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
Claim 1 is pending and is under consideration in the instant office action.
Priority
This application is a continuation of U.S. Appl. 17/009,316 dated 11/16/2020 which is a continuation of US application 16/356,663. filed March 18, 2019, which is a continuation of U.S. Appl. No. 15/101,878. issued as U.S. Patent No. 10,231,962. which is the U.S. National Stage Entry of PCT/US 14/68527. filed December 4. 2014. which claims the benefit of priorities to U.S. Appl. Nos. 61/913,216, filed December 6, 2013; 61/914,938, filed December 11, 2013; 6 1/984,580, filed April 25, 2014, and 14/322,8 10, filed July 2, 2014, issued as U.S. Patent No. 8,969, 371
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102 (a) (1)) as being anticipated by the publication entitled 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing The Occurrence Of Major Adverse Cardiovascular Events (MACE) In Overweight And Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR: Clinical Trials Identifier. NCT01601704' by ClinicalTrials.gov Archive , 05/07/2013(hereinafter 'ClinicalTrials').
Instant claim is drawn to a method of treating a subject at increased risk of major adverse cardiovascular event (MACE) comprising: selecting for treatment a subject at increased risk of MACE; and administering to said subject an amount of naltrexone, or a pharmaceutically acceptable salt thereof and bupropion, or a pharmaceutically acceptable salt thereof, effective to reduce said increased risk..
ClinicalTrials discloses a method of treating a subject at increased risk of major adverse cardiovascular event (MACE) (administration of naltrexone and bupropion for treating a subject at increased risk of major adverse cardiovascular event; page 1, second paragraph to page 1, third paragraph) comprising: selecting for treatment a subject at increased risk of MACE (selecting for treatment a subject at increased risk of MACE; pages 3-4); and administering to said subject an amount of naltrexone (administering to said subject 32 mg/day of naltrexone; page 2, tenth paragraph), or a pharmaceutically acceptable salt thereof and bupropion (administering to said subject 360 mg/day of bupropion; page 2, tenth paragraph), or a pharmaceutically acceptable salt thereof, effective to reduce said increased risk (Naltrexone SR 32 mg/Bupropion SR 360 mg/day (amount effective to reduce said increased risk), page 2, tenth paragraph; as further indicated by the instant PCT application. Naltrexone SR 32 mg/Bupropion SR 360 mg/day is an amount effective to reduce the risk of a MACE, figure 2 of the instant PCT application). ClinicalTrials further discloses wherein the subject has one or more of the following characteristics at the time of treatment: Type II diabetes (page 3, second paragraph); existing cardiovascular disease (page 3, second paragraph) or a high likelihood of cardiovascular disease (page 3, second paragraph); congestive heart failure; family history of cardiovascular disease; current smoker (page 3, second paragraph); genetically predisposed to cardiovascular diseases; has or has had cardiac arrhythmia; has or has had atrial fibrillation, ventricular fibrillation, or tachyarrhythmia; does not have sinus tachycardia; has unstable angina; has hypertension (page 3, second paragraph); has had a stroke or is at increased risk of stroke; has an aneurysm; or has elevated triglycerides, elevated LDL, and/or low HDL (page 3, second paragraph). Also disclose wherein said subject has at least one of: a history of documented myocardial infarction > 3 months prior to said identifying (a history of documented myocardial infarction > 3 months prior to said identifying; page 3, second paragraph); a history of coronary revascularization (a history of coronary revascularization; page 3, second paragraph); a history of carotid or peripheral revascularization (a history of carotid or peripheral revascularization; page 3, second paragraph); angina with ischemic changes (angina with ischemic changes; page 3, second paragraph); ECG changes on a graded exercise test (ECG changes on a graded exercise test; page 3, second paragraph); positive cardiac imaging study (positive cardiac imaging study; page 3, second paragraph); ankle brachial index <0.9 within 2 years prior to said identifying (ankle brachial index <0.9 within 2 years prior to said identifying; page 3, second paragraph); or >50% stenosis of a coronary artery, carotid artery, or lower extremity artery within 2 years prior to treatment (>50% stenosis of a coronary artery, carotid artery, or lower extremity artery within 2 years prior to treatment; page 3, second paragraph). As per claims 8, ClinicalTrials further discloses wherein the subject is obese (page 1, second paragraph) or overweight (page 1, second paragraph).
Therefore the 'ClinicalTrials').. fully anticipates instant claims 1
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 claims at issue 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); 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting over claim 1-6 of U. S. Patent No 8,969,371 (‘371) and claims 1-3 of US patent no 9,119,850 (‘850) , Claims 1-20 of US patent 10,231,964 (‘964), claims 1-14 of US patent 10,231,962(‘962), Claims 1-20 of US patent 10,828,294 (‘294) and claims 1-21 of US patent 10,835,527 (‘527) since the claims, if allowed, would improperly extend the "right to exclude" already granted in the patent.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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). Although the conflicting claims are not identical, they are not patentably distinct from each other because instant claims are generic to all that is recited in claims 1-16 of 371’, 1-3 of ‘850 , claims 1-20 of ‘964, 1-14 of ‘962 , claims 1-20 of ‘294 and claims 1-21 of ‘527 specifically, The method treating a subject for overweight or obesity claimed in these patents a specie of genus of "subject who is at increased risk of major adverse cardiovascular event (MACE)” instantly claimed. Therefore subject matter disclosed in claims instant claims1 is fully taught in claim in claims 1-16 of 371’, 1-3 of ‘850 , claims 1-20 of ‘964, 1-14 of ‘962 , claims 1-20 of ‘294 and claims 1-21 of ‘527and hence anticipates the instant claims.
Conclusion
Claim 1 is rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
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/SAVITHA M RAO/Primary Examiner, Art Unit 1691
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