Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-13 are original claims and are pending. Claims 1-13 are under examination in the instant office action.
Election/Restrictions
The Examiner notes that the restriction requirement set forth in the parent application (Application No. 17/630,301 (now abandoned)) did not include any groups of invention drawn to any methods and was withdrawn in the Non-Final Office Action mailed on August 24, 2023.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/630,301 (now abandoned), filed on January 26, 2022.
The instant application is a divisional (DIV) of Application No. 17/630,301, filed on January 26, 2022, which is a national phase application (371) of PCT/JP2020/029532, which claims foreign priority to JP 2019-142482, filed on August 1, 2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 19, 2024 and April 25, 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The listing of references in the specification at pages 8-11 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on an information disclosure statement (IDS), they have not been considered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Roufa et al. (US Patent No. 6,417,173; Issued July 9, 2002; cited on IDS filed on March 19, 2024) (“Roufa”).
Roufa discloses methods for inhibition of fibrosis, scar formation, and adhesions (title; abstract). Roufa teaches the use of adhesive polymers including fibrin (col. 4, lines 6-26; col. 8, lines 44-57; col. 9, lines 41-56; claim 28). Roufa teaches applying the compositions to the lesions, including where fibrotic disorder (e.g., a fibrosis) has already manifested (col. 6, lines 62-67; col. 10, lines 5-45; col. 11, lines 39-57; col. 12, lines 11-29 and 64-67). These teachings anticipate claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Applicant Claims
2. Determining the scope and contents of the prior art.
3. Ascertaining the differences between the prior art and the claims at issue, and resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-13 are rejected under 35 U.S.C. 103 as being obvious over Roufa et al. (US Patent No. 6,417,173; Issued July 9, 2002; cited on IDS filed on March 19, 2024) (“Roufa”) in view of Saga et al. (WO 2016/143746; published September 15, 2016, filed March 7, 2016;cited on IDS of March 19, 2024; citations below are to the English language equivalent of US PG-PUB 2018/0078679, also cited on the March 19, 2024 IDS) (“Saga”).
The applied reference (i.e., Saga) has a common Applicant (i.e., KM Biologics Co., LTD.) and joint inventor (i.e., Hideki Saga-), with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2) and 102(a)(1).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant Claims
Applicant claims methods of inhibiting tissue fibrosis or tissue adhesion (e.g., claim 10) comprising applying a biocompatible polymer (e.g., fibrin) to a tissue (e.g., claim 1) and in some embodiments suturing and fixing a cell scaffold material to a tissue defect site in another tissue (e.g., claim 2).
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Roufa are set forth above and incorporated herein by reference.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Roufa does not teach combination with a cell scaffold material, such as, decellularized tissue. This deficiency is cured by Saga.
Saga teaches anti-adhesion materials comprising decellularized tissue (title; abstract). Saga further teaches kits comprising a decellularized tissue and a biocompatible polymer, and fibrin is taught as said biocompatible polymer (abstract; [0042], [0044]-[5], [6], [12], [16], [25], [35], [0071], [0078], [0093]; Examples 5-7; claims 6, 16, 25, 35). The decellularized material may be made from pericardium, bladder, amnion, dura mater, peritoneum, diaphragm, fascia, small intestine submucosa and skin ([0044]-[0052]). Saga teaches repair of the epicardium and pericardium ([0004], [0075], [0077], [0098], [0100]).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious at the time of the earliest effective filing date of the instant application with a reasonable expectation of success to combine the teachings of Roufa and Saga because both references are in the same field of endeavor and include the focus on the inhibition of adhesions, which the Examiner understands are a kind of tissue fibrosis. Moreover, both references contemplate the use of similar biocompatible polymers, such as, fibrin, to obtain materials suitable for inhibiting the formation of tissue fibrosis and tissue adhesions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,033,661 (USPN ‘661) in view of Roufa et al. (US Patent No. 6,417,173; Issued July 9, 2002; cited on IDS filed on March 19, 2024) (“Roufa”).1 Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims constitute a prima facie obvious use of the claimed fibrin-based anti-adhesion material comprising decellularized material (e.g., decellularized pericardium, dura mater, etc. [See conflicting claims 1 and 8) and claimed fibrin-based biomembrane comprising decellularized material (e.g., see conflicting claims 14) of USPN ‘661. The claimed products of USPN ‘661 The differences between the rejected claims and the cited claims of USPN ‘661 are that (1) the conflicting claims of USPN ‘661 are drawn to products whereas the rejected claims are drawn to a method of use; (2) the conflicting claims do not recite or suggest a step of suturing the claimed anti-adhesion material nor the claimed biomembrane to tissue per se; and (3) the conflicting claims do not specific recite inhibition of tissue fibrosis. However, looking to the specification of USPN ‘661 it is apparent that the intended use of the claimed anti-adhesion material and claimed biomembrane of USPN ‘661 is in the context of surgery with the goal of preventing the formation of adhesions in various tissues of the subject being operated on and this intended use of these surgical products contemplates the surgical fixation of these surgical products to various tissues where adhesions could form peri- or post-operatively. See, for example, col. 4, lines 5-35 and col. 6, lines 45-55. Alternatively, the teachings of Roufa, set forth above and incorporated herein by reference, establish that fibrin containing materials are suitable for the inhibition of tissue fibrosis and formation of adhesions. Consequently, the POSITA would have been motivated to use the claimed products of USPN ‘661 in methods of inhibiting tissue fibrosis and formation of adhesions with a reasonable expectation of success.
With respect to rejected claim 5 that recites the tissue in which tissue fibrosis (e.g., formation of an adhesion) is to be inhibited is the epicardium, it would have been prima facie obvious to use the claimed products of USPN ‘661 to prevent the formation of adhesions on the epicardium, which is the external surface of the heart, because surgery on the heart would necessarily involve damage to the external surface of the heart (epicardium) and would, thus, be a location where the person of ordinary skill in the art would consider applying the anti-adhesion material of USPN ‘661 to prevent the formation of adhesions. With respect to the Examiner’s consultation of the specification of USPN ‘661 in the instant rejection, it is proper to consult the specification of a conflicting patent or patent application to assess the contemplated uses of a claimed product, as in the instant case. This is consistent with the holding of Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). In summary, conflicting claims 1-20 of USPN ‘661 in view of Roufa et al. (US Patent No. 6,417,173; Issued July 9, 2002; cited on IDS filed on March 19, 2024) (“Roufa”) render instant claims 1-13 prima facie obvious.
Conclusion
Claims 1-13 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES H. ALSTRUM-ACEVEDO whose telephone number is (571)272-5548. The examiner can normally be reached M-T/R-F 10 AM to 7:00 PM EDT; W 10 AM to 5 PM EDT.
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, Jennifer “Jenni” K. Michener can be reached at (571) 272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JAMES HENRY ALSTRUM-ACEVEDO
Supervisory Patent Examiner
Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
1 The Examiner notes that USPN ‘661 was previously published as US PG-PUB 2018/0078679 on March 22, 2018 (formerly US patent application No. 15/556,776), which was the publication of the US national phase application of PCT/JP2016/057014, which claimed foreign priority to JP 2015-04922 that was filed on March 12, 2015. The Examiner also notes that USPN ‘661 is to another as the named Applicants and inventive entity are different than that of the instant application. Finally, the Examiner notes that USPN ‘661 is not part of the patent family of the instant application, thus, there is no 121 shield.