DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-9 are pending and represent all claims currently under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claims 1-9 are considered to have an effective filing date of 01/10/2023.
Information Disclosure Statement
The information disclosure statement filed 01/06/2025 has been considered.
Claim Objections
Claim 6 is objected to because of the following informalities. Appropriate correction is required.
Regarding claim 6, “dandriff” should read “dandruff”.
Specification
The use of the term Octopirox, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
The specification filed 01/08/2025 does not contain a cross-reference to related applications.
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 4-5 and 8-9 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.
Regarding claim 4, the claim recites the limitation "the at least one compound of formula 1". There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the Examiner has interpreted this limitation to refer to the methylheptyl glycerin of claim 2.
Regarding claims 4-5, the claims recite the limitation "the total weight". There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 8, the claim recites the limitation "the bacterial colonization". There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 8-9, the claims recite the limitation "the genus". There is insufficient antecedent basis for this limitation in the claim.
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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 6, 10, and 13-14 of copending Application No. 18/906,741 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, the reference application teaches a method comprising applying a hair treatment agent to hair or scalp (reference, claim 14) wherein the hair treatment agent comprises a compound of formula 1 (reference, claim 1). The reference further teaches a compound of formula 1 is methylheptylglycerin (reference, claim 6).
Regarding claim 2, the reference application teaches the invention as applied to claim 1. As above, the reference application teaches a method comprising applying a hair treatment agent to hair or scalp (i.e., a cosmetic formulation; reference, claim 14).
Regarding claim 3, the reference application teaches the invention as applied to claim 2. The reference application teaches the hair treatment agent is a shampoo (reference, claim 13).
Regarding claim 4, the reference application teaches the invention as applied to claim 2. The reference application teaches the compound of formula 1 in 0.1-3 wt% (reference, claim 3), 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. See MPEP §2144.05(I).
Regarding claim 5, the reference application teaches the invention as applied to claim 2. The reference application teaches at least one surfactant in 0.5-20 wt% (reference, claim 10), 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. See MPEP §2144.05(I).
Regarding claim 6, the reference application teaches the invention as applied to claim 1. The reference application teaches a method for controlling scalp dandruff (i.e., treating for a dandruff condition), comprising applying a treatment agent to hair or scalp (reference, claim 14).
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Fricke (WO 2020007571 A1).
Regarding claim 1, Fricke teaches a method of caring for keratinous material comprising applying a cosmetic composition to the keratinous material (Fricke, page 2, 3rd paragraph), and teaches a cosmetic composition which can be a shampoo (Fricke, page 55, 2nd paragraph), suggesting the keratinous material is the hair. Fricke teaches the composition comprises one or more glycerol derivatives selected from a group comprising 3-[(2-octyl)oxy]1,2-propanediol (i.e., methylheptyl glycerin as evidenced by Fricke, page 107, structure 4; Fricke, claim 1).
Fricke is considered to be analogous to the claimed invention, because both Fricke and the instant invention are in the same field of hair treatment cosmetic compositions. 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 arrived at the claimed invention based on the teachings of Fricke under the meaning of 35 U.S.C. 103.
Regarding claim 2, Fricke teaches all the elements of the current invention according to claim 1. As above, Fricke teaches applying a cosmetic composition (i.e., formulation; Fricke, page 2, 3rd paragraph)
Regarding claim 3, Fricke teaches all the elements of the current invention according to claim 2. As above, Fricke teaches a cosmetic composition which can be a shampoo (Fricke, page 55, 2nd paragraph).
Regarding claim 4, Fricke teaches all the elements of the current invention according to claim 2. Fricke further teaches the composition comprises about 0.2 to 0.6 wt% of the glycerol derivative by weight (Fricke, page 10, 3rd paragraph), which lies within the claimed range.
Regarding claim 5, Fricke teaches all the elements of the current invention according to claim 2. Fricke further teaches the composition comprises one or more surfactant (Fricke, page 13, last paragraph) in 2 to 20 wt% (Fricke, page 14, 2nd paragraph), which lies within the claimed range.
Regarding claim 6, Fricke teaches all the elements of the current invention according to claim 1. Fricke further teaches the composition comprises an anti-dandruff agent (Fricke, page 31, 2nd paragraph). Therefore, it would be prima facie obvious to one of ordinary skill in the art to utilize the composition to treat a dandruff condition as claimed.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Schaal (EP 3944852 A1; IDS reference, 01/06/2025), further in view of Fricke (WO 2020007571 A1), and as evidenced by PubChem.
Regarding claim 1, Schaal teaches cosmetic compositions which comprise a booster comprising alcohols having 2 to 5 hydroxy groups and 2 to 20 carbon groups (Schaal, claim 12) and which are preferably shampoo compositions (Schaal, page 2, paragraph 0010), and teaches a method of treating hair and/or scalp comprising applying the shampoo condition onto hair and/or scalp (Schaal, page 17, paragraph 0182).
Schaal does not specifically teach methylheptyl glycerin, but does teach ethylhexyl glycerin as a suitable booster (Schaal, claim 13). Fricke teaches a cosmetic composition which can be a shampoo (Fricke, page 55, 2nd paragraph), comprising one or more glycerol derivatives selected from a group comprising 3-[(2-ethylhexyl)oxy]1,2-propanediol (i.e., ethylhexylglycerin as evidenced by PubChem) and 3-[(2-octyl)oxy]1,2-propanediol (i.e., methylheptyl glycerin as evidenced by Fricke, page 107, structure 4; Fricke, claim 1).
Further, methylheptyl glycerin and ethylhexyl glycerin are isomers, and compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See MPEP 2144.09(II).
Schaal and Fricke are considered to be analogous to the claimed invention, because Schaal, Fricke, and the instant invention are in the same field of glycerin containing cosmetic compositions. 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 modified the composition of Schaal to use methylheptyl glycerin as a substitute for ethylhexyl glycerin, because Schaal teaches the invention can be prepared by methods known in the art (Schaal, page 6, paragraph 0075) and Fricke teaches both to be alternative isomers used for the same purpose in cosmetic compositions (Fricke, claim 1).
Regarding claim 2, Schaal and Fricke together teach all the elements of the current invention according to claim 1. Schaal teaches the booster is present in a cosmetic composition (i.e., formulation; Schaal, claim 10).
Regarding claim 3, Schaal and Fricke together teach all the elements of the current invention according to claim 2. Schaal teaches the cosmetic composition is preferably a shampoo (Schaal, claim 10).
Regarding claim 4, Schaal and Fricke together teach all the elements of the current invention according to claim 2. Schaal teaches the booster is preferably from 0.1-2 wt% based on the total weight of the cosmetic composition (Schaal, claim 11), which lies within the claimed range.
Regarding claim 5, Schaal and Fricke together teach all the elements of the current invention according to claim 2. Schaal teaches one or more further components which can be a surfactant (Schaal, page 7, paragraph 0095) in most preferably 0.5-20% by weight (Schaal, page 7, paragraph 0094), which lies within the claimed range.
Regarding claim 6, Schaal and Fricke together teach all the elements of the current invention according to claim 1. Schaal teaches the cosmetic composition is preferably an anti-dandruff shampoo composition (i.e., treats a dandruff condition; Schaal, page 2, paragraph 0010).
Regarding claim 7, Schaal and Fricke together teach all the elements of the current invention according to claim 1. Schaal teaches the use of piroctone olamine as an anti-dandruff agent to control the growth of microorganisms which irritate the scalp (i.e., provides soothing to the skin by removing irritants; Schaal, page 2, paragraphs 0001-0002).
Regarding claim 8, Schaal and Fricke together teach all the elements of the current invention according to claim 1. As above, Schaal teaches a method of treating hair and/or scalp comprising applying a shampoo condition onto hair and/or scalp (Schaal, page 17, paragraph 0182), which is preferably an anti-dandruff shampoo composition (Schaal, page 2, paragraph 0010). Schaal further teaches the use of preservatives to inhibit the growth of bacteria and fungi (i.e., bacterial colonization; Schaal, page 2, paragraph 0003), and specifies that the dandruff is caused by Malassezia species (Schaal, page 2, paragraph 0011).
Regarding claim 9, Schaal and Fricke together teach all the elements of the current invention according to claim 1. As above, Schaal teaches a method of treating hair and/or scalp comprising applying a shampoo condition onto hair and/or scalp (Schaal, page 17, paragraph 0182), which is preferably an anti-dandruff shampoo composition (Schaal, page 2, paragraph 0010). Schaal further teaches the use of preservatives to inhibit the growth of bacteria and fungi (i.e., bacterial colonization; Schaal, page 2, paragraph 0003), and specifies that the dandruff is caused by Malassezia furfur and Malassezia globosa (Schaal, page 2, paragraph 0011).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHASITY P JANOSKO whose telephone number is (703)756-5307. The examiner can normally be reached 7:30-3:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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