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
This office action is in response to applicant’s reply filed on June 24, 2026.
Status of Claims
Amendment of claims 7 and 9 is acknowledged.
Claims 1-20 are currently pending and are the subject of this office action.
Claims 1-6 and 13-20 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 29, 2025.
Claims 7-12 are under examination.
Priority
The present application claims priority to provisional application No. 63/380,404 filed on 10/21/2022.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 102 (New Rejection Necessitated by Amendment).
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 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.
Claim(s) 7-10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fang et. al. (Brain, Behavior, and Immunity (2021) 92:127-138).
CLAIM INTERPRETATION: the subjects in need of “decreasing A-beta level and hyperphosphorylated Tau” are considered subjects suffering from Parkinson’s Disease (PD) (see instant specification paragraphs [0001] through [0006]).
For claims 7 and 9, Fang teaches a method of treating Parkinson’s Disease (PD) comprising administering a subject (rat) suffering from PD a composition comprising the histamine H4 receptor antagonist: JNJ7777120: (identical to instantly claimed compound of Formula II):
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(see abstract and page 129, left column, first full paragraph).
The prior art is silent regarding “decreasing A-beta level and hyperphosphorylated Tau”. However, as evidenced by the specification (see [0003]) patients that suffer from PD have A-beta deposition and hyperphosphorylated Tau. As such: “decreasing A-beta level and hyperphosphorylated Tau” will inevitably flow from the method anticipated by the prior art (see above rejection), since the same compound (histamine H4 receptor antagonist JNJ7777120) is being administered to the same subjects (subjects suffering from PD). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “decreasing A-beta level and hyperphosphorylated Tau”, by practicing the method made obvious by the prior art: “the administration of a composition comprising the histamine H4 receptor antagonist JNJ7777120 to patients suffering from PD", one will also be “decreasing A-beta level and hyperphosphorylated Tau”, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("decreasing A-beta level and hyperphosphorylated Tau”) of the method anticipated by the prior art (“the administration of a composition comprising the histamine H4 receptor antagonist JNJ7777120 to patients suffering from PD").
For claim 8, the prior art is silent regarding: “wherein the A-beta level both in the hippocampus and cortex are reduced”.
However, the above statements do not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “the administration of a composition comprising the histamine H4 receptor antagonist JNJ7777120 to patients suffering from PD".
MPEP 2114.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326,
1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored
in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “wherein the A-beta level both in the hippocampus and cortex are reduced” appears to be the result of the process anticipated by the prior art: “the administration of a composition comprising the histamine H4 receptor antagonist JNJ7777120 to patients suffering from PD", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
For claim 10, Fang further teaches the administration of 0.005 mg/day of the JNJ7777120 compound to 270 g rats (see page 129, left column, first full paragraph)
which translates into 0.018 mg/kg/day, which anticipates the range of claim 10 (0.01 mg/kg/day to about 16 mg/kg/day).
For claim 12, Fang teaches the intracerebroventricular administration of the JNJ7777120 compound (see page 129, left column, first full paragraph).
Response to Applicant’s arguments
Since a new rejection was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant are no longer applicable or have been considered/answered in the rejection itself.
Claim Rejections - 35 USC § 103 (New Rejection Necessitated by Amendment).
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.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fang et. al. (Brain, Behavior, and Immunity (2021) 92:127-138).
The prior art teaches all the limitations of claims 11 (see 102(a)(1) rejection above), except for the administration lasting from about 21 days to about 3 months.
However, dose regimen optimization is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize given the guidance of the prior art. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. As such, before the effective filing date of the claimed invention it would have been prima facie obvious for a person of ordinary skill in the art to determine the optimal dose regimen to achieve the best result for a particular patient, thus resulting in the practice of claim 11 with a reasonable expectation of success.
Response to Applicant’s arguments
Since a new rejection was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant are no longer applicable or have been considered/answered in the rejection itself.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 20, 2026.
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