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 .
Priority
This application is a CON of 17085166 filed 10/30/2020 (ABN).
17085166 is a CON of PCT/US2019/030011 filed 04/30/2019.
PCT/US2019/030011 has PRO of 62664766 filed 04/30/2018.
Accordingly, claims 1-20 of this instant application are afforded the effective filing date of 04/30/2018.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/08/2024 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
Claims 1-20 are pending in this instant application, and examined herein on the merits for patentability.
Claim Objections
Claim 2 is objected to because of the following informalities: please remove the “in” before “at least about” in line 3 of claim 2, as this “in” is redundant to the earlier “in” in line 2 of the claim. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: please add %” after “10” so that there is proper unit of measurement. 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.
Claim 2 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.
Regarding claim 2, the limitation of “at least about” in said claim 2 (lines 2-3 of the claim) is indefinite. The phrase "at least” typically indicates a minimum point; however, the phrase “at least” is controverted by the term “about,” which implies that values above and below the indicated amount are permitted. Therefore, the juxtaposition of these two terms makes it unclear what maximum dimensions are encompassed by the claim. In Amgen, Inc. v. Chugai Pharmaceutical co., 927 F.2d 1200 (CAFC 1991), the CAFC stated, “[t]he district court held claims 4 and 6 of the patent invalid because their specific activity of “at least about 160,000” was indefinite.” After review, the CAFC states “[w]e therefore affirm the district court’s determination on this issue.” Thus, the CAFC found the phrase “at least about” indefinite where the metes and bounds of the term were not defined in the specification.
As a result, claim 2 does not clearly set forth the metes and bound of patent protection desired.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 is not further limiting from claim 1 because emollient as recited in claim 12 is already present in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-8, 12, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Efthimios (US 2018/0015022 A1), and as evidenced by Dow (Dowsil™ EL-8050 ID Silicone Organic Elastomer Blend Technical Data Sheet, 2019, pages 1-6).
Regarding claim 1, Efthimios teaches an anhydrous composition dimethicone/Bis-Isobutyl PPG-20 crosspolymer in isododecane (Dow Corning® EL 8050 ID), Helianthus Annuus seed oil (sunflower seed oil), an emollient, and at least one powder such as silica (a viscosity enhancement agent), wherein the composition is the form of a sunscreen, thereby does not contain a healthcare active (Abstract; [0014]-[0030], [0032], [0036]-[0038], [0054]-[0057], [0114], [0116]; claims 17-33). Efthimios teaches the composition is applied to the skin ([0015], [0030]-[0032], [0034]; claim 17), thereby is suitable for topical administration. It is noted that “formulated for topical or transdermal adminstration of a healthcare active onto a subject” is a recitation of intended use. As discussed above, each and every structural components of the claimed composition (a silicone-based excipient, a carrier oil, an emollient, and a viscosity enhancement agent, wherein the composition does not comprise the healthcare active) have been taught by Efthimios. Thus, there is no structural difference between the composition of Efthimios and the composition of the claimed invention. It is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As such, the composition of Efthimios being structurally the same as the composition of the claimed invention would capable of performing the intended use of “formulated for topical or transdermal adminstration of a healthcare active onto a subject” as recited in claim 1.
Regarding claim 3-4, as discussed above, Efthimios teaches the dimethicone/Bis-Isobutyl PPG-20 Crosspolymer is provided in isododecane.
Regarding claim 5, as discussed above, Efthimios teaches the anhydrous composition contains dimethicone/Bis-Isobutyl PPG-20 crosspolymer in isododecane (Dow Corning® EL 8050 ID), thereby meeting the claimed “the weight ratio of carrier fluid to silicone-based excipient is about 85:15” per evidenced from Dow Dowsil™ EL-8050 ID Silicone Organic Elastomer Blend Technical Data Sheet, which indicates a non-volatile content of about 15%, i.e., isododecane at about 85%.
Regarding claims 6-8, as discussed above, Efthimios teaches the anhydrous composition contains Helianthus Annuus seed oil (sunflower seed oil).
Regarding claim 12, as discussed above, Efthimios teaches the anhydrous composition contains emollient.
Regarding claim 18, Efthimios teaches the anhydrous composition is in the form of an anhydrous gel ([0014], [0032], [0086]).
Regarding claim 19, Efthimios teaches the anhydrous composition is applied to skin (Abstract; [0014]-[0015], [0032]; claim 19), thereby is for topical administration.
As a result, the aforementioned teachings from Efthimios (and as evidenced by Dow) are anticipatory to claims 1, 3-8, 12, and 18-19 of the instant invention.
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.
Claim(s) 1-8, 12, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Efthimios (US 2018/0015022 A1), and as evidenced by Dow (cited above).
The compositions of claims 1, 3-8, 12, and 18-19 are discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 2, Efthimios teaches the anhydrous composition contain from about 30% to about 90% w/w of dimethicone/Bis-Isobutyl PPG-20 crosspolymer in isododecane (Abstract; [0016], [0033]; claim 17).
It would have been obvious to one of ordinary skill in the art to optimize the concentration of dimethicone/Bis-Isobutyl PPG-20 crosspolymer in isododecane in the anhydrous composition to “an amount of about 55% by weight, about 60% by weight, about 65% by weight, about 70% by weight, about 75% by weight, in at least about 80% by weight, about 85% by weight, about 90% by weight, about 95% by weight, or about 99% by weight,” and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Efthimios provides the guidance for optimizing the amount of dimethicone/Bis-Isobutyl PPG-20 crosspolymer in isododecane to an amount from about 30% to about 90% w/w, which is a range that overlaps the claimed amounts of “an amount of about 55% by weight, about 60% by weight, about 65% by weight, about 70% by weight, about 75% by weight, in at least about 80% by weight, about 85% by weight, about 90% by weight, about 95% by weight, or about 99% by weight.” Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed amounts, the optimization of the amount of silicone-based excipient in the composition would have been obvious before the effective filing date of Applicant’s invention. “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the reference, especially in the absence of evidence to the contrary.
Claim(s) 1, 3-12, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Efthimios (US 2018/0015022 A1) and as evidenced by Dow (cited above), and further in view of Bara (US 6,184,277 B1).
The compositions of claims 1, 3-8, 12, and 18-19 are discussed above, said discussion being incorporated herein in its entirety.
However, Efthimios does not teach the amount of carrier oil of claim 9; and the weight ratio of silicon-based excipient to carrier oil of claims 10 and 11.
Regarding claim 9, Bara teaches a composition in the form of an anhydrous gel comprising an silicone elastomer, and a polar oil such as sunflower oil, wherein the polar oil such as sunflower oil is from 1% to 50% by weight (Abstract; columns 2-4; Example 1; claims 1-19).
It would have been obvious to one of ordinary skill in the art to optimize the concentration of sunflower oil in the composition of Efthimios to an amount an amount from about 10% to about 20% by weight, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Bara provided the guidance to do so by teaching that the amount of sunflower oil can be optimize in an anhydrous gel containing silicone elastomer to an amount from 1% to 50% by weight, which overlaps the claimed range of from about 10% to about 20% by weight Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amount of carrier oil in the composition would have been obvious before the effective filing date of Applicant’s invention. "Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
Regarding claim 10-11, Bara teaches the composition contains the silicone elastomer in an amount of 2% to 60% by weight and the polar oil such as sunflower oil is in an amount from 1% to 50% by weight (column 3, lines 23-26; column 4, lines 10-35).
It would have been obvious to one of ordinary skill in the art to optimize the concentrations of silicone elastomer and the polar oil such as sunflower oil to a weight ratio as claimed in claim 10 and 11, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Bara teaches that the silicone elastomer can be present in the composition in an amount of 2% to 60% by weight and the polar oil such as sunflower oil can be present in the composition in an amount of 1% to 50% by weight, which are concentration ranges that fall within or overlap the claimed weight ratios. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the weight ratio of silicone-based excipient to carrier oil in the composition would have been obvious before the effective filing date of Applicant’s invention. "Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the reference, especially in the absence of evidence to the contrary.
Claim(s) 1, 3-8, and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Efthimios (US 2018/0015022 A1) and as evidenced by Dow (cited above), and further in view of Shimizu et al (US 2015/0320673 A1).
The compositions of claims 1, 3-8, 12, and 18-19 are discussed above, said discussion being incorporated herein in its entirety.
However, Efthimios does not teach the emollient of claims 13 and 14; the silicone fluid of claims 15-17; and the viscosity enhancement agent is silica silylate of claim 20.
Regarding claims 13-14, Shimizu teaches an anhydrous composition comprising silicone elastomer, non-volatile hydrocarbonated polar oil such as ester of a fatty acid and triglyceride ([0015]-[0028], [0086], [0087], [0091], [0103], [0133], [0141], [0202]-[0208], [0226]-[0227], [0384]-[0418], [0445]-[0447]; claims 20 and 26).
It would have been obvious to one of ordinary skill in the art to include an ester of a fatty acid or triglyceride in the anhydrous composition of Efthimios, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Shimizu provided the guidance to do so by teaching that ester of a fatty acid or triglyceride can be added to the anhydrous composition, as ester of a fatty acid and triglyceride are common oils commonly used in cosmetic anhydrous composition to provide a resultant composition that improve softness of the skin (Shimizu: [0017], [0019], [0202-[0208], and [0226[]-[0227]). Thus, an ordinary artisan seeking to provide a cosmetic anhydrous composition that improve softness of the skin would have looked including an ester of a fatty acid or triglyceride in the anhydrous composition of Efthimios, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claim 15-17, Shimizu teaches the anhydrous composition further contains silicone fluid such as phenyl trimethicone ([0077], [0087], [0091], [0103], [0127], [0133]; claim 26).
It would have been obvious to one of ordinary skill in the art to include phenyl trimethicone in the anhydrous composition of Efthimios, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Shimizu provided the guidance to do so by teaching that phenyl trimethicone can be advantageously added to the anhydrous composition with non-volatile hydrocarbonated polar oil such as ester of a fatty acid and triglyceride so as to provide cosmetic anhydrous composition that is not-tacky and enable forming a nontransfer deposition in association with the non-volatile hydrocarbonated oil (Shimizu: [0010], [0015], [0019]-[0020], [0141] and [0454]). Thus, an ordinary artisan seeking to provide an anhydrous composition that is not tacky and non-transferring when applied to the skin, would have looked to including phenyl trimethicone together with non-volatile hydrocarbonated oil such as ester of a fatty acid and triglyceride in the anhydrous composition of Efthimios, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claim 20, Shimizu teaches the anhydrous composition further contains fillers such as silica silylate ([0410], [0414], [0416]).
It would have been obvious to one of ordinary skill in the art to include silica silylate as one of the powder in the anhydrous composition of Efthimios, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Shimizu provided the guidance to do so by teaching that aside from silica disclosed in Shimizu, silica silylate is also suitable as the powder component in an anhydrous composition, as the addition of silica silylate aid in modifying the rheology or the texture of the composition. One of ordinary skill in the art would have reasonable expectation of success of including silica silylate because Efthimios also listed silica silylate as one of the suitable powder for including in the anhydrous composition (Efthimios: [0028] and [0056]). Thus, an ordinary artisan seeking to provide an anhydrous composition with a desired rheology and texture, would have looked to including silica silylate as one of the powder in the anhydrous composition of Efthimios, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the reference, especially in the absence of evidence to the contrary.
Claim(s) 1, 3-8, and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over St. Laurent et al (US 2013/0089577 A1) in view of Lin et al (US 2012/0258057 A1), and as evidenced by Dow (Dowsil™ EL-8050 ID Silicone Organic Elastomer Blend Technical Data Sheet, 2019, pages 1-6).
Regarding claim 1, St. Laurent teaches an anhydrous composition comprising isododecane dimethicone/bis-isobutyl PPG-20 crosspolymer (Dow Corning® EL 8050 ID), sunflower seed oil, triglyceride, stearyl lactate, and silica silylate ([0137]-[0149], [0153]; Example and Table 1). St. Laurent teaches the composition is for topical administration ([0003], [0022]. [0040], [0050], [0058], [0138] and [0148]).
While St. Laurent teaches the composition contains a healthcare active, it would have been obvious replace the healthcare active with a personal care active in view of the guidance from Lin.
Lin teaches an anhydrous composition comprising silicone elastomer, isododecane, and an personal care active or healthcare active (Abstract; [0006]-[0013], [0091]-[0130], [0137]-[0140], [0200]; claims 1-6). Lin teaches the composition is applied to the skin ([0095], [0120], [0122]-[0123] and [0143]), thereby is used for topical administration.
It would have been obvious to one of ordinary skill in the art to modify the anhydrous composition of St. Laurent such that the healthcare active is replaced with other active ingredient such as a personal care active, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Lin provided the guidance to do so by teaching that either healthcare active or an personal active can be included as the active ingredient in the anhydrous composition containing an silicone elastomer (Lin: [0006]-[0013], [0091]-[0130], [0137]-[0140], [0200]; claims 1-6). Thus, an ordinary artisan seeking to produce a cosmetic anhydrous composition would have looked to modifying the anhydrous composition of St. Laurent such that the healthcare active is replaced with a personal care active such as sunscreens, and produce Applicant’s claimed invention with reasonable expectation of success.
It is noted that “formulated for topical or transdermal adminstration of a healthcare active onto a subject” as recited in claim 1, is a recitation of intended use. As discussed above, St. Laurent in view of Lin teach and rendered obvious Applicant’s claimed composition as recited in claim 1, as well as, both St. Laurent and Lin teach their compositions is suitable for topical administration. Thus, it is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claims 3-4, as discussed above, St. Laurent teaches the anhydrous composition contains dimethicone/bis-isobutyl PPG-20 crosspolymer in isododecane.
Regarding claim 5, as discussed above, St. Laurent teaches the anhydrous composition contains dimethicone/Bis-Isobutyl PPG-20 crosspolymer in isododecane (Dow Corning® EL 8050 ID), thereby meeting the claimed “the weight ratio of carrier fluid to silicone-based excipient is about 85:15” per evidenced from Dow Dowsil™ EL-8050 ID Silicone Organic Elastomer Blend Technical Data Sheet, which indicates a non-volatile content of about 15%, i.e., isododecane at about 85%.
Regarding claims 6-8, as discussed above, St. Laurent teaches the anhydrous composition contains sunflower seed oil.
Regarding claim 12-14, as discussed above, St. Laurent teaches the anhydrous composition contains triglyceride and stearyl lactate (an ester of fatty acid).
Regarding claim 15-17, St. Laurent teaches the anhydrous composition further contains phenyl trimethicone (Example 1, Table 1).
Regarding claim 18, St. Laurent teaches the anhydrous composition is an anhydrous gel ([0040], [0050]; Example 1, Table 1).
Regarding claim 19, St. Laurent teaches the anhydrous composition is suitable for topical administration ([0003], [0022], [0040], [0050], [0058], [0148]).
Regarding claim 20, as discussed above, St. Laurent teaches the anhydrous composition contains silica silylate.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the reference, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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