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 .
DETAILED ACTION
This action is in response to papers filed December 4, 2025. Applicant’s response to the restriction/election requirement of October 10, 2025 has been entered. Claims 1-41 have been canceled. Claims 42-59 are pending in the application.
Priority
Applicant’s claim for the benefit as a division of prior-filed U.S. Patent Application No. 15/233,184, filed August 10, 2016, which claims the benefit of prior-filed U.S. Provisional Patent Application No. 62/203,142, filed August 10, 2015 under 35 U.S.C. 119(e), is acknowledged.
Election/Restrictions
Applicant's elections with traverse of i) “cosmetic” as the single disclosed species of composition, ii) “water” as the single disclosed species of solvent, iii) “co-emulsifier with HLB value of 1-20” as the single disclosed species of further constituent, iv) “preservative” as the single disclosed species of auxiliary material, v) “nonionic” as the single disclosed species of the nature of the co-emulsifier with HLB value of 1-20, vi) “isopropanol” as the single disclosed species of alcohol solvent, vii) “C12-C22 alkyltrimethylammonium salt of Formula VI” as the single disclosed species of positively-charged molecule, and viii) “chloride” as the single disclosed species of X- are all hereby acknowledged. The Examiner has determined that claims 42, 43, 45, 47-49, 51, and 54-58 read on the elected subject matter.
The traversal is on the ground(s) that “under MPEP §803 (and §803.02 for Markush claims), the burden is on the Examiner to explain how the identified species are distinct and how examining them together would impose a serious search and examination burden”.
This is not found persuasive for the following reasons:
1. As already clearly explained in the restriction/election letter itself, the identified species are distinct and impose a search burden due to their mutually exclusive characteristics.
2. Only a subset of the required species elections are based on Markush claims. However, Applicant has pointed to MPEP 803.02. It is noted that MPEP 803.02 expressly states first that “a Markush claim may include independent and distinct inventions”, so merely because species are presented in a Markush claim does not preclude an election of species; and second that an election of species is proper in the context of a Markush claim “where two or more of the members are so unrelated and diverse that a prior art reference anticipating the claim with respect to one of the members would not render the claim obvious under 35 USC 103 with respect to the other member(s).
3. As an example, consider the Markush group of claim 49. None of the recited members is similar in structure to any other member. There is no common core structure at all. Indeed, without question, the recited elements are so different and unrelated in structure that a prior art reference anticipating the claim with respect to one of the members would not render the claim obvious under 35 USC 103 with respect to the other member(s). Moreover, the other Markush claims also present members with mutually exclusive structures and/or functions. Applicant has not presented any evidence, or even any argument, to the contrary.
Accordingly, claims 44, 46, 50, 52, 53, and 59 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable generic or linking claim. The election of species requirement is still deemed proper, maintained, and is therefore made FINAL.
Applicant timely traversed the restriction (election) requirement in the reply filed on December 4, 2025. Claims 42, 43, 45, 47-49, 51, and 54-58 are under examination.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requisite ingredients. If the invention is a method, the abstract should recite the key requisite active steps.
2. The abstract merely informs the reader in a rather generic and cryptic manner that the invention is “water-based”, and contains a “sugar-based” delivery system together with a co-emulsifier, a positively-charged molecule, and an oil. Water-based compositions are nothing new to the art. Sugar-based delivery systems are nothing new to the art either, even ones that contain emulsifiers, oils, and positively charged molecules. Hence, the rather generic invention described in the abstract is not new to the art, and does not appear to properly inform the reader of the key technical aspects of the invention.
3. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art, e.g. “able to stabilize the substance and reduce its irritation potential”.
4. The abstract contains English grammatical and formatting errors. For example, the phrases “water based” and “sugar based” should be hyphenated. The expressions “The composition is encapsulated to be used” and “The composition is penetrating into the skin” are awkward and even ambiguous (e.g. what does it mean “the composition is encapsulated to be used”).
5. The phrase “the composition is…able to stabilize the substance and reduce its irritation potential” lacks any clear precedent or context identifying what “substance” is specifically being referenced.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 42 and 49 are objected to because of the following:
i) In claim 42, there should be a hyphen between “skin” and “penetrating”; there should be a comma between “penetrating” and “water-based”. There should be a hyphen between “water” and “soluble”, There should be a semicolon rather than a comma between “150 mV” and “wherein”.
ii) Claim 49 first provides that the positively charged molecule is “at least one” selected from the group consisting of those recited, which includes “one or more positively charged quaternary C12-C22 alkyltrimethylammonium salts with Formula (VI)”. In this case, the “one or more” is effectively redundant and should be deleted.
iii) In claim 49, the expression “selected from the group consisting of cosmetically and pharmaceutically compatible carboxylic acid and cosmetically and pharmaceutically compatible sulfonic acid” appear to be in awkward and improper English grammatical format.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 42, 43, 45, 47-49, 51, and 54-58 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 42 is indefinite for the following reasons:
1. Claim 42 provides that the sugar-based vesicles are “made of” the recited elements. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of “made of”. For example, is “made of” equivalent to “comprising”, “consisting essentially of”, or “consisting of”. Or, alternatively, is “made of” even broader in scope than e.g. “comprising” such that the recited elements are constituents of the vesicle itself and also of its medium in which it is contained?
***For examination at this time, “made of” is being broadly interpreted as equivalent to comprising, and that the recited elements can be constituents of the vesicle itself and also of the medium in which it is contained.
2. Claim 42 first provides that the composition as a whole is “water-based”, then provides that the composition comprises “sugar-based vesicles”, then provides for a “solvent”, which can be e.g. water. One of ordinary skill in the art cannot definitively ascertain whether the “solvent” is contained in the vesicle or rather whether the vesicle is contained in the “solvent”. In other words, one of ordinary skill in the art cannot definitively ascertain whether the solvent is a constituent contained within the sugar-based vesicle, or rather is a constituent of the medium in which the sugar-based vesicle is contained, or either one, or both.
Claim 49 is indefinite for the following reasons:
1. Claim 49 is in improper Markush format and thus one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter. Applicant is advised that a proper Markush claim has the general format “selected from the group consisting of A, B, C, and D”, not “selected from the group consisting of A, B which can be X or Y, C which can be chosen from V or W, D, E, and either F or G”.
2. For compound III, claim 49 does not properly define a, b, and c. Claim 49 merely provides that a+b+c =3. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed compound. For example, can a=0, if b=1 and c=2?
3. Claim 49 provides that the positively-charged molecule can be compound IV, as defined, but then slips in the additional limitation “as well as N-(3-ricinylamido)propyl-N-N-dimethyl-N-(2,3-dihydroxypropyl)-ammonium salts”. One of ordinary skill in the art thus cannot make heads or tails of this, and cannot definitively ascertain the metes and bounds of the claimed subject matter.
4. Claim 49, for compound V, provides that “R” represents “honey; hyaluronic acid; xanthan gum; trehalose; a hydrolysate from silk, wheat starch, corn starch, or keratin; and a protein hydrolysate from wheat, rice, soya, or oats”. One of ordinary skill in the art cannot definitively ascertain how “R” can be all of honey, hyaluronic acid, xanthan gum, trehalose, a hydrolysate, and a protein hydrolysate, but in the context of these elements being part of a Markush group, cannot make heads or tails out of the various alternatives (or) of the hydrolysate and the protein hydrolysate.
5. Claim 49, element “f)”, provides for “one or more” positively charged quaternary C12-C22 alkyltrimethylammonium salts with Formula VI. One of ordinary skill in the art cannot definitively ascertain which “one or more” of these compounds are necessarily included within the claimed Markush group.
6. Claim 49 stipulates that X- is “a halide ion or an anion of an organic acid selected from the group consisting of…carboxylic acid and…sulfonic acid”. This appears to be a Markush group within a Markush group and one of ordinary skill in the art cannot make heads or tails out of the metes and bounds of the claimed subject matter.
Claim 54 stipulates in a wherein clause that “a proportion” of the at least one sugar-based emulsifier within the composition “is 1-20 wt%”. However, the claim never discloses what “proportion” of the sugar-based emulsifier within the composition is being referenced, and never discloses what the percentage is relative to. The “proportion” is arbitrary and subjective” and the percentage is based on an unknown variable. For example, of the 100% of the sugar-based emulsifier that is present in the composition, the claim never defines what proportion of this is the percentage specified, and what the percentage is based on. One of ordinary skill in the art is left to randomly guess, e.g. half of the sugar-based emulsifier within the composition is 1-20 wt% of the vesicle shell? Oe what?
Claims 55-58 also disclose that “a proportion” of the element contained in the composition is some specified “percentage” of some unknown variable, and thus suffer from the same indefiniteness issue of claim 54 just discussed.
***For examination at this time, claims 54-58 are being interpreted as an attempt to stipulate that the composition comprises the recited percentage of the constituent element. For example, claim 54 is being interpreted as if the claim stated e.g. “wherein the composition comprises 1-20 wt% of the at least one sugar-based emulsifier”, or e.g. “wherein the at least one sugar-based emulsifier is present in the composition in the amount of 1-20 wt%, based on the total weight of the composition”.
Claim 57 is directed to “the composition according to claim 42”, stipulates in a wherein clause the “proportion” etc., but then further stipulates “depending on the composition”. One of ordinary skill in the art cannot make heads or tails out of the stipulation “depending on the composition”. One of ordinary skill in the art cannot definitively ascertain what “composition” is being claimed, e.g. the composition of claim 42? Some other composition? Moreover, one of ordinary skill in the art cannot definitively ascertain in what manner and to what extent the limitation of claim 57 “depends on”, is controlled by, or somehow varies with “the composition”. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 58 is indefinite for the following reasons:
1. Claim 58, which depends from claim 42, stipulates in a wherein clause that “a proportion of active ingredients within the composition is 1-50 wt%”. Claim 42 discloses that retinol is the active ingredient. One of ordinary skill in the art thus cannot definitively ascertain whether the 1-50 wt% is the amount of retinol only, or rather is the amount of all active ingredients that are present, i.e. retinol + all other actives. Moreover, claim 42 is directed to a composition, not to a method of treatment. Since the disease, disorder, or condition being treated is an unknown, the “active” for that unknown is also an unknown. One of ordinary skill in the art thus also cannot definitively ascertain what compounds are “actives” and which compound is not an “active”. For example, is water an “active” or not an “active”? How about Vitamin C?
2. Claim 58 is also directed to “the composition according to claim 42”, stipulates in a wherein clause the “proportion” etc., but then further stipulates “depending on the composition”. One of ordinary skill in the art cannot make heads or tails out of the stipulation “depending on the composition”. One of ordinary skill in the art cannot definitively ascertain what “composition” is being claimed, e.g. the composition of claim 42? Some other composition? Moreover, one of ordinary skill in the art cannot definitively ascertain in what manner and to what extent the limitation of claim 58 “depends on”, is controlled by, or somehow varies with “the composition”. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 43, 45, 47-49, 51, and 54-58 are (also) indefinite for depending from an indefinite 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 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 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 42, 43, 45, 47-49, 51, and 54-58 are rejected under 35 U.S.C. 103 as being unpatentable over Beyer et al. (U.S. Patent Application Pub. No. 2014/0134221), in view of Murad (Happi [online]; 2012) and El Maghraby et al. (Int. J. Pharm. 2000; 196: 63-74).
Applicant Claims
Applicant’s elected subject matter is directed to a skin-penetrating composition comprising a vesicle comprising an emulsifier comprising an inulin molecule modified by linear C8-C22 alkyl groups, a co-emulsifier comprising a polyoxyethylene molecule consisting of 20 oxyethylene groups esterified with one C8-C22 fatty acid, a positively charged C12-C22-alkyltrimethylammonium salt (of Formula VI); a solvent; and retinol (i.e. vitamin active); wherein the vesicle has a particle size of 50-1000 nm, and a zeta potential of 1-150 mV; and wherein the emulsifier, the co-emulsifier, the positively-charged molecule, the solvent, and the retinol are present in the amounts of 1-20 wt%, 0.1-20 wt%, 0.1-10 wt%, 1-30 wt%, and 1-50 wt%, respectively.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Beyer et al. disclose a skin-penetrating composition comprising a positively-charged vesicle with good adhesion to the skin comprising e.g. phospholipids in which at least one antioxidant is encapsulated therein; wherein said antioxidant can be present in the amount of 0.01-20 wt% and can be e.g. a vitamin, and wherein the lipid vesicle has a particle size of 10-1000 nm and a zeta potential of 1-100 mV, and comprises 5-25 wt% of e.g. inulin lauryl carbamate (i.e. an inulin molecule modified by linear C8-C22 alkyl groups, i.e. a sugar) having a degree of modification most preferably of 0.03-0.15, and 0.1-10 wt% of a positively charged molecule, e.g. C12-C22 alkyltrimethylammonium salt; wherein the composition can further comprise 0.01-10 wt% e.g. polyol (e.g. glycerol, a solvent), and wherein the positive surface charge affords the advantages that it permits stable incorporation of large amounts of lipophilic active in the vesicle, permits good adhesion to the skin surviving several washings, and permits incorporation of the encapsulated lipophilic active in a hydrophilic (e.g. water-based, i.e. water solvent) cosmetic formulation product (abstract; paragraphs 0009, 0010, 0034, 0037-0039, 0041, 0044, 0050, 0054, 0057, 0059, 0067, 0069-0071, 0074, 0081; claims 19-21, 25).
Murad discloses that retinol is a vitamin (i.e. Vitamin A) and a potent antioxidant, and that micro-encapsulated retinol applied to skin can help reduce the appearance of deep wrinkles.
El Maghraby et al. disclose lipid vesicles that penetrate the skin comprising phosphatidylcholine (i.e. phospholipid) and an edge activator such as e.g. 10 wt% TWEEN 80 (i.e. Polysorbate 80, i.e. polyoxyethylene (20) sorbitan monooleate; i.e. a polysorbate consisting of e.g. 20 oxyethylene groups esterified with one C8-C22 fatty acid); wherein the lipid vesicle has a particle size of 133 ± 25 nm, and wherein TWEEN 80 significantly improved the transdermal delivery of estradiol, the model lipophilic drug encapsulated therein (abstract; pages 64, 70, 72).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Beyer et al. do not explicitly disclose that the antioxidant vitamin active is retinol, and that the lipid vesicle further contains 0.1-10 wt% of a polysorbate consisting of e.g. 20 oxyethylene groups esterified with one C8-C22 fatty acid. These deficiencies are cured by the teachings of Murad and El Maghraby et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Beyer et al., Murad, and El Maghraby et al., outlined supra, to devise Applicant's instantly claimed skin penetrating composition.
Beyer et al. disclose a skin penetrating “variant” of a UV protective lipid vesicle carrier with good adhesion to the skin comprising a liposomal carrier system that penetrates the skin comprising e.g. phospholipids in which at least one antioxidant is encapsulated therein; wherein said antioxidant can be present in the amount of 0.01-20 wt% and can be a vitamin, and wherein the lipid vesicle has a particle size of 10-1000 nm. Since anyone of ordinary skill in the art would know that good skin adhesion is the first requisite step to successful skin penetration, since Beyer et al. disclose that their lipid vesicle carrier system affords good skin adhesion surviving several washings, can include e.g. oils and antioxidants, and further provides via the positive surface charge of 1-150 mV the advantages of permitting large amounts of lipophilic actives to be stably encapsulated therein and permits incorporation of the encapsulated lipophilic active in hydrophilic (e.g. water-based) cosmetic and pharmaceutical formulations; since Murad discloses that retinol (i.e. Vitamin A) is a potent antioxidant, and that micro-encapsulated retinol applied to skin can help reduce the appearance of deep wrinkles; and since El Maghraby et al. disclose that liposomal carrier systems comprising e.g. TWEEN 80 (i.e. Polysorbate 80, i.e. polyoxyethylene (20) sorbitan monooleate; i.e. a polysorbate consisting of e.g. 20 oxyethylene groups esterified with one C8-C22 fatty acid) exhibit enhanced penetration of the skin with significantly improved transdermal delivery of the lipophilic drug encapsulated therein (e.g. estradiol) (abstract; pages 64, 70, 72); one of ordinary skill in the art would be motivated to formulate the Beyer et al. skin penetrating “variant” lipid vesicle carrier by combining e.g. inulin lauryl carbamate, a positively charged molecule (e.g. C12-C22 alkyltrimethylammonium salt), TWEEN 80, polyol, and phospholipids, with e.g. 0.01-20 wt% retinol incorporated therein, wherein the composition has a positive surface charge of 1-150 mV; with the reasonable expectation that the resulting composition will adhere to and successfully penetrate the skin, and permit stable incorporation of large amounts of lipophilic retinol oil in the particle and stable incorporation of the particle with encapsulated lipophilic active in water-based cosmetic and pharmaceutical formulations.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
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 at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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