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 .
Status of Claims
Receipt of Applicant’s response, dated 04/11/2025, is acknowledged.
In view of the new rejections below, this action is a non-final rejection.
Claims 1-13 are pending.
Claims 2-3 and 10 are amended.
Claims 1-13 are under consideration in the instant Office action.
Information Disclosure Statement
The information disclosure statement (IDS) filed 02/26/2025 has been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Rejections Withdrawn
Claim Rejections - 35 USC § 112(b)
The indefiniteness rejection of claim 3 set forth in the Office action dated 12/11/2024 is hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112(d)
The rejection of claim 2 set forth in the Office action dated 12/11/2024 is hereby withdrawn in light of Applicant’s amendments to the claims.
Claim Rejections - 35 USC § 102
The anticipation rejection of claims 1 and 4-12 over Kelly et al. set forth in the Office action dated 12/11/2024 is hereby withdrawn in light of Applicant’s arguments and amendments to the claims.
Claim Rejections - 35 USC § 103
The obviousness rejection of claims 2-3 over Kelly et al. and the obviousness rejection of claim 13 over Kelly et al. in view of Back et al. set forth in the Office action dated 12/11/2024 are hereby withdrawn in light of Applicant’s arguments and amendments to the claims and in favor of the new ground of rejection set forth below.
Double Patenting
The obviousness-type double patenting provisional rejection over copending Application No. 17/787,649 set forth in the Office action dated 12/11/2024 is hereby withdrawn in light of Applicant’s arguments and amendments to the claims and in favor of the new ground of rejection set forth below.
New Grounds of Rejection
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 9-10 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 9 and 10 are indefinite in the recitation of “A non-therapeutic method” because neither the claims nor the specification contain a definition for ‘non-therapeutic’, and therefore it is unclear what is excluded from the shampoo composition or if the term ‘non-therapeutic’ alters the application of the shampoo in the claimed process.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. (US 2019/0000735 A1, published 1/3/2019, cited in IDS dated 10/10/2022).
Kelly et al. teach hair care compositions, referring to products for and/or methods relating to treating hair, including shampooing (e.g., [0015]).
The hair care composition comprises a 2-pyridinol-N-oxide material and an iron chelator, the combination providing a high anti-fungal efficacy (e.g., [0003]). The 2-pyridinol-N-oxide material may be 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone monoethanolamine salt (e.g., [0041]), which is synonymous with piroctone olamine (e.g., [0132]). The hair care composition may contain from about 0.1% to about 10% of the 2-pyridinol N-oxide material (e.g., [0042]).
The hair care composition can be a shampoo composition (e.g., [0065]). The shampoo composition delivers consumer desired shampooing in addition to scalp anti-dandruff efficacy benefit (e.g., [0065]). The shampoo composition is applied to the hair and then rinsed from the hair using water (e.g., [0067]).
The shampoo composition may comprise one or more detersive surfactants, which provides cleaning performance to the composition. The one or more detersive surfactants in turn may comprise an anionic surfactant, amphoteric or zwitterionic surfactants, or mixtures thereof (e.g., [0069]). The concentration of the detersive surfactant component in the shampoo composition should be sufficient to provide the desired cleaning and lather performance, and generally ranges from about 2 wt % to about 50 wt % (e.g., [0070]).
Anionic surfactants suitable for use in the compositions are the alkyl and alkyl ether sulfates, and exemplary anionic surfactants for use in the shampoo composition include sodium laureth sulfate, and specifically as, sodium lauryl ether sulfate (SLE3S) (i.e., sodium laureth sulfate 3EO) (e.g., [0071]-[0072], [0132]). Suitable amphoteric or zwitterionic surfactants for use in the shampoo composition herein include those which are known for use in shampoo or other personal care cleansing, such as betaines, e.g., cocoamidopropyl betaine (e.g., [0073], [0075], [0132]). Concentrations of such amphoteric or zwitterionic surfactants range from about 0.5 wt % to about 20 wt % (e.g., [0073]).
The shampoo composition may optionally comprise one or more additional components known for use in hair care or personal care products, provided that the additional components are physically and chemically compatible with the essential components described herein, or do not otherwise unduly impair product stability, aesthetics or performance (e.g., [0117]), wherein suitable additional components include natural cationic deposition polymers and synthetic cationic deposition polymers (i.e., cationic polymers) (e.g., [0118]).
The hair care compositions may comprise one or more conditioning agents, i.e., materials that are used to give a particular conditioning benefit to hair (e.g., [0120]). Suitable conditioning agents include silicones (e.g., [0120], [0122]).
The hair care composition of Kelly et al., specifically a shampoo composition, comprising:
piroctone olamine as the 2-pyridinol-N-oxide material present from about 0.1% to about 10%;
an iron chelator;
detersive surfactant comprising a) sodium laureth sulfate 3EO as the anionic surfactant and b) cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant, wherein b) is present from about 0.5 wt % to about 20 wt % and a) + b) (i.e., total detersive surfactant) is present from about 2 wt % to about 50 wt %;
a cationic polymer; and
a silicone
renders obvious the shampoo composition of instant claims 1-12.
The aforementioned shampoo composition of Kelly et al. comprises the detersive surfactant, which comprises sodium laureth sulfate 3EO as the anionic surfactant and cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant, from about 2 wt % to about 50 wt % which renders obvious the limitation of a total cleansing surfactant level being from 6 to 12 wt % of instant claim 1. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
The detersive surfactant, which comprises sodium laureth sulfate 3EO as the anionic surfactant and cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant, being present from about 2 wt % to about 50 wt % and cocoamidopropyl betaine as the amphoteric or zwitterionic surfactant being present from about 0.5 wt % to about 20 wt % renders obvious the limitation of a ratio of ethoxylated anionic surfactant to amphoteric surfactant being from 3:1 to 4:1 of instant claim 1 (e.g., the shampoo composition of Kelly et al. comprising 4 wt% detersive surfactant and 1 wt% cocoamidopropyl betaine has a weight ratio of sodium laureth sulfate 3EO to cocoamidopropyl betaine of 3:1).
The shampoo composition of Kelly et al. comprising sodium laureth sulfate 3EO as the anionic surfactant renders obvious the shampoo compositions of instant claim 2 in which the anionic surfactant consists of sodium laureth sulfate and of instant claim 3 in which the ethoxylated alkyl sulfate is sodium laureth sulfate 3EO.
The shampoo composition of Kelly et al. comprising piroctone olamine as the 2-pyridinol-N-oxide material present from about 0.1% to about 10% renders obvious the shampoo composition of instant claims 8 and 12, which require a total level of piroctone compound being from 0.1 to 5 wt% and 0.2 to 3 wt%, respectively. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Regarding instant claims 9-11, per MPEP 2111.02, a recitation of the preamble must result in structural difference to limit the claim. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation (Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). “A non-therapeutic method” and “a method of enhancing the deposition of a piroctone compound” are statements in the preamble that do not structurally limit the claim and merely recite the purpose of applying the shampoo product to the hair or scalp. The active method steps of applying the shampoo composition to hair or scalp and rinsing are taught by Kelly et al. (Kelly et al. teach a shampoo composition referring to methods relating to treating/shampooing hair, applying the composition to the hair and then rinsing from the hair using water; see supra) and therefore Kelly et al. teaches the same methods as instant claims 9-11. Further, the teachings of Kelly et al. necessarily are a ‘non-therapeutic’ method of treating the hair or scalp and would necessarily enhance the deposition of 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2-pyridone monoethanolamine salt (i.e., piroctone olamine).
The specific combination of features claimed is disclosed within the broad generic ranges taught by Kelly et al. 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 of variables of a shampoo composition, 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. A.G. 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 U.S.C. 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 one of ordinary skill in the art, before the effective filing date of the claimed invention, to have selected various combinations of various disclosed ingredients of a shampoo composition from within the prior art disclosure of Kelly et al., to arrive at the composition of the instant claims “yielding no more than one would expect from such an arrangement.”
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kelly et al. (US 2019/0000735 A1, published 1/3/2019, cited in IDS dated 10/10/2022) as applied to claims 1-12 above, and further in view of Back et al. (WO 2019/228988 A1, published 12/5/2019).
The shampoo composition of Kelly et al. is discussed supra.
Kelly et al. do not teach the piroctone compound being a diethanolamine salt and/or a triethanolamine salt of piroctone acid of instant claim 13.
This deficiency is made up for in the teaching of Back et al.
Back et al. teach compositions including a shampoo composition (e.g., Page 69 Lines 32-33). Back et al. teach that piroctone olamine, which is used in the treatment of fungal infections, is the monoethanolamine salt of 1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)-2(1 H)-pyridone (e.g., Page 1 Lines 28-31), that that monoethanolamine is not desired by consumers in consumer products because of the risk of the presence of nitrosamines, and that there is a need for more efficacious preserving and anti-fungal substances (as alternative to monoethanolamine) that meet present performance requirements as well as modern consumer desires and expectations (Page 3 Lines 8-19). Back et al. teach that by using the diethanolamine or triethanolamine salts of piroctone acid rather than the monoethanolamine salt, there is less potential for nitrosamines while providing a preserving and anti-fungal activity (Page 9 Lines 10-14).
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 substitute piroctone olamine in the shampoo composition of Kelly et al. with the diethanolamine salt and/or the triethanolamine salt of piroctone acid. One of ordinary skilled in the art would have been motivated to do so because of the advantages offered by Back et al. of using the diethanolamine salt and/or the triethanolamine salt rather than the monoethanolamine salt, i.e., reduced potential of the presence of nitrosamines while providing the desired preserving and anti-fungal activity. There would have been a reasonable expectation of success because 1) the shampoo composition of Kelly et al. is taught as compatible with an olamine salt of piroctone acid and 2) Back et al. teach that the diethanolamine salt and/or the triethanolamine salt of piroctone acid exhibit anti-fungal activity, which is a desired feature of the shampoo composition of Kelly et al.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 15-20 of copending Application No 17/787,649 (hereafter Application ‘649).
This is a provisional nonstatutory double patenting rejection.
Claim 1 of ‘649 recites a personal cleansing composition comprising: i) a piroctone compound; ii) a cleansing surfactant comprising an amphoteric surfactant and an anionic surfactant consisting of an ethoxylated alkyl sulphate surfactant, wherein the weight ratio of ethoxylated alkyl sulphate to amphoteric surfactant is from 2:1 to 6:1; and the total cleansing surfactant level is from 3 to 20 wt% of the total composition.iii) a cationic polymer in which the cationic polymer is polyquaternium 6. Claim 2 of ‘649 recites the weight ratio of ethoxylated alkyl sulphate to amphoteric surfactant is from 3:1 to 4:1. Claim 3 of ‘649 recites the total cleansing surfactant level is less than 11 wt% of the total composition. Claim 4 of ‘649 recites the amphoteric surfactant is cocamidopropyl betaine. Claim 5 of ‘649 recites the anionic surfactant has an average degree of ethoxylation of 2 or greater. Claim 6 of ‘649 recites the anionic surfactant is sodium laureth sulphate (3EO). Claim 7 of ‘649 recites the piroctone compound is piroctone olamine. Claim 8 of ‘649 recites the composition further comprises a silicone. Claims 9 and 18 of ‘649 recite a total level of piroctone compound from 0.1 to 5 wt% of the total composition and from 0.2 to 3 wt% of the total composition, respectively. Claim 10 of ‘649 recites the composition is a shampoo. Claim 11 of ‘649 recites a method of treating hair or the scalp, comprising applying of a hair treatment composition according to claim 1, to the hair or scalp. Claim 12 of ‘649 recites the method further comprising washing the composition off the hair or scalp after use. Claims 15 and 20 of ‘649 recite the total cleansing surfactant level is less than 10 wt% of the total composition and from 6 to 12 wt% of the total composition, respectively. Claims 16-17 of ‘649 recite the anionic surfactant has an average degree of ethoxylation of 2.5 or greater and 3 or greater, respectively. Claim 19 of ‘649 recites the piroctone compound is selected from piroctone acid, a primary, secondary or tertiary olamine salt of piroctone acid, and mixtures thereof.
Therefore, the personal cleansing composition of the claims of ‘649 is not patentably distinct from the shampoo composition of instant claims 1-13.
Response to Applicant’s Arguments
Applicant’s arguments filed on 04/11/2025 have been considered.
Applicant argues the anticipation and obviousness rejections made in the Office action mailed 12/11/2024 because the composition of the instant claims require an anionic surfactant consisting of an ethoxylated alkyl sulphate, the total level of anionic surfactant having an average degree of ethoxylation of 3 or greater, and a total cleansing surfactant level from 6 to 12 wt percent of the total composition, and the teachings of Kelly et al. do not meet these requirements.
The above arguments have been fully considered by the Examiner and the anticipation and obviousness rejections made in the Office action mailed 12/11/2024 have been withdrawn by the Examiner. However, as seen in the new grounds of rejection of instant claims 1-12 above, Kelly et al. does teach a shampoo composition comprising a detersive surfactant, which comprises sodium laureth sulfate 3EO as the anionic surfactant, wherein the total amount of detersive surfactant is from about 2 wt % to about 50 wt %. The teachings of Kelly et al. render obvious the shampoo composition of instant claims 1-12 comprising an anionic surfactant consisting of an ethoxylated alkyl sulphate, the total level of anionic surfactant having an average degree of ethoxylation of 3 or greater, and a total cleansing surfactant level from 6 to 12 wt percent of the total composition. Further, as seen in the new grounds of rejection of instant claim 13 above, Back et al. provide a motivation for the substitution of the monoethanolamine salt of piroctone acid with the diethanolamine or triethanolamine salts of piroctone acid as being a lesser potential for nitrosamines while providing a preserving and anti-fungal activity. Therefore, instant claims 1-13 remain rejected over the prior art teachings of Kelly et al. and Back et al.
Applicant requests that the Examiner hold the obviousness-type double patenting provisional rejection over copending Application No. 17/787,649 set forth in the Office action dated 12/11/2024 in abeyance until such time as the claims at issue are deemed otherwise allowable.
The above argument has been fully considered by the Examiner but is not found persuasive because a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02). Thus, the double patenting rejections of record have been maintained as no action regarding these rejections has been taken by applicants at this time.
Conclusion
In view of the new rejections contained in this Office action, this action is a non-final rejection.
No claims are allowable.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619