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
Status of Application, Amendments, and/or Claims
1. Claims 44-63 are pending and currently under consideration.
Information Disclosure Statement
2. The information disclosure statement filed on 03/29/2024 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
3. The drawings filed on 03/29/2024 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 102 (a)(1)
4. 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.
5. Claims 44-63 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Ray-Coquard et al. (N. Engl. J. Med. 381 (25): 2416-2428, December 18, 2019).
Ray-Coquard et al. teach a method of treating ovarian cancer in a subject, the method comprising administering to the subject olaparib at the dose of 300 mg twice daily for up to 24 months and administering to the subject bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The subject has a BRCA mutation (Methods in Abstract). Ray-Coquard et al. teach olaparib plus bevacizumab as first-line maintenance in ovarian cancer in a subject. The subject had newly diagnosed, advanced, high-grade ovarian cancer, and were having a response after first-line platinum–taxane chemotherapy plus bevacizumab (Methods in Abstract). Ray-Coquard et al. further teach that olaparib plusbevacizumab reduced proteinuria in the subject in all grades as compared to proteinuria in the subject when the subject receives bevacizumab plus placebo (Table 2). Thus, , the teachings of Ray-Coquard et al. meet the limitations of claims 44-63.
Claim Rejections[Symbol font/0xBE] Nonstatutory Obviousness-Type Double Patenting
6. Basis for nonstatutory 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. See 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);and, 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/ guidance/eTD-info-I.jsp.
7. Claims 44-63 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-23 of US Patent No. 11,970,530 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-23 of US Patent No. 11,970,530 B2 are drawn to a method for treating ovarian cancer, fallopian tube cancer, primary peritoneal cancer, breast cancer, and/or pancreatic cancer in a subject, the method comprising: administering to the subject a therapeutically effective amount of bevacizumab, and administering to the subject a therapeutically effective amount of 4-[(3-{[4-(cyclopropane- carbonyl)piperazine-1-yl]carbonyl}-4-fluorophenyl)methyl]-2H-phthalazin-1-one (olaparib), or a hydrate, solvate, or prodrug thereof,wherein the therapeutically effective amount of bevacizumab is in the range of about 10 to 20 mg/kg of body weight every 3 weeks; wherein the therapeutically effective amount of olaparib is about 300 mg twice daily, wherein the therapeutically effective amount of olaparib [[is]] reduces Common Terminology Criteria for Adverse Events (CTCAE) Grade 2, Grade 3, or Grade 4 hypertension in the subject as compared to hypertension in the subject when the subject receives bevacizumab alone; and wherein the progression free survival is at least about 4 months greater than for subjects receiving bevacizumab alone.
On the other hand, claims 44-63 of the instant application are drawn to a. method for controlling or reducing proteinuria in a subject receiving a therapeutically effective amount of bevacizumab, the method comprising administering to the subject a therapeutically effective amount of 4-[(3-{[4-(cyclopropane- carbonyl)piperazine-1-yl]carbonyl}-4-fluorophenyl)methyl]-2H-phthalazin-1-one (olaparib), or a hydrate, solvate, or prodrug thereof,wherein the therapeutically effective amount of olaparib is sufficient to reduce proteinuria in the subject as compared to proteinuria in the subject when the subject receives bevacizumab alone.
Claims 1-23 of US Patent No. 11,970,530 B2 do not recite the property -- administering to a subject a therapeutically effective amount of Olaparib to reduce proteinuria in the subject as compared to proteinuria in the subject when the subject receives bevacizumab alone. However, such a property of reduce proteinuria is inherent to a therapeutically effective amount of Olaparib.
MPEP §2112 provides guidance as to the examiner’s burden of proof for a rejection of claims under 35 U.S.C. 102 or 103 based upon the express, implicit, and inherent disclosures of a prior art reference. The case law clearly states that something which is old does not become patentable upon the discovery of a new property.
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property that is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Further, the court has held that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004)(“[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.”); Abbott Labs v. Geneva Pharms., Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed.Cir.1999). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 1-23 of US Patent No. 11,970,530 B2 and claims 44-63 of the instant application vary in scope and are obvious over each other.
Conclusion
8. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/ Examiner, Art Unit 1674
September 1, 2026
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