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 .
Priority
The instant application is a national stage entry of PCT/TR2022/050458 (filed on 5/20/2022), which claims foreign priority under 35 U.S.C. 119(a)-(d) based on application TR2021/008431 (filed on 5/21/2021 in Turkey). Certified copy of the foreign priority document is on file.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Information Disclosure Statement
The two information disclosure statement (IDSs) submitted on 1/31/2024 are in compliance with the provisions of 37 C.F.R. 1.97. Accordingly, all references cited in these IDSs have been fully considered.
However, the listing of references in the specification is not a proper IDS. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Thus, unless the references have been cited by the examiner or listed in the submitted IDSs, they have 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.
Claims 1-6 are rejected 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.
Claim 1 requires that the tissue transglutaminase is “configured as a biomarker”, while claims 2 and 5 stipulate that the tissue transglutaminase is “configured as the biomarker together with at least one marker” selected from the recited group. It is unclear what structural or biochemical features the tissue transglutaminase must possess in order to be considered a biomarker, so these claims are deemed indefinite. Claim 4 is also indefinite for depending on claim 1. For the purpose of applying prior art, any form of the tissue transglutaminase is considered suitable to serve as a biomarker.
Claim 3 recites “wherein the endometriosis diagnostic kit is configured for measuring gene and/or protein levels in the isolated endometrial mesenchymal stem cells”, which is confusing because the claim only specifies that the kit comprises “the tissue transglutaminase according to claim 1” as a component but said component is not capable of measuring gene and/or protein levels of itself. In the interest of compact prosecution, claim 3 is interpreted to mean the kit comprises at least one agent that detects and/or measures tissue transglutaminase (i.e., the “tissue transglutaminase” is a tissue transglutaminase detecting agent such as an antibody).
Claim 6 is also indefinite because it requires the gene and protein expression levels of the biomarker to be “configured for detecting a success of drugs used in a treatment”. It cannot be determined what properties are imparted by this recitation.
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 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature and natural phenomenon without significantly more.
The United States Patent and Trademark Office (USPTO) issued a revised guidance for evaluating subject matter eligibility, referred to as “2019 Revised Patent Subject Matter Eligibility Guidance”, which became effective on January 7, 2019 (see 84 Fed. Reg. 50) and updated on October 2019 and July 2024. In the instant application, claims 1-6 recite a law of nature and natural phenomenon. This judicial exception is not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than said judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP 2106:
Step (1). Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A). Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an abstract idea?
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application? Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See Vanda Memo
Applying the judicial exception with, or by use of, a particular machine. See MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP 2106.05(e) and Vanda Memo.
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis in View of the Interim Guidance
The answer to Step (1) is “yes” since the claims are directed to a composition of matter, which is a statutory category.
The answer to Step (2A) is “yes” because the claims are directed to a law of nature and natural phenomenon, specifically a natural product.
Prong 1: Claims 1-2, 4, and 6 are drawn to “A tissue transglutaminase” while claims 3 and 5 are drawn to “An endometriosis diagnostic kit” comprising the tissue transglutaminase of claim 1. Since tissue transglutaminase is found in tissues and organs of animals, the claimed products are considered nature-based products. Applicant’s nature-based products are not found to be markedly different from naturally occurring tissue transglutaminase.
Prong 2: There are no additional elements that integrate the recited judicial exception into a practical application.
The answer to Step (2B) is “no”. The claimed nature-based products are well-understood and conventional in the art as supported by Mansfield et al. (US 2014/0364341 A1). Mansfield et al. teaches biomarkers associated with ovarian cancer, which includes tissue transglutaminase (“TgII” in Table IV; par. [0082]). Mansfield et al. also provides test kits comprising a set of reagents like binding molecules or antibodies for measuring the level of one or more biomarkers in a specimen (claims 1-2, page 13).
The claims as a whole therefore do not qualify as eligible subject matter under 35 U.S.C § 101.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Mansfield et al. (US 2014/0364341 A1).
Mansfield et al. discloses biomarkers, test kits, and methods for predicting the presence, subtype, and stage of ovarian cancer (Abstract; par. [0008]). One of the biomarkers found to be present in a subject’s sample like a tissue sample and associated with ovarian cancer is tissue transglutaminase (“TgII” in Table IV; par. [0082]).
Mansfield et al. reads on the instant application as follows:
Regarding claim 1: the tissue transglutaminase biomarker is the same as “A tissue transglutaminase”.
The instant claim recites “wherein the tissue transglutaminase is configured as a biomarker”. As set forth above (see rejection under 112(b)), this phrase is interpreted to mean that any form of the tissue transglutaminase can be a biomarker.
It is noted that the claim also recites “for a diagnosis of an endometriosis in isolated endometrial mesenchymal stem cells derived from an endometrial biopsy and/or a menstrual blood from endometriosis patients”. This merely states the intended use of the claimed invention and is not considered a limitation. Thus, it does not bear any patentable weight to the claimed product. Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Regarding claims 2, 4, and 6: the instant claims also recite intended uses for the tissue transglutaminase. Accordingly, they are of no significance in determining the novelty of the claimed product.
Regarding claims 3 and 5: the test kits comprising a set of reagents like binding molecules or antibodies for measuring the level of one or more biomarkers in a specimen, such as a reagent for measuring the level of TgII (claims 1-3, page 13) is equivalent to “An endometriosis diagnostic kit” comprising at least one agent that detects and/or measures tissue transglutaminase.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651