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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 5, 2026, has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I (i.e., claims 1-10 and 12-19 drawn to a combination comprising (a) a sulfonylurea and (b) at least one of (i) an insulin modulator, and (ii) an aldosterone antagonist) in the reply filed on January 15, 2025, is acknowledged. Additionally, Applicant’s election without traverse of Species A (i.e., a single and specific combination as glibenclamide as a sulfonylurea and potassium canrenoate as an aldosterone antagonist); and Species B (i.e., ischemia as a single and specific disease) in the reply filed on January 15, 2025, is acknowledged.
Status of Claims
Claims 1-65 were originally filed on January 4, 2022.
The amendment received on August 12, 2022, canceled claims 11, 20-32, 44-50, 52-55, 57-59, and 62-64; and amended claims 2-10, 12-14, 16-19, 34-43, 51, 56, 60-61, and 65. The amendment received on September 9, 2025, canceled claims 2-3, 9-10, 16-18, and 37; and amended claims 1, 4-5, 15, 19, 33-34, 38, 40, 42, and 56. The amendment received on March 5, 2026, amended claims 1 and 15.
Claims 1, 4-5, 7-8, 12-15, 19, 33-36, 38-43, 51, 56, 60-61, and 65 are currently pending and claims 1 and 13-15 are under consideration as claims 33-36, 38-43, 51, 56, 60-61, and 65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and claims 4-5, 7-8, 12, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 15, 2025.
Priority
The present application claims status as a 371 (National Stage) of PCT/EP2020/069343 filed July 9, 2020, and claims priority under 119(a)-(d) to Greek Application No. 20190100288 filed on July 9, 2019.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for Greek Application No. 20190100288, which papers have been placed of record in the file. Please note that the Greek application is in English and therefore no further action is necessary.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
Claims 1 and 13-15 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.
Independent claim 1 is drawn to combination comprising glibenclamide and potassium canrenoate. Independent claim 15 is drawn to a pharmaceutical product comprising a combination comprising glibenclamide and potassium canrenoate. In each claim, the combination is to be synergistic. Synergy is defined in the instant specification as when the combined effect of two drugs exceeds the effects of each drug given alone (See instant, pg. 24, 3rd paragraph). As such, the combination either alone or in pharmaceutical product must exhibit the function of synergy such that the combined effect of glibenclamide and potassium canrenoate exceeds the effects of each drug given alone. As such, the “function” of the claimed combination and pharmaceutical product is that they are synergistic. Thus, this is clearly the function to which the claims refer.
Regarding the structure of the claimed combined combination and pharmaceutical products, the structures of glibenclamide and potassium canrenoate are clear. The instant specification teaches that potassium canrenoate is an aldosterone antagonist of the spirolactone group (See instant specification, pg. 17, last paragraph to pg. 18, 1st paragraph). The instant specification also depicts the chemical structure of potassium canrenoate (See instant specification, pg. 18, 5th paragraph). Potassium canrenoate is typically given intravenously at doses ranging between 200 mg/day and 600 mg/day (See instant specification, pg. 14, 2nd paragraph). Moreover, the instant specification teaches that glibenclamide is a second-generation sulfonylurea (See instant, pg. 7, last paragraph). The chemical structure of glibenclamide is depicted on pg. 9, 4th paragraph). It is a sulfonylurea receptor-1 (Sur-1) antagonist that is used as a hypoglycemic agent to treat diabetes (See instant, pg. 10, 1st paragraph). It is available as a generic and sold in doses of 1.25, 2.5 and 5 mg and is administered orally for treatment of T2D (See instant, pg. 10, 2nd paragraph). The usual starting dose of glibenclamide as initial therapy is 2.5 to 5 mg daily and the usual maintenance dose is in the range of 1.25 to 20 mg daily (See instant, pg. 10, 2nd paragraph).
The written description requirement may be met by provided a representative number of species of the genus and/or in light of the state of the art. With regard to the state of the art, there is no expressed correlation between these two agents being synergistic in a combination or in a pharmaceutical product for any effect taught in the prior art.
Alternatively, the written description requirement may be met by providing a representative number of species of the genus. In this, the instant specification fails to define or clearly identity what constitutes a synergistic combination or a pharmaceutical product thereof comprising glibenclamide and potassium canrenoate. In Example 1, the combination of potassium canrenoate and glibenclamide was evaluated in a rat model of cerebral ischemia and reperfusion injury (See instant, Example 1). Potassium canrenoate was administered at dosages of 0.33 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg, and glibenclamide was administered at dosages of 1 mcg/kg, 3 mcg/kg, 10 mcg/kg, and 30 mcg/kg (See instant, pg. 68, 2nd paragraph). All monotherapies with the exception of the lowest doses of potassium canrenoate and glibenclamide (treatments E and I) showed a statistically significant decrease in the brain infarct size when compared with the control group (See instant, pg. 68, last paragraph). With respect to the modified neurological severity score, the lowest doses of both agents did not show statistically significant decrease when compared to the control group on days 2 and 7 (See instant, pg. 69, 1st paragraph). There were two combinations of glibenclamide and potassium canrenoate examined: potassium canrenoate at a dosage of 0.33 mg/kg and glibenclamide at a dosage of 1 mcg/kg (i.e., Group O), and potassium canrenoate at a dosage of 1 mg/kg and glibenclamide at a dosage of 10 mcg/kg (i.e., Group R) (See instant, pg. 69, 1st paragraph). The instant specification states that the double combinations, i.e., groups O and R, showed a statistically significant change in brain infarct size and decrease in the modified NSS when compared with control groups on Day 2 and 7 (See instant, pg. 70, 2nd to 3rd paragraph). In conclusion, the instant specification indicates that it is clear from the results that the low dosages of potassium canrenoate and glibenclamide, which are ineffective when administered as monotherapies, show a statistically significant efficacy when they are combined (See instant, pg. 71, 1st paragraph). Furthermore, the instant specification teaches that the dose of glibenclamide, which produced a synergistic effect in Group O (i.e., 1 mcg/kg twice daily, that is 0.66 mcg in the rats weighing 330 g) was significantly lower than the dose previously reported in the literature for stroke, i.e., daily infusions of 200 ng/h, that is 4.8 mcg (See instant, pg. 71, 1st paragraph). Table 2 demonstrates that the Group O double combination resulted in a synergistic effect, i.e., brain infarct size and decreased modified NSS on Days 2 and 7, when compared to monotherapies (See instant, Table 2), but the Group R double combination did not result in a synergistic effect when compared to monotherapies (See instant, Table 2). As such, the instant specification only teaches a single species of combination that exhibits synergy. However, the claimed invention is directed to a composition and not a method of using the composition. Thus, the dosage that is dependent upon the subject body weight is not dispositive as to whether Applicants are in possession of a representative number of synergistic combinations of glibenclamide and potassium canrenoate. Nor is there any indication a core combination structure necessary for the combination to exhibit a synergistic effect. Therefore, the claims are directed to a combination of glibenclamide and potassium canrenoate with a certain function, i.e., being synergistic, but no correlated structure associated with that function other than one specific combination, i.e., Group O. Without such structure, the specification does not convey possession of the breadth of the claimed genus.
While the instant specification describes experiments demonstrating the efficacy of a combination of glibenclamide and potassium canrenoate (i.e., Group O) in synergistically reducing brain infarct volume, e.g., Example 1, Tables 1-2, such an example does not clearly indicate a core structure necessary for a combination of glibenclamide and potassium canrenoate to exhibit synergy. As such, the combination described in the example is not representative of the scope of claimed invention. Thus, this is not sufficient for the skilled artisan to envisage which combinations preserve function.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, what is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides which preserve the required function, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Therefore, claims 1 and 13-15 do not meet the written description requirement.
Maintained/Modified Rejections in light of Applicants’ Amendments
Claim Rejections - 35 USC § 102
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.
Claims 1 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sorrentino et al., J. Cardiovasc. Pharmacol. 36:230-235 (2000) (note: page number references below will be from pages 1-15 based on the printout of the article), alone or as evidenced by, Synergy”, Dictionary.com, available online at https://www.dictionary.com/browse/synergy, 6 pages (accessed 2019). Please note that the rejection has been updated in light of Applicants’ amendments.
For claims 1 and 13, Sorrentino et al. discloses a set of experiments to study the probable interaction of drugs with K+ channels, the relaxation of precontracted phenylephrine (1 µM) aorta rings induced by spironolactone, canrenone, or potassium canrenoate in the presence of glibenclamide (30 µM) or tetraethylammonium (10 µM), which are known K+ channel inhibitors (See Sorrentino article, pg. 3, last paragraph to pg. 4, 1st paragraph). The inhibitors were added to the organ bath 15 min before phenylephrine-induced contraction (See Sorrentino article, pg. 4, 1st paragraph). The organ bath contained excised rat thoracic aortae that were cut in rings and placed in 2.5 ml water filled with thermostated (37°C) and gassed (95% O2 and 5% CO2) Krebs solution with the following composition (mM): NaCl, KCl, CaCl2, MgSO4, KHPO4, NaHCO3, and glucose (See Sorrentino article, pg. 3, 4th paragraph). Potassium canrenoate was added to the organ bath in 0.5 log unit in a cumulative manner from 0.1 to 10 mM) (See Sorrentino article, pg. 3, 5th paragraph). Therefore, potassium canrenoate and glibenclamide were combined in the same organ bath thereby satisfying the claim limitations with respect to a combination comprising (a) glibenclamide as a sulfonylurea and (b) potassium canrenoate as an aldosterone antagonist as recited in instant claim 1. Moreover, since the two drugs are in an organ bath that contains water and a Krebs solution where water or any of the components in the Krebs solution constitute a pharmaceutically acceptable carrier, diluent or excipient, the combination of the two drugs in the organ bath constitute a pharmaceutical composition as recited in instant claim 13.
For claims 1 and 15, with respect to the combination being a synergistic combination, pursuant to MPEP 2111, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1).
It is noted that the instant specification defines a “synergistic” drug interaction if the combined effect of the two drugs exceeds the effects of each drug given alone (See instant, pg. 24, 3rd paragraph). Such a definition is analogous to the plain and ordinary meaning of the term where “synergy” is defined as the interaction that when combined produce a total effect that is greater than the sum of the individual elements, contributions, etc. (See “Synergy”, Dictionary.com, available online at https://www.dictionary.com/browse/synergy, 6 pages (accessed 2019) at pg. 1). In light of the definitions of the term, the scope of claim 1 encompasses a combined effect of glibenclamide and potassium canrenoate that exceeds the effects of each individual agent alone. In other words, a combination of glibenclamide and potassium canrenoate that will produce a total effect that is greater than the sum of each individual agent. As such, the combination being “synergistic” where the combination produces a total effect or results in a combined effect that is greater than the sum of each individual agent constitutes the resulting intended use of the combination and/or a functional inherent property of the combination that is dependent upon the claimed combination structure. Properties are the same when the structure and composition are the same. Thus, burden shifts to applicant to show unexpected results, by declaration or otherwise. In re Fitzgerald, 205 USPQ 594. In the alternative, the claimed properties would have been present once the composition was employed in its intended use. In re Best, 195 USPQ 433.
Furthermore, since Sorrentino et al. teaches a combination of glibenclamide and potassium canrenoate thereby satisfying the required structural limitations of claims 1 and 15, the functional property (i.e., being a synergistic combination) of the combination as claimed and the prior art combination would necessarily read upon the same. The discovery of a previously unappreciated property of a prior art composition, or a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new functional property (i.e., being a synergistic combination) which would necessarily read upon the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 4333 (CCPA 1977).
Additionally and/or alternatively, when interpreting “synergy” as an intended use of the combination, pursuant under MPEP 2111.02(II):
statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein. (emphasis added).
As such, a combination (i.e., glibenclamide and potassium canrenoate in this case) is intended to produce a total effect that is greater than the sum of each individual agent. Thus, the claimed combination being a synergistic preparation is the intended use of the combination. Since Sorrentino et al. discloses a specific combination of glibenclamide and potassium canrenoate thereby satisfying the structural limitations of instant claim 1, it would then follow that the Sorrentino combination is capable of performing the claimed intended use, i.e., being synergistic. Therefore, the teachings of Sorrentino et al. satisfy the claim limitation with respect to where the combination is synergistic as recited in instant claims 1 and 15.
For claim 14, as discussed supra, Sorrentino et al. discloses potassium canrenoate and glibenclamide in an organ bath with water and Krebs solution. As such, the two drugs in the organ bath are in a form that is suitable for parenteral administration, i.e., a liquid. Although, Sorrentino et al. does not expressly disclose that the combination of drugs are suitable for parenteral administration, the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02. Moreover, “[t]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. As such, claim 14 can be deemed to recite an intended use of the claimed pharmaceutical composition, but requires the structure of the claimed pharmaceutical composition to be in a form that is capable of being administered via parenteral administration. A recitation of an intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Accordingly, since Sorrentino et al. discloses the drugs in a form that is capable of being administered parenterally, the intended use of the composition is also anticipated.
For claim 15, as discussed supra, Sorrentino et al. discloses a pharmaceutical composition comprising glibenclamide, potassium canrenoate, and a pharmaceutically acceptable carrier, diluent or excipient. Pursuant to MPEP 2111, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1).
Although the instant specification teaches that a pharmaceutical product can be a kit of parts (See instant, pg. 35, 3rd paragraph), the specification does not define what constitutes a pharmaceutical product. As such, the broadest reasonable interpretation of a “pharmaceutical product” encompasses any type of product that comprises both glibenclamide and potassium canrenoate in some fashion, e.g., a pharmaceutical composition. As such, a pharmaceutical composition constitutes a species of pharmaceutical product. Thus, since Sorrentino et al. discloses a pharmaceutical composition comprising both components as discussed supra, it would also follow that Sorrentino et al. discloses a pharmaceutical product comprising both components. Therefore, the disclosure of Sorrentino et al. satisfies the claim limitations as recited in instant claim 15.
Accordingly, the disclosure of Sorrentino et al. anticipates instant claims 1 and 13-15.
Applicants’ Arguments
Applicants contend that the claimed invention is novel over Sorrentino because Sorrentino does not teach a synergistic combination of the claimed agents; especially since Sorrentino discloses that the presence of glibenclamide has no effect on the relaxation effect of potassium canrenoate on pre-contracted aorta rings (See Applicant’s Response, received on 3/5/26, pg. 6-7). Applicants also assert that the claimed invention exhibits an unexpected synergistic effect that could not have been predicted based on the cited art (See Applicant’s Response, received on 3/5/26, pg. 7-8).
Response to Arguments
Applicant's arguments filed 3/5/26 have been fully considered but they are not persuasive for the following reasons.
In response to Applicant’s first argument, i.e., Sorrentino does not teach a synergistic combination of the claimed agents; especially since Sorrentino discloses that the presence of glibenclamide has no effect on the relaxation effect of potassium canrenoate on pre-contracted aorta rings, it is found unpersuasive. Pursuant to MPEP 2152.02(b), if a claimed invention is described in a patent, published patent application, or printed publication, such a document may be available as prior art under AIA 35 U.S.C. 102(a)(1). The prior art provisions of AIA 35 U.S.C. 102(a)(1) and (a)(2) require only that the claimed invention is "described" in a prior art document (patent, published patent application, or printed publication).
The two basic requirements that must be met by a prior art document in order to describe a claimed invention such that it is anticipated under AIA 35 U.S.C. 102 are the same as those under pre-AIA 35 U.S.C. 102. First, "each and every element of the claimed invention" must be disclosed either explicitly or inherently, and the elements must be "arranged or combined in the same way as in the claim." See In re Gleave, 560 F.3d 1331, 1334, 90 USPQ2d 1235, 1237-38 (Fed. Cir. 2009). Second, a person of ordinary skill in the art must have been enabled to make the invention without undue experimentation. See Gleave, 560 F.3d at 1334, 90 USPQ2d at 1238 (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314, 88 USPQ2d 1381, 1383 (Fed. Cir. 2008), and In re LeGrice, 301 F.2d 929, 940-44, 133 USPQ 365, 372 (CCPA 1962)). Thus, in order for a prior art document to describe a claimed invention such that it is anticipated under AIA 35 U.S.C. 102(a)(1) or (a)(2), it must disclose all elements of the claimed invention arranged as they are in the claim, and also provide sufficient guidance to enable a person skilled in the art to make the claimed invention.
There is, however, no requirement that a prior art document meet the "how to use" requirement of 35 U.S.C. 112(a) in order to qualify as prior art. See Gleave, 560 F.3d at 1334, 90 USPQ2d at 1237-38; see also In re Schoenwald, 964 F.2d 1122, 1124, 22 USPQ2d 1671, 1673 (Fed. Cir. 1992) (holding that a claimed compound was anticipated even though the prior art reference did not disclose a use for the compound); Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1380-81, 67 USPQ2d 1664, 1670 (Fed. Cir. 2003) (pointing out that actually reducing the invention to practice is not necessary in order for a prior art reference to anticipate); Impax Labs, 468 F.3d at 1382 (stating that "proof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation"). Furthermore, compliance with the "how to make" requirement is judged from the viewpoint of a person of ordinary skill in the art, and thus does not require that the prior art document explicitly disclose information within the knowledge of such a person. See In re Donohue, 766 F.2d 531, 533, 226 USPQ 619, 621 (Fed. Cir. 1985).
In the instant case, regarding the first basic requirement, as discussed in the rejection supra, the Sorrentino expressly discloses a combination comprising glibenclamide and potassium canrenoate where the combination is present in water, i.e., a water bath. It is noted that the features upon which applicant relies (i.e., amounts of each glibenclamide and potassium canrenoate) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As such, there is no required structural limitation that both potassium canrenoate and glibenclamide are present in any amount, let alone an amount that would result in synergy. The Examiner notes that a vial containing glibenclamide and a vial containing potassium canrenoate sitting next to each other on a pharmacy shelf would read on the structure of instant claim 1. Thus, the Sorrentino disclosure expressly discloses every structural claim limitation as recited in instant claims 1 and 13-15.
The remaining limitation, i.e., the combination being synergistic, appears to be the crux of Applicant’s argument as not being disclosed by Sorrentino. As such, the question is whether the Sorrentino disclosure expressly or inherently teaches this limitation. Although it is acknowledged that Sorrentino does not expressly disclose that the combination of glibenclamide and potassium canrenoate is synergistic and even discloses that glibenclamide did not affect the function of potassium canrenoate on pre-contracted aorta rings, the answer to the above question is yes. As discussed in the rejection supra, this limitation is inherently disclosed by Sorrentino. More specifically, the claimed combination being synergistic constitutes the intended use/functional property of the claimed combination/pharmaceutical products in the preamble of claim 1 and 15. As acknowledged by Applicant, the definition of “synergy” in the instant specification refers to the combined effect exceeding the effects of each drug given alone, but there is no limit as to which combined effect would exceed the effects of each drug given alone thereby encompassing any combined effect. Plus, it is noted that the definition requires the drugs to be provided/administered/given to a subject or culture in order for the combined effect to result. As such, the definition of “synergy” requires a manipulative step in order to achieve a synergistic effect. However, Applicant is respectfully reminded that the claimed invention is directed to a product and not a method of using the product. Pursuant to MPEP 2111.02(II),
[i]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation).
During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) (emphasis added).
In the instant case, since Sorrentino et al. discloses a specific combination of glibenclamide and potassium canrenoate in a water bath thereby satisfying the structural limitations of instant claims 1 and 15, it would then follow that the Sorrentino combination is capable of performing the claimed intended use, i.e., being synergistic such that there is a combined effect exceeding the effects of each drug given alone. Thus, given the structure of the Sorrentino’s combination/pharmaceutical product is encompassed by the scope of the claimed combination/pharmaceutical product, it would then follow that Sorrentino’s combination/pharmaceutical product is capable of performing the claimed functional property/intended use.
Furthermore, pursuant to MPEP 2112(I),
the claiming of a new use, new function or unknown property which is necessarily present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The discovery of a previously unappreciated property of a prior art composition, or a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
Moreover, pursuant to MPEP 2112.01(I),
where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Pursuant to MPEP 2112.01(II), “[p]roducts of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. In the instant case, as discussed supra, Sorrentino discloses the claimed structural limitations of a combination/pharmaceutical product comprising potassium canrenoate and glibenclamide. Thus, given that the teachings of Sorrentino anticipate the claimed structure of the combination/pharmaceutical product, the teachings of Sorrentino would also inherently anticipate the claimed function/intended. Therefore, contrary to Applicant’s argument, Sorrentino expressly discloses a synergistic combination/pharmaceutical product comprising potassium canrenoate and glibenclamide.
Regarding the second basic requirement for a 102 rejection, Sorrentino expressly combines glibenclamide and potassium canrenoate in a water bath. Therefore, an ordinary skilled artisan would be enabled to make the invention without undue experimentation. Importantly, as stated supra, the MPEP makes clear that there no requirement that a prior art document meet the "how to use" requirement of 35 U.S.C. 112(a) in order to qualify as prior art. The Federal Circuit has found that the intended use of an invention does not need to be expressly disclosed, and an invention does not need to be reduced to practice in order for anticipation of an invention. Thus, a person of ordinary skill in the art would be enabled to make the invention without undue experimentation in light of the Sorrentino disclosure.
In response to Applicant’s second argument, i.e., the claimed invention exhibits an unexpected synergistic effect that could not have been predicted based on the cited art, it is found unpersuasive. Pursuant to MPEP 2152.06, in addition to persuasively arguing that the claims are patentably distinguishable over the prior art or amending the claims to overcome the prior art rejection, a rejection under 35 U.S.C. 102(a)(1) or 102(a)(2) can be overcome by:
(A) Submitting a benefit claim under 35 U.S.C. 120 within the time period set in 37 CFR 1.78 by providing the required reference to a prior application in a corrected application data sheet under 37 CFR 1.76 and by establishing that the prior application satisfies the enablement and written description requirements of 35 U.S.C. 112(a), or filing a grantable petition to accept an unintentionally delayed benefit claim under 37 CFR 1.78. See MPEP § 211 et seq.; or
(B) Submitting a benefit claim under 35 U.S.C. 119(e) within the time period set in 37 CFR 1.78 by providing the required reference to a prior provisional application in a corrected application data sheet under 37 CFR 1.76 and by establishing that the prior application satisfies the enablement and written description requirements of 35 U.S.C. 112(a) or filing a grantable petition to accept an unintentionally delayed benefit claim under 37 CFR 1.78. See MPEP § 211 et seq.; or
(C) Submitting a claim to priority under 35 U.S.C. 119(a) - (d) within the time period set in 37 CFR 1.55 by identifying a prior foreign application in a corrected application data sheet under 37 CFR 1.76 and by establishing that the prior foreign application satisfies the enablement and written description requirements of 35 U.S.C. 112(a) or filing a grantable petition to accept a delayed priority claim under 37 CFR 1.55. See MPEP §§ 213 - 216. The foreign priority filing date must antedate the reference and be perfected. The filing date of the priority document is not perfected unless applicant has filed a certified priority document in the application (and an English language translation, if the document is not in English) (see 37 CFR 1.55(g) ); or
(D) Filing an affidavit or declaration under 37 CFR 1.130 to establish that an applied disclosure that was not made under 35 U.S.C. 102(a)(1) more than one year before the effective filing date of the claimed invention is not prior art under 35 U.S.C. 102(a) due to an exception listed in 35 U.S.C. 102(b). Under 37 CFR 1.130(a), an affidavit or declaration of attribution may be submitted to except a disclosure as prior art because it was made by the inventor or a joint inventor, or the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor. Under 37 CFR 1.130(b), an affidavit or declaration of prior public disclosure may be submitted to except an intervening disclosure as prior art if the subject matter disclosed had been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or joint inventor (1) before the date the intervening disclosure was made on which the rejection is based, or (2) before the date the subject matter in the U.S. patent, U.S. patent application publication, or WIPO published application on which the rejection is based was effectively filed. See MPEP §§ 717 and 2155; or
(E) Establishing common ownership or establishing evidence of a Joint Research Agreement to overcome a 35 U.S.C. 102(a)(2) rejection or a 35 U.S.C. 103 rejection based on prior art under 35 U.S.C. 102(a)(2) by establishing entitlement to the 35 U.S.C. 102(b)(2)(C) exception. See MPEP §§ 717.02 and 2154.02(c).
As such, potential unexpected results are not a means of overcoming a 102(a)(1) rejection. Rather, potential unexpected results constitute a secondary consideration that may overcome an 103 rejection. See MPEP 2145. Therefore, an evaluation of whether the claimed invention exhibits unexpected results is unnecessary as the rejection is one of anticipation and not obviousness.
Accordingly, the rejection of claims 1 and 13-15 is maintained as Applicants’ arguments are found unpersuasive.
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 and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 and 34-58 of copending Application No. 18/684,454 (Vogiatzis et al. US 2024/0366729 A1). Please note that the rejection has been updated in light of Applicants’ amendments. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘454 claims:
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(‘454 claims 1, 4-5, 9-10, and 18). It is noted that since the transitional phrase utilized in the instantly claimed invention is “comprising” the inclusion of a Nurr1 agonist in ‘454 is inherently encompassed by the instant combination/composition/product. Moreover, although ‘454 does not expressly claim that the combination/composition is synergistic, such a limitation is inherently present for the reasons stated in the 102 rejection supra. Thus, since ‘454 claims a combination of a sulfonylurea such as glibenclamide and an aldosterone antagonists such as potassium canrenoate, the ‘454 claims anticipate instant claims 1 and 13-15. ‘454 claims 38-58 are directed to a method of using the combination, which also anticipates the instantly claimed invention. Therefore, the ‘454 claimed invention is not patentably indistinct from the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants’ Arguments
Applicants contend that the obviousness-type double patenting rejection over the ‘454 application should be withdrawn pursuant to MPEP 804(I)(B)(1)(b)(i) given that it has a patent term filing date of August 26, 2022, as compared to the instant application that has a patent term filing date of July 9, 2020 (See Applicants Response received on 3/5/26, pg. 8).
Response to Arguments
Applicant's arguments filed 3/5/26 have been fully considered but they are not persuasive because the provisional nonstatutory double patenting rejection over the ‘454 is not the only remaining rejection. It is acknowledged that the ‘454 application has a later effective filing date than the instant application. However, the provisional rejection is maintained until it is the only remaining rejection. Thus, the double-patenting rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
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