DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed July 30, 2026. Currently, claims 10-16, 19-24, 26-27, 31-33 are pending. Claims 26-27, 31-33 have been withdrawn as drawn to non-elected subject matter.
Election/Restrictions
Applicant's election with traverse of Group I, Claims 10-19, 19-24 in the paper filed April 20, 2026 is acknowledged.
The response argues no serious burden has been show and cites MPEP 803. This argument has been reviewed but is not persuasive. The instant application is a 371 application. The standard for restriction in 371 applications is Lack of Unity. The lack of unity standard does not include burden. Thus, the examiner does not have to articulate a rationale for burden. The examiner separated the inventions based on lack of unity and there was no contribution over the art. Thus, restriction is proper.
Claims 26-27, 31-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
This application contains claims 26-27, 31-33 are drawn to an invention nonelected with traverse in the paper filed April 20, 2026. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Priority
This application is a 371 of PCT/US22/25469, filed April 20, 2022 and claims priority to provisional 63/177,189, filed April 20, 2021.
Claim Rejections - 35 USC § 112- Second Paragraph
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.
Claims 19-24 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 19-24 recites a deletion of the nucleotides….(SEQ ID NO: 3) located at positions corresponding to positions….according to SEQ ID NO:1. It is unclear what “corresponding” is intended to encompass. It is unclear if this means the position is not the recited positions of SEQ ID NO: 1. Applicant may wish to amend the claims to require a deletion of nucleotides AAAGGTAAGG (SEQ ID NO: 3) located at positions 97,182 to 97,191 of SEQ ID NO: 1.
Claim 21 is directed to sequencing “the entire LRRK2 genomic nucleic acid molecule”. “The entire LRRK2 genomic nucleic acid molecule” lacks proper antecedent basis. Claims 19-20 are directed to the nucleic acid molecule is mRNA and then reverse transcribed into cDNA. It is unclear what the nucleic acid molecule is referring to. cDNA is not the entire LRRK2 genomic nucleic acid molecule. Thus, Claim 21 does not appear to limit Claim 19 that requires mRNA is reverse transcribed into cDNA prior to assaying the sample. Correction is required.
Claim Rejections - 35 USC § 103
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.
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.
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) 19-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. (WO 2020/006267, January 2, 2020) in view of
Cole teaches a method for isolating RNA and measuring LRRK2 RNA levels using quantitative real-time PCR (Example 1 and 2). Real-time PCR relies upon the RNA sample to be first reverse-transcribed to complementary DNA (cDNA) with reverse transcriptase. Cole teaches using a forward primer and a reverse primer and a probe, namely SEQ ID NO: 11-19, for detecting alterations in the human LRRK2 nucleic acid to different regions of LRRK2.
Cole does not teach analysis of a deletion of SEQ ID NO: 3 using a probe or primer to the region.
However, Ziangya teaches high-throughput sequencing, next generation sequencing labels sequences and capture probes capture these specific genomic regions and detected. Ziangya teaches capture probes for LRRK2 gene comprising SEQ ID NO: 144, which comprises 100% sequence identify to SEQ ID NO: 3. Ziangya teaches sample preparation comprises extracting gDNA from peripheral venous blood samples. The genomic DNA is extracted, purified and PCR amplified to generate a library.
Therefore, it would have been prima facie obvious prior to the effective filing date of the claimed invention to have modified the probe of Cole to use the probes of Ziangya to study additional LRRK2 sequences. The ordinary artisan would have been motivated to have designed the primers and probes to the known region of SEQ ID NO: 3 to detect and study the alterations, as taught by Cole. Cole teaches oligonucleotides to the human LRRK2 nucleic acid were designed and tested for their effect on LRRK2 RNA in vitro using high-throughput sequencing (page 63, lines 30-31). The ordinary artisan would have been motivated to have tested additional sequences to determine the effect, including SEQ ID NO: 3.
Conclusion
No claims allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cheung et al. (Human Molecular Genetics, Vol. 30, No. 18, pages 1750-1761, May 18, 2021) teaches LRRK2 mutations associated with mesothelioma. This is applicant’s post-filing art describing the mutation in 12 MM patients.
Paisan-Ruiz et al (Human Mutation, Vol. 29, No. 4, pages 485-490, 2008).
Paisan-Ruiz teaches a comprehensive analysis of LRRK2 by sequencing the large gene for mutations. Paisan-Ruiz teaches screening the entire coding sequence (abstract). Paisan-Ruiz teaches PCR analysis was performed using forward and reverse primers designed by Exon Primer (page 486, col. 2).
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on July 30, 2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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, Wu-Cheng (Winston) Shen can be reached on (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
August 18, 2026
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