DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 3-5, 8-9, 11-12, 21, 35-36, 59, 61, 76, and 83-88 are under examination.
Claim Rejections - 35 USC § 112
2. 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, 3-5, 8-9, 11-12, 21, 35-36, 59, 61, 76, and 83-88 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.
Regarding claims 1, 3, 4, and 76, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Dependent claims 5, 8-9, 11-12, 21, 35-36, 59, 61, and 83-88 are also rejected for depending from claims 1, 3, 4, or 76.
Claim Rejections - 35 USC § 101
3. 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, 3-5, 8-9, 11-12, 21, 35-36, 59, 61, 76, and 83-88 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
4. Instant claim 1 recites a step of “responsive to an increased value of responder status, e.g. compared to a reference value of responder status, administering to the subject the therapy.” As written, the step of administering to the subject the therapy is contingent on an increase value of responder status. The MPEP §2111.04 (II) states “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.“ Since the step of administering to the subject the therapy is written as a contingent limitation, the step of administering the therapy is not required.
5. Claims 1, 5, 8, 9, 11, 12, 35, 36, 59, and 61 are directed to method of selecting a therapy. As described in Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S._, 134 S. Cr. 2347, 110 U.S.P.Q.2d 1976 (2014), a two-step analysis is required in considering the patent eligibility of the claimed subject matter. The first step requires determining if the claimed subject matter is directed to a judicial exception. The instant claims require the steps of comparing values to a reference value and selecting a therapy. These steps are mental steps, which are a judicial exception. Dependent claims 5, 8, 9, 11, 12, 35, 36, 59, and 61 are drawn to the type of data to be used in the judicial exception. Thus, the instant claims are drawn to a judicial exception.
This judicial exception is not integrated into a practical application. The instant claims do not recite an element that reflects an improvement in the functioning of a computer or other technology, an element that applies the judicial exception to effect a particular treatment, an element that implements the judicial exception with a particular machine, or an element that effects a transformation of a particular article to a different state or thing. The instant claims recite acquiring the value of responder status for a subject. However, this is an extra solution data gathering step. Extra solution data gathering steps are not sufficient to integrate the judicial exception into a practical application.
The second part of the analysis requires determining if the claims include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant claims recite the additional elements of acquiring the value of responder status to a therapy. However, this element is a well-understood, conventional, and routine data gathering step (MPEP §2106.05(d)(II)). Reciting such well-understood, routine, and conventional elements do not transform a judicial exception into patent eligible subject matter. In addition, the recitation of specific types of data, to be used in the judicial exception does not transform the abstract idea into a non-abstract idea. (See buySAFE, Inc. v Google, Inc. 765 F.3d 1350, 112 U.S.P.Q.2d 1093 (Fed.Cir.2014)). Furthermore, the elements taken as a combination are also well-understood, routine, and conventional, since the elements are merely specifying the types of data for a data gathering step. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
6. Claims 3, 4, 76, and 83-88 are directed to method of selecting a therapy or evaluating a subject. As described in Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S._, 134 S. Cr. 2347, 110 U.S.P.Q.2d 1976 (2014), a two-step analysis is required in considering the patent eligibility of the claimed subject matter. The first step requires determining if the claimed subject matter is directed to a judicial exception. The instant claims require the steps of comparing values to a reference value, identifying a responder, selecting a therapy, and evaluating a subject. These steps are mental steps, which are a judicial exception. Dependent claims 83-88 are drawn to the type of data to be used in the judicial exception. Thus, the instant claims are drawn to a judicial exception.
This judicial exception is not integrated into a practical application. The instant claims do not recite an element that reflects an improvement in the functioning of a computer or other technology, an element that applies the judicial exception to effect a particular treatment, an element that implements the judicial exception with a particular machine, or an element that effects a transformation of a particular article to a different state or thing. The instant claims recite acquiring the value of responder status for a subject. However, this is an extra solution data gathering step. Extra solution data gathering steps are not sufficient to integrate the judicial exception into a practical application. The instant claims also recite a system, memory and processor. However, the claims do not recite structural limitations of the system, memory and processor. Thus, the claims do not recite a particular machine and do not integrate the judicial exception into a practical application.
The second part of the analysis requires determining if the claims include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant claims recite the additional elements of acquiring the value of responder status to a therapy. However, this element is a well-understood, conventional, and routine data gathering step (MPEP §2106.05(d)(II)). In addition, the instant claims recite elements of a processor, system and memory. However, these elements are well-understood, conventional, and routine components of a computer (MPEP §2106.05(d)(II)). Reciting such well-understood, routine, and conventional elements do not transform a judicial exception into patent eligible subject matter. In addition, the recitation of specific types of data, to be used in the judicial exception does not transform the abstract idea into a non-abstract idea. (See buySAFE, Inc. v Google, Inc. 765 F.3d 1350, 112 U.S.P.Q.2d 1093 (Fed.Cir.2014)). Furthermore, the elements taken as a combination are also well-understood, routine, and conventional, since the elements are merely specifying the types of data for a data gathering step and a general computer for implementing the judicial exception. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 102
7. 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 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.
8. Claims 1, 3, 4, 8-9, 21, 59, 61, and 76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chan et al. (WO 2015/103037 A2).
Regarding claim 1, Chan et al. discloses a method of treating a subject having a melanoma, the method comprising: (a) acquiring a value of responder status to a therapy comprising an inhibitor of PD-1 or PDL1 for the subject (paragraphs [5], [95], and [23]), wherein said value of responder status comprises a measure of the tumor mutational burden (TMB) in a melanoma sample, or a sample derived from the melanoma, from the subject (paragraphs [94] and [123]); and (b) responsive to an increased value of responder status compared to a reference value of responder status (paragraph [94]), administering to the subject the therapy, thereby treating the subject (paragraph [101], [95] , and [122]).
Regarding claim 3, Chan et al. discloses a method of selecting a therapy comprising an inhibitor of PD-1 or PD-L1 for a subject having a melanoma (paragraphs [21], [95], [122]), the method comprising: acquiring a value of responder status to the therapy for the subject, wherein said value of responder status comprises a measure of the tumor mutational burden in a melanoma sample, or a sample derived from the melanoma, from the subject and wherein an increased value of responder status compared to a reference value of responder status, indicates that said subject is, or is likely to be, a responder, or said subject will respond, or will likely respond, to the therapy (paragraphs [123], [94], [132]), thereby selecting the therapy (paragraph [21]).
Regarding claim 4, Chan et al. discloses a method of evaluating a subject having a melanoma (paragraphs [15] and [122]) the method comprising: (a) acquiring a value of responder status to a therapy comprising an inhibitor of PD-1 or PD-L1 for the subject (paragraphs [101] and [95]), wherein said value of responder status comprises a measure of the tumor mutational burden in a melanoma sample from the subject (paragraphs [123] and [132]) and (b) identifying the subject as a responder, a complete responder, a partial responder, or a non-responder to the therapy, wherein a value of responder status equal to or greater than a reference value of responder status indicates that said subject is a responder to the therapy; or wherein a value of responder status less than a reference value of responder status indicates that said subject is a non-responder, thereby evaluating the subject (paragraph [94] and [132]).
Regarding claim 8, Chan et al. teach where the reference value of responder status is a value of responder status for a non-responder in therapy (paragraph [94]).
Regarding claim 9, Chan et al. discloses that the therapy is administered to the subject, responsive to an increased level of tumor mutational burden in the sample from the subject, compared to a reference level of tumor mutational burden (paragraphs [123, [94], and [132]).
Regarding claim 21, Chan et al. discloses administering an altered dose of the therapy to the subject (paragraphs [103]).
Regarding claim 59, Chan et that the inhibitor of PD-1 is the anti-PD-1 antibody pembrolizumab (paragraph [95]).
Regarding claim 61, Chan et that the inhibitor of PD-L1 is the anti-PD-L1 antibody (paragraph [95])
Regarding claim 76, Chan et al. teaches a system for evaluating a subject having a melanoma (abstract, paragraph [23]), comprising: (a) acquire a value of responder status to a therapy comprising an inhibitor of PD-1 or PD-L1 for the subject (paragraphs [15] and [95]) wherein said value of responder status comprises a measure of the tumor mutational burden in a melanoma sample, or a sample derived from the melanoma, from the subject (paragraphs [126], [129], [94], [123]); (b) identify the subject as a responder a complete responder, a partial responder, or non-responder to the therapy, wherein a value of responder status equal to or greater than a reference value of responder status indicates that said subject is, or is likely to be, a responder, or will respond, or will likely respond, to the therapy; or wherein a value of responder status less than a reference value of responder status indicates that said subject is, or is likely to be, a non-responder, or will not respond, or will not likely respond, to the therapy, thereby evaluating the subject (paragraph [94] and [62]). Furthermore, Chan et al. teach utilizing computer programs to calculate their method (paragraph [32], [62], [137], and [156]), which would require a computer with a processor connected to a memory.
Claim Rejections - 35 USC § 103
9. 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 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.
10. Claims 5, 11, 12, 35, 36, 83-88 are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al. (WO 2015/103037 A2) as applied to claims 1-4, 9, 21, 49, 51, 59, and 76 above, and further in view of Rizvi et al (“Mutational Landscape Determines Sensitivity to PD-1 Blockade in Non-Small Cell Lung Cancer” Cancer Immunology (2015) Volume 348(6230), pages 124-128).
Chan et al. is applied as above.
However, Chan et al. do not teach the number of one or more somatic alterations in a set of genes; increased number of one or more somatic alterations in a set of genes; a decreased number of somatic alterations in a predetermined set of gene.
Regarding claims 5, 83, and 86, Rizvi et al. teaches analyzing somatic mutations in all exomes while measuring TMB (page 124, third column, last paragraph to page 125, second column, supplementary Tables S4 and S5).
Regarding claims 11, 84, and 87, Rizvi et al. teach determining the pattern of mutational changes in all exomes which would include determining if the somatic alterations have increased (page 124, third column, last paragraph to page 125, second column, supplementary Tables S4 and S5).
Regarding claims 12, 85, and 88, Rizvi et al. teach determining the pattern of mutational changes in all exomes which would include determining if the somatic alterations have decreased or remained unchanged (page 124, third column, last paragraph to page 125, second column, supplementary Tables S4 and S5).
Regarding claim 35, Rizvi et al. teach where the therapy is administered to a subject that is responsive to a determination than a somatic alteration is present in the coding region of the NF1 gene.(supplementary Tables S4 and S5).
Regarding claim 36, Rizvi et al. teach where the presence of a somatic alteration in the coding region of the NF1 gene indicates that the subject is a responder to a therapy (supplementary Tables S4 and S5).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to combine the references of Chan et al. and Rizvi et al. Chan et al. teach that their claimed invention may be applied to melanoma or non-small-cell lung carcinoma (page 4, paragraph [23]). Thus, one of skill in the art would have been motivated to utilize the cancer data in Rizvi et al. the method of Chan et al. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success, since Chan et al. states their method may be applied to melanoma or non-small-cell lung carcinoma.
Double Patenting
11. 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.
12. Claims 1, 3-5, 8-9, 11-12, 21, 35-36, 59, 61, 76, and 83-88 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,725,247. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims and the claims of the U.S. Patent recite similar limitations. The instant claims differ from the claims of the U.S. Patent in that claims of the U.S. Patent also recite a listing of genes. The claims of the U.S. Patent require all the limitations of the instant claims with additional limitations. Thus, the scope of the instant claims encompasses the subject matter of the U.S. Patent and are not patentably distinct.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERRY LIN whose telephone number is (571)272-2561. The examiner can normally be reached T-F 7am-5pm.
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/JERRY LIN/Primary Examiner, Art Unit 1685
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