DETAILED ACTION
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 . 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.
Priority
The instant application is a 371 of PCT/EP2020/064159 filed on 05/20/2020 and claims foreign priority to French application no. FR1905504 filed on 05/24/2019. The certified copy of the foreign priority application filed on 11/24/2021 is acknowledged.
Status of the Claims
The claim amendments and remarks filed on 06/24/2026 is acknowledged. Claim 12 is amended. Claim 2 is cancelled.
Accordingly, claims 1 and 3-24 are pending and being examined on the merits herein.
Withdrawn Objections/Rejections
The objection to claim 12 is withdrawn in view of the corrected spelling of “1,4- butanediol diglycidyl ether”.
The 35 USC 103 rejections over White in view of CN’795 for claims 1, 4-14, 16-19, and 22-24, over White in view of CN’795 and Muslim for claim 3, over White in view of CN’795 and Zhao for claim 15, and over Patchornik in view of White and CN’795 for claims 1, 16, and 19-21 are withdrawn after re-consideration and as indicated in the allowable subject matter section below.
The nonstautory double patenting rejections over US’342 and US’281 are withdrawn after re-consideration and as indicated in the allowable subject matter section below.
The following grounds of rejection are 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 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, 4-14, and 16-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,896,607 in view of White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025).
Claim 1 of US‘607 recites a method of therapeutic treatment for osteoarthritis or repairing a cartilage defect, said method comprising administering a carboxyalkyl chitosan to a subject in need thereof, wherein said carboxyalkyl chitosan is administered via injection into the synovial fluid or via implantation in the cartilage, wherein said carboxyalkyl chitosan comprises glucosamine units, N-acetyl-glucosamine units, and glucosamine units substituted by a carboxyalkyl group, wherein the carboxyalkyl chitosan is N,O-carboxyalkyl chitosan and has: a zeta potential, measured at pH 7.5, that is lower than or equal to −18 mV; a degree of acetylation in a range of about 40% to about 80%, expressed at the number of moles of N-acetyl-glucosamine units relative to the number of moles of total units; and a degree of substitution by the carboxyalkyl group that is greater than 70% expressed as the number of moles of the substituent carboxyalkyl group relative to the number of moles of total units, and wherein the carboxyalkyl chitosan is water-soluble at a pH less than 3.5 and at a physiological pH and is sufficiently pure and suitable for providing a non-opalescent aqueous solution for injection, implantation, or instillation to a human or animal subject. Claim 4 of US’607 recites wherein the chitosan is derived from the group consisting of Basidiomycetes, mycelium of Ascomycetes, and a mixture thereof. Claim 9 of US’607 recites wherein said aqueous solution further comprises hyaluronic acid or sodium hyaluronate, either crosslinked or not crosslinked by covalent bonds. Claims 6 and 11-12 of US’607 recite the composition is sterilized, in a medical device, and a pharmaceutical composition.
US’607, however, does not recite a cohesive gel or a recited crosslinking agent.
White et al. discloses novel compositions consisting of semi-interpenetrating network of cross-linked water-soluble derivatives of basic polysaccharides and a non-cross-linked component (see Abstract). White discloses that the composition can be formed into films, sponges or hydrogels, and can find further use in a wide range of medical applications such as dermatology, plastic surgery, urology, and orthopedics (see paragraph 0020 and Abstract). White et al. discloses their compositions can be formed into biomaterials for use in medical applications such as to produce an injectable hydrogel (see paragraph [0022]). White discloses that the hydrogel compositions can comprise of a chitosan derivative such as N-Carboxy methyl chitosan, O-Carboxy methyl chitosan or O-Hydroxy ethyl chitosan or a partially N-acetylated chitosan (paragraph 0017). White discloses that the partially N-acetylated chitosan can be produced by partially deacetylating chitin or by re-acetylating chitosan, and in either case, the degree of acetylation is 45% to 55% (paragraph 0017). White discloses that a re-acetylated chitosan having a degree of acetylation of 45-55% is used in order to achieve water soluble properties (see paragraph 0027), and further discloses that approximately 50% re-acetylated chitosan is used since it can be solubilized in neutral media without protonation of the amine groups (see paragraph 0027).
White et al. demonstrates in Example 6 a process of preparing their hydrogels, in which a crosslinking agent, BDDE, was added at 0.7 grams to a mixture solution of re-acetylated chitosan (1.9 grams and 5% weight) and hyaluronic acid (prepared by fermentation and 1.9 grams and 5% weight) to form a crosslinked hydrogel having a 12.5 mg/mL final concentration for each polymer (or 25 mg/mL final concentration of polymers) (see paragraph 0043).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the preparation of the hydrogel recited in the claims of US’607 by including the preparation steps of White and using the BDDE crosslinking agent and a hyaluronan obtained by fermentation as disclosed in White to arrive at the claimed invention. One of ordinary skill in the art could have combined the claims of US’607 and White according to known methods to yield predictable results because both the claims of US’607 and White recite a hydrogel matrix via crosslinking a chitosan derivative and hyaluronic acid.
Lastly, the recited cohesive gel or viscoelastic cohesive gel, and the recited covalent crosslinking of carboxyalkyl chitosan chains as well as the co-crosslinking of carboxyalkyl chitosan and hyaluronan in the instant claims would all flow naturally and would be necessarily present in the combination of the claims of US’607and White because the combination described above recites forming the instant composition as disclosed in Example 6 of White by using 5% by weight for the N,O-carboxyalkyl chitosan and hyaluronic acid (10% by weight total and 1.9 grams each or 50:50 mass ratio), a BDDE/polymer percent of ~18% (0.7 g BDDE / 3.8 g polymers), and a final concentration of each polymer at 12.5 mg/mL (or 25 mg/mL total polymer), and as demonstrated in Tables 3a and 3b (pages 40-41) of the instant specification, a co-crosslinked carboxyalkyl chitosan (CC) and hyaluronic acid (HA) composition that was formed using 11% concentration of polymers, 75:25, 50:50, or 25:75 CC/HA mass ratio, 13% or 18% BDDE/polymers, and 22-24 mg/mL final concentration of polymers had the recited crosslinking, cohesive gel, and viscoelasticity. Therefore, these recited properties would all flow naturally and would be necessarily present as the combination described above recite forming the same composition using the same amounts/ratio of the same polymers and crosslinking components.
MPEP 2145 II states that “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
MPEP 2112 section I states that "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable”. Furthermore, MPEP 2112.01 section II recites “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
In regards to instant claim 4, it would have also been prima facie obvious before the effective filing date of the claimed invention to have modified the N,O-carboxymethyl chitosan – hyaluronic acid crosslinked composition as recited by the combination of the claims of US’607 and White described above by re-acetylating the chitosan as disclosed in White. One of ordinary skill in the art could have combined prior art elements according to known methods to yield predictable results because White provides guidance that the degree of acetylation to 45% to 55% can be adjusted by either de-acetylating chitin or re-acetylating chitosan.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,896,607 in view of White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025) and Muslim et al. (International journal of biological macromolecules, 2018 in PTO-892 dated 04/02/2026).
The claims of US’607 and the teachings of White are as described to arrive at the matrix recited in instant claim 1 as discussed above.
The combination, however, does not recite a chitosan being derived from the mycelium of an Ascomycete fungus.
Muslim teaches biological methods for extraction of chitosan and as an alternative for chemical methods (see Abstract). Muslim teaches that chitosan is less commonly found in living organisms than chitin and can be found in the cell walls of fungi (see second paragraph left column page 52). Muslim discloses that chitosan has many unique biocompatible, biodegradable, and biological properties, making them suitable for a wide variety of applications such as cosmetics, pharmaceuticals, food additives, and agriculture (see right column page 52).
Muslim demonstrates extracting chitosan from the mycelium of Aspergillus flavus (an Ascomycete fungus) by using lactic acid bacteria for demineralization followed by deproteinization by a proteolytic bacterium (see section 2.3 on page 53). Muslim discloses that the production of chitosan from endophytic fungi can be considered as an alternative source to chitosan production from the shells of crustaceans, and further discloses that the recovery of produced chitosan from fungi can be appropriated and scaled up for large scale production (see last paragraph right column page 55). Muslim further demonstrates in Figs. 2-3 and 6 (pages 56-57) the antimicrobial properties of the extracted chitosan, in which biofilm formation was significantly decreased in the presence of the chitosan. Muslim discloses that the extracted chitosan also decreased expression of lasR and rhlR genes and had a synergistic effect with combined with antibiotics (also see Tables 3 and 4 on pages 55-56), thus the chitosan may be useful as an adjuvant agent for treatment of many bacterial infections (see Abstract).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the N,O-carboxymethyl chitosan – hyaluronic acid crosslinked composition as recited by the combination of the claims of US’607 and White described above by using a chitosan derived from the mycelium of Aspergillus flavus as disclosed in Muslim. One of ordinary skill in the art would have been motivated to use a chitosan derived from the mycelium of Aspergillus flavus because Muslim discloses that this extracted chitosan had significant antimicrobial properties as well as a synergistic effect with antibiotics. One of ordinary skill in the art would have a reasonable expectation of success because Muslim discloses that their chitosan production can be used as an alternative source to chitosan produced from the shells of crustaceans.
Claims 1 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,896,607 in view of White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025) and Zhao et al. (Carbohydrate Polymers, 2011 in PTO-892 dated 09/03/2025).
The claims of US’607 and the teachings of White are as described to arrive at the matrix recited in instant claim 1 as discussed above.
The combination, however, does not recite wherein the matrix has an antioxidant capacity by scavenging free radicals.
Zhao et al. discloses the biochemical activity of N,O-carboxymethyl chitosan from squid cartilage (see Abstract). Zhao et al. discloses their carboxymethyl chitosan had a degree of substitution of 0.64, 0.81, 1.0, 1.33, and 1.59 (see Abstract). Zho et al. demonstrates in Fig. 2 (page 834) that the carboxymethyl derivatives had a higher scavenging effect towards DPPH radicals (free radicals) than unmodified chitosan. Zhao et al. discloses that DPPH free radical scavenging by antioxidants is due to their hydrogen-donating ability, and further discloses that the introduction of carboxymethyl groups on the chitosan may improve its hydrogen-donating ability (see first paragraph left column on page 835). Zhao et al. concludes that based on their results, carboxymethyl chitosan may be used as a source of antioxidants, and a possible food supplement or ingredient in the pharmaceutical industry (see last paragraph left column page 836).
It would have been prima facie obvious before the effective filing date of the claimed invention that the modified carboxymethyl chitosan composition as suggested by the combination of the claims US’607 and the teachings of White described above would also possess an antioxidant capacity by scavenging free radicals as disclosed in Zhou et al. One of ordinary skill in the art would have this reasonable expectation because Zhou et al. establishes that similar N,O-carboxymethyl chitosans with similar degrees of substitution possess this antioxidant capacity by free radical scavenging, and further discloses that the carboxymethyl groups on the chitosan may improve its hydrogen-donating ability for free radical scavenging.
Response to Arguments
Applicant’s arguments filed on 06/24/2026 have been fully considered but were not persuasive.
Applicant states in response to the nonstatutory double patenting rejections over US’607 that these rejections fail for the same reasons as the combination of White and CN’795 in the prior art rejection fails.
Applicant’s arguments described above were not found persuasive because the prior art rejection over the combination of White and CN’795 relies on a substitution rationale to substitute to the NOCC of CN’795, whereas the nonstatutory double patenting rejections over US’607 relies on a different modification and rationale using White as discussed and does not rely on substitution with the NOCC of CN’795 to arrive at the claimed invention. Therefore, Applicant’s argument is rendered moot.
Furthermore, MPEP 2122.01 I states that “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established … When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not”.
In this case, US’607 recites identical structural features of the crosslinked NOCC – hyaluronic acid hydrogel (40-80% DA and greater than 70% DS), and White provides guidance of all of the same preparation steps and reagent amounts as discussed above such that the recited “cohesive” hydrogel limitation would have flowed naturally and have been necessarily present.
Applicant further states in response to the nonstatutory double patenting rejections over US’607 that the additional references used (Muslim, Zhao, and Patchornik) fail for the same reasons set forth in Section II.D through II.F of the filed response.
Applicant states that the motivation to use a chitosan of fungal origin is speculative at best because the ordinary skilled artisan would have no motivation to choose this specific property, particularly when the reference does not characterize the chitosan’s properties in a manner relevant to hydrogel formation.
Applicant’s argument above was not found persuasive because Muslim discloses that that their fungal chitosan production can be used as an alternative source to chitosan produced from the shells of crustaceans, and the preparation steps of White teach the use of a starting chitosan produced from crustaceans (squid pen). Therefore, the ordinary skilled artisan would have a reasonable expectation of success in using the fungal chitosan in Muslim and obtain the potential benefits of fungal-derived chitosans.
Applicant states that the added combination of Zhao or Patchornik fails because the combination of White and CN’795 fail to arrive at claimed invention recited in claim 1.
However, as discussed above, the combination of White and CN’795 relies on a substitution rationale by substituting with the NOCC of CN’795, whereas the nonstatutory double patenting rejections over US’607 relies on a different modification and rationale of using White and does not rely on substitution with the NOCC of CN’795 to arrive at the claimed invention. Therefore, Applicant’s argument regarding the additional references of Zhao or Patchornik are also rendered moot.
Allowable Subject Matter
Claims 1 and 3-24 are rejected. However, if Applicant were to overcome the nonstatutory double patenting rejections over US’607 through the approval of a Terminal Disclaimer, then claims 1 and 3-24 would be allowable.
As described above, White discloses chitosan-hyaluronic acid crosslinked hydrogels using a BDDE crosslinking agent as demonstrated in Example 6 (paragraph 0043).
White further discloses that their hydrogel compositions can comprise of a chitosan derivative such as N-Carboxy methyl chitosan, O-Carboxy methyl chitosan or O-Hydroxy ethyl chitosan or a partially N-acetylated chitosan (paragraph 0017).
However, White does not discloses their compositions are cohesive hydrogels and does not include a N,O-carboxymethyl chitosan (NOCC) with the recited degree of acetylation (DA) and substitution (DS) ranges.
CN’795 (CN102526795 in PTO-892 dated 04/02/2026, an English translation is also provided) discloses crosslinked NOCC compositions with a DA of 20-60% and a DS of 20-80%.
While it may have been prima facie obvious to substitute the NOCC of CN‘795 with the chitosan component of White, Applicant has demonstrated an unexpected criticality of a crosslinked NOCC having a DA of greater than 40% to form a “cohesive” hydrogel that is non-obvious over the prior art.
As stated in MPEP 716.02(e), the showing of unexpected results must be compared to the closest prior art to be effective to rebut a prima facie case of obviousness.
In this case, the closest prior art is CN’795, which as described above discloses crosslinked NOCC compositions have a DA of 20-60% and a DS of 20-80%.
Applicant has demonstrated that crosslinked NOCC hydrogels comprising greater than 40% degree of acetylation (DA) resulted in cohesive hydrogels and NOCC hydrogels comprising less than 40% DA such as 28% DA did not result in a cohesive hydrogel as determined by the disclosed water test (see page 6 lines 26-34, Table 2a pages 36-37, Table 11a page 51, and Table 11c page 52 in specification). The NOCC of CN’795 encompasses a DA range (20-39% DA) that Applicant has demonstrated would not form a cohesive gel, and CN’795 does not further disclose specific embodiments of a NOCC having a DA of greater than 40%.
Furthermore, an ordinary skilled artisan would not have been able to routinely optimize and increase the DA to greater than 40% for the NOCC of CN’795 to arrive at the claimed invention because there is no additional guidance or suggestions in the prior art for increasing the DA percentage in NOCC hydrogels past 40% DA as a result-effective variable. Therefore, Applicant has demonstrated a criticality of a NOCC of greater than 40% DA to form a “cohesive” hydrogel that is non-obvious over the closest prior art (CN’795).
Lastly, US’342 and US’281 recite NOCC crosslinked hydrogels having a degree of acetylation of 30-80% as described above. While It may have also been prima facie obvious before the effective filing date of the claimed invention to have modified the preparation of the hydrogel recited in the claims of US’342 and US’281 by including the preparation steps of White and using the BDDE crosslinking agent and a hyaluronan obtained by fermentation as disclosed in White to arrive at the claimed invention, US’342 and US’281 also encompass a degree of acetylation range of 39-39%, and there is no recitation or secondary teachings that this is lower degree of acetylation range would have also resulted in the formation of a cohesive hydrogel as demonstrated by the examples in the specification as discussed above. Furthermore, an ordinary skilled artisan would not have been able to routinely optimize and increase the DA to greater than 40% for the NOCC recited in US’342 and US’281 because there is no additional guidance or suggestions in the prior art for increasing the DA percentage in NOCC hydrogels past 40% DA as a result-effective variable. Therefore, Applicant has also demonstrated an unexpected criticality of a NOCC of greater than 40% DA to form a “cohesive” hydrogel that is non-obvious over US’342 and US’281.
Conclusion
Claims 1 and 3-24 are rejected. However, if Applicant were to overcome the nonstatutory double patenting rejections over US’607, US’342, and US’281 through the approval of a Terminal Disclaimer, then claims 1 and 3-24 would be allowable.
THIS ACTION IS MADE FINAL. 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.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
