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 .
U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
DETAILED ACTION
Claims 1-16 and 23-38 are pending, claims 17-22 are canceled in this application. This application is a national stage entry of PCT/JP2022/004983, filled on 02/08/2022, which claims foreign priority to JP 2021-019175, filed on 02/09/2021 in Japan.
Election/Restrictions
Applicants’ election without traverse of Group I, claims 1-16, filed on 03/25/2026 is acknowledged.
Claims 23-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group or species, there being no allowable generic or linking claim.
Claims 1-16 will presently be examined to the extent they read on the elected subject matter of record.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) for failure to comply with the written description requirement.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984). (Holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.’)
Mere indistinct terms (such as density, dissolution rate, and density to degree of swelling ratio used herein), however, may not suffice to meet the written description requirement. This is particularly true when a material is claimed in purely functional terms. See Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886 (CAFC 2004) at 1892, stating:
The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice…. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).
Conversely, a description of a material will usually comprise a recitation of identifying chemical and/or physical characteristics of a material resulting in the claimed functions and/or properties. See Univ. of Calf. V. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under Section 112, ¶ 1, by showing the enablement of a representative number of species within the genus.
A material genus with the claimed density, dissolution rate, and density to degree of swelling ratio can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. See MPEP 2163. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. MPEP 2163.
Here, the specification does not provide a reasonably representative disclosure of useful material with the claimed density, dissolution rate, and density to degree of swelling ratio generally, a potentially huge genus inclusive of many different materials including future, undiscovered materials (reach-through). Specifically, the specification discloses only a limited number of species in paragraph 50 (particularly example 1 and 2, both are particular thermally crosslinked gelatins under a specific condition of 5% by mass relative to physiological saline), and these are not viewed as being reasonably representative of the genus in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus.
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.
Claims 1-12, 15, and 16 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Akiro Hagiwara et al. (JP 2013226166 A, IDS dated 08/07/2023).
Akiro Hagiwara et al. meet all of the limitations of claims 1-10. Akiro Hagiwara et al. disclose
a bioabsorbable anti-adhesion material comprising a thermally crosslinked gelatin (same as the gelatin in the examples 1 and 2 in the instant specification and thus the claimed bioabsorbable material (A) and (A1) in the instant claims 1-9, and would have the same density in the instant claims 1-3, 6, and 7, density to degree of swelling ratio in the instant claims 2, 3, 6, 7, the claimed degree of swelling in the instant claim 5, and the claimed dissolution rate in the instant claims 1, 2, 4, and 7) film (the claimed implantation device and also the surface of itself in the instant claims 1 and 10)
having 50-90% after 2 days (10-50% dissolution 2 days after implantation, i.e., immersion in physiological environment which is physiological saline mimicking → < 10-50% dissolution 1 day after implantation = 24 hours, also the claimed dissolution rate in the instant claims 1, 2, 4, and 7) of implantation in a living body (abstract).
Akiro Hagiwara et al. meet all of the limitations of claims 11, 12, and 15. Akiro Hagiwara et al. disclose polyethylene glycol being added for imparting flexibility to the film (polyoxyethylene, the claimed polyoxyalkylene non-bioabsorbable material (B) with adhesion preventive ability in the instant claims 11, 12, and 15) according to the instant specification paragraph 88 and 91) (paragraph 11).
Akiro Hagiwara et al. meet all of the limitations of claim 16. Growth factor is not disclosed by Akiro Hagiwara et al.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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).
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. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Akiro Hagiwara et al. (JP 2013226166 A).
The teachings of Akiro Hagiwara et al. are discussed above and applied in the same manner. Akiro Hagiwara et al.’s teaching of adding polyethylene glycol to the fil comprising crosslinked gelatin results in >0% by volume of polyethylene glycol relative to the volume of crosslinked gelatin.
Akiro Hagiwara et al. do not specify the volume of polyethylene glycol relative to the volume of crosslinked gelatin in the instant claims 13 and 14 (>0% vs the claimed 1-100% and 10-100%).
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed ranges of volume of polyethylene glycol relative to the volume of crosslinked gelatin is 1-100% and 10-100% and the range of volume of polyethylene glycol relative to the volume of crosslinked gelatin taught in the prior art is >0% and therefor, includes the claimed ranges.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-16 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, and 4-15 (02/27/2026, notice of allowance dated 03/26/2026) of copending Application No. 18/276,124. Although the patent and instant claims are not identical, they are not patentably distinct from each other.
Although the patent and instant claims are not identical, they are not patentably distinct from each other because claims in both applications are drawn to the same device.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
Prosecution Insights