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 .
Applicant’s preliminary amendment filed 12/29/2023 is acknowledged. Claims 1, 4-7, 9-13 have been amended. Claims 2-3 and 8 have been canceled. Claims 1, 4-7 and 9-13 are pending.
It is noted that the claims 4 and 5 have been amended but do not recite the status identifier “Currently amended”. Applicant is reminded that the status of every claim must be indicated after its claim number by using one of the following status identifiers: (Original), (Currently amended), (Canceled), (Previously presented), (New), (Not entered), (Withdrawn) and (Withdrawn-currently amended).
The claims 1, 4-7 and 9-13 are under examination.
Priority
This application is a 371 of PCT/EP2022/068483 filed 07/04/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/29/2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 12/29/2023. These drawings are found acceptable by the examiner.
Incorporation by Reference
The specification is objected to because the specification contains publications and documents at pages 5, 7-9, 25 that applicants disclose were relied upon to develop the disclosed subject matter that describes the Applicant’s invention. While the documents were properly disclosed on the information disclosure statement filed 12/29/2023, applicant has not properly incorporated the essential subject matter by incorporation by reference.
37 CFR 1.57 states at (c) through (e) the following:
“(c) Except as provided in paragraphs (a) or (b) of this section, an incorporation by reference must be set forth in the specification and must:
(1) Express a clear intent to incorporate by reference by using the root words "incorporat(e)" and "reference" (e.g. , "incorporate by reference"); and
(2) Clearly identify the referenced patent, application, or publication.
(d) "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. "Essential material" is material that is necessary to:
(1) Provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a);
(2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or
(3) Describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f).
(e) Other material ("Nonessential material") may be incorporated by reference to U.S. patents, U.S. patent application publications, foreign patents, foreign published applications, prior and concurrently filed commonly owned U.S. applications, or non-patent publications. An incorporation by reference by hyperlink or other form of browser executable code is not permitted.
37 CFR 1.57 further states at (h) states “An incorporation of material by reference that does not comply with paragraphs (c), (d), or (e) of this section is not effective to incorporate such material unless corrected within any time period set by the Office, but in no case later than the close of prosecution as defined by § 1.114(b), or abandonment of the application, whichever occurs earlier. In addition:
(1) A correction to comply with paragraph (c)(1) of this section is permitted only if the application as filed clearly conveys an intent to incorporate the material by reference. A mere reference to material does not convey an intent to incorporate the material by reference.
(2) A correction to comply with paragraph (c)(2) of this section is only permitted for material that was sufficiently described to uniquely identify the document.
(i) An application transmittal letter limited to the transmittal of a copy of the specification and drawings from a previously filed application submitted under paragraph (a) or (b) of this section may be signed by a juristic applicant or patent owner.
Specification
The disclosure is objected to because of the following informalities:
(a) The disclosure is objected at pages 5, 30-32 and 41-46 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.
(b) The specification contains a typo at page 10, line 32. It is suggested deleting “he” in line 32 and changing it to ---be---.
Appropriate correction is required.
Claim Objections
10. Claim 1 is objected to because of the following informalities:
(a) The gene names in the claim 1 should be spelled out with the abbreviations in parentheses for clarity because the genes may be known by several other names in the scientific literature and databases.
Claim Rejections - 35 USC § 112(b)
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, 4-7 and 9-12 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.
(a) Claims 1, 4-7 and 9-12 are indefinite in the claim 1 because the claim does not provide a clear nexus between the step such that the goal of predicting the survival time for a patient suffering from a renal cell carcinoma and treating the patient is achieved. The claims do not make clear the correlation between determining the expression and identifying a patient having expression levels that are higher than a predetermined reference values as having a shorter survival time because no actual reference points and/or expression level values or limiting definition for “shorter survival time” are recited such that one can clearly conclude that a patient has a shorter survival time or not.
(b) Claims 1, 4-7 and 9-12 are indefinite in the claim 1 at the recitation of “higher than” because the limitation is a relative term of degree, the specification does not provide a limiting definition of the term as it relates to the recited biomarkers and thus the metes and bounds of the limitation is unclear as it relates to administering any type of treatment based on any prediction of survival time.
(c) Claims 1, 4-7, and 9-12 are indefinite in the claims 1 at the recitation of “…biomarkers i) ADAM8, ARHGAP33, BTG3, COL6Al, CYBA, DNAJCI2, DYRK4,FKBP 10, IL34, MTMR7, PADI3, PLAU, RCN3, and TPRG 1, ii) ARHGAP33, BTG3, C4o1f48, CKAP4, CRABP2, CYP3A4, DNAJCl2, DYRK4, EREG, GFPT2, HIST1H1E, KCTD17, KDELR3, MMP14, NCAM1, NME4, PIGZ, PLAU, PLOD2, RGS19, SERPINA3, TBX4, TMEM45A, and TPRG1, and/or iii) BCL3, CFB, COL6A1, CYP3A4, IOSEC3, KCTD17, KRT19, LOXL2, LRG1, PCBP3, SAA1, SAA2, SERPNA3, SOCS3, UCK2, and WT1”. Specifically, the recitation of “and” and “and/or” is confusing because it is unclear if Applicant is suggesting that all or a combination of one or more or a combination of some but not the others is within the scope of interpretation of the claims. The metes and bounds of the limitation(s) are unclear and therefore a clear interpretation cannot be ascertained.
(d) Claims 1, 4-7 and 9-12 are indefinite in the claim 1 at the recitation of “predicting the survival time of a patient suffering from a renal and treating the patient” in the preamble because it cannot be determined from the method steps if the goal of the preamble is achieved; and if so, in what steps it is achieved. Specifically, it cannot be determined if the method is intended to recited a method of treating patients having shorter survival time with an intended step of identifying patients intended to be treated as it relates to the patients surivival or alternatively, if the method is intended to recite a method of predicating the survival time of a patient with an additional treating steps. In either case, a clear interpretation of the claims as currently written cannot be ascertained. While minute details are not required in method claims, at least the basic steps must be recited in a positive, active fashion (see ex parte Erlich, 3 UsPQ2d1011, p.1011 (Bd. Pat, Applicant. Int.1986).
(e) Claim 6 is indefinite at ‘determining if a therapeutic region is appropriate for the patient identified as having a poor prognosis” because the claim does not make clear how one is to determine “if a therapeutic regimen is appropriate” or what constitutes a regimen being “appropriate” given the method step recited therein.
(f) Claim 7 is indefinite at the recitation of “identifying a patient as having a good prognosis and administering the patient a maintenance dose” because metes and bounds of the limitation “good prognosis” as it relates to the patient and administering a treatment. Likewise, it is unclear as to one is encompassed by the limitation “maintenance dose” as it relates to the patient and administering a treat. A clear interpretation cannot be ascertained.
Closest Prior Art
12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
i. Zhao et al (PLoS Med. 3(1):e13, 1-10, January 2006) teach a method of gene expression profiling to predict survival in conventional renal cell carcinoma, the method comprising extracting RNA from a RCC tissue sample, mixing Cy5-labeled total RNA from cRRC sample with Cy3 labeled universal human reference RNA and hybridize to cDNA microarrays by the Stanford functional Genomic Facility that contained over 40,000 cDNA clones representing 27,290 unique UniGene clusters, performing hierarchical clustering analysis wherein genes with highly variable expression were defined as those whose expression was higher or lower by factor of at least three than the average expression of all RCC samples in at least ten samples, performing a two-way (gene-against-samples) average-linkage hierarchical clustering and used TreeView to visualize the results (see pages 0116 – 0117 and 0119). Zhou teaches that the compared the survival times of the five genes expression subgroups using Kaplan-Meier survival analysis and the log-rank test (pages 0116-0117, 0119). Zhou teaches the gene sequence COL12A1 gene in a subgroup of genes expression patterns wherein 5 different subgroups of gene expression profiling for prognostication in RCC and highlights the value of unsupervised analytic methods to provide insights into clinical and biological heterogeneity of RCC (page 0121). While Zhao et al supports RCC gene expression survival prediction with some overlap in scope with the instant invention, the reference does not teach the full claimed combination of method steps as recited in the instant invention.
ii. Guan et al (WO 2019090263, May 2019) teach a method of identifying an individual having a cancer who may benefit from treatment with an anti-cancer therapy comprising an immunotherapy and a suppressive stromal antagonist, the method comprising determining the expression level of three or more of the following genes in a sample from the individual : ACTA2, ADAM19, COMP, CTGF, TGFB1 , or TGFBR2, wherein an expression level of three or more of ACTA2, ADAM1 9, COMP, CTGF, TGFB1 , or TGFBR2 in the sample that is at or above a reference expression level of the three or more genes identifies the individual as one who may benefit from treatment with an anti-cancer therapy comprising an immunotherapy and a suppressive stromal antagonist (see pages 179 – 195). Guan et al teach wherein the method is based on the discovery that expression levels of one or more biomarkers as described therein in a sample form an individual having cancer can be used in methods of identifying an individual having a cancer who may benefit with an anti-cancer therapy that includes an immunotherapy and having a suppressive stromal antagonist, methods for selecting a therapy for an individual having cancer, methods of treating an individual having cancer, methods for assessing a response or monitoring for response of an individual to treatment with an anti-cancer therapy that includes an immunotherapy and a suppressive stromal antagonist (abstract). Guan teaches one gene lysyl oxidase homolog2 as a biomarker associated with diagnostic and therapeutic methods for the treatment of cancer. Guan teaches gene-expression-based treatment selection and immunotherapy administration, but in a different cancer-treatment framework. Even though there is some overlap of teachings of Guan with the claims of the instant invention, the reference does not disclose the full claim combination of method steps as recited in the instant invention.
Conclusion
13. No claims are allowed. However, the claims have not been rejected under prior art.
With regards to analysis under 35 USC 101, the claims 1, 4-7, 9-12 when considered as a whole, were found to comprise elements that amounted to significantly more than the judicial exceptions recited therein and therefore qualifies as eligible subject matter under 35 USC 101.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681
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