydrochloride that has high storage stability.  The Delegate noted that the claimed combination as a whole must be considered when considering inventiveness and not the individual features.

The evidence from the experts indicated that there were a number of alternative strategies that could be employed to formulate the active ingredient, and even if seeking an excipient to improve the stability of the formulation, there were a number of alternatives that could be employed. 

As a result, the Delegate found that on balance there was insufficient evidence to determine that the claims are invalid on the ground of lack of inventive step in view the cited art and the common general knowledge. 

Implications

This decision reinforces the understanding by practitioners that re-examination should be relied on as an alternative to opposition and revocation proceedings when the matters to be considered are relatively straightforward.  That is, the substantive grounds relied upon by a third party is inter alia novelty and support.

Reliance of re-examination proceedings are typically difficult when attempting to invalidate a patent based on the ground of inventive step. 

This difficulty was also noted by the Delegate which stated that “[t]he present determination has also not been helped by the evidentiary constraints of re-examination where the requestor is not a party to the process and there is no opportunity for further iterations of evidence or, in the case of post-grant court proceedings, cross examination to further explore the issues in contention”.[1] 

For matters relating to the ground of inventive step, it is recommended that invalidity be established by opposition proceedings (pre-grant) or revocation in Court (post-grant) proceedings as these are inter partes proceedings such that a third party can have the opportunity to heard in full.

Alternative grounds

Despite the high bar encountered during re-examination in the context of inventive step, re-examination can still be a useful and cost-effective tool when relying on the alternative expanded grounds as discussed above.

This was highlighted in an earlier Patent Office decision of Huping Hu (2014) APO 17.  Unusually in this case, the Commissioner exercised their discretion in requesting re-examination after grant compared to a request filed by a third party.  During re-examination, the Commissioner raised additional grounds relating to utility, patentable subject matter (lack of manner of manufacture) and full description.

In this decision, the Delegate found that the patent lacked utility, patentable subject matter and the specification did not fully describe the invention.

The Delegate revoked the patent as the Delegate considered that the deficiencies could not be addressed by amendment.

Recommendation

As a result of the expanded grounds, re-examination can be a useful tool to challenge validity.  If a potentially infringing commercial product relies only on a specific embodiment such as using specific chemical compositions, re-examination can be used to potentially force a patentee to amend the claims which may exclude a potential commercial product by relying on the grounds of support and disclosure for example.

For instance, if a patent application or patent has unduly broad claims potentially covering the embodiment but is arguably not supported or enabled by the description and examples (often observed in the Chemical and Life Sciences space), raising the ground of support can potentially force the patentee to amend claims by narrowing which are no longer covered by the scope of the amended claims and avoid potential infringement.

Since more grounds are now available under the post-Raising the Bar Act, the prospects for successfully challenging validity through re-examination have improved but the thresholds remain high and patentees are given ample opportunity to save their claims through amendment.  This can make a potential infringer’s position better from a freedom to operate perspective but worse from a revocation perspective.

If you are interested in requesting re-examination of a patent or would like further information, please contact one of our expert attorneys.


[1] Merck & Cie [2020] APO 45, [98].

Authored by David Hvasanov, PhD and Charles Tansey, PhD

12 min read

Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477

Summary

Australia’s Federal Court has delivered judgment in a dispute concerning patents covering improvements in vaccines against Streptococcus pneumoniae, a leading cause of serious infections, particularly in children.  The judgment provides the first detailed analysis by a Federal Court judge of the Raising the Bar reforms to Australian patent law concerning sufficiency and support.  The decision demonstrates the profound implications of those reforms for permissible claim breadth in Australian patents.

Key takeaways

  • Australian patent law concerning sufficiency of description and support for claims underwent significant changes in 2012 as a result of the Raising the Bar amendments to the Patents Act 1990 (Cth) (Patents Act).
  • Due to generous transitional provisions, the amended law is only now coming before Australia’s Federal Court for interpretation and application.
  • European and UK authorities provide guidance on how the amended provisions of Australia’s Patents Act are likely to be interpreted and applied. In some cases, the amendments will result in a reduction in permissible claim breadth for Australian patents.
  • As a result of the transitional arrangements, many Australian patent disputes between now and least 2033 are likely to involve both patents subject to the pre-Raising the Bar law and patents subject the post-Raising the Bar Amendments may be required to avoid the latter patents being held invalid under the new, more stringent standards of sufficiency and support.

On 14 October 2020, Justice Stephen Burley delivered the judgment of the Federal Court of Australia in Merck Sharp & Dohme Corporation v Wyeth LLC (No 3) [2020] FCA 1477.  The case concerned three patents owned by Wyeth LLC (Wyeth) relating to improvements in immunisation against infection by Streptococcus pneumoniae, a bacterium responsible for meningitis, pneumonia and other serious illnesses, especially in children.

Justice Burley’s decision provides the first detailed analysis by the Federal Court of Australia concerning amendments made in 2012 to Australian patent law on the topics of sufficiency of description and support for claims.  The decision highlights the significant implications of those amendments for patent validity and claim scope.

The technology

Streptococcus pneumoniae (also referred to as “pneumococcus”) has an outer capsule that incorporates complex sugars known as polysaccharides.  Differences in capsular polysaccharides distinguish variants of pneumococcus, called “serotypes”.  More than 90 distinct serotypes have been described.  A more limited group of virulent serotypes are responsible for most serious pneumococcal infections.

The antibody response to capsular polysaccharides is generally poor in young children.  As a result, they are particularly susceptible to pneumococcal infections, which globally account for around 1 to 2 million childhood deaths each year.

To address this problem, “polysaccharide-protein conjugate vaccines” were developed with the aim of stimulating immunity against serotypes of pneumococcus known to be responsible for a high proportion of human infections.  In such vaccines, capsular polysaccharides are joined (“conjugated”) to a carrier protein, leading to a stronger antibody response than is achievable with vaccines based on capsular polysaccharides alone.

A polysaccharide-protein conjugate vaccine against pneumococcus developed by Wyeth, known as Prevnar 7®, was in clinical use before the priority date of the Composition Patents.  That product is a “7-valent” vaccine.  It comprises capsular polysaccharides from 7 different pneumococcus serotypes, in each case conjugated to a single protein (known as “CRM197”).  Evidence led in the case indicated that, before the priority date, steps had been taken to develop 9-valent and 11-valent polysaccharide-protein conjugate vaccines against pneumococcus, but no such products had yet been licensed or launched.

The patents

Three patents were at issue in this proceeding.  Two of them, referred to by Burley J as the “Composition Patents”, were related members of the same patent family.  The more senior family member (referred to here as the “Parent Composition Patent”) was subject to the provisions of Australia’s Patents Act as they stood prior to the Raising the Bar amendments.  The more junior family member (referred to here as the “Child Composition Patent”) was subject to the post-Raising the Bar Patents Act.  The body of the specification was substantially the same in the parent and child patents.  It described multivalent immunogenic compositions (that is, vaccines) comprising 13 distinct polysaccharide-protein conjugates, thereby providing increased coverage of pneumococcal serotypes compared to the existing Prevnar 7® vaccine.

A third patent asserted by Wyeth in the proceeding, referred to by Burley J as the “Container Patent”, disclosed siliconized container means for the stabilization of polysaccharide conjugates.  The issues raised in the proceeding in relation to the Container Patent are not discussed here.

The proceedings

Merck Sharp & Dohme (MSD) sought revocation of Wyeth’s Composition Patents on a variety of grounds, including lack of novelty, lack of inventive step (i.e., obviousness), false suggestion, lack of clarity, lack of fair basis (in relation to the pre-Raising the Bar Parent patent) and lack of support (in relation to the post-Raising the Bar Child patent).

By a cross-claim, Wyeth alleged that a 15-valent pneumococcal vaccine which MSD proposed to launch and market in Australia would infringe selected claims of all three of the asserted patents.

Wyeth’s allegation that the Composition Patents would be infringed by marketing of MSD’s 15-valent vaccine in Australia gave rise to a critical issue of claim construction in the proceeding, namely, whether the claims of those patents were limited to 13-valent vaccines (as MSD contended) or extended to vaccines covering 13 or more serotypes (as Wyeth submitted).

The construction issue

Claim 1 of the Parent Composition Patent was in the following terms:

A multivalent immunogenic composition, comprising: 13 distinct polysaccharide-protein conjugates, together with a physiologically acceptable vehicle, wherein each of the conjugates comprises a capsular polysaccharide from a different serotype of Streptococcus pneumoniae conjugated to a carrier protein, and the capsular polysaccharides are prepared from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F and wherein said carrier protein is CRM197.

Insofar as is presently relevant, claim 1 of the Child Composition Patent was in similar (although not identical) terms.

The specification of each of the Composition Patents included text (standard in Australian patents) indicating that “comprising” is used in an inclusive sense (“including”) rather than an exhaustive sense (“consisting of”).  That text provided the basis for Wyeth’s submission that, because MSD’s 15-valent vaccine included the 13 serotypes identified in the claims of the Composition Patents, it fell within those claims.  On Wyeth’s construction, the presence of two additional serotypes in MSD’s 15-valent vaccine was irrelevant to infringement.

Arguing to the contrary, MSD submitted that its construction (limiting the claims to 13-valent vaccines) was the only construction consistent with the description of Wyeth’s invention in the specification taken as a whole.  A corresponding submission, based on similar (but not identical) claim language, had been accepted in related UK proceedings between MSD and Wyeth (see Merck Sharp & Dohme Limited v Wyeth LLC [2020] EWHC 2636 (Pat) at [251]-[270]).

However, on this key issue, Burley J preferred Wyeth’s construction.  In his Honour’s analysis, the inclusive definition of “comprising” was decisive.  Provided that a vaccine included each integer of Wyeth’s claims (including, relevantly, the 13 specified serotypes), it would infringe – a conclusion not altered by the presence in the infringing product of additional serotypes.

What is notable for present purposes is the very substantial breadth given to Wyeth’s claims on the construction adopted by Burley J.  On that construction, the range of valences covered by Wyeth’s claim would appear to have no upper bound.

Unsurprisingly, in view of this broad construction, a question arose as to whether the claims were fairly based on, or supported by, the disclosure contained in the body of the Composition Patent specification.  On that legal issue, the Raising the Bar amendments have brought about a profound shift in Australian law, as Burley J’s judgment demonstrates.

Raising the Bar reforms

The Raising the Bar reforms were introduced to address concerns that Australia’s patent standards were lower than those of its major trading partners, causing Australia’s innovation landscape to become cluttered with unduly broad patents.  The amendments were expressly directed at aligning key aspects of Australian patent law, including on sufficiency of disclosure and support for claims, with the standards applied by UK courts and the European Patent Office (EPO) Boards of Appeal.

Although the Raising the Bar amendments were enacted in April 2012, lengthy transitional provisions mean that many of the key reforms, including those concerning sufficiency and support, are only now coming before the courts for interpretation and application.

The law pre-Raising the Bar

Prior to the Raising the Bar reforms, the relationship between the disclosure in the body of a patent specification and the breadth of the claims was governed by the legal requirement for “fair basis”.  The leading authority on that requirement (Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (2004) 217 CLR 274) established that fair basis does not turn on any inquiry into the patentee’s “technical contribution to the art”, but rather on whether each claim corresponds textually with what the patentee has described as their invention in the body of the patent specification.

The practical effect of Lockwood’s permissive interpretation of the fair basis requirement was amplified by the equally permissive interpretation of the sufficiency requirement given in the leading authority pre-Raising the Bar (Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd (2001) 207 CLR 1).  That case stands as authority for the proposition that a patent specification will have adequately described the invention if it would enable a person skilled in the relevant art to produce “something” falling within each claim (referred to colloquially as the “one way rule”).

That body of law is of continuing relevance for Australian standard and innovation patents for which examination was requested before 15 April 2013.  In the present case, that “old” body of law applied to the Parent Composition Patent.

Applying those authorities, Burley J found little difficulty in concluding that, notwithstanding his Honour’s broad interpretation of the claims of the Parent Composition Patent, those claims were fairly based.  Reflecting the essentially textual nature of the pre-Raising the Bar test for fair basis, that conclusion followed from the fact that the description of the invention in the body of the Parent Composition Patent employed the same inclusive language (“comprising”) as appeared in the claims.

The law post-Raising the Bar

Following the Raising the Bar amendments, the provisions of Australia’s Patents Act dealing with sufficiency and support are in substantially the same terms as the corresponding provisions of the European Patent Convention and the United Kingdom’s Patents Act 1977.  Parliamentary records make clear that those provisions were intended to have substantially the same effect as their European and UK counterparts, and that Australia courts are expected to have regard to decisions of the EPO Boards of Appeal and of UK courts in interpreting those provisions.

Burley J reviewed a number of EPO and UK authorities, including the recent decision of the UK Supreme Court in Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27, to interpret the post-Raising the Bar requirement that the claims be “supported by matter disclosed in the specification”.

Referring to the landmark decision of the House of Lords in Biogen Inc v Medeva Plc [1997] RPC 1, Burley J observed that the claim support obligation has come to be understood as falling “under the umbrella of the requirement that the patent specification contain an enabling disclosure”.  His Honour noted that, although the requirement for sufficient description is directed to the specification as a whole, while the requirement for support is directed specifically to the claims, both requirements serve to ensure that a person skilled in the relevant art, armed with the patentee’s specification, is enabled to perform the invention over the whole area claimed without undue burden.

Referring to the decision of the EPO Board of Appeal in Exxon/Fuel Oils (T 409/91) [1994] EPOR 149, Burley J noted that the requirement for enablement across the full claim scope has been recognised as reflecting the general legal principle that the scope of a patent monopoly, as defined by the claims, should correspond to the patentee’s technical contribution to the art, as disclosed in their specification.

Applying those authorities, Burley J concluded that the claims of the Child Composition Patent were not supported by the matter disclosed in the specification.  On the construction advanced by Wyeth and accepted by His Honour, those claims encompassed any polysaccharide-protein conjugate pneumococcal vaccine comprising 13 or more serotypes (provided the other claim integers were satisfied).  While there was no dispute that the specification of the Composition Patents would enable a skilled person to make and use a 13-valent vaccine, uncontested evidence established that the disclosure of the specification could not be extrapolated to vaccines containing other, additional serotypes.  Manufacture of polysaccharide-protein conjugate vaccines comprising more than 13 serotypes was not enabled.

In the result, the asserted claims of the Parent Composition Patent were held to be valid and infringed, while the asserted claims of the Child Composition Patent were held invalid for lack of support.

Significance of the judgment

The disparate conclusions reached in this case concerning the Parent and Child Composition Patents serve to illustrate the profound changes to Australian law brought about by the Raising the Bar reforms.

Observers in other jurisdictions may find it curious that such starkly different findings could be made on the basis of very closely similar patent specifications.  The principle upon which the Child Composition Patent was held invalid (i.e., the requirement that claim breadth correspond to the patentee’s technical contribution to the art) is said to reflect the “essential patent bargain” whereby the patent holder is granted a time-limited monopoly in return for disclosing their invention in terms sufficiently clear and complete for it to be performed by those skilled in the art.  The fact that this requirement did not apply to the Parent Composition Patent serves to illustrate the extent to which, in the pre-Raising the Bar era, Australian patent law had diverged from the law applied by its major trading partners.

Such disparate outcomes are likely to remain a feature of Australian patent disputes for some years to come.  Australian patents subject to the pre-Raising the Bar law are expected to remain in force until at least 2033.

This decision also demonstrates that the post-Raising the Bar incarnations of Australia’s written disclosure requirements in s 40 of the Patents Act 1990 (Cth) can be a much more powerful weapon in the arsenal of a party seeking to revoke an Australian patent.  Historically, the low thresholds for fair basis and sufficiency have provided relatively wide scope for Australian patentees in advancing positions on claim construction to capture alleged infringements.  This main constraint for patentees in advancing claim construction under the pre-Raising the Bar body of law has been (and will remain) potential novelty and inventive step consequences arising from constructions being so broad as to capture prior art or common general knowledge.  The onerous post-Raising the Bar support and sufficiency requirements will add an extra dimension to these construction “squeezes” and another powerful validity ground which must be fended off.

Furthermore, notwithstanding parliament’s intention that the post-Raising the Bar provisions concerning sufficiency of description and claim support be interpreted so as to have substantially the same effect as the corresponding provisions of European and UK law, lingering disparities between the law of those jurisdictions and the terms of Australia’s Patents Act mean that some independent development of Australian law on sufficiency and support appears inevitable.  Two examples may be noted.

First, under the UK’s Patents Act 1977, although both sufficiency and support are requirements for a valid patent application, only lack of sufficiency is available as a ground of revocation for granted patents.  UK courts have remedied that “logical gap” by recognising both requirements as aspects of a single unifying requirement for an enabling disclosure.  No such logical gap exists in Australia’s Patents Act, where both lack of sufficiency and lack of support are available as grounds for revocation.  Whether this difference will lead Australian courts to seek to disentangle the threads of sufficiency and support in the UK authorities remains to be seen.

Secondly, by contrast to the requirements of European and UK law, Australia’s post-Raising the Bar Patents Act continues to impose a requirement to disclose the “best method”.  European and UK authorities provide no guidance on how that requirement is to be accommodated with the law regarding sufficiency and support.  For such guidance, it may be necessary for Australian courts to look to United States authorities.  Whether they will choose to do so remains to be seen.

Given the significant commercial interests at stake, and the complexity of the legal and factual issues raised by the Prevnar® case, the likelihood of an appeal appears reasonably high.  Whether any appeal judgment casts further light on Australian patent law post-Raising the Bar is likely to depend upon whether the appeal court upholds the broad construction of Wyeth’s Composition Patent claims that was accepted by Burley J.

Authored by Andrew Rankine, Charles Tansey, PhD, Duncan Longstaff

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Authored by Gareth Dixon, PhD and Charles Tansey, PhD

Shelston IP is proud to announce that we have been appointed as one of the preferred IP service providers to UNSW Sydney.  As readers know, UNSW is a powerhouse of cutting-edge research, teaching and innovation, and is the #1 institution attended by Australian start-up founders. The University is one of the top 100 universities in the world, and is a founding member of the prestigious Group of Eight – a coalition of Australia’s leading research-intensive universities.

We are delighted to continue our association with UNSW.

We believe our appointment reflects the calibre of our attorneys and the consistent high quality of service that we provide to our clients, as exemplified by our recent ranking by MIP as a Tier 1 firm for patent prosecution in Australia. (https://www.shelstonip.com/news/shelston-ip-tier-one-firm-patents-trade-marks/).

Authored by Charles Tansey, PhD

Shelston IP is proud to announce that we have been reappointed as one of the exclusive IP service providers to CSIRO. As readers know, CSIRO is Australia’s leading multidisciplinary research organisation, with more than 5,000 talented people working out of centers in Australia and internationally. CSIRO plays a vital role in enhancing collaboration within the Australian national innovation system, and as a trusted advisor to government, industry and the community.

We are delighted to continue our long association with CSIRO.

We believe our appointment reflects the caliber of our attorneys and the consistent high quality of service that we provide to our clients, as exemplified by our recent ranking by Managing IP as a Tier 1 firm for patent prosecution in Australia (https://www.shelstonip.com/news/shelston-ip-tier-one-firm-patents-trade-marks/).

Please do not hesitate to contact our attorneys and lawyers for advice on any IP-related issues.

Authored by Peter Treloar and Charles Tansey, PhD

4 min read

The sentence above is a quote from a journalist, Sharon Begley, in an article interviewing the astronomer, Carl Sagan, and is often misattributed to him.  How does it apply to patent searching?  You’re the one with an idea for the incredible something, and you will want it known, but as I often see, just because that something isn’t known to you, doesn’t mean it isn’t known.  A brainwave today just may have been someone else’s one hundred years ago too.

I’ve recently been telling you how to conduct aspects of your search, but I’ve never mentioned where you should go to conduct it, or why.

If you want to know if your idea is new, you’re going to conduct what is known as a novelty or patentability search.

You’re in Australia, you’ve heard of IP Australia, and that leads you to AusPat, or you’re in New Zealand and you find your way to IPONZ, and so on around the world.  Is a search there enough?  Not really.  Novelty is global these days, and goes back further in time than either of those two, or any, databases cover.

While there are a few commercial patent databases available, you’re going to have search one (or more) of the freely available databases that contain a collection of patent applications from around the world.  There are a couple of good collections by intellectual property organisations.  These are WIPO’s PatentScope and the European Patent Office’s Espacenet.  They don’t cover every country but they do have country coverage pages, so if you are particularly interested in a country not covered, you may have to go directly to that country’s national patent database.

A few other freely available collections not run by intellectual property organisations include Google Patents and The Lens.  Try them all out as the interfaces are different, and you will find one is more comfortable and intuitive to use.

A second type of search that might commonly be undertaken at a layperson’s level, although far more risky if you get it wrong, is a freedom to operate search, sometimes known as an infringement or clearance search.  This time you’re interested in knowing if you will be infringing someone else’s rights by importing, manufacturing or selling a product.

In this case you generally only need to consider the country or countries you will be doing any of those things in (bearing in mind that imporrting and exporting patented goods and processes is something of a legal minefield), so if that’s Australia you only need to search in AusPat.  The other aspect of a freedom to operate search is that you only need to search applications or patents with a live status, or in AusPat speak, an ‘active’ status.  You may also need to consider any application that recently became inactive as they could be restored to an active status.  If you’re searching in a database that doesn’t allow status searching then a useful substitute is restricting the search to filing dates less than 20 years old (or 25 if you’re searching for a pharmaceutical).  You’ll be searching through some inactive statuses but you will capture all active applications.

You can still use the collection databases above but you’ll also have to add a country restriction to your search.

If you want to find the location of your national database, here is a good place to start.

A third useful type of search is a state of the art search, or landscape search.  This is where you want to know what’s out there in a particular field.  As you’re more interested in what’s new, think of it as a date restricted novelty search, so instead of searching back as far as you can, possibly beyond the first instance of the field, you should restrict the filing date to a recent period such as the last ten or five years, depending on how fast the technology is moving.  The most useful databases in this instance are the collection databases.

There is one last type of search you may have heard of, which is an invalidity or validity search.  The two names appear contradictory but it just depends on which side of the pitch you’re on, whether you’re attacking or defending.  It’s unlikely a layperson would ever have to conduct a search such as this, but think of it as a novelty search on steroids.  You not only look at patent literature but also scour non patent literature as well, digging and digging until you’ve exhausted your options or your budget.  A good novelty search takes me somewhere around five hours to complete, but an invalidity search will take many more than that.

So, go somewhere and look for that incredible something, and if you can’t find it, it’s already yours.

6 min read

You’re probably already lacing up your running shoes at the very thought of the mention of the International Patent Classification (IPC), but please stick around; I promise this will be almost painless.

If you’re like me, your introduction to the IPC was a seemingly random string of letters and numbers rolling off someone’s tongue.  It made no sense at the time, and yet, despite the years, when one might think they have it down pat, there are still times when it’s a head scratcher.

I’m going to try to help you, firstly, find the right patent classification for your idea, and secondly, help you use that information in a meaningful way, but before all that, a few letters and numbers.

A typical IPC classification looks like A61K31/192.  This one happens to relate to pharmaceutical compositions containing ibuprofen, but let’s break it down into its constituent parts.

An IPC classification is composed of five parts: section; class; subclass; group; and subgroup, each building on what has come before.  In the example above the section is A; the class is A61; the subclass is A61K; the group is A61K31, and the subgroup is A61K31/192.

Sometimes you’ll see IPC classifications with a space between the subclass and the group, or with some extra zeros in the group numbers.  They all mean the same thing.

There are eight sections, labelled A to H, and these cover broad technology areas as follows:

A             Human necessities

B             Performing operations; Transporting

C             Chemistry; Metallurgy

D             Textiles; Paper

E              Fixed constructions

F              Mechanical engineering; Lighting; Heating; Weapons; Blasting

G             Physics

H             Electricity

These sections get subdivided and further subdivided until you end up with these figures for the most recent iteration of the IPC published in January 2020.

Eight sections – 131 classes – 646 subclasses – 7518 groups – 68030 subgroups.

I know those are daunting numbers if you want to find the right classification but the IPC is a hierarchical system that is laid out in a very orderly fashion.

Here’s the IPC layout for A61K31/192.

A61K31

There are a series of dots known as 1-dot subgroups, 2-dot subgroups and so on. All 2-dot subgroups are subsets of 1-dot subgroups, and 3-dot subgroups are subsets of 2-dot subgroups.  What we are aiming for is the last possible subgroup into which we could put our idea, or in this case, ibuprofen.

We’re looking for pharmaceutical compositions containing an organic compound which brings us to the group A61K31.  Ibuprofen is an acid, so A61K31/185 (1-dot).  It’s also a carboxylic acid, so A61K31/19 (2-dot).  It’s not an acyclic carboxylic acid so we drop down to the next 3-dot, and it is a carboxylic acid having aromatic groups, so A61K31/192.  It doesn’t have two carboxyl groups nor does it have an amino group, so we stop at A61K31/192.

Still here?

I can’t imagine I’ve made your views on the IPC more positive so far, but this is where I make it easier.

The bottom line is:  Forget about all those dots (if you want).

The easiest way to find the right classification for your idea is to use the knowledge of someone who knows the IPC inside out.  Conducting a narrow keyword search for your idea should bring up earlier patent applications in the same technology area.  All of these earlier applications will have an IPC classification on their front page, and they are there because a patent examiner or searcher has determined they are relevant to each of those inventions.  The subgroups (e.g., A61K31/192) might be different but you will find that they all have the same group (e.g., A61K31), and it’s the group you’re after.

Now you can look up that IPC group online and see if you can further classify your idea.  Then, in AusPat for example, you can conduct a search for an IPC classification (or IPC Mark as it’s described there) by looking for A61K31/* as in our example.  The /* after the group is necessary for the search to capture all of A61K31 in this database.

Another method of finding the right IPC classification is to use a tool such as the IPC Search tool.  For this I’ll go back to the battery powered surfboard idea from my previous article on quick patent searches.

A search in the IPC Search tool for “surfboard” brings up two classes which are for two different subgroups in the group B63B32 (water sports boards).

Unfortunately for my example’s purposes, WIPO has just created a new class for surfboards or water sports boards in general.  In the 2019 edition surfboards were classified within a class for vessels adapted for special purposes, so until the relevant patent applications are reclassified we also have to search the subgroup B63B35/79.

Doing the same thing for “battery” gives 75 or so results, which should be expected for something that occurs in multiple applications including vehicles and circuits, and also has a military definition.  We need to check each classification until we find the one most appropriate for our needs.  In this case it is H01M.  We are at the subclass level now as the different groups cover various types of battery.

In the previous article we focussed solely on keywords to reduce the number of patent applications to consider in a search for a battery powered surfboard.  The keyword search gave us about 300 hits in the search results.

It would be possible to combine the classifications we have found in a search that looks for patent applications in both the surfboard and battery classes.  It’s not something I do a lot of, and is mainly for trying to pick out a combination of features that has been described in an unusual way or misclassified within the class of interest, such as describing a surfboard as a water sports board.

If we do that search we get about 30 hits in the search results.  It’s not too many, and useful to consider them even if they would also appear in the next couple of searches as well.

The following searches are essentially backups to the earlier keyword search, where we will swap one of the keywords (or set of keywords) for the equivalent IPC classification.  I previously identified the following variations on describing a surfboard:  a surfing board, a watercraft board, a water sports board, a surfing device, and a surf board.  There could be others, but chances are most of them have been classified in B63B32 or B63B35/79.

The search then is, (IPC = B63B32 OR B63B35/79) AND (keyword = battery OR batteries OR …).  You would also need to find a set of keywords that describe a battery.  Doing this search gives about 350 hits, which is consistent with the keyword only search.

Searching the other way round, i.e., (IPC = H01M) AND (keyword = surfboard OR surf board OR …) gives about 50 hits.

Putting all these four searches together gives about 400 hits because there is a lot of overlap between them, but you are getting more than a keyword search alone, so the IPC can be invaluable even at a very high level to provide additional patent applications you would otherwise have been unaware of.

So, take a deep breath and dive into the IPC as far down as you dare.  Even just having a paddle can make your searching much more effective.

Authored by Frazer McLennan and Charles Tansey, PhD

6 min read

I often hear that a patent search won’t take long, or it will be a small search, or get asked to do a quick search, and in some cases that’s probably right, but in other cases, by which I mean most, things are not always as small as they appear.  I’m going to risk expulsion from some secret society by pulling back the curtain and revealing some the black magic that occurs when someone asks for a patent search.

Why do people think a search will be small or not take long?

Perhaps they only know of three or four other companies that do what they do, or that the idea is a relatively simple concept, or that you only need to look for the doohickey part of the whole thingamajig, or that whenever they’ve done a search they only get a few results to look at, or maybe they just don’t understand the scale of what constitutes patent literature.

Two estimates, made in the last three or four years, of the total number of patent applications filed put the figure at about 90 million, and between 80 and 100 million.  If you want something a little more concrete, WIPO says that there are just over 56 million patent applications up to the end of 2018, which is close, but they’ve only been keeping count since 1985, so it’s definitely an underestimate given there are a couple of hundred years of applications they haven’t counted.  This number is set to rise, and rise exponentially.  To single out the highest filing country of recent times, China became the first country to file over one million patent applications in a calendar year, which happened in 2015, and just three years later they have increased that by half again.

The exact number, or even a credible estimate, doesn’t matter.  It’s a big number, and there’s no way any one of us can look through them all.  The thing is though, we have to, and when it comes to your idea, and I mean Your. Actual. Personal. Idea., at the point you say “Can you do a quick search on…”, every one of those 100 or so million patent applications is relevant, and they remain relevant until I can find a reason to exclude them.  What’s left after I find those reasons are your search results.  That’s going to be a relatively tiny number, and that’s what makes a patent search look small or quick.

So how can you exclude millions of potential search results?

The fastest way to get a more manageable set of results is to apply a patent classification code.  A patent classification code is assigned to a patent application when it is filed, and then further refined upon examination of that application.  You’re relying on people with experience in a subject matter field to say that this patent application belongs in this patent class, so when you apply that patent class in your search, your reason for excluding some of those 100 million patent applications is that other people­—experts—say they aren’t relevant.

If we take one patent classification code relating to pharmaceutical compositions containing a chemical compound as the active ingredient, and apply it at its broadest level, A61K31, to that 100 million, we already bring ourselves down to fewer than 3 million patent applications.  We’ve already excluded 97% by broadly applying a patent classification.

Patent classification systems are something for another day (but if you’re keen here’s the IPC and the CPC) so I won’t go too deep, but if you’re looking for something common such as esomeprazole (Nexium), the relevant classification is A61K31/4439, which brings us down to fewer than 70 thousand patent applications, so you have excluded over 99.9% of all patent applications.

Keywords can also be useful tools for excluding patent applications you don’t need to consider.  Some aren’t so useful, such as the brand name for midazolam, which is Versed.  Versed is also a word used in patent applications, commonly found at the end of a specification in a sentence that includes the words “… those versed in the art will appreciate …” that indicates subject matter experts will understand that some minor differences in the invention are obvious, but that doesn’t assist anyone in a search for midazolam by increasing the number of search results by tens of thousands.

Even if you have a keyword that will be useful and restrict your results to a manageable level, you still have to be aware of variations on that keyword.  The English language is very colourful and allows for a wide range of potential descriptions for a single object.

Consider a surfboard.  It’s a well known object and you would be hard pressed to find someone who described it otherwise when asked.  I’ve had a quick look and I can find reference to a surfing board, a watercraft board, a water sports board, a surfing device, and of course, a surf board (with the space between the words).  In terms of how much that restricts your search, ‘surfboard’ provides 15 thousand results while ‘surf board’ provides 80 thousand.

What’s even more useful than a single keyword is a combination of two or more.  We can take an object (the surfboard) and combine it with an essential feature (and apologies to anyone whose hopes and dreams I’m just about to destroy, a battery).  Combining these two sets of keywords so that we are locating them essentially within the same paragraph in a patent specification, i.e. (surfboard OR surf board) NEAR (battery) we can whittle down the 100 million patent applications to just 300 or so, which is eminently searchable.

The last method of reducing the number of search results you have to consider relates to the type of search you are undertaking.  It’s really a novelty search or a validity search that has to consider all 100 million patent applications as relevant at the start of a search.  An infringement search or freedom to operate search has features that automatically reduce the overall numbers to consider, and that’s before you start to think about patent classifications or keywords.  These searches are restricted to a single country, so with the pharmaceutical class A61K31 above, we have already reduced that number by 75%.  These searches are also restricted by filing date to patent applications that have a live status, which in most cases is within the last 20 years, or the last 25 years for pharmaceuticals.  To continue our pharmaceutical example we have removed a further 50%, and that’s before we even consider what the actual status is.  If you were to look through Australian patent applications in the broad pharmaceutical class A61K31 that have a live status, you would be looking at just over 20 thousand records, which is a lot less than the 3 million we found above.

With most of these examples the numbers of search results are still enormous and I’m not saying you would search them but it shows you how the application of a few parameters, alone or in combination, can substantially reduce them to a manageable level, and make that ‘quick’ search, well, quick.

Authored by Frazer McLennan and Charles Tansey, PhD

It’s that time of the year once more in Australia: National Ride2Work Day (Wednesday 16 October 2019).  In celebration of pedal power, here’s a tour of some weird and wacky cycling patents.

One wheeled vehicle (US patent 325,548)

This curious vehicle, where the rider sits inside the wheel, was patented by John Otto Lose in 1885.  I love the way the illustrator has gone to the trouble of including a little umbrella in case of rain (not an essential feature of the invention).

Aerial bicycle (US patent 563,793)

Another slightly bizarre contraption was invented by Hiram Nickerson and patented in 1896.  The crucial problem, which seems to render this invention almost completely impractical, is that without a network of elevated track, the aerial bicycle can’t go anywhere.

Rowing bicycle (US patent 642,544)

Like the idea of rowing and fresh air but scared of the water?  No problem!  Louis Burbank has the solution for you with this rowing bicycle, patented in 1900.  More recent iterations of such a machine are available for purchase in 2019, but I suspect it’s probably a niche market.

Double bicycle for looping the loop (US patent 790,063)

Next up, it’s Karl Lange’s patent, granted in 1905, for a “double bicycle for looping the loop for circus and other performances.”  I’m not sure I fancy my chances with this one.  Especially without a helmet.

Exercising device for water use (US patent 4,241,688)

More recently, Ralph and Kathryn Mansolill’s 1980 patent is for a device useful for exercising in a swimming pool or other body of water.  The general idea is not to achieve some sort of miraculous unicycling on water.  In essence, the device is buoyant so that it can support a person “in a substantially seated upright position in the body of water such that the neck, head and upper shoulders of the person remain out of the water, allowing the person to exercise the legs, arms and torso while neutrally buoyant.”

Mowing apparatus adapted to be towed by a pedal-operated vehicle and the like (US patent 5,410,864)

Can’t afford a motorised ride-on lawnmower?  In 1995, Thomas Lacy and Kenneth Shackles, Jr. patented this mowing apparatus adapted to mount to the frame of a vehicle such as a bike.  Especially handy if you have a long, thin lawn.

Apparatus for harnessing wind to drive a bicycle (US patent 6,932,368)

Granted in 2005, Vladimir Zam’s patent protects his sail attachment which, when connected to a bicycle, harnesses wind to drive the bicycle forward.  My assumption is that it’s not intended for use on crowded city streets and I guess it might take a bit of practice not to fall off and hurt yourself when the wind changes direction.  However, Google suggests that others have also proposed bicycles with similar attachments – so perhaps this idea may have wind in its sails yet.

Body-connected bike (US patent 6,805,657)

Do you live in a small apartment and don’t have space for a bicycle?  Just do away with the frame.  And the pedals.  Indeed, Justin Trenary’s 2004 patent does just that.  It’s an interesting concept, probably quite exciting for downhill riding, but I’m not tempted to replace my commuting bike with one of these any time soon.

Authored by Serena White, DPhil and Charles Tansey, PhD

First of all, what is a patent family?  Like a family made up of people, it’s a collection of things that are related in some way, where the things just happen to be patent documents.  Although all methods of constructing a patent family are artificial, some are more artificial than others, which, I guess, implies that some are almost natural.

There are really two main types of patent family:  simple and extended.  These two are the most logical, but there are a few that aren’t so logical, and really just exist so as to give a convenient name to a particular collection of patent documents.

The table below can be found in quite a few publications explaining how patent families are constructed.  I’ll add a bit of colour to it as we go to help explain the difference between the various types.

Patent families table 1

Simple

In a simple patent family all of the patent documents have exactly the same priority document (or documents), which means they all include basically the same inventive subject matter.

Essentially we’re looking at a nuclear family.  Mum and/or Dad are the priority documents, and their offspring are the patent documents.

Family 1 is a single parent family with one kid, while Family 2 is a two parent family with two kids, and so on.  Things are kept, well, simple and easy to understand.

Patent families table 2

While each patent document belongs to a single family, this table clearly shows that a priority document can belong to more than one family, so where I say above that a patent family covers an inventive subject matter, it’s not necessarily mutually exclusive with the subject matter of a second patent family.  For example, Family 4 has the elements of Priority P3, which must also form part of Family 3’s subject matter, but Family 3 also contains the elements of Priority P2, which is sufficient to differentiate it from Family 4 and to call it a separate patent family.

So, why don’t we define a patent family by a single priority document instead…

Complex

A complex patent family is generally defined as one where all patent documents are linked by at least one priority document.

The definition says ‘at least one’ but the table below doesn’t provide an example.  In the table above, Family 2 could also be considered to be a complex patent family as it has a pair of priority documents that are both shared by Patent documents 2 and 3.  It doesn’t include Patent documents 1 and 4 as they don’t share both priority documents.

Otherwise, this is a people family where the parents have separated.  You have Family 1 with Mum with three kids, and Family 2 with Dad, also with three kids, but where two of the kids are in common.  Depending on which family you are looking at, sometimes the kids in common are staying with Mum, and sometimes with Dad, and Dad’s just hanging out for that one weekend in a blue moon when he has no kids at home and he can go and play a round of golf.

Patent families table 3

I prefer the simple patent family approach to this one as, in complex families, a single patent document can belong to more than one family.  The simple family allows for the concept of patent equivalents.  As the priority document and subject matter are the same, you can say that Patent document 2 is an equivalent of Patent document 3.  You can look at the claims of one and be certain that they will be substantially the same as the other.  It’s handy when one of the patent documents is not in English as you can read an equivalent that is.  You can’t say the same about Patent documents 1 and 2 in complex Family 1.

So, what’s the solution…

Extended

In an extended patent family all patent documents have at least one priority document in common with at least one other family member.  An extended patent family is the marriage between a simple patent family and a complex patent family.

This can lead, in some instances, to extraordinarily large patent families where the family members are in a similar technical area, but with potentially a larger diversity because two family members with different priorities may cover different inventions.

Now you have Mum, your stepdad, Dad, Dad’s new girlfriend, half brothers and sisters, cousins, second cousins once removed, aunts, and mad Uncle Bob, all of whom may live in different cities or countries, perhaps never having had met except for that one time when your grandmother died, and you wouldn’t know them if you passed them in the street.

Patent families table 4

An extended patent family does provide the whole picture by putting everything you need to know in one place.  From there you can tease out a number of simple patent families (or complex ones if that’s your thing), or report the family as a whole.  It really depends on the question you are looking to answer.

Technical

This is perhaps the most artificial of all the patent families.  It draws together patent documents that are not related by a common priority, but is determined intellectually, i.e. by sitting down and using your necktop computer.  Patent documents in technical families will sometimes have priority documents in common, but others will have same inventor(s), and the same or similar title, subject matter and drawings, and so should be included for a sense of completeness.

Patent documents can become separated from what would have been their simple patent family as a result of missing a convention filing or divisional applications not being connected properly with their parent application.

This has to be Kevin from Home Alone.  Mom and Dad (Inventors 1 & 2) have applied for “Christmas Vacation” in the United States but have forgotten one of their patent documents when it came to flying out to the “Paris Convention”.

Patent families table 5

National

A national patent family consists of any patent applications from a single country having at least one priority in common, so for example, in addition to the original application, patents of addition, divisional children, and continuations.

Domestic

A domestic patent family relates to subsequent publications of same application, i.e. with same number but with different kind codes. For example the published application (A1) and the granted patent (B1).

Where can you find patent family data?

In an automated world, patent family information has to be constructed from priority data, which is why the technical family above has to be constructed manually.  It also goes some way to explaining why some members can get separated from their patent family as priority data isn’t particularly standardised.  Even if you apply a reasonable standard, a missing or extra zero somewhere can throw the system out, but that’s up to people like me to notice and correct.

The best free aggregating sources are the European Patent Office’s INPADOC database available via Espacenet, and to a large degree, WIPO’s PatentScope.  Google Patents should also provide a reasonable patent family.

There are other free patent information databases, like Depatis and the USPTO, among many others, that you can use to construct your own patent family if you are so inclined, but that level of enthusiasm is best reserved for looking for any outliers in countries not usually covered by the aggregating sources.

The other sources are commercial patent databases such as PatBase or Derwent Innovation, among a few others, but of course you will need to pay for the privilege.  Commercial patent database providers define patent families for their own purposes, whether it’s to differentiate themselves from their competitors, or it’s just easier to do from a technical viewpoint, but they are always mixtures of the types described above, and sometimes you have the option of choosing your family, unlike the real world.

Authored by Frazer McLennan and Charles Tansey, PhD