DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ amendment and remarks, filed on 10/01/2025, in which claims 1-6, 8-10, 12-14, and 16-18 are amended, claims 7 and 19-20 are canceled, and claims 21-23 are newly added.
Claims 1-6, 8-18, and 21-23 are pending and are examined on the merits herein.
Priority
The instant application is a 371 of PCT/IN2021/050451, filed on 05/10/2021, which claims foreign priority to India 202021019866, filed on 05/11/2020.
Objections and Rejections Withdrawn
Applicant’s amendment and remarks, filed 10/01/2025, with respect that the drawings are objected to because the legend in figure 5 and the labels on the axis in figures 6-7 are not legible has been fully considered and is persuasive, as the amended drawings are legible.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 6, 10, 13-14, 16-17, and 19-20 are objected to because of typographical errors has been fully considered and is persuasive, as the errors have been corrected.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 1-4, 6-9, 11-13, 15-16, and 18-19 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention has been fully considered and is persuasive, as claim 1 has been amended to specify that E is selected from C, N, and salts of N thereof, claims 1-3 have been amended to recite
PNG
media_image1.png
108
123
media_image1.png
Greyscale
and thus specify the point of attachment, claim 1 has been amended to recite “a denotes the presence or absence of a double bond between CR4-ER3 and b denote the presence of absence of a double bond between CR5-CR6’, claims 1-3 have been amended to remove the language “such as”, claims 2-3 have amended the connectivity of E, claim 4 has been amended to replace “Formula I” with “Formula W”, claim 9 has been amended to be dependent from claim 1 and claim 19 has been canceled, and claim 12 has been amended to recite “a virus infected cell” and thus provide proper antecedence for the claim. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 2-3 and 6 are rejected under 35 U.S.C. 112(d) has been fully considered and is persuasive, as claim 1 has been amended to include compounds wherein R3 is absent, claim 4 has been amended to be an independent claim, and claim 6 has been amended to encompass a pharmaceutical composition. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 1-4, 7-9, 11, and 18, are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Davisson has been fully considered and is persuasive, as claim 1 is amended to recite wherein in the presence of
PNG
media_image2.png
46
52
media_image2.png
Greyscale
, R4-6 are each independently selected from -H and -OH, and claim 7 is canceled. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claim 7 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yadav has been fully considered and is persuasive, as claim 7 is canceled. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Yadav and Zhang has been fully considered and is persuasive, as claims 19-20 are canceled. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 1, 6, 12-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Davisson has been fully considered and is persuasive, as the scope of the claim 1 has been amended to recite wherein in the presence of
PNG
media_image2.png
46
52
media_image2.png
Greyscale
, R4-6 are each independently selected from -H and -OH. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 1-5, 7-10 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,084,843 has been fully considered and is persuasive, as a terminal disclaimer has been approved for this patent. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 6, 11-17, and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,084,843, as applied to claim 1, further in view of Yadav, Zhang, and Chen, has been fully considered and is persuasive, as a terminal disclaimer has been approved for this patent. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 1-4, 6-10 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-12, 17, and 25-29 of copending Application No. 17/415,676 has been fully considered and is persuasive, as a terminal disclaimer has been approved for this application. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 1-10 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-12, 17, 25-27 and 29 of copending Application No. 18/692,298 has been fully considered and is persuasive, as a terminal disclaimer has been approved for this application. This rejection has been withdrawn.
Applicant’s amendment and remarks, filed 10/01/2025, with respect that claims 11-17 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-27 and 29 of copending Application No. 18/692,298 further in view of Yadav, Zhang, and Chen has been fully considered and is persuasive, as a terminal disclaimer has been approved for this application. This rejection has been withdrawn.
The following are maintained or modified grounds of rejection necessitated by Applicant’s amendment, in which the scope of the claim 1 has been amended to recite wherein in the presence of
PNG
media_image2.png
46
52
media_image2.png
Greyscale
R4, R5, and R6 are each independently selected from -H and -OH.
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 1-3, 6, 8-9, 11-13, 15-16, 18, and 22-23 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-3 have been amended to recite “R4, R5, and R6 are each independently selected from” on line 11 of page 4, line 6 of page 6, and line 6 of page 8. The variables R4, R5, and R6 are not previously recited as occurring in Formula I-III. It is unclear whether what variables are being limited in this recitation. For purposes of compact prosecution, the claim will be interpreted as further limiting the structures of R4, R5, and R6.
Claim 3 recites Formula III, wherein “a denotes the presence or absence of a double bond between CR4-ER3 and b denote the presence of absence of a double bond between CR5-CR6.” However, Formula III does not recite any of CR4, CR5 or CR6. For purposes of compact prosecution, the claim will be interpreted in light of the positions of CR4, CR5 and CR6 in claim 1 from which it depends.
Claim Rejections - 35 USC § 112(a)
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 1-3, 6, 8-9, 11-13, 15-16, 18, and 22-23 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1-3 have been amended to recite wherein in the presence of
PNG
media_image2.png
46
52
media_image2.png
Greyscale
R4, R5, and R6 are each independently selected from -H and -OH. Thus the scope of claims 1-3, 6, 8-9, 11-13, 15-16, 18, and 22-23 now excludes the sub-genus of compounds of Formula I which contain a morpholino functional group and an alkoxy group on any of R4, R5, or R6. However, this sub-genus has not been previously disclosed and thus there is no support for a claim excluding the recited sub-genus. MPEP 2163(I)(B) states that newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure. MPEP 2173.05(i) states that any negative limitations or exclusionary proviso must have basis in the original disclosure and that the mere absence of a positive recitation is not basis for an exclusion.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 8, and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomena without significantly more.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes. The claim is drawn to a composition of matter which is one of the four statutory categories.
Step 2A, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes. The claims are directed towards the natural phenomenon of chemical structures including the compound Cleistanthin-A. As evidenced by Zhang et al. (European Journal of Medicinal Chemistry, 2014; PTO-892), Cleistanthin-A (Figure 1, reproduced in part below) is a naturally occurring compound (abstract), and thus a nature-based product. Furthermore, there is no indication in the record that isolation of formula A results in a marked difference in structure, function, or other properties as compared to Cleistanthin-A as such this is a product of nature exception.
PNG
media_image3.png
221
213
media_image3.png
Greyscale
Step 2A, Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
No. This judicial exception is not integrated into a practical application because merely stating an intended use for the composition does not provide a structural limitation or add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The structural elements of the composition in the claim are limited to including the chemical formula, and intended use does not provide an additional element that amounts to significantly more than the judicial exception. Thus the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not include additional structural elements beyond that of the chemical formula.
As the instant claims recite judicial exceptions and intended use for which the judicial exception is not integrated into a practical application and no elements that amount to significantly more than the judicial exception are recited, the claims were found to not be drawn to eligible subject matter under 35 USC 101.
Response to Arguments
Applicant's arguments filed 10/01/2025 have been fully considered but they are not persuasive.
Insofar as Applicant’s arguments are applicable to the current rejections, Applicant argues that the claims have been amended to include new structural limitations and now recites "An antiviral V-ATPase inhibitor compound”. This is not persuasive.
The instant formula encompasses the chemical structure of Cleistanthin-A. The characterization of “antiviral V-ATPase inhibitor compound” does not change the structure of the compounds of the instant claims, nor does it provide an additional structural limitation to the recited compounds. Rather, it recites a property of the compounds. Because the formula of the instant claims encompasses Cleistanthin-A, they encompass a natural compound which possesses those same properties and do not provide any additional structural limitation. MPEP 2112.01(II) states that products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable.
Because Applicant’s arguments are not persuasive, the instant claims are rejected for the reasons of record with modifications made to account for the claim amendments filed 10/01/2025.
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 1-5, 8-10, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yadav et al. (WO 2018/193476 A2; IDS 11/10/2020).
Yadav discloses compounds for the treatment of cancer, in particular cancer stem cells (page 1, line 22 to page 2, line 2). Yadav discloses specific compounds of instant claim 4. These compounds include Formula V (page 4, line 11) which corresponds to formula E of instant claims 4 and 5, Formula VI (page 5, line 1) which corresponds to formula D of instant claim 4, Formula VII (page 5, line 5) which corresponds to formula B of instant claim 4, Formula X (page 5, line 11) which corresponds to formula C of instant claim 4, Formula XII (page 7, line 1) which corresponds to formula G of instant claim 4, and Formula XIII (page 7, line 4) which is a salt of formula H of instant claim 4. Thus Yadav anticipates instant claims 1, 4-5, 8-10 and 18. Yadav also anticipates instant claims 2 and 3 in that it discloses compounds of instant Formula II and III. For example, Yadav Formula V is a compound of instant formula II in which E is CH, Q is O, n is 0, R is
PNG
media_image4.png
161
175
media_image4.png
Greyscale
in which R12 is alkoxy/the attachment point to formula II, R1-2, 4-5, and 11 are H, and R9-10 are alkoxy groups. Similarly, Formula V is a compound of instant formula III in which double bonds are present at a and b, E is CH, Q is O, n is 0, R7 and R8 together form a 5 membered ring containing O, R is
PNG
media_image4.png
161
175
media_image4.png
Greyscale
in which R12 is alkoxy/the attachment point to formula II, R9-10 are alkoxy groups, and R11 is H. It is noted that Yadav does not provide a single embodiment of the composition used in the manner instantly claimed, for inhibition of v-ATPase activity in a cell as recited in instant claims 8-9 or for inhibition of SARS-CoV-2 virus as recited in instant claim 10, or for inhibition of SARS-CoV-2 virus as recited in instant claim 10, or for preparing a medicament to inhibit V-ATPase activity as recited in instant claim 18. However, these cited recitations are considered an “intended use” of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Response to Arguments
Applicant's arguments filed 10/01/2025 have been fully considered but they are not persuasive.
Insofar as Applicant’s arguments are applicable to the current rejections, Applicant argues that the compounds in Yadav do not fall within the scope of amended claims because Yadav merely discloses compounds for the treatment of cancer and not Applicant's claimed antiviral V-ATPase inhibitor compound (remarks, page 24, paragraphs 2-3). This is not persuasive.
The compounds of the instant claim have the same chemical structure as those disclosed by Yadav. The characterization of “antiviral V-ATPase inhibitor compound” in the preamble does not change the structure of the compounds of the instant claims, as it does not confer any structural limitations and rather recites a property of the compounds. Because the compounds of the instant claims are the same as those of Yadav, they have the same properties and thus anticipated. MPEP 2112.01(II) states that products of identical chemical composition cannot have mutually exclusive properties. 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.
Because Applicant’s arguments are not persuasive, the instant claims are rejected for the reasons of record with modifications made to account for the claim amendments filed 10/01/2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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, 6, 11-17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Antiviral Research, 2013; PTO-892) in view of Yadav et al. (WO 2018/193476 A2; IDS 11/10/2020) and Zhang et al. (European Journal of Medicinal Chemistry, 2014; PTO-892).
Chen teaches that the mechanism of influenza viral infection has shown that endosomal acidification plays a major role in facilitating the fusion between viral and endosomal membranes (abstract). Chen teaches that v-ATPase activity is a regulating factor on influenza virus replication and that diphyllin alters cellular susceptibility to influenza viruses through the inhibition of endosomal acidification, thus interfering with downstream virus replication (abstract). Blocking v-ATPase activity, therefore, presents an opportunity to impede influenza infection by preventing the low pH-dependent membrane fusion between endosomes and virions. Chen teaches that other viruses also have a mechanism of infection that involves endosomal acidification, including flaviviruses, vaccina viruses, and coronaviruses (page 372, paragraph 1).
Chen goes on to characterize the application of diphyllin as an antiviral for various influenza virus strains (page 372, paragraph 2). Chen teaches that diphyllin interferes with the low pH-dependent membrane fusion between virus and intracellular endosomes (paragraph bridging pages 379-380). Pretreatment of cells with diphyllin was effective in altering the cellular susceptibility to influenza virus infection (page 374, paragraph 3). Chen teaches that broad-spectrum antiviral agents of high potency and low toxicity may be further developed through the existing compounds or derivatives of diphyllin (paragraph bridging pages 378-379).
Chen does not disclose a compound of formula I (instant claim 1).
Yadav discloses compounds for the treatment of cancer, in particular cancer stem cells (page 1, line 22 to page 2, line 2). The compounds may be in the form of pharmaceutically acceptable salts (page 24, lines 3-7). In particular, Yadav discloses specific compounds of instant claim 4, including Formula V (page 4, line 11 and claim 3), which corresponds to instant formula E and is shown below. Formula V is taught as having activity against breast cancer cells (page 74, lines 17-18) and prostate cancer cells (page 75, lines 2-3).
PNG
media_image5.png
205
151
media_image5.png
Greyscale
Yadav teaches that the compound of Formula V may be formulated as a pharmaceutical composition further comprising a pharmaceutically acceptable excipient (page 8, lines 8-9), and that the compounds of the invention may be formulated in a composition along with other active agents (page 25, lines 5-7). Formula V is taught as belonging to general formula IV (claim 2), which is shown below.
PNG
media_image6.png
183
181
media_image6.png
Greyscale
The scope of general formula IV includes compounds such as Formula VII (page 5, line 1), which corresponds to instant formula D and Formula VII (page 5, line 5), which corresponds to instant formula B. Compounds of general formula IV are described as diphyllin esters (page 51, line 19) and diphyllin derivatives (page 29, line 21).
Zhang discusses the anticancer activity of v-ATPases. In particular, Zhao discloses the synthesis and anti-proliferative activities of two natural diphyllin glycosides, Cleistanthin-A and Cleistanthoside-A, against cancer cells including MCF-7 breast cancer cells (abstract). The structure of Cleistanthoside-A is disclosed in figure 1 and shown below.
PNG
media_image3.png
221
213
media_image3.png
Greyscale
Zhang teaches that the acidic tumor microenvironment is critical to managing cancer development, progression and metastasis; v-ATPases are responsible for microenvironment acidification and play a major role in tumor invasion and metastasis development (page 466, paragraph 1). Diphyllin potently inhibits v-ATPase and cancer cell proliferation development (page 466, paragraph 2). Similarly, the diphyllin glycosides Cleistanthin-A and Cleistanthoside-A exert their antiproliferative activities mainly through inhibiting v-ATPase (page 466, paragraph 3).
It would have been prima facie obvious to combine the teachings of Yadav, Zhang and Chen before the effective filing date of the claimed invention by administering the v-ATPase compound Formula V of Yadav for the treatment of viral infections, including influenza viral infections, to arrive at the instantly claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to administer Formula V for the treatment of influenza viral infections because Chen teaches that derivatives of diphyllin are v-ATPase inhibitors useful for the treatment of viruses that rely on endosomal acidification. One of ordinary skill in the art would have a reasonable expectation of success because Chen teaches that broad-spectrum antiviral agents of high potency and low toxicity may be further developed through existing compounds or derivatives of diphyllin. Furthermore, it would have been prima facie obvious to expect that the compound of Formula V – taught by Yadav as an anti-cancer compound derived from the same general formula that includes compounds described as diphyllin derivatives and bearing the same sugar and a similar structural core to Cleistanthin-A – has anti-cancer activity through inhibiting v-ATPase, which is taught by Zhang as the mechanism of action for diphyllin glycosides including Cleistanthin-A.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (Antiviral Research, 2013; PTO-892) in view of Yadav et al. (WO 2018/193476 A2; IDS 11/10/2020) and Zhang et al. (European Journal of Medicinal Chemistry, 2014; PTO-892) as applied to claims 1 and 12, further in view of Yang et al. (International Journal of Biological Sciences, 2020; PTO-892).
The combined teachings of Chen, Yadav, and Zhang are as above.
The combined teachings of Chen, Yadav, and Zhang differ from that of the instantly claimed invention in that they do not teach the treatment of SARS CoV-2.
Yang teaches that a key element in viral infection by COVID-19 is the process of viral entry into the host cells. As a result, the endocytic pathway, including endosomes and lysosomes, has become an important target for the development of therapeutic strategies in combating diseases caused by coronaviruses (abstract). Yang teaches that autophagy by lysosomes requires an acidic internal pH which is generated by the action of a V-ATPase, a proton-pumping membrane protein complex (page 1725, paragraph 2). Yang concludes that targeting autophagy is a novel therapeutic strategy against coronaviruses, including both SARS-CoV and SARS-CoV-2 (page 1728, paragraphs 4-5 and page 1729, paragraph 5).
It would have been prima facie obvious to administer the antiviral treatment suggested by the combined teachings of Chen, Yadav, and Zhang for the treatment of SARS-CoV-2, because Chen teaches and suggests that broad-spectrum antiviral agents – including those for treatment of coronaviruses – of high potency and low toxicity may be developed from existing compounds or derivatives of diphyllin because diphyllin interferes with the low pH-dependent membrane fusion between virus and intracellular endosomes by v-ATPase, Yadav teaches derivatives of diphyllin, and Yang teaches that inhibition of the endocytic pathway and autophagy through inhibition of v-ATPase is a strategy for treating infections by SARS-CoV-2. One of ordinary skill in the art would have had a reasonable expectation of success because Zhang teaches that the mechanism of action for diphyllin glycosides including Cleistanthin-A is inhibition of v-ATPase.
Response to Arguments
Applicant's arguments filed 10/01/2025 have been fully considered but they are not persuasive.
Applicant argues that since Chen does not teach or anticipate Applicant's antiviral V-ATPase inhibitor compound of Formula I, there would be no motivation to use the structures of Yadav for the treatment of viral infections to arrive at Applicant's claimed invention (Remarks, page 29, paragraph 2). This is not persuasive.
Chen alone is not required to teach or anticipate the compounds of the instant claims in order for the combined teachings of Chen, Yadav, and Zhang to render obvious the instant claims. Rather, Yadav teaches the structures of the instant claims, and thus the combined teachings do disclose these structures and thus teach each limitation of the instant claims. As indicated in the above grounds of rejection, it would have been prima facie obvious for one of ordinary skill in the art to administer Formula V of Yadav for the treatment of influenza viral infections because Chen teaches that derivatives of diphyllin are v-ATPase inhibitors useful for the treatment of viruses that rely on endosomal acidification, Yadav teaches that Formula V is a glycosidic diphyllin derivative, Zhang teaches that the mechanism of action for anti-cancer diphyllin glycosides is through inhibiting v-ATPase. Thus the teachings of the prior art would have suggested to one of ordinary skill in the art that the compounds of Yadav would be effective for the treatment of viral infections because they are derivatives of diphyllin having v-ATPase inhibition as the mode of action, and derivatives of diphyllin that are v-ATPase inhibitors are effective for treating viral infections.
Because Applicant’s arguments are not persuasive, the instant claims are rejected for the reasons of record with modifications made to account for the claim amendments filed 10/01/2025.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sarah Grace Scrivener whose telephone number is (703)756-5341. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm (EST). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.G.H./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693