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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/8/2025 has been entered.
Election/Restrictions
Claims 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/10/2022.
Response to Arguments
In the reply filed on 8/8/2025 Applicant remarks that the claims as amended are distinct from those presented to the board and they are believed to be free of the previously applied prior art.
While the scope of the claims presented is distinct from those presented to the Board, the claims remain obvious over the prior art. Applicant’s are directed to the rejection below which has been modified in view of the amendments to the claims.
Modified Claim Rejections - 35 USC § 103
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 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beilfuss (US 2003/0232729) and Beilfuss (WO2017/042001). All references are previously cited.
Claim 1 recites "consisting essentially of" language. However, the specification lacks a clear disclosure regarding what ingredients/components would materially change the basic and novel characteristics of the composition, in fact the specification teaches that substances/excipients/additives can be added. Therefore, "consisting essentially of" is interpreted to be "comprising" language.
MPEP 2111.03: For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention.
Beilfuss’729 discloses the use of glyceryl ethers as preservatives for cooling lubricant (Abs).
Regarding claims 1b: Beilfuss’729 teaches the glyceryl ether to preferably be a monoalkyl ether, such as 1-(2-ethylhexyl) glyceryl ether, also known as ethylhexylglycerin [0012].
Regarding claims 1a: Beilfuss’729 teaches the preservative to preferably be a mixture of a glyceryl ether with one or more aromatic alcohols [0011], the aromatic alcohols are preferably phenoxyethanol and phenoxy-propanols [0013], therefore the use of phenoxyethanol is prima facie obvious.
Regarding claim 10: Beilfuss’729 teaches the glyceryl ethers and the aromatic alcohols to be used in a weight ratio of 1:20 to 20:1, in particular 1:5 to 5:1.The working examples of Beilfuss’729 exemplify a preservative mixture comprising 20T of 1-(2-ethylhexyl) glyceryl ether (SC50) and 80T of POE (phenoxyethanol) (i.e. a ratio of 1:4). Beilfuss’729 also teaches amounts of SC50 of 10% and phenoxyethanol 80% [0047], which falls within the claimed concentration amounts.
While Beilfuss’729 teaches the preservative to be added to a cooling lubricant, Beilfuss’729 teaches that the preservative component is added to an unpreserved cooling lubricant [0026], therefore it would have been prima facie obvious for a skilled artisan to prepare a mixture consisting of the preservative components (i.e. glyceryl ether and the aromatic alcohol) prior to addition to the final composition (i.e. cooling lubricant), this mixture of preservative components reads on the claimed composition, wherein the preservative composition only has 1-(2-ethylhexyl) glyceryl ether and phenoxyethanol, and as discussed above, the prior art teaches the glyceryl ethers and the aromatic alcohols to be used in a weight ratio of 1:20 to 20:1, in particular 1:5 to 5:1 (overlapping with the ratio of 0.3 or less as recited by instant claim 10) and exemplifies a preservative composition comprising a 1:4 ratio of glyceryl ether, Thus Beilfuss’729 teaches amounts of glyceryl ether and aromatic alcohols with overlap with the claimed ranges recited by instant claims 1a and 1b.
However, Beilfuss’729 does not teach the preservative mixture to further comprise octenidine hydrochloride in an amount of 0.01-1% as recited by instant claims 1c.
Beilfuss’001 teaches a liquid concentrate for preserving cosmetics having:
-- an aromatic alcohol selected from aryloxyalkanols and arylakanols, acid, octenidine dihydrochloride and a 1- or 2- (C3-C24 alkyl) glycerol ether, preferably Sensiva SC50 (Beilfuss’001– claim 8; and Pg. 7).
Beilfuss’001 teaches phenoxyethanol to be a preferred aromatic alcohol for use (Beilfuss’001– claim 2 and pg. 4) and teaches a preferred glyceryl ether to be 1-(2-ethylhexyl)glycerol ether, also known as ethylhexylglycerol (i.e. ethylhexylglycerin) (pg. 7).
Beilfuss’001 teaches that while octenidine dihydrochloride does not have its own antimicrobial effect, it assists in the antimicrobial efficacy of the composition (Pg. 16). Beilfuss’001 teaches that the combination of octenidine dihydrochloride with ethylhexylglycerol is advantageous for improving the interfacial activity and for boosting the microbial efficacy of the active ingredient (i.e. the aromatic alcohol and acid) (Pg. 8). The octenidine dihydrochloride can be used in amounts 0.04-0.2% of the liquid concentrate (Pg. 6).
The aromatic alcohols are taught to be used in amounts ranging from 55-90%, preferably 60-85%; the octenidine to be used in amounts ranging from 0.04-0.25, preferably 0.05-0.1; and the glycerol ether to be used in amounts of 0.5-10%, preferably 1-5% (Beilfuss’001 - claims 1, 4 and 7-9).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Beilfuss’729 with those of Beilfuss’001 and add 0.04-0.2% of octenidine dihydrochloride to the preservative composition of Beilfuss’729 made obvious above, as octenidine dihydrochloride is taught to improve the interfacial activity and boost the microbial efficacy of aromatic alcohol, when combined with ethyhexylglycerol ether. One of skill in the art would have a reasonable expectation of success as both Beilfuss’729 and Beilfuss’001 teach preservative compositions comprising aromatic alcohol and glyceryl ethers.
As discussed above, the prior art make obvious a preservative composition comprising 0.04-0.2% of octenidine dihydrochloride with the remainder of the composition being 1-(2-ethylhexyl) glyceryl ether and phenoxyethanol.
Regarding claims 1 and 9: The ratio of component c to component a and b can be calculated to be (.04-0.2)/(99.96-99.8) = .0004-.002 which completely falls within the range of .0001-0.01.
Reinstated Claim Rejections - 35 USC § 103
Claim(s) 1 and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beilfuss (WO2017/042001). Beilfuss is cited on the 2/26/2021 IDS.
Claim 1 recites "consisting essentially of" language. However, the specification lacks a clear disclosure regarding what ingredients/components would materially change the basic and novel characteristics of the composition, in fact the specification teaches that substances/excipients/additives can be added. Therefore, "consisting essentially of" is interpreted to be "comprising" language.
MPEP 2111.03: For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant’s invention.
Beilfuss teaches a liquid concentrate having:
-- an aromatic alcohol selected from aryloxyalkanols and arylakanols;
--acid,
--octenidine dihydrochloride – reading on claim 1c; and
--- a 1- or 2- (C3-C24 alkyl) glycerol ether (Beilfuss – claims 1 and 8).
The aromatic alcohols are taught to be used in amounts ranging from 55-90%, preferably 60-85%; the octenidine to be used in amounts ranging from 0.04-0.25, preferably 0.05-0.1; and the glycerol ether to be used in amounts of 0.5-10%, preferably 1-5% (Beilfuss claims 1, 4 and 7-9).
Regarding claim 1a: Beilfuss teaches phenoxyethanol to be a preferred aromatic alcohol for use (Beilfuss – claim 2 and pg. 4).
Regarding claim 1b: Beilfuss teaches a preferred glyceryl ether to be 1-(2-ethylhexyl)glycerol ether (pg. 7).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination 80-99% phenoxyethanol, 1-30% 1-(2-ethylhexyl)glycerol ether and 0.01-1% octenidine dihydrochloride , anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. AG. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is... a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of various disclosed ingredients including 80-99% phenoxyethanol, 1-30% 1-(2-ethylhexyl)glycerol ether and 0.01-1% octenidine dihydrochloride from within a preferred prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Regarding claims 1 and 9: The ratio of component c to component a and b can be calculated to be (.05-0.1)/((60+1)-(85+5)) = .00056-.0016 which completely falls within the range of 0.01 or less and .0001-0.01.
Regarding claim 10: The ratio of component b to component a can be calculated to be (1-5)/(60-85) = .012-.083.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613