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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/30/26 has been entered.
Claims 1, 4, 12, 13, and 19-55 are pending. Claims 2, 3, 5-11 and 14-18 have been cancelled. Claim 1 has been amended. Claims 1, 4, 12, 13, and 19-55 are under consideration.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
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 1, 4, 12, 13, and 19-55 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “wherein there is a weight ratio of 1:0.9 to 4:1 of the salicylate salts or acids to the benzoate salts or acids” and the narrower recitation of “from 0.07 to 0.15% of salicylate salts or acids” and “from 0.07 to 0.15% of benzoate salts or acids”. The greatest ratio possible, given the ranges claimed, is approximately 2.14:1. Accordingly, the metes and bounds of the claim are unclear. Claims 4, 12, 13 and 19-55 are rejected as depending from and not clarifying Claim 1.
Similarly, the ratios of Claims 12 and 13 are indefinite because the upper limits of 3.75:1 and 3:1 are not possible to achieve given the amended concentration range of claim 1.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 4, 12, 13, and 19-55 are rejected under 35 U.S.C. 103 as being unpatentable over Mann et al. (US 2016/0015615A1) in view of Klug (US 2017/0000710).
Mann et al. teach active ingredient combinations of alkylamidothiazoles and one or more cosmetically or dermatologically acceptable preservatives (e.g. abstract). Mann et al. teach that the compositions include compositions for cleaning the skin and the hair comprising surfactants (e.g. paragraph 0083; Examples). Mann et al. exemplify antidandruff shampoo formulations comprising
- 9.0 or 10.0 wt% sodium lauryl ether sulfate and 4.0 or 3.0 wt% cocamidopropylbetaine (i.e. 12-14 wt% of one or more surfactants, and 3-4% amphoteric co-surfactant);
- 0.3 or 0.2 wt% sodium salicylate;
- 0.25 or 0.3% sodium benzoate;
While the ranges of sodium salicylate and sodium benzoate are slightly above those claimed, Mann et al. more broadly teach that the one or more preservatives are preferably present at 0.005-3 wt% and may include sodium benzoate and salicylic acid (e.g. paragraphs 0021-0024), which overlaps with the claimed ranges of 0.07-0.15%. It is obvious to optimize within prior art conditions or through routine experimentation. In addition, the ranges result in ratios of salicylate salts to the benzoate salts of 1:625 to 600:1, which overlaps the claimed range. 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) (MPEP 2144.05.I).
Mann is silent as to the pH of the composition. This is made up for by the teachings of Klug.
Klug teaches shampoo compositions (e.g. abstract; Examples). Klug et al. exemplify a shampoo comprising 8% sodium lauryl ether sulfate and 3% cocamidopropyl betaine (11% of one or more surfactants, 3% amphoteric so-surfactant), 0.1% sodium salicylate and 0.1% sodium benzoate (e.g. Examples 3 and 6, paragraph 0141). Klug et al. exemplify the compositions having a pH of 5.0 (e.g. Examples 3 and 6, paragraph 0141).
Regarding Claims 1, 4, 12, 13, and 23-33, it would have been obvious to one of ordinary skill in the art to have selected a pH of 5 as in the shampoo of Klug for use in the shampoos of Mann et al. Mann et al. are silent as to the pH, but Klug et al. teach shampoo compositions comprising substantially similar ingredients. Given that Mann is silent as to the pH, one of ordinary skill in the art would have been motivated to seek guidance on an appropriate pH for their shampoo, and further would have predicted success as both Mann et al. and Klug et al. teach shampoos comprising substantially similar ingredients.
In addition, it would have been obvious to one of ordinary skill in the art at the time of filing to vary the salicylate and benzoate concentrations through routine experimentation in order to optimize the resulting product. 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). In addition, Klug et al. exemplify 0.1% sodium salicylate and 0.1% sodium benzoate, which while this is outside of the claimed ratio, demonstrates that concentrations within the claimed ranges are typical and known to one of ordinary skill in the art (e.g. Examples 3 and 6, paragraph 0141).
Regarding Claims 19-22, Mann et al. are silent as to the bacteria log reduction. However, as Mann et al. teach the claimed preservatives (salicylate and benzoate) in the claimed concentrations in a shampoo formulation, then the outcome of bacteria log reduction would necessarily occur. The instant specification (page 1) links the antibacterial properties to the sodium salicylate and sodium benzoate which are taught by Mann et al. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding Claims 34-38, Mann et al. teach 0.2% guar hydroxypropyltrimonium chloride (e.g. paragraph 0106, Examples 87 and 88).
Regarding Claims 39 and 40, Mann et al. teach the inclusion of thickeners including polyacrylate (e.g. paragraph 0092, 0106, Examples 87 and 88).
Regarding Claims 41-55, Mann et al. teach the inclusion of 0.45% climbazole, 1.0 and 0.5% piroctone olamine, 0.2% selenium sulfide, and 1.0% zinc pyrithione (e.g. paragraphs 0105 and 0106, Examples 85-88).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 4, 12, 13, and 19-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 and 32-53 of copending Application No. 17/980,169.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims require a hair care composition comprising: from about 10 to about 17% of one or more surfactants; from about 0.07 to about 0.15% of salicylate salts or acids, and from about 0.07 to about 0.15% of benzoate salts or acids. The copending claims recite a ratio of salicylate salts or acids to benzoate salts or acids of about 1:1 to 2.5:1, which overlaps with the instant claimed ratio of 1:0.9 to 4:1. 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) (MPEP 2144.05.I). Dependent claims include the claimed surfactants, benzoate salts, thickener, and antidandruff/scalp health agents, and amounts thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 12, 13, and 19-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-53 of copending Application No. 17/980,199.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and copending claims require a hair care composition comprising: from about 10 to about 17% of one or more surfactants; from about 0.07 to about 0.15% of salicylate salts or acids, and from about 0.07 to about 0.15% of benzoate salts or acids. The copending claims recite a ratio of salicylate salts or acids to benzoate salts or acids of about 1:1 to 2.5:1, which overlaps with the instant claimed ratio of 1:0.9 to 4:1. 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) (MPEP 2144.05.I). Dependent claims include the claimed surfactants, benzoate salts, thickener, and antidandruff/scalp health agents, and amounts thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 12, 13, and 19-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 11,523,979.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and patented claims require a hair care composition comprising: a. from about 10 to about 17% of one or more surfactants; 0.1-0.25% salicylate salts or acids; and 0.1-0.25% benzoate salts or acids. The patented claims recite a ratio of salicylate salts or acids to benzoate salts or acids of about 1:1 to 2.5:1, which overlaps with the instant claimed ratio of 1:0.9 to 4:1. 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) (MPEP 2144.05.I). Dependent claims include the claimed surfactants, benzoate salts, thickener, and antidandruff/scalp health agents, and amounts thereof.
Claims 1, 4, 12, 13, and 19-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 of U.S. Patent No. 11,684,558.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant and patented claims require a hair care composition comprising: a. from about 8 to about 17% of one or more surfactants; 0.07-0.15% salicylate salts or acids; and 0.07-0.15% benzoate salts or acids. The patented claims recite a ratio of salicylate salts or acids to benzoate salts or acids of about 1:1 to 1:0.08, which overlaps with the instant claimed ratio of 1:0.9 to 4:1. 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) (MPEP 2144.05.I). Dependent claims include the claimed surfactants, benzoate salts, thickener, and antidandruff/scalp health agents, and amounts thereof.
Response to Arguments
Applicant's arguments filed 6/30/26 have been fully considered but they are not persuasive.
Applicant argues that the amendment to Claim 1 herein addresses the Examiner's and Board's concerns regarding the breadth of the claimed ranges and the pH limitation. Applicant argues that while the Board suggested comparison to the upper end of the claimed range, the unexpected efficacy at the lower end of the claimed range, specifically at 0.07% for Example 3, is a key point of distinction. This efficacy at substantially reduced levels, while meeting consumer demand for "lower preservative levels", constitutes an unexpected result that would not have been predicted by merely optimizing higher-concentration systems.
This is not found persuasive. First, it is noted that Example 3 falls outside of the pending claims because it has a pH of 6.0, which is above the claimed range, and does not comprise a benzoate salt or acid. Second, Applicant has not demonstrated an unexpected result. Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). It is unclear why the results should be considered surprising. Applicant is claiming a composition and not a method. The composition comprises from about 8 to about 17% of one or more surfactants, from about 0.07 to about 0.15% of salicylate salts or acids, and from 0.07 to 0.15% of benzoate salts or acids, wherein there is a weight ratio of 1:0.9 to 4:1 of the salicylate salts or acids to the benzoate salts or acids, and wherein the composition has a pH of 4.5 to 5.5. The bacteria log reduction is an inherent property of the ingredients and the concentrations thereof. “Products of identical chemical composition can not have mutually exclusive properties.”. Mann et al. teach that the one or more preservatives are preferably present at 0.005-3 wt% and may include sodium benzoate and salicylic acid (e.g. paragraphs 0021-0024). Therefore, it would have been obvious to have selected a value as low as 0.005 wt% for each ingredient and it is obvious to optimize within prior art conditions or through routine experimentation.
Applicant further argues that the amended pH range of "from 4.5 to 5.5" (Claim 1, as amended) is critical. While Klug et al. teaches a broader preferred pH range of 4-6 (Klug et al., Paragraph 0102), the narrower range of the amended claim is a "more specific" range from the present invention that provides an optimum environment for the low levels of preservatives to function effectively.
This is not found persuasive. First, it is noted that none of the data provided in the Specification or Declaration have the “critical” pH range of 4.5-5.5, therefore the Examiner is unable to assess the criticality of the range. Second, Mann et al. are silent as to the pH of their compositions (i.e. they may or may not meet the claimed range of 4.5-5.5), however Klug et al. teach shampoo compositions and a shampoo comprising 0.1% sodium salicylate and 0.1% sodium benzoate having a pH of 5.0 (e.g. Examples 3 and 6, paragraph 0141) and more broadly teach a preferred pH range of 4-6 (e.g. paragraph 0102). Mann et al. are silent as to the pH, but Klug et al. teach shampoo compositions comprising substantially similar ingredients. Given that Mann is silent as to the pH, one of ordinary skill in the art would have been motivated to seek guidance on an appropriate pH for their shampoo, and further would have predicted success as both Mann et al. and Klug et al. teach shampoos comprising substantially similar ingredients.
Accordingly, the rejections are maintained.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE P BABSON/Primary Examiner, Art Unit 1619
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