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 . 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.
Claim Rejections - 35 USC § 112 –
Indefiniteness and Broad Range followed by Narrow Range
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.
Claim 13 is 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 13 recites the broad recitation “Sun Protection Factor”, and the claim also recites “(SPF)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The Applicant is encouraged to remove the parenthesis from the claim.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1-2 and 5-22 are rejected under 35 U.S.C. 103 as being unpatentable over Au et al (US 2020/0297606 A1), in view of LaRosa et al (US 2021/0093529 A1).
Au taught personal care compositions comprising sunscreens [0030, 0093], including:
one or more, each of:
(reading on claim 1(i)):
from about 0.1 % to about 10 wt. % of 4-t-butyl-4′-methoxydibenzoylmethane [0095]; from about 0.1 % to about 20 wt. % of octyl salicylate and 2-ethylhexyl 2-cyano-3,3-diphenyl-2-propenoate [0093];
and
(reading on claim 1(ii): from about 0.1 % to about 20 wt. % of phenylbezimidazole sulfonic acid [0093-0094];
further comprising:
(reading on claim 1(iii): from 0.1 % to 90 % surfactant, including polyoxyethylene sorbitan [0087-0088];
and
(reading on claim 1(iv): from about 0.1 % to about 10 wt. % niacinamide [0101];
and,
(reading on claim 1(v): from 0.0001% to 10% vitamin C, or derivatives thereof [0111].
At ¶s [0060 and 0080], Au generally taught thickeners; and, at ¶ [0081], Au taught thickeners in amounts of from 0.0001 to 10%.
However, Au did not teach the claim 1(v) limitation of stearic acid, and amounts thereof.
Nevertheless, LaRosa taught topical sunscreen compositions [title and abstract] comprising stearic acid, as a thickening agent [claim 9].
Since Au generally taught thickeners, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Au, stearic acid, as taught by LaRosa. 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. In the instant case, it is prima facie obvious to select stearic acid for incorporation into a sunscreen, based on its recognized suitability for its intended use, as a thickener, as taught by LaRosa at claim 9.
The instant claims 1 and 18 recite 8-10 % oil soluble sunscreen; 0.2-5 % or 0.2-1.5 % water soluble UVB sunscreen; 0.1-5 % non-ionic surfactant; 0.5-3 % or 0.5 to 1.25 % vitamin B3 or niacinamide; 0.01-5 % or 0.01-0.25 % vitamin C or sodium ascorbyl phosphate; 3-25 % or 3-6 % stearic acid.
The instant claim 7 recites 4-23 % stearic acid.
Au taught from about 0.1 % to about 10 wt. % of 4-t-butyl-4′-methoxydibenzoylmethane; from about 0.1 % to about 20 wt. % of octyl salicylate and 2-ethylhexyl 2-cyano-3,3-diphenyl-2-propenoate; from about 0.1 % to about 20 wt. % of phenylbezimidazole sulfonic acid; from 0.1 % to 90 % surfactant, including polyoxyethylene sorbitan; from about 0.1 % to about 10 wt. % niacinamide; from 0.0001% to 10% vitamin C. Additionally, Au taught thickeners in amounts of from 0.0001 to 10%. LaRosa taught stearic acid as a thickener. LaRosa also taught [see the below discussion over the instant claim 18] sodium ascorbyl phosphate (e.g., vitamin C derivative) and PEG-100 stearate (e.g., reads on fatty acid ethoxylate).
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.
Au, in view of LaRosa, reads on claims 1-2, 5-6 and 18.
Claim 8 is rendered prima facie obvious because Au taught palmitic acid [0078].
Claims 9-10 and 19-20 are rendered prima facie obvious because Au taught humectants, including propylene glycol, at from 0.5 to 50%, alternatively between 1 and 15% by weight of the composition [0081].
The instant claim 9 recites humectants from 0.4 to 10 %.
The instant claim 19 recites humectants from 1 to 10 %.
Au taught humectants at from 0.5 to 50%, alternatively between 1 and 15%. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 11 is rendered prima facie obvious because Au taught Dimethicone/Vinyl Dimethicone Crosspolymer from 0.1% to 95% by weight [0063, 0068]; silica [0091].
The instant claim 11 recites a polymer from 0.25 to 5 %. Au taught the polymer from 0.1% to 95%. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claims 12 and 21-22 are rendered prima facie obvious because LaRosa taught Aluminum Starch Octenylsuccinate [Examples 44, 57, 68, 74, 77, 80, 110, 112, 130-131, 163, 178-181, 190-191, 222]. The motivation to combine La Rosa with Au was previously discussed.
Claim 13 is rendered prima facie obvious because Au taught SPF values above 15 [see Table 3]. At claim 14, Au taught applying the composition to the skin [see also claims 13 and 15; and at [¶s 0029-0031].
Regarding the instant claims 14-15, the instant Specification, at page 16 (4th and 5th paragraphs), stated that the compositions instantly disclosed (e.g., those reading on compositions taught by the combined teachings of Au and LaRosa) protect, when applied to skin, against UVA-, UVB- and visible light-induced inflammation and oxidative stress.
It appears that the compositions of the instant claims and those of the combined teachings of the prior art would reasonably be expected to have substantially the same physical and chemical properties (e.g., protection against UVA-, UVB- and visible light-induced inflammation and oxidative stress).
Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition and its properties are inseparable. If the prior art teaches the identical chemical compounds, then the properties that the Applicant discloses and/or claims are necessarily present.
Claims 16-17 and further regarding claim 18, the claims are rendered prima facie obvious because LaRosa taught PEG-100 stearate (e.g., reads on fatty acid ethoxylate) [claim 7]; sodium ascorbyl phosphate [Examples 49, 117, 151, 153, 160, 163-166]. The motivation to combine La Rosa with Au was previously discussed.
Nonstatutory Double Patenting
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 1-2 and 5-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/685,324, in view of Au et al (US 2020/0297606 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are further limited by a vitamin B3 compound, or derivatives thereof, and by vitamin C, or derivatives thereof, which are not required of the copending claims.
Au taught personal care compositions comprising sunscreens, further comprising from about 0.1 % to about 10 wt. % niacinamide, and from 0.0001% to 10% vitamin C, each including derivatives thereof.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the copending claims, a vitamin B3 compound, or derivatives thereof, and a vitamin C, or derivatives thereof, as taught by Au, each at amounts as taught by Au. The ordinarily skilled artisan would have been motivated to formulate the sunscreen, as taught by Au.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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