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 without traverse of Group I, claims 13-16 in the reply filed on January 26, 2026 is acknowledged.
Claims 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 26, 2026.
Claims 15-16 are amended in the response filed January 26, 2026. Claims 1-12 are canceled. Claims 17-18 stand withdrawn.
Claims 13-16 are pending and will be examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 30, 2021 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement filed December 30, 2021 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The transmittal letter indicates copies of the references were supplied in the parent application 15779108. No copy of the office action reference was found within the parent application. That reference was therefore lined through and not considered.
Specification - Objection
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Paragraph 82 within Example 4 includes an embedded hyperlink that refers to the Ion AmpliSeq panel. Correction to remove the hyperlink is requested.
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 13-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a method that includes multiple abstract steps without significantly more. The claim(s) recite(s) a preamble which includes a determination or verification of “a difference in therapeutic effect against kidney cancer according to the gender of a patient with kidney cancer”. The claim also includes steps that include “treating the patient with kidney cancer … with any candidate material” and “choosing any candidate material for treating kidney cancer or any method of treating kidney cancer as a therapeutic candidate material or a therapeutic method”. This judicial exception is not integrated into a practical application because while the claimed method includes the identifying the presence or absence of a gender specific marker before the steps of treatment, the treatment is not specified and the application into a method of treatment is recited at a high level of generality. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because while the gender specific marker and particular mutation is not described within the art, the treatment steps are very general and not described in any specific detail either within the claims or within the specification.
According to the 2019 Revised Patent Subject Matter Eligibility Guidance, an initial two step analysis is required for determining statutory eligibility.
According to the Manual of Patent Examination Procedure (MPEP) sections 2103 through 2106.07(c), which now incorporates the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG), October 2019 Patent Eligibility Guidance Update (October 2019 Update),
and the Berkheimer Memo, an initial two step analysis is required for determining statutory
eligibility.
Step 1 requires a determination of whether the claims are directed to a process, machine,
manufacture, or a composition of matter. In the instant case, the Step 1 requirement is satisfied as
the claims are directed towards a process.
Step 2
The Step 2 analysis is a two-part analysis, Step 2A and Step 2B.
Step 2A. prong 1
Step 2A, prong 1 requires a determination of whether the claims are directed towards a
judicial exception, i.e. a law of nature, natural phenomenon, or an abstract idea, while step 2A, prong 2 requires an analysis of whether the judicial exception integrated into a practical
application if the claim recites a judicial exception under Prong 1.
Step 2A. prong 2
Step 2A, prong 2 requires an analysis of whether the judicial exception integrated into a
practical application if the claim recites a judicial exception under Prong 1.
Step 2B
The second part, Step 2B of the two-step analysis is drawn to determining whether any
element or combination of elements, in the instant claims is/are sufficient to ensure that the
claims as a whole amount to significantly more than the judicial exception.
Following the analysis below the claims are not patent eligible under 35 U.S.C. 101.
Concerning Step 1: YES. Claims 13-16 are directed to methods, therefore the claims are directed to a process, which is a statutory category.
Concerning Step 2A: YES. Claims 13-16 recite methods of treatment of patients with kidney cancer following identification of the presence or absence of a gender specific marker. Claims 13-16 rely on an abstract step to treat the patient with kidney cancer “with any candidate material” or “heal[ing] the patient with kidney cancer using any method. In other words, claims 13-16 rely on a judicially excluded abstract idea associated with a method of treatment, without significantly more.
Concerning Step 2A, prong 1, claims 13-16 are directed towards a judicial
exception, i.e. a law of nature, as noted above. Claims 13-16 recite abstract ideas of comparing and parsing data, as these claims recite step(s) of “a difference in therapeutic effect…according to the gender of a patient” in a manner that could be achieved as a mental step.
The step of treating or healing the patient using any candidate material or any method, falls within the grouping of abstract ideas and as they merely instruct a user to analyze various target sequence(s) (analyze natural law/natural sequences) and to draw a conclusion (i.e. treating a patient/person) is suitable for treatment.
Concerning Step 2A, prong 2, the judicial exception of the abstract step of claims 13-16 are not integrated into a practical application because of the following.
A claim that integrates a judicial exception into a practical application will apply, rely on,
or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial
exception. When the exception is so integrated, then the claim is not directed to a judicial
exception.
Claims 13-16 do not recite steps beyond the recited steps of identifying the presence of a specific marker to determine a patient is suitable for treatment.
Claims 13-16 do not recite steps/elements that are construed to be a practical application that apply, rely on, or use the judicial exceptions. The steps of treatment or healing is not a practical application as this step must be applied to realize the judicial exception(s).
They are also recited with a high level of generality and therefore do not add any meaningful limitation to practicing the natural law and/or abstract idea.
Concerning Step 2B, claims 13-16 do not recite any additional elements that ensure that the claims as a whole amount to significantly more than the judicial exception(s).
The steps of treating or healing a patient with kidney cancer as associated with treatment response constitute well understood, routine, conventional activity.
There is no inventive concept in claims 13-16, besides the presence of the marker within kidney cancer patients and thus they are rejected as being ineligible under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112 – first paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claimed invention is drawn to a method of detecting a gender specific marker within a lung cancer patient and treating or healing using any candidate material for treating of any method for healing kidney cancer.
The specification fails to demonstrate possession of the steps of using any particular candidate materials or any particular methods which can heal or treat kidney cancer based on the detected gender specific marker, as claimed.
While the specification generally teaches the presence of the gender specific marker and the same general methods of treatment or healing, as claimed, the specification does not teach any particular or specific candidate materials for treating kidney cancer or methods for treating kidney cancer.
Legal Analysis
In analysis of the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note regarding genus/species situations that “Satisfactory disclosure of a ``representative number'' depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed.” (See: Federal Register: December 21, 1999 (Volume 64, Number 244), revised guidelines for written description.).
In the instant case, while the specification generally teaches the presence of the gender specific marker and the same general methods of treatment or healing, as claimed, the specification does not teach any particular or specific candidate materials for treating kidney cancer or methods for treating kidney cancer.
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand applicant to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species).
MPEP § 2164(II)(A)(3)(a)(ii). “Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed.” MPEP § 2163.02. In other words, an essential purpose of the written description requirement is to enforce compliance with Applicants’ half of the critical patent trade-off: public disclosure to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.
Conclusion
In the application at the time of filing, there is no record or description which would demonstrate possession of the specific step of the method which broadly requires treating or healing using any candidate material for treating of any method for healing kidney cancer, as claimed. While the specification teaches a variety of gender specific markers and mutations or variants within those gender specific markers, the specification is not particular regarding the treatment or healing steps that are included within the method claims currently recited. Therefore, the claims fail to meet the written description requirement by encompassing method steps which are not properly described in the specification.
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.
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 13-16 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.
Claims 13-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: The preamble of claim 13 recites “A method of providing information required to verify a difference in therapeutic effect against kidney cancer according to the gender of a patient with kidney cancer”; however, there are no steps or limitations which include any comparison or difference in therapeutic effect based on gender or any other measure. Without a step which achieves this difference, the claim is a method of detection of a marker followed by general guidance to treat, not a method which includes a difference in therapeutic effect, as claimed.
Conclusion
No claims are allowed. All claims stand rejected.
While there are references that generally teach the presence of the genes of either ADAM21 or ZNF449 and a general connection with cancer or with kidney or renal cancer, see Lucca et al. (Nature Rev Urol, 2015, 12:585-592), Vasserot et al. (US Patent 10279018; May 2019) and Skog et al. (US PgPub 20140045915; February 2014), there are no references which specifically teach the N265Y mutation within ADAM21 or the F183I mutation within ZNF449. Therefore the claims are free of the art but stand rejected for other reasons as noted above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE KANE MUMMERT whose telephone number is (571)272-8503. The examiner can normally be reached M-F 9:00-5:30.
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681