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 .
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.
Election/Restrictions
Applicant's election with traverse of “formula (I-H)” as species of “genus formula I” and “Parkinson’s disease” as “species of disease”, in the reply filed on 12 September 2025, is acknowledged. The traversal is on the ground(s) that Examiner did not carry his burden by showing lack of unity of the invention (see Applicants’ traverse within pages 7-8 of the 12 September 2025 Reply).
While the Examiner does not agree with Applicants’ traversal, he is nevertheless withdrawing the Election of Species Requirement of 6 August 2025, since all claims are free of the prior art.
All claims have been examined on the merits.
Current Status of 18/031,632
This Office Action is responsive to the amended claims of 12 September 2025.
Previously presented claims 14-27 have been examined on the merits.
Priority
The effective filing date is 14 October 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6 November 2024; and 13 April 2023, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 23-27 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.
Claim 23 recites the limitation "step (b)". There is insufficient antecedent basis for this limitation in the claim because there is a missing step – “step (a)”.
Claim 23 is an independent claim. Independent claims are supposed to be “self-contained”, which means that they should not have lack of antecedent basis issues. While Examiner understands that dependent claim 25 adds a “further comprising” and then proceeds to define step (a) within claim 25 as preceding step (b) of independent claim 23, the independent claim 23 is nevertheless interpreted to be lacking antecedent basis. When an independent claim begins with “step (b)”, it lacks antecedent basis because the artisan naturally wonders “where is step (a) within the independent claim?” Since claim 23 begins with “step (b)” without first defining its antecedent / preceding -- step (a) -- , this renders the metes and bounds of claim 23 undefined (hence rendering claim 23 indefinite).
Claims 24-27 are similarly rejected as indefinite since these claims refer back to claim 23 but do not remedy the rationale underpinning the basis for rejecting claim 23.
To resolve this rejection: Refer to “step (b)” as -- step (a) -- in claim 23 and then in claim 25, revise to: -- wherein said process further comprises, before step (a) of claim 23, a step of: [[(a)]] -- . Please note that all amendments must find explicit, inherent, or implicit support in the original disclosure to avoid future written description/new matter rejections.
Conclusion
Claims 23-27 are not presently allowable as written.
Claims 14-22 are presently allowable as written. Furthermore, claim 23 is free of the prior art.
There is no known prior art reference that either teaches or anticipates a compound of formula I (or I-H), a method of use thereof, or a method of preparation thereof, according to instant claims 14, 19, 21, and 23.
The reference PARATEK (WO 2004/064728 A2, provided by Applicants-see IDS of 13 April 2023) discloses tetracycline compounds (see “Abstract”). However, PARATEK does not teach, suggest, or anticipate the compounds of genus formula I (or I-H), methods of preparation thereof, or methods of use, according to the instant claims.
Moreover, the Examiner does not see any room for an obviousness rejection. There is no reason to use PARATEK as an obviousness reference since the instant Specification Example 2 and Figure 1 each show that the instantly claimed compounds of formula I and I-H show a surprisingly/unexpectedly higher efficacy toward reducing alpha-synuclein aggregation than the doxycycline and tetracycline compounds known in the art and exemplified by PARATEK (see page 23 of Specification).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625