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 .
Claim Status
Claims 9-20 are rejected.
No claims are allowed.
New 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 9 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 9 recites both croscarmellose sodium and micronized croscarmellose sodium. A broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation croscarmellose sodium, and the claim also recites micronized croscarmellose sodium which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
New Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 9 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mondon et al., (US 2019/0269597 A1, Sept. 05, 2019) (hereinafter Mondon) in view of Park et al., (WO 1998/051408 A1, Nov. 19, 2011) (cited by Examiner Form 892 dated 10/24/2025) (hereinafter Park).
Mondon discloses a method for preparing a dermal filler composition comprising hyaluronic acid crosslinked with citric acid and its use for aesthetic purposes, in particular for skin rejuvenation and correction of fine lines (i.e., skin imperfections) (abstract), which is injected ([0009]) as a hydrogel ([0024]). The method for making a dermal filler composition comprises (a) providing an aqueous mixture comprising hyaluronic acid (HA) in the non-crosslinked state and citric acid or a salt thereof, (b) reacting the aqueous mixture so as to obtain a citric acid-crosslinked HA gel product, (c) purifying the citric acid-crosslinked HA gel product, and (d) sterilizing the citric acid-crosslinked HA gel product to obtain a dermal filler composition ([0010]). The dermal filler composition may further comprise non-crosslinked HA, for example as a lubricant to improve the filler's rheological properties such as to lower its extrusion force ([0039]). The dermal filler may also comprise at least one crosslinked and/or non-crosslinked polysaccharide other than HA, such as cellulose derivatives (e.g. carboxymethyl cellulose (CMC)). In one embodiment, the other polysaccharide is (non-crosslinked) carboxymethyl cellulose (CMC) ([0041]). These optional compounds may be added to the crosslinked HA gel at any appropriate process stage before final sterilization ([0068]). The crosslinking temperature is at least 50° C ([0057]) and those skilled in the art will be readily able to select appropriate upper limit temperatures to limit degradation of HA to an acceptable level ([0058]). The aqueous mixture can be provided in any way and is not limited to a particular sequence of steps. For example, HA may be combined with an aqueous solution such as phosphate buffered saline (i.e., sodium chloride) to obtain an aqueous mixture of hydrated HA in the non-crosslinked state, followed by contacting the aqueous mixture with citric acid ([0054]). In the method of preparation a 22% citric acid solution with pH 6.6 was prepared by placing 38.65 g of a 5 M NaOH (i.e., sodium hydroxide) solution and 11.11 g of citric acid in a 50 ml flask. The pH was checked and, if the pH was 6.6, distilled water was added q.s. 50 ml and, if not, the pH was appropriately adjusted using a 5 M NaOH solution or a 1 M HCl solution. In addition, a 22% citric acid solution with pH 8.0 was prepared in the same manner, except that 38.7 g of a 5 M NaOH solution was placed in a 50 ml flask. Furthermore, a 22% citric acid solution with pH 9.8 was prepared in the same manner, except that 46.7 g of a 5 M NaOH solution was placed in a 50 ml flask ([0088]). 33 g of each of the 22% (w/v) citric acid (CA) solution with pH 6.6 or pH 8.0 or pH 9.6 were then added to 3.3 g dry sodium hyaluronate (NaHA) fibers. The resulting mixture was homogenized by hand mixing and then allowed to crosslink ([0089]).
Mondon differs from the instant claims insofar as not disclosing wherein the mixed components comprise micronized croscarmellose sodium.
However, Park discloses a superporous hydrogel composite formed by polymerizing one or more ethylenically-unsaturated monomers, and a multiolefinic cross-linking agent, in the presence of particles of a disintegrant and a blowing agent (Abstract). Ac-Di-Sol® (FMC Corporation) (i.e., croscarmellose sodium) is a crosslinked sodium carboxymethylcellulose that exists as stiff fibers with diameter of 10-20 μm and length of 100-200 μm (i.e., micronized) (page 41, lines 26-29). Particles of a disintegrant used include crosslinked sodium carboxymethylcellulose (page 11, lines 9-14) and non- crosslinked forms of the polymer can also be used (i.e., sodium carboxymethylcellulose) (page 11, lines 25-28). Superporous hydrogels can be used as a platform for long-term oral drug delivery (page 57, lines 8-10). In the biomedical area, their unique pore structure provides advantages in making artificial skin; articular cartilage; soft tissue substitutes (page 57, lines 26-29). The freeze-dried superporous hydrogels were compressed, elongated, or changed to any shape without breaking (page 38, lines 32-34). Ac-Di-Sol® was found to significantly increase the mechanical strength of conventional, non-porous hydrogels (page 47, lines 16-18).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Mondon discloses wherein the composition comprises crosslinked carboxymethyl cellulose. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated Ac-Di-Sol® (i.e., croscarmellose sodium) having stiff fibers with diameter of 10-20 μm and length of 100-200 μm (i.e., micronized), into the composition of Mondon since it is a known and effective crosslinked carboxymethyl cellulose that increases the mechanical strength of conventional, non-porous hydrogels as taught by Park.
Regarding the limitation of claims 17 and 20 reciting wherein the mixed components further comprise carboxymethylcellulose sodium, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Mondon discloses wherein the composition comprises non-crosslinked carboxymethyl cellulose. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated non-crosslinked sodium carboxymethylcellulose into the composition of Mondon since it is a known and effective non-crosslinked carboxymethyl cellulose used in medical hydrogels as taught by Park.
2. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Mondon et al., (US 2019/0269597 A1, Sept. 05, 2019) (hereinafter Mondon) in view of Park et al., (WO 1998/051408 A1, Nov. 19, 2011) (cited by Examiner Form 892 dated 10/24/2025) (hereinafter Park), and further in view of Wang (CN 106946996 A, Sept. 27, 2019) (cited by Examiner on Form 892 dated 05/06/2025) (hereinafter Wang).
As discussed above, Mondon and Park disclose the limitations of claim 9, but do not teach wherein the method comprises prior to said mixing, obtaining the croscarmellose sodium by a carboxymethylcellulose cross-linking process in an acidic environment.
However, Wang discloses the preparation method of Ac-Di-Sol which includes heat-treating sodium carboxymethylcellulose and water, cooling the mixture, adding ethanol, and then subjecting the mixture to acidification and conditions to induce cross-linking. The dried product is crushed to make the pharmaceutic adjuvant Ac-Di-Sol (abstract). It is preferable that the grain diameter of the product after crushing is the mesh of 150 (page 4, step 5).
Mondon and Park teach hydrogel formulations comprising croscarmellose sodium but does not disclose how croscarmellose sodium is made. Wang discloses the production method of Ac-Di-Sol, which is a cross-linked sodium carboxymethylcellulose wherein the method includes acidification. Accordingly, it would have been obvious to one of ordinary skill in the art to have produced the croscarmellose sodium of Park by a carboxymethylcellulose cross-linking process in an acidic environment since this is a known and effective method of croscarmellose sodium production as taught by Wang.
Regarding the limitation reciting prior to said mixing, as discussed above, the croscarmellose sodium used in the method of Park is Ac-Di-Sol. Accordingly, because the production method of Ac-Di-Sol comprises cross-linking sodium carboxymethylcellulose in an acidic environment to produce Ac-Di-Sol, and Ac-Di-Sol is croscarmellose sodium, it would have been obvious that the Ac-Di-Sol (i.e., croscarmellose sodium) of Park was obtained by cross-linking sodium carboxymethylcellulose in an acidic environment prior to it being mixed with the additional components in the method of Mondon in view of Park.
3. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mondon et al., (US 2019/0269597 A1, Sept. 05, 2019) (hereinafter Mondon) in view of Park et al., (WO 1998/051408 A1, Nov. 19, 2011) (cited by Examiner Form 892 dated 10/24/2025) (hereinafter Park), Wang (CN 106946996 A, Sept. 27, 2019) (cited by Examiner on Form 892 dated 05/06/2025) (hereinafter Wang), and further in view of Wuhan University of Technology WUT (CN 107200853 B, Jan 31, 2020) (cited by Examiner on Form 892 dated 05/06/2025) (hereinafter WUT).
As discussed above, Mondon, Park and Wang make obvious the limitations of claims 1, 9 and 10, but do not teach wherein said acidic environment comprises deionized water, and hydrochloric acid.
However, WUT discloses a method of cross-linking carboxymethyl cellulose (abstract), wherein the carboxymethyl cellulose is dissolved and in a series of following steps deionized water, ethanol, and a hydrochloric acid solution are then added (page 2, steps 1-4 and subsequent 2 sentences). The result is a cross-linked network structure of the carboxymethyl cellulose superabsorbent gel suitable for medical materials (page 2, Application of the above dendrimer/carboxymethyl cellulose superabsorbent gel in the fields of personal hygiene and medical materials).
Wang discloses the preparation method of Ac-Di-Sol which includes sodium carboxymethylcellulose and water, adding ethanol, and then subjecting the mixture to acidification and conditions to induce cross-linking. Accordingly, it would have been obvious to one of ordinary skill in the art to have added deionized water and hydrochloric acid into the method of Wang since they are known and effective types of water and acid used in the carboxymethylcellulose cross-linking process as taught by WUT.
4. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mondon et al., (US 2019/0269597 A1, Sept. 05, 2019) (hereinafter Mondon) in view of Park et al., (WO 1998/051408 A1, Nov. 19, 2011) (hereinafter Park), and further in view of He et al., (An overview of hydrogel-based intra-articular drug delivery for the treatment of osteoarthritis, June 1, 2017) (hereinafter He).
The teachings of Mondon and Park are discussed above. Mondon and Park do not teach a method of use of the composition comprising using the composition in an intra-articular injection in a joint to increase lubricating capacities of synovial fluid of the joint.
However, He teaches that injectable materials such as hydrogels have been extensively studied for their applications as intra-articular injection for the treatment of OA, which is attributed to their minimally invasive manner, extended drug retention time and high loading efficiency (Abstract). Viscosupplementation (VS) is a recommended intervention in intra-articular injection treatment of knee OA. Hyaluronic acid (HA) is not only an abundant material in the synovial fluid, but also a natural material to form hydrogels (page 34, third paragraph). Intra-articular injection of hyaluronic acid (HA) is known as viscosupplementation. (page 34, 3. OA intra-articular injection treatment strategies).
As discussed above, Mondon discloses hydrogels comprising hyaluronic acid suitable for biomedical applications. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have used the hydrogel of Mondon in an intra-articular injection in a joint since intra-articular injection of hydrogels comprising hyaluronic acid (HA), known as viscosupplementation, is a recommended intervention in intra-articular injection treatment of knee OA as taught by He.
Regarding the limitation of claim 12 reciting to increase lubricating capacities of synovial fluid of the joint, as noted on page 4 line 30 – page 5 line 2 of the instant specification, hyaluronic acid is naturally found in the synovial fluid, of which it is the main substance responsible for the high lubricating capacities thanks to the viscosity thereof. Hyaluronic acid contributes to lubricating the joint and cushioning mechanical stresses, and therefore has a lubricating function. Accordingly, because the composition of Mondon comprises hyaluronic acid, it would necessarily increase lubricating capacities of synovial fluid of the joint.
Response to Applicant’s Arguments
Applicant’s arguments have been considered but are moot because new rejections necessitated by Applicant’s amendments have been made.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./Examiner, Art Unit 1614
/TRACY LIU/Primary Examiner, Art Unit 1614