DETAILED CORRESPONDENCE
The present application is a domestic application filed 06 September 2023, which is a continuation of US Application No. 17/346,475 (now abandoned), filed 14 June 2021, which is a continuation of US Application No. 16/695,324 (now abandoned), filed 26 November 2019, which is a continuation of 15/936,927 (now abandoned), filed 27 March 2018, which is a continuation of US Application No. 13/539,713 (now abandoned), filed 02 July 2012, which claims priority to US Provisional Application No. 61/505,598, filed 08 July 2011.
Claims 1-14 are pending in the current application and are examined on the merits herein.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Objections
Claim 8 is objected to because of the following informalities:
Regarding claim 8, the phrase "e.g. after renal mass reduction by surgery" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase “e.g.” are part of the claimed invention. See MPEP § 2173.05(d).
Appropriate correction is required.
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 1-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Himmelsbach et al. (US Patent No. 7,713,938, cited in IDS submitted 23 April 2024) in view of Malatiali et al. (Experimental Diabetes Research, 2008, volume 2008, 7 pages, cited in IDS submitted 23 April 2024) and further in view of Vervoort et al. (European Journal of Clinical Investigation, 2005, vol. 35, pp.330-336, cited in IDS submitted 23 April 2024).
Himmelsbach et al. teach a pharmaceutical composition comprising 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene (claim 4), also known as empagliflozin (hereinafter referred to as empagliflozin). Himmelsbach et al. teach empagliflozin is an SGLT2 inhibitor (column 1, lines 25-47), and is suitable for preventing, slowing, delaying or treating conditions including type 1 diabetes mellitus and complications of diabetes such as nephropathy; as well as acute renal failure (column 6, lines 21-51; also see column 6-7, bridging paragraph). Himmelsbach et al. teach empagliflozin is particularly suitable for the prevention or treatment of individuals diagnosed with one of the following conditions: overweight, obesity, visceral obesity and/or abdominal obesity (column 7, lines 4-7). Himmelsbach et al. teach an oral dosage preferably comprising 1 to 30 mg of compound of claim 4, administered 1 to 4 times a day (column 7, lines 13-16).
Himmelsbach et al. do not expressly disclose wherein the patient has a GFR equal to or greater than 125 mL/min/1.73 m2 or 140 ml/min/1.73 m2 (present claims 1, 5, 6, 8, 12, and 13).
Malatiali et al. teach phlorizin, an SGLT inhibitor, prevents glomerular hyperfiltration in subjects with diabetes (title and p.4, section 3.3). Malatiali et al. teach there is an increased tubular Na+ glucose reabsorption in uncontrolled diabetes due to increased expression of SGLT1 and SGLT2 transporters in proximal tubule cells (p.1, fourth paragraph). Malatiali et al. teach this reabsorption causes decreased distal delivery of Na+ which increases the glomerular filtration rate (GFR) through tubuloglomerular feedback (TGF) (p.1, fourth paragraph) and suggest it may be the cause of glomerular hyperfiltration. Malatiali et al. teach phlorizin prevented renal growth observed in diabetic rats (p.3, section 3.1). Malatiali et al. teach phlorizin inhibits the proximal tubule sodium glucose reabsorption in patients with diabetes (i.e. an SGLT2 inhibitor), (p.4, section 3.3).
Vervoort et al. teach glomerular hyperfiltration is involved in the pathophysiology of diabetic nephropathy, wherein an increase in glomerular filtration rate (GFR) appears to be caused by an increase in proximal tubular sodium reabsorption (abstract: conclusions). Vervoort et al. teach glomerular hyperfiltration is defined as patients having a GFR equal to or greater than 130 ml/min/1.73 m2 (abstract: results; also see p.332, last paragraph).
It would have been obvious at the time the invention was made to administer empagliflozin to a patient having type 1 diabetes, wherein the patient has a GFR equal to or greater than 130 ml/min/1.73 m2.
One having ordinary skill in the art would have been motivated to administer empagliflozin to a patient having type 1 diabetes because Himmelsbach et al. expressly teach the compound can be used to treat patients having type 1 diabetes.
As discussed above, Malatiali et al. teach uncontrolled diabetics have an increased expression of SGLT1 and SGLT2 transporters in proximal tubule cells, which increases tubular Na+ glucose reabsorption, which in turn decreases distal delivery of Na+, which increases the GFR through TGF.
The ordinary artisan would have been motivated to treat glomerular hyperfiltration by administering empagliflozin because it is functionally similar to phlorizin, in that they are both SGLT inhibitors for treating conditions associated with nephropathy, wherein the SGLT inhibitor phlorizin was demonstrated to prevent glomerular hyperfiltration in subjects with diabetes because of its role as an SGLT inhibitor. Specifically, Malatiali et al. found phlorizin prevented glomerular hyperfiltration by inhibiting the proximal tubule sodium glucose reabsorption in the kidney of patients with diabetes.
The skilled artisan would have had a reasonable expectation of success in using empagliflozin for preventing the progression of glomerular hyperfiltration injury because empagliflozin is a known SGLT inhibitor and has been demonstrated to have therapeutic effect on the kidneys, including nephropathy and acute renal failure. Furthermore, the drug is suitable for preventing, slowing, delaying or treating type 1 diabetes mellitus.
The skilled artisan would have been motivated to treat a patient having a GFR equal to or greater than 130 ml/min/1.73 m2 because glomerular hyperfiltration is defined as patients having a GFR equal to or greater than 130 ml/min/1.73 m2. The GFR range taught by Vervoort et al. encompasses the range recited in present claims 1, 5, 6, 8, 12, 13 (GFR equal to or greater than 140 ml/min/1.73 m2).
Finally, it is noted that administering empagliflozin to a subject having diabetes (as required in present claims 3 and 10), will necessarily result in preventing glomerular hyperfiltration. Performing the positively recited steps of administering the empagliflozin to a subject having diabetes meets the preamble limitation, since the preamble does not require the subject to have glomerular hyperfiltration. See MPEP 2111.02, section II, “If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim.”.
The amount of empagliflozin taught by Himmelsbach et al. substantially overlaps and encompasses the amount recited in the present claims. See MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”.
MPEP 2144.05, section I 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.”; and MPEP 2144.05, section II states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.”.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
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.
I. Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 8,551,957 in view of Malatiali et al. and Vervoort et al. (cited above).
Claim 4 of the ‘957 Patent is directed towards a method of slowing the progression of, delaying or treating type 1 diabetes mellitus, type 2 diabetes mellitus, overweight and obesity comprising administering 1-chloro-4-(β-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene to a patient in need thereof. Claim 7 is directed towards a method of treating complications of diabetes including nephropathy. Claims 20 and 30 teaches administering the composition orally. Claims 42 and 43 of the ‘957 Patent discloses the compound is administered in an amount of 10 mg or 25 mg once daily.
The claims of the ‘957 Patent do not expressly disclose the GFR of the patient in need thereof (present claims 1, 5, 6, 8, 12, and 13).
Malatiali et al. and Vervoort et al. teach as discussed above.
It would have been obvious at the time the invention was made to administer empagliflozin once a day to a patient having a GFR equal to or greater than 130 ml/min/1.73 m2.
The skilled artisan would have been motivated to treat a patient having a GFR equal to or greater than 130 ml/min/1.73 m2 for the reasons discussed above. The GFR range taught by Vervoort et al. encompasses the range recited in instant claim 1.
The recitation “for preventing…renal hyperfiltrative injury in a patient in need thereof” is broadly and reasonably interpreted as a patient having diabetes mellitus and acute renal failure as per instant claim 2; type 1 or type 2 diabetes mellitus as per instant claims 3 and 4; an individual diagnosed as being overweight or having obesity, visceral obesity and abdominal obesity as per instant claim 7.
Claims 1-14 are prima facie obvious over claims 1-48 of the ‘957 Patent in view of Malatiali et al. and Vervoort et al.
II. Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9,192,617 in view of Himmelsbach et al. (cited above), Malatiali et al. (cited above) and Vervoort et al. (cited above).
Claim 2 of the ‘617 Patent are directed towards a method of preventing, slowing the progression of, delaying or treating a metabolic disorder including diabetes mellitus comprising administering empagliflozin. Claim 4 of the ‘617 Patent is directed towards treating an overweight or obese patient having diabetes mellitus.
The claims of the ‘617 Patent do not expressly disclose the GFR of the patient in need thereof (present claims 1, 5, 6, 8, 12, and 13). The claims of the ‘617 Patent do not expressly disclose a dosage of empagliflozin (instant claims 9 and 18).
Himmelsbach et al., Malatiali et al. and Vervoort et al. teach as discussed above.
The obviousness rational is the same as discussed above.
Claims 1-14 are prima facie obvious over claims 1-14 of the ‘617 Patent in view of Himmelsbach et al. and Vervoort et al.
III. Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,949,997 in view of Himmelsbach et al. (cited above), Malatiali et al. (cited above) and Vervoort et al. (cited above).
The claims of the ‘997 Patent are directed towards reducing the risk of cardiovascular death in a patient with diabetes mellitus, the method comprising administering 10 or 25 mg empagliflozin to the patient.
The claims of the ‘997 Patent do not expressly disclose the GFR of the patient in need thereof (present claims 1, 5, 6, 8, 12, and 13). The claims of the ‘997 Patent do not expressly disclose wherein the patient is an individual diagnosed as being overweight, having obesity, visceral obesity and abdominal obesity (instant claims 6, 13).
Himmelsbach et al., Malatiali et al. and Vervoort et al. teach as discussed above.
The obviousness rational regarding the GFR limitation is the same as discussed above.
It would have been obvious at the time the invention was made to administer empagliflozin to a subject diagnosed as being overweight, having obesity, visceral obesity and abdominal obesity because Himmelsbach et al. teach administering empagliflozin to this particular patient population and also having diabetes, as recited in the claims of the ‘997 Patent.
Claims 1-14 are prima facie obvious over claims 1-18 of the ‘997 Patent in view of Himmelsbach et al., Malatiali et al. and Vervoort et al.
IV. Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,406,172 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
The claims of the reference Patent are directed towards a pharmaceutical composition comprising in a single dosage form, empagliflozin. The claims are also drawn towards administering the composition to a patient with type 2 diabetes for improving glycemic control, wherein the composition comprises 25 mg of the empagliflozin. The claims of the patent include the same patient populations recited in the instant claims.
The claims of the Patent do not expressly disclose the GFR.
It would have been obvious at the time the invention was made to administer empagliflozin to a patient having a GFR equal to or greater than 130 ml/min/1.73 m2.
The skilled artisan would have been motivated to treat a patient having a GFR equal to or greater than 130 ml/min/1.73 m2 because Vervoort et al. teach glomerular hyperfiltration is defined as patients having a GFR equal to or greater than 130 ml/min/1.73 m2, wherein glomerular hyperfiltration is a condition associated with diabetes and nephropathy. The GFR range taught by Vervoort et al. encompasses the range recited in instant claim 1.
Claims 1-14 are prima facie obvious over claims 1-24 of the ‘172 Patent in view of Himmelsbach et al. and Vervoort et al.
The following are additional rejections on the ground of nonstatutory double patenting, having the same or similar fact patterns as the above US Patents. Namely, the following US Patents are similarly directed towards empagliflozin and its use as an SGLT2 inhibitor, including for the treatment of the disorders recited in the instant claims (including obesity, diabetes type I and type II) as those recited in the instant claims. For the sake of brevity, these have been summarized as below: The below patents are silent with respect to the glomerular filtration rate and dosage of drug.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 7,683,160 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 7,723,309 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 8,507,450 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,596,120 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,610,489 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-17, 19-24, 26-27, 30-32 of US Patent No. 11,666,590 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,813,275 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 10-19, 21, 23-30 of U.S. Patent No. 11,813,275 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-12, 14 and 15 of U.S. Patent No. 11,813,275 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,427,161 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15, 17-20, 22-26, 28-30 and 41 of U.S. Patent No. 12,433,906 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-12, 14 and 15 of U.S. Patent No. 12,263,157 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 15, 17-26, 28-30 and 41 of U.S. Patent No. 12,263,157 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
The obviousness rational is the same as discussed above.
Thus, the instant claims are prima facie obvious over the claims of the reference Patent.
The following are additional provisional rejections on the ground of nonstatutory double patenting, having the same or similar fact patterns as the above US Patents. Namely, the following US Patents are similarly directed towards empagliflozin and its use as an SGLT2 inhibitor, including for the treatment of the disorders recited in the instant claims (including obesity, diabetes type I and type II) as those recited in the instant claims. For the sake of brevity, these have been summarized as below:
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8 of copending Application No. 18/930,470 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/123,359 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 9-11, 13-16 of copending Application No. 18/413,822 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-9 of copending Application No. 19/051,292 in view of Himmelsbach et al. (cited above), and Vervoort et al. (cited above).
The obviousness rational is the same as discussed above.
Thus, the present claims are prima facie obvious over the claims of the copending Application.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699