DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed March 27, 2026. Currently, claims 14, 23-30 are pending.
Election/Restrictions
Applicant's election without traverse of Group I and rs10502560, Claims 14, 23-30 in the paper filed March 27, 2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application is a 371 of PCT/KR2022/005977, filed April 27, 2022 and claims priority to foreign Korea 10/2021/0055764, filed April 29, 2021.
It is noted that a translation of the foreign document has not been received.
Drawings
The drawings are acceptable.
Claim Objections
Claims 29, 30 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 28. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Here, rs10502560 SNP is the only SNP located in the DSC1 gene and also in Tables 1-3. Thus, Claim 28 and 29 are identical in scope.
With respect to Claim 30, SNP rs10502560 is located at chromosome 18 position 28666826 of DSC1. Thus, there is no difference in scope.
Improper Markush Rejection
Claims 14, 23-30 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
A Markush claim contains an “improper Markush grouping” if:
(1) the species of the Markush group do not share a “single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent. See MPEP § 2117.
Here each species is considered to each of the skin turnover and hyper-keratinization SNPs listed in Table 1-3. Table 1 comprises 51 SNPs in different genes, in different regions with different chromosomes. Table 2 is 36 different SNPs. Table 3 is 47 different SNPs.
The recited alternative species in the groups set forth here do not share a single structural similarity, as each different SNP that could be detected is itself located in a separate region of the genome and has its own structure. The genes recited in the instant claims, do not share a single structural similarity since each consists of a different nucleotide sequences with different associations. Table 3 is associated with coarse flakes, Table 2 is gene polymorphism markers associated with desquamation index and Table 1 is SNPs associated with skin turnover. The only structural similarity present is that all detected positions are part of nucleic acid molecules. The fact that the markers comprise nucleotides per se does not support a conclusion that they have a common single structural similarity because the structure of comprising a nucleotide alone is not essential to the common activity of being correlated with skin turnover and hyper keratinization. Accordingly, while the different markers are asserted to have the property of being correlated with skin turnover and hyper keratinization, they do not share a single structural similarity.
MPEP 2117 (II)(A) provides the following guidance as to what constitutes a physical, chemical, or art recognized class:
A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved”
The recited genes do not belong to a recognized chemical class because there is no expectation from the knowledge in the art that the genes will behave in the same manner and can be substituted for one another with the same intended result achieved. In other words, there is no expectation from the knowledge in the art that each of the recited genes would function in the same way in the claimed method; it is only in the context of this specification that it was disclosed that all members of this group may behave in the same way in the context of the claimed invention. Further there is no evidence of record to establish that it is clear from their very nature that each of the recited genes possess the common property of being correlated with skin turnover and hyper keratinization.
MPEP 2117 (II) further states the following:
Where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the compounds do not appear to be members of a recognized physical or chemical class or members of an art-recognized class, the members are considered to share a "single structural similarity" and common use when the alternatively usable compounds share a substantial structural feature that is essential to a common use. Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
The recited alternative species do not share a substantial common structure just because they all have a sugar phosphate backbone. The sugar phosphate backbone of a nucleic acid chain is not considered to be a substantial common structural feature to the group of genes being claimed because it is shared by ALL nucleic acids. Further, the fact that the genes all have a sugar phosphate backbone does not support a conclusion that they have a common single structural similarity because the structure of comprising a sugar phosphate backbone alone is not essential to the asserted common use of being correlated with skin turnover and hyper keratinization.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Following this analysis, the claims are rejected as containing an improper Markush grouping.
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, 23-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II.
Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility.
Question 1
The claimed invention is directed to a process that involves a natural principle and a judicial exception.
Question 2A Prong I
The claims are taken to be directed to an abstract idea, a law of nature and a natural phenomenon.
Claim 14 is directed to “a method for treating skin turnover and hyper-keratinization”.
Claim 14 is directed to a process that involves the judicial exceptions of an abstract idea (i.e. the abstract steps of “prescribing an effective among of skin care product”, “SNPs for determining reduced skin turnover and hyper-keratinization””) and a law of nature/natural phenomenon (i.e. the natural correlation between rs10502560 SNP and skin turnover and hyper-keratinization).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons that follow.
Herein, claim 14 involves the patent-ineligible concept of an abstract process. Claim 14 requires performing the step of “prescribing”. Neither the specification nor the claims set forth a limiting definition for "prescribing” and the claims do not set forth how “prescribing” is accomplished. As broadly recited the prescribing step may be accomplished mentally being told what to do. The plain and ordinary meaning of “prescribing” or “prescribe” in the context of a medical or pharmaceutical field is evidenced by The Pocket Oxford American Dictionary of Current English (“Prescribe,” Oxford University Press, New York: 2002, pp. 623): v. 1.tr. advise the use of (a medicine, etc.), esp. by an authorized prescription. The plain and ordinary meaning of “advise” is: “v. 1. tr. give advice to. 2. tr. recommend. 3 tr. inform; notify.” Id. at 11. Thus, the broadest reasonable interpretation consistent with the specification is that “prescribing” means “to recommend, give advice, inform, or notify (someone) to use a medicine.” This plain and ordinary meaning of prescribing does not require that the prescribing occur in writing and encompasses orally telling an individual in need thereof to take a particular course of action. The plain and ordinary meaning of “prescribing” also does not require that the individual in need thereof do anything other than receive, such as, hear, a recommendation. Prescribing is merely verbal or written instructions to perform a task. It does not require the task is completed. Thus, the prescribing step constitutes an abstract process idea.
The claims also require identifying a SNP that is an effect allele. The step of identifying is a mental step that requires a mere detection. Neither the specification nor the claims set forth a limiting definition for " identifying a SNP that is an effect allele” and the claims do not set forth how “identifying a SNP that is an effect allele” is accomplished. As broadly recited the prescribing step may be accomplished mentally being told what to do.
A correlation that preexists in the human is an unpatentable phenomenon. The association between rs10502560 SNP and skin turnover and hyper-keratinization is a law of nature/natural phenomenon. The recitation in step a) which tells users of the process to amplify a SNP for determining reduced skin turnover and hyper-keratinization, amounts to no more than an "instruction to apply the natural law". This recitation is no more than a mental step. The recitation fails to provide the “practical assurance” sought by the Prometheus Court that the “process is more than a drafting effort designed to monopolize the law of nature itself.”
Question 2A Prong II
The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception. While the claim recites amplifying a SNP, this is not an integration of the exception into a practical application. Instead, this element is data gathering required to perform the method. Thus, the claim is “directed to” the exception.
Even if the “prescribing” is considered to be a step that is not an abstract idea, it does not integrate the abstract diagnosing or the natural phenomenon because it is merely an instruction regarding therapy but does not require the therapy be delivered or administered. Furthermore, the claims do not provide for which patients are prescribed the skin care product. If all subjects are prescribed the skin care product, this is not an integration of a particular treatment. The claim does not specify which patients are treated or only treat a specific patient population based upon their genetic composition.
Accordingly, the claims are directed to judicial exceptions.
Question 2B
The second step of Alice involves determining whether the remaining elements, either in isolation or combination with the other non patent ineligible elements, are sufficient to “’transform the nature of the claim’ into a patent eligible application” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
The claims are not sufficiently defined to provide a method which is significantly more from a statement of a natural principle for at least these reasons:
The claims do not include applying the judicial exception, or by use of, a particular machine. The claims do not tie the steps to a “particular machine" and therefore do not meet the machine or transformation test on these grounds. The use of machines generally does not impose a meaningful limit on claim scope.
The claims also do not add a specific limitation other than what is well-understood, routine and conventional in the field. The amplifying a SNP is mere data gathering step that amounts to extra solution activity to the judicial exception. It merely tells the users of the method to determine the biomarkers of a sample without further specification as to how the sample should be analyzed. The claim does not recite a new, innovative method for such determination. The determining step essentially tells users to determine the markers through whatever known processes they wish to use.
The step of amplifying a SNP was well known in the art at the time the invention was made. The prior art teaches that commercially available biochips and arrays that comprise the claimed SNPs. The rs10502560, elected SNP, is found on the Illumina 450K array. The steps are recited at a high level of generality. The claim merely instructs a scientist to use any amplification method to amplify the SNP. The claim does not require the use of any particular non-conventional reagents. When recited at this high level of generality, there is no meaningful limitation that distinguishes this step from well understood, routine and conventional activities engaged in by scientists prior to applicant’s invention and at the time the application was filed.
Additionally, the teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements were well known.
Further it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)
For these reasons the claims are rejected under section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 112- Second Paragraph
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.
Claims 14, 23-30 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 pre-AIA the applicant regards as the invention.
The claims are indefinite. It is not clear how the recited preamble is intended to breathe life and meaning into the claim. The preamble of Claim 14 is directed to a method for treating skin turnover and hyper-keratinization. However, the claim only provides for prescribing an effective amount of a skin care product. Thus, it is not clear if applicant intends to cover any method prescribing an effective amount of a skin care product, or if the method is intended to somehow require more to accomplish the goal set forth in the preamble. Prescribing a product is not a method of treating. Prescribing only requires telling a patient to do something, it does not require actually treating a patient with a treatment. If the claim requires something more, it is unclear what additional active process step the method requires and it appears that the claims are incomplete. The claims fail to provide any active steps that clearly accomplish the goal set for the by the preamble of the claims. Claims 23-30 are similarly indefinite
The claim refers to tables. Table 1 comprises 51 SNPs in different genes, in different regions with different chromosomes. Table 2 is 36 different SNPs. Table 3 is 47 different SNPs.
MPEP 2173.05(s) states:
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parteFressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
The claim is not complete since an incorporated table cannot be used to define a claim. In this case, listing 15 genes and/or gene products in the claim would not be difficult, and as such the contents of table 1 should be completely put in the claims.
Appropriate correction is required.
The claims are indefinite because it is unclear whether the SNPs are associated with reduced skin turnover AND hyper-keratiniazation or whether the SNPs are associated with one or the other. Applicant elected rs10502560. rs10502560 is only found in Table 1 and not in Table 2 or 3. It is unclear whether rs10502560 is for determining reduced hyper-keratinization or only skin turnover. Clarification is required.
Claims 14, 23-30 are indefinite over the recitation “said patient” because it is unclear which patient is being referred to. The claim does not recite a patient. Claim 14(a) provides obtaining a sample from a “subject”. Step (b) is directed to identifying an effect allele, however does not provide this was in a patient. “Said patient” lacks proper antecedent basis. Furthermore, it is unclear whether the skin care product is prescribed for all patients or only a subset of patients because it is not clear which subject/patient is being referred to.
Claim 30 is directed to the SNP located at chromosome 18, position 28666826 of DSC1 gene. The DSC1 gene does not have 28,666,826 positions. Thus, it is unclear whether the position is relative to the chromosome 18 or the DSC1 gene. Further, positions are relative to a start site. The specification provides no framework or guidance what the recited position is relative to or which version of chromosome 18 is relied upon.
Conclusion
No claims allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hunt et al. (Eur. J. of Human Genetics, Vol. 9, pages 197-203, 2001) teaches analysis of mutations in desmoglein 1 (DSC1) that cause skin disease striate palmoplantar keratoderma. Hunt teaches mutations in the coding region, primers for each of the exons but does not teach intron mutations, such as elected rs10502560.
Cheng et al. (Mol. Cell Biol. Vol. 24, No. 1, pages 154-163, Jan 2004) teaches assessment of splice variant functions of desmolcollin 1 in the skin. Chen teaches extracellular domain of Dsc1 and maybe the cytoplasmic domain that is common to Dsc1a, Dsc1b, and the truncated Dsc1 receptor are necessary and sufficient for normal epidermal development and homeostasis.
King et al. (J. of Investigative Dermatology, Vol. 107, pages 531-538, 1996) teaches the sequence of desmocollin 1 in murine, human and compares the sequences. King teaches DSC1 is a “skin-type” desmosomal cadherin and associated with keratinization.
Humphries (Br. J. of Dermatology, Vol. 139, pages 577-584, 1998) teaches desmoglein expression is reduced in the epidermal in response to all-trans-retinoic acid and SDS.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
April 24, 2026
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