DETAILED ACTION
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 .
Priority
This application is a CON of 16/763,269 filed on 05/12/2020, now PAT 11576950. 16/763,269 is a 371 of PCT/US2018/060716 filed on 11/13/2018. PCT/US2018/060716 has PRO 62/589,244 filed on 11/21/2017.
Claim Status
Claims 36-51 are being examined on the merits in this office action.
Examiner’s Comment
Examiner notes that this action is Non-Final. Applicant representative brought to Examiner’s attention that even though the cited reference (MPR) indicates that it was published in 2014, the teachings of the dose of 3mg and 4.5 mg, were not disclosed until May 2020 according to the wayback machine. Examiner agrees with Applicant’s representative has issued the new rejection below.
Claim Rejections - 35 USC § 103 - New
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 (i.e., changing from AIA to pre-AIA ) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 36-37, 39-40, 42-44, 46-48, and 50-51 are rejected under 35 U.S.C. 103 as being unpatentable over Burness et al. (BioDrugs (2015) 29:407-418) in view of Barrington et al. (Diabetes, Obesity and Metabolism 13: 426–433, 2011) and Barrington 2009 (Abstract American Diabetes Association, 69th Scientific Sessions (2009)).
Burness teaches treatment of diabetes by administering once weekly Dulaglutide (Abstract). Burness teaches that the method of administering Dulaglutide led to improvements in glycemic control and bodyweight (Abstract). Burness teaches the initial starting dosage is 0.75 mg once weekly and may be increased to 1.5 mg once weekly for additional glycemic control (Page 415, left col., 3rd paragraph, line 7-9). Burness teaches Dulaglutide for use in providing improvements in glycemic control and bodyweight and for the treatment of T2DM (Abstract; Section 4). Burness teaches and show on Table 1 that the higher dose of Dulaglutide resulted in improved glycemic control and control in body weight (See Table 1 on Page 410). Burness teaches that Dulaglutide is injected via a single-dose pen injection system (Page 416, right col., last paragraph).
Burness does not teach the dose escalation to 3.0 mg.
With regards to dose escalation, Barrington teaches a method of using LY2189265 (LY), which is the same dulaglutide, in subjects having T2D (Abstract). Barrington further teaches that LY was administered once weekly for 5 weeks, (which reads on the instant minimum of 4 weeks) and that the doses were 0.05, 0.3, 1, 3, 5 and 8 mg and that the doses were escalated between cohorts (p. 427, col. 2, line 1-9). Barrington further teaches that the effect of LY as being Glycemic reduction (p. 428, col 2, “pharmacodynamics section” line 16-17; p. 429, col. 2, line 9-10; p. 432, col. 1, “conclusion section, paragraph 3, line 4-6). Barrington teaches that LY was found to be safe and well tolerated and provided significant glycemic benefit to subjects with type 2 diabetes as well as modest weight loss (p. 432, col. 1, last paragraph, line 6-8).
Further, Barrington 2009 discloses single subcutaneous doses of LY2189265 (0.1 mg to 12 mg) where twenty subjects randomly received 2 escalating doses of LY2189265 and placebo given ≥3 weeks apart (abstract). Barrington further discloses that LY2189265 was well tolerated up to 6 mg (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a method of treatment that comprises administering dulaglutide at a dose of 0.75mg, 1.5mg for 4 weeks and then 3mg once a week because Barrington teaches dosages including 3 mg and teaches that the dosage were safe and well tolerated in patients with T2D. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying Burness and increasing the dulaglutide dosage as taught by Barrington for additional glycemic control. In addition, one of ordinary skill in the art would be willing to administer dulaglutide at the high dosages suggested by Barrington and Barrington 2009 because both reference teach that the dosages were safe and well tolerated in patients with T2D. In addition, the references teach the once weekly administration for at least 4 weeks. The instant claim 36 is therefore rendered obvious.
Regarding claims 37 and 40, Barrington teaches that a body weight mean reduction from baseline of approximately 1% were observed after 5 weeks of treatment at higher doses (Page 428, right col., last paragraph). Examiner notes that the teachings of Barrington render obvious claim 37 because Barrington teaches that the increased dosage led to increased weight loss.
Regarding claims 39 and 48, Burness teaches the initial starting dosage is 0.75 mg once weekly and may be increased to 1.5 mg once weekly for additional glycemic control (Page 415, left col., 3rd paragraph, line 7-9). Further, both Barrington references teach dose escalation up to 12 mg (Abstract). Further, Barrington teaches the dose of 5 mg led to better mean reduction in body weight (Page 429, left paragraph, last paragraph). Examiner notes that the instant dose of 4.5 mg falls with the dose range of Barrington and one of ordinary skill in the through routine optimization would arrive to the dose of 4.5 mg. It would have been obvious to increase the Dulaglutide dosage to 4.5 mg for additional glycemic effect.
Regarding claim 42, Burness teaches that Dulaglutide is available as a prefilled pen that completely hides the needle during all steps of the injection process and has simple instructions (‘‘uncap, place and unlock, inject’’) making it relatively easy to use (Page 416, right col., line 1-8). Examiner notes that the disclosure reads on an autoinjector.
Regarding claims 43, 46, 50, Burness teaches treatment of diabetes by administering once weekly Dulaglutide (Abstract). Burness teaches that the method of administering Dulaglutide led to improvements in glycemic control and bodyweight (Abstract). Burness teaches the initial starting dosage is 0.75 mg once weekly and may be increased to 1.5 mg once weekly for additional glycemic control (Page 415, left col., 3rd paragraph, line 7-9). Burnes further teaches administration of Dulaglutide in combination with metformin (Page 414, left col., section 5.2).
Regarding claims 44 and 47, Burness teaches the initial starting dosage is 0.75 mg once weekly and may be increased to 1.5 mg once weekly for additional glycemic control (Page 415, left col., 3rd paragraph, line 7-9). Burness teaches that Dulaglutide is injected via a single-dose pen injection system (Page 416, right col., last paragraph). Further, Barrington further teaches that LY was administered once weekly for 5 weeks, (which reads on the instant minimum of 4 weeks) and that the doses include 3 mg (p. 427, col. 2, line 1-9). It would have been obvious to administer the Dulaglutide at a dosage of 3 mg for additional glycemic effect.
Regarding claims 51, Burness teaches the initial starting dosage is 0.75 mg once weekly and may be increased to 1.5 mg once weekly for additional glycemic control (Page 415, left col., 3rd paragraph, line 7-9). Burness teaches that Dulaglutide is injected via a single-dose pen injection system (Page 416, right col., last paragraph). Further, Barrington further teaches that LY was administered once weekly for 5 weeks, (which reads on the instant at least 4 weeks) and that the doses include 3 mg (p. 427, col. 2, line 1-9). Further, both Barrington references teach dose escalation up to 12 mg (Abstract). Further, Barrington teaches the dose of 5 mg led to better mean reduction in body weight (Page 429, left paragraph, last paragraph). Examiner notes that the instant dose of 4.5 mg falls with the dose range of Barrington and one of ordinary skill in the through routine optimization would arrive to the dose of 4.5 mg. It would have been obvious to increase the Dulaglutide dosage to 4.5 mg for additional glycemic effect.
Claims 38, 41, 45, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Burness et al. (BioDrugs (2015) 29:407-418) in view of Barrington et al in (Diabetes, Obesity and Metabolism 13: 426–433, 2011) and Barrington 2009 (Abstract American Diabetes Association, 69th Scientific Sessions (2009)), as applied to claim 36, 39, 44, 48 above, and further in view of Matfin et al. (J. Diabetes Sci. Technol. 2015 21; 9(5): 1071–1079).
The teachings of Burness, Barrington and Barrington 2009 are disclosed above and incorporated herein by reference.
Burness does not teach that Dulaglutide is provided as a 0.5 mL aqueous solution.
Matfin teaches safe and effective use of once weekly Dulaglutide single-dose pen Injection to treat patients with Type 2 Diabetes (Title and Abstract). Matfin teaches that the dulaglutide single-dose pen is a disposable injection device that contains a prefilled syringe and is designed for subcutaneous delivery of a single 0.5 mL dose of once weekly, long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, dulaglutide, that the injection is user-initiated; however, needle insertion, dose delivery, and needle retraction are automated via a spring-loaded mechanism following initiation. Matfin teaches that the single-dose pen is a small, ready-to-use device (steps to use: uncap, place and unlock, and press to inject) with a hidden 29-gauge needle (5 mm injection depth) that enables a quick injection process (5-10 seconds) and provides dose confirmation and that the flat base of the single-dose pen allows it to be held firmly against the skin at the injection site (Page 1072, left col.,; Fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Burness and provide the dulaglutide in an 0.5 mL auto injector as taught by Matfin since Matfin teaches that the single dose pen is easy to use and provides dose confirmation. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using Dulaglutide in a 0.5 mL auto injector as taught by Matfin since Matfin teaches that the single-dose pen is a small, ready-to-use device (steps to use: uncap, place and unlock, and press to inject) with a hidden 29-gauge needle (Page 1072, left col.,; Fig. 1). The disclosures render obvious claims 38, 41, 45, and 49.
Response to Arguments
Applicant’s arguments, see Applicant Arguments, filed 10/28/2025, with respect to the rejection(s) of claim(s) 36-51 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Barrington et al.
Double Patenting - New
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.
Claims 36-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11576950, in view of Trulicity label (https://www.glucagon.com/pdfs/trulicity-uspi.pdf - 2014).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite a method of improving glycemic control in a subject in need thereof with type 2 diabetes comprising: a) administering to said subject an initial dose of 0.75 mg of dulaglutide once weekly; b) increasing the dose to 1.5 mg of dulaglutide once weekly; c) increasing the dose to 3.0 mg of dulaglutide once weekly after at least 4 weeks on the 1.5 mg dose; and d) increasing the dose to 4.5 mg of dulaglutide once weekly after at least 4 weeks on the 3.0 mg dose (claim 1).
The instant claims recite a method of improving glycemic control in a subject in need thereof with type 2 diabetes comprising administering dulaglutide to the subject, wherein the administering comprises a) a starting dose of 0.75 mg of dulaglutide administered once weekly; b) increasing the dose to 1.5 mg of Dulaglutide administered once weekly for at least 4 weeks; and c) further increasing the once weekly administered dulaglutide dose to a dose of 3.0 mg.
The difference between the claims of the patent and the instant claims is that the claims of the patent do not recite “herein each dulaglutide dose is provided as a 0.5 mL aqueous solution containing 0.75 mg, 1.5 mg, or 3.0 mg of dulaglutide” and “wherein each dulaglutide dose is provided in an autoinjector” as recited in claims 41 and 42.
However, these teachings are known as taught by the Trulicity label.
The Trulicity label teaches that Trulicity solution contains 0.75 mg or 1.5 mg of dulaglutide. Each single-dose pen or prefilled syringe contains 0.5 mL of solution and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg), trisodium citrate dihydrate (1.37 mg), in water for injection (Page 8, “Description” section), which reads on aqueous solution. Examiner notes that a single dose prefilled syringe reads on autoinjector.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent and provide Dulaglutide in a 0.5 mL aqueous solution containing 0.75 mg, 1.5 mg, or 3.0 mg of dulaglutide as an autoinjector as taught by Trulicity label for ease of administration. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using Dulaglutide as an aqueous solution in an auto injector pen to provide the required dose to the subject. The disclosures render obvious claims 36, 39, and 44.
Regarding claim 37, the patent recites a method of improving glycemic control in a subject in need thereof with type 2 diabetes comprising: increasing the dose to 3.0 mg of dulaglutide once weekly after at least 4 weeks on the 1.5 mg dose (claim 1).
Regarding claims 38 and 41, the claims of the patent recite administering Dulaglutide of 0.75 mg, 1.5 mg, 3 mg, and 4.5 mg. Further, The Trulicity label teaches that Trulicity solution contains 0.75 mg or 1.5 mg of dulaglutide. Each single-dose pen or prefilled syringe contains 0.5 mL of solution and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg), trisodium citrate dihydrate (1.37 mg), in water for injection (Page 8, “Description” section), which reads on aqueous solution. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the claims of the patent and provide Dulaglutide in a 0.5 mL aqueous solution containing 0.75 mg, 1.5 mg, or 3.0 mg of dulaglutide as an autoinjector as taught by Trulicity label for ease of administration.
Regarding claims 40, the claims of the patent recite wherein administration of 4.5 mg of dulaglutide once weekly results in a greater body weight reduction than administration of 1.5 mg of dulaglutide once weekly (claim 3).
Regarding claims 42, 45, 49, The Trulicity label teaches that Trulicity solution contains 0.75 mg or 1.5 mg of dulaglutide. Each single-dose pen or prefilled syringe contains 0.5 mL of solution and the following excipients: citric acid anhydrous (0.07 mg), mannitol (23.2 mg), polysorbate 80 (0.10 mg), trisodium citrate dihydrate (1.37 mg), in water for injection (Page 8, “Description” section), which reads on aqueous solution. Examiner notes that a single dose prefilled syringe reads on autoinjector. It would have been obvious to modify the claims of the patent and provide Dulaglutide in a 0.5 mL aqueous solution containing 0.75 mg, 1.5 mg, or 3.0 mg or 4.5 mg of dulaglutide as an autoinjector as taught by Trulicity label for ease of administration.
Regarding claim 43, 46, 50, the Trulicity label teaches on Table 3 addition of metformin resulting in statistically significant reduction in HbA1c compared to placebo (Table 3, and Page 13 section 14.2). It would have been obvious to one of ordinary skill in the art to modify the claims of the patent and administer Trulicity in combination with metformin as taught by Trulicity label for additional improved glycemic control and control in body weight.
Regarding claims 47, 48, and 51, the claims of the patent recite a method of improving glycemic control in a subject in need thereof with type 2 diabetes comprising: a) administering to said subject an initial dose of 0.75 mg of dulaglutide once weekly; b) increasing the dose to 1.5 mg of dulaglutide once weekly; c) increasing the dose to 3.0 mg of dulaglutide once weekly after at least 4 weeks on the 1.5 mg dose; and d) increasing the dose to 4.5 mg of dulaglutide once weekly after at least 4 weeks on the 3.0 mg dose (claim 1).
Conclusion
Due to new grounds of rejection, this rejection is Non-Final.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654