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 .
The supplemental amendment filed 24 November 2025 has been received, entered and considered. The following information has been made of record in the instant amendment:
1. Claims 11 and 17 have been canceled.
2. New Claims 21-23 have been added.
3. Claims 1-2, 4-5, 7, 13, 15-16 and 18 have been amended.
4. Remarks drawn to IDS, and rejections under 35 USC 112, 102, 103 and double patenting.
The following objection(s)/rejection(s) has/have been overcome:
5. The rejection of claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for recitation of ‘at least about’ has been withdrawn in view of applicant’s remarks. The rejection of claim 11 has been rendered moot.
6. The rejection of Claim 11 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) has been rendered moot by cancelation.
7. The rejection of Claims 11 and 17 provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 18-34 of copending Application No. 18/021,935 (‘935) in view of Zhang (CN 108451973, machine English translation; pages 1-6; cited in IDS filed 06/21/2023) and further in view of WO 2020096281A1 (‘281; Machine English translation, Description pages 1-67, claims pages 1-4) 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 Claims 5-9 and 18-19 have been withdrawn as being drawn to non-elected invention. Claims 1-4, 10, 12-16, and 20-23 are under prosecution in this Action.
The following rejections are necessitated by Applicant's amendment filed 24 November 2025wherein the limitations in pending claims 1-2, 4-5, 7, 13, 15-16 and 18 have been amended.
Information Disclosure Statement
Applicant has stated that the Examiner has omitted the IDS filed on July 7, 2025. The said IDS was considered, initialed, signed and dated on 30 September 2025. The signed copy appears in the Table of Contents of the application on 9/30/2025, which is also date on which the Office Action was mailed. The partial English translation of the Japanese document cited in the IDS filed July 23, 2025 has been considered. An initialed, signed copy of this IDS is attached.
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.
Claims 1-4, 10, 12-16 and 20-23 are 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.
Amended claim 1 recites ‘ionically crosslinked with an aliphatic C3-C12 hetero-substituted dicarboxylate by multivalent cations’. The amendment is still not clear. The same recitation also appears in claim 2. The claims are examined as drawn to an alginate crosslinked with either an aliphatic C3-C12 hetero-substituted dicarboxylate or by multivalent cations or by both.
Claims 3-4, 10, 12-16 and 20-23, which depend from a rejected base claim that is unclear/indefinite are also rendered unclear/indefinite and are rejected for the same reasons. All claims which depend from an indefinite claim are also indefinite. Ex parte Cordova, 10 U.S.P.Q. 2d 1949, 1952 (P.T.O. Bd. App. 1989).
Response Applicant’s Remarks
Applicant has stated in the remarks that the multivalent cation crosslinks the alginate through the heterosubstituted dicarboxylate. Claims 1-2 have been amended to clarify the crosslinking and that the amendment is supported by at least paragraph 0061 of the specification (page 8 of remarks).
Claims 1 and 2 as amended are still not clear regarding the crosslinking. If the multivalent cation crosslinks the alginate through the heterosubstituted dicarboxylate as in para 0061 then it should be recited in claims 1-2. The amendment as such does not convey this aspect of the crosslinking. The rejection is maintained.
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 2 is rejected 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).
Zhang teaches a polymer comprising alginate which is crosslinked with calcium tartrate (page 1, claims 1-6; page 2, paras 2-7 under sub-title: Invention content; the polymer as in claim 2). Calcium ion is a multivalent ion and tartrate is a heterosubstituted dicarboxylate. The recitation in claim 2 regarding how the polymer is made is not given patentable weight.
Claim 2 is a Product-by-Process claim. Product-by-Process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Therefore, claim 2 is anticipated by Zhang.
Response to Applicant’s Remarks
Applicant has traversed the rejection of claim 2 under 35 USC 102 over Zhang arguing that in Zhang the gelling agent is alginate, such as sodium, potassium or ammonium alginate. The crosslinking agent is acid-soluble and is not water-soluble. In addition, the dicarboxylate chelates the multivalent ions, preventing the multivalent ions from reacting until they are released by the addition of acid, at which point the multivalent ions become dicarboxylic acids and do not participate in further crosslinking. In the claimed embodiments the soluble dicarboxylates participate by becoming part of the ionic crosslinked polymer.
In Zhang the dicarboxylate modulate the rate of the crosslinking reaction through slow release of the multivalent metal ions. The metal ions then crosslink with the alginate. For this reason, favorable reconsideration is requested. (pages 9-10 of remarks).
Applicant’s arguments are not persuasive. Claim 2 is drawn to an alginate crosslinked with a C3-C12 hetero-substituted dicarboxylate by multivalent cations. Zhang teaches an alginate which is mixed with calcium tartrate. Calcium is multivalent cation and tartrate is a hetero-substituted dicarboxylate. Combination of these two should produce the claimed alginate polymer even if the dicarboxylate (tartrate in the instant case) modulates the rate of crosslinking. Applicant’s arguments do not clearly establish that this is not so. The rejection is maintained.
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, 3-4, 12-16, and 21-23 are rejected 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).
Zhang’s teachings are set forth above. The teachings of Zhang meet part of the limitations of claims 1, 3, 4 (regarding alginate ionically crosslinked with a heterosubstituted dicarboxylate by multivalent cations), and claims 12 and 22 for tartaric acid. Zhang’s teaching also reads on the polymer of claim 1 except for the molar equivalent of the dicarboxylate.
Zhang does not expressly teach that the dicarboxylates are present in at least about 0.05 molar equivalent with respect to the alginate carboxylate content as in claim 1, does not teach the limitations of claim 3 regarding the molar equivalent of the dicarboxylate, and does not teach the limitations of claims 13-16, 21 and 23.
‘281, drawn to alginate-based gel, teaches alginate crosslinked with multivalent metal ions like calcium aspartate, calcium saccharate, and a crosslinking speed regulator like malic acid. The crosslinking agent and the regulator are not limited in their ratios but is preferable to use a molar ratio of 0.1 to 0.4 times based on the mole number (X) of carboxylic acid groups present in alginic acid (Abstract; paras 0009, 0015, 0019-0022; molar ratio of dicarboxylate as in claim 1, limitation of claims 12, 21 and 23-malic acid, saccharic acid, and limitation of claim 16-aspartic acid).
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, alginic acid which is ionically crosslinked C3-C12 with hetero-substituted dicarboxylate by multivalent cations in the claimed dicarboxylate ratios are known in the art and are useful to encapsulate a drug for slow release at the injected lesion site (‘281-para 0038). Thus, it is obvious to arrive at the claimed invention in view of the combined teachings of the prior art.
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. Also, preparing an injectable hydrogel based on crosslinked alginate containing a drug can have a long-lasting effect and the desired effect of the drug can be achieved in the target area by injecting a small amount of the drug while reducing the side effects of the drug on the surrounding tissues (‘281-para 0038). This teaching provides additional motivation for making the claimed alginate polymers.
It would be obvious to one of ordinary skill in the art to make the polymers as in claim 3, and the polymer of claim 1 having the dicarboxylates as in claims 11-16. One of ordinary skill in the art would be motivated to make alginate products using the dicarboxylates as in claims 11-16 in order to look for crosslinked alginates which have optimal properties for the use taught by ‘281 (para 0038).
Response to Applicant’s Remarks
Applicant has traversed the rejection of claims under 35 USC 103 over Zhang and Choi arguing that claim 1 is patentable over Zhang and Choi for similar reasons discussed for claim 2 above.
Choi relates to an alginic acid-based injectable hydrogels for imaging or drug delivery purposes. Choi pertains to alginate crosslinked with metal ions, and not a polymer comprising an alginate which is ionically crosslinked through hetero-substituted dicarboxylate bridged multivalent cations (see para 0090 of choi). The acids of Choi are used as crosslinking rate controllers (para 0017). Accordingly, favorable reconsideration is requested. (pages 11-12 of Remarks).
Applicant’s arguments are not persuasive. As explained above, Zhang teaches an alginate which is mixed with calcium tartrate. Calcium is multivalent cation and tartrate is a hetero-substituted dicarboxylate. Combination of these two should produce the claimed alginate polymer even if the dicarboxylate modulates the rate of crosslinking even as in Choi.
Choi teaches alginate crosslinked with multivalent metal ions like calcium aspartate, calcium saccharate, and a crosslinking speed regulator like malic acid. Even though malic acid may be used as a speed regulator, it can still crosslink the alginate via the calcium ion as instantly claimed when mixed together. Choi’s teaching is also used for suggesting the ratio as in claim 1. Therefore, the combined teachings of Zhang and Choi do render the instant claims obvious. The rejection is maintained.
Claim(s) 10 and 20 are rejected 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).
The teachings of Zhang and ‘281 are set forth above. Both references do not teach a fiber of the polymer as in claims 10 and 20.
Otom 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; part of the limitations of the fiber of claims 10 and 20: alginate crosslinked with dicarboxylate-bridged multivalent cations). 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).
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. Even though Otom does not expressly teach the use of heterosubstituted dicarboxylates for making fibers as instantly claimed, one of ordinary skill in the art would find it obvious to substitute terephthalic acid with the heterosubstituted dicarboxylates taught by Zhang and the ‘281 references to make fibers also.
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, dicarboxylate bridged alginates display properties that are advantageous and fibers of these in combination with hydroxyapatite has been used as mimics of biological bones (Otom). Thus, it is obvious to make fibers of alginate which is ionically crosslinked with hetero-substituted dicarboxylate-bridged multivalent cations as instantly claimed.
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 will be motivated to look for other fibers of alginate which is ionically crosslinked with hetero-substituted dicarboxylate-bridged multivalent cations as instantly claimed in order to look for products with beneficial properties for use in the applications taught by the prior art.
Response to Applicant’s Remarks
Applicant has traversed the rejection of claims 10 and 20 under 35 USC 103 over Zhang, Choi and Al-Otom arguing that Al-Otom is concerned exclusively with the preparation of controlled release pharmaceutical formulations. It is not concerned with preparation of industrial products having optimized mechanical integrity, such as fibers for applications in the textile industry. No consideration is given in Al-Otom to matters such as elasticity, resilience and/or tenacity of the polymers described therein. Al-Otom’s polymers are metal-ion crosslinked alginate-terephthalate beads. Al-Otom’s polymer lacks the aliphatic dicarboxylate bridging component of the polymers recited in the present claims. Al-otom dose not discuss fibers comprising such polymers, processes for preparing such fibers or fabrics prepared from such fibers, which are also claimed in the present application.
Al-Otom places significant importance on the hydrophobic aromatic nature of its terephthalate component for achieving the specific technical effects being sought, namely of modulating the release profile of the model MB drug loaded into the beads as well as preventing drug leaching during preparation of the beads. The skilled person would have had no reason to consider such polymers as useful starting point for working on the claimed embodiments, with its entirely different goals and desired technical properties. The addition of heteroatoms to a polymer chain would decrease it hydrophobicity. Thus, the polymers of the claimed embodiments would not be useful in Al-Otom and vice-versa. The artisan would not be led to use the current crosslinkers in the polymers of Al-Otom, since Al-Otom teaches the importance of using the more rigid terephthalate bridges. For these reasons favorable reconsideration is requested. (pages 12-15).
Applicant’s arguments ae not persuasive. Al-Otom may teach the preparation of controlled release pharmaceutical formulations. However, it teaches combination of terephthalate (a dicarboxylate) and hydroxyapatite (has calcium ions) to give composite fibers that mimic bone structures (page 2, left col., last para, lines 5-7). Even though there is no express teaching regarding the use of alginate, in view of the teachings of Zhang and Choi, one of ordinary skill in the art would make the fiber as claimed in order to look for other fibers having ideal properties for the use described. The artisan would also look for fibers as claimed instead of beads, to make a matrix in order to look for ideal drug release profile for application as drug carriers.
Al-Otom need not necessarily be concerned with preparation of industrial products having optimized mechanical integrity, such as fibers for applications in the textile industry, and need not give consideration to matters such as elasticity, resilience and/or tenacity of the polymers described therein. The prior art need not necessarily give considerations to properties that may by relevant to an embodiment of the present invention which is claimed. Al-Otoms teachings in view of Zhang and Choi are relevant to the fibers comprising the crosslinked alginates as claimed. Since Zhang and Choi teach aliphatic dicarboxylate bridging components for alginate as claimed, Al-Otom need not teach the same.
Al-Otom has explored the terephthalate bridging for modulating the release profile of the model MB drug loaded into the beads as well as preventing drug leaching during preparation of the beads. The skilled person would consider such polymers as useful starting point for looking at modulating the release profiles of drugs using a matrix made from fibers or beads having alginates with the C3-C12 aliphatic hetero-substituted dicarboxylate by multivalent cations in view of Zhang and Choi, and also look at the fibers for use as mimics as taught by Al-Otom. The instant dicarboxylate bridge also has aliphatic carbon chain which will impart some hydrophobicity. Such is well within the skill level of the artisan to recognize and perform in view of the combined teachings of the prior art. Regarding the calcium-crosslinked alginate-terephthalate beads Al-Otom teaches that illustrated enteric release behavior regardless of their curing temperatures (Abstract). There is no teaching or suggestion of any unexpected properties using the terephthalate bridges in Al-Otom.
The combined teachings of the cited references do render the instant claims obvious. The rejection is maintained.
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 1-10, 12-16, and 18-23 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 18-34 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-; of record4). 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, 11-16 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 18 of ‘935 is drawn to a polymer comprising an alginate, which is ionically crosslinked with unsubstituted, aliphatic dicarboxylate-bridged multivalent cations. Dependent claims 19-24 recite limitations drawn to dicarboxylates. 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 18. 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 process of preparing a fiber by wet spinning.
There is overlap of instant claims 1-4 and 11-16 with the claims 18-24 of ‘935, overlap of instant claims 5 and 7-9 with claim 25 of ‘935, overlap of claim 6 with claim 26 of ‘935, overlap of instant claims 7-8 and 18-19 with claims 28-30 of ‘935, and overlap of instant claims 10 and 20 with claims 27, 32 and 33 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 in order 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.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Applicant’s Remarks
Applicant has traversed the double patenting rejection of record arguing that the Examiner’s comments are merely conclusory. The Examiner merely argues that the proposed modification would have been obvious due to product improvement but provides no further technical comments. This is insufficient to satisfy the burden of establishing non-statutory obviousness-type double patenting. For this reason, favorable reconsideration is requested (Remarks-page 15).
Applicant’s arguments are not found to be persuasive. The Examiner ahs stated product improvement as the motivation and has also mentioned that the artisan would do it in order to look for crosslinked alginates which have optimal properties for the use taught by the prior art. The motivation taught is sufficient to establish non-statutory obviousness-type double patenting. The rejection is maintained.
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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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