MVS Filewrapper® Blog: Federal Circuit Schedules Oral Hearing in First Appeal of Inter Partes Review

Post by Jonathan Kennedy

The Federal Circuit has scheduled oral arguments for the first appeal of an inter partes review ("IPR") decision by the Patent Trial and Appeal Board ("PTAB").  Oral arguments have been scheduled for November 3, 2014.  The appeal involves a number of interesting issues.  First, it arises from the first IPR filed with the PTAB—Garmin USA, Inc. v. Cuozzo Speed Technologies, LLC (IPR2012-00001).  In that IPR, the PTAB invalidated three claims (claims 10, 14, and 17) of U.S. Patent No. 6,778,074.  Second, pursuant to a settlement agreement, Garmin agreed not to take part in any appeal.  Instead, once Cuozzo appealed the PTAB's decision, the Patent Office intervened under 35 USC § 143 to oppose Cuozzo's appeal, effectively taking Garmin's place. 

 

Cuozzo appealed four issues from the PTAB decision, relating both to procedural and substantive matters:  (1) "Whether the PTAB lacked authority to institute IPR for claims 10 and 14 on grounds of unpatentability not identified in the Petition"; (2) "Whether the B[roadest] R[easonable] I[nterpretation] standard applies to IPR, and whether the PTAB erred by construing the term 'integrally attached'"; (3) "Whether, if the PTAB had jurisdiction over claim 10, it erred in cancelling claim 10 as invalid under 35 U.S.C. § 103"; and (4) "Whether the PTAB erred in denying Cuozzo's motion to amend the claims." 

 

The petition for IPR originally filed by Garmin alleged forty-three different grounds of invalidity based on a number of patents.  The PTAB rejected forty-one of those grounds and chose to institute the IPR based on two grounds of invalidity alleged by Garmin against dependent claim 17.  However, when instituting the IPR the PTAB applied those same two grounds of invalidity against claims 10 and 14, even though Garmin had not asserted those grounds against claims 10 or 14.  In its final decision, the PTAB cancelled claims 10, 14, and 17 based on the two grounds Garmin had raised against claim 17.  Whether the PTAB can expand the scope of its review by applying grounds of invalidity against claims in a manner not raised by the Petitioner is a significant question and clarity from the Federal Circuit is greatly anticipated. 

 

Garmin's petition did not set forth any proposed claim constructions.  Despite this, in instituting the IPR—without any input from either party—the PTAB chose to construe the claim term "integrally attached" based on the broadest reasonable interpretation standard.  In its brief, Cuozzo argues this standard is improper for PTAB and only appropriate during examination and reexamination.  Instead, Cuozzo argues that the PTAB should be held to the standards set forth in the Federal Circuit's Phillips' decision.  The PTAB's construction of the term was pivotal in the other decisions in the IPR.  For example, the PTAB denied Cuozzo's motion to amend claims during the IPR under 35 USC § 316(d) based on the construction of the term "integrally attached."  Clarification regarding the claim construction standard that applies to the PTAB will be critical moving forward.

MVS Filewrapper® Blog: USPTO Issues Report on Virtual Patent Marking Under the AIA

Among the provisions of the America Invents Act that went into effect on September 16, 2011 was a change to the patent marking provisions contained in 35 U.S.C. § 287(a).  Marking an article as with a patent number provides constructive notice to the public that the article is patented, and failure to appropriately mark an article can preclude the recovery of damages for infringement until effective notice is given. The revised marking statute allows patent owners to identify their products with the web address containing the patent information, limits false marking lawsuits to those filed by the U.S. government or by a competitor who can prove competitive injury, and does away with provisions making it a violation to mark a product with a patent that covered the product, but has since expired.

 

The USPTO has issued a Report on Virtual Marking that provides analysis of the effectiveness of virtual marking under the AIA; whether virtual marking has limited or improved the ability of the general public to access information about patents; legal issues, if any, that arise from virtual marking; and any deficiencies arising from virtual marking.  The report is based on comments solicited by the USPTO, along with independent research. 

 

The conclusion the USPTO Report is that virtual marking has likely met its intended objectives of reducing manufacturing costs and facilitating public notice.  The Report identifies several benefits demonstrated by the analysis, in particular the ability of patent owners to dynamically update patent information, to provide a real-time, complete list of associated patents, and to include additional patent-related information, which all may help increase transparency by improving the public’s ability to access a wider scope of information about relevant patents.  The Report also notes that there is little applicable case law on the subject, due to the recency of the new marking provisions, and that virtual marking may have deficiencies that are not yet totally apparent, and as a result the issues may need to be revisited at a later date. 

 

The full report is available here.

MVS Filewrapper® Blog: Legitimate Advocacy and Genuine Misrepresentation of Material Facts

The Federal Circuit has issued a decision in Apotex Inc. v. UCB, Inc., upholding a district court's finding that Apotex's U.S. Patent No. 6,767,556 ("the '556 patent") is unenforceable due to inequitable conduct. 

 

Dr. Sherman, founder and chairman of Apotex, wrote the '556 patent application and is its sole inventor.  The '556 is based on Canadian application filed on April 5, 2000.  The ’556 patent is generally directed to a process for manufacturing tablets of moexipril tablets—an angiotensin-converting enzyme (“ACE”) inhibitor used to treat hypertension. The ’556 patent discloses a process of making moexipril tablets consisting mostly of moexipril magnesium obtained by reacting moexipril or its acid addition salts with an alkaline magnesium compound to improve stability and prevent degradation of the normally instable moexipril hydrochloride.

 

Two existing drugs— Univasc and Uniretic—were both cited as prior art in the prosecution of the '556 patent, and were also asserted to infringe the '556 patent after issuance.  During prosecution, Dr. Sherman, through his patent attorney, asserted that the prior drugs did not render the invention of the '556 patent obvious because the process for making them simply combined components, rather than reacting them.  However, evidence presented at trial indicated that Dr. Sherman suspected that the existing drugs were made by the process recited in his application at the time the application was filed, and later conducted experiments to confirm that the components in those existing drugs were reacted, rather than simply combined as he represented to the PTO.  The court also found that Dr. Sherman has misled or failed to inform a declarant, Dr. Lipp, regarding the true nature of the existing drugs in relation to the claimed invention, resulting in a declaration by Dr. Lipp that perpetuated Dr. Sherman's mischaracterizations of those existing drugs.  In addition, the court determined that Dr. Sherman withheld relevant prior art from the PTO.  The district court held the combined misrepresentations and withholdings were material to the prosecution of the '556 patent, and that Dr. Sherman intended to deceive the PTO based on his overall pattern of misconduct, and therefore the '556 patent was unenforceable due to inequitable misconduct. 

 

On appeal, Dr. Sherman argued that the conduct before the PTO was merely advocating a particular interpretation of the prior art.  However, the Federal Circuit determined that his statements were not mere advocacy for a preferred interpretation; his statements were factual in nature and contrary to the true information he had in his possession.  The court clarified that there is no duty to disclose suspicions or beliefs regarding the prior art, and that there is nothing wrong with advocating, in good faith, a reasonable interpretation of the teachings of the prior art.  However, affirmatively and knowingly misrepresenting material facts regarding the prior art goes beyond failing to disclose a personal belief or alternative interpretations of the prior art, and enters the realm of inequitable conduct, which may result in an unenforceable patent.

 

The full opinion is available here.  

 

MVS Filewrapper® Blog: Critical Versus Optional, but Desireable Claim Elements

On August 6, 2014, the Federal Circuit Court of Appeals issued its opinion in ScriptPro, LLC v. Innovation Associates, Inc. In 2006, the Petitioner ScriptPro, LLC sued Innovation Associates, Inc. for infringement of claims 1, 2, 4, and 8 of U.S. Patent No. 6,910,601 ("the '601 patent").  The '601 patent describes a "collating unit" that uses sensors to automatically dispense and organize prescriptions according to individual patients.  Shortly after the lawsuit was filed, Innovation Associates filed an Inter Partes Reexamination with the USPTO, and the district court stayed the proceedings pending the result of the re-exam.  In January of 2011, the USPTO concluded its reexamination of the claims of the '601 patent, confirming claims 1, 2, 4, and 8. 

 

The district court resumed proceedings and Innovation Associates moved for summary judgment, arguing that the claims were invalid under section 112 on the grounds that the patent's specification did not describe the subject matter of the asserted claims.  The claims at issue did not require the use of sensors.  However, the district court agreed with Innovation Associates that the specification of the '601 patent implied that the use of "sensors" is critical to the functionality of the machine. Specifically, the court held, "no reasonable jury could find that the inventors were in possession of a collating unit that operated without sensors." Accordingly, the district court granted Innovation Associate's motion for summary judgment of invalidity for failure to satisfy the written description requirements of § 112. 

 

On appeal, the Federal Circuit reviewed de novo the language of the specification and—after pointing to several places in the specification suggesting the sensor may or may not be used—found that the wording of the specifications made the sensors an "optional, though desirable," feature of the invention.  The Court also pointed to the original claims as filed and noted "[w]hen a specification is ambiguous about which of several features are stand-alone inventions, the original claims can help resolve the ambiguity, though even original claims may be insufficient as descriptions or be insufficiently supported by the rest of the specification."  The Federal Circuit reversed the grant of summary judgment holding that, ScriptPro could establish that a person of skill in the art would be able to tell from description of the specification that "the inventor[s] actually invented the invention claimed."  The Court concluded that, although the machine would be more efficient with the sensors, it could be fully functional without them and, therefore, the written description was sufficient.

MVS Filewrapper® Blog: USPTO Issues Preliminary Guidance on Patentability Based on Alice Corp.

On June 25, 2014 the USPTO Deputy Commissioner for Patent Examination Policy released a Memorandum to the Patent Examining Corps that provides examiners with preliminary instructions related to subject matter eligibility of claims involving abstract ideas under 35 U.S.C. § 101 in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International.  The memo provides the following guidance with respect to the application of the Mayo framework to the examination of claims involving abstract ideas in light of the Alice decision:

 

(1)  Alice Corp. establishes that the same analysis should be used for all types of judicial exceptions, whereas prior USPTO guidance applied a different analysis to claims with abstract ideas (Bilski guidance in MPEP 2106(II)(B)) than to claims with laws of nature (Mayo guidance in MPEP 2106.01).

 

(2)  Alice Corp. also establishes that the same analysis should be used for all categories of claims (e.g., product and process claims), whereas prior guidance applied a different analysis to product claims involving abstract ideas (relying on tangibility in MPEP 2106(II)(A)) than to process claims (Bilski guidance).

 

The memo then explains that, despite these changes, the basic inquiries and examination procedures as to subject matter eligibility remain the same after the Alice decision. 

 

The instructions also set out a "Two-Part Analysis for Abstract Ideas."  First, the examiner is to determine whether the claim is directed to an abstract idea such as "fundamental economic practices," "certain methods of organizing human activities," "an idea of itself," or "mathematical relationships/formulas."   If the examiner concludes that the claim is directed to an abstract idea, the examiner must then determine "whether any element, or combination of elements, in the claim is sufficient to ensure that the claim amounts to significantly more than the abstract idea itself."  The instructions provide examples of what would qualify and what would not qualify as "significantly more" as referenced in the Alice decision: 

 

Would qualify: Improvement to technology or technical field, improvements to functioning of computer itself, and "meaningful limitations."

 

Would not qualify:  Adding the words "apply it," and requiring no more than a generic computer to perform generic computer functions.

 

The instructions direct examiners to reject claims under 35 U.S.C. § 101 as being directed to non-statutory subject matter if they do not amount to "significantly more" than the abstract idea. 

 

These examination instructions are only initial guidelines, and will be updated and modified as needed after additional consideration of the decision and public feedback.  Accordingly, the USPTO has issued a Request for Comments and Extension of Comment Period on Examination Instruction and Guidance Pertaining to Patent-Eligible Subject Matter that is open through July 31, 2014. 

MVS Filewrapper® Blog: USPTO Glossary Pilot Program

The USPTO has instituted a new program, the Glossary Pilot Program, which began June 2, 2014. The program will allow applicants for computer-related inventions to petition to make special entry into the Glossary Pilot Program with the filing of an application. Applications accepted into this pilot program will receive expedited processing and be placed on an examiner’s special docket prior to the first office action, with special status up to the issuance of the first Office action.

This program is set to run for six (6) moths through December 31, 2014, but may be cut off once the USPTO accepts 200 grantable petitions.  The program is intended to encourage the use of a glossary that provides clear definitions for some terms used in the claims in order to help the reader understand the disclosed invention with a higher level of clarity.

In order to qualify for the Glossary Pilot Program, all of the conditions set forth in the Federal Register Notice, must be met. Specifically:

(1)   The application must be an original, non-reissue, non-provisional utility application that does not claim benefit of a prior filed non-provisional U.S. application, unless the application is a continuation-in-part application filed for the purposes of providing a glossary.

(2)   The application and petition must use Form PTO/SB/436 and must be filed after June 2, 2014 and before the pilot deadline expires.

(3)   The claimed invention must be classified in one of the Art Areas related to computer-related and business method inventions, including those involving Computer Architecture Software and Information Security (Technology Center 2100); Computer Networks, Multiplex, Cable and Cryptography/Security (Technology Center 2400); Communications (Technology Center 2600); and Transportation, Electronic Commerce, Construction, Agriculture, Licensing and Review (Technology Center 3600).  The complete list of qualifying Art Areas is available here.

(4)   The glossary must be placed at the beginning of the detailed description portion of the original specification of the application, identified with a heading, and presented on filing of the application. Definitions for key terminology found in the claims, terms with special definitions, abbreviations, relative terms, terms of degree and functional terminology should be provided, but cannot rely on other parts of the application for completeness, cannot consist of what the term does not mean, cannot be open-ended, cannot consist solely of examples and synonyms, and cannot be disavowed elsewhere in the specifications.

(5)   Filing must be done via EFS-Web.

(6)   The application must contain at least one claim, but no more than four independent claims, and no more than 30 claims total.

 

Status of the petition will be available via Private PAIR. If a dismissal decision is received, the applicant can file a petition if it is believed that the dismissal is not proper. Also, any preliminary amendment filed after the application has entered the pilot program but before the issuance of the first Office Action will be entered unless the amendment causes the application to be non-compliant with the requirements of the program. More information can be found at the USPTO's website.

MVS Filewrapper® Blog: Federal Circuit Finds Clones Unpatentable

The Federal Circuit issued its opinion in In re Roslin Institute, a case involving cloned animals.  The Roslin Institute (Roslin) owns a patent for methods of cloning animals, based on the work that created Dolly the Sheep.  The inventors of that patent also assigned to Roslin an application claiming protection for the clones themselves.  During prosecution, the USPTO deemed the claims to the clones contained in that application to be directed to non-statutory subject matter under 35 U.S.C. § 101 because the clones constituted a natural phenomenon that did not possess markedly different characteristics than any found in nature.  The USPTO decision was appealed to the Patent Trial and Appeal Board, which upheld the rejection. 

 

On appeal to the Federal Circuit, the appellate court affirmed the PTAB decision, concluding that genetic identity of a clone to a progenitor/donor animal precludes it from patent protection, despite the fact that such a clone itself does not exist in nature.  The court held that "clones are exact genetic copies of patent ineligible subject matter, [and as a result] they are not eligible for patent protection."

 

Interestingly, the court dismissed Roslin's arguments that environmental factors lead to phenotypic differences between its clones and their donor mammals that render their claimed subject matter patentable, stating that any such differences were not claimed.  In contrast, the court focused on the genetic aspect of the clones—which although similarly unclaimed—the court determined was implicit in the use of the term "clones".  The court further discounted any phenotypic differences as being the result of "environmental factors" uninfluenced by Roslin's efforts. 

 

The court ultimately qualified it's holding, stating that "having the same nuclear DNA as the donor . . . may not necessarily result in patent ineligibility in every case," but that in this case "the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies."

 

The full opinion is available here

MVS Filewrapper® Blog: "Insolubly Ambiguous" Standard not Applicable at the USPTO

In In re Packard the Federal Circuit held that the USPTO need not follow the insolubly ambiguous standard in order to satisfy a prima facie rejection for indefiniteness.  Rather, the Federal Circuit held that

when the USPTO has initially issued a well-grounded rejection that identifies ways in which language in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention, and thereafter the applicant fails to provide a satisfactory response, the USPTO can properly reject the claims claim as [indefinite]. 

(emphasis added).  The Federal Circuit tempered this holding by citing to Georgia-Pacific Corp. v. U.S. Plywood Corp., 258 F.2d 124, 136 (2d Cir. 1958), stating,

At the same time, this requirement is not a demand for unreasonable precision.  The requirement, applied to the real world of modern technology, does not contemplate in every case a verbal precision of the kind found in mathematics. . . .  Rather, how much clarity is required necessarily invokes some standard of reasonable precision in the use of language in the context of the circumstances.

 The patent application on appeal (Serial No. 12/004,324) was directed to a coin change holder shown in Figures 1 and 2 above.  Claims 28 through 37 were on appeal—claims 1 through 27 were cancelled during prosecution.  Claim 28 is representative of the issue on appeal:

28.       I claim a small, thin, flat plane, rectangular change holding card and wallet/billfold or purse construction with the front top side of the card comprising three raised, straight, parallel, double flanged separators and two raised, straight, parallel, double flanged side edges and a raised side edge end thereby forming four parallel, side by side, flanged coin holding channels or rows of the same length and of different widths, one for quarters, one for dimes, one for nickels, and one for pennies, that are similarly blocked at one side edge by the raised side end edge with the other side of the channel/rows open except for small, fixed, flexible, partially moveable, rubber or plastic retainers that are attached to the topside and ends of the double flanged separators such that coins can be retained on the card and yet slide freely above the surface of the card and obliquely overlap as necessary within the channel/rows between the separators while the bottom, back side of the card is constructed with a wallet, billfold or purse extending from it.

The Examiner rejected the claim as indefinite for lack of written description and as obvious.  The Examiner asserted that multiple limitations were indefinite for lacking antecedent basis or "were otherwise unclear."  Mr. Packard appealed to the Patent Trial and Appeal Board (PTAB).  The PTAB affirmed the rejection citing MPEP § 2173.05(e) which states, "[a] claim is indefinite when it contains words or phrases whose meaning is unclear."  Mr. Packard appealed the PTAB's decision to the Federal Circuit.  On appeal, Mr. Packard argued that the test applied by the PTAB, as set forth in the MPEP, fails to meet the insolubly ambiguous standard articulated by the Federal Circuit. 

The Federal Circuit noted that no case had previously addressed the question presented by this case—"what standard for indefiniteness should the U.S. Patent and Trademark Office apply to pre-issuance claims." The Federal Circuit made clear that a different standard applies to pre-issuance claims (i.e. patent applications under prosecution) that to post-issuance claims (i.e. when an issued patent is being challenged).  Further, the Federal Circuit noted a basis for its decision is that "Congress assigned to the USPTO the responsibility to examine applications to ensure compliance with the statutory criteria for issuance of a patent."  Thus, "indefiniteness rejections by the USPTO arise in a different posture from that of indefiniteness challenges to an issued patent."  

MVS Filewrapper® Blog: USPTO Issues New Examination Guidelines for Patent Subject Matter Eligibility

The basic requirements for filing a U.S. utility patent are rather straightforward. Patents are granted for new, useful and non-obvious processes, products or compositions of matter. Similarly, any new, useful and non-obvious improvement to these categories of inventions may be granted a patent. Although seemingly straightforward, the three basic requirements for patentability are impacted by an evolving legal landscape which is largely dictated by court-created case law. 

 

For much of the last thirty years, the case law addressing patent eligibility has had some consistency.  However, a series of court decisions in recent years has changed the understanding of what is considered patent-eligible.  As a result, the USPTO released guidelines last month providing an analytical framework to evaluate whether a patent claim meets these patent subject matter eligibility requirements (as set forth in 35 USC § 101). These guidelines titled "Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products" are particularly relevant for those dealing with patent applications (and portfolios) in the fields of biotechnology, chemistry and/or life sciences. Although subject matter eligibility is applicable for all fields of patenting, the guidelines were provided to patent examiners to specifically address examination of claims “reciting or involving laws of nature/natural principles, natural phenomena, and/or natural products” (i.e. applying the legal principles set forth in the Myriad and Prometheus decisions, see earlier FileWrapper postings for further detail).

 

A few key points to consider in light of the USPTO guidelines (available at http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf) include the following:

 

1.      The guidelines apply to all claims (excluding "abstract ideas")

Any claims that “recite or involve laws of nature/natural principles, natural phenomena, and/or natural products” are to be examined using the new guidelines. The only exclusion is a claim which is alleged to recite an “abstract idea,” which will not be examined using the new guidelines.

 

2.      Natural products are very broadly defined

The guidelines define natural products broadly, including “substances found in or derived from nature.” The take-home for patent Examiners is that claimed subject matter for a product must be non-naturally occurring to be subject matter eligible. In addition, to meet requirements of non-obviousness, the non-naturally occurring product must be “markedly different in structure from naturally occurring products.”

 

3.      There is a 3-part eligibility test to be applied by Examiners

The guidelines provide Examiners with a decision tree for determining patent subject matter eligibility (reproduced at the beginning of this post).  The first question asked by an examiner when evaluating a patent claim will be whether the claimed invention is directed to a statutory patent-eligible subject matter category (process, machine, manufacture, or composition of matter).

If the first threshold is met, the examiner will next question whether the claim recites or involves a judicial exception, which therefore precludes patentability. Examples of these exceptions include abstract ideas, laws of nature (i.e. natural principles), natural phenomena, and natural products.

Finally, the third question to be assessed by an examiner under the guidelines is whether the claim as a whole recites something "significantly different" than the mentioned judicial exception. The guidelines provide more extensive analysis of what constitutes a "significant" difference. Generally, there must be a showing that the product claimed has a marked difference from what exists in nature, or also recites a meaningful limitation to add something of significance to the patent claim.



We note that the guidelines were created by the USPTO for the USPTO examiners. Therefore, they are an interpretation of case law relating to subject matter eligibility. They are not binding law, and they are subject to change and/or judicial challenge. However, they can be helpful in navigating the area between patentable and unpatentable subject matter. 

 

MVS Filewrapper® Blog: Federal Circuit Clarifies Patent Term Adjustment

The U.S. Court of Appeals for the Federal Circuit has issued an opinion that provides guidance for how Patent Term Adjustments should be calculated.

Between June 2009 and May 2011, Novartis filed four civil lawsuits against the Director of the United States Patent and Trademark Office (PTO) in the United States District Court for the District of Columbia claiming that, for twenty-three of its issued patents, the Director had improperly determined the amount of patent term adjustment (PTA).  On February 16, 2012, the district court consolidated the cases.    

Novartis claimed that the Director’s determinations of the patent term adjustment were erroneous because they were based on two mistaken interpretations of the PTA statute as it applies to an applicant’s request for continued examination (RCE).   The District Court held that for the patents where review of PTA was applicable, the Director’s determinations were incorrect, and granted Novartis the additional patent term.  On appeal, the Federal Circuit court affirmed-in-part and reversed-in-part the District Court’s ruling, concluding that Novartis was entitled to most—but not all—of the additional patent term adjustment it sought.   

The portion of the PTA statute relevant to this case is set out in in 35 U.S.C. § 154(b).  This provision states:

 

if the issue of an original patent is delayed due to the failure of the United States Patent and Trademark Office to issue a patent within 3 years after the actual filing date of the application under section 111(a) in the United States or, in the case of an international application, the date of commencement of the national stage under section 371 in the international application, not including—

(i)      any time consumed by continued examination of the application requested by the applicant under section 132(b);

(ii)     any time consumed by a proceeding  under section 135(a), any time consumed by the imposition of an order under section 181, or any time consumed by appellate review by the Patent Trial and Appeal Board or by a Federal court; or

(iii)    any delay in the processing of the application by the United States Patent and Trademark Office requested by the applicant except as permitted by paragraph (3)(C), the term of the patent shall be extended 1 day for each day after the end of that 3-year period until the patent is issued.

Novartis asserted that the PTA it was granted on its patents was incorrect because the Director erroneously interpreted this provision to provide that (1) time spent in any continuing examination, no matter when initiated by the applicant, does not count towards tolling the statute’s three year allotment, and (2) both the time from initiation of continued examination to allowance and the time from allowance to issuance do not count toward tolling the three year allotment.  The Federal Circuit agreed with the PTO on the first issue and Novartis on the second.    

In finding that the Director's first interpretation of § 154(b) is correct, the court held that the best reading of the statute is that "the [PTA] time should be calculated by determining the length of the time between application and patent issuance, then subtracting any continued examination time and determining the extent to which the result exceeds three years."   The court concluded that this interpretation is fairest to the applicant while also conforming to the statute's purpose.

In ruling for Novartis on the second issue, the court determined that there is no basis in the statute for distinguishing a continued-examination case from a case not involving a continued examination.  As a result the court held that any time between allowance and issuance should count toward the PTO’s three year allotment, regardless of whether there has been any continued examination.  

The full opinion is available here.

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