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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 05/19/2026 is acknowledged. The traversal is on the ground(s) that the prior art document cited to break unity of invention Korzuschnik (US2007/0299512) discloses coatings for implants in particular stents which are composed of hydrophobic materials such as cholesterol or cholesterol esters and may contain hydrophobic active agents. The coatings are produced by immersing the implant into a solution with chloroform and subsequently drying it to form a hydrophobic film and the aim of the disclosure is to provide a hydrophobic coating structure that controls implant degradation and affects drug release. The process described is a conventional film formation by solvent evaporation not a self-organizing or molecularly oriented assembly. Applicant contrasts this with claim 1 of the present invention relates to a molecular arrangement of amphiphilic molecules that self-organize into ordered layered structures when deposited from a solution in a polar aprotic solvent and having the characteristics of a hydrophobic portion larger than the hydrophilic portion, the solubility in polar aprotic solvents, their spontaneous formation of oriented layers upon solvent removal. Applicant argues that in the resulting structures, the molecules preferentially orient at an interface, for this reason the claim requires that the amphiphilic molecules in the formed layer structure are in contact with an aqueous environment, and therefore not dry.
This is not found persuasive because for several reasons: In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., molecules that self-organize into ordered layered structures when deposited from a solution in a polar aprotic solvent and having the characteristics of a hydrophobic portion larger than the hydrophilic portion, the solubility in polar aprotic solvents, their spontaneous formation of oriented layers upon solvent removal. Applicant argues that in the resulting structures, the molecules preferentially orient at an interface, for this reason the claim requires that the amphiphilic molecules in the formed layer structure are in contact with an aqueous environment, and therefore not dry) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The shared technical feature in the restricted claim groups was identified in the restriction requirement to be a molecular assembly comprising a structural formation of amphiphilic molecules, wherein the amphiphilic molecules are selected from a group containing amphiphilic molecules which a) have a hydrophobic moiety, which is larger than a hydrophilic moiety in relation to the molecular weight, b) are soluble in a polar aprotic solvent and form self-organizing layer structures out of the solution in the absence of the polar aprotic solvent, and c) orient molecularly in formed layer structures by way of an interfacial layer, in an aqueous environment. Only group 1 requires the limitation “wherein the amphiphilic molecules in the formed layer structure are in contact with an aqueous environment”, therefore this is not part of the shared technical feature. Moreover, the claim only requires more than one molecule having properties (a), (b), and (c) noted above to be present in an assembly. As noted in the restriction requirement, cholesterol possesses properties (a), (b), and (c), and reads on at least two cholesterol molecules in an “assembly”. The examiner considers the coating to be an assembly of cholesterol molecules, and therefore a coating of cholesterol as disclosed by Korzuschnik establishes that the shared technical feature is not a special technical feature within the meaning of PCT Rule 13.2. The claims also lack unity of invention because the shared technical feature does not make a contribution over the prior art cited in the rejection of the claims under 35 USC 103.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without traverse of the species cholesterol molecules in the reply filed on 05/19/2026 is also acknowledged.
Claims 10-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/19/2026.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-6, 8, 9, 13, and 14 are under current examination.
Information Disclosure Statement
The information disclosure statement filed 12/03/2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
The information disclosure statement (IDS) submitted on 12/12/2025 is a replica of the 12/03/2025 IDS and was filed with the proper size fee assertion. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 4 is objected to because of the following informalities: claim 4 recites reference numbers “(3)” in lines 3 and 6; however, the reference number in the specification only refers to the phrase “layer structure”, and is therefore redundant. Moreover MPEP 2173.05(s) states in part: Where possible, claims are to be complete in themselves. In this case, the reference number does not add anything to the claim that is not already stated in words. The examiner recommends deleting the “(3)” in both instances to overcome the objection.
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.
Claims 1-6 8, 9, 13, and 14 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 1 recites “a hydrophilic moiety” in line 4. This renders the claim indefinite because it is unclear whether the phrase “a hydrophilic moiety” refers to a portion of the claimed amphiphilic molecule. To overcome the rejection, the examiner recommends amending the claim to recite “wherein the amphiphilic molecules contain a hydrophilic moiety and a hydrophobic moiety and wherein the hydrophobic moiety is larger in molecular weight than the hydrophilic moiety”. This would remove ambiguity as to the antecedent basis of the hydrophilic moiety.
Claim 1 recites “wherein the amphiphilic molecules on one side of the formed layer structure of the molecular assembly are completely wetted with water” This renders the claim indefinite because it is unclear whether an aqueous environment or a layer structure is required by the claim or whether the layer structure described in claim 1 is functional language describing the behavior of the amphiphilic molecules under the conditions of an aqueous environment. Additionally, the antecedent basis of the phrase “the formed layer structure” in line 9 is ambiguous because the limitations of the claim in lines 1-8 do not require a layer structure to be present in the claimed molecular assembly but merely describe how the amphiphilic molecules behave in an aqueous environment.
Claim 4 recites the limitation "formed interfacial layers" in line 3. The antecedent basis for this limitation in the claim is unclear because claim 1 does not clearly require the presence of formed interfacial layers.
Regarding claim 5, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 recites “… retinol molecules are used as amphiphilic molecules” in lines 3-4. The phrase “are used as” implies method steps; however, the claim is directed to a product, “the molecular assembly of claim 1”. Please refer to MPEP 2173.05(p) which indicates that a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). Amending the claim to recites “wherein the amphiphilic molecules are cholesterol molecules, dehydrocholesterol molecules, stigmasterol molecules, cholecalciferol molecules, or retinol molecules” would obviate the rejection.
Regarding claim 9, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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 1-6, 8, 9, 13, and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 1 recites “A molecular assembly comprising a structural formation of amphiphilic molecules, wherein the amphiphilic molecules a) have a hydrophobic moiety, which is larger in molecular weight than a hydrophilic moiety, b) are soluble in a polar aprotic solvent and form self-organizing layer structures out of the solution in the absence of the polar aprotic solvent, and c) orient molecularly in formed layer structures, by way of an interfacial layer, in an aqueous environment, wherein the amphiphilic molecules on one side of the formed layer structure of the molecular assembly are completely wetted with water”. The claim is directed to a molecular assembly, which is a composition of matter and therefore falls within one of the four statutory categories under 35 USC 101. Given the broadest reasonable interpretation in view of the guidelines set forth in MPEP 2111, the claim is interpreted as follows: The phrase “A molecular assembly comprising a structural formation of amphiphilic molecules” reads on two or more of the claimed amphiphilic molecules assembled together in any fashion. The remaining claim language describes the properties of the amphiphilic molecules, and the instant specification indicates that the naturally occurring substance, cholesterol, meets all of the functional requirements recited in the claim. Thus the claim reads on any collection of at least two cholesterol molecules, or simply purified cholesterol molecules, which are attracted to one another due to shared hydrophobicity, and therefore in an assembly. Cholesterol is a naturally occurring substance and therefore the claim reads on a judicial exception. This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not require any further structural elements besides the judicial exception itself.
Dependent claims 2-6, 8, 13, and 14 further limit the identity of the amphiphilic molecule either by structure of by function; however, each of these claims still read on any collection of at least two cholesterol molecules without requiring any further structural elements and therefore embrace patent ineligible subject matter exactly as set forth for instant claim 1.
Claim 9 recites the additional limitation that the molecular assembly also comprise nonamphiphilic molecules in a proportion of up to 99 wt %. Thus claim 9 requires a molecular assembly of cholesterol and non-amphiphilic molecules. Such assemblies exist in many naturally occurring products. For example, “[a]ccording to a recent analysis of sebum, it comprises about 5% squalene, 25% of triglycerides, 20% free unsaturated fatty acids and 10% of free saturated fatty acids. It also contains a small percentage of free cholesterol, usually, from 0.6 to 2.4% and a total cholesterol content of about 2 to 5 %. (See Menda et al. (US 4,000,317; col 6, lines 35-41.) As such, claims 1-6, 8, 9, 13, and 14 each read on the naturally occurring substance, sebum and the claims are directed to a judicial exception. This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not require any further structural elements besides the judicial exception.
Claim Rejections - 35 USC § 102
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.
(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.
Claims 1-6, 8, 9, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Menda et al. (US 4,000,317; issue date: 12/28/1976).
Menda discloses “[a]ccording to a recent analysis of sebum, it comprises about 5% squalene, 25% of triglycerides, 20% free unsaturated fatty acids and 10% of free saturated fatty acids. It also contains a small percentage of free cholesterol, usually, from 0.6 to 2.4% and a total cholesterol content of about 2 to 5 % (col 6, lines 35-41). Sebum falls entirely within the scope of each of claims 1-6, 8, 9, 13, and 14 as follows:
Following the guidelines set forth in MPEP 2111, the claim is interpreted as follows: The phrase “A molecular assembly comprising a structural formation of amphiphilic molecules” reads on two or more amphiphilic molecules assembled together in any fashion. The remaining claim language describes the properties of the amphiphilic molecules, and the instant specification indicates that the naturally occurring substance, cholesterol, meets all of the functional requirements recited in the claim. Thus the claim reads on any collection of at least two cholesterol molecules associated in such a way to be in a molecular assembly. Dependent claims 2-6, 8, 13, and 14 further limit the identity of the amphiphilic molecule either by structure of by function; however, each of these claims still read on any collection of at least two cholesterol molecules without requiring any further structural elements. Thus, given the broadest reasonable interpretation claims 1-6, 8, 13, and 14 read on an assembly of cholesterol molecules and claim 9 requires the presence of non-amphiphilic molecules in an amount of up to 99 wt%. The cholesterol within the sebum falls entirely within the scope of claims 1-6, 8, 13, and 14. Sebum falls within the scope of molecular assembly because the hydrophobic molecules in the substance are all associated with each other via hydrophobic interactions. Sebum contains cholesterol, a molecule having properties (a) - (c) recited in instant claim 1 (see e.g. page 4 of the instant specification), thus sebum is a molecular assembly comprising a structural formation of amphiphilic molecules that the requisite properties recited in claims 1-6, 8, and 13.
With regard to claim 14, this claim requires “at least 10% of the amphiphilic molecules [to be] cholesterol molecules and/or dehydrocholesterol molecules”. The phrase “the amphiphilic molecules” finds antecedent basis in the amphiphilic molecules having properties (a) - (c) delimited in claim 1. although sebum contains other amphiphilic molecules such as fatty acids, the instant specification indicates that substances such as these do not possess property (c), in particular. That is they are not capable of reorienting based upon the polarity of the solvent with which they may be in contact. Thus, in sebum 100 % of “the amphiphilic molecules” limited by the claim are cholesterol.
The examiner also points out that the substance, sebum, is secreted be sebaceous glands and forms a coating over the skin that would become “completely wetted by water” any time a mammal is submerged in water, such as during swimming or bathing. Under these circumstances the functional requirements recited in instant claims 1 and 4 would be realized because this layer contains a molecular film of lipids, including cholesterol.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
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