DETAILED ACTION
Claims 1-23 are pending and are the subject of the Office Action below.
Priority
The instant application filed 2/24/2023 is a Continuation of 17862150, filed 7/11/2022, now abandoned. 17862150 is a Continuation of 15716764, filed 9/27/2017, now abandoned and having 2 RCE-type filing therein. 15716764 is a Divisional of 14193632, filed 2/28/2014, now abandoned and having 1 RCE-type filing therein. 14193632 Claims Priority from Provisional Application 61771441, filed 3/1/2013 and Priority from Provisional Application 61828942, filed 5/30/2013.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 7/12/2023, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the Examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-8 and 13-22 are rejected under pre-AIA 35 U.S.C. 102(b) as anticipated by ANCHOR Results published April 2011; with evidence of properties and intended use are included in Manku US 2010/0278879 published November 4, 2010 in the IDS; Bays et al. The American Journal of Cardiology 2011 (108) 682-690 in the IDS; and Braeckman et al. Clinical Drug Investigation 2015 (35) 45–51.
Applicants’ claim 1 is directed towards a method of reducing triglycerides in a subject on atorvastatin therapy, the method comprising administering to the subject a pharmaceutical composition comprising at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.
ANCHOR study slide we see that AMR101 was co-administered with atorvastatin, see slide 8. The AMR101 was administered at 2g or 4g per day.
Manku teaches AMR101, a capsule shell containing 500mg of ethyl eicosapentaenoate. Manku teaches that the ethyl eicosapentaenoate compositions contain less than about 1% of any individual fatty acid other than ethyl eicosapentaenoate.
Bays states that AMR101 is an omega-3 fatty acid agent containing >96% eicosapentaenoic acid ethyl ester and no docosahexaenoic acid. Bays shows dosing of 2g and 4g per day.
Braeckman shows that the pharmacokinetics of atorvastatin does not change with the administration of AMR101, the known composition meeting all the limitations of the instant claims. This reference shows the inherent properties of AMR101.
Applicant’s dependent claims simply recite inherent properties of the anticipatory combination of atorvastatin with the standard 2g or 4 g dose of AMR101. If Applicant believes the dependent claims actually avoid this anticipatory species, then Applicant would need to provide a showing that this combination does not have the properties outlined in the dependent claims. The Office does not have a lab to make this assessment.
Claim Rejections - 35 USC § 102
Claims 1-10 and 13-23 are rejected under pre-AIA 35 U.S.C. 102(b) as anticipated by Osterloh et al. US 2011/0034555 A1 published February 10, 2011; with evidence of properties and intended use are included in Manku US 2010/0278879 published November 4, 2010 in the IDS; Bays et al. The American Journal of Cardiology 2011 (108) 682-690 in the IDS; and Braeckman et al. Clinical Drug Investigation 2015 (35) 45–51.
Applicants’ claim 1 is directed towards a method of reducing triglycerides in a subject on atorvastatin therapy, the method comprising administering to the subject a pharmaceutical composition comprising at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.
Osterloh teaches in claim 1; a method of lowering triglycerides in a subject on stable statin therapy having baseline fasting triglycerides of about 200 mg/dl to about 500 mg/dl, the method comprising administering to the subject a pharmaceutical composition comprising about 1 g to about 4 g of ultra-pure EPA per day, wherein (1) upon administering the composition to the subject daily for a period of 12 weeks the subject exhibits at least 5% lower fasting triglycerides than a placebo controlled subject maintained on stable statin therapy without concomitant ultra-pure EPA for a period of 12 weeks, (2) the subject exhibits substantially no serum LDL-C increase, and (3) the placebo controlled subject also has baseline fasting triglycerides of about 200 mg/dl to about 500 mg/dl. Claim 14, the method of claim 1 wherein the statin is selected from the group consisting of atorvastatin, rosuvastatin and simvastatin. At [0108] a dosage form comprising about 500 mg to about 1 g.
Manku teaches AMR101, a capsule shell containing 500mg of ethyl eicosapentaenoate. Manku teaches that the ethyl eicosapentaenoate compositions contain less than about 1% of any individual fatty acid other than ethyl eicosapentaenoate.
Bays states that AMR101 is an omega-3 fatty acid agent containing >96% eicosapentaenoic acid ethyl ester and no docosahexaenoic acid. Bays shows dosing of 2g and 4g per day.
Braeckman shows that the pharmacokinetics of atorvastatin does not change with the administration of AMR101, the known composition meeting all the limitations of the instant claims. This reference shows the inherent properties of AMR101.
Applicant’s dependent claims simply recite inherent properties of the anticipatory combination of atorvastatin with the standard 2g or 4 g dose of AMR101. If Applicant believes the dependent claims actually avoid this anticipatory species, then Applicant would need to provide a showing that this combination does not have the properties outlined in the dependent claims. The Office does not have a lab to make this assessment.
Claim Rejections - 35 USC § 103
Claims 1-23 are rejected under pre-AIA 35 U.S.C. 103(a) as unpatentable by Ebrahim et al. “Statins for all by the age of 50 years?” Lancet 2012 (380) 545-547; Manku, US 2010/0278879 published November 4, 2010 in the IDS; and ANCHOR Results published April 2011; evidence of properties and intended use are included in Bays et al. The American Journal of Cardiology 2011 (108) 682-690 in the IDS; and Braeckman et al. Clinical Drug Investigation 2015 (35) 45–51.
Applicants’ claim 1 is directed towards a method of reducing triglycerides in a subject on atorvastatin therapy, the method comprising administering to the subject a pharmaceutical composition comprising at least about 80%, by weight of all fatty acids (and/or derivatives thereof) present, ethyl eicosapentaenoate.
This claim simply requires, “a subject on atorvastatin therapy.” Therefore the patient population is extremely broad as the indication of treatment is not limited in any way.
The claim only has one active step, “administering to the subject a pharmaceutical composition.” Note that the claim oddly doesn’t require an administration of atorvastatin, though the claim implies the step. However, without containing the active step the claim is confusing, regardless the “atorvastatin therapy” is highly generic and broad. The claim scope would be less generic and broad if Applicant clarified the administration of the atorvastatin therapy with a dosing schedule. Moreover, at the time the invention was made, the art through extensive clinical trials and studies have shown atorvastatin therapy (Lipitor) was safe and effective in many patient populations and that a maintenance dose between 10 mg to 80 mg orally once a day was routine and conventional. Also, the medical profession has argued that nearly all patients over 50 years of age would benefit from a generic statin treatment, see Ebrahim.
Manku teaches AMR101, a capsule shell containing 500mg of ethyl eicosapentaenoate. Manku teaches that the ethyl eicosapentaenoate compositions contain less than about 1% of any individual fatty acid other than ethyl eicosapentaenoate, see claim 3. Manku teaches teating all levels of fasting triglycerides:[0073] In another embodiment, the subject or subject group being treated has a baseline triglyceride level (or median baseline triglyceride level in the case of a subject group), fed or fasting, of at least about 300 mg/dl, at least about 400 mg/dl, at least about 500 mg/dl, (required by instant claims 11-12) at least about 600 mg/dl, at least about 700 mg/dl, at least about 800 mg/dl, at least about 900 mg/dl, at least about 1000 mg/dl, at least about 1100 mg/dl, at least about 1200 mg/dl, at least about 1300 mg/dl, at least about 1400 mg/dl, or at least about 1500 mg/dl, for example about 400 mg/dl to about 2500 mg/dl, about 450 mg/dl to about 2000 mg/dl or about 500 mg/dl to about 1500 mg/dl.
Bays states that AMR101 is an omega-3 fatty acid agent containing >96% eicosapentaenoic acid ethyl ester and no docosahexaenoic acid. Bays shows dosing of 2g and 4g per day.
Braeckman shows that the pharmacokinetics of atorvastatin does not change with the administration of AMR101, the known composition meeting all the limitations of the instant claims. This reference shows the inherent properties of AMR101.
So the art clearly shows that AMR101 is known in the art prior to the instant invention. Next looking to the ACHOR study slide we see that AMR101 was co-administered with atorvastatin, see slide 8.
A person of ordinary skill in the art would have a reasonable expectation of success in combining the standard dose of atorvastatin with the standard 2g or 4 g dose of AMR101 for co-administration. Therefore the instant invention was prima facie obvious at the time it was made.
Applicant’s dependent claims simply recite inherent properties of the obvious combination of a dose of atorvastatin with the standard 2 g or 4 g dose of AMR101. If Applicant believes the dependent claims actually avoid this obvious species, then Applicant would need to provide a showing that this obvious combination does not have the properties outlined in the dependent claims.
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 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.
U.S. Patent No. 10,561,631
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,561,631. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘631 claims are directed to an anticipatory patient (fasting baseline triglycerides of at least 500 mg/dl) taking EPA-E on statin, including atorvastatin (claims 10-11). The action of the drug within the patient is inherent, therefore this patient of the ‘631 in an embodiment within the scope of the instant claims.
U.S. Patent No. 10,265,290
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,265,290. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘290 claims are directed to an anticipatory patient (fasting baseline triglycerides of 200 to 499 mg/dl) taking EPA-E on statin, including atorvastatin. The action of the drug within the patient is inherent, therefore this patient of the ‘290 in an embodiment within the scope of the instant claims.
U.S. Patent No. 10,610,508
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,610,508. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘508 claims are directed to an anticipatory patient (fasting baseline triglycerides of 200 to 499 mg/dl) taking EPA-E on statin, including atorvastatin. The action of the drug within the patient is inherent, therefore this patient of the ‘508 in an embodiment within the scope of the instant claims.
U.S. Patent No. 11,185,525
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,185,525. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘525 claims are directed to an anticipatory patient (fasting baseline triglycerides of 200 to 499 mg/dl) taking EPA-E on statin, including atorvastatin. The action of the drug within the patient is inherent, therefore this patient of the ‘525 in an embodiment within the scope of the instant claims.
U.S. Patent No. 8,703,185
Claims 1-8 and 13-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 8,703,185. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘185 claims are directed to an anticipatory patient taking EPA-E on statin, including atorvastatin. The action of the drug within the patient is inherent, therefore this patient of the ‘185 in an embodiment within the scope of the instant claims.
U.S. Patent No. 8,709,475
Claims 1-8 and 13-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 8,709,475. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘475 claims are directed to an anticipatory patient taking EPA-E on statin, including atorvastatin. The action of the drug within the patient is inherent, therefore this patient of the ‘475 in an embodiment within the scope of the instant claims.
U.S. Patent No. 9,827,219
Claims 1-8 and 13-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,827,219. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘219 claims are directed to an anticipatory patient taking EPA-E on statin, including atorvastatin. The action of the drug within the patient is inherent, therefore this patient of the ‘219 in an embodiment within the scope of the instant claims.
U.S. Patent No. 10,842,768
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,842,768. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘768 claims are directed to an anticipatory patient taking EPA-E on statin, including atorvastatin. The action of the drug within the patient is inherent, therefore this patient of the ‘768 in an embodiment within the scope of the instant claims.
Conclusion
No claims allowed.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached on M-F 8-6 MidDay Flex.
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/MICHAEL SCHMITT/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629