DETAILED ACTION
This Office action details a final action on the merits for the above referenced application No. Claims 1-9, and 12-20 are pending in this application.
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 .
Status of Claims
Claim 1 is amended. Claims 10-11 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 May 2026 has been considered by the examiner.
Response to Amendment
The amendments filed on 11 May 2026 have been entered.
Response to Arguments
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) 1-9, and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramirez et al. (US 2009/0076170 A1; published 19 Mar. 2008), in view of Abou-Chacra et al. (WO 2008/00688 A1; published 17 Jan. 2008) and Orsoni et al. (AU 2002364437 B2; published 2002) for the reasons cited in the Office action filed on 12 Nov. 2025.
Applicants Arguments
Applicants assert that none of the cited references disclose or suggest a first container or a plurality of first containers containing BPO wherein the BPO is greater than about 95% pure. Ramirez does not disclose BPO that is greater than about 95% pure. Ramirez explicitly teaches that the organic BPO is present in the compositions in an amount of about 1 to 70% by wt of total composition. Therefore at least 30% by weight of the composition of Ramirez must be something other than BPO. Therefore, Ramirez does not disclose that BPO is greater than 95% pure. In Abou-Chacra, the BPO is described as being a preferentially 2.5% BPO and the pharmaceutical compositions are described as preferably a gel, cream or lotion. Orsoni discloses compositions comprising between 0.0001% and 20% by wt of BPO. Orsoni does not disclose a first containing therein BPO wherein the BPO is greater than 95% pure.
Applicant's arguments filed 11 May 20265 have been fully considered but they are not persuasive. Ramirez does disclose and suggest a container containing therein BPO wherein the BPO is greater than about 95% pure and is in crystalline powder form. At [0015], Ramirez discloses that BPO is available as pure (98% active) crystals. At [0009], Ramirez discloses that the organic peroxide may be solid in which antioxidant can be dispersed. At [0017], Ramirez teaches that molecules in solution will react much more readily than in solid crystal form. At the same place, Ramirez discloses that decomposition of BPO will result in benzoic acid, benzene, phenyl benzoate and biphenyls all such materials can be toxic to a cell. Accordingly, a person of ordinary skill in the art would have had reason and motivation from Ramirez alone to arrive at a first container containing therein wherein the BPO is greater than about 95% and is in crystalline powder form. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. See In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). A person of ordinary skilled art would have been motivated to modify the examples and preferred embodiments of Ramirez so that the kit comprises a first container containing therein BPO, wherein the BPO is greater than 95% pure and in crystalline powder form because the purity and crystalline form would have been expected to enable the use of an equivalent commercially available BPO advantageously less reactive than in solution and less prone to decomposition products that can be toxic to a cell. While at [0014], Ramirez teaches that typically the organic peroxide will be present in an amount of about 1 to 70 percent, Ramirez also teaches at the same place that the amount of organic peroxide will depend on a number of factors. Accordingly, the amount of BPO in kit composition embodiment of Ramirez is result effective variable that a person of ordinary skill in the art would have been motivated to optimize at the time of invention. MPEP 2144.05.II. A first container containing therein commercially available crystalline BPO with a small amount of dispersed antioxidant still reads on a BPO that is 95% pure and in crystalline powder form. Ramirez, Orsoni, and Abou-Chacra teach and suggest all the limitations of claim. The basic technique of use a commercially available BPO that is greater than 95% pure and in solid crystalline form in the first container of the kit embodiment of Ramirez yielded no more than a predictable outcome and is therefore obvious.
Claim(s) 1-9, and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramirez et al. (US 2009/00766170 A1; published 19 Mar. 2008), in view of Abou-Chacra et al. (WO 2008/00688 A1; published 17 Jan. 2008) and Orsoni et al. (AU 2002364437 B2; published 2002), in further view of Vishnupad et al. (CA 2174031 C; issued 17 Dec. 2002) for the reasons cited in the Office action filed on 12 Nov. 2025.
Applicants Arguments
Applicants assert that Vishnupad fails to cure the deficits of Ramirez, Abou-Chacra, and Orsoni. Although Vishnupad disclose that the BPO will constitute 1 to 99 wt% of the BPO/benzoate ester mixture, Vishnupad also disclose that the method of mixing BPO with benzoate mixture changes the crystalline BPO to a fine soft peroxide slurry. The BPO compositions described by Vishnupad as suitable for cosmetic preparations are non-crystalline or amorphous and are not crystalline as required by amended claim 1.
Applicant's arguments filed 11 May 20265 have been fully considered but they are not persuasive. Ramirez, Abou-Chacra, and Orsoni are not deficient for the reasons discussed above. At pg. 4, Vishnupad teaches a commercially available pure BPO (98% active) active crystals. At pg 5, Vishnupad teaches that the BPO can constitute up to 99 wt percent of the mixture. Accordingly, Vishnupad teaches that up to 99 wt percent of BPO can be useful for cosmetic preparations. Vishnupad does not show that a 99 wt percent crystalline pure BPO having a small amount of benzoate ester and antioxidant dispersed therein would be an amorphous solid. Ramirez teaches that molecules in solution will react much more readily than in solid crystal form. It would have been further obvious to a person of ordinary skill in the art before the effective filing date to modify the kit of Ramirez so the first container contains therein a BPO wherein the BPO is greater than about 95% pure and is in crystalline powder form because that first container of the kit would have been expected to enable the use of commercially available pure BPO that is in less reactive crystalline powder form whereby reducing toxicity to cell.
Conclusion
THIS ACTION IS MADE FINAL. 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 SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
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