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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed 21 July 2026 has been entered.
The Request for Continued Examination has been considered. The following information has been made of record in the RCE filed for the instant application:
1. Claims 11 and 17 have been canceled.
2. No new Claims have been added.
3. Claims 1-3, 7, 8, 12-16, 18-19 and 21-23 have been amended.
4. Response to rejections under 35 USC 112, 102, 103 and double patenting.
5. An affidavit under 37 CFR 1.132 by Mathew Gande.
The rejection of Claims 1-4, 10, 12-16 and 20-23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph has been overcome by amendment.
The rejection of Claim 2 under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (CN 108451973, machine English translation; pages 1-6; cited in IDS filed 06/21/2023; of record) has been withdrawn in view of Applicants’ remarks and the affidavit filed. In Zhang the dicarboxylates are not involved in crosslinking. Therefore, Zhang does not anticipate claim 2.
The rejection of Claim(s) 1, 3-4, 12-16, and 21-23 under 35 U.S.C. 103 as being unpatentable over Zhang (CN 108451973, machine English translation; pages 1-6; cited in IDS filed 06/21/2023; of record) in view of WO 2020096281A1 (‘281; Machine English translation, Description pages 1-67, claims pages 1-4; of record), and the rejection of Claim(s) 10 and 20 under 35 U.S.C. 103 as being unpatentable over Zhang (CN 108451973, machine English translation; pages 1-6; cited in IDS filed 06/21/2023; of record) in view of WO 2020096281A1 (‘281; Machine English translation, Description pages 1-67, claims pages 1-4; of record), and further in view of Otom et al (Pharmazie, 2013, 68, 1-9; cited in IDS filed 11/18/202; of record) have been withdrawn in view of applicants’ remarks. In Zhang the dicarboxylates are not involved in crosslinking. The secondary references do not compensate for the deficiencies of Zhang.
The rejection of Claims 1-10, 12-16, and 18-23 provisionally on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 19-24 and 26-34 of copending Application No. 18/021,935 (‘935) in view of Zhang (CN 108451973, machine English translation; pages 1-6; cited in IDS filed 06/21/202; of record3) and further in view of WO 2020096281A1 (‘281; Machine English translation, Description pages 1-67, claims pages 1-4; of record) has been withdrawn in view of Applicants’ remarks. The rejection of claims 18 and 25 has been rendered moot by cancelation.
Claims 1-10, 12-16, and 18-23 are pending in the case. Claims 5-9 and 18-19 have been withdrawn from consideration as being drawn to non-elected invention. Claims 1-4, 10, 12-16 and 20-23 are under examination.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 10, 12-16, and 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Otoum et al (Pharmazie, 2013, 68, 1-9; cited in IDS filed 11/18/2024) in view of Melman (US 2012/0288479A1).
Al-Otoum teaches crosslinking of alginate using terephthalic acid wherein a first alginate is bound to a dicarboxylate via a first multivalent cation and the dicarboxylate is also ionically bound to a second alginate via second multivalent cation (page 2, para 2.1, Fig. 2B; page 4, Fig. 4; page 4, para 2.2; page 5, para 2.3; part of the limitations of claims 1-2, and 4 regarding first alginate and second alginate being crosslinked via cation and a dicarboxylate).
Otoum et al teaches that ionically crosslinked alginate beads suffer generally from poor drug loading, poor stability in biorelevant media and hence fast drug release profiles. Hence, metal ion crosslinked alginates complexes via incorporation of the dicarboxylic acid, terephthalic acid, which is proposed to act as a bridging crosslinking aid was studied (Abstract). Polyethylene terephthalate was combined with hydroxyapatite to yield composite microfibers that mimic the structure of biological bone (page 2, left col., last para; see also parts 2.1-2.3 and 2.6; part of the limitations of claims 10 and 20 regarding fiber). From this teaching of Otom one of ordinary skill in the art will recognize that making alginate polymer which is ionically crosslinked with dicarboxylate-bridged multivalent cations have beneficial properties for use in biomedical applications.
Ottoum does not teach the use of an aliphatic C3-C12 hetero-substituted dicarboxylate for crosslinking and the ratio of dicarboxylates to the alginate carboxylate content as in claims 1-3, 12-16, and 21-23.
Melman teaches that alginates have useful properties such as formation of complexes with multivalent metal cations that crosslink the polysaccharide chains (para 0005). An embodiment of its invention is an alginate polymer which includes a hetero-substituted carboxylate and a multivalent metal ion (para 0010-0011). The carboxylate compound can be tartaric acid and malic acid (para 0032; C3-C12 hetero-substituted dicarboxylate as in claims 1-4, 12-13, and 21-22). In view of the teachings of Melman it would be obvious to one of ordinary skill in the art to make the polymer as claimed by substituting the terephthalic acid of Ottum with hetero-substituted dicarboxylates taught by Melman in the method of making the crosslinked alginate as taught by Otoum. In view of Melman the artisan can make the crosslinked alginates of Ottum using the other dicarboxylates as in claims 1-4, 12-16 and 23, and the fibers as in claims 10 and 20. Both Otoum and Melman teach the ratio of the dicarboxylate to the alginate carboxyl content (Otoum-page 4, part 2.2; and Melman-para 0034).
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since, based on the prior art teachings, alginate polymers having the type of crosslinks as claimed is known in the art to be useful as controlled release matrices (Otoum) and Melman teaches the use of heterosubstituted dicarboxylates for crosslinking.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Product improvement is the motivation. Since Otoum teaches that the crosslinked alginates as instantly claimed are useful as controlled-release matrices, one of ordinary skill in the art will be motivated to look for other crosslinked alginates which are ionically crosslinked with hetero-substituted dicarboxylate-bridged multivalent cations and their fibers as instantly claimed in order to look for products with enhanced beneficial properties for use in the applications taught by the prior art.
It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients in order to achieve a beneficial effect. See In re Boesch, 205 USPQ 215 (CCPA 1980).
Response to Applicants’ Remarks
In view of the amendments and applicants’ remarks the rejection under 35 USC 103 as set forth above is made of record.
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).
The USPTO Internet website contains Terminal Disclaimer forms which may be used. Please visit www.uspto.gov/forms/. The 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 10, 12-16 and 20-23 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 19-24 and 26-40 of copending Application No. 18/021,935 (‘935) in view of Al-Otoum et al (Pharmazie, 2013, 68, 1-9; cited in IDS filed 11/18/2024) and further in view of Melman (US 2012/0288479A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant Claim 1 is drawn to a polymer comprising an alginate which is ionically crosslinked with an aliphatic C3-C12 heterosubstituted dicarboxylate by multivalent cations wherein the dicarboxylates are present in at least about 0.05 equivalents with respect to the alginate carboxylate content. Dependent claims 2-4, 10, 12-16 and 20-23 recite limitations regarding dicarboxylate content, fiber prepared from the polymer of claim 1, formula of dicarboxylates used, and specific dicarboxylates. Claims 5, 7-9 and 17-19 are drawn to process for preparing the polymer of claim 1. Claim 6 is drawn to a process for preparing a shaped article from a polymer of claim 1.
Claim 23 of ‘935 is drawn to a polymer comprising an alginate, which is ionically crosslinked with unsubstituted, aliphatic dicarboxylate-bridged multivalent cations. Dependent claims 19-22, 24, 26, 28-31, and 34-38 are drawn to a process for making the polymers and fibers of claim 23 and 28. Claim 24 is a product-by-process claim, which is a product claim. Claim 26 is drawn to a process for preparing a shaped article from the polymer of claim 23. Claims 27, 32 and 33 are drawn to a fiber and fabric. Claims 28-31 are drawn to a process for preparing the fiber of claim 27 and claim 34 is drawn to a process of preparing a fiber by wet spinning. Claims 39-40 are product-by-process claims drawn to a fiber by the process of claims 37 and 39 respectively.
There is overlap of the instant claims with those of ‘935.
The copending claims of ‘935 differ from the instant claims in that the instant claims are drawn to alginate which is ionically crosslinked with an aliphatic C3-C12 heterosubstituted dicarboxylate by multivalent cations, whereas the claims of ‘935 are drawn to alginate which is ionically crosslinked with unsubstituted aliphatic dicarboxylate bridged multivalent cations.
Although the claims of '935 teach alginate which is ionically crosslinked with unsubstituted aliphatic dicarboxylate bridged multivalent cations, one of ordinary skill in the art would readily recognize that the scheme taught by '935 can be modified to arrive at the instant invention with a reasonable expectation of success in view of the teachings of the secondary references which are set forth above.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Product improvement is the motivation. One of ordinary skill in the art would be motivated to make alginate products using the dicarboxylates as in the instant claims in order to look for crosslinked alginates which have optimal properties for the use taught by the prior art (Al-Otoum).
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Applicant’s Remarks
The obviousness-type double patenting as set forth above is made of record.
Conclusion
1. Elected claim(s) 1-4, 10, 12-16 and 20-23 (Group I) are rejected.
2. Group II, claim(s) 5, 7-9, and 17-19, and Group III, claim 6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
3. Claims 11 and 17 have been canceled.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHY KRISHNAN whose telephone number is (571)272-0654. The examiner can normally be reached M-F 8.30am-5pm.
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693
