DETAILED ACTION
This Office Action is in response to the Amendment filed on 10/14/2025. Claim 20 has been added. Claims 5, 7-9, 11-15 and 20 are now pending in the application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/14/2025 has been entered.
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5 sets forth “comprising at least unit selected from” in line two. This is assumed to be an error of omission and read as “comprising at least one unit selected from” Appropriate correction is required.
Claim 20 is objected to because of the following informalities: Claim 20 sets forth “comprising at least unit selected from” in line two. This is assumed to be an error of omission and read as “comprising at least one unit selected from” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 is rejected as being indefinite because claim 20 refers to A, n1, n2, n3, R, R2, and R3, none of which are defined in the claim. For purposes of examination, these moieties will be interpreted as the same moieties set forth in Claim 5.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 5 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2016050788 to Schultze et al. (as found on the IDS dated 5/18/2022).
Regarding Claim 5 and 12-14 Schultze teaches a sulfhydryl modified polymer compound which is obtained from hyaluronic acid (reading on the polymer compound to be modified, which comprises -OH groups). The hyaluronic acid is then modified with acrylic anhydride [Page 23, lines 12-25] and further reacted with dithiothreitol [page 28, Example 1a’].
Schultze teaches the sulfhydryl modified polymer compound wherein an acrylate modified polymer compound (hyaluronic acid reacted with acrylic anhydride) has the below structure (left) without the indicated methyl group, and is reacted with dithiothreitol [page 28, Example 1a’] to form the structure (right) without the indicated methyl group.
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(see figure 12 of instant application)
Though Schultze does not expressly show the structure of the obtained sulfhydryl modified polymer compound, the reaction disclosed by Schulze is substantially the same reaction as in instant application’s Example 4 wherein methacrylic anhydride is reacted with hyaluronic acid [instant application, 0184] and further reacted with dithiothreitol [Instant application, 0226]. The only difference between applicant’s process in Example 4 and the process of Schulze is that applicant uses methacrylic anhydride, while Schulze uses acrylic anhydride. Methacrylic anhydride differs from acrylic anhydride only by the presence of a single methyl group. It is then the Office’s position that it would be reasonably expected that the process of preparing a sulfhydryl-modified polymer compound in Example 1a’ of Schultze yields the above structure except that the above indicated methyl group is absent. Such a compound reads on the sulfhydryl-modified polymer compound shown below
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in which at least part of the OH-groups of the hyaluronic acid polymer have been modified to form a polymer compound wherein R1, R2, and R3 are hydrogen, R4 is the fragment of dithiothreitol (reading on the -S-R4-SH fragment is introduced from a polysulfhydryl compound selected from
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, A is a fragment of the hyaluronic acid polymer compound comprising at least one of the -OH groups, n1 is n2 represent the number of acrylate modified groups, and n3 represent the number of acrylate modified groups that have been further sulfhydryl-modified.
Schultze is silent regarding the sulfhydryl content of the sulfhydryl-modified polymer compound as determined by an Ellman method.
However, Schultze, when modified in the manner proposed above, teaches a product prepared from all of the claimed ingredients in the claimed amounts by a substantially similar process. Therefore, the claimed effects and physical properties - i.e. sulfhydryl content of the sulfhydryl-modified polymer compound as determined by the Ellman method is 0.01-30 mmol/g - would implicitly be achieved in a product prepared from all of the claimed ingredients in the claimed amounts by a substantially similar process. See In Re Spada, 911, F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) and MPEP 2111.01 (I)(II). If it is applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position and (2) it would be the Office’s position that the application contains inadequate disclosure as to how to obtain the claimed properties in a product prepared from all of the claimed ingredients in the claimed amounts by a substantially similar process.
Regarding Claim 11, Schultze teaches the sulfhydryl-modified polymer of claim 5, wherein the -s-R4-SH fragment is introduced from dithiothreitol [page 28, Example 1a’] corresponding to the below structure
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wherein n4, n5, and n6, are not required, therefore reading on the limitations set forth in claim 11.
Regarding Claim 15, Schultze teaches the sulfhydryl-modified polymer of claim 5, comprising the following structure as set forth in the rejection of claim 5:
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reading on the following structure:
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Wherein * represents the linking site between repeating units of the main chain and ** represents a linking site between -OH and the fragment.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 20 are rejected under 35 U.S.C. 103 as being unpatentable over WO2016050788 to Schultze et al. (as found on the IDS dated 5/18/2022).
Regarding Claim 20, Schultze teaches a sulfhydryl modified polymer compound which is obtained from hyaluronic acid (reading on the polymer compound to be modified, which comprises -OH groups). The hyaluronic acid is then modified with acrylic anhydride [Page 23, lines 12-25] and further reacted with dithiothreitol [page 28, Example 1a’].
Schultze teaches the sulfhydryl modified polymer compound wherein an acrylate modified polymer compound (hyaluronic acid reacted with acrylic anhydride) has the below structure (left) without the indicated methyl group, and is reacted with dithiothreitol [page 28, Example 1a’] to form the structure (right) without the indicated methyl group.
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(see figure 12 of instant application)
Though Schultze does not expressly show the structure of the obtained sulfhydryl modified polymer compound, the reaction disclosed by Schulze is substantially the same reaction as in instant application’s Example 4 wherein methacrylic anhydride is reacted with hyaluronic acid [instant application, 0184] and further reacted with dithiothreitol [Instant application, 0226]. The only difference between applicant’s process in Example 4 and the process of Schulze is that applicant uses methacrylic anhydride, while Schulze uses acrylic anhydride. Methacrylic anhydride differs from acrylic anhydride only by the presence of a single methyl group. It is then the Office’s position that it would be reasonably expected that the process of preparing a sulfhydryl-modified polymer compound in Example 1a’ of Schultze yields the above structure except that the above indicated methyl group is absent. Such a compound reads on the sulfhydryl-modified polymer compound shown below
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in which at least part of the OH-groups of the hyaluronic acid polymer have been modified to form a polymer compound wherein R1 is hydrogen.
Schultze does not particularly teach that R1 is halogen, an aliphatic group, or an aromatic group in the selected embodiment.
However, Schultze teaches the hyaluronic acid grafted with (meth)acrylate groups can be obtained by reaction of hyaluronic acid with (meth)acrylic anhydride [P4, L7-L12], thereby including methacrylic anhydride or acrylic anhydride as suitable options. The reaction of methacrylic anhydride with hyaluronic acid, and further reacted with dithiothreitol will yield the above structure wherein R1 is a methyl group, thereby reading on R1 is an aliphatic group.
Before the effective filing date, it would have been obvious to one of ordinary skill in the art to substitute acrylic anhydride for methacrylic anhydride.
The motivation would have been that it is obvious to substitute equivalents known for the same purpose. (MPEP 2144.06) Schultze teaches that both acrylic anhydride and methacrylic anhydride are suitable modifiers for the sulfhydryl-modified polymer compounds, thus providing evidence of obviousness in substituting one for the other in the disclosed compositions.
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 5, 11-15, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, and 11-15 of copending Application No. 17/756183. Although the claims at issue are not identical, they are not patentably distinct from each other.
It is clear that all the elements of the instant claims are to be found in the claims of Application No. 17/756183, as the instant claims fully encompass the claims of Application No. 17/756183. The difference between the instant claims and the claims of Application No. 17/756183 lies in the fact that the latter claims include more elements, e.g. the hydrogel set forth in Application No. 17/756183 comprises the instantly claimed polymer, and is therefore more specific. The invention of the claims of Application No. 17/756183 is thus in effect a "species" of the "generic" invention of the instant claims. It has been held that the generic invention is "anticipated" by the "species". See In Re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the instant claims are anticipated by the claims of Application No. 17/756183, they are not patentably distinct from these claims.
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive.
Applicant states amended claim 5 is not anticipated by Schultze, since R’ groups in the amended units neither contain a heteroatom nor a methylene group. However, claim 5 recites a Markush group for the sulfhydryl-modified polymer compound including the multiple structures. Attention is drawn to the rejection of claim 5 in which Schultze is found to anticipate the following structure of claim 5:
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The limitations directed to R’ do not further limit the above embodiment because this embodiment lacks an R’ moiety. As such, the Office maintains the position that claim 5 is properly rejected under 35 U.S.C. 102(a)(1) by expressly teaching one of the members of the Markush group as set forth above.
CorrespondenceAny inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN MITCHELL DARLING whose telephone number is (703)756-5411. The examiner can normally be reached Monday - Friday 7:30am - 5:00pm.
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/DEVIN MITCHELL DARLING/Examiner, Art Unit 1764
/MELISSA A RIOJA/Primary Examiner, Art Unit 1764