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 .
This action is in response to papers filed 6/03/2026.
Applicant’s election of Group I and the species of IFIT, CSK, SLC39A11 in the reply filed on 12/05/2025 is acknowledged. Because applicants did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-19 are pending. Claims 2-4, 6-7 and 11-18 are withdrawn as being drawn to nonelected species or invention. Claims 20-22 have been cancelled.
The following rejections for claims 1, 5, 8-10, and 19 are newly applied or modified with response to arguments. These rejections are necessitated by amendment.
Withdrawn Objections and Rejections
The objection to claim 22 made in the previous office action is withdrawn based upon cancellation of the claim.
The 35 USC 112b and 35 USC 102 rejections made in the previous office action are withdrawn based upon amendments to the claims.
Modified Claim Rejections - 35 USC § 112
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 1, 5, 8-10, and 19 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 claims are drawn to a method predicting response of a prostate cancer subject comprising determining a gene expression profile of IFIT, CSK, SLC39A11 and determining prediction of prediction of the therapy response and/or the personalization therapy based on the gene expression profile. The specification has not provided a description of any gene expression and any response.
In analyzing whether the written description requirement is met for genus claims, it is first determined whether a representative number of species have been described by their complete structure.
The specification appears to be asserting expressions of IFIT, CSK and SLC39A11. The specification uses these genes and expression levels in particular functional algorithms (p. 34-35). The specification does not provide any description of using these expression levels to determine any treatment or any personalized therapy. The specification has not provided which expression levels are associated with these treatments or personalized therapy.
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: 'Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.) In the instant case, the specification fails to teach the necessary common attributes or features of the samples and controls consistently in view of the species disclosed. As such, one of skill in the art would not recognize that applicant was in possession of the prediction of treatment
Response to Arguments
It is noted that some of the issues set forth in the rejection have been overcome. The reply asserts that the claims have been amended to human prostate cancer and comprising prostate tissue or blood (p. 10). However, the claim amendments do not address the issue with regard to any expression and determining therapy as set forth above.
Newly Applied 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, 5, 8-10, and 19 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 1, 5, 8-10, and 19 are vague, unclear and appear incomplete over A in claim 1. In particular it is not clear what prediction of response to therapy is being received as the wherein clause is only requiring “obtaining” expression. As such it is not clear how the prediction is being determined as it appears that it is based upon unrecited data analysis. Further, the claims are drawn to “personalization” which appears to be related to individual determinations of therapy. However, the claims do not provide how the obtaining expression is being personalized. Further, it appears unclear how the treatment is performed based upon step A.
The wherein clauses are drawn to “a positive” or “a negative” response to the therapy, however, step A does not require a determination of a positive or negative response.
With regard to “radiotherapy provided earlier than is standard” in claim 1. However, it is not clear the metes and bounds of the term “standard”. It does not appear to be specific radiotherapy that would be standard, as there are numerous factors that would affect dose, including stage and type of prostate cancer.
With regard to “radiotherapy with an increased radiation dose” in claim 1. The term increased radiation” in claim 1 is a relative term which renders the claim indefinite. The term “increased radiation” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As there is no radiation dose that is performed, it is not clear which radiotherapy is increased.
Maintained Claim Rejections - 35 USC § 112
Claims 1, 5, 8-10, and 19 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.
The Markush grouping of one or more of the genes in each of ai-av listed is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The recited alternative species in the groups set forth here do not share a single structural similarity, as each method relies on detection of different biomarker positions. Each biomarker that could be detected is itself located in a separate region of the genome and has its own structure. The nature of genes is that they are differences within a population. The only structural similarity present is that all detected positions are part the nucleic acid structure. 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 treatment. For example, the biomarker AIM2 has a distinct chemical structure as compared to, for example, APOBEC3A since the gene can only be understood within the context of the nucleotides, which are structurally dissimilar. Accordingly, while the different markers are asserted to have the property of being indicative of treatment, they do not share a single structural similarity. Nor is the functionality is clear from the very nature of the biomarkers.
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.
Response to Arguments
The reply traverses the rejection. A summary of the arguments made in the reply is summarized below with response to arguments following. The reply asserts that the genes belong to highly characterized art recognized biological pathways (p. 11). This arguetmsn has been reviewed but have not been found persuasive. Although Groups I and II are part of pathways, group 3 is based upon genes that are statistically correlated with PDE4D7 in prostate cancer (p. 11). Therefore the genes are not described as having a structural similarity from “their very nature”. The genes would have to first be detection to be correlated to PDE4D7 in prostate cancer, which would involve lab determinations.
Modified 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, 5, 8-10, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation and abstract ideas without significantly more. The claim(s) recite(s) a judicial exception of abstract step of recitive a prediction or a personalization of therapy. This judicial exception is not integrated into a practical application because the claims require steps of determining expression does not provide a step to integrate the judicial exception. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not integrate the judicial exception to steps that are not considered routine and conventional steps.
These judicial exceptions are not integrated into a practical application because the claims only recite the abstract ideas and routine and convention steps, wherein the routine and convention steps does not integrate the judicial expectation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps are considered general and routine knowledge in the prior art as exemplified by the prior (as discussed below).
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, a natural phenomenon.
The correlation of expression and determining prediction of therapy or personalization therapy is considered a natural correlation. The step of treating in the sample are considered a routine and conventional step as detailed below that encompass general treatments of prostate cancer.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as the steps require only routine and convention steps and does not integrate the judicial exception to a practical application.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No as the claims do not require any elements that integrate the judicial exception.
The steps that are not considered judicial expectations are the steps of treating as it is not clear how the judicial expectation of prediction or personalization is integrated into the step of treating.
McClelland et al. (US Patent Application Publication 2011/0236903 September 29,2011) teaches a method of obtaining expression levels of IFIT1, CSK and SLC39A11 in a sample (Table 42, para 3780-382). McClelland et al. teaches that these expression levels can be used for therapy determinations (para 380-385). McClelland et al. teaches that the samples are from patients that have not had treatment for prostate cancer as they do not have prostate cancer (para 7-8). McClelland et al. teaches that the therapy is radical radiation therapy (para 572).
The dependent claims of 8-10,19 only limit the claims to naturally occurring genes, conventional samples that are taught by McClelland et al. or limit the correlation which is considered the judicial exception.
The dependent claim of 5 does not provide more than adding clinical parameters that can be considered conventional knowledge of the patient (for example medical history).
These methods are considered generic recitations of general methods of expression determination that do not overcome the rejection.
Response to Arguments
The reply traverses the rejection. A summary of the arguments made in the reply is summarized below with response to arguments following. The reply asserts that the method is a medical treatment that integrates the judicial exception into a practical application (p. 11). The reply asserts that “Vanda standard” provides exception to treat a specific medical condition or disease (p. 12). The reply asserts that the claims recites a physical active step of treating that is conditional upon the prediction (p. 12-13).
These arguetmsn have been reviewed but have not been found persuasive.
First it is noted that the treatment is not a specific treatment but treating with a high level of generality. For example, the claims read upon any therapy that is not radiation, or providing radiotherapy earlier than standard. Furthermore the repose positions to the wherein clauses of positive and negative response, however, the claims do not require a step for determination of such responses. As noted above the amendment to the claims encompass an abstract step for A and therefore the claims only require a general steps of treating for step b. As such the judicial expectation is not integrated.
Maintained Claim Rejections - 35 USC § 103
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 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.
This application is currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 5, 8-10, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over McClelland et al. (US Patent Application Publication 2011/0236903 September 29,2011) in view of Hoffmann et al. (US Patent Application 20170073778 March 16, 2017)
With regard to claim 1, McClelland et al. teaches a method of obtaining expression levels of IFIT1, CSK and SLC39A11 in a sample (Table 42, para 3780-382). McClelland et al. teaches that these expression levels can be used for therapy determinations (para 380-385). McClelland et al. teaches that these expression levels can be used for determination and treatment (para 380-385). McClelland et al. teaches that the therapy is radical radiation therapy (para 572). Therefore, McClelland does suggest treatment of radiotherapy and expression screening, but does not teach radical or salvage radiotherapy.
With regard to claim 5, McClelland et al. teaches a method of measuring clinical parameters for therapy determinations (para 145, 192-195).
With regard to claim 8, McClelland et al. teaches that the samples are from patients that have not had treatment for prostate cancer as they do not have prostate cancer (para 7-8).
With regard to claim 9, McClelland et al. teaches that the therapy is radical radiation therapy (para 572).
With regard to claim 10, McClelland et al. teaches associations with therapy, as it is not clear the metes and bounds of the term “positive” McClelland et al. suggests an association that can be considered positive with a therapy recommendation (para 380-385).
With regard to claim 19, McClelland et al. teaches a method of obtaining expression levels of IFIT1, CSK and SLC39A11 in a sample (Table 42, para 3780-382).
With regard to claim 1, Hoffmann et al teaches that salvage radiation therapy associated with gene expression can be detected (para 19, 45, 159 and 171).
Therefore, it would be prima facie obvious at the time of the effective filing date to modify the method of McClelland et al. to screen other known radiotherapy methods such as savage radiation therapy to determine gene expression correlations. The ordinary artisan would have a reasonable expectation as Hoffman et all teaches that salvage radiation therapy has an effect on gene expression, in general. As such one would be motivated to determine if the gene expression measured in McClelland radiotherapy includes salvage radiotherapy associations.
Response to Arguments
The reply traverses the rejection. A summary of the arguments made in the reply is summarized below with response to arguments following. The reply asserts that the genes of CSK and IFIT1 are listed in table 29 and 8B and that the specification of McClelland do not tie the tables of genes together (p. 14). It is noted that McClelland does teach obtaining expressions, as noted in the 35 USC 112b it is not clear the metes and bounds of “receiving …”. It is noted that the step can be interpreted as data print out. As such the step of treating appears to be the required active step. As the wherein claims are drawn to positive and negative responses which are not recited in the claims, the teaching of expression of the genes and treating encompasses the breadth of the claims.
Modified Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1,5,8-10,19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 18-20 of copending Application No. 18271793 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim steps both are drawn to expression of the same genes and determination of prediction of therapy. Although the applications differ in the type of cancer for the subject, the type of cancer does not limit the steps of the claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1,5,8-10,19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-10 of copending Application No. 18022565 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claim steps both are drawn to expression of the same genes and determination of prediction of therapy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
No arguetmsn have been provided and as such the rejections are maintained.
Conclusion
No claims are allowed.
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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, Wu Cheng (Winston) Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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