DETAILED ACTION
Claims 1-23 are pending. Of these, claims 10-13 are withdrawn as directed to a nonelected invention. Therefore, claims 1-9 and 14-23 are under consideration on the merits.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restriction
Applicant’s election of Group I is acknowledged. The election having been made without traverse, the restriction requirement is still considered proper and is made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/12/26, 4/17/26, and 6/4/26 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Claim Rejections - 35 USC § 112
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 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as 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 8 recites a ratio of loss modulus to elastic modulus of “between 10-2 and 1.” The meaning of “10-2” is unclear. Clarification is required.
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.
Claims 1-9, 14-16, and 18-23 are rejected under 35 U.S.C. 103 as unpatentable over CN110760103 (published 9.14.21; of record in IDS) as evidenced by the English translation thereof (of record in IDS) in view of Balakrishan et al. (J. Mater. Chem. 8, 2013, 1, 5564-5577; of record in IDS).
As to claims 1-9, 14-16, and 18-23, CN110760103 discloses a viscoelastic injectable hydrogel for applications including cartilage regeneration (paragraphs 2,8) comprising oxidized nanocrystalline cellulose and collagen (paragraph 12) which are crosslinked via imine moieties (claim 2)(paragraphs 13, 93). The hydrogel is prepared in a buffer solution (paragraph 24) and possesses high elastic modulus (paragraph 15).
Regarding claim 15, the ingredients may be mixed together to form the hydrogel in a syringe (paragraph 28).
As to claim 23, the skilled artisan would recognize that the CN110760103 hydrogel will be miscible in synovial fluid.
As to claims 1-9, 14-16, and 18-23, CN110760103 does not further expressly disclose that the oxidized nanocrystalline cellulose is crosslinked with gelatine peptide chains as recited by claim 1, as opposed to being crosslinked with collagen as disclosed by CN110760103, nor the degree of crosslinking recited by claims 1 and 9. Nor does CN110760103 disclose the crosslinking degree of claims 1 and 9, the gelatine and oxidized nanocrystalline cellulose concentrations of claim 3 or the hydrogel concentrations of claims 4 and 22, or that the elastic modulus is within the range of claim 5 or the loss modulus (claim 6), ratio of loss modulus to elastic modulus (claim 7), or the complex viscosity of claim 8. Nor does CN110760103 disclose a method of treating symptoms of osteoarthritis comprising administering the injectable hydrogel (claim 14) in the amount of 2 wt% (claim 21) to a mammal such as a human (claims 16, 18) and into a pathological or osteoarthritic joint (claims 20-21).
Balakrishnan discloses injectable hydrogels for cartilage regeneration such as in the treatment of osteoarthritis, wherein the hydrogels are formed by crosslinking oxidized carboxymethyl cellulose with gelatin using an imine formed via a Schiff reaction (Abstract and 1st paragraph of Section 1). Balakrishnan teaches that the morphology of the gels plays a significant role in controlling the distribution and migration of cells within the matrix, and that the morphology can be manipulated by varying the concentrations of the oxidized carboxymethyl cellulose (CDA) and gelatin (Sections 3.4.2 and 4). Balakrishan teaches that about 9.6% of men and 18% of women have symptomatic osteoarthritis (first sentence of Section 1).
As to claims 1-9, 14-16, and 18-23, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the injectable hydrogel of CN110760103 by selecting gelatin instead of collagen as the peptide that is crosslinked with the oxidized nanocrystalline cellulose, because Balakrishan teaches that an injectable hydrogel for cartilage regeneration can be formed by crosslinking gelatin to the cellulose, and the skilled artisan would recognize that gelatin is highly structurally similar to collagen in that it is derived from collagen by breaking down the collagen into shorter peptide chains, such that the skilled artisan reasonably would have expected that gelatin could be used as the peptide for crosslinking to the cellulose in the cartilage regeneration material of CN110760103. Such a modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
It further would have been prima facie obvious to use a hydrogel with a crosslinking degree within the ranges of claims 1 and 9, because the crosslinking is necessary to form the hydrogel as discussed by CN110760103 such that the degree of crosslinking is a result effective variable that will affect the ability to form the hydrogel, and there would have been a reasonable expectation of success in arriving at the claimed ranges because both the CN110760103 hydrogel and the claimed hydrogel are for use in cartilage regeneration such that the skilled artisan would have been optimizing the hydrogel to perform the same function. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 3-4 and 22, it further would have been prima facie obvious to select an amount of the cellulose and gelatin peptide that is within the claimed ranges and a 2 wt% concentration of the hydrogel as recited by claim 21 with a reasonable expectation of success because the amount of the ingredients needed to form the hydrogel are result effective variables that will affect the ability to form the hydrogel and the amount of the hydrogel is a result effective variables that will affect the composition’s cartilage regeneration ability, and the skilled artisan would be optimizing the amounts for the same function recited by the claims and disclosed by the present specification (e.g., for the formation of an injectable hydrogel for cartilage regeneration such as in the treatment of osteoarthritis). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The resulting hydrogel will possess the elastic modulus (claim 5), loss modulus (claim 6), ratio of loss modulus to elastic modulus (claim 7), and complex viscosity (claim 8) recited by the claims, because it comprises the same ingredients and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01. Additionally, “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As to claims 14, 16, and 18-21, it further would have been prima facie obvious to administer the injectable hydrogel into a pathological joint such as an osteoarthritic joint of a mammal such as a human, because Balakrishan teaches that osteoarthritis afflicts humans and that injectable hydrogels can promote cartilage regeneration in osteoarthritic joints. Regarding claim 21, it further would have been prima facie obvious to select a 2 wt% concentration of the hydrogel as recited by claim 21 with a reasonable expectation of success because the hydrogel is the active substance and therefore the amount of the hydrogel is a result effective variable that will affect the composition’s cartilage regeneration ability, and the skilled artisan would be optimizing the amount for the same function recited by the claims, i.e., the treatment of osteoarthritis). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 17 is rejected under 35 U.S.C. 103 as unpatentable over CN110760103 (published 9.14.21) as evidenced by the English translation thereof in view of Balakrishan et al. (J. Mater. Chem. 8, 2013, 1, 5564-5577) as applied to claims 1-9, 14-16, and 18-23 above, and further in view of Mcllwraith et al. (Bone Joint Res 2012;1:297-309).
The teachings of CN110760103 and Balakrishan are relied upon as discussed above, but they do not further expressly disclose that the treated mammal is a horse.
Mcllwraith teaches that osteoarthritis is a common problem in both horses and humans (Abstract and Introduction section).
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the method of treating osteoarthritic joints of CN110760103 and Balakrishan as combined supra by selecting a horse as the subject, because Mcllwraith teaches that osteoarthritis is a common problem in both humans and horses, such that the skilled artisan reasonably would have expected that the method could be used to treat horses having osteoarthritis.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-9 and 14-23 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 18/970,883 and in view of CN110760103 (published 9.14.21) as evidenced by the English translation, Balakrishan et al. (J. Mater. Chem. 8, 2013, 1, 5564-5577), and/or Mcllwraith et al. (Bone Joint Res 2012;1:297-309) where indicated below.
The teachings of the cited secondary references are relied upon as discussed above.
The reference claims recite an injectable hydrogel comprising oxidized nanocrystalline cellulose crosslinked with gelatine peptide chains via imine moieties in the same concentrations recited by the present claims and comprising the same elastic modulus, loss modulus, ratio of loss modulus to elastic modulus, complex viscosity, and degree of crosslinking, along with a syringe comprising the hydrogel. The hydrogel will be miscible in synovial fluid.
The reference claims do not recite the presence of a buffer solution nor a method for treating symptoms of osteoarthritis in a horse or human comprising injecting the hydrogel in a concentration of 2% into a pathological or osteoarthritic joint as recited by the present claims, but it would have been prima facie obvious to form the hydrogel in a buffer solution because CN110760103 teaches that injectable hydrogels can be formed using a buffer solution.
It would have been prima facie obvious to administer the injectable hydrogel into a pathological joint such as an osteoarthritic joint of a mammal such as a human or horse because Balakrishan teaches that osteoarthritis afflicts humans and that injectable hydrogels can promote cartilage regeneration in osteoarthritic joints, and Mcllwraith teaches that osteoarthritis is a common problem in both humans and horses, such that the skilled artisan reasonably would have expected that the method could be used to treat horses as well.
It further would have been prima facie obvious to select a 2 wt% concentration of the hydrogel as recited by claim 21 with a reasonable expectation of success because the hydrogel is the active substance and therefore the amount of the hydrogel is a result effective variable that will affect the composition’s cartilage regeneration ability, and the skilled artisan would be optimizing the amount for the same function recited by the claims, i.e., the treatment of osteoarthritis). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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