DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Status of the Claims
Claims 1-13 are pending. Claims 10 and 11 are withdrawn. Claims 1-9, 12, and 13 are under consideration in this action.
Election/Restrictions
Applicant’s election of Group I (Claims 1-9, 12, and 13) and the species, personal care (product type) in the reply filed on June 16, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 16, 2026.
Claim Objections
Claims 12 and 13 are objected to because of the following informalities: both claims recite “personal care personal care”. The second “personal care” should be deleted. Appropriate correction is required.
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 2, 4, 5, 8, 12, and 13 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.
Claim 2 recites “[a] formulation consisting (essentially) of” in line 1. The parentheses renders the claim indefinite because it is unclear if the limitation in the parentheses is required by the claim. The transitional phrase “consisting of” and “consisting essentially of” are not identical in scope regarding the inclusion of unrecited elements, and as it is unclear if “essentially” is a required term or not, it is unclear what the metes and bounds of the claim are.
Claims 4 and 8 contain parentheses which raises the question as to which term is required by the claim because the subject matter in the parentheses is not identical in scope. Essentially, the claims use both narrow and broad limitations. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Further regarding Claim 4, the term “preferably” at the end of line 4 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
With regards to Claim 5, the limitation “wherein the solvent is polysorbate 20” is indefinite because claim 1, which claim 5 depends from, recites “at least one solvent”. As currently written, it is unclear if “the solvent” as recited in claim 5 is referring to just one of the “at least one solvent” or the entirety of “at least one solvent”.
The preamble of Claim 12 recites “[f]ood, feed, pharma and personal care personal care products”. It is unclear whether the claim is intended to be directed to a product that meets all four recited intended uses, just a single one, or if it is attempting to claim multiple products in a single claim.
The preamble of Claim 13 recites “[p]ersonal care personal care products”. The pluralization of “products” renders the claim unclear as to whether the scope of the claim is directed to a single personal care product or if it is directed to multiple products, and if that’s the case, how the scope of multiple products are to be interpreted. Furthermore, the claim recites that the personal care products comprise “at least one formulation according to claim 1.” However, there is a lack of antecedent basis for the limitation as claim 1 is directed to a single formulation and does not encompass more than one formulation.
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 1-6, 8, 9, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Shaffer et al. (Shaffer) (US 20180243196 A1; of record) and Anderson et al. (Anderson) (US 2002/0006383 A1; of record).
With regards to Claims 1-6, Shaffer discloses stable, non-irritating retinoid containing formulations and delivery systems for topical application to the skin (abstract). The retinoid composition comprises 0.001-60% (w/w) retinol and 0.01-25% (w/w) polysorbate 20 (Shaffer claims 1 and 10; para.0021, 0032, 0042).
Polysorbate 20 reads on the compound of formula (I) as shown in claim 1, wherein R is a linear C11-alkyl moiety and w, x, y, and z each are integers which sum up to 20. The polysorbate 20 serves as a solubilizing agent and provides stability to the disclosed formulations and retinoid delivery systems (para.0042).
Shaffer further discloses the compositions may further comprise one or more antioxidants (para.0045).
With regards to Claims 12 and 13, Shaffer is directed to a formulation that provides effective topical treatment with a low incidence of irritation, supports the skin barrier, and increases cell turnover in the skin, thereby reducing the appearance of fine lines, wrinkles, and age spots, as well as improving skin texture and tone and promoting a collagen-rich appearance (para.0009, 0010, 0038, 0039, 0040). Thus, Shaffer’s formulation reads on a personal care product.
Shaffer does not appear to explicitly disclose the inclusion of mixed tocopherol. Anderson is relied upon for this disclosure. The teachings of Anderson are set forth herein below.
Anderson discloses skin treatment compositions (abstract). The composition may contain an antioxidant. Among the suitable antioxidants include mixed tocopherol (a mixture of isomers of Vitamin E). Preferably, the antioxidant is present in an amount of about 0.01-5.0 wt.% of the total weight of the composition (para.0048).
With regards to the inclusion of mixed tocopherol as recited in Claims 1, 2, and 9, Shaffer and Anderson are both directed to topically applied skin treatment compositions. As discussed above, Shaffer discloses their composition comprises at least one antioxidant. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Shaffer and Anderson and incorporate mixed tocopherol in an amount of 0.01-5.0 wt.% as the antioxidant component in Shaffer’s skin treatment composition. One of ordinary skill in the art would have been motivated to do so as Anderson discloses mixed tocopherol as an art recognized and conventional antioxidant for skin treatment compositions, and discloses that antioxidants are known to be incorporated into skin treatment compositions in amounts ranging from 0.01-5.0 wt.%. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Shaffer explicitly discloses the inclusion of at least one antioxidant in their skin treatment composition, and Anderson discloses mixed tocopherol as an antioxidant suitable for skin treatment compositions. Furthermore, 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.
With regards to Claim 8, Shaffer at its broadest disclosure discloses their composition comprises one or more antioxidants, thus encompassing a formulation having just one antioxidant component. Thus, the skin treatment composition of the combined teachings of Shaffer and Anderson discussed above encompasses a formulation wherein the mixed tocopherol is the only antioxidant component in the formulation.
With regards to the transitional phrase “consisting essentially of” in Claim 2, 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. PPG Industries Inc. V Guardian Industries Corp. 48 USPQ2d 1351 (Fed. Cir. 1998) and In re De Lajarte 337 F.2d 870, 143 USPQ 256 (CCPA 1964) See MPEP 2111.03.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shaffer et al. (Shaffer) (US 20180243196 A1; of record) and Anderson et al. (Anderson) (US 2002/0006383 A1; of record) as applied to Claims 1-6, 8, 9, 12, and 13 set forth above, further in view of Udell et al. (Udell) (US 6,716,451 B1; published Apr. 6, 2004).
The teachings of Shaffer and Anderson and the motivation for their combination as they apply to Claims 1-6, 8, 9, 12, and 13 are set forth above and incorporated herein.
The combined teachings of Shaffer and Anderson do not appear to explicitly disclose the components of the mixed tocopherol as recited in Claim 7. Udell is relied upon for this disclosure. The teachings of Udell are set forth herein below.
Udell discloses a formulation of Vitamin E isomers for improved antioxidant capacity, bioavailability, dissolution, and efficacy. Udell discloses that the potent antioxidant capacity of the formulation affords protection against oxidative damage of cell membranes, heart disease, cancer, and eye and skin disease (abstract). The formulation may be in any delivery system that can provide beneficial antioxidant to living beings, whether human or other animals (col.5, ln.55-63).
Udell discloses the use of mixed tocopherols that comprise (based on the total weight of the mixed tocopherol) 9.6 wt.% α-tocopherol, 1.0 wt.% β-tocopherol, 42.0 wt.% γ-tocopherol, and 13.0 wt.% δ-tocopherol (col.7, ln.10-29).
With regards to Claim 7, as discussed above, the combined teachings of Shaffer and Anderson are directed to skin treatment formulations, wherein one of the components is mixed tocopherols as the antioxidant. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of Shaffer and Anderson with the teachings of Udell and use Udell’s mixed tocopherol comprising 9.6 wt.% α-tocopherol, 1.0 wt.% β-tocopherol, 42.0 wt.% γ-tocopherol, and 13.0 wt.% δ-tocopherol as the mixed tocopherol antioxidant in the skin treatment composition of the combined teachings of Shaffer and Anderson. One of ordinary skill in the art would have been motivated with a reasonable expectation of success in doing so as Anderson discloses that mixed tocopherol (a mixture of isomers of Vitamin E) is an art recognized and conventional antioxidant for skin treatment compositions, and Udell discloses that their particular mixed tocopherol (a mixture of isomers of Vitamin E) is known to be an antioxidant suitable for providing antioxidant capacity and providing protection against oxidative damage of cell membranes and skin disease. Furthermore, 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.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
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 1-9, 12, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
(i) claims 1-9, 12, and 13 of copending Application No. 18/555,104 (Copending 104),
(ii) claims 1-9, 12, and 13 of copending Application No. 18/555,154 (Copending 154),
(iii) claims 1-10, 13, and 14 of copending Application No. 18/838,710 (Copending 710),
(iv) claims 1-10, 13, and 14 of copending Application No. 18/838,904 (Copending 904),
(v) claims 1-10, 13, and 14 of copending Application No. 18/838,971 (Copending 971),
each in view of Shaffer et al. (Shaffer) (US 20180243196 A1; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the cited claims of the copending applications are all directed to substantially similar and overlapping formulations comprising 40-75 wt.%, based on the total weight of the formulation, of retinol, 20-55 wt.% based on the total weight of the formulation, of at least one solvent, and 0.1-5 wt.%, based on the total weight of the formulation, of mixed tocopherol. Each of the copending applications also are directed to personal care products incorporating the aforementioned formulation.
The primary difference between the instant claims the cited copending applications is the at least one solvent. The instant application claims wherein the at least one solvent is a compound of formula (I), such as polysorbate 20. However, this is a prima facie obvious modification in view of Shaffer. The teaching of Shaffer are set forth above and incorporated herein.
As discussed above, each of the Copending applications are directed to retinol-containing formulations, which may be used in personal care products. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Shaffer with the claims of Copending104/Copending 154/Copending 710/Copending 904/Copending 971 and add Shaffer’s polysorbate 20 in an amount of 0.01-25 wt.% to the formulation of Copending104/Copending 154/Copending 710/Copending 904/Copending 971. One of ordinary skill in the art would have been motivated to do so as Shaffer discloses that polysorbate 20 provides stability to retinoid (e.g., retinol) delivery systems. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as each of the copending applications are directed to retinol-containing formulations, which may be used in personal care products, and Shafer discloses that polysorbate 20 is known to be incorporated in amounts of 0.01-25 wt.% into skin treatment formulations containing retinol.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-9, 12, and 13 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MONICA A SHIN/Primary Examiner, Art Unit 1616
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