The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
CONTINUING DATA
This application is a CON of 17/073,827 10/19/2020 ABN
17/073,827 is a CON of 16/658,542 10/21/2019 ABN
16/658,542 is a CON of 15/902,643 02/22/2018 ABN
15/902,643 is a CON of 14/949,986 11/24/2015 ABN
14/949,986 is a CON of 13/484,506 05/31/2012 ABN
FOREIGN APPLICATIONS
EP 11168641.6 06/03/2011
EP 12153052.1 01/30/2012
Claims 1-37 are pending.
Claim Rejections - 35 USC § 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation “greater than 100 mg/dL,” and the claim also recites “in particular greater than 125 mg/dL,” which is the narrower statement of the range/limitation. In the present instance, claim 12 recites the broad recitation “equal to or greater than 6.5%,” and the claim also recites “in particular equal to or greater than 8.0%,” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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 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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1, 4-5, 7-9, 18, 21-22, 24-26, 28-29, 31-32, and 35-36 is/are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Keil (US2009/0325942 A1).
Keil teaches compounds of formula I (claim 1) which are neuroleptic agents because they are phenothiazines and may be used to treat schizophrenia (claim 17). The compound of formula (I) is administered in combination with SGLT2 inhibitors such as KGA-2727, T-1095, SGL-0010, AVE 2268 and SAR 7226 [0201].
The compounds of formula I are phenothiazine derivatives [0002], which are typical antipsychotics. See first paragraph of Ramachandraiah (Indian J Psychiatry 2009;51:324-6).
Administering Keil’s neuroleptic agent with an SGLT2 inhibitor would have inherently prevented a metabolic disorder, or prevented an increase in body weight, or prevented an increase of hyperglycemia to at least some extent because that is the function of SGLT2 inhibitors, and because Keil’s formula I is used for treating diabetes, metabolic syndrome, or lowering blood glucose level (claim 17).
Administration of the combination of drugs would necessarily have been combination or sequential because there is no other way to administer two drugs (either at the same time or not at the same time).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lieberman (Prim Care Companion J Clin Psychiatry 2004;6 (suppl 2), pp. 8-13) and Wu et al. (JAMA, January 9/16 2008 – Vol 299, No. 2, pp. 185-193) in view of Himmelsbach et al. (CA 2557801, October 2005).
Lieberman teaches that the use of antipsychotics is associated with weight gain, impaired glucose metabolism, exacerbation of existing type I and type 2 diabetes, new onset of type 2 diabetes, and diabetic ketoacidosis, and increases the probability of metabolic syndrome. See paragraph bridging pages 8-9. Features of Metabolic Syndrome include impaired glucose metabolism or diabetes, obesity, raised blood pressure, raised plasma triglyceride and LDL levels, and low HDL cholesterol levels. See Table 1. Hyperglycemia and impaired glucose levels are often seen in patients suffering from diabetes or metabolic
syndrome. Atypical antipsychotics can increase the risk of hyperglycemia and impaired glucose levels and subsequently increase the risk of metabolic syndrome. Page 9, Hyperglycemia and Glucose Levels. Antipsychotics include conventional antipsychotics, clozapine, risperidone (a benzisoxazole), quetiapine, or olanzapine. See page 11, top of second column. The induction of obesity by antipsychotic agents has been documented for many years. See introduction.
Wu also teaches that weight gain is a common adverse effect of antipsychotic medications and is associated with medical comorbidities, such as weight gain, hyperlipidemia, and glucose intolerance. See page 185, context. Wu teaches that metformin was effective for treating antipsychotic-induced weight gain. See page 185, Conclusions. Antipsychotics include clozapine, olanzapine, quetiapine, risperidone, ziprasidone, and apriprazole. See paragraph bridging pages 185-186.
Lieberman and Wu do not teach administration of an SGLT2 inhibitor with the neuroleptic agent.
Himmelsbach teaches the use of the following SGLT2 inhibitors for treating metabolic disorders. See abstract.
PNG
media_image1.png
254
478
media_image1.png
Greyscale
A preferred compound is the following, recited on page 29 and illustrated on page 74. This preferred compound is empagliflozin.
PNG
media_image2.png
82
866
media_image2.png
Greyscale
PNG
media_image3.png
372
862
media_image3.png
Greyscale
The metabolic disorders to be treated include diabetes, metabolic syndrome, insulin resistance, and obesity. See page 46. Additional therapeutic agents such as metformin may be included. See page 47.
It would have been obvious to one of ordinary skill in the art to administer an SGLT2 inhibitor to treat a metabolic disorder in a patient being treated with a neuroleptic agent, such as a patient being treated for a psychotic disorder. Metabolic disorders which are common in patients who are taking antipsychotics include weight gain, type 2 diabetes, hyperglycemia, and metabolic syndrome. SGLT2 inhibitors are known for treating metabolic disorders such as diabetes, metabolic syndrome, and obesity. The skilled artisan would have administered SGLT2 inhibitors to patients taking neuroleptics because SGLT2 inhibitors treat the metabolic disorders that neuroleptics cause. Metformin has been used to treat weight gain in patients taking antipsychotics and metformin is also used in combination with SGLT2 inhibitors. The skilled artisan would have had a reasonable expectation of success in replacing metformin with an SGLT2 inhibitor or combining the metformin with an SGLT2 inhibitor because they are used for the same purpose and are known to be used in combination. The administration would have been in combination, or alternation, or sequential because there is no other way to administer two different drugs.
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.
Claims 1-37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10610489 in view of Himmelsbach, Lieberman, and Wu.
The’489 patent claims a composition comprising an SGLT-2 inhibitor and metformin. See claim 1.
The ‘489 patent does not claim a composition comprising a neuroleptic agent, or methods of treatment.
Himmelsbach teaches as set forth above, that SGLT-2 inhibitors are used for treating diabetes, metabolic syndrome, insulin resistance, and obesity. See page 46. Additional therapeutic agents such as metformin may be included. See page 47.
Lieberman and Wu teach as set forth above, that antipsychotic medications cause weight gain and metabolic syndrome.
It would have been obvious to one of ordinary skill in the art at the time the application was filed to use the’489 composition for treating or preventing metabolic syndrome because the’489 composition contains an SGLT-2 inhibitor and SGLT-2 inhibitors are used for treating metabolic syndrome. It would have been obvious to administer the composition to a subject taking a neuroleptic agent because neuroleptic agents cause metabolic syndrome. The skilled artisan would have combined the neuroleptic agent and the SGLT-2 inhibitor (in the presence or absence of metformin as well) in order to treat the psychotic disorder while preventing metabolic syndrome that can be caused by the neuroleptic agent.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached on 7:00-3:00 CST, M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on 571-270-5241. 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.
/LAYLA D BERRY/Primary Examiner, Art Unit 1693
Prosecution Insights