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 .
Detailed Action
Amended Claims 1-12 (dated 09/27/2024) are pending and now under consideration.
Priority
Applicants’ claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a 371 of PCT/US2023/065023 filed on 03/28/2023, which claims benefit of Provisional application 63/324,492 filed on 03/28/2022.
Information disclosure statement
The information disclosure statements (IDS) submitted on 09/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Objections-Abstract/Specification
The Abstract of the disclosure is objected to because, Abstract should be on a separate sheet of paper. The abstract of the disclosure is objected to because the abstract is presented as part of the first page of a WO publication. The abstract should be presented as a single sheet apart from all other bibliographic material including the information included on the first page of a WO publication. If EFS is used to submit a replacement abstract, the appropriate abstract (ABST) document code should be used for the one-page document. Correction is required. See MPEP § 608.01 (b).
Claim Rejections: 35 USC § 112(b)
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.
Claims 1, 4-7, 9-11 (claims 2-3, 8 and 12 depending therefrom) are 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 applicant regards as the invention.
Claims 1, 6-7 and 11 recites the phrase “effective amount…”; claims 4-5 recites the phrase “reduces…”; claim 9 recites the phrase “increased time…”; and claim 10 recites the phrase “…not significantly“ are considered to be a relative term which renders the claim indefinite. Claims 1-12 do not recite the conditions/metrics/measure under which the “effective amount…”, “reduces…” and “…not significantly“ is measured. In the art what is considered “effective amount…”, “reduces…”, “increased time…” and “…not significantly“ varies widely depending on the individual situation as well as the person making the determination. It is not clear to the examiner as to metes and bounds and, the scope of the claim is unclear. Clarification and correction is required.
Claim Rejections: 35 USC § 112(a)
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
I. Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus.”). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the biomolecule, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.”
“The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice . . ., reduction to drawings . . ., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.” MPEP 2163.
Furthermore, a “‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure ‘indicates that the patentee has invented species sufficient to constitute the gen[us].’ See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (‘[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.’). ‘A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).” MPEP 2163.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). See MPEP 2163(I).
Claims 1-12 as interpreted encompass a genera of structural elements in the claimed method and pharmaceutical compositions of treating reperfusion edema, said method and compositions comprising (i) any one or more inhibitors of sodium D-glucose cotransporter 2 (SGLT2) of undefined and unlimited structures in any patient and administering any dosage (as in claims 1-2 and 4-12); (ii) said pharmaceutical compositions comprising any recombinant tissue plasminogen activator (rtPA) including variants and mutants of undefined and unlimited structures in any patient and administering any dosage; and (iii) SGLT2 inhibitor is selected from the group consisting of canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin, luseogliflozin, remogliflozin etabonate, sergliflozin etabonate, sotagliflozin, tofogliflozin and combinations thereof for effectively treating reperfusion edema in any patient and administering any dosage (as in claim 3; also see 35 U.S.C. 112(b) rejections above for claims interpretation).
No information, beyond the characterization of a single composition comprising specific structure canagliflozin in an animal model (see Examples 2-4, pages 32-40 of specification) has been provided by the applicants’, which would indicate that they had possession of claimed genera of structural elements in the claimed method and pharmaceutical compositions of treating reperfusion edema, said method and compositions comprising (i) any one or more inhibitors of sodium D-glucose cotransporter 2 (SGLT2) of undefined and unlimited structures in any patient and administering any dosage (as in claims 1-2 and 4-12); (ii) said pharmaceutical compositions comprising any recombinant tissue plasminogen activator (rtPA) including variants and mutants of undefined and unlimited structures in any patient and administering any dosage; and (iii) SGLT2 inhibitor is selected from the group consisting of canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin, luseogliflozin, remogliflozin etabonate, sergliflozin etabonate, sotagliflozin, tofogliflozin and combinations thereof for effectively treating reperfusion edema in any patient and administering any dosage (as in claim 3; also see 35 U.S.C. 112(b) rejections above for claims interpretation).
As the claimed genera of structural elements in the claimed method and pharmaceutical compositions of treating reperfusion edema having widely variable structures and associated function in the claimed method and compositions, since minor changes in structure may result in changes affecting function and no additional information correlating structure with function has been provided. Furthermore, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features” (See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895).
Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed. Applicants are referred to the revised guidelines concerning compliance with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Enablement
II. Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for characterization of a single composition comprising specific structure canagliflozin in an animal model (see Examples 2-4, pages 32-40 of specification), does not reasonably provide enablement for a genera of structural elements in the claimed method and pharmaceutical compositions of treating reperfusion edema, said method and compositions comprising (i) any one or more inhibitors of sodium D-glucose cotransporter 2 (SGLT2) of undefined and unlimited structures in any patient and administering any dosage (as in claims 1-2 and 4-12); (ii) said pharmaceutical compositions comprising any recombinant tissue plasminogen activator (rtPA) including variants and mutants of undefined and unlimited structures in any patient and administering any dosage; and (iii) SGLT2 inhibitor is selected from the group consisting of canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin, luseogliflozin, remogliflozin etabonate, sergliflozin etabonate, sotagliflozin, tofogliflozin and combinations thereof for effectively treating reperfusion edema in any patient and administering any dosage (as in claim 3; also see 35 U.S.C. 112(b) rejections above for claims interpretation). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims without undue experimentation.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Claims 1-12, broadly encompass a genera of structural elements in the claimed method and pharmaceutical compositions of treating reperfusion edema, said method and compositions comprising (i) any one or more inhibitors of sodium D-glucose cotransporter 2 (SGLT2) of undefined and unlimited structures in any patient and administering any dosage (as in claims 1-2 and 4-12); (ii) said pharmaceutical compositions comprising any recombinant tissue plasminogen activator (rtPA) including variants and mutants of undefined and unlimited structures in any patient and administering any dosage; and (iii) SGLT2 inhibitor is selected from the group consisting of canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin, luseogliflozin, remogliflozin etabonate, sergliflozin etabonate, sotagliflozin, tofogliflozin and combinations thereof for effectively treating reperfusion edema in any patient and administering any dosage (as in claim 3; also see 35 U.S.C. 112(b) rejections above for claims interpretation). While the use of a few SGLT2 inhibitor comprising specific structural elements and rtPA are known in the art, there are no reports of procedures for use of the claimed structural elements in treating reperfusion edema i.e., a genera of structural elements in the claimed method and pharmaceutical compositions of treating reperfusion edema, said method and compositions comprising (i) any one or more inhibitors of sodium D-glucose cotransporter 2 (SGLT2) of undefined and unlimited structures in any patient and administering any dosage (as in claims 1-2 and 4-12); (ii) said pharmaceutical compositions comprising any recombinant tissue plasminogen activator (rtPA) including variants and mutants of undefined and unlimited structures in any patient and administering any dosage; and (iii) SGLT2 inhibitor is selected from the group consisting of canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin, luseogliflozin, remogliflozin etabonate, sergliflozin etabonate, sotagliflozin, tofogliflozin and combinations thereof for effectively treating reperfusion edema in any patient and administering any dosage (as in claim 3; also see 35 U.S.C. 112(b) rejections above for claims interpretation). Because there is no such readily available guidance in prior art, nor does the specification provides one, it would be undue experimentation for those skilled in the art to make and use said genera of molecules for intended purposes.
In view of the great breadth of the claims, amount of experimentation required to make and use the claimed composition, the lack of guidance, working examples, and unpredictability of the art in predicting the use of molecules and compositions described in the present invention for treating claimed disease condition(s). For the above purpose, the claimed invention would require undue experimentation. As such, the specification fails to teach one of ordinary skill how to use the full scope of the composition encompassed by the claims in the claimed method.
Thus, applicants have not provided sufficient guidance or shown any therapeutic procedures in their working examples to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including: a genera of structural elements in the claimed method and pharmaceutical compositions of treating reperfusion edema, said method and compositions comprising (i) any one or more inhibitors of sodium D-glucose cotransporter 2 (SGLT2) of undefined and unlimited structures in any patient and administering any dosage (as in claims 1-2 and 4-12); (ii) said pharmaceutical compositions comprising any recombinant tissue plasminogen activator (rtPA) including variants and mutants of undefined and unlimited structures in any patient and administering any dosage; and (iii) SGLT2 inhibitor is selected from the group consisting of canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin, luseogliflozin, remogliflozin etabonate, sergliflozin etabonate, sotagliflozin, tofogliflozin and combinations thereof for effectively treating reperfusion edema in any patient and administering any dosage (as in claim 3; also see 35 U.S.C. 112(b) rejections above for claims interpretation). The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 1924 (CCPA 1970)). Without sufficient guidance, determination of compositions for making and using said compositions in the claimed method is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly extensive and undue. See In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988). However, claims reading on significant numbers of inoperative embodiments would render claims non-enabled when the specification does not clearly identify the operative embodiments and undue experimentation is involved in determining those that are operative.” Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971); MPEP 2164.08(b). Here, the claims read on a significant number of inoperative embodiments.
In this regard, the application disclosure and claims are compared per the factors indicated in the decision In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). These factors are considered when determining whether there is sufficient evidence to support a description that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. The factors include but are not limited to: (1) the nature of the invention; (2) the breath of the claims; (3) the predictability or unpredictability of the art; (4) the amount of direction or guidance presented; (5) the presence or absence of working examples; (6) the quantity of experimentation necessary; (7) the relative skill of those skilled in the art. Each factor is here addressed on the basis of a comparison of the disclosure, the claims, and the state of the prior art in the assessment of undue experimentation. Without sufficient guidance, determination of a genera of active molecules having no specific structural elements in the claimed method and composition is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
Although the claims are examined in the light of the specification, specification cannot be read into the claims, i.e., the limitations of the specification cannot be read into the claims (see MPEP 2111 R-5).
415 F.3d at 1316, 75 USPQ2d at 1329. See also In re Hyatt, 211 F.3d 1367, 1372,54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969) (Claim 9 was directed to a process of analyzing data generated by mass spectrographic analysis of a gas. The process comprised selecting the data to be analyzed by subjecting the data to a mathematical manipulation. The examiner made rejections under 35 U.S.C. 101 and 102. In the 35 U.S.C. 102 rejection, the examiner explained that the claim was anticipated by a mental process augmented by pencil and paper markings. The court agreed that the claim was not limited to using a machine to carry out the process since the claim did not explicitly set forth the machine. The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997) (The court held that the PTO is not required, in the course of prosecution, to interpret claims in applications in the same manner as a court would interpret claims in an infringement suit. Rather, the “PTO applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant’s specification.”). The broadest reasonable interpretation of the claims must also be consistent with the interpretation that those skilled in the art would reach.
Claim Rejections: 35 USC § 102 (AIA )
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Al Mudhafar et al., (Annals of R.S.C.B., 2021, Vol. 25(3): 4876-488) when given the broadest reasonable interpretation.
Regarding claims 1-6 and 8-11, Al Mudhafar et al., disclose “Neuroprotective Effect of Empagliflozin (inhibitors of sodium D-glucose cotransporter 2 (SGLT2) on Cerebral Ischemia/Reperfusion Injury in Rat Model” see Abstract; Materials and Method; and entire document i.e., “an experimental model of 30 Sprague-Dawley rats were randomly allocated to five groups, sham group, I/R group, I/R+(DMSO as a vehicle), I/R+ intraperitoneal (i.p) Empagliflozin 5mg/kg 1 hour before induction of BCCAO, and I/R+ intraperitoneal Empagliflozin 10mg/kg 1hour before induction of BCCAO. Results: histopathological examination showed that Empagliflozin ameliorated the histological lesions induced by CI/R. Besides, the assessment of cerebral infarction size in each group showed that Empagliflozin reduced the infarction size in both used doses in the study. The immunohistochemical analysis of cerebral tissue expressed that CI/R causes a reduction in neuronal nuclear protein (NeuN protein) in the control and control-vehicle group as compared to sham group, while pre-treatment with Empagliflozin caused re-appearance of NeuN protein in both doses groups. Conclusions: The study concluded that Empagliflozin has a neuroprotective effect by reduction of cell necrosis and apoptosis due to inhibition of different mechanisms that cause cerebral tissue damage and neuronal death”;
Al Mudhafar et al., regarding claims 7-9 disclose “the patient is preferred to be treated within 4.5 hours of stroke onset with an intravenous plasminogen activator or mechanical thrombectomy” (page 4877);
Al Mudhafar et al., regarding claim 10, discloses mode of action of Empagliflozin “Its mode of action is exceptional, as it is independent of the extent of insulin sensitivity or the activity of pancreatic β-cells (page 4877); also see Results; see Fig. 1-3 (pages 4880-4883); discloses "Reperfusion phase" begins when the cerebral blood supply is restored to the ischemic area either by Thrombolysis or mechanical thrombectomy with activation of inflammatory elements, the release of neurotransmitters, endothelial cells dysfunction that leads to disruption of BBB, edema and neurological deficit” (see Discussion, page 4882).
Therefore, the reference of by Al Mudhafar et al., (Annals of R.S.C.B., 2021, Vol. 25(3): 4876-488) is deemed to anticipate claims 1-11 as written and when given the broadest reasonable interpretation and rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2).
Since the Office does not have the facilities for examining and comparing applicants’ method with the method of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed method and the method of the prior art (i.e., that the method of the prior art does not possess the same material structural and functional characteristics of the method of the instant invention). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Claim Rejections: 35 USC § 103
The following is a quotation of 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 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 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 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.
Claims 1-12 are rejected under 35 U.S.C. 103(a) as being unpatentable Al Mudhafar et al., (Annals of R.S.C.B., 2021, Vol. 25(3): 4876-488) as applied to claims 1-11 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Huang et al., (J. Pharmacol Exp Ther., 2022, Vol. 380: 230-241; published 03/01/2022), Langkilde AM., (US 10,973,836) and Labhasetwar V., (US 12,409,147).
The disclosure of Al Mudhafar et al., (Annals of R.S.C.B., 2021, Vol. 25(3): 4876-488) as applied to claims 1-11 is described above (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2). However, Al Mudhafar et al., are silent regarding wherein the composition comprises recombinant tissue plasminogen activator (rtPA) (as in claim 12).
Regarding claims 1-6 and 10-11, Huang et al., (J. Pharmacol Exp Ther., 2022, Vol. 380: 230-241; published 03/01/2022) also provide teaching, suggestion and motivation for the choice of one or more inhibitors of sodium D-glucose cotransporter 2 (SGLT2) for treating reperfusion edema and disclose “Empagliflozin Protects against Pulmonary Ischemia/Reperfusion Injury” (see Abstract; Fig. 1, page 232; Fig. 8, page 239; and entire document); provide teaching, suggestion and motivation for combination therapy comprising sodium D-glucose cotransporter 2 (SGLT2) and tissue plasminogen activator for treating reperfusion edema (see col. 1, ¶ 2, page 240).
Regarding claims 3 and 12, the following references provides teaching, suggestion and motivation to a skilled artisan regrading compositions comprising sodium D-glucose cotransporter 2 (SGLT2) and anti-thrombotic agent/tissue plasminogen activator:
Langkilde AM., (US 10,973,836) disclose pharmaceutical compositions comprising one or more inhibitors of sodium D-glucose cotransporter 2 (SGLT2) including treatment of stroke (Abstract; and entire document); wherein the inhibitor is selected from the group consisting of canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin, luseogliflozin, remogliflozin etabonate, sergliflozin etabonate, sotagliflozin, tofogliflozin and combinations thereof; said reference also suggests sodium D-glucose cotransporter 2 (SGLT2) in combination with antithrombotic agent (col. 2, lines 58-67 to col. 31-35); in the treatment of stroke (col. 5, lines 47-65); and end-organ perfusion or volume overload (col. 6, lines 45-60).
Labhasetwar V., (US 12,409,147) disclose pharmaceutical compositions comprising nanoparticle encapsulated recombinant tissue plasminogen activator (tPA) in combination with other therapeutic agents for the treatment of stroke (see Abstract; claims and entire document).
As such, disclosure of strategy and methods for “compositions comprising sodium D-glucose cotransporter 2 (SGLT2) and anti-thrombotic agent/tissue plasminogen activator”, as in claims 3, 7 and 11-12 of the instant invention, such as that of references of Langkilde AM., and Labhasetwar V., teaching the advantages of said modifications, clearly suggests to a skilled artisan to modify the teachings of Al Mudhafar et al., and Huang et al., and incorporate the structural and functional elements of Langkilde AM., and Labhasetwar V., in the claimed method and pharmaceutical compositions for combination therapy comprising sodium D-glucose cotransporter 2 (SGLT2) and tissue plasminogen activator for treating reperfusion edema as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since the method and pharmaceutical composition for combination therapy comprising sodium D-glucose cotransporter 2 (SGLT2) and tissue plasminogen activator for treating reperfusion edema are well known in the art.
Regarding specific choice of sodium D-glucose cotransporter 2 (SGLT2) are also provided/suggested in the combination of references, and examiner also takes the position the following position; optimization of known variables, and the examiner finds support in: MPEP 2144.05 [R-5]: A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in choice of sodium D-glucose cotransporter 2 (SGLT2) will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". As to optimization results, a patent will not be granted based upon the optimization of result effective variables when the optimization is obtained through routine experimentation unless there is a showing of unexpected results which properly rebuts the prima facie case of obviousness. See In re Boesch, 617 F.2d 272,276,205 USPQ 215,219 (CCPA 1980). See also In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990), and In re Aller, 220 F2d 454,456,105 USPQ 233,235 (CCPA 1955). Furthermore, "it is prima facie obvious to combine two or more methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Therefore, claims 1-12 are rejected under 35 U.S.C. 103(a) as being unpatentable Al Mudhafar et al., (Annals of R.S.C.B., 2021, Vol. 25(3): 4876-488) as applied to claims 1-11 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Huang et al., (J. Pharmacol Exp Ther., 2022, Vol. 380: 230-241; published 03/01/2022), Langkilde AM., (US 10,973,836) and Labhasetwar V., (US 12,409,147).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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