Notice of Pre-AIA Status
The present reissue application is being examined under the pre-AIA first to invent provisions. It is noted that while the examination of the current reissue application falls under the pre-AIA first to invent provisions due to the priority date of US Patent No. 8,292,850 (the ‘850 patent); the application for reissue filing date is after September 16, 2012 and therefore is subject to the reissue rule changes enacted under the Leahy-Smith American Invents Act (AIA ), see Federal Register, Vol. 77, No. 157, pg. 48820, August 16, 2012. For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Reissue Applications and Prosecution History
Applicant is reminded of the continuing obligation under 37 CFR § 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which the ‘850 patent is or was involved. These proceedings would include interferences, reissues, reexaminations and litigations.
The present reissue application is a reissue of the ‘850 patent and a continuation reissue of reissue application 14/984,273 resulting in US Pat. No. RE47379 which is a continuation reissue of reissue application 14/195,435 resulting in US Pat. No. RE46116 which is a continuation reissue of reissue application 14/070,161 resulting in US Pat. No. RE45380 which is a reissue of the ‘850 patent. Reissue application 14/195,385 resulting in US Pat. No. RE45760 and reissue application 14/195,413 resulting in US Pat. No. RE45776 were filed contemporaneously to reissue application 14/195,435 as copending continuation reissue applications of reissue application 14/070,161, The ‘850 patent is a DIV of US Pat. No. 8,142,413 which is a DIV of US Pat. No. 8,048,032. US Pat. No. 8,048,032 is subject to Inter Partes Reviews IPR2020-00126 and IPR2020-00127 which were instituted and each include Final Decisions mailed on 6/17/21. A Notice of Appeal was filed in both reviews on 9/27/21. US Pat. No. 8,142,413 is subject to Inter Partes Reviews IPR2020-01341 and IPR2020-01342 which have been instituted and a Final Decision was mailed on 2/07/22 in both reviews. A Notice of Appeal was filed in both reviews on 4/06/22. RE45380 is subject to Inter Partes Reviews IPR2020-00128; IPR2020-00129; and IPR2020-00130 which were instituted and include respective Final Decisions mailed on 6/17/21. A Notice of Appeal was filed in all three reviews on 9/27/21. RE45760 is subject to IPR2020-00132 and IPR2020-00134 which were instituted and each include Final Decisions mailed on 6/17/21. A Notice of Appeal was filed in both reviews on 9/27/21. RE45776 is subject to IPR2020-00135 and IPR2020-00136 which were instituted and each include Final Decisions mailed on 6/17/21. A Notice of Appeal was filed in both reviews on 9/27/21. RE46116 is subject to Inter Partes Reviews IPR2020-001343 and IPR2020-01344 which have been instituted and a Final Decision was mailed on 2/23/22 in both reviews. A Notice of Appeal was filed in both reviews on 4/22/22. RE47379 is subject to Inter Partes Reviews IPR2020-00137 and IPR2020-00138 which were instituted and a Final Decision was mailed on 6/17/21 and 6/22/21, respectively. A Notice of Appeal was filed in both reviews on 9/27/21.
The CAFC Decision in the consolidated appeals in Nos. IPR2020-00126; IPR2020-00128; IPR2020-00132; IPR2020-00135; and IPR2020-00137 was decided on May 24, 2023 and the CAFC affirmed the PTAB’s Final Decision that Itou does not qualify as prior art to the challenged patents under 35 USC 102(e) and that the challenged claims are not unpatentable. The CAFC Decision in the Appeals in Nos. IPR2020-00129; IPR2020-00134; and IPR2020-00138 was decided on June 5, 2023 and the CAFC affirmed the PTAB’s Final Decision regarding the claims found not unpatentable and granting issuance of the substitute claims. The CAFC Decision in the Appeals in Nos. IPR2020-00127; IPR2020-00130; and IPR2020-00136 was decided on June 5, 2023 and the CAFC affirmed the PTAB’s Final Decision regarding the claims found not unpatentable and granting issuance of the substitute claims. The appeals of the Final Decisions in IPR2020-01341; IPR2020-01342; IPR2020-01343; and IPR2020-01344 are still pending at the CAFC as of the mailing of this office action.
Applicant is further reminded of the continuing obligation under 37 CFR § 1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Oath/Declaration
The reissue oath/declaration filed with this application is defective because the error which is relied upon to support the reissue application is not an error upon which a reissue can be based. See 37 CFR 1.175and MPEP § 1414.
The Reissue Declaration by the Inventor filed 09/18/2020 sets forth that the limitations of "A system" and "a guide catheter having a continuous lumen extending for a predefined length from a proximal end at a hemostatic valve to a distal end adapted to be placed in the branch artery, the continuous lumen of the guide catheter having a circular cross-sectional inner diameter sized such that interventional cardiology devices are insertable into and through the continuous lumen of the guide catheter" from original claim 1 of the ‘850 patent caused the ‘850 patent to be in error. However, these limitations were previously relied upon in the error statements as the basis of a reissue proceeding in reissue applications 14/070,161; 14/195,385; 14/195,413; 14/195,435 and 14/984,273. Therefore, this error is considered to have already been corrected in the issuance of Reissue Pat. Nos. RE45380; RE45760; RE45776; RE46116 and RE47379. Specifically, each of these reissue patents issued with claims either amending or entirely eliminating the same limitations being relied upon again as causing an error as the basis for reissue of the ‘850 patent. Additionally, the same error, i.e. original claim limitations causing the error, is being relied upon in this reissue as is being relied upon in each of co-pending reissue applications 16/184,706; 16/220,925; 16/220,996 and 16/220,975.
While, the issuance of multiple reissue patents from a single original patent is permitted. See 37 CFR 1.177; once a reissue claim has gone to issuance, the error providing the basis for that reissue patent is considered to have been corrected. If the same error corrected in the parent, e.g. reissue application 14/070,161 resulting in Pat. No. RE45380, is also being corrected in a continuation reissue application, but the error is being corrected in a different way, a statement is needed to explain compliance with 37 CFR 1.175(f)(2) for a reissue application filed on or after September 16, 2012. Since the current error statement relies on the same limitations listed in each of applications 14/070,161; 14/195,385; 14/195,413; 14/195,435; 14/984,273; 16/184,706; 16/220,925; 16/220,996 and 16/220,975, the statement explaining that the error is being corrected in a different way would need to differentiate from each of these applications.
Claims 25-58 are rejected as being based upon a defective reissue declaration error statement under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the error statement is set forth in the discussion above in this Office action.
Double Patenting
The nonstatutory double patenting rejections have been withdrawn in light of the Terminal Disclaimer filed and approved 4/19/21.
Original Patent
The following is a quotation of 35 USC §251:
(a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.
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(c) APPLICABILITY OF THIS TITLE.— The provisions of this title relating to applications for patent shall be applicable to applications for reissue of a patent, except that application for reissue may be made and sworn to by the assignee of the entire interest if the application does not seek to enlarge the scope of the claims of the original patent or the application for the original patent was filed by the assignee of the entire interest.
MPEP § 1412.01 states that the reissue claims must be for the same invention as that disclosed as being the invention of the original patent. MPEP § 1412.01 further provides guidelines for determining whether the reissue claims are “for the invention disclosed in the original patent” as:
(A) The claims presented in the reissue application are described in the original patent specification and enabled by the original patent specification such that 35 USC §112, first paragraph is satisfied; and
(B) Nothing in the original patent specification indicates an intent not to claim the subject matter of the claims presented in the reissue application.
The presence of some disclosure (description and enablement) in the original patent should evidence that applicant intended to claim or that applicant considered the material now claimed to be his or her invention.
Further, the Federal Circuit addressed the “original patent” requirement of 35 USC §251 in Antares Pharma, Inc. v. Medac Pharma Inc. and Medac GMBH, 771 F.3d 1354, 112 USPQ2d 1865 (Fed. Cir. 2014). In Antares the reissue claims covered embodiments of injection devices (not restricted to jet-injection devices) which the Applicant admitted was a different invention from what was originally claimed. Id. At 1356 The Federal Circuit adopted the Supreme Court’s explanation of the “same invention” requirement as “if the original patent specification fully describes the claimed invention, but not if the broader claims ‘are [] merely suggested or indicated in the original specification’”. Id. At 1359. The Federal Circuit further stated that although wording in 35 USC §251 was changed from “same invention” to “original patent” no change in substance was intended. Id. At 1360.
Based on Antares, a review of the specification is necessary to determine whether the original specification adequately discloses the invention of the reissue claims.
The side opening limitation
Like in Antares, the specification states the following throughout the ‘850 patent, see, e.g., col. 6, lines 50-64:
Rigid portion 20 may be secured to braid or coil reinforcement by, for example, welding or bonding. … Rigid portion 20 includes first full circumference portion 34, hemicylindrical portion 36, arcuate portion 38, and second full circumference portion 40.
First full circumference portion 34 is joined to braid or coil reinforcement 32. First full circumference portion 34 extends for a relatively short distance, for example, 0.25 cm.
Hemicylindrical portion 36 desirably includes 40% to 70% of the circumference of the tube. Hemicylindrical portion 36 may extend, for example, approximately 20 to 75 cm in length.
Hemicylindrical portion 36 tapers into arcuate portion 38.
Arcuate portion 38 extends from 25% to 40% of the circumference of the tube. Arcuate portion 38 may extend linearly, for example, for about 15 cm.
[Emphasis Added]
However, the ‘850 patent specification does not disclose “a transition region,” separate from the rigid portion 20, that includes “a proximal side opening” which is included in independent claim 25. Likewise, the ‘850 patent specification does not disclose a “a side opening defined at the proximal portion of the tubular structure and the distal portion of the substantially rigid portion” which is included in independent claim 34. Instead, the ‘850 patent discloses in the specification and figures that the side opening is part of the rigid portion 20. Additionally, the ‘850 patent specification does not teach that “a side opening” is separate from “a substantially rigid portion” which is recited in independent claim 41.
Therefore, independent claims 25, 34 and 41 and thereby dependent claims 26-33, 35-40 and 42-45, which are directed to “a transition between the substantially rigid portion and the tubular portion includes a proximal side opening;” “a side opening defined at the proximal portion of the tubular structure and the distal portion of the substantially rigid portion,” “a side opening” separate from “a substantially rigid portion” are rejected under 35 USC §251 for not claiming subject matter directed to the invention disclosure in the original patent.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/16/2021, with respect to the rejections below have been fully considered and are persuasive.
The rejection of claims 25-26, 34, 41, 43, and 46-50 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US Pat. No. 5,439,445 to Kontos (“Kontos”) in view of US Pub. No. 2004/0010280 to Adams (“Adams ‘280”) has been withdrawn in light of applicant’s remarks filed 04/19/2021.
The rejection of claims 25, 27-28, 34-35, 41-42, 45-46 and 51-52 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 and in further view of US Pub. No. 2005/0015073 to Kataishi et al. (“Kataishi”) has been withdrawn in light of applicant’s remarks filed 04/19/2021.
The rejection of claims 30-33, 37-40 and 55-58 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 with or without Kataishi and in further view of US Pat. No. 5,911,715 to Berg (“Berg”) has been withdrawn in light of applicant’s remarks filed 04/19/2021.
The rejection of claims 25-27, 29, 34, 41, 43-44, 46, 47-50 and 53-54 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 in further view of US Patent No. 7,604,612 to Ressemann et al. (“Ressemann”) has been withdrawn in light of applicant’s remarks filed 04/19/2021.
The rejection of claims 25-28; 34-36, 41, 42, 43, 45-46 and 48, 49, 50, 51,52 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 and Ressemann and in further view of Kataishi has been withdrawn.
The rejection of claims 25-28; 34-36, 41,42,43, 45-46 and 48-51, 52 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kontos in view of Adams ‘280 and Ressemann and in further view of US Pat. No. 5,980,486 to Enger (“Enger”) has been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eileen Lillis can be reached on 571-272-6928. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE S WILLIAMS/Reexamination Specialist, Art Unit 3993
Conferees:
/Patricia L Engle/Reexamination Specialist, Art Unit 3993
/EILEEN D LILLIS/SPRS, Art Unit 3993
Prosecution Insights