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 .
Status of Claims
A new claim set was filed on 5/5/26 with the following:
Amended claims
19, 23, 31, 35
Newly canceled claims
Newly added claims
Previously canceled claims
1-18, 20, 34
Previously withdrawn claims
Claims under instant examination
19, 21-33, 34-40
Withdrawn Claim Rejections
The rejections of claims 23 and 35 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention are hereby withdrawn in view of the claim amendments filed on 5/5/26.
Modified Claim Rejections - 35 USC § 103
Applicant' s claim amendments have necessitated the following modified grounds of rejection.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 19, 21-33, 36-38 and 40 remain rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR101869976B1; published 22 June 2018; cited in the IDS filed 18 October 2022) in view of Schmaus et al. (US20180353392A1; published 13 December 2018; cited on PTO-892 mailed 11/19/2024).
The passages cited below which indicate the teachings of KR101869976B1 are based on its English translation, of record 11/19/2024.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Kim teaches a pack (mask) cosmetic composition [0001] that comprises sodium or potassium alginate at 1-30 wt% [0023], calcium sulphate at 1-50 wt% [0024], oils at 10-70 wt% [0026], a delaying agent, sodium pyrophosphate, at 0.1-20 wt% [0025] (i.e., complexing agent), emulsifiers at 0.1-30 wt% [0027] and polyglycerol-4 isostearate [0017]. Kim teaches “a composition consisting of a mixture containing no water” [0042] (i.e., anhydrous, limitation of claim 19) and can be used by mixing the composition with water in a volume ratio of 1:1 to 1:3 [0029] (limitations of claims 37-38 and 40). 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(1).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Kim does not specifically teach wherein polyglycerol-4 isostearate is present in the composition in a concentration ranging from 0.5 to 6.5 wt%, based on the total weight of the composition, as required by instant claim 19.
Kim does not teach “at least one polyol”, “wherein the one or more polyol comprises one or more of propylene glycol, butylene glycol, glycerin, or sorbitol”, “wherein the one or more polyol comprises glycerin”, “wherein the total concentration of the at least one [polyol] is from 15 wt% to 50 wt %, based on the total weight of the composition”, “wherein the at least one oil comprises at least one of” a Markush grouping of oils, and wherein the composition further comprises licochalcone A as required by instant claims 19, 21-23, 30 and 36. However, these deficiencies are made up for in the teachings of Schmaus et al.
Schmaus et al. teaches a cosmetic delivery system for actives in the form of a face mask [Abstract]. Schmaus et al. discloses a composition where the carrier is selected from a group containing the alginate salts: sodium alginate, potassium alginate, ammonium alginate, and calcium alginate [0013]. Schmaus et al. further discloses the use of polyol carriers including glycerol (glycerin), sorbitol, propylene glycol, and butylene glycol as skin moisturizing agents [0213], where the carriers are present at 5-50 wt% [0020, limitation of claims 20-23]. In addition, Schmaus et al. discloses the use of caprylic/capric triglyceride oil, as a glycosaminoglycan stimulator at 10 wt% [Table 3, limitation of claim 30] and the use of licochalcone A, as a skin pigment modulator [0201, limitation of claim 36] in a face mask formulation.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding the concentration of polyglycerol-4 isostearate as specified in claim 19, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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).
Furthermore, it is noted that Kim teaches that ester oils such as polyglycerol-4 isostearate can be used alone or in combination with two or more kinds of oil. Kim teaches that the oils include silicone-based fluid oils, ester oils or vegetable oils and that the total amount of oil in the composition ranges from 10-70 wt% (see claims). Kim teaches that the oils play a role in helping to achieve proper viscosity and stabilization of the water-soluble ingredients in the composition. The Applicants' specification provides no evidence that the selected concentration range in claim 1 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to numerous physical/chemical/biological properties of various chemicals (e.g., stability and viscosity function), it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine these teachings and alter the concentration. One of ordinary skill in the art would have been motivated to change the concentration as this could be expected to be advantageous for altering the stability and viscosity.
Based on these teachings, 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 modify the cosmetic composition of Kim and with the polyols, caprylic/capric triglyceride oil, and licochalcone A of Schmaus et al. and arrive at the compositions of these instant claims. One of ordinary skill in the art would have been motivated to do to create face mask with skin moisturizing agents, glycosaminoglycan stimulators to retain moisture in the skin, and skin pigment modulators. Therefore, the combination of known prior art elements is expected to yield predictable results. See MPEP 2143(A).
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claim(s) 34-35 and 39 remain rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR101869976B1; published 22 June 2018; cited in the IDS filed 18 October 2022) in view of Schmaus et al. (US20180353392A1; published 13 December 2018; cited on PTO-892 mailed 11/19/2024) as applied to claims 19, 21-33, 36-38 and 40 above, and further in view of O’Neill et al. (WO 2013/153358A1, published 10/17/2013; of record) and Whitfill (US 2019/0298780, priority to 9/5/2017; of record).
The teachings of Kim and Schmaus as applied to claims 19, 21-33, 36-38 and 40 above has been described supra. Kim and Schmaus od not further teach wherein the cosmetic composition comprises at least one probiotically active bacterial strain from the genus Staphylococcus or Cutibacterium, which has a positive effect on skin health, or wherein the composition further comprises at least one protector strain of the genus Lactobacillus, which promotes colonization of the probiotically active bacterial strain. These deficiencies are made up for in the teachings of O’Neill et al. and Whitfill.
O’Neill et al. teaches probiotic bacterium and lysates thereof for medical and cosmetic applications, wherein the probiotic bacterium is Lactobacillus rhamnosus, Lactobacillus reuteri and/or Bifidobacterium longum, wherein cosmetic applications include cosmetic compositions for improving hydration of the skin and/or improving the appearance of skin comprising one or more probiotic bacterium or lysate thereof of Lactobacillus rhamnosus, Lactobacillus reuteri and Bifidobacterium longum, wherein the cosmetic composition is topically applied to the skin in various forms including gels, pastes, ointments, creams, lotions, oils and patches (see entire document, particularly pages 4-6, 10-11, 18-25 and 27-28).
Whitfill teaches methods of treating various skin diseases or disorders comprising topically administering a living biotherapeutic composition comprising at least one recombinant probiotic microorganism that secretes therapeutic proteins such as filaggrin due its role in the skin barrier and ability to reduce transepidermal water loss and improve skin hydration (see entire document, particularly, pars [0004] [0006-0010], [0035], [0050]-[0055], [0106], 01110]-[0111]). Whitfill teaches that engineered probiotics leverage the skin microbiome for therapeutic purposes and an engineered probiotic has important advantages over other methods of drug delivery, as it will establish residence on the patient's skin and continuously and stably deliver therapeutic proteins in situ, par [0004]. Whitfill teaches the engineered probiotic microorganism is Staphylococcus epidermidis, but can also include various additional engineered probiotic microorganisms including Lactobacillus, pars, [0007], [0052]. Whitfill teaches the topical formulation includes any form suitable for administration to the body surface including a cream, lotion, spray, solution, gel ointment, or paste and may be nonaqueous, pars [0010]-[0011].
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 modify the anhydrous cosmetic composition/gel of Kim and Schmaus et al, which comprises 1-30 wt% sodium or potassium alginate, 1-50 wt% calcium sulphate, 10-70 wt% oils, a delaying agent, 0.1-20 wt% sodium pyrophosphate (complexing agent), 0.1-30 wt% emulsifiers, polyglycerol-4 isostearate, polyols, caprylic/capric triglyceride oil, and licochalcone A (Kim and Schmaus et al, supra), to further include engineered probiotic bacteria including Staphylococcus epidermidis and Lactobacillus rhamnosus and/or Lactobacillus reuteri that secrete therapeutic proteins such as filaggrin. One of ordinary skill in the art would have been motivated to include engineered probiotic bacteria including Staphylococcus epidermidis and Lactobacillus rhamnosus and/or Lactobacillus reuteri that secrete filaggrin in order reduce transepidermal water loss and improve hydration of the skin, and/or improving the appearance of skin because O'Neill et al teach that topical application of Lactobacillus rhamnosus and/or Lactobacillus reuteri cometic improve hydration of the skin and improve the appearance of skin, and Whitfill teaches topical application of engineered probiotics Staphylococcus epidermidis and Lactobacillus that secrete filaggrin reduce transepidermal water loss, improve skin hydration, and offer the advantages of establishing residence on the patient's skin to continuously and stably deliver therapeutic proteins (e.g., "when colonized on skin, has a positive effect on skin health", claim 34). The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983). One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications because both O'Neill et al and Whitfill both teach topical application of probiotic bacterium in the form a gel that can be nonaqueous (anhydrous) according to Whitfill.
With respect to claim 35 and the recitation "at least one protector strain of genus Lactobacillus which promotes a colonization of the probiotically active bacteria strain.", while the prior art does not expressly use that exact language, Lactobacillus rhamnosus and Lactobacillus reuteri taught by O'Neill et al are identical to the Lactobacillus rhamnosus and Lactobacillus reuteri that serve as protector strains and therefore Lactobacillus rhamnosus and Lactobacillus reuteri of O'Neill et al would necessarily function as a 'protector strain, which 'promotes a colonization of the probiotically active bacteria strain'. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. V. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicants’ arguments have been fully considered, but are not found persuasive.
Applicants argue that a person of ordinary skill in the art reading Kim would understand polyglyceryl-4 isostearate to serve as an oil component, contributing to the 10-70 wt% oil phase that Kim identifies as essential for base stability and viscosity control and therefore, the Examiner’s mapping of polyglyceryl-4 isostearate to the claimed emulsifier category is improper (Remarks: p. 8)
This is not found persuasive. In response, and with regards to the “emulsifier” limitation of instant claim 19, the prior art teaches the same compound (i.e., polyglyceryl-4 isostearate) as claimed and therefore, the compound's properties are necessarily present; the Examiner directs attention to MPEP 2112.01(II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present”.
Applicants argue that Kim provides no express teaching, preference or motivation that would direct a person of ordinary skill in the art toward polyglyceryl-4 isostearate as Kim’s sole working example employs an entirely different compound class (polysorbate-80) as an emulsifier and jojoba seed oil as its oil (Remarks: p. 8).
This is not found persuasive. In response, the rejection is made under 103 and does not need to exemplify all embodiments, only suggest. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See MPEP 2123.
Applicants argue that claim 19 as amended requires the total concentration of the emulsifiers to range from 0.5 to 6.5 wt% and Kim classifies polyglyceryl-4 isostearate as an oil and that the oil component is present at 10-70 wt%, which does not overlap with the claimed range (Remarks: p. 9).
This is not found persuasive. As such is a new claim limitation, the Examiner addresses such in the above modified 103 rejection (see above rejection for detailed explanation of obviousness).
Applicants argue that Kim and Schmaus are structurally and conceptually completely different, governed by different formulation and considerations (Remarks: p. 10-12).
This is not found persuasive. In response, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, as indicated in the previous Office action, the Examiner maintains the following response: The Examiner disputes that one of ordinary skill in the art would only rely on part of the prior art. Prior art "must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole." In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Applicants state that the Examiner dismissed arguments presented previously about unpredictable results and indicated that the claims do not contain functional language regarding the prevention of phase separation upon water addition (Remarks: p. 13). Then, Applicants argue that the Examiner’s reasoning appears to conflate claim construction with the evaluation of objective indicia of non-obviousness and that courts have consistently held that unexpected properties of a claimed composition – even those not explicitly recited in the claims – are to be considered in the discussion of obviousness (Remarks: p. 13).
This is not found persuasive. The Examiner does not content that unexpected results presented in the specification or in a Declaration can be considered and found persuasive to overcome a 103 rejection. However, in the instant case, the unexpected results argument was not found persuasive. The Examiner maintains her previous response as duplicated below:
Secondly, in response to Applicants’ argument of unexpected results, the Examiner responds with the following statements:
(a) It is noted that Kim teaches that its anhydrous composition can be added to water prior to use [0067] and is assumed to be stable because Kim does not address stability issues upon addition of water. Furthermore, the instant specification states that “for use in the process according to the invention, the composition according to the invention is mixed with water in a weight ratio to water of from 10:90 to 60:40, preferably from 15:85 to 40:60, and in particular preferably from 20:80 to 35:65. During mixing, a homogeneous composition is obtained. The mask composition obtained in this way is advantageously applied to the skin within 10 minutes after mixing.” Such suggests that the stability might not be for very long since the application of the final product (post addition of water) needs to be within 10 minutes of addition of water. However, the data presented merely indicates “The examples which are not in accordance with the invention and the mixtures containing the composition which are not in accordance with the invention (1, 3, 6) showed immediate phase separation. Consequently, these mixtures were unstable. Mixtures of the compositions according to the invention (2, 4, 5) with water were significantly more stable.“
(b) Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims (See MPEP § 716.02(b)-III). In the instant case, the instant specification does not provide any side-by-side comparable data.
(c) Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range (see MPEP § 716.02(d)). See note (a) for what the specification discloses. It is not clear from the data, how long the stability lasts. Of the claimed emulsifiers, data is only presented for polyglyceryl-4 isostearate and polyglyceryl-10 caprylate/caprate and therefore it is not clear if the stability occurs when the emulsifier is the other claimed emulsifiers that are structurally different. Furthermore, does the amount of the emulsifier affect the stability upon addition of water? Such is not clear from the data presented in the specification. In the instant case, the claims are directed to a broad range of components and unlimited concentration ranges whereas the compositions compared in the specification are much more limited (e.g., one data point (concentration) per studied emulsifier).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
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