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 the invention of Group I, claims 1-7, in the reply filed on 05/06/2026 is acknowledged. The traversal is on the ground(s) that the inventions are based on a single inventive concept (remarks, pages 5-6). This argument has been fully considered but is not found persuasive because the instant application was filed under US practice, and so the question of whether the inventions share a common inventive concept is not relevant. The relevant questions for US restrictions are whether the inventions are distinct and whether there would be an undue search burden on the Examiner to examine the inventions in one application. These requirements were demonstrated in the Office action of 03/16/2026 (see pages 2-3). Applicant has not demonstrated that the inventions, drawn to two methods comprising entirely different steps and a kit, do not have materially different designs and are not obvious variants of each other. Applicant has not demonstrated that the claimed kit could not possibly be used in any materially different method besides the two recited methods. Applicant has not demonstrated that the inventions share a classification and that searching one of the inventions would necessarily result in a full and complete search of the other inventions.
Accordingly, the requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amendment of 05/06/2026 has been entered. Claims 1-10 are pending in this US patent application. Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 05/06/2026.
Claims 1-7 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed 07/31/2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
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 1-7 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 the limitation "the control" in line 7. There is insufficient antecedent basis for this limitation in the claim, which introduces confusion because it is unclear to which previous limitation “the control” is intended to refer. As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claim 1, rendering it indefinite.
Because claims 2-7 depend from claim 1 and do not provide further clarification of the indefinite language therein, these claims are also indefinite. Therefore, claims 1-7 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted “the control” of claim 1 to read “a control.”
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The statutory categories of invention under 35 U.S.C. 101 are processes, machines, manufactures, and compositions of matter. However, certain members of these categories constitute judicial exceptions, i.e., the courts have determined that these entities are not patentable subject matter. These judicial exceptions include abstract ideas, laws of nature, and natural phenomena. The Office released guidance on January 7, 2019 for the examination of claims reciting natural products under 35 U.S.C. 101 in light of the recent Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics, Inc. (569 U.S. ___, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013)) and Mayo Collaborative Services v. Prometheus Laboratories (566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012)). This guidance indicates that claims must pass an eligibility test to avoid rejection under 35 U.S.C. 101. Under this test, the product must (a) not be directed to a judicial exception or must (b) contain additional elements that amount to significantly more than the judicial exception itself.
‘Directed to a judicial exception’ analysis:
Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Non-limiting examples of characteristics that can determine the presence of a marked difference include biological or pharmacological functions or activities; chemical and physical properties; phenotype, including functional and structural characteristics; and structure and form, whether chemical, genetic, or physical.
Claim 1 recites a method of measuring the level of one or more of SPDEF, ARG2, and AEBP1 in a sample from a subject, comparing the measured level with the level in a control sample, and determining the patient to have extramammary Paget disease when the levels of the biomarker proteins are higher in the patient sample than in the control sample. The comparing step represents an abstract idea, and determination step represents an abstract idea and a natural correlation (the connection between protein levels in the sample and the presence of extramammary Paget disease). As such, claim 1 and its dependent claims recite judicial exceptions.
Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 1 recites a step of measuring biomarker levels in a patient sample at a high level of generality, which constitutes insignificant extra-solution activity and does not integrate the judicial exception into a practical application. Claim 1 further recites a step of determining that a patient has extramammary Paget disease when the patient has certain biomarker levels and then a step of administering an agent for preventing or treating extramammary Paget disease to a subject determined to have extramammary Paget disease. These steps both contain conditional elements: not all patients whose samples are tested in the instantly recited method will have extramammary Paget disease, and so not all iterations of the instantly recited method will involve the administration of a treatment. In addition, the treatment administered (“an agent for preventing or treating extramammary Paget disease”) is recited at a sufficiently high level of generality that it does not constitute a particular treatment or prophylaxis that represents the integration of the judicial exceptions into a practical application. As such, claim 1 does not integrate the judicial exceptions into a practical application.
Claims 4-5 recite steps of administering agents for treating particular types of extramammary Paget disease to subjects. However, the treatment administered (“an agent for preventing or treating” the particular type of extramammary Paget disease) is recited at a sufficiently high level of generality that it does not constitute a particular treatment or prophylaxis that represents the integration of the judicial exceptions into a practical application. As such, claims 4-5 do not integrate the judicial exceptions into a practical application.
Claims 2-3 and 6-7 recite limitations of the type of sample taken or the type of extramammary Paget’s disease, which represent insignificant extra-solution activity that is required for the determination of the judicial exception. As such, claims 2-3 and 6-7 do not integrate the judicial exceptions into a practical application.
‘Significantly more’ analysis:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because all of the steps of the instantly recited method are recited at such a high level of generality that they are necessarily well-understood, routine, and conventional—steps of measuring protein levels and administering drugs are well-understood in the art.
Therefore, claims 1-7 are directed to subject matter that is not patent-eligible and are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
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 nonobviousness.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al., Cell Res. 30: 854-872 (2020).
Song teaches that Paget cells are the primary pathognomonic feature of mammary/extramammary Paget disease (see entire document, including page 854, left column, paragraph 1). Differential gene expression analysis showed that the transcription factor SPDEF was uniquely expressed in Paget cells, suggesting the identification of novel marker genes for Paget cells (page 855, right column, paragraph 4, to page 857, left column, paragraph 1; cf. claims 1-3 and 5). Extramammary Paget disease patients were administered topical rapamycin, which alleviated symptoms in the patients (page 864, right column, paragraph 2; cf. claims 1 and 5). The Paget cell and normal cell samples were obtained from surgical excision of skin tissue from human extramammary Paget disease patients (page 868, left column, paragraph 4; cf. claim 6).
However, Song does not explicitly teach using SPDEF as a diagnostic biomarker for extramammary Paget disease or its particular forms.
While Song does not explicitly teach using SPDEF as a diagnostic biomarker for extramammary Paget disease or any of the particular forms of the disease recited in claims 2-3 and 5, it would have been obvious to one of ordinary skill in the art to do so because Song teaches that SPDEF is uniquely expressed in Paget cells as compared with normal skin cells, suggesting that it is a novel marker gene for Paget cells. One of ordinary skill in the art would have a reasonable expectation that using SPDEF as a marker gene for Paget cells would successfully result in the identification of Paget cells in patients with skin lesions.
Therefore, claims 1-3 and 5-6 are rendered obvious by Song and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 07/14/2026
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