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 .
Summary
Claims 1-15 are pending in this office action. All pending claims are under examination in this application.
Priority
The current application was filed on February 12, 2024 is a 371 of PCT/EP2022/073482 filed August 23, 2022. The current application claims foreign priority to EP21192699.3 filed August 24, 2021.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on February 12, 2024 is acknowledged. A signed copy of the document is attached to this office action.
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, 7-9, 12 and 14-15 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 claims 2, 7-9, and 12, the term "preferably" or phrase “most preferably” renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 14 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claim 14 and 15 are written as a “use” claim and does not recite process steps. Additionally, claims 14 and 15 does not comply with the four statutory categories. They are, therefore, indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14 and 15 are directed to non-statutory subject matter. The claims 14 and 15 do not fall within at least one of the four categories of patent eligible subject matter because it is written as a “use” claim.
Claim Rejections - 35 USC § 103
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.
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 non-obviousness.
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Butz et al. (US2019/0380940A1) in view of Lee et al. (KR20180102431A), Chan et al. (Journal of Clinical and Aesthetic Dermatology, 2019), and Huang et al. (WO2018/112187A1).
[The Examiner is going to introduce each new reference and then combine them where appropriate to reject the instant claims.]
1. Butz et al.
Butz et al. is the considered the closest prior art as it teaches a foam boosting saccharide blend (see title). In addition, Butz et al. disclose a foam booster that is capable of producing or increasing the amount of foam in any given composition. The foam booster includes a saccharide blend having 30 wt. % to 50 wt. % of an aldohexose or mixture of aldohexoses, 20 wt. % to 55 wt. % of a ketohexose or mixture of ketohexoses; and 10 wt. % to 20 wt. % of a disaccharide or mixture of disaccharides (see abstract).
2. Lee et al.
Lee et al. teach a cosmetic composition for anti-aging comprising fucosyllactose (see title). Additionally, Lee et al. disclose that the present invention relates to a composition for alleviating skin aging and to a functional cosmetic product for alleviating skin aging. According to the cosmetic composition or the functional cosmetic product according to one aspect, fucosyllactose inhibits the expression of MMP-1, IL-6, and IL-8 and significantly increases the synthesis of collagen, and since the fucosyllactose has no toxicity, the fucosyllactose can be safely used for development of a composition for the alleviating skin aging and functional cosmetics (see abstract).
3. Chan et al.
Chan et al. teach comparison of irritancy potential of sodium lauryl sulfate-free aqueous cream to other moisturizers: an intraindividual skin occlusive study (see title). Also, Chan et al. disclose that aqueous cream BP (British Pharmacopoeia) has been used as a moisturizer for xerotic skin conditions since 1958. It is a light, paraffin-based, oil-in-water emulsion, compounded from liquid paraffin, white soft paraffin, phenoxyethanol, purifed water, and emulsifying wax. Cetostearyl alcohol and sodium lauryl sulfate (SLS) comprise the emulsifying wax, which provides the consistency and base for the oil-water phase mixing of aqueous cream. However, recent reports on adverse cutaneous reactions from SLS-containing aqueous cream
has attracted criticism to the previously popular moisturizer. This prompted the Medicines and Healthcare products Regulatory Agency to issue a Drug Safety Update in March 2013 with an official warning that aqueous cream is likely to cause skin irritation. Research has shown that SLS-containing aqueous cream thins the stratum corneum, increases epidermal turnover rate, provokes greater transepidermal water loss (TEWL), decreases corneocyte maturity and size, and accelerates inflammatory protease activity. Several authors have postulated that the skin irritancy effects are secondary to SLS, a known irritant, and have since recommended against the use of SLS-containing aqueous cream, both as a leave-on emollient and a wash-off product.
Despite the recent criticism of aqueous cream, it remains one of the most commonly used, inexpensive moisturizers on the market. In addition, SLS-free aqueous cream is now widely available as a substitute for SLS-containing aqueous cream. To our knowledge, there has not yet been a comprehensive study to evaluate the irritancy potential of SLS-free aqueous cream. Therefore, the aim of this pilot study was to compare the irritancy potential of SLS-free aqueous cream to SLS-containing aqueous
cream and other generic and commercial moisturizers. We hope that this study will aid in appraising moisturizers with the least irritation potential, ensuring safer and more affordable patient care (see page 52, paragraph 1 and 2).
4. Huang et al.
Huang et al. teach amphiphilic polysaccharide derivatives and compositions comprising same (see title). Furthermore, Huang et al. disclose compositions comprising a polysaccharide derivative, wherein the polysaccharide derivative comprises a polysaccharide substituted with a) at least one hydrophobic group, and b) at least one hydrophilic group, wherein the polysaccharide is poly alpha-1,3-glucan, poly alpha-1,6-glucan, or poly alpha-1,3-1,6-glucan (see abstract).
Combination of Butz et al., Lee et al., Chan et al., and Huang et al.
Regarding instant claim 1, Butz et al., Lee et al., Chan et al., and Huang et al. teach a sulfate-free cleansing composition. The necessary citations of Butz et al., Lee et al., Chan et al., and Huang et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Butz et al., Lee et al., Chan et al., and Huang et al. Citations
A sulfate-free cleansing composition comprising
Butz et al. is directed to a blend of saccharides that can be used as a foam booster or foam-enhancing agent to enhance the foaming capabilities of given composition (see abstract within Butz et al.). The saccharide blend can include a combination of an aldohexose (e.g., glucose or dextrose or both), a ketohexose (e.g. fructose), and a disaccharide (e.g., maltose) (see paragraph [0002] within Butz et al.). The foam boosting saccharide blend comprises dextrose, maltose and maltotriose (see Table 1 within Butz et al.). The formulation of table 3 is set to test the foam boosting blend in which cocoamidopropyl betaine is used and no sulfate derived surfactant is present.
The use of human milk oligosaccharides is not foreseen in this document.
Chan et al. disclose that sodium lauryl sulfate (SLS)-free aqueous cream has a lower irritancy potential than SLS-containing aqueous cream, with the same level of maintenance of skin barrier integrity and hydration. SLS-free aqueous
cream also appears to be less irritating to the
skin than other non-SLS generic and commercial
moisturizers tested (see abstract and page 25, paragraph 1 and 2; both within Chan et al.).
at least one zwitterionic surfactant containing at least 8 carbon atoms and one or more human milk oligosaccharide.
However, Lee et al. incorporates human milk oligosaccharides into their cosmetic.
Lee et al. disclose a cosmetic composition for improving skin aging, comprising fucosyllacatose wherein the fucosyllactose is derived from human breast milk (see claims 1, 6, and paragraph [0004]; all within Lee et al.).
Huang et al. disclose the use of zwitterionic surfactants (see page 61, line 32 within Huang et al.).
Furthermore, Butz et al. disclose the use of amphoteric surfactants (equivalent to zwitterionic surfactants; see PTO-892 NPL X). Butz et al. disclose the use of the amphoteric surfactant, cocoamidopropyl betaine (see Table 3 within Butz et al.; 19 carbons).
Therefore, a skilled artisan (POSITA; person of ordinary skill in the art) would consult the disclosures of Butz et al., Lee et al., Chan et al., and Huang et al. to teach all the elements of instant claim 1.
Regarding instant claims 2 and 3, Butz et al., Lee et al., Chan et al., and Huang et al. teach wherein the amount of the at least one human milk oligosaccharide is selected in the range from 0.01 to 10 wt.-%, preferably in the range from 0.1 to 7.5 wt.-%, most preferably in the range from 0.2 to 5 wt.-%, based on the total weight of the composition. Lee et al. disclose the composition may contain 0.001 wt% to 50 wt% of fucosyllactose (including 2-fucosyllactose and 3-fucosyllactose; see paragraph [0004] within Lee et al.; also see PTO-892 NPL V) relative to the total weight of the cosmetic (see paragraph [0018] within Lee et al.).
Regarding instant claim 4, Butz et al., Lee et al., Chan et al., and Huang et al. teach wherein the composition further comprises at least one non-ionic surfactant. Butz et al. disclose the use of at least one non-ionic surfactant (see paragraph [0011] within Butz et al.).
Regarding instant claim 5, Butz et al., Lee et al., Chan et al., and Huang et al. teach wherein the at least one non-ionic surfactant is selected from the group consisting of alkyl (poly)glucosides, (poly)glyceryl fatty acid esters and polyethyleneglycol (PEG) based surfactants. Butz et al. disclose non-limiting examples of nonionic surfactants include polyethoxylated compounds, polypropoxylated compounds, alkanolamides, amine oxides, or fatty acids of polyhydric alcohols, or combinations thereof (see paragraph [0011] within Butz et al.).
Regarding instant claim 6, Butz et al., Lee et al., Chan et al., and Huang et al. teach wherein the at least one non-ionic surfactant is selected from the group consisting of lauryl glucoside, glyceryl stearate, PEG-100 stearate, PEG-200 hydrogenated glyceryl palmate and PEG-7 glyceryl cocoate. Please see the discussion and citations within instant claim 5. Butz et al. does not list specific examples of non-ionic surfactants. However, a skilled artisan (POSITA) would select, for example, common non-ionic surfactants such as PEG-100 stearate, PEG-200 hydrogenated glyceryl palmate and PEG-7 glyceryl cocoate (all common within cosmetics).
Regarding instant claim 7, Butz et al., Lee et al., Chan et al., and Huang et al. teach wherein the at least one one zwitterionic surfactant is selected from the group consisting of alkyl amidopropyl betaines, preferably the at least one zwitterionic surfactant is cocamidopropyl betaine. Butz et al. disclose the use of the zwitterionic/amphoteric surfactant, cocoamidopropyl betaine (see Table 3 within Butz et al.; 19 carbons).
Regarding instant claim 8, Butz et al., Lee et al., Chan et al., and Huang et al. teach wherein the amount of the at least one surfactant is selected in the range from 25 to 75 wt.-%, preferably in the range from 30 to 60 wt.-%, most preferably in the range from 30 to 55 wt.-%, based on the total weight of the cleansing composition. Huang et al. disclose a product comprising: from about 1 % to about 60% by weight of a surfactant…(see claim 21 within Huang et al.).
Regarding instant claim 9, Butz et al., Lee et al., Chan et al., and Huang et al. teach wherein the cleansing composition comprises at least 35 wt.-% of water, preferably at least 40 wt.-% of water, most preferably at least 45 wt.-% of water, based on the total weight of the cleansing composition. Butz et al. disclose water contents from a hand soap example ranging from 36%-46% by weight (see Example 5 within Butz et al.).
Regarding instant claim 10, Butz et al., Lee et al., Chan et al., and Huang et al. teach wherein the cleansing composition is a rinse-off composition. Butz et al. disclose the rinse off formulation (hand soap) and its testing for foam, the foam volume produced, the bubble sizeproduced, the lubricity of the formulation, the foam density produced, and the difficulty to rinse off the formulation (see Example 5 within Butz et al.).
Regarding instant claim 11, Butz et al., Lee et al., Chan et al., and Huang et al. teach wherein the cleansing composition is a shower gel, a liquid soap, a wash gel, a body wash, a soap bar, a foam bath, a shampoo or a shaving preparations. Butz et al. disclose the composition is a cleansing composition such as a shampoo, body wash, soap, hand cleanser, etc. (see paragraph [0011] within Butz et al.).
Regarding instant claim 12, Butz et al., Lee et al., Chan et al., and Huang et al. teach wherein the cleansing composition further comprises at least one humectant, preferably sodium hyaluronate. Huang et al. disclose that personal care products can include the polysaccharide derivatives as disclosed herein, and can further comprise personal care active ingredient materials including sun screen agents, moisturizers, humectants…(see page 51, lines 27-29 within Huang et al.).
Regarding instant claims 13-15, Butz et al., Lee et al., Chan et al., and Huang et al. teach a method of increasing the foaming properties of sulfate-free cleansing compositions comprising at least one surfactant, said method comprising the step of adding at least one human milk oligosaccharide into said cleansing composition. Please see the discussion and citations within instant claim 1 incorporating all the instant claim 13 limitations. Furthermore, Butz et al. disclose the enhancement of foaming properties (foam volume and booster; see paragraphs [0009] and [0012] within Butz et al.).
Analogous Art
The Butz et al., Lee et al., Chan et al., and Huang et al. references are directed to the same field of endeavor as the instant claims, that is, a sulfate-free cleansing composition disclosed within instant claim 1.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the cleansing composition disclosed by Butz et al., using the teachings of Lee et al. to incorporate human milk oligosaccharides, additionally, the teachings of Chan et al. to produce a sulfate-free cosmetic, and further in light of the claim-specific features described in Huang et al. regarding surfactants and humectants, in order to arrive at the subject matter of the instant claims.
The Butz et al., Lee et al., Chan et al., and Huang et al. references all have considerable overlap with the development of personal care cosmetics. In this instance, both Butz et al. and Lee et al. supply the cosmetic formulation for a body care composition comprising human milk oligosaccharides, Chan et al. supports the production of a sulfate-free cosmetic, while Huang et al. supplies cosmetic specific claimed features regarding surfactants and humectants. All references are directed to personal care cosmetics and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the four references when seeking to improve or adapt a sulfate-free cleansing composition.
Starting with Butz et al., the skilled person only had to try the necessary claim limitations disclosed by Chan et al., Lee et al., and Huang et al. The combination of Butz et al., Chan et al., Lee et al., and Huang et al. would allow one to arrive at the present application without employing inventive skill. This combination of the cleansing composition taught by Butz et al. along with the use of the necessary claim limitations taught by Chan et al., Lee et al., and Huang et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the cleansing composition disclosed by Butz et al. with the use of the necessary claim limitations taught by Chan et al., Lee et al., and Huang et al. Incorporating the disclosure of Butz et al. into the sulphate-free cosmetic suggested by Chan et al., and the human milk oligosaccharides and claim-specific surfactants and humectants by Lee et al. and Huang et al., respectively, represents a predictable use of prior art elements according to their established functions, consistent with MPEP §2143 and KSR.
Furthermore, the additional claim limitations taught by Chan et al., Lee et al., and Huang et al. would have been viewed by a POSITA as routine design optimizations or known modifications to expand and develop the personal care cosmetic. Implementing these features in Butz et al.’s cleansing composition would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Butz et al., supplemented by Chan et al., Lee et al., and Huang et al. provides all the elements of the claimed invention. The resulting cleansing composition cosmetic constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 1-11 and 13-15 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-3, 7-11, 13, and 15 of co-pending Application No. 18/683627 (reference application) in view of Chan et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Application ‘627 encompass a cosmetic cleansing composition for personal care.
The difference between the instant claims and that of Application ‘627 is the use of a sulfate-free cleanser.
However, Chan et al. teach comparison of irritancy potential of sodium lauryl sulfate-free aqueous cream to other moisturizers: an intraindividual skin occlusive study (see title). Also, Chan et al. disclose that aqueous cream BP (British Pharmacopoeia) has been used as a moisturizer for xerotic skin conditions since 1958. It is a light, paraffin-based, oil-in-water emulsion, compounded from liquid paraffin, white soft paraffin, phenoxyethanol, purifed water, and emulsifying wax. Cetostearyl alcohol and sodium lauryl sulfate (SLS) comprise the emulsifying wax, which provides the consistency and base for the oil-water phase mixing of aqueous cream. However, recent reports on adverse cutaneous reactions from SLS-containing aqueous cream
has attracted criticism to the previously popular moisturizer. This prompted the Medicines and Healthcare products Regulatory Agency to issue a Drug Safety Update in March 2013 with an official warning that aqueous cream is likely to cause skin irritation. Research has shown that SLS-containing aqueous cream thins the stratum corneum, increases epidermal turnover rate, provokes greater transepidermal water loss (TEWL), decreases corneocyte maturity and size, and accelerates inflammatory protease activity. Several authors have postulated that the skin irritancy effects are secondary to SLS, a known irritant, and have since recommended against the use of SLS-containing aqueous cream, both as a leave-on emollient and a wash-off product.
Despite the recent criticism of aqueous cream, it remains one of the most commonly used, inexpensive moisturizers on the market. In addition, SLS-free aqueous cream is now widely available as a substitute for SLS-containing aqueous cream. To our knowledge, there has not yet been a comprehensive study to evaluate the irritancy potential of SLS-free aqueous cream. Therefore, the aim of this pilot study was to compare the irritancy potential of SLS-free aqueous cream to SLS-containing aqueous
cream and other generic and commercial moisturizers. We hope that this study will aid in appraising moisturizers with the least irritation potential, ensuring safer and more affordable patient care (see page 52, paragraph 1 and 2 within Chan et al.).
It would have been prima facie obvious to incorporate a sulfate-free cosmetic product with application ‘627 due to the documented irritation of the skin (see page 52, paragraph 1 and 2 within Chan et al.) as suggested by Chan et al. There would have been a reasonable expectation of success in doing so as both Chan et al. and Application ‘627 are both within the personal care cosmetic industry.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN W LIPPERT III whose telephone number is (571)270-0862. The examiner can normally be reached Monday - Thursday 9:00 AM - 5:00 PM.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615