Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The amendment filed October 24, 2025 has been entered.
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.
Claims 15-22 and 42-46 are 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 15 recites the limitation "the array of step (e)" in step (e). There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the phrase will be interpreted as the array of step (d).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 15-16, 20-21 and 42-43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Park (US 2010/0048744).
Claim 15: Park discloses a method for forming an array of microprotrusions (abstract; figs. 2A-2B). The method includes preparing a first solution atop a mold having an array of microprotrusion cavities corresponding to the negative of the array of microprotrusions, the first solution including a first solvent, a biodegradable first polymer, and an active ingredient (¶¶ 13, 22, 39-40; figs. 2A-2B), removing the first solvent to form a first layer (¶ 40), preparing a second solution atop the first layer, the second solution including a second solvent and a second polymer, wherein the second polymer is different from the first polymer (¶¶ 21, 39-40; figs. 2A-2B), removing the second solvent to form the array (¶ 40), and demolding the array (¶ 57). Park is silent as to casting the solutions. However, whether the solutions are cast atop the mold or prepared atop the mold, the end result is the same – solutions containing the claimed components atop the mold. The selection of any order of mixing ingredients is prima facie obvious. In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).
Claim 16: Park discloses reducing the pressure to remove the first solvent (¶ 40).
Claim 20: Park discloses the mold made from a ceramic material (¶ 12).
Claim 21: Park discloses sonicating the mold following steps (a) or (c) (¶¶ 28-30).
Claim 42: Park discloses the biodegradable first polymer is PLA (¶ 13).
Claim 43: Park discloses the second polymer being polymethacrylate (¶ 21).
Claims 17-19, 22 and 44-46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Park (US 2010/0048744), as applied to claim 15 above, in view of Prausnitz (US 2002/0082543).
Claim 17: Park is silent as to applying a pressure higher than atmospheric pressure. However, Prausnitz discloses a method for forming an array of microprotrusions including applying a pressure higher than atmospheric pressure (¶ 18). As taught by Prausnitz molding the polymer by compression molding allows the polymer to take the shape of the microneedles (¶ 18). It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have utilized compression molding to allow the polymer to take the shape of the microneedles.
Claims 18 and 22: Prausnitz discloses placing the mold under compression (¶ 18).
Claim 19: Prausnitz discloses placing the polymer under an atmosphere including a gaseous substance which passes readily through the first solvent (¶ 18).
Claims 44-46: Prausnitz discloses water-swellable polymers, water and organic solvent (¶¶ 9, 86, 148).
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 LARRY THROWER whose telephone number is (571)270-5517. The examiner can normally be reached 9am-5pm MT M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Susan Leong can be reached at 571-270-1487. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LARRY W THROWER/Primary Examiner, Art Unit 1754