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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/22/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/22/2026 has been considered by the examiner.
Status of the Claims
Previous product claim elections are noted to include a guanide compound as the biocide and polyglyceryl-10 caprylate/caprate as the polyglycerol ester.
Claim 2 previously was canceled. Claims 3-8, 11, 12, 15, and 16 remain withdrawn. Accordingly, claims 1, 9, 10, 13, and 14 remain pending and under examination as presented in the claims filed 4/22/2026, which are now entered upon entry of the RCE filed 5/22/2026.
Withdrawn Rejections and Response to Arguments
The following rejection as previously presented is withdrawn in view of the claim amendments filed 4/22/26: the rejection of claims 1, 9, 10, 13, and 14 under 35 U.S.C. 103 as being unpatentable over WO2019/178043A1 (hereafter, “Pambou”)
Applicant’s arguments filed 4/22/2026 (hereafter, “Remarks”) have been fully considered and are addressed as follows. The claims as amended recite narrowed scope which is addressed below in the new grounds of rejection necessitated by amendment, however it is noted that no new reference has been cited.
Applicant argues that Pambauo does not teach the ratio claimed and that Table 2 of the instant disclosure shows log reduction lower than when the same biocidal agent was tested in combination with PGE such that the instant claims recite a non-trivial effect. In reply, Applicant’s argument has been fully considered but is not persasuive since the purported evidence of unexpected results is not both of practical and statistical significance and commensurate in scope with the claim language at hand.
Applicant requests rejoinder, however there has been no finding of allowable subject matter at this time.
New Grounds of Rejection Necessitated by Amendments filed 4/22/26, No New Reference Cited
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.
Claims 1, 9, 10, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019/178043A1 (hereafter, “Pambou”).
The claims are drawn to a composition comprising (i) a biocidal agent and (ii) a polyglycerol ester in a ratio further specified in the claims. Instantly elected, the biocidal agent is a guanide.
Pambou teaches antiperspirant/deodorant compositions in various disclosed formulation forms (see abstract, in particular). The formulations may comprise a preservative in an amount of 0.01 to about 10% w/w, or 0.1 to about 7% w/w (see [0077]), and the preservative may be chlorhexidine for instance (see [0075])(limitation of claims 9 and 10). Chlorhexidine is noted specifically to be a guanide and more specifically a biguanide. Polyglyceryl-10 oleate may be included for instance in an amount of 0.60% w/w as exemplified in Example 5 (see [0099] and [0100])(limitation of claims 13 and 14). More specifically, Pambou teaches Example 6 which is a formulation for various antiperspirants wherein polyglyceryl-10 dipalmitate is included in an amount of 4% in Example 6A and in the same example where a gluconolactone/sodium benzoate/ calcium gluconate component is included in a w/w% amount of 1.00% (see [0103]). Accordingly, Example 6A teaches a preservative component embodied which Pambou teaches as functionally equivalent to the preservative which is chlorhexidine (a guanide) (see [0075] and [0076]).
Because Pambou does not teach a single embodiment including the instantly elected components, this rejection is made using obviousness rationale. Pambou’s Example 6A teaches a weight ratio range of polyglycerol ester to biocidal agent disclosed to be functionally equivalent to the instantly elected guanide to be 4:1, a value within the previously claimed range but outside the amended claim range. However, Pambou considered as a whole teaches chlorhexidine to be included as a preservative wherein said preservative is included in an amount of 0.01% and 10% by weight and preferably 0.1 to 7% by weight (see [0075] and [0077]); simultaneously, Pambou teaches polyglycerol ester to be included in an amount of 0.01 to 20% for emulsification benefit (see [0081]). These ranges include a weight ratio of 1:1 which is reduced to 1.0, a value within the instantly claimed range. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute one of Pambou’s preservatives for another in Pambou’s Example 6A for instance, with a reasonable expectation of success since Pambou teaches both of these components to function as preservatives alike. Further, one would have been motivated to perform routine optimization procedures as to the optimization of amounts of preservatives including those within the parameters of Pambou’s suggestions as noted above, based on routine inquiry in the art, where including the two claimed components in amoutns recommended by Pambou includes values within the weight ratio range instantly recited thereby providing a reasonable expectation of success.
As to the difference between Pembou’s cited example and Pembou’s disclosure as a whole, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range."). See also In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range.
Moreover, 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Further still, it is the examiner’s position that optimizing the relative amounts of the two components detailed above constitutes the use of known technique to a known product to yield predictable results since the prior art teaches known functional benefits of each respective component in a product to be used for the same or substantially the same purpose as instantly claimed.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/Primary Examiner, Art Unit 1617
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