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 in the reply filed on 6/16/2026 is acknowledged.
Claims 1-15 are pending. Claims 8-15 are withdrawn as being drawn to nonelected invention.
An action on the merits for claims 1-7 is set forth below.
Claim Objections
Claims 1-7 are objected to because of the following informalities: Claim 1 should be amended such that the first word of the steps are lowercase. Further the term “ORF” should be spelled out for clarity. Claims 2-7 are objected to as being depended from claim 1. Appropriate correction is required.
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.
Claims 1-7 are indefinite over the steps of claim 1. The preamble of the claim is drawn to “responder or non-responder” however there is not step for determining non-responder.
Claims 1-7 are indefinite over step b of claim 1. Regarding claim 1, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 2 recites both “preferably” and “such as” and “most preferably. These phrases render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 3 recite both “preferably” and “such as”. These phrases render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 4 recite both “preferably”. These phrases render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 recite “such as”. This phrase renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 5 contains the trademark/trade name rogaratinib and Debio 1347 Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe inhibitor and, accordingly, the identification/description is indefinite.
Claim 7 recite both “preferably”. These phrases render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 natural correlation without significantly more. The claim(s) recite(s) a judicial exception of correlation of response of FGFR1 inhibitor and an alteration in the FGFR1 gene. This judicial exception is not integrated into a practical application because the claims require steps providing a sample and determining the presence or absence of an alteration and 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 natural correlation, wherein the step of comparing 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 art (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 alteration of FGFR1 and response to inhibitor therapy is considered a natural correlation. The step of providing a sample, determining the alteration are considered a routine and conventional step.
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 obtaining sample and determining presence or absence. Hambleton et al. (US Patent Application Publication 2016/0067307 March 10, 2016) teaches providing a biological sample (para 24-26 and 68). Hambleton et al. teaches the determination of presence or absence of a fusion alterations (e.g. chromosomal break) of the FGFR1 gene (para 108-111).
Further, the steps are recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g. mere data gathering steps necessary to determine response. The steps of providing a sample and determining alteration presence, merely instructs the scientists to use any method known in the art to assess the correlation between the expression level and the presence of response. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional machine or transformation of a particular article, in these steps that distinguish them from well-understood, routine and conventional data gathering activity engaged in by scientists prior to applicant’s invention and at the time the application was filed.
For those reasons, claims 1-7 are rejected under section 101 as being directed to non-statutory subject matter.
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.
Claim(s) 1-4, 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hambleton et al. (US Patent Application Publication 2016/0067307 March 10, 2016).
With regard to claims 1 and 6-7, Hambleton et al. teaches providing a biological sample (para 24-26 and 68). Hambleton et al. teaches the determination of presence or absence of a fusion alteration (e.g. chromosomal break) of the FGFR1 gene (para 108-111). It is noted that the recitation of BFB-like appears to be optional. With regard to the wherein clause, the clause only requires an association when there is a presence. As such Hambleton et al. teaches presence or absence. Furhtermore the wherein clause appears to be the intended result of detection of an alteration.
With regard to claims 2-3 Hambleton et al. teaches a method wherein the cancer is NSCLC (para 222).
With regard to claim 4, Hambleton et al. teaches a biological sample that is a tumor biopsy (para 66-68).
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 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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hambleton et al. (US Patent Application Publication 2016/0067307 March 10, 2016) in view of Borad et al. (US Patent Application Publication 2016/0038492 February 11, 2016).
Hambleton et al. teaches providing a biological sample (para 24-26 and 68). Hambleton et al. teaches the determination of presence or absence of a fusion alterations (e.g. chromosomal break) of the FGFR1 gene (para 108-111). It is noted that the recitation of BFB-like appears to be optional. With regard to the wherein clause, the clause only requires an association when there is a presence. As such Hambleton et al. teaches presence or absence. Furhtermore the wherein clause appears to be the intended result of detection of an alteration.
Hambleton et al. teaches an FGFR1 inhibitor (para 120-124) but does not teaches the inhibitors listed in claim 5.
With regard to claim 5, Borad et al. teaches a method of treating that includes FGFR inhibitor that is ponatinib (para 25).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Hambleton et al. to use one of the finite numbers of FGFR1 treatments including ponatinib as taught by Borad et al. The ordinary artisan would be motivated to modify the method by including one of the known FGFR1 treatments as these inhibitors encompass one of the finite numbers of FGFR1 inhibitors which are known to treat.
Conclusion
No claims are allowed.
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.
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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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