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
The preliminary amendment dated 7 December 2023, in which claims 1, 5-19, 23-24, 28-29, 31-32 have been amended, and claims 2-4, 20-22, 25-27, 30 have been canceled, is acknowledged.
Claims 1, 5-19, 23-24, 28-29, 31-32 are pending in the instant application.
Claims 6-9, 14-17, 28 are withdrawn, as being drawn to a non-elected invention or to a non-elected species.
Claims 1, 5, 10-13, 18-19, 23-24, 29, 31-32 are being examined on their merits herein.
Priority
The instant application is a National Stage entry of International Application No. PCT/EP2022/055276, filed on 7 June 2022, claiming priority to Italian Patent Applications No.102021000015098, filed on 9 June 2021.
A certified copy of the priority documents, in Italian, was submitted on 7 December 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7 December 2023 is acknowledged and considered.
Election/Restrictions
Applicant’s election with traverse of Group II, claims 1, 5-19, 23-24, 29, 31-32, drawn to a method of preventing and/or treating a degenerative retinal disease which comprises administering to a patient in need thereof an effective amount of a TRPA1 channel antagonist compound or composition thereof, in the reply filed on 11 May 2026, is acknowledged. Claim 28 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse.
Applicant’s election with traverse of macular degeneration as the degenerative retinal disease to be treated; the election of
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as the TRPA1 antagonist to be administered in the method; the lection of ranibizumab as the anti-VEGF agent; and dexamethasone as the corticosteroid, in the reply filed on 11 May 2026, is acknowledged. Claims 1, 5, 10-13, 18-19, 23-24, 29, 31-32, read on the elected species. Claims 6-9, 14-17 are withdrawn, as being drawn to a non-elected species.
Applicant traverses the requirement for restriction (Response of 11 May 2026, pages 2-5) and argues (page 4) that unity of invention between Groups I and II exists because there is a technical relationship that involves the same special technical feature.
In response, as indicated in the Requirement for restriction mailed on 9 February 2026, even though the common feature of Groups I-II is a TRPA1 channel antagonist compound, said common technical feature is not a special technical feature because it is anticipated by Svensson et al. (US 2014/0148466, cited in IDS).
Svensson et al. (US 2014/0148466) teach [0006]-[0007] a TRPA1 channel antagonist compound
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, and a pharmaceutical composition containing said compound [0028], used in the treatment of ophthalmic disorders such as, for example, diabetic retinopathy [0025].
Thus, a TRPA1 channel antagonist compound and a composition comprising said compound are anticipated by Svensson. Since the common technical feature, a TRPA1 channel antagonist compound is anticipated by the prior art, this common feature is not a special technical feature. Therefore, no unity of invention exists.
Applicant further traverses the requirement for restriction (Response of 11 May 2026, pages 2-5) on the basis that it would not be an undue burden (page 4, last paragraph, page 5, first paragraph) to examine all claims since the International Search Authority searched all the claims together. Applicant further argues (page 5) that the Office has not provided any reasons or examples to support a conclusion that the species are patentable distinct.
This is not persuasive. As indicated in the Requirement for restriction mailed on 9 February 2026, this application contains claims directed to the following patentably distinct species: TRPA1 channel antagonist compounds including sulfonamide derivatives; compounds of formula (A1); polycyclic heteroaromatic derivatives; compounds of formula (A2); indazole derivatives, and bioisosteres; compounds of formula (A3); Anti-VEGF drugs; Corticosteroid drugs; degenerative retinal diseases to be treated.
These species are independent or distinct because, for example, the genus of TRPA1 channel antagonist compounds encompasses a variety of possible compounds, such as, for example, sulfonamide derivatives, including compounds of formula (A1); polycyclic heteroaromatic derivatives, such as compounds of formula (A2); indazole derivatives, and bioisosteres, such as compounds of formula (A3), each having different structural elements. Each combination of elements requires different structural search and/or a different classification based on its structural elements. There is a search and/or examination burden for the patentably distinct TRPA1 channel antagonist compounds, because the compounds require a different field of search based on the combination of structural elements present. For example, based on their structural elements, the instant TRPA1 channel antagonist compounds can be classified, at a minimum, in CPC class A61K31/416, A61K31/4178, A61K31/56, A61K31/506, A61K31/517, A61K31/519, A61K31/573.
For all the reasons above, the requirement for restriction/election is maintained and is herein made FINAL.
Claims 1, 5, 10-13, 18-19, 23-24, 29, 31-32 have been examined to the extent they read on the elected species, and the following objections are rejections are made below.
Claim objection
Claims 6-9, 14-17, 28, while currently withdrawn, are objected to because of the following informality: The withdrawn claims are objected to for being presented in a non-compliant form. Specifically, the status identifiers state the claims are “(Currently amended)”, but the claims are withdrawn because of the election made by the Applicant on 11 May 2026. As such, claims 6-9, 14-17, 28 should be identified as "(Withdrawn)" until such time as examiner rejoins the claims for examination. Appropriate correction is required. See MPEP 714(C).
Claims 1, 12, 29 are objected to because they recite “a method of preventing and/or treating”, which includes the option of preventing and treating a disease at the same time. The claims should recite a method of treating.
Claim Rejections - 35 USC § 112
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 5, 13 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 pre-AIA the applicant regards as the invention. Claim 5 is drawn to the method of claim 1, wherein the TRPA1 channel antagonist compound belongs to one of the following classes:
2) sulfonamide derivatives;
5) polycyclic heteroaromatic derivatives; or
6) indazole derivatives and bioisosteres,
the salts thereof, optical isomers, solvates and prodrugs.
It is unclear what is meant by the text compound “belongs to a class”. If the claim is to define the TRPA1 antagonist based on its chemical structure (“class”), the claim should indicate what the chemical structure is. Claims must particularly point out and distinctly claim the invention. In this case, in the absence of a definition for the term “derivative”, one is left with questions regarding what are, chemically speaking, such “derivatives”? How large are they? In chemistry, a derivative is a compound that is derived from a similar compound by a chemical reaction. But the term “derivative” may also encompass compounds formed by replacing one atom or group of atoms in a compound with another atom or group of atoms. Does the term “derivative” encompass any molecule, no matter how large, that contains a sulfonamide? Or does the term “derivative” encompass any molecule, no matter how large, that contains an indazole? Does the term “derivative” encompass modified molecules (in what way?) such that one atom or group of atoms replaced by another atom or group of atoms? The Specification teaches “sulfonamide derivatives such as those shown among others in (a number of literature) documents”. Yet, the recitation “such as those shown”, as written in the Specification, leaves a doubt regarding what else, what other chemical compounds having distinct chemical structures, are encompassed by the genus of derivatives in claim 5. While the Specification and claims 6-11, which depend on claim 5, provide examples of derivatives defined by a chemical structure, it is unclear what other structures, beyond those in dependent claims 6-11, are encompassed by the genus of derivatives in claim 5. There is no definition for the term “bioisosteres” of indazole, and it is unclear what chemical structures are encompassed by the term “indazole bioisosteres”. The same analysis applies to claim 13, which depends on claim 12.
For these reasons, the metes and bounds of the present claims cannot be determined and one having ordinary skill in the art would not necessarily be reasonably apprised of the scope of the claims.
Further, in claims 5, 13, the recitation “the salts thereof, optical isomers, solvates and prodrugs” is unclear. What optical isomers? What is the relationship between the rest of the claim and the last line of the claim? Are “the salts” part of the “classes”?
Appropriate clarification of the claim language is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 12, 23, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Svensson et al. (US 2014/0148466, cited in IDS).
Svensson et al. (US 2014/0148466) teach [0006]-[0007] a TRPA1 channel antagonist compound
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, and a pharmaceutical composition containing said compound [0028], used in the treatment of ophthalmic disorders such as, for example, diabetic retinopathy [0025], which is a disease of the instant claims.
It would have been obvious to use the teachings of Svensson to arrive at the instant invention. The person of ordinary skill in the art would have used the TRPA1 channel antagonist taught by Svensson in a method of treating diabetic retinopathy, with a reasonable expectation of success. With regards to claims 12, 23, 24, the person of ordinary skill in the art would have formulated the TRPA1 antagonist taught by Svensson as a topical ophthalmic composition to be administered in the method of treatment, because the topical route of administration is routinely used to treat ophthalmic diseases.
As such, claims 1, 12, 23, 24 are rejected as prima facie obvious.
Claims 1, 12, 23, 24, 29, 32 are rejected under 35 U.S.C. 103 as being unpatentable over Fleck et al. (WO 2021/074198, published 22 April 2021, cited in IDS).
Fleck teaches tetrazoles (Abstract, chemical structures on pages 32, 33) as inhibitors of TRPA1 activity, and pharmaceutical compositions containing said compounds, used in the treatment of, for example, ophthalmic disorders such as age-related macular degeneration, or diabetic retinopathy (page 16, lines 6-7; page 18, lines 17-18), which are diseases of the instant claims.
Fleck also teaches combination treatment with corticosteroids such as dexamethasone or prednisolone (page 20, lines 20-21), as in instant claims 29, 32.
It would have been obvious to use the teachings of Fleck to arrive at the instant invention. The person of ordinary skill in the art would have used an inhibitor of TRPA1 activity taught by Fleck in a method of treating age related macular degeneration, or diabetic retinopathy, with a reasonable expectation of success. With regards to claims 12, 23, 24, the person of ordinary skill in the art would have formulated the inhibitor of TRPA1 activity taught by Fleck as a topical ophthalmic composition, because the topical route of administration is routinely used to treat ophthalmic diseases.
With regards to claims 29, 32, the person of ordinary skill in the art would have combined the inhibitor of TRPA1 activity taught by Fleck with a corticosteroid such as dexamethasone or prednisolone, because Fleck teaches such combination treatment with the compounds of the invention.
As such, claims 1, 12, 23, 24, 29, 32 are rejected as prima facie obvious.
Claims 1, 5, 10-13, 18-19, 23-24, 29, 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Rooney et al. (J Med Chem 2014, 57, 5129-5140, cited in PTO-892), in view of Fleck et al. (WO 2021/074198, published 22 April 2021, cited in IDS), in further view of Wang et al. (Eye 2011, 25, 127-139, cited in PTO-892).
Rooney et al. (J Med Chem 2014, 57, 5129-5140) discloses 5-(2-trifluoromethyl)phenyl indazoles, specifically compound 31 below:
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, which is a compound of instant claims 5, 10, 11, 13, 18, 19,
as antagonists of the transient receptor potential A1 (TRPA1) ion channel, useful to treat pain.
Compound 31 above is an indazole derivative of instant claims 5, 13; is a compound of formula A3
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of instant claims 10, 18, for which the following definitions apply: R8 = H; R6 = CF3; R7 = methyl (C1 alkyl);
and is a compound of instant claims 11, 18.
Rooney also discloses the following 5-(2-trifluoromethyl)phenyl indazoles as antagonists of the human transient receptor potential A1 (TRPA1) ion channel
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The compounds above are indazole derivatives of instant claims 5, 13; and are compounds of formula A3
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of instant claims 10, 18, for which the following definitions apply: R8 = H or methyl; R6 is H, F, Cl, C1-C3 alkyl, or CF3; R7 is H, F, Cl, or C1-C3 alkyl.
Rooney also teaches pharmaceutical compositions comprising the compounds above and a pharmaceutically acceptable excipient, as in instant claim 12.
Rooney does not teach that the antagonists of TRPA1 disclosed are effective to treat macular degeneration, alone or in combination with an anti-VEGF drug and/or a corticosteroid drug, as in the instant claims.
Rooney does not teach that the antagonists of TRPA1 disclosed are administered as a topical ophthalmic composition, as in instant claims 23, 24.
Fleck teaches inhibitors of TRPA1 activity, and pharmaceutical compositions containing said compounds, used in the treatment of, for example, ophthalmic disorders such as age-related macular degeneration (page 16, lines 6-7; page 18, lines 17-18), which is a degenerative retinal disease of the instant claims (Applicant’s elected species).
Fleck also teaches combination treatment of inhibitors of TRPA1 activity with corticosteroids such as dexamethasone or prednisolone (page 20, lines 20-21), as in instant claims 29, 32.
Wang et al. (Eye 2011, 25, 127-139) teach (Figure 1, also page 129, right column, last two paragraphs, page 130, left column, first paragraph) that age-related macular degeneration is treated with corticosteroids such as dexamethasone, as in instant claim 32, and anti-VEGF agents such as bevacizumab, as in instant claim 31.
It would have been obvious to a person of ordinary skill in the art to combine the teachings of Rooney and Fleck to arrive at the instant invention. The person of ordinary skill in the art would have been motivated to administer a 5-(2-trifluoromethyl)phenyl indazole such as compound 31 disclosed by Rooney to a patient suffering from age-related macular degeneration, because Rooney teaches that the 5-(2-trifluoromethyl)phenyl indazoles such as compound 31 are antagonists of the transient receptor potential A1 (TRPA1) ion channel and are used in the treatments of diseases and conditions wherein antagonists of TRPA1 provides a benefit, and Fleck teaches that inhibitors of TRPA1 activity are useful to treat age-related macular degeneration.
Therefore, a person of ordinary skill in the art would have administered an antagonist of the transient receptor potential A1 (TRPA1) ion channel taught by Rooney to a patient with age-related macular degeneration, with the expectation that said antagonist of TRPA1 is effective to treat age-related macular degeneration.
Regarding claims 23, 24, the person of ordinary skill in the art would have formulated the therapeutic agent as a topical ophthalmic composition, because the topical ophthalmic compositions are routinely used to treat ophthalmic diseases.
Regarding claims 29, 31, 32, it would have been obvious to a person of ordinary skill in the art to co-administer a 5-(2-trifluoromethyl)phenyl indazole such as compound 31 disclosed by Rooney, and an anti-VEGF drug and/or a corticosteroid such as dexamethasone, to a patient suffering from age-related macular degeneration (AMD). One of ordinary skill in the art would have reasonably expected that combining an antagonist of the human transient receptor potential A1 (TRPA1) ion channel and an anti-VEGF drug and/or a corticosteroid such as dexamethasone, known/expected to be useful for the same purpose, i.e. treating AMD, in a method of treating AMD, would result in therapeutic effect. Since all compounds for co-administration herein are known/expected to be useful to treat AMD, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
As such, claims 1, 5, 10-13, 18-19, 23-24, 29, 31-32 are rejected as prima facie obvious.
Claims 1, 5, 10-13, 18-19, 23-24, 29, 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Rooney et al. (J Med Chem 2014, 57, 5129-5140, cited in PTO-892), in view of de Araujo et al. (Cell Death and Disease 2020, 11, 633, p. 1-14, cited in PTO-892) and Renner et al. (Frontiers in Cellular Neuroscience 2017, 11, 254, p. 1-11, cited in PTO-892), in further view of Wang et al. (Eye 2011, 25, 127-139, cited in PTO-892).
Rooney et al. (J Med Chem 2014, 57, 5129-5140) discloses 5-(2-trifluoromethyl)phenyl indazoles, specifically compound 31 below:
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, which is a compound of instant claims 5, 10, 11, 13, 18, 19,
as antagonists of the transient receptor potential A1 (TRPA1) ion channel, useful to treat pain.
Compound 31 above is an indazole derivative of instant claims 5, 13; is a compound of formula A3
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of instant claims 10, 18, for which the following definitions apply: R8 = H; R6 = CF3; R7 = methyl (C1 alkyl);
and is a compound of instant claims 11, 19.
Rooney also discloses the following 5-(2-trifluoromethyl)phenyl indazoles as antagonists of the human transient receptor potential A1 (TRPA1) ion channel
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The compounds above are indazole derivatives of instant claims 5, 13; and are compounds of formula A3
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of instant claims 10, 18, for which the following definitions apply: R8 = H or methyl; R6 is H, F, Cl, C1-C3 alkyl, or CF3; R7 is H, F, Cl, or C1-C3 alkyl.
Rooney also teaches pharmaceutical compositions comprising the compounds above and a pharmaceutically acceptable excipient, as in instant claim 12.
Rooney does not teach that the antagonists of TRPA1 disclosed are effective to treat macular degeneration, as in the instant claims.
Rooney does not teach that the antagonists of TRPA1 disclosed are administered as a topical ophthalmic composition, as in instant claims 23, 24.
De Araujo (Cell Death and Disease 2020, 11, 633, p. 1-14) teaches that TRPA1 mediates damage of the retina induced by ischemia and reperfusion. De Araujo teaches (Abstract) that daily instillation of eye drops, which are topical ophthalmic compositions of instant claims 23, 24, of two different TRPA1 antagonists protected the retinas of mice exposed to ischemia reperfusion I/R by attenuating the I/R induced retinal damage (page 6, right column, last paragraph).
De Araujo also teaches (Abstract) that TRPA1 is expressed by human retinal cells.
Renner et al. (Frontiers in Cellular Neuroscience 2017, 11, 254, p. 1-11) teach (page 1, first paragraph) that retinal ischemia is a common pathomechanism in ocular disorders such as age-related macular degeneration (AMD), or diabetic retinopathy.
Wang et al. (Eye 2011, 25, 127-139) teach (Figure 1, also page 129, right column, last two paragraphs, page 130, left column, first paragraph) that age-related macular degeneration is treated with corticosteroids such as dexamethasone, as in instant claim 32, and anti-VEGF agents such as bevacizumab, as in instant claim 31.
It would have been obvious to a person of ordinary skill in the art to combine the teachings of Rooney, De Araujo and Renner to arrive at the instant invention. The person of ordinary skill in the art would have been motivated to administer an antagonist of TRPA1 5-(2-trifluoromethyl)phenyl indazole such as compound 31 disclosed by Rooney to a patient suffering from age-related macular degeneration, or diabetic retinopathy, because
Rooney teaches that the 5-(2-trifluoromethyl)phenyl indazoles such as compound 31 are antagonists of the transient receptor potential A1 (TRPA1) ion channel and are used in the treatment of diseases and conditions wherein antagonists of TRPA1 provide a benefit,
De Araujo teaches that instillation of eye drops, which are topical ophthalmic compositions of instant claims 23, 24, of TRPA1 antagonists protect the retinas of mice exposed to ischemia reperfusion I/R by attenuating the I/R induced retinal damage,
and Renner teaches that retinal ischemia is a common pathomechanism in ocular disorders such as age-related macular degeneration (AMD), or diabetic retinopathy.
Therefore, a person of ordinary skill in the art would have administered an antagonist of the transient receptor potential A1 (TRPA1) ion channel taught by Rooney, as eye drops/topical ophthalmic formulation, to a patient with age-related macular degeneration, or diabetic retinopathy with the expectation that said antagonist of TRPA1 is effective to protect the retina against I/R injury in said patient.
Regarding claims 29, 31, 32, it would have been obvious to a person of ordinary skill in the art to co-administer a 5-(2-trifluoromethyl)phenyl indazole such as compound 31 disclosed by Rooney, and an anti-VEGF drug and/or a corticosteroid such as dexamethasone, to a patient suffering from age-related macular degeneration (AMD). One of ordinary skill in the art would have reasonably expected that combining an antagonist of the human transient receptor potential A1 (TRPA1) ion channel and an anti-VEGF drug and/or a corticosteroid such as dexamethasone, known/expected to be useful for the same purpose, i.e. treating AMD, in a method of treating AMD, would result in therapeutic effect. Since all compounds for co-administration herein are known/expected to be useful to treat AMD, it is considered prima facie obvious to co-administer them in a method used for the same purpose. At least additive therapeutic effects would have been reasonably expected. See In re Kerkhoven, 205 USPQ 1069 (CCPA 1980).
As such, claims 1, 5, 10-13, 18-19, 23-24, 29, 31-32 are rejected as prima facie obvious.
CONCLUSION
Claims 1, 5, 10-13, 18-19, 23-24, 29, 31-32 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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, JEFFREY S. LUNDGREN can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
