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 .
Priority
The instant application was filed 21 July 2023 and is the national stage entry of PCT/US2022/013244 filed 21 January 2022. The Applicant claims priority to provisional application 63/140,537 filed 22 January 2021. The effective filing date of the instant application is 22 January 2021.
Examiner’s Note
The Applicant's amendments and arguments filed 11 March 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 11 March 2026, it is noted that claims 1, 7, and 26 have been amended and no new claims have been added. Support for the amendments can be found on pg. 15 of the specification. No new matter has been added.
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.
Claim(s) 1, 4, 5, 7, 15, 17, 26, 28, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nadal et al. (US 8846099 B2) and Jeon et al. (Investigating the Role of FGF18 in the Cultivation and Osteogenic Differentiation of Mesenchymal Stem Cells, PLoS ONE, 2012).
Nadal et al. teach microspheres (title; entire teaching) or particles (abs) that may comprise active ingredients, such as HGH and IGF-1, and a biodegradable excipient. The particles may have a diameter of between 10-20 microns (col. 3, lns. 10-22), addressing claims 4 and 30, and partially claim 1. Nadal provides an example of PLGA microspheres and human serum albumin (col. 25, lns. 55-62), addressing claims 5 and 28. The microspheres may also comprise VEGF (claim 1), addressing Applicant’s election and claim 7. The composition may comprise a mixed population of particles with one or more different active ingredients (claim 10), which is interpreted as addressing claim 26. The concentration of active ingredient may be in the range of 1 ng up to 4 mg (claim 6) and active ingredients include FGF, TGF-beta (claim 4), IGF-1 (Example 1), and growth hormones (col. 9, lns. 60-64), addressing claim 17.
Nadal does not specifically teach FGF-18 in claim 1. Nadal also does not specifically teach weight percentages for the different active ingredients in claim 15.
Jeon teaches that FGF-18 helps to stimulate proliferation in several tissues (abs).
Since Nadal does not specifically teach FGF-18 in claim 1, one of ordinary skill in the art would have been motivated to use Jeon’s teaching with a reasonable expectation of success. A skilled artisan would have recognized the added benefit of using FGF-18 to help stimulate the proliferation in tissues, as Nadal teaches using FGF (claim 4) for use in stimulating regenerative capacity of slid tissues (col. 1, lns. 33-37). “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).”
Nadal teaches a concentration of 1 ng to 4 mg for the active ingredients (claim 6), as well as different ratios for the amount of actives and excipients (col. 8, lns. 33-39) for claim 15. That being said and in lieu of objective evidence of unexpected results, the weight % can be viewed as a variable that achieves the recognized result of successfully making the microsphere composition. The optimum or workable range of weight % can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized weight % of active ingredients as nonobvious.
Response to Arguments
Applicant's arguments filed 11 March 2026 have been fully considered but they are not persuasive.
The Applicant argues that Nadal fails to teach or suggest all of the claimed elements in claim 1 (Remarks, pgs. 14-15).
Applicant’s argument is not found persuasive. Nadal et al. teach microspheres (title; entire teaching) or particles (abs) that may comprise active ingredients, such as HGH, FGF, TGF-beta (claim 4), IGF-1 (Example 1), and growth hormones (col. 9, lns. 60-64). Since Nadal does not specifically teach FGF-18 in claim 1, one of ordinary skill in the art would have been motivated to use Jeon’s teaching with a reasonable expectation of success. A skilled artisan would have recognized the added benefit of using FGF-18 to help stimulate the proliferation in tissues, as Nadal teaches using FGF (claim 4) for use in stimulating regenerative capacity of slid tissues (col. 1, lns. 33-37). “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).”
The Applicant argues that a skilled artisan would not have arrived at the claimed amounts and ratios in claim 15 (Remarks, pgs. 15-16).
Applicant’s argument is not found persuasive. Nadal teaches a concentration of 1 ng to 4 mg for the active ingredients (claim 6), as well as different ratios for the amount of actives and excipients (col. 8, lns. 33-39) for claim 15. That being said and in lieu of objective evidence of unexpected results, the weight % can be viewed as a variable that achieves the recognized result of successfully making the microsphere composition. It is obvious to a skilled artisan that optimizing the amounts of active agents, especially when Nadal provides a concentration range suitable for the active ingredients, would influence and affect the microsphere composition for delivery of drugs, and is therefore a results-effective variable. The optimum or workable range of weight % can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized weight % of active ingredients as nonobvious.
Furthermore, the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. “[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). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results. Therefore, it would have been obvious to adjust the amounts of active agents in Nadal’s microsphere composition for the intended purpose of optimizing the delivery of drugs to tissues.
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.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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