DETAILED ACTION
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 .
Status of the Claims.
Claims 6-9 and 11 are pending.
Applicants’ arguments filed on 12/16/2025, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 12/16/2025, have each been entered into the record. Applicants have cancelled claims 1-5 and 10. Therefore, claims 6-9 and 11 are subject of the Office action below.
Claim Objections-Withdrawn
The objection to claims 6 and 9-11 under 37 CFR 1.75, is withdrawn because 6 and 9-11 have been amended to correct the informalities.
Maintained Rejections
Claim Rejections - 35 USC § 103-Maintained
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.
The rejection of claims 6-9 and 11 under 35 U.S.C. 103 as being unpatentable over Wang of record (Scientific Reports, 2015) in view of Xinmin of record (WO2017083867A1), is maintained for the reasons of record set forth in the previous Office action, of which said reasons are herein reiterated.
By way of background, Applicant discloses a method for treating a condition or disorder (e.g., pain and itching), in which the therapeutic intervention is at the inhibition of T-type Cav3 ion channel (see, e.g., ¶s 0003, 00124, 00170 and Table 1 of the specification).
Independent claim 6 is directed toward a method for treating itching with a compound selected from the group consisting of the list disclosed therein, or a pharmaceutically acceptable salt thereof.
Similar to the Applicant’s invention (see discussions above), Wang teaches a method of treating itching, in which the therapeutic intervention is at the inhibition of T-type Cav3 ion channel (see abstract and discussions therein). Specifically, Wang teaches that pharmacological blockade of T-type Cav3.2 channel by T-type Cav3.2 channel inhibitors (not compounds of the claimed invention), or silencing of T-type Cav3.2 channel by Cav3.2 siRNA, was found to dramatically decreased itching (e.g., see abstract). Accordingly, at the time of the instant invention, a person skilled in the art would have envisioned a method for treating itching with a T-type Cav3.2 channel by T-type Cav3.2 channel inhibitor (e.g., a compounds of the claimed invention), from the Wang disclosure.
Although Wang is not explicit in disclosing a compound of the claimed invention (e.g., EX-130) as a T-type Cav3.2 channel inhibitor, the claimed invention would have been obvious over Wang. This is because at the time of the instant invention, a T-type Cav3.2 channel inhibitor of the claimed invention (e.g., EX-130), was known in the art.
For example, Xinmin teaches a method for inhibiting a T-type Cav3 channel (e.g., T-type Cav3.2 channel) with compounds such as compound EX-130 (see, e.g., ¶ 00429 and Table 1). Similar to Wang (see discussions above), Xinmin relates to a method for treating a condition or disorder (e.g., neuropathic and/or inflammatory pain), in which the therapeutic intervention is at the inhibition of T-type Cav3 ion channel (see, e.g., abstract, ¶s 0003 and 0014). Xinmin teaches treating pain with compounds such as compound EX-130 (see ¶s 0017-0025, 00136 and Figures 1-5). Xinmin discloses that patients may describe pain as itching (see ¶ 0072).
Accordingly, at the time of the instant invention, one skilled in the art would have found it obvious to substitute one known T-type Cav3 channel inhibitor (e.g., a T-type Cav3 channel inhibitor of Wang) for another (e.g., compound EX-130 of Xinmin) for the predictable result of treating a condition or disorder (e.g., itching), in which the therapeutic intervention is at the inhibition of T-type Cav3 channel. This is because the arts of record:
i) established a T-type Cav3 channel as a therapeutic target for the therapy of itching (see discussions above); and
ii) disclosed using a T-type Cav3 channel inhibitor for treating itching (see discussions above).
The use of simple substitution of one known element for another to obtain predictable results as a requirement of a prima facie case of obviousness has been deemed as proper (see MPEP § 2143). In the instant case, the one known element is a T-type Cav3 channel inhibitor and the predictable results is treating itching.
Therefore, one of ordinary skill in the art at the time of the instant invention would have found it obvious to substitute one known T-type Cav3 channel inhibitor (e.g., a T-type Cav3 channel inhibitor of Wang) for another (e.g., compound EX-130 of Xinmin), with a reasonable expectation of treating itching.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Therefore, claim 6 is obvious over Wang and Xinmin.
Regarding claim 7-8, Xinmin teaches Diabetes (see ¶ 0072).
Regarding claim 9, Xinmin teaches compound EX-130 (see discussions above).
Regarding claim 11, Xinmin discloses administration can be orally (see ¶ 00162) or by inhalation (see ¶s 00168, 00177).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited reference.
Response to Applicants’ Arguments
Applicants raised several arguments (see pages 5-7 of Remarks), alleging that the instant claims are non-obvious over the cited references on the grounds that:
1) Wang fails to establish a nexus between inhibition of T-type Cav3.2 channel and treating itching (see pages 5-7 of Remarks).
Response:
Applicant’s arguments have fully considered but they are not found to be persuasive. This is because Wang teaches that pharmacological blockade of T-type Cav3.2 channel by T-type Cav3.2 channel inhibitors (not compounds of the claimed invention), or silencing of T-type Cav3.2 channel by Cav3.2 siRNA, was found to dramatically decreased itching (e.g., see abstract).
2) Xinmin cannot be employed to address the deficiency in the teachings of Wang because Xinmin fails to disclose a method for treating itching with a T-type Cav3.2 channel inhibitor such as compound EX-130 of Xinmin (see page 7 of Remarks).
Response:
Applicant’s arguments have fully considered but they are not found to be persuasive. Although Wang teaches a method of treating itching, in which the therapeutic intervention is at the inhibition of T-type Cav3 ion channel (see discussions above), Wang is not explicit in disclosing a compound of the claimed invention (e.g., EX-130) as a T-type Cav3.2 channel inhibitor. Xinmin was cited for teaching a method for inhibiting a T-type Cav3 channel (e.g., T-type Cav3.2 channel) with compounds such as Applicant’s compound EX-130 (see discussions above). Similar to Wang (see discussions above), Xinmin relates to a method for treating a condition or disorder (e.g., neuropathic and/or inflammatory pain), in which the therapeutic intervention is at the inhibition of a T-type Cav3 ion channel (see discussions above). Xinmin teaches treating pain with compounds such as compound EX-130 (see discussions above). Xinmin also discloses that patients may describe pain as itching (see discussions above).
Accordingly, at the time of the instant invention, one skilled in the art would have found it obvious to substitute one known T-type Cav3 channel inhibitor (e.g., a T-type Cav3 channel inhibitor of Wang) for another (e.g., compound EX-130 of Xinmin) for the predictable result of treating a condition or disorder (e.g., itching), in which the therapeutic intervention is at the inhibition of T-type Cav3 channel. Therefore, the use of Xinmin in order to address the deficiency in the teachings of Wang, is proper.
For the reasons above, and those made of record in the previous Office action, the rejections are maintained.
Non-Statutory Double Patenting Rejection-Maintained
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 6-9 and 11 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. patent No. 10/562,857, is maintained for the reasons of record set forth in the Office action.
Response to Applicants’ Arguments/Remarks
Applicants have not properly addressed the specific grounds of rejections as discussed in the previous Office action setting. Applicants request that the obvious-type double patenting rejections be held in abeyance. Please see page 7of Remarks.
Response
Applicants’ comments are acknowledged. However, the rejections will be maintained until a terminal disclaimer is filed or the claims are amended to obviate the rejections.
Conclusion
No claim is allowable.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 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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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629