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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/02/2026 has been entered.
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/02/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The claim amendments and remarks filed on 02/02/2026 is acknowledged. Claims 6 and 12-14 are amended. Claim 2 is cancelled.
Accordingly, claims 1 and 3-24 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 112(d) rejection over claims 6 and 13-14 are withdrawn in view of claim 6 now reciting a “viscoelastic cohesive hydrogel”, and claims 13-14 being amended to recite a matrix that is injectable.
The 35 USC 103 rejection over White in view of Jaidee for claims 1, 4-14, and 16-24, over White in view of Jaidee and Zhu for claim 3, and over White in view of Jaidee and Zhao for claim 15 are withdrawn in favor of the new rejections below.
The nonstatutory double patenting rejection over co-pending application 17/790,180 is withdrawn in favor of the new rejections below.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites “4 butanediol diglycidyl ether”. The compound name should be “1,4- butanediol diglycidyl ether” as recited in the specification (see page 17 line 16).
Appropriate correction is required.
The following grounds of rejection are new.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1, 4-14, 16-19, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025) in view of CN102526795 (in PTO-892, an English translation is also provided in PTO-892 and used as the basis for this rejection).
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).
The difference between White and the claimed invention is that White does not teach a carboxyalkyl chitosan that is a N,O-carboxyalkyl chitosan with the recited degree of acetylation and substitution range.
CN’795 discloses a chitosan-based hemostatic sponge with thrombin immobilization for use in wound and surgical hemostasis (paragraph 0002). CN’795 discloses the sponge is a porous sponge made of chitosan and a hemostatic agent (paragraph 0011). CN’795 discloses the chitosan can be a carboxymethyl chitosan such as N,O-carboxymethyl chitosan having a degree of deacetylation of 40% to 80% (acetylation of 20% to 60%) and a degree of substitution of 0.2 to 0.8 (20% to 80%) (paragraph 0015). CN’795 discloses the hemostatic agent can be thrombin, calcium alginate, collagens, or others (paragraph 0016). CN’795 discloses their invention involves the use of a crosslinking reaction and discloses crosslinking agents such as formaldehyde, methylglyoxal, glutaraldehyde, and others (paragraph 0023).
CN’795 discloses the preparation of their chitosan-based hemostatic sponge involves mixing the chitosan and hemostatic agent, further adding the crosslinking agent, then freeze drying the material (paragraphs 24-29). CN’795 discloses that the freeze-dried sponge is then sealed and sterilized to obtain the final product (paragraph 0030).
CN’795 demonstrates the effective wound healing effects of their chitosan-based sponge on experimental animal studies in paragraphs 0060-0075, in which the sponge was applied to various wounded animals and demonstrated a significant hemostatic and wound healing effect (paragraph 0075). CN’795 discloses that their chitosan-based sponge has broad applications in medical fields such as war wounds, trauma emergency hemostasis, perioperative hemostasis, and wound healing (paragraph 0075).
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the re-acetylated chitosan in the re-acetylated-chitosan-hyaluronic acid cross-linked gel disclosed of White with the N,O-carboxymethyl chitosan having a degree of acetylation of 20% to 60% and a degree of substitution of 20% to 80% as disclosed in CN’795. One of ordinary skill in the art could have simply substituted one known element (re-acetylated chitosan) for another (N,O-carboxymethyl chitosan) to obtain predictable results because both White and CN’795 disclose the use of chitosan derivatives that are crosslinked to another biomaterial component via a crosslinking agent to form a hydrogel or sponge for similar medical applications such as in surgery. Furthermore, CN’795 discloses an overlapping range for the degree of acetylation and substitution, rendering the recited ranges obvious. See MPEP 2144.05 I.
Lastly, the recited cohesive gel or viscoelastic cohesive gel, and the recited covalent crosslinking of carboxyalkyl chitosan chains or hyaluronan as well as the co-crosslinking of carboxyalkyl chitosan and hyaluronan would all flow naturally and would be necessarily present in the teachings of the prior art. Here, the combined teachings described above teach forming the recited 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 combined teachings described above teach forming the same composition using the same amounts/ratio of the recited polymers and crosslinking components.
MPEP 2145 II recites “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 recite "[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 gel as disclosed by the combined teachings of White and CN’795 described above by re-acetylating the chitosan as disclosed in White to a degree of acetylation of 20% to 60% as disclosed in CN’795. 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.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025) in view of CN102526795 (in PTO-892, an English translation is also provided in PTO-892 and used as the basis for this rejection), as applied to claim 1 above, and further in view of Muslim et al. (International journal of biological macromolecules, 2018 in PTO-892).
The combined teachings of White and CN’795 are as described above and teach the composition of claim 1 as discussed above.
The combined references, however, do not teach wherein the chitosan is 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 gel as disclosed by the combined teachings of White and CN’795 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.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025) in view of CN102526795 (in PTO-892, an English translation is also provided in PTO-892 and used as the basis for this rejection), and further in view of Zhao et al. (Carbohydrate Polymers, 2011 in PTO-892 dated 09/03/2025).
The combined teachings of White et al. and CN’795 disclose the matrix recited in claim 1 as discussed above.
The combined teachings, however, do not teach 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 combined teachings of White et al and CN’795 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 chitosan 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.
Claim(s) 1, 16, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Patchornik et al. (Advances in Orthopedics, 2012 in PTO-892) in view of White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025) and CN102526795 (in PTO-892, an English translation is also provided in PTO-892 and used as the basis for this rejection).
Patchornik teaches the use of chitosan-hyaluronate hybrid gels for treating osteoarthritis (Abstract). Patchornik teaches that chitosan has a wide variety of medical applications, and tends to support tissue healing by encouraging blood coagulation and wound healing (see right column page 1). Patchornik teaches that while intra-articular injection of chitosan was problematic in the past due to high inflammation, the effect depends on the type of chitosan used (see first paragraph left column page 2). Patchornik teaches a previous study demonstrated that the intra-injection of 2% carboxymethyl chitosan mitigated osteoarthritis in a rabbit ACL-transection model without observing an inflammatory effect (see first paragraph left column page 2). Patchornik further teaches that the crosslinking of chitosan can also mitigate the inflammatory effect of chitosan and help prevent adhesion formation following cartilage damage (see second paragraph left column page 2).
Patchornik assessed the effect of the chitosan-hyaluronate hybrid gel in an experimental osteoarthritis rat model, in which knee osteoarthritis was induced in rats and were subsequently injected with the hybrid gel as well as a control saline solution and hyaluronate only gel (Abstract). Patchornik discloses after two weeks, rats had less pain in the hybrid gel treated knee than control and the hyaluronate only gel treated knee (Abstract). Patchornik discloses that the histological appearance of the hybrid gel treated knee was superior to that of the controls, and was indicated by thicker cartilage remaining on the medical femoral condyle as well as less cyst formation (Abstract and Figure 1 on page 3). Patchornik concludes that the injected hybrid gel delays osteoarthritis progression with possible mechanisms such as adherence to cartilage as described for osteochondral cartilage defects or a direct cartilage proliferation-enhancing effect (see first paragraph right column page 4). Patchornik also concludes that the hyaluronate also acts to mitigate the inflammatory effect observed when chitosan is degraded, thus explaining the better weight-bearing and histological features observed in their study (see right column first paragraph page 4).
The difference between Patchornik and the claimed invention is that Patchornik does not disclose the recited matrix in instant claim 1.
The independent teachings of White and CN’795 are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the chitosan-hyaluronate hybrid disclosed in Patchornik with the crosslinked N,O-carboxymethyl chitosan-hyaluronic acid composition disclosed by the combined teachings of White and CN’795 as described above. One of ordinary skill in the art could have simply substituted one known element (chitosan-hyaluronate hybrid gel) for another (crosslinked N,O-carboxymethyl chitosan-hyaluronic acid composition) to obtain predictable results because both Patchornik and the combined teachings of White and CN’795 described above disclose chitosan-hyaluronic acid crosslinked gels, and Patchornik provides further guidance these crosslinked gels can treat osteoarthritis. Furthermore, Patchornik provides guidance that carboxymethyl chitosan is an effective chitosan derivative for use against osteoarthritis.
Response to Arguments
Applicant’s arguments filed on 02/02/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant provides several arguments against the teachings of White in view of the teachings of Jaidee and why an ordinary skilled artisan could not have arrived at the claimed matrix.
Applicant’s arguments described above are rendered moot because the new rejection relies on White in view of CN’795 and does not cite Jaidee. Furthermore, the modification described in the new rejection relies on a simple substitution of the re-acetylated chitosan of White with the N,O-carboxyalkyl chitosan of CN’795 to obtain predictable results and not a certain motivation to modify the acetylation or substitution degree on the chitosan of White as described in the previous rejection. Therefore, even though the teachings of White are still used in the new rejection, the rationale to establish obviousness in the new rejection is different, thus rendering Applicant’s arguments moot.
Applicant states that the cohesive gel property being necessarily present in the previous rejection is misplaced. Applicant states that inherency cannot be established by combining multiple references or by relying on knowledge outside the four corners of a single reference. Applicant states that when a rejection relies on multiple prior art references to supply the alleged inherent feature, the analysis necessarily falls under 35 USC 103 rejection and not a 35 USC 102 rejection therefore MPEP 2112.01 does not apply. Applicant states that the assertion of inherency is improper and cannot support the rejection.
Applicant’s arguments described above were not found persuasive because MPEP 2112 IV states that “[I]n order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art." Id. at 1195-96, 112 USPQ2d at 1952. But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). The court found that pharmacokinetic limitations of the asserted claims were inherently met by combining prior art references because the limitations were necessarily present in the prior art combination.”
Here, the recited “cohesive gel” property flows naturally from the following suggestions of the prior art and would be necessarily present because as described above the combined teachings of White and CN’795 teach all of the same amounts/ratio of the same polymers and crosslinking components to form the same matrix compositions in Tables 3a and 3b (pages 40-41) of the instant specification, which were determined to be cohesive gels.
Applicant also states the “cohesive gel” property would still be nonobvious because for the alleged inherent property or result to be obvious, the prior art had to recognize cohesiveness was a function of a particular parameter – a known result-effective variable – the degree of acetylation in a carboxyalkyl chitosan having a degree of substitution greater than 70%. Applicant states that recognition of this functionality is an essential prerequisite for conducting experiments to determine the degree of acetylation sufficient to result in a cohesive hydrogel, and that this functionality can only be determined from data disclosed in the instant application and not from prior art references.
Applicant’s arguments described above were not found persuasive because according to MPEP 2145 II, prima facie obviousness cannot be rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art. Here, while the combined references do not disclose the recited “cohesive gel”, this property would flow naturally from the following the suggestions of the prior art and would be necessarily present as described above.
Furthermore, in regards to Applicant’s argument that a degree of substitution greater than 70% on the carboxyalkyl chitosan is necessary to form the recited cohesive hydrogel, MPEP 2144.05 III states that “Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range."
Here, Applicant has not demonstrated the criticality of the recited carboxyalkyl chitosan having a degree of substitution greater than 70% in order to form the cohesive gel because as seen in Table 1b on page 35 and Tables 3a / 3b on pages 40-41, Applicant has only provided evidence of forming cohesive hydrogels using a carboxymethyl chitosan having a degree of substitution between 81%-90%, and CN’795 discloses N,O-carboxymethyl chitosan having a degree of substitution of 0.2 to 0.8 (20% to 80%) as described above. Therefore, Applicant has not shown that the recited degree of substitution greater than 70% is critical for forming the cohesive gel over the prior art range (20% to 80% as disclosed in CN’795).
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, 16-20, and 22-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-29, 32-36, 38, 40-44, and 46-71 of copending Application No. 17/790,180 (‘180) in view of White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025).
Claim 41 of ‘180 recites a method of aesthetic treatment or aesthetic care comprising administering to a human or animal in need thereof, by injection or implantation, a composition comprising a plurality of beads dispersed within an aqueous phase, wherein the beads comprise a hydrogel matrix, wherein the hydrogel matrix comprises at least one carboxyalkyl chitosan having glucosamine units, N-acetyl-glucosamine units, and glucosamine units substituted with a carboxyalkyl group, said carboxyalkyl chitosan having a degree of substitution with a group of carboxyalkyl higher than 50%, expressed in number of moles of the substituent with respect to the number of moles of total units, wherein the carboxyalkyl chitosan is crosslinked by covalent bonds between chains of the carboxyalkyl chitosan and/or co-crosslinked by covalent bonds with one or more other polymers. Claim 64 of ‘180 recites the carboxyalkyl chitosan having a degree of acetylation between 30-80%. Claim 34 of ‘180 recites the hydrogel matrix comprises at least hyaluronan cross-linked by covalent bonds with carboxyalkyl chitosan. Claims 35-36 of ‘180 recite wherein crosslinking is formed by a crosslinking agent forming said covalent bonds, and the crosslinking agent is selected from several agents including 1,4 butanediol diglycidyl ether. Claim 65 of ‘180 recites the composition is sterile. Claim 43 of ‘180 recites wherein said method is for repairing or filling at least one body liquid or tissue requiring a repair or filling. Claim 46 of ‘180 recites a method of preparing the hydrogel matrix by preparing a solution of the carboxyalkyl chitosan, crosslinking agent, and one or more polymers to form the hydrogel matrix.
The claims of ‘180, however, do not recite a cohesive hydrogel.
The teachings of White are as described above.
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 ‘180 by including the preparation steps 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 ‘180 and White according to known methods to yield predictable results because both the claims of ‘180 and White recite a method of preparing a hydrogel matrix via crosslinking a chitosan derivative and hyaluronic acid via a BDDE crosslinking agent. Furthermore, the claims of ‘180 recite overlapping acetylation and substitution degrees, rendering the instant ranges obvious. See MPEP 2144.05 I.
Lastly, the recited cohesive gel or viscoelastic cohesive gel, and the recited covalent crosslinking of carboxyalkyl chitosan chains or hyaluronan in the instant claims would all flow naturally and would be necessarily present in the combination of the claims of ‘180 and 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 recites “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 recite "[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 ‘180 and White described above by re-acetylating the chitosan as disclosed in White to a degree of acetylation of 30-80% recited in the claims of ‘180. 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-29, 32-36, 38, 40-44, and 46-71 of copending Application No. 17/790,180 (‘180) 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).
The claims of ‘180 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.
The teachings of Muslim are as described above.
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 ‘180 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-29, 32-36, 38, 40-44, and 46-71 of copending Application No. 17/790,180 (‘180) 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 ‘180 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.
The teachings of Zhao et al. are as described above.
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 ‘180 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 16, and 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 27-29, 32-36, 38, 40-44, and 46-71 of copending Application No. 17/790,180 (‘180) in view of White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025) and Patchornik et al. (Advances in Orthopedics, 2012 in PTO-892).
The claims of ‘180 and the teachings of White are as described to arrive at the matrix recited in instant claims 1, 16, and 19-20 as discussed above.
The combination, however, does not recite wherein said method is for treating osteoarthritis, or repairing a cartilage defect.
The teachings of Patchornik are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the chitosan-hyaluronate hybrid disclosed in Patchornik with the crosslinked N,O-carboxymethyl chitosan-hyaluronic acid composition as recited by the combination of the claims of ‘180 and White described above. One of ordinary skill in the art could have simply substituted one known element (chitosan-hyaluronate hybrid gel) for another (crosslinked N,O-carboxymethyl chitosan-hyaluronic acid composition) to obtain predictable results because both Patchornik and the combination of the claims of ‘180 and White described above recite chitosan-hyaluronic acid crosslinked gels, and Patchornik provides further guidance these crosslinked gels can treat osteoarthritis. Furthermore, Patchornik provides guidance that carboxymethyl chitosan is an effective chitosan derivative for use against osteoarthritis.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
The teachings of White are as described above.
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 recites “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 recite "[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).
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.
The teachings of Muslim are as described above.
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.
The teachings of Zhao et al. are as described above.
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.
Claims 1, 4-14, 16-20, and 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 12,508,281 in view of White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025).
Claim 20 of US‘281 recites a method of aesthetic treatment by dermal filling, wherein said method comprises subcutaneously or intradermally injecting or implanting an aqueous formulation comprising a carboxyalkyl chitosan to a subject in need thereof, wherein said carboxyalkyl chitosan comprises glucosamine units, N-acetyl-glucosamine units, and glucosamine units substituted by a carboxyalkyl group, wherein the carboxyalkyl chitosan 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 30% 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. Claim 22 of US’281 recites wherein the carboxyalkyl chitosan is sterilized. Claim 3 of US’381 recites wherein said carboxy alkyl chitosan is a N,O-carboxyalkyl chitosan. Claim 6 of US’281 recites wherein the chitosan is derived from the group consisting of Basidiomycetes, mycelium of Ascomycetes, and a mixture thereof. Clams 15 of US’281 recites the composition is comprised in a medical device. Claim 24 of US’281 recites wherein said aqueous solution further comprises hyaluronic acid or sodium hyaluronate, either crosslinked or not crosslinked by covalent bonds.
US’281, however, does not recite a cohesive gel or a recited crosslinking agent.
The teachings of White are as described above.
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’281by 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’281 and White according to known methods to yield predictable results because both the claims of US’281 and White recite a hydrogel matrix via crosslinking a chitosan derivative and hyaluronic acid. Furthermore, the claims of ‘180 recite overlapping acetylation and degree, rendering the instant ranges obvious. See MPEP 2144.05 I.
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’281 and 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 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 recites “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 recite "[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’281 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 1-31 of U.S. Patent No. 12,508,281 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).
The claims of US’281 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.
The teachings of Muslim are as described above.
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’281 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 1-31 of U.S. Patent No. 12,508,281 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’281 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.
The teachings of Zhao et al. are as described above.
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’281 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.
Claims 1, 16, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-31 of U.S. Patent No. 12,508,281 in view of White et al. (US 20070197754 previously cited in PTO-892 dated 03/28/2025) and Patchornik et al. (Advances in Orthopedics, 2012 in PTO-892).
The claims of US’281 and the teachings of White are as described to arrive at the matrix recited in instant claim 1, 16, and 19-20 as discussed above.
The combination, however, does not recite wherein said method is for treating osteoarthritis, or repairing a cartilage defect.
The teachings of Patchornik are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the chitosan-hyaluronate hybrid disclosed in Patchornik with the crosslinked N,O-carboxymethyl chitosan-hyaluronic acid composition as recited by the combination of the claims of US’281 and White described above. One of ordinary skill in the art could have simply substituted one known element (chitosan-hyaluronate hybrid gel) for another (crosslinked N,O-carboxymethyl chitosan-hyaluronic acid composition) to obtain predictable results because both Patchornik and the combination of the claims of US’281 and White described above recite chitosan-hyaluronic acid crosslinked gels, and Patchornik provides further guidance these crosslinked gels can treat osteoarthritis. Furthermore, Patchornik provides guidance that carboxymethyl chitosan is an effective chitosan derivative for use against osteoarthritis.
Response to Arguments
Applicant requests withdrawal of the provisional nonstatutory double patenting rejection over ‘180 because the amendments and arguments presented obviate and/or traverse all rejections under 102, 103, and 112.
However, since there is a new 35 USC 103 rejection over the instant claims, the provisional nonstatutory double patenting rejection over ‘180 is maintained. Furthermore, it is noted that a notice of allowance was sent on 12/16/2025 for co-pending ‘180. Therefore, the current provisional double patenting rejection over ‘180 will convert to a double patenting rejection once the patent is issued for the ‘180 application.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
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