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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/11/2026 has been entered.
Priority
The instant application is continuation of US application no. 16/767,571 filed on 05/27/2020, which is a 371 of PCT/EP2018/080767 filed on 11/09/2018, and claims foreign priority to French application no. FR1761323 filed on 11/28/2017. The certified copy was filed in parent Application No. 16/767,571 on 05/27/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/11/2026 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 02/11/2026 is acknowledged. Claim 1-6 8-12, 14, 16-19, 21-22, 24-25, and 29-30 are amended. Claim 7 is cancelled. Claims 1-6 and 8-30 are pending.
Claims 19-30 were previously withdrawn in the office action dated 03/10/2025 from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being
no allowable generic or linking claim.
Accordingly, claims 1-6 and 8-18 are being examined on the merits herein.
Withdrawn Objections/Rejections
The objection to claims 10-13 is withdrawn because these claims now recite a comma after “9”.
The 35 USC 103 rejection over Elson in view of Hayes, Zhu, and Ben-Shalon for claims 1-11 and 13, over Elson in view of Hayes, Zhu, Ben-Shalon, and Brunelli for claim 12, over Elson in view of Hayes, Zhu, Ben-Shalom, and Li for claims 14-18 are withdrawn because the claims now recite a new limitation that the immunocompatibility is exhibited by several recited parameters, which has changed the scope of the claims and requires further search and consideration.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites “… wherein said carboxyalkyl is sterilized.” It appears “chitosan” is missing between “carboxyalkyl” and “is”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites “wherein said pharmaceutical composition is a mixture of a synovial fluid with a composition”.
Claim 12 is indefinite because it is unclear if the recited “a composition” is referring to the recited pharmaceutical composition or if the “a composition” is referring to an additional composition.
For purposes of examination, the recited “a composition” is being interpreted as the recited pharmaceutical composition. Support for this interpretation can be found in the specification, which states “the present invention relates to a mixture of a synovial fluid with a composition according to the present invention …” (page 26 lines 10-13).
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) 1-5, 8-9, 11, 13-15, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Biomaterials, 2014 in IDS filed 09/06/2023) in view of Abreu et al. (Polimeros, 2005 in PTO-892) and Muslim et al. (International journal of biological macromolecules, 2018 published online 08/30/2017 in PTO-892).
Li et al. discloses a biodegradable and injectable composition of N,O-carboxymethyl chitosan (NOCC) and aldehyde hyaluronic acid (A-HA) for postoperative adhesion prevention (see Abstract).
Li discloses that postsurgical peritoneal adhesion is a common and serious complication after surgery and are a consequence of tissue injury that may result from mechanical or thermal injury, ischemia, abrasion, infection, or foreign-body reaction (first paragraph left column page 3903). Li discloses that many studies have been performed to find an effective approach to prevent postsurgical adhesion including solid sheets and hydrogels comprising chitosan, cellulose, and hyaluronates (right column second paragraph page 3903). However, Li discloses that these solid barrier sheets have limitations such as complete coverage of the injured surface and difficult handling to affix these materials to the wound site (first paragraph left column page 3904). Therefore, Li discloses more attention has been paid on injectable in situ cross-linking hydrogels (first paragraph left column page 3904), and further discloses a need to improve the effectiveness of these barrier sheet-based systems (first paragraph left column page 3915).
Li discloses that chitosan has been applied in biomedical field by virtue of its biocompatibility and biodegradability, however the poor solubility in physiological solvents greatly limits its applications (second paragraph left column page 3904). Therefore, Li discloses that in order to improve the solubility of chitosan in neutral aqueous solution, carboxymethyl groups to the N-position and O-position of the glucosamine and N-acetyl-glucosamine of chitosan were introduced (see third paragraph left column page 3904).
Li demonstrates an in vivo anti-adhesion evaluation of their NOCC/A-HA hydrogel (see page 3906, left column under section 2.7). Here, a rat model of sidewall defect-cecum abrasion was used, and gel pre-cursor solutions (0.5 mL of NOCC and 0.5 mL of A-HA) were placed into 10 mL syringes and injected on to the damaged cecum surface as well as the abdominal wall defect. The deposited gel solution was allowed to fully congeal (2-3 mins) and the incision was closed. Here, the syringe meets the limitation of the article and medical device recited in instant claims 14-15 and 17-18. The rats were evaluated two weeks after the surgery according to a standard adhesion scoring system and as seen in Table 2 page 3913, rats that were injected with the NOCC/A-HA hydrogel had a significant reduction of peritoneal adhesion formation compared to commercial hyaluronic acid and a control saline group (Abstract). Li concludes their injectable hydrogel system was suitable for adhesion prevention with no cytotoxicity and had biocompatibility (second paragraph left column page 3917).
Here, Li discloses an injectable NOCC composition using syringes. However, Li does not disclose their NOCC being of fungal origin and the recited degree of acetylation and substitution that will be immunocompatible as exhibited by the recited parameters.
Abreu discloses the preparation and characterization of carboxymethyl chitosan (Abstract).
Abreu discloses that chitin/chitosan and their derivatives prepared by chemical modifications have been used in many applications in the food industry, in cosmetic formulations, for medical and pharmaceutical applications, in the agriculture and in the wastewater treatment for the removal of metallic ions and humic acids (second paragraph left column page 79). Abreu discloses that the poor solubility of chitosan when pH>6.5 is a serious drawback in many of its potential applications. Thus, the preparation of chitosan derivatives has been envisaged to overcome its limited solubility in aqueous media. Such an adequate chemical modification results, for instance, when the carboxymethylation of chitosan is carried out since carboxymethyl chitosan is soluble in a wide range of pH (first paragraph right column page 79).
Abreu demonstrates that their preparation of carboxymethyl chitosan had the following degree of substitution and degree of acetylation shown below (also Table 1 in page 82):
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Here, QC10E is a carboxymethyl chitosan sample that had a degree of substitution of 1.44 (144%) and degree of acetylation of 44.4 (44.4%) as determined by conductivity (a).
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 NOCC/A-HA composition of Li by substituting the NOCC with the QC10E of Abreu and further modifying the preparation of the QC10E of Abreu by using a chitosan derived from the mycelium of Aspergillus flavus as disclosed in Muslim to arrive at the claimed invention.
One of ordinary skill in the art would have substituted one known element (NOCC of Li) for another (QC10E of Abreu) to obtain predictable results and would have a reasonable expectation of success in doing so because both Li and Abreu disclose the use of carboxymethyl chitosan for similar medical / pharmaceutical applications as well as modifying the chitosan with carboxymethyl groups to improve its solubility at physiological pH conditions.
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 fungal 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 and scaled up for large scale production. Furthermore, Li, Abreu, and Muslim further disclose the use of chitosan for similar applications such as in pharmaceutical applications.
Lastly, even though the combined teachings of Li, Abreu, and Muslim described above do not explicitly teach the immunocompatibility as exhibited by the recited parameters, these properties would flow naturally from the following the suggestions of the prior art because the combined teachings described above disclose a composition comprising the same carboxymethyl chitosan derived from fungal origin with the same degree of acetylation (44%) and degree of substitution (144%), and as evidenced in the summarized Table (pages 5-6) in the Remarks filed on 02/11 2026, CC-8 through CC-10, which were NOCCs derived from fungal origin that had a DA between 41-50% and a DS between 80-167%, had all four of the recited immunocompatibility parameters.
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.").”
Claim(s) 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Biomaterials, 2014 in IDS filed 09/06/2023) in view of Abreu et al. (Polimeros, 2005 in PTO-892) and Muslim et al. (International journal of biological macromolecules, 2018 published online 08/30/2017 in PTO-892), as applied to claims 1 and 14 above, and further in view of Elson et al. (US 5679658 previously cited in PTO-892 dated 03/10/2025)
The combined teachings of Li, Abreu, and Muslim are as described above and teach the composition recited in instant claims 1 and 14 as discussed above.
The combined teachings, however, do not teach that the composition is sterilized.
Elson et al. teaches administering an aqueous solution of N,O-carboxymethyl chitosan (NOCC) for the prevention of surgical adhesions (see Abstract and col. 2, lines 23-37).
Elson et al. further discloses a kit for post-surgical lavage of surgical incisions to reduce adhesions comprising a sterile 0.5-4% by weight solution of N,O-carboxymethyl chitosan in a pharmaceutically acceptable carrier (see claim 13), which meets the limitations of a composition that is sterilized or sterile as recited in claims 6 and 16.
Elson et al. demonstrates in Example 1 a standard abdominal adhesion rat model to compare their NOCC composition with hyaluronic acid in effectiveness for treatment. Elson et al. discloses the adhesion model involved shaving/cleaning the abdomen of the rat, identifying the cecum, abrading the cecum with a dry 4x4 gauge needle until a puncture hemorrhage was formed, and further closing the wound with sutures and covering with a Bacitracin ointment (see Example 1 in column 3). Elson et al. demonstrates that twenty rats were either given no treatment as a control, a topical placement of 1-2% NOCC solution, a topical placement 1% NOCC gel covalently cross-linked with glyoxal, and a topical placement of 0.4% hyaluronic acid at the hemorrhage site and surrounding tissue (see column 4). Elson et al. disclose that all groups treated with NOCC had significantly less adhesion compared to the control group and was just as effective as hyaluronic acid (see column 4).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the NOCC/A-HA composition as disclosed by the combined teachings of Li, Abreu, and Muslim described above by using a sterile composition as disclosed in Elson to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the combined teachings of Li, Abreu, and Muslim described above and Elson disclose similar NOCC based compositions that are useful for surgical adhesion prevention.
Claim(s) 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Biomaterials, 2014 in IDS filed 09/06/2023) in view of Abreu et al. (Polimeros, 2005 in PTO-892) and Muslim et al. (International journal of biological macromolecules, 2018 published online 08/30/2017 in PTO-892), as applied to claim 9 above, and further in view of Ben-Shalom et al. (US 20090004276 previously cited in PTO-892 dated 03/10/2025).
The combined teachings of Li, Abreu, and Muslim are as described above and teach the composition recited in instant claim 9 as discussed above.
The combined teachings, however, do not teach that the composition is an artificial synovial fluid with a composition comprising carboxyalkyl chitosan (instant claim 10) or that the composition is a mixture of a synovial fluid with said composition (instant claim 12).
Ben-Shalom discloses a novel injectable chitosan hydrogel comprising of a chitosan having a degree of acetylation in the range from about 30% to about 60% (see Abstract). Ben-Shalom discloses that their chitosan composition can further comprise negatively charged polysaccharides such as hyaluronic acids and others (paragraph 0067).
Ben-Shalom discloses that hydrogels have been shown to have easier application combined with longer survival periods at the site of application as compared to non-thermosensitive hydrogels, and are therefore advantageous as slow-release drug delivery systems (paragraph 0005). Ben-Shalom et al. discloses that chitosan is biocompatible, non-toxic, and non-immunogenic, allowing for its use in the medical, pharmaceutical, cosmetic and tissue construction fields, and provides examples of topical ocular applicant and intraocular injections or transplantation in the vicinity of the retina (see paragraph 0010).
Ben-Shalom et al. discloses their composition can be useful for several applications including drug delivery, tissue reconstruction, wound-healing, synovial replacement, and others (paragraph 0072). Ben-Shalom teaches that their composition can also be used as an anti-adhesion device in surgical or synovial replacement applications and can be used as a delivery device for various proteins or non-protein agents (paragraph 0075-0076).
It would have been prima facie obvious before the effective filing date of the claimed invention to have used the NOCC/A-HA composition as disclosed by the combined teachings of Li, Abreu, and Muslim described above for applications such as synovial replacement as disclosed in Ben-Shalom to arrive at the claimed invention.
One of ordinary skill in the art would have combined prior art elements according to known methods to yield predictable results and would have a reasonable expectation of success in doing so because both the combined teachings of Li, Abreu, and Muslim described above and Ben-Shalom disclose the use of similar chitosan-based hydrogels for similar medical applications, and Ben-Shalom provides further guidance that these chitosan hydrogels can be injectable and used in synovial replacement applications.
Furthermore, the NOCC composition as disclosed by the combined teachings of CN’795, Muslim, and Ben-Shalom described above meets the limitations of an artificial synovial fluid with a composition comprising the recited carboxyalkyl chitosan (instant claim 10) or that the composition is a mixture of a synovial fluid with the recited composition (instant claim 12) because the application of the NOCC composition as a synovial replacement to the joint as suggested by the combined teachings would meet the structural limitations of an artificial synovial fluid and would further be a mixture of existing synovial fluid and the NOCC composition.
Response to Arguments
Applicant’s arguments in the response filed on 02/11/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant previously argued that the claimed carboxyalkyl chitosan has an unexpected result for improving immunocompatibility for a human or animal via injection, instillation, or implantation. Applicant has further amended the claims such that the claimed composition exhibits immunocompatibility based on the recited four parameters. Applicant previously presented evidence measuring the number of white blood cells, concentration of IL1-beta, KC/CXCL1, and TNF-alpha and comparing these values from their claimed carboxyalkyl chitosan composition to various other chitosan compositions outside of the scope of their claimed carboxyalkyl chitosan composition.
Applicant states that the Office’s characterization of Applicant’s evidence is not entirely accurate in that while the specification does not contain comparisons of animal and fungal origin NOCCs with identical DA and DS values, there is data that compares animal and fungal origin NOCCs with similar DA and DS values. Applicant has compiled the data from the various tables in the specification of NOCC formulations with varying DA and DS values and the number of white blood cells, concentration of IL1-beta, KC/CXCL1, and TNF-alpha values for these NOCC formulations as shown in Pages 5-6 in the Remarks filed on 02/11/2026.
Here, Applicant states the source/origin of the CC is the primary, but not the only, factor for KC-CKCL1 concentration, and that the importance of the fungal origin compared to animal origin is unexpected in view of the art. Applicant states that CC-5 and CC-6 in the Table, both of fungal origin, had KC-CKCL1 concentrations in accordance with the claim required regardless of both of these formulations having a DS less than 50% (outside of the claimed scope). In contrast, Applicant states that CC-3, even with a DA of 71% and a DS of 149% had a KC-CXCL1 concentration that was substantially greater than the required maximum, despite satisfying the three other requirements of immunocompatibility. Applicant further points to a comparison between CC-4 (animal origin) and CC-5 (fungal original), which have similar DA and DS values. Here, Applicant states the animal origin CC-4 had four times the recited maximum concentration of the KC-CXCL1. Applicant also points to a comparison between CC-3 (animal original) and CC-10 (fungal origin) to further demonstrate that the primary factor for the KC-CXCL1 concentration is the origin of the CC.
Applicant also states that DS is another factor for KC-CXCL1 concentration and points to how despite CC-3 and CC-4 being non-immunocompatible according to the recited parameters, the DS increase from 24% to 149% significantly improved the KC-CXCL1 concentration. Applicant further points to CC-5 and CC-6 as well as CC-7 through CC-11, where increasing DS had a consistent effect on improving the KC-CXCL1 concentration.
Applicant states that DS is also the primary factor for TNF-alpha concentration and points to CC-5 through CC-10, CC-12 through CC-15, and CC-3 through CC-6, where increasing the DS significantly improved the TNF-alpha concentration.
In response to Applicant’s showing of an unexpected result, it is first noted that the claims do not appear to be commensurate in scope with the presented unexpected results. Here, the only NOCC formulations that had all four of the recited parameters were CC-8 through CC-10, which were NOCCs derived from fungal origin that had a DA between 41-50% and a DS between 80-167%.
The claims currently recite a NOCC of fungal origin having a DA between 30-80% and a DS of greater than 50%, and Applicant has shown, for example, CC-7 (DA 57% and DS 70%), which is currently in scope with the claims, did not have all four of the recited parameters. Therefore, Applicant’s unexpected results are not commensurate in scope with the claims.
Furthermore, assuming arguendo Applicant were to amend the claims to be commensurate in scope with the unexpected results (eg. NOCC derived from fungal origin having a DA between 41-50% and a DS between 80-167%), Applicant’s showing of unexpected results in regards to the recited immunocompatibility parameters does not appear to be sufficient.
While Applicant has appeared to demonstrate that the fungal origin and a DS greater than 80% is critical to have the recited KC/CXCL1 concentration parameter as well as the other three recited parameters, Applicant has not demonstrated or discussed the influence of the degree of acetylation (DA) and whether these unexpected results would be consistent for NOCCs having a lower degree of acetylation such as around 40% DA, which is also within scope of the closest prior art NOCC composition (Abreu discloses a carboxymethyl chitosan with 44.4% DA and 144% DS)
As evidenced in Barbosa (in PTO-892), the degree of acetylation in chitosan-based compositions play a significant role in the inflammatory response, in which higher degrees of acetylation induced a more intense inflammatory response in comparison to a lower degree of acetylation on the chitosan (Abstract).
Here, as described above, the CC-4 (animal origin) and CC-5 (fungal origin) are comparable in regards to the DA and DS values and shows that the animal origin NOCC induced a much higher KC-CXCL1 concentration. Furthermore, the increase in DS appears to correlate with reduced KC-CXCL1 concentration. However, the comparable data such as CC-4 and CC-5 is comparing NOCCs with higher DA (~70%) and not lower DA values such as 40-50% DA. Therefore, it cannot be ascertained if the same results would apply at lower degrees of acetylation because Applicant has not provided comparable animal vs fungal origin data with NOCCs having lower degrees of acetylation or has not provided an explanation that their results would also apply at lower degrees of acetylation. Furthermore, Applicant’s comparison of CC-3 (animal original) and CC-10 (fungal origin) is comparing between two different acetylation degrees (CC-3 71% DA and CC-10 46% DA), and therefore it is also difficult to ascertain in this comparison the influence of the degree of acetylation and the immunocompatibility. It is noted that Applicant has a CC-11 composition with lower degrees of acetylation (DA 23%), but has not presented the values for the recited parameters.
Applicant further presents several arguments as to why the previous rejections over Elson, Hayes, Zhu, and Ben-Shalom were deficient to establish obviousness to arrive at the claimed invention.
Here, the new rejections do not cite Hayes, and Zhu. Furthermore, Elson and Ben-Shalom are only used as a secondary reference to establish obviousness to arrive at the sterile composition as well as injectable compositions for synovial replacement applications and not for modifying the DA on the chitosan. Therefore, Applicant arguments here are rendered moot.
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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