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 .
Claims Status
Claims 1-3, 5, and 7-8 are under current examination to the extent of the elected species to: crosslinked polymer of hyaluronic acid crosslinked with carboxymethylcellulose crosslinked and BDDE.
Claims 10-17 are withdrawn.
Applicants' arguments and remarks filed on 09/30/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New rejections necessitated by claim amendments
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (United States Patent 10821205) and Ju et al. (KR20190084840A-published 7/17/2019).
Clams: The instant claims are being examined to the extent of the elected species to hyaluronic acid-carboxymethylcellulose crosslinked with BDDE.
Claim interpretation: Regarding instant claim 8, in that the medical composition is injectable, claim 8 is the intended use of the medical composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The tissue composition of Zu is injectable, see column 1, lines 8-10.
Xu et al. teach compositions comprising an adipose extracellular matrix with HA biopolymer present from 1:10 ratio of 20mg/ml cross-linked hyaluronic acid (meeting a medical composition having adipose derived ECM and crosslinked product of a biocompatible polymer), see column 3, lines 18-45, column 4, lines 14-35, column 9, lines37-60, column 17, lines 57-59 and column 18, lines 37-60 . The adipose matrix can comprise 50-2800 microns and can be adjusted according to the desired biological response, see column 8, lines 56-67 to column 9, lines 1-11. The crosslinking agent can be BDDE, see column 10, lines 50-67. The product can be used as fillers, (satisfying the intended use of claim 8) see column 14, lines 1-8.
Xu et al. does not expressly teach that the hyaluronic acid is crosslinked with carboxymethylcellulose and 1,4-buthanediol diglycidyl ether (BDDE) wherein the crosslinked hyaluronic acid with carboxymethylcullulose is present from 0.1-20 parts by weight.
Ju et al. teach a thermosensitive composition which comprises poloxamer and polymer comprising hyaluronic acid crosslinked with carboxymethylcellulose utilizing BDDE crosslinking agent, see abstract and pages 2-7. The hyaluronic acid/carboxymethylcellulose polymer comprises 1-20% by weight, see pages 4 and 9. The BDDE enables enhanced decomposition in the body, see pages 7 and 9. The thermosensitive composition can be used as a filler composition, see page 9 and claim 9. The thermosensitive composition which includes poloxamer and polymer is easily absorbed and decomposed in a decomposition process and gives a synergistic effect to the prevention of adhesion, and has excellent in biocompatibility, see page 7.
It would have been prima facie obvious to provide the hyaluronic acid of Xu with the thermosensitive composition of Ju having polymers of crosslinked hyaluronic acid with carboxymethylcullulose using BDDE crosslinker in amounts from 1-20% by weight and poloxamer.
One of ordinary skill in the art would have been motivated to do because Ju et al. teach that such thermosensitive compositions are more easily absorbed and provide excellent biocompatibility.
There would have been a reasonable expectation of success because Xu teaches the combination of crosslinked hyaluronic acid with adipose tissue extracellular matrix and both Xu and Ju teach that their products can be used as fillers.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Xu et al. (United States Patent 10821205) and Ju et al. (KR20190084840A-published 7/17/2019 as applied to all claims 1-3, 5 and 8, and further in view of Hagedorn al. (WO2016074794) and Nahas (United States Patent 11078461).
The teachings of the modified Xu are discussed above.
The fillers of Xu et al. are injectable.
Hagedorn teaches fillers which comprise an extrusion force of about 35-75N, see paragraph [0059]. The polymers provide low extrusion force with mechanical properties that are maintained or even improved, see paragraph [0005]. The use of carboxymethylcellulose decreases the extrusion force of hyaluronic acid polymers, see Example 8 and paragraph [0035]. The composition is easily injectable, see paragraph [0080].
It would have been prima facie obvious to provide the dermal filler of the modified Xu with an extrusion force between 35-75N to render the composition easily injectable since the use of carboxymethylcullulose decreases extrusion force of hyaluronic acid polymers.
The modified Xu does not expressly teach the complex viscosity, elastic modulus, viscous modulus (instant claim 7).
Since Xu and Ju render obvious the composition instantly claimed which comprises hyaluronic acid crosslinked with carboxymethyl cellulose via the crosslinker of BDDE together with adipose tissue ECM, the viscous modulus, elastic modulus, complex viscosity and extrusion force would necessarily follow as a composition and it’s properties are inseparable.
Nevertheless, Nahas et al. teach adipose tissue ECM compositions which can comprise hyaluronic acid and carboxymethylcellulose, see claims 13-16. The tissue can be processed to have a complex viscosity of 1,000-100000, viscous modulus of 1000-100000, elastic modulus of 1000-10000, see column 2, lines 52-68. Tailoring the elastic modulus and viscous modulus can adjust the stiffness and elastic like properties of the composition. The elastic modulus and viscous modulus can be modulated in the processed adipose tissue by adjusting the concentration of the processed adipose tissue material and the concentration of the crosslinker with the biopolymer, see column 33, lines 37-66. Complex viscosity can be adjusted to a desired amount by addition of peracetic acid with higher amounts of peracetic acid reducing the complex viscosity values, see column 38, lines 55-60 and figure 6. Nahas suggests that the composition can provide a viscosity that enables ease of injection, see column 7, lines 45-49.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the amount of the complex viscosity, elastic modulus, and viscous modulus of the adipose ECM and crosslinked polymer of the modified Xu et al. to arrive at values within the instant claimed ranges.
One of ordinary skill in the art would have been motivated to do so because Nahas teaches that the elastic modulus and viscous modulus can be adjusted in processed adipose tissue ECM compositions by adjusting the concentrations of the processed adipose tissue and crosslinker with polymer. The composition can be adjusted to the desired stiffness and elastic properties. With regards to the complex viscosity, the ECM composition of Xu can be adjusted to the desired complex viscosity for ease of injection and one of ordinary skill in the art could readily do so using peracetic acid as suggested in Nahas.
With regards the elastic modulus, complex viscosity and viscous modulus, the teachings of Nahas overlap the claimed amounts and therefore render obvious the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to remarks
Applicants argue that HA-CMC crosslinked having 0.1-20 parts based on the total composition show excellent effects such as extrusion force and viscoelasticity .
Examiner respectfully submits that the examples of the instant specification utilize HA-CMC carrier from 1-10% by weight with 5-15% by weight of adipose tissue derived matrices showed the enhanced physical properties. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). Here, the amount of adipose tissue is not required by claim 1 and the biocompatible polymer encompasses amounts outside the ranges exemplified for the improved properties. Furthermore, the extrusion force and viscoelasticity properties are not required with the composition of claim 1.
Applicants’ remarks with regards to the combination of Xu and Hagedorn not teaching crosslinked CMC with HA are considered moot in view of the newly presented rejections which incorporate Ju et al.
Conclusion
The amendment to the claims necessitated new grounds of rejections. 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).
Currently, no claims are allowed and all claims are rejected.
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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached at 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619