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 .
DETAILED ACTION
Application status
Claims 17, 21-24, 26, 30-33, 37-41, 45-49 and 53-56 are pending in this application.
Priority
The instant application is the 371 national stage entry of PCT/US2021/064539, filed on 12/21/2021, which claims benefit of 63129393 filed on 12/22/2020.
Election
Applicant's election without traverse of Group II, Claims 26 and 30-32, and species arbiraterone; and with traverse of species PRC1 in the response filed on 06/15/2026, is acknowledged.
Applicants argue that because the different polypeptides are members of a biomarker panel, these are not patentably distinct species of a genus.
Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons. Even though the different polypeptides recited in claim 1 may be members of a biomarker panel, one must determine the differential level of expression for each and every one of the polypeptides separately as these markers can behave differently in cancer cells. As such, Applicants’ argument, that all of these polypeptides cannot be mutually exclusive, are not deemed persuasive.
Claims 17, 21-24, 33, 37-41, 45-49 and 53-56 are withdrawn from further consideration by the Examiner, 37 CFR 1.142(b) as being drawn to a non-elected invention.
For the reasons provided above, this restriction requirement is deemed proper, and therefore, it is made final.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/31/2024 and 10/22/2024 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 26 is objected to because of the following informalities:
Claim 26 recites “CCNA2 polypeptide, a CCNB1 polypeptide, a CCNB2 polypeptide, a PRC1 polypeptide, a SMC2 polypeptide, a DLGAP5 polypeptide, an ECT2 polypeptide, a FBXO5 polypeptide, a CDK1 polypeptide, a NCAPG polypeptide, and a KIF4A polypeptide” which is objected to for containing many abbreviations. Applicants are advised to write out the abbreviations in full, i.e., Protein regulator of cytokinesis 1 (PRC1).
Appropriate correction is required.
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 26 and 30-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon) without significantly more.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of the following steps:
(1) whether the claim is directed to one of the four categories recited in §101 (process, machine, manufacture or composition of matter);
(Revised 2A - Prong 1) do the claims recite an abstract idea (mathematical concepts, mental processes or method of organizing human activity), law of nature or natural phenomenon;
(Revised 2A - Prong 2) do the claims recite additional elements that integrate the judicial exception into a practical application; and
(2B) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. (See 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG))
Question 1: Yes; the claims are directed to a judicial exception – specifically, a law of nature (the natural correlation between expression levels of polypeptides in prostate cancer cells and administering a known class of drugs based on that correlation) – see Mayo Collaborative Servs. V. Prometheus Labs., Inc., 556 US. 66 (2012).
Question 2A – Prong 1: Yes, the claims recite a natural phenomenon, namely, a naturally occurring differential expression levels of proteins in prostate cancer.
Question 2A – Prong 2: No, the claims do not recite anything additional which integrate the naturally occurring differential expression levels into a practical application.
Question 2B: As noted in answering that of 2A – Prong 2 above, there is nothing in the claims which amounts to significantly more. In this case, the detection of expression levels of polypeptides in a sample and, administering a known anti-androgen agent do not integrate the exception into a practical application or amount to “significantly more” than the judicial exception. Detection of differential expression of polypeptides was routine and conventional prior to the effective filing date of the instant application; and administering anti-androgen agents, i.e., abiraterone, was standard-of-care as evidenced by page 1996, left column of de Bono et al. (Abiraterone and Increased Survival in Metastatic Prostate Cancer, New England Journal of Medicine, Vol. 364, No. 21, pg. 1995-2005, 05/26/2011). Thus, the claims are drawn to a judicial exception, namely, a naturally occurring product.
Claim Rejections - 35 U.S.C. § 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.
Claims 26 and 30-32 are rejected under 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 26 (30-32 dependent therefrom) recites “detecting, in a sample obtained from said mammal, an absence of an increased level of expression of a CCNA2 polypeptide, a CCNB1 polypeptide, a CCNB2 polypeptide, a PRC1 polypeptide, a SMC2 polypeptide, a DLGAP5 polypeptide, an ECT2 polypeptide, a FBXO5 polypeptide, a CDK1 polypeptide, a NCAPG polypeptide, and a KIF4A polypeptide” is confusing and unclear. It is unclear with regard to whether the absence of an increased level of expression must be detected for all of the listed polypeptides or a single polypeptide in order to move forward with the anti-androgen therapy (italicized for added emphasis). In the interest of advancing prosecution, the noted phrase is interpreted to be requiring detection of an absence of an increased level of expression of at least one single polypeptide from the list recited in claim 26.
Claim 26 (30-32 dependent therefrom) recites “an increased level of expression” which is indefinite. The reason is that without a reference point to which this ‘increased level of expression’ is measured against, the metes and bounds of the noted phrase is unclear. In the interest of advancing prosecution, the noted phrase is interpreted to be inclusive of “any level of expression”.
Claim Rejections - 35 USC § 103
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 26 and 30-32 are rejected under 35 U.S.C. 103 as being unpatentable over Luo et al. (Protein regulator of cytokinesis 1 overexpression predicts biochemical recurrence in men with prostate cancer, Biomedicine & Pharmacotherapy, 78 (2016 116-120), in view of de Bono et al. (Abiraterone and Increased Survival in Metastatic Prostate Cancer, New England Journal of Medicine, Vol. 364, No. 21, pg. 1995-2005, 05/26/2011), and Antonarakis et al. ("AR-V7 and resistance to enzalutamide and abiraterone in prostate cancer," N. Engl. J. Med., September 2014, 371(11):1028-1038, see IDS).
The instant claims are drawn to a method for treating a mammal having prostate cancer, wherein said method comprises: (a) detecting, in a sample obtained from said mammal, an absence of an increased level of expression of CCNA2 polypeptide, a CCNB1 polypeptide, a CCNB2 polypeptide, a PRC1 polypeptide, a SMC2 polypeptide, a DLGAP5 polypeptide, an ECT2 polypeptide, a FBXO5 polypeptide, a CDK1 polypeptide, a NCAPG polypeptide, and a KIF4A polypeptide; and(b) administering an anti-androgen agent to said mammal.
Luo et al. teach that PRC1 is overexpressed in prostate cancer, and that higher PRC1 expression correlates with more aggressive prostate cancer and poorer outcomes (see Abstract and Fig. 2 on page 119).
Luo et al. do not teach administration of abiraterone.
de Bono et al. teach methods of treating patients with metastatic prostate cancer by administering abiraterone (Phase 3 trial), demonstrating that abiraterone significantly improves overall survival in patients with metastatic castration-resistant prostate cancer. de Bono et al. clearly points out that administering abiraterone as a therapeutic agent and a commonly used as a standard-of-care for prostate cancer patients (see pages 1995-2000).
It would have been obvious to a person of ordinary skill in the art (POSITA) prior to the effective filing date of the instant application to practice a method of detecting PRC1 expression levels in a prostate cancer sample from patients, and administer abiraterone to those patients showing an absence of high PRC1 expression levels as taught by Luo et al. and de Bono et al. A POSITA would have been motivated to practice such methods because [1] Antonarakis et al. teach that concept of using a detectable biomarker in a patient sample to predict response (or resistance) to abiraterone and to guide treatment decisions; and [2] a POSITA would have been motivated to apply the same biomarker-guided approach using PRC1 as the biomarker, because high PRC1 overexpression is linked to proliferation and poorer outcomes – exactly the type of marker useful for stratifying patients for abiraterone therapy. A POSITA would have had a reasonable expectation of success to make and use such composition because all of the required biochemical reagents and techniques were readily available and rampantly used as evidenced by Luo et al., de Bono et al., and Antonarakis et al. prior to the filing of the instant application.
For the reasons provided herein, the invention as claimed is prima facie obvious over the combined teachings of the prior art.
Conclusion
Claims 26 and 30-32 are rejected for the reasons as stated above. Applicants must respond to the objections/rejections in this Office action to be fully responsive in prosecution.
The instant Office action is non-final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAE W LEE whose telephone number is (571)272-9949. The examiner can normally be reached on M-F between 9:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached on (571)272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAE W LEE/
Examiner, Art Unit 1656
/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656
Prosecution Insights