DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 10 and 11 are pending.
Claims 1-9, 12, and 13 are cancelled.
Claim 10 is currently amended.
Claims 10 and 11 are currently under consideration to the extent they read upon Applicant’s elected groups and species.
Withdrawn Rejections
The rejection of claims 12 and 13 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Manuchehri et al. (WO 2008055940) is withdrawn in view of Applicant’s cancellation of said claims.
Maintained Rejections
Claim Rejections - 35 USC § 103
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 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 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, 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 10 and 11 (all claims currently under consideration) are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Manuchehri et al. (WO 2008055940)(IDS Reference).
Manuchehri teaches a pharmaceutical composition comprised of one or more SGLT-2 inhibitor compound(s) in combination with one or more therapeutic agents which is suitable for the treatment of metabolic disorders including type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance, hyperglycemia, postprandial hyperglycemia, overweight, obesity, including class I obesity, class II obesity, class III obesity, visceral obesity and abdominal obesity, and metabolic syndrome (see entire document, for instance, Abstract). Manuchehri teaches a glucopyranosyl-substituted phenyl derivative, which can be selected from a group which includes 1-chloro-4-(β-D-glucopyranos-l-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]- benzene (i.e. the SGLT-2 inhibitor as instantly claimed, see entire document, for instance, page 5, compound 3). Manuchehri teaches that the second therapeutic agent is suitable in the treatment or prevention of one or more conditions selected from type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance and hyperglycemia (see entire document, for instance, page 6, lines 6-10). Manuchehri teaches that the active ingredient B (the second therapeutic agent) can be selected from a group which includes insulin, and specifically glargine and lispro (which the instant specification, page 46, lines 23-24, asserts is a basal insulin) (see entire document for instance, Abstract, page 1, lines 9-10, page 5, compound 3, page 6, lines 6-9, page 21, line 18, and page 22, lines 24-26). Manuchehri teaches SGLT-2 inhibitors, due to their unique mode of action, are expected to lower blood glucose and HbAIc with a low associated risk of hypoglycemia (see entire document, for instance, page 7, lines 29-30). Manuchehri teaches limiting the danger of hypoglycemia in treated patients (i.e. reducing the risk of hypoglycaemia in a patient, see entire document for instance, page 7, lines 23-25). Manuchehri teaches that the active ingredients can be administered in a single pharmaceutical composition or administered individually, and specifically teaches that the one or more SGLT-2 inhibitor compound(s) and the one or more second therapeutic agent(s) are present in a single dosage form or the one or more SGLT-2 inhibitor compound(s) and the one or more second therapeutic agent(s) are present each in a separate dosage form (i.e. in combination or alternation to the patient, see page 5, lines 7-14). Manuchehri further teaches that ingredient A is administered in a dose level range of preferably 1 to 100 mg, by oral route, 1 to 4 times a day (see entire document, for instance, page 26, lines 19-22).
Although Manuchehri teaches the combination of 1-chloro-4-(β-D-glucopyranos-l-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene and insulin and teaches the treatment of metabolic disorders including type 1 diabetes mellitus, type 2 diabetes mellitus, impaired glucose tolerance, hyperglycemia, postprandial hyperglycemia, overweight, obesity, including class I obesity, class II obesity, class III obesity, visceral obesity and abdominal obesity, and metabolic syndrome, the reference does not exemplify the instant embodiments.
It would have been obvious to a person of ordinary skill in the art at the time that the invention was made to utilize 1-chloro-4-(β-D-glucopyranos-l-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene and insulin in reducing the risk of hypoglycaemia. One would be motivated to do so with a reasonable expectation of success as Manuchehri suggests the combination of 1-chloro-4-(β-D-glucopyranos-l-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene and insulin and teaches that the composition is expected to lower blood glucose and HbAIc with a low associated risk of hypoglycemia, as well as treating types I and II diabetes mellitus, impaired glucose tolerance, hyperglycemia, obesity, and metabolic disorders, among other things (see entire document, for instance, claim 2 and page 7). The MPEP states that the selection of known materials based on their suitability for their intended uses is prima facie obvious. See MPEP § 2144.07. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).
With regard to the dosage being 10mg, it is noted that the prior art directly overlaps the instantly claimed amount. Therefore, it would have been obvious to arrive at the instantly claimed amounts. It is noted that MPEP 2144.05 states: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997).
Response to Arguments
Applicant argues in the Remarks filed 07/30/2026 that the prior art, while teaching the instantly claimed elements in amounts that directly overlap the instantly claimed amounts, does not provide sufficient guidance to arrive at the instantly claimed invention. Applicant states “Manucherhri does not describe any example of a combination of empagliflozin in an amount of 10 mg and insulin to improve glycemic control and treat or reduce the risk of hypoglycemia as recited in amended claim 10. Applicant’s argument is not found persuasive. First, it is noted that the instant claims are rejected under 103 and not 102. Second, one of ordinary skill in the art, by merely following the guidance set forth in Manuchehri would have arrived at the instantly claimed components, in their specific orientations, and specifically claimed amount. Applicant has not established a criticality of the elements or of the amounts of the specific components, wherein the prior art provides motivation for arriving at said components and amount.
New Grounds of Rejection – Necessitated by Applicant’s Amendments
Claims 10 and 11 (all claims currently under consideration) are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Washburn et al. (US 7,589,193) and Himmelsbach et al (US 2007/0249544) (IDS References).
Washburn teaches the following SGLT2 inhibitor (see entire document, for instance, Claim 3),
PNG
media_image1.png
247
375
media_image1.png
Greyscale
[AltContent: textbox (FIGURE 1)]
and in combination with a second anti-diabetic agent, of which insulin is disclosed (see entire document, for instance, Claims 4 and 5). Washburn teaches that the active component is typically present in solid formulations in an amount of 10-500 mg, and administered in a single dose or in the form of individual doses 1-4 times per day (see entire document, for instance, column 23, lines 2-6). Further, Washburn teaches a method for treating type II diabetes comprising administering a therapeutically effective amount of the SGLT2 inhibitor of FIGURE 1 above with at least one other anti-diabetic agent (see entire document, for instance, Claim 15), of which insulin is disclosed (see entire document, for instance, column 17, lines 4-10 and Claims 4 and 5). Washburn further teaches that the active of Figure 1 is combined with an anti-obesity agent (see entire document, for instance, claim 3).
Washburn does not teach the specific SGLT2 inhibitor claimed.
Himmelsbach teaches the SGLT2 inhibitor 1-chloro-4-(ß-D-glucopyranos-1-yl)-2-
[4-(S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene (see entire document, for instance,
[0003] and [0004]). Himmelsbach further teaches pharmaceutical preparations of the
SGLT2 inhibitor for the treatment of type 1 and type 2 diabetes, overweight, obesity,
visceral obesity and abdominal obesity (see entire document, for instance, [0057]-
[0060]).
It would have been obvious to one of ordinary skill in the art before the invention was made to substitute one known SGLT2 inhibitor for another known in the art for the treatment of diabetes. Specifically, it would have been obvious to one of ordinary skill in the art to substitute the SGLT2 inhibitor of Himmelsbach for the SGLT2 inhibitor of Washburn and to have arrived at Applicants' invention with a reasonable expectation of success and without any surprising results.
With regard to the dosage being 10mg, it is noted that the prior art directly overlaps the instantly claimed amount. Therefore, it would have been obvious to arrive at the instantly claimed amounts. It is noted that MPEP 2144.05 states: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997).
Response to Arguments
Applicant does not argue the rejection of claims 10 and 11 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Washburn et al. (US 7,589,193) and Himmelsbach et al (US 2007/0249544) in the Remarks filed 07/30/2026. As such, the rejection is maintained.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TREVOR LOVE/Primary Examiner, Art Unit 1611
Prosecution Insights