IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC., WATSON LABORATORIES, INC., DR. REDDY’S LABORATORIES,
`INC., DR. REDDY’S LABORATORIES, LTD., and SUN
`PHARMACEUTICALS INDUSTRIES LTD.1
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`_________________________
`Case IPR2020-00040
`U.S. Patent 7,326,708 B2
`___________________________
`
`PETITIONERS’ OPPOSITION TO PATENT OWNER’S MOTION TO
`FILE REQUEST FOR CERTIFICATE OF CORRECTION OF CLAIMS 5–7
`
`1 Teva Pharmaceuticals USA, Inc. and Watson Laboratories, Inc. were joined as a
`party to this proceeding via Motion for Joinder in IPR2020-01045; Dr. Reddy’s
`Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. were joined as a party to this
`proceeding via a Motion for Joinder in IPR2020-01060; and Sun Pharmaceuticals
`Industries Ltd. was joined as a party to this proceeding via Motion for Joinder in
`IPR2020-01072.
`
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`TABLE OF CONTENTS
`
`Page
`ARGUMENT ............................................................................................................. 1
`1.
`No Mistake of a Clerical or Typographical Nature ............................... 2
`2.
`Merck Cites No Authority where the PTO has Before Allowed
`What Merck Seeks................................................................................. 3
`No Mistake “of Minor Character” ......................................................... 4
`The Proposed Corrections Constitute New Matter or Would
`Require Reexamination ......................................................................... 5
`Evidence of Inattention and Lack of Diligence Does Not Show
`“Good Faith” ......................................................................................... 7
`Patent Owner Should Be Ordered to Provide This Opposition to
`the Director When Filing any Correction Request ..............................10
`CONCLUSION ........................................................................................................10
`
`3.
`4.
`
`5.
`
`6.
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Arthrocare Corp. v. Smith & Nephew, Inc.,
`406 F.3d 1365 (Fed. Cir. 2005) ............................................................................ 7
`ASM IP Holding BV v. Kokusai Electric Corp.,
`IPR2019-00378, Paper 17 (PTAB July 5, 2019) ............................................ 1, 10
`Central Admixture Pharmacy v. Advanced Cardiac,
`482 F.3d 1347 (Fed. Cir. 2007) ............................................................................ 2
`Fina Technology, Inc. v. Ewen,
`
`265 F. 3d 1325 (Fed. Cir. 2001) ...................................................................... 6, 7
`Honeywell Int’l, Inc. v. Arkema Inc.,
`939 F.3d 1345 (Fed. Cir. 2019) ........................................................................ 1, 4
`In re Arnott,
`19 U.S.P.Q.2d 1049, 1991 WL 326548 ........................................................ 3, 4, 5
`In re U.S. Patent No. 7,168,818 ............................................................................. 5, 7
`In re U.S. Patent No. 7,475,261 ................................................................................. 4
`In re U.S. Patent 6,660,701 .................................................................................... 7, 9
`Intuitive Surgical, Inc. v. Ethicon LLC,
`IPR2020-00050, Paper 13 (PTAB Feb. 26, 2020) .......................................... 1, 10
`Nautilus Inc. v. Biosig Instruments, Inc.,
`134 S. Ct. 2120 (2014) .......................................................................................... 5
`Southwest Software, Inc. v. Harlequin Inc.,
`226 F.3d 1280 (Fed. Cir. 2000) ............................................................................ 8
`Superior Fireplace Co. v. Majestic Products Co.,
`270 F. 3d 1358 (Fed. Cir. 2001) ............................................................... 2, 3, 7, 8
`
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`Statutes
`35 U.S.C. § 251 .......................................................................................................... 6
`35 U.S.C. § 255 ...................................................................................................... 2, 6
`Regulations
`37 C.F.R. § 42.6(e) ................................................................................................... 12
`37 C.F.R. § 42.24(d) ................................................................................................ 12
`Other Authorities
`MPEP §1481 .............................................................................................................. 5
`MPEP §1490 .............................................................................................................. 4
`
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`The District Court found Claims 5–7 indefinite. EX2282, 7. Rather than seek
`
`Reissue, Merck attempts to evade substantive review of its so-called ‘corrections’ to
`
`Claims 5-7 of the ’708 patent by using the Certificate of Correction procedure.
`
`While Claims 5-7 are not at issue in this IPR, the Panel must decide whether Patent
`
`Owner “has demonstrated a sufficient basis that the mistake may be correctable.”
`
`Honeywell Int’l, Inc. v. Arkema Inc., 939 F.3d 1345, 1349 (Fed. Cir. 2019). A
`
`“sufficient basis” exists if there is at least a “legitimate question as to whether the
`
`issuance of a Certificate of Correction is an appropriate course of action.” Intuitive
`
`Surgical, Inc. v. Ethicon LLC, IPR2020-00050, Paper 13, at 4–5 (PTAB Feb. 26,
`
`2020). There is none here.
`
`That said, should the Board cede its exclusive jurisdiction over the ’708 patent
`
`as it relates to this single issue—which it should not—Petitioner requests that the
`
`Board instruct Merck to include this Opposition with any request for correction to
`
`the Director. Intuitive Surgical, IPR2020-00050 at 5; ASM IP Holding BV v.
`
`Kokusai Electric Corp., IPR2019-00378, Paper 17 at 5–6 (PTAB July 5, 2019).
`
`ARGUMENT
`
`Claims 5–7 of the ’708 patent currently recite “absorption bands obtained
`
`from the X-ray powder diffraction pattern at spectral” d-spacings of particular
`
`angstroms. EX1001 (“the ’708 Patent”). The District Court found “absorption
`
`bands” to be indefinite. EX2282, 7. The District Court was correct. Attempting to
`
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`rescue its claims, Merck now contends Claims 5-7 should have always referred to
`
`“diffraction peaks” rather than “absorption bands.” Request, 1. But this is not a
`
`“mistake of a clerical or typographical nature, or of minor character” that can be
`
`remedied via a Certificate of Correction. 35 U.S.C. § 255. Diffraction peaks are
`
`different from absorption bands. Merck knows this. EX2281, ¶6. And, the law is
`
`clear: a Certificate of Correction may not “involve[] changes in the patent as would
`
`constitute new matter or would require reexamination.” Id. Merck’s request should
`
`be denied.
`
`1. No Mistake of a Clerical or Typographical Nature
`
`Merck must establish that the alleged mistake is correctable through the
`
`Certificate of Correction procedure. It has not done so. As noted, changing
`
`“diffraction peaks” to “absorption bands” is not a “mistake of a clerical or
`
`typographical nature.” “[C]lerical or typographical mistakes are generally
`
`understood to include simple mistakes such as obvious misspellings that are
`
`immediately apparent. Upon viewing such a misspelling, there is no doubt that a
`
`mistake, indeed a clerical or typographical mistake, has occurred.”
`
`Superior
`
`Fireplace Co. v. Majestic Products Co., 270 F. 3d 1358, 1370 (Fed. Cir. 2001);
`
`Central Admixture Pharmacy v. Advanced Cardiac, 482 F.3d 1347, 1350 (Fed. Cir.
`
`2007) (noting the change from “osmolarity” with “osmolality”); In re Arnott, 19
`
`U.S.P.Q.2d 1049; 1991 WL 326548, *6 (Com’r Pat. & Trademarks 1991).
`
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`Merck’s proposed corrections are a wholesale rewrite of the claim; the current
`
`language of Claims 5-7 “is itself syntactically correct and on its face raises no
`
`question of a mistake.” Superior Fireplace, 270 F. 3d at 1375. Merck’s own
`
`evidence indicates that its proposed corrections are not a clerical or typographical
`
`mistake. With its Request, Merck submitted the Third Declaration of Inventor (Dr.)
`
`Wenslow, in addition to other parol evidence. EX2281; see also EX2278-2280. But
`
`“[r]eference to ‘parol’ evidence beyond the patent file should not be necessary to
`
`establish the existence of a clerical or typographical mistake.” In re Arnott, 1991
`
`WL 326548, *6. The inquiry ends there.
`
`2. Merck Cites No Authority where the PTO has Before Allowed
`What Merck Seeks
`
`Merck fails to cite a single instance where the PTO has allowed a patentee to
`
`correct a claim that a District Court had found indefinite through the Certificate of
`
`Correction procedure. While Merck refers to dicta in Novo Indus., LP v. Micro
`
`Molds Corp.—which makes a passing reference to indefiniteness—Novo Indus.
`
`never held that Certificate of Correction is the proper mechanism to correct a claim
`
`rendered indefinite. 350 F.3d 1348, 1356 (Fed. Cir. 2003).2
`
`2 Although the Federal Circuit in Honeywell noted the PTO’s longstanding practice
`
`of using Certificates of Corrections to correct priority issues, Honeywell, 939 F.3d
`
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`The propriety of using the Certificate of Correction procedure to correct
`
`indefiniteness is part of the showing Merck must make for its request. Honeywell,
`
`939 F.3d at 1350. As the Office of Petitions has noted, the MPEP will guide it in
`
`determining the propriety of using the Certificate of Correction procedure. In re
`
`U.S. Patent No. 7,475,261 (“However, as noted in MPEP §1490, a mistake in filing
`
`a terminal disclaimer does not fall within any of the categories of mistake for which
`
`a certificate of correction of applicant’s mistake is permissible.”).3 Merck has not
`
`pointed to any provision in the MPEP (or other authority) permitting a Certificate of
`
`Correction to rewrite claim recitations a District Court had previously found to be
`
`indefinite.
`
`3. No Mistake “of Minor Character”
`
`As explained above, the MPEP will guide the PTO. As the MPEP clearly
`
`states: “[a] mistake is not considered to be of the ‘minor’ character required for the
`
`issuance of a certificate of correction if the requested change would materially affect
`
`the scope or meaning of the patent.” MPEP §1481; In re U.S. Patent 6,660,701 at
`
`at 1350, it has never authorized the use of a certificate of correction to resurrect a
`
`claim found indefinite.
`
`3 Mylan attaches In re U.S. Patent No. 7,475,261, In re U.S. Patent 6,660,701, and
`
`In re U.S. Patent No. 7,168,818 as Exhibits A, B and C respectively to this Paper.
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`p. 7; Arnott, 1991 WL 326548, *7 (“[t]he difference between having and not having
`
`a claim of particular scope is significant.”). Indefiniteness means the claim fails to
`
`“inform those skilled in the art about the scope of the invention with reasonable
`
`certainty.” Nautilus Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120, 2129 (2014).
`
`To undo the District Court’s indefiniteness determination, Merck is attempting to
`
`change the scope of the claims. That is improper. “Usually, any mistake affecting
`
`claim scope must be corrected by reissue.” MPEP §1481; In re U.S. Patent
`
`6,660,701 at p. 7.
`
`Another test used by the PTO to consider if a claim’s scope is changed by the
`
`proposed correction is “if the patent owner would be able to sue any party for
`
`infringement who previously could not have been sued for infringement.” In re U.S.
`
`Patent No. 7,168,818 at p. 6. Once again, this clearly undermines Merck’s position.
`
`Given the indefiniteness of these claims as written, Merck could not sue any party
`
`for infringement of Claims 5-7. The requested corrections change the scope of those
`
`claims and for that reason are not of “minor character.” Id. Again, “[e]xamples of
`
`mistakes that fall under § 255 typically include correcting a misspelled word or
`
`adding a prior art reference that was submitted to and discussed by the examiner but
`
`inadvertently omitted by the applicant on PTO Form 1449 for listing references.”
`
`Fina Technology, Inc. v. Ewen, 265 F. 3d 1325, 1328 (Fed. Cir. 2001).
`
`4. The Proposed Corrections Constitute New Matter or Would
`Require Reexamination
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`Merck has failed to show any basis that its proposed corrections “would [not]
`
`constitute new matter or would [not] require reexamination.” 35 U.S.C § 255. By
`
`using the Certificate of Correction, Merck appears to be attempting to evade
`
`examination. 35 U.S.C. § 251. “What [Merck] now proposes to do, in the guise of
`
`a Certificate of Correction is to present a claim to subject matter that has never been
`
`examined by the examiner, was never passed to issue by the examiner, and never
`
`given any patent protection by the USPTO.” In re U.S. Patent 6,660,701 at p. 6. For
`
`this added reason, Merck’s request should be denied.
`
`Even assuming arguendo that Merck has shown written support for its
`
`proposed corrections in the specification of the ’708 patent (Request, 5-6),
`
`patentability is not determined simply on whether or not written support exists.
`
`Rather, other conditions such as, inter alia, subject matter eligibility, utility, novelty
`
`and enablement must be met. “[It] clearly would require reexamination for the
`
`requested correction as the [requested] embodiment was never claimed or examined
`
`during the pendency of the original application for patent, and was never issued by
`
`the USPTO.” In re U.S. Patent 6,660,701 at p. 6.
`
`The Federal Circuit has repeatedly emphasized a Certificate of Correction is
`
`proper when it is “clearly evident from the specifications, drawings, and
`
`prosecution history how the error should appropriately be corrected to one of skill
`
`in the art.” Arthrocare Corp. v. Smith & Nephew, Inc., 406 F.3d 1365, 1374–75
`
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`(Fed. Cir. 2005); Superior Fireplace Co., 270 F.3d at 1372, 1374 (discussing events
`
`that occurred during examination); Fina Technology, 265 F. 3d at 1328 (discussing
`
`a “prior art reference that was submitted to and discussed by the examiner”); In re
`
`U.S. Patent No. 7,168,818 at p. 6.
`
`Merck concedes that there is nothing from the prosecution history of the ’708
`
`patent showing “how the error should appropriately be corrected.” In fact, Merck
`
`recognizes that “if there had been, the mistake presumably would have been
`
`addressed during the original prosecution.” Request, 6-7. This, however, places the
`
`proverbial cart before the horse. The Examiner is not charged with understanding
`
`the subjective mindset of the inventors as to what they intended to present for
`
`examination, or determining any mistakes based on a claim that was never presented.
`
`In re U.S. Patent No. 6,550,701 at p. 5 (“Claim 4 was passed to issue by the examiner
`
`exactly as it was drafted by the applicant and presented on filing.”). Merck’s effort
`
`to place any responsibility on the examination process for its mistake is simply
`
`improper. In Re U.S. Patent 6,550,701 at p.5 (“The primary responsibility for
`
`presenting claims that provide adequate coverage for disclosed inventions rests with
`
`applicant.”).
`
`5. Evidence of Inattention and Lack of Diligence Does Not Show
`“Good Faith”
`Merck claims the error occurred in alleged “good faith.” Request, 7. The
`
`only so-called evidence Merck presents is that of an inattentive review of the ’708
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`patent’s claims by Merck’s attorneys and inventors. Dr. Wenslow alleges the alleged
`
`mistake was obvious. EX2281, ¶4 (“As scientists who perform X-ray powder
`
`diffraction would know, and I knew at the time the application was filed, X-ray
`
`powder diffraction does not involve absorption or absorption bands, nor are d-
`
`spacings “spectral”). Despite the very apparent nature of the alleged mistake, Dr.
`
`Wenslow’s admits he did not catch this error during his inattentive review of the
`
`patent. Id. ¶6 (“When I reviewed the draft patent application, I did not catch the
`
`error in these claims. . . . and if I had noticed the mistake during the prosecution of
`
`the patent, I would have taken steps to correct this error then.”).
`
`The Office of Petitions has taken a dim view of a patentee’s failure to properly
`
`review its claims with evaluating alleged mistakes. In re U.S. Patent 6,660,701 at
`
`p. 4 (citing Superior Fireplace Co., 270 F.3d at 1376 (noting “the critical importance
`
`of reviewing claims” before the allowed claims issue)); Southwest Software, Inc. v.
`
`Harlequin Inc., 226 F.3d 1280, 1296 (Fed. Cir. 2000) (“it does not seem to us to be
`
`asking too much to expect a patentee to check a patent when it is issued in order to
`
`determine whether it contains any errors.”). Even if, as Merck contends, “[t]he
`
`correction fixes the claims to recite what they plainly were intended to cover all
`
`along” (Request, 7), “suggestions that we compare claim scope by considering what
`
`was ‘intended’ by the parties, rather than by construing the claims for what they
`
`actually recite, is completely without merit.” Superior Fireplace Co., 270 F.3d at
`
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`1375.
`
`Further, the ’708 patent issued 12 years ago. In those twelve (12) years,
`
`Merck never once sought a Certificate of Correction. Merck presumably also did an
`
`initial pre-filing investigation before asserting Claims 5-7 against multiple
`
`defendants in the underlying litigations (again, according to Dr. Wenslow, the
`
`mistake would have been clear during that initial investigation). EX2281, ¶4, ¶6.
`
`Yet, it took a Court’s indefiniteness finding more than a year into the underlying
`
`litigations for Merck to seek a Certificate of Correction. That does not show good
`
`faith:
`
`[The] equitable powers [of the PTO] should not be
`invoked to excuse the performance of a condition by, as
`here, a party that has not acted with reasonable, due care
`and diligence….Petitioner does not offer any reason that
`would excuse the inordinate delay in this case. Any
`contention
`that petitioner was diligent
`in seeking
`correction of this matter is simply not supported by the
`record. The Office, where it has the power to do so, should
`not relax the requirements of established practice in order
`to save an applicant from the consequence(s) of his delay.
`In Re U.S. Patent No. 7,475,261 at p.8.
`
`Put simply, what Merck intended to get is exactly what it got from the USPTO
`
`and the Certificate of Correction procedure should be unavailable to Merck. In re
`
`U.S. Patent No. 6,550,701 at p. 5 (“Claim 4 was passed to issue by the examiner
`
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`exactly as it was drafted by the applicant and presented on filing.”). Merck’s own
`
`admitted failure to participate properly in the examination process, inattention, lack
`
`of diligence, and delay is not evidence of good faith.
`
`6. Patent Owner Should Be Ordered to Provide This Opposition to
`the Director When Filing any Correction Request
`Alternatively, should the Board cede its exclusive jurisdiction and refer the
`
`matter to the Director, which Petitioner respectfully submits there is no basis for,
`
`Petitioner requests the Board to instruct Merck to include this Opposition with any
`
`request to the Director. Intuitive Surgical, IPR2020-00050 at 5; ASM IP Holding,
`
`IPR2019-00378 at 5–6. “Petitioner’s Opposition may be useful to the Director in
`
`determining whether the issuance of a Certificate of Correction is appropriate.”
`
`Intuitive Surgical, IPR2020-00050 at 5; ASM IP Holding, IPR2019-00378 at 5–6
`
`(“in the interests of transparency, and in order for those Branches of the Office to be
`
`aware of the events leading up to Patent Owner’s request(s)”).
`
`CONCLUSION
`
`The Board should DENY Merck’s Request to file for a Certificate of
`
`Correction, or in the alternative, ORDER Merck to provide this Opposition with any
`
`request to the Director.
`
`Date: December 4, 2020
`
`Respectfully submitted,
`
`/s Jitendra Malik/
`Jitendra Malik, Ph.D.
`
`10
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`Exhibit A
`
`Exhibit A
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`Commissioner for Patents
`United States Patent and Trademark Office
`PO. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`MATTINGLY, STANGER & MALUR, P.C.
`We 37.0
`1800 Diagonal Road
`Alexandria VA 22314
`
`In re Patent No. 7,475,261
`
`Issue Date: January 6, 2009
`Application No. 10/768,136
`Filed: February 2, 2004
`Patentee: Y. TOTSUKA et a1.
`
`Attorney Docket No. ASA-788-02
`
`MAILED
`
`JUL 2 9 2011
`OFFICE OF Famous
`
`:
`: DECISION ON PETITION
`'
`
`This is a decision on the renewed petitions filed September 30, 2010, requesting under the
`provisions of 37 CFR 1.182 or in the alternative under 37 CFR 1.183, a review of the Decision
`mailed July 30, 2010, that dismissed the petitioner’s request for a review of the Office’s decision
`of August 4, 2009 denying patentee's request for Certificate of Correction filed July 6, 2009.
`
`The petitions are DENIED.
`
`BACKGROUND
`
`1.
`
`2.
`
`3.
`
`4.
`
`On February-2, 2004, the instant applicationwas filed as a continuation of Application
`having the serial number 09/308,488.
`
`The non-final Office action dated March 25, 2008 included a rejection under the grounds
`of non-statutory obviousness-type double patenting noting that the claims were
`unpatentable “over claims 1-9 of US. Patent No. 6,715,090 in view of Smith et al., and in
`View of Martin, US. Patent No. 5,111,058.”
`
`The applicants filed a response on June 25, 2008 that included a Terminal Disclaimer
`signed by the petitioner herein, disclaiming the terminal part of the statutory term of the
`instant patent “which would extend beyond the expiration date of the full statutory term
`defined in 35 U.S.C. 154 to 156 and 173, as presently shortened by any terminal
`disclaimer, of US. Patent No. 6,715,090 and US. Patent No. 5,111,058.”
`
`The Terminal Disclaimer was accepted and a Notice of Allowance was mailed on
`September 2, 2008.
`
`

`

`Patent No. 7,475,261
`
`Page 2
`
`5.
`
`6.
`
`The instant patent issued on January 6, 2009.
`
`On July 6, 2009 petitioner filed a request for a certificate of correction to have the
`Terminal Disclaimer filed August 25, 2008, corrected by directing the Certificate of
`Corrections Branch to issue the Certificate of Correction by deleting "and US. Patent No.
`5,111,058", in said Terminal Disclaimer "in order to clarify the record so that the patent is
`only disclaimed with respect to co-owned US Patent No. 6,715,090."
`
`In a decision filed August 4, 2009, the request was not approved.
`
`A petition was filed on October 7, 2009 seeking a review of this earlier decision by the
`Office that disapproved the request for a certificate of correction.
`
`In a decision mailed July 30, 2010 the petition was dismissed.
`
`10.
`
`The instant petitiOn was filed September 30, 2010 requesting a review of the earlier
`decisions refusing to grant the requested certificate of correction.
`
`STATUTE, REGULATION, AND EXAMINING PROCEDURE
`
`35 U.S.C. § 121(Blg2) provides, in part, that:
`
`The Office-— may, establish regulations, not inconsistent with law, which
`
`(A) shall govern for the conduct ofproceedings in Office.
`
`35 U.S.C. 253 Disclaimer
`
`Whenever, without any deceptive intention, a claim ofa patent is invalid the remaining
`claims shall not thereby be rendered invalid. A patentee, whether ofthe whole or any
`sectional interest therein, may, on payment ofthe fee required by law, make disclaimer of
`any complete claim, stating therein the extent ofhis interest in such patent. Such
`V
`disclaimer shall be in writing and recorded in the Patent and Trademark Oflice, and it
`shall thereafter be considered as part ofthe original patent to the extent ofthe interest
`possessed by the disclaimant and by those claiming under him.
`
`In like manner any patentee or applicant may disclaim or dedicate to the public the entire
`term, or any terminal part ofthe term, ofthe patent granted or to be granted.
`
`

`

`Patent No. 7,475,261
`
`Page 3
`
`35 U.S.C. 255 Certificate of correction of applicant’s mistake
`
`Whenever a mistake ofa clerical or typographical nature, or ofminor character, which
`was not the fault ofthe Patent and Trademark Office, appears in a patent and a showing
`has been made that such mistake occurred in goodfaith, the Director may, upon payment
`ofthe requiredfee, issue a certificate ofcorrection, ifthe correction does not involve
`such changes in the potent as would constitute new matter or would require
`reexamination. Such patent, together with the certificate, shall have the same effect and
`operation in law on the trial ofactions for causes thereafter arising as ifthe same had
`been originally issued in such correctedform.
`
`37 CFR § 1.182 Questions not specifically provided for
`
`All situations not specifically providedfor in the regulations ofthis part will be decided
`in accordance with the merits ofeach situation by or under the authority ofthe Director,
`subject to such other requirements as may be imposed, and such decision will be
`communicated to the 1nterestedpart1es in writing. Any petition seeking a decision under
`this section must be accompanied by the petztzon fee setforth in § 1.1 70‘).
`
`37 CFR § 1.183 Suspension of rules
`
`In an extraordinary situation, when justice requires, any requirement ofthe regulations
`in this part which is not a requirement ofthe statutes may be suspended or waived by the
`Director or the Director 's designee, sua sponte, or on petition ofthe interested party,
`subject to such other requirements as may be imposed. Any petition under this section
`must be accompanied by the petition fee setforth in § 1.1 709.
`
`37 CFR 1.321. Statutog disclaimers, including terminal disclaimers - states in the pertinent part:
`
`(b) An applicant or assignee may disclaim or dedicate to the public the entire term, or
`any terminal part ofthe term, ofa patent to be granted Such terminal disclaimer is
`binding upon the grantee and its successors or assigns. The terminal disclaimer, to be
`recorded in the Patent and Trademark Office, must:
`(I)
`be signed:
`(1)
`by the applicant, or
`(it)
`ifthere is an assignee ofrecord ofan undivided part interest, by the applicant and
`such assignee, or
`(iii)
`ifthere is an assignee ofrecord ofthe entire interest, by such assignee. or
`(iv)
`by an attorney or agent ofrecord;
`(2)
`specify the portion ofthe term ofthe patent being disclaimed;
`(3)
`state the present extent ofapplicant ’s or assignee ’s ownership interest in the
`patent to be granted; and
`
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`

`Patent No. 7,475,261
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`'
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`Page 4
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`be accompanied by the fee setforth in § 1.20(d).
`(4)
`(c) A terminal disclaimer, when filed to obviate judicially created double patenting in a
`patent application or in a reexamination proceeding except as providedfor in paragraph
`(d) ofthis section,
`must:
`
`'
`
`(1) Comply with the provisions ofparagraphs (b)(2) through (b)(4) ofthis section;
`(2) Be signed in accordance with paragraph (b)(1) ofthis section iffiled in a patent
`application or in accordance with paragraph (a) (1) ofthis section iffiled in a
`reexamination proceeding; and
`(3)
`Include a provision that any patent granted on that application or any patent
`subject to the reexamination proceeding shall be enforceable only for and during such
`period that saidpatent is commonly owned with the application or patent which formed
`the basisfor the judicially created double patenting.
`
`37 CFR § 1.325 Other mistakes not corrected
`
`Mistakes other than those providedfor in §§ 1.322, 1.323, 1.324, and not affording legal
`grounds for reissue orfor reexamination, will not be corrected after the date ofthe
`patent.
`
`MPEP §1490§VII) - Withdrawing A Recorded Terminal Disclaimer
`
`B.
`
`After Issuance Of Patent
`
`The mechanisms to correct a patent — Certificate of Correction (35 US. C. 255), reissue
`(35 US. C. 251), and reexamination (35 US. C. 305) — are not available to withdraw or
`otherwise nullifi/ the effect ofa recorded terminal disclaimer. As a general principle,
`public policy does notfavor the restoration to the patent owner ofsomething that has
`been freely dedicated to the public, particularly where the public interest is not protected
`in some manner — e. g., intervening rights in the case ofa reissue patent. See, e. g.,
`Altoona Publix Theatres v. American Tri-Ergon Corp, 294 US. 477, 24 USPQ 308
`(1 935).
`
`Certificates ofCorrection (3 5 US. C. 255) are available for the correction ofan
`applicant’s mistake. The scope ofthis remedial provision is limited in two ways — by the
`nature ofthe mistake for which correction is sought and the nature ofthe proposed
`
`correction. In re Arnott 19 USPQ2d 1049 (Comm ’r Pat. 1991). The nature ofthe mistake
`for which correction is sought is limited to those mistakes that are:
`(A)
`'ofa clerical nature;
`(B)
`ofa typographical nature; or
`(C)
`ofa minor character.
`
`The nature ofthe proposed correction is limited to those situations where the correction
`does not involve changes which would:
`(A)
`constitute new matter, or
`
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`

`Patent No. 7,475,261
`
`’ Page 5
`
`(B)
`
`' require reexamination.
`
`A mistake in filing a terminal disclaimer does notfall within any ofthe categories of
`mistake for which a certificate ofcorrection ofapplicant ’s mistake is permissible, and
`any attempt to remove or nullify the effect ofthe terminal disclaimer would typically
`require reexamination 0fthe circumstances under which it was filed
`
`Although the remedial nature ofreissue (35 US. C. 251) is well recognized, reissue is not-
`available to correct all errors. It has been the Office position that reissue is not available
`to withdraw or otherwise nullify the effect ofa terminal disclaimer recorded in an issued
`
`patent.
`
`OPINION
`
`Petitioner seeks by way of the instant petition to amend the previously recorded terminal
`disclaimer in the instant patent over US. Patents 6,715,090 and 5,111,058. The specific relief
`requested by the petitioner is that “that the Certificate of Corrections Branch be directed to issue
`the Certificate of Correction filed July 6, 2009 which deletes "and US. Patent No. 5,111,058" in
`the Terminal Disclaimer in order to clarify the record so that the record is clear that the only
`patent which is the target of the Terminal Disclaimer is co-owned US. Patent No. 6,715,090.”
`
`Petitioner’s arguments and the declaration of Lynn Maxwell concerning the instant request for a
`certificate of correction have been considered. However, as noted in MPEP §l490, a mistake in
`filing a terminal disclaimer does not fall within any of the categories of mistake for which a
`certificate of correction of applicant’s mistake is permissible. Applicants should have filed a
`corrected terminal disclaimer during the prosecution of the application, i.e., prior to its issuance
`as a patent. The USPTO will not grant a request to withdraw or amend a recorded terminal
`disclaimer in an issued patent as the rules of practice and 35 USC 253 do not include a
`mechanism for withdrawal or amendment of such a terminal disclaimer. Unfortunately, once a
`patent issues, the USPTO cannot remove the effect of a recorded terminal disclaimer in an issued
`patent. See MPEP §1490; Bayer AG v. Carlsbad Technology Inc., 298 F.3d 1377, 64 USPQ2d
`1045, 1048-49 (CAFC 2002) (hereafter “Bayer AG”).While petitioner may now consider the
`previously filed disclaimer to be unnecessary, or unnecessarily limiting, petitioner is,
`nevertheless, confronted with what has been characterized as “an unhappy circumstance,” rather
`than a circumstance necessitating relief. See In re Jentoft, 392 F.2d 633, 639 n. 6, 157 USPQ
`363, 368 n. 6 (CCPA 1968); MPEP 1490(A).
`
`In arguing that the petition meets the requirements for a certificate of correction, petitioner states
`that: (a) “the mistake is of a clerical nature as the wrong patent number was added to the
`Terminal Disclaimer in addition to the correct patent number at the time of preparation and filing
`of the Terminal Disclaimer”; (b) “the US. Patent No. 5,1 11,058 is not related (by 35 U.S.C.§
`120) to the '261 patent and not commonly owned by the assignee”; (c) “the correction of the
`mistake requested by the Certificate of Correction will not require examination as a result, for the
`same reasons”; and (d) “further, entry of the proposed correction will not introduce new matter.”
`
`

`

`Patent No. 7,475,261
`
`Page6
`
`Petitioner's request for issuance of a Certificate of Correction under 35 U.S.C. § 254 to correct
`the alleged error in the expiration date of the above-identified patent is refused. By statue (§ 254)
`and regulation (37 CFR 1.322), for a Certificate of Correction to be issue