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 .
Claim Status
Claims 1, 3-14, 16-17 and 19-23 are rejected.
No claims are allowed.
Maintained Claim Rejections - 35 USC § 112(b)
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 1, 3-14, 16-17, and 19-23 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.
Claims 1, 9, and 16 recite a Stability Test as described herein. The claims are indefinite since none of the instant claims recite a Stability Test; therefore, it is unclear what Stability Test is described herein. If the Stability Test of the claims is the one described on page 23 of the specification, the claims would need to recite the steps of the test since claims are to be complete in themselves. See MPEP 2173.05(s).
The term “substantially free” in claim 17 is a relative term which renders the claim
indefinite. The term “substantially free” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although page 10 of the specification discloses wherein a concentrated composition can be substantially free from a non-ionic surfactant when it includes less than 1% of a non-ionic surfactant, this does not mean it is always limited to less than 1% of a non-ionic surfactant. Therefore, the scope of “substantially free” is unclear when the non-ionic surfactant is present in more than or equal to 1%.
Claims 2-8 and 21 are rejected in view of their dependency on Claim 1.
Claims 10-14 and 22 are rejected in view of their dependency on Claim 9.
Claims 19-20 and 23 are rejected in view of their dependency on Claim 16.
Response to Applicant’s Arguments
Applicant argues that claims 1, 9, and 16 do not need to incorporate every step and detail of this test method into the actual claim language for one of ordinary skill in the art to understand what is claimed when reading the claims in light of the specification.
Applicant’s argument has been fully considered but found not to be persuasive. Claims 1, 9, and 16 recite “according to Stability Testing as described herein.” It is not clear what “described herein” is referring to. It is unclear whether the independent claims are supposed to describe the test further down in the claims, whether the dependent claims are supposed to describe the test, or whether the specification is supposed to describe the test. If the specification is supposed to describe the test, Applicant’s argument is still unpersuasive. Incorporation by reference to a specific figure or table is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience. See MPEP 2173.05(s). Because reciting the steps of the test in the claims would permit them to be complete in themselves, there exists a practical way to define the invention in words. Thus the rejection is maintained.
Applicant argues that the amendment to claim 17 clarifying that the composition is substantially free from a non-ionic surfactant, instead of the composition is substantially free from a surfactant as previously stated, overcomes the rejection.
Applicant’s argument has been fully considered but found not to be persuasive. As discussed above, although page 10 of the specification discloses wherein a concentrated composition can be substantially free from a non-ionic surfactant when it includes less than 1% of a non-ionic surfactant, the use of the phrase can be does not mean it is always limited to less than 1% of a non-ionic surfactant. Therefore, it is unclear if the composition is still substantially free of a non-ionic surfactant even in instances when it comprises more than or equal to 1% or if in order to be “substantially free” of a non-ionic surfactant the composition must comprise less than 1%.
Modified 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.
1. Claims 1, 3-6, 8-13, 16-17, and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Pesaro et al., (US 2019/0282478 A1, Sept. 09, 2019) (hereinafter Pesaro).
Pesaro discloses a preservation mixture comprising (a) at least one first antimicrobial agent selected from the aromatic ester or amide derivatives of formula (I), (b) at least one second antimicrobial agent, such as, 4-hydroxyacetophenone, and (c) at least one hydroxyl compound, such as, 1,2-octanediol (i.e., caprylyl glycol, a second glycol) ([0103]-[0106]). Component (c) can be present in an amount of about 1 to 25% b.w., calculated on the total mixtures (i.e., a second weight percentage) ([0116]). The additional antimicrobial agents, other than those of at least one compound of formula (I), might be present in amounts of from about 0.01 to about 10% b.w.—calculated on the total composition ([0119]). These components also formulate antifungal mixtures (Claim 20). Hydrotropes may be used to improve flow behavior ([0290]), including butylene glycol (i.e., a first glycol comprising a carbon chain with less than six carbons) ([0293]), in an amount of 5 wt% (i.e., a first weight percentage) (TABLE XXXXI). Polysorbate 80 (i.e., non-ionic surfactant) may be incorporated as a matrix-metalloproteinase inhibitor ([0268]). The composition may comprise nonionic (co-)surfactants ([0326]), in 0.1 wt. % to 90 wt. % ([0348]).
Pesaro discloses compositions containing butylene glycol (i.e., a first glycol comprising a carbon chain with less than six carbons) ([0293]), 1,2-octanediol (i.e., caprylyl glycol, a second glycol) ([0106]), nonionic (co-)surfactants ([0326]), and 4-hydroxyacetophenone ([0105]) in 0.01 to about 10% b.w. (i.e., encompasses at least 10%) ([0119]). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
Regarding the limitations of claims 1, 9, and 16 reciting wherein the composition is stable for at least 1 month at 5°C according to Stability Testing as described herein, as noted in Table 4 on page 11 of the instant specification, a composition comprising hydroxyacetophenone, butylene glycol, caprylyl glycol, and polysorbate 20 (i.e., a non-ionic surfactant) shows no precipitate at 5°C for one month (i.e., is stable). Further, as noted on pages 8-9 and Table 2 of the instant application, other non-ionic surfactants, such as polysorbate 80, demonstrated stability in the composition for at least 1 month at 5°C. Accordingly, the composition taught by Pesaro comprising 4-hydroxyacetophenone, butylene glycol, caprylyl glycol, and polysorbate 80 (i.e., non-ionic surfactant) would necessarily be stable for at least 1 month at 5°C like the claimed invention.
Regarding the limitation of claim 8 reciting a ratio of the non-ionic surfactant to the hydroxyacetophenone is at least 1.0, as discussed above, Pesaro teaches 4-hydroxyacetophenone in 0.01 to about 10% b.w. and nonionic (co-)surfactants in 0.1 wt. % to 90 wt. %. Thus, the claimed ratio would have been obvious since after selecting an amount of 4-hydroxyacetophenone and an amount of nonionic (co-)surfactants one would have arrived at a ratio between nonionic (co-)surfactants/4-hydroxyacetophenone that overlaps with the claimed ratio. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding the limitation of claim 16 reciting wherein a ratio of the total glycol weight percentage to the amount of hydroxyacetophenone is greater than 4.0, as discussed above, Pesaro teaches butylene glycol (i.e., a first glycol), in an amount of 5 wt% (i.e., a first weight percentage), 1,2-octanediol (i.e., caprylyl glycol, a second glycol) in an amount of about 1 to 25% b.w. (i.e., a second weight percentage), and 4-hydroxyacetophenone in 0.01 to about 10% b.w. Thus, the claimed ratio would have been obvious since after selecting an amount of 4-hydroxyacetophenone, an amount of butylene glycol, and an amount of 1,2-octanediol, one would have arrived at a ratio between total glycol weight percentage/4-hydroxyacetophenone that overlaps with the claimed ratio, as no other glycols are required in the composition. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding claim 17, Pesaro teaches that the composition MAY include anionic, nonionic, cationic, amphoteric, or zwitterionic surfactants ([0326]), thus making their inclusion optional. Accordingly, it would have been obvious to one of ordinary skill in the art that the composition of Pesaro may be free of surfactants since they are optional.
Regarding the limitation of claim 20 reciting wherein a ratio of the second weight percentage of the composition to the amount of hydroxyacetophenone is greater than 2.5, as discussed above, Pesaro teaches 1,2-octanediol (i.e., caprylyl glycol, a second glycol) in an amount of about 1 to 25% b.w. (i.e., a second weight percentage), and 4-hydroxyacetophenone in 0.01 to about 10% b.w. Thus, the claimed ratio would have been obvious since after selecting an amount of 4-hydroxyacetophenone and an amount of a second glycol, one would have arrived at a ratio between the second weight percentage/4-hydroxyacetophenone that overlaps with the claimed ratio. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding claims 21-23, as discussed above, Pesaro teaches butylene glycol (i.e., a first glycol) ([0293]), in an amount of 5 wt% and nonionic (co-)surfactants in 0.1 wt. % to 90 wt. %. Thus, the claimed ratio would have been obvious since after selecting an amount of butylene glycol and an amount of nonionic (co-)surfactants one would have arrived at a ratio between nonionic (co-)surfactants/butylene glycol (i.e., a first glycol) of from 1:50 to 18:1, which overlaps with the claimed ratio. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
2. Claims 7 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pesaro et al., (US 2019/0282478 A1, Sept. 09, 2019) (hereinafter Pesaro) in view of Li et al., (US 2016/0007594 A1, Jan. 14, 2019) (hereinafter Li).
As discussed above, Pesaro makes obvious the limitations of claims 1 and 9 but does not teach wherein the non-ionic surfactant comprises polysorbate-20.
However, Li discloses an antimicrobial formulation comprising a non-ionic surfactant (Claim 1), including polysorbates (Claim 5). Specifically, polysorbate 20 is an example of the polysorbate nonionic surfactant (Claim 18). The antimicrobial formulations may be used in any method in which reduction in microorganisms is desired and may be used in personal care products such as antifungal creams (0020]).
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. Pesaro discloses wherein the antimicrobial composition comprises nonionic surfactants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated polysorbate-20 into the antimicrobial composition of Pesaro since it is a known and effective nonionic surfactant as taught by Li.
Response to Applicant’s Arguments
Applicant argues that the claimed stability in the composition is a direct result of glycols having a carbon chain length with less than six carbons (such as propylene glycol, butylene glycol, methylpropanediol), which is an unexpected result not appreciated by Pesaro and Li.
Applicant’s argument has been fully considered but found not to be persuasive. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See MPEP 716.02(d). As noted in Table 1, pages 6-7 of the instant application, code L is a composition comprising hydroxyacetophenone and pentylene glycol and does show a precipitate (i.e., is not stable). Pentylene glycol comprises a carbon chain with less than six carbons since the carbon chain comprises 5 carbons. Thus, because a precipitate was noted with the use of pentylene glycol comprising a 5 carbon chain, the unexpected results of the claimed stability do not occur over the entire claimed range of all glycols comprising a carbon chain with less than six carbons and the presented evidence is not commensurate in scope with the claims.
Additionally, independent claim 1 does not recite a ratio of the at least one glycol to the other claimed components. However, the instant specification discloses in the second paragraph on page 6 that only butylene glycol and isoprene glycol did not exhibit precipitation when combined at a 2:1 ratio with hydroxyacetophenone (i.e., achieved stability). Further, as disclosed at the bottom of page 8, polysorbate-20 was combined with hydroxyacetophenone and butylene glycol in a nonaqueous blend at a 10:20:9 ratio by weight and ratios of 20:15:10, 10:15:10, and 10:25:10 all successfully passed stability testing but, 20:5:10 and 20:15:20 ratios did not exhibit stability. However, as noted in the last paragraph on page 10, blends that incorporate caprylyl glycol along with another short chain glycol may remain stable even in the absence of a non-ionic surfactant and Table 4 discloses compositions Q and R which showed no precipitate when hydroxyacetophenone was combined with a short chain glycol and caprylyl glycol but without a non-ionic surfactant (i.e., were stable). Thus, since Applicant discloses in the instant specification that the ratio is important to achieving the stability and the claimed stability can be achieved with additional ingredients such as caprylyl glycol, one would not expect that any ratio of the at least one glycol to the other claimed components, as currently recited in instant claim 1, would achieve the unexpected results and without the ratio the claimed invention would not be unexpected.
Applicant argues that the claimed ratio of non-ionic surfactant to hydroxyacetophenone is important to achieving the claimed stability, citing Applicant's testing documented on page 8 of the instant specification.
Applicant’s argument has been fully considered but found not to be persuasive. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. See MPEP 716.02(d). Instant claim 8 recites wherein a ratio of the non-ionic surfactant to the hydroxyacetophenone is at least 1.0, which includes all ratios of 1 and greater. Applicant has not shown wherein all the ratios within that range are unexpected.
Applicant argues that Pesaro teaches such wide ranges of 1,2-octanediol and 4-hydroxyacetophenone that one of ordinary skill in the art may arrive at a total glycol weight percentage to the amount of hydroxyacetophenone that is less than 4.0.
Applicant’s argument has been fully considered but found not to be persuasive. As discussed in the rejection, the claimed ratio would have been obvious since there is an overlap in range. In cases involving overlapping ranges, even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cit. 2003). As such, Applicant’s argument that the range is too wide is not persuasive.
Applicant argues that the claimed ratio of the total glycol weight percentage to the amount of hydroxyacetophenone being greater than 4.0 is critical to achieving the claimed stability.
Applicant’s argument has been fully considered but found not to be persuasive. As noted in Table 4 on page 11 of the instant specification, the compositions with codes Q and R comprise no non-ionic surfactant and a ratio of total glycol weight percentage to the amount of hydroxyacetophenone of approximately 5:1, which is greater than 4.0. However, the percentage of caprylyl glycol is 50%, and the percentage of the short chain glycol is 33.33% in both formulations. Thus, the percentage of caprylyl glycol is significantly higher than the percentage of short chain glycol in both compositions with codes Q and R. Further, the bottom paragraph on page 11 indicates that a significant concentration of caprylyl glycol relative to hydroxyacetophenone may be necessary to achieve stability. Thus, it is unclear if the claimed stability is achieved due to the claimed ratio of the total glycol weight percentage to the amount of hydroxyacetophenone or a significant concentration of caprylyl glycol relative to hydroxyacetophenone.
For the foregoing reasons the rejection is modified and maintained.
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.
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/S.J.K./Examiner, Art Unit 1614
/TRACY LIU/Primary Examiner, Art Unit 1614