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 Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 35-45, 49, 52-57 and 59 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ankorina-Stark et al. (WO2017167348, disclosed by applicant).
Ankorina-Stark et al. disclose polyacrylamide hydrogel for treating osteoarthritis Ankorina-Stark discloses the polyacrylamide hydrogel is administered by injection under sterile conditions; wherein 0.1-20 ml polyacrylamide hydrogel is administered by injection into the intraarticular cavity from one to 10 times (reference claims). Ankorina-Stark et al. disclose KL grade scores of 2 and/or 3, a human patient no more than 70 years old, a female and/or male, a BMI of less than 25 (Table 5). Ankorina-Stark et al. disclose WOMAC pain score for patient reported treatment with a score change of 45.5 (Table 8, p. 33). Ankorina-Stark et al. disclose the hydrogel has an elasticity modulus of about 10 to 100 Pa (p. 12, lines 25-28). Ankorina-Stark et al. disclose treatments at 26, 32 and 212 weeks (p. 31, lines 6-9).
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.
Claim(s) 46-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ankorina-Stark et al. (WO2017167348, disclosed by applicant).
Ankorina-Stark is discussed above and differs from the instant claims insofar as they do not disclose the WOMAC pain subscale in said human at week 26.
Ankorina-Stark disclose WOMAC pain subscale of patients obtained after at least 12 weeks of treatment comprising pain sub-score or no pain -10 (±1.4) and improved -4.9 (±3.9) with total score of no pain -45.5 (±2.1) and improved -21.5 (±15.9) (Table 8).
It would have been obvious to one of ordinary skill in the art to have expected various text results at different points after treatment. It would appear the results would have been variations of those disclosed if taken at the specific time frame, i.e. 26 weeks.
Claim(s) 35, 50, 51 and 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ankorina-Stark et al. (WO2017167348, disclosed by applicant) as applied to claims 35-45, 49, 52-57 and 59 above, in view of Peterson (US Patent Pub. 20020150550).
Ankorina-Stark et al. is discussed above and differs from the instant claims insofar as they do not teach the pH of the polyacrylamide hydrogel.
Peterson et al. disclose polyacrylamide hydrogel for treating mammal soft tissue (Abstract). Peterson et al. disclose the polyacrylamide hydrogel has pH in the range of 6.5 to 9.0 ([0018]).
It is prima facie obviousness to select a known material based on its suitability for its intended use. Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. MPEP 2144.07. It would have been obvious to have used polyacrylamide hydrogel at the claimed pH since it is known to use hydrogels at said pH for treating mammals.
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 35-45, 49, 58-57 and 59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 10,772,991. Although the claims at issue are not identical, they are not patentably distinct from each other because in each case the claims are directed to a polyacrylamide hydrogel for use in prevention and/or treatment of osteoarthritis. Therefore, the claims are not patentably distinct.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANNETTE HOLLOMAN whose telephone number is (571)270-5231. The examiner can normally be reached Monday-Friday 9am-6pm.
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/NANNETTE HOLLOMAN/Primary Examiner, Art Unit 1612