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. Election/Restrictions Applicant’s election without traverse of Group I (drawn to a modified oligonucleotide) in the reply filed on 09/26/2025 is acknowledged. Claim s 48, 51-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/26/2025 . Applicant’s election without traverse of the species SEQ ID NO:41 in the reply filed on 09/26/2025 is acknowledged. However, the species election requirement has been withdrawn. Claims Status Claims 2, 4, 6-10, 19, 24-46, 49-50, 54-83 is/are cancelled and claims 84-85 is/are newly added. Claims 1, 3, 5, 11-18, 20-23, 47-48, 51-53, 84-85 is/are currently pending with claims 48, 51-53 withdrawn. Claims 1, 3, 5, 11-18, 20-23, 47, 84-85 is/are under examination. Specification The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. Hyperlinks were found in paragraph [0242]. Applicant is advised to review the specification in order to ensure that all hyperlinks are identified and appropriately removed. Claim Rejections - 35 USC § 112 112(b) : 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 appl icant regards as his invention. Claim 5 is 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 5 recites the limitation " the SEQ ID NO " in line 1 . There is insufficient antecedent basis for this limitation in the claim. Claim 3, on which claim 5 depends, recites “the nucleobase sequences of SEQ ID NOs:16-618” (line 4). As “SEQ ID NO” indexes individual sequences, and claim 3 does not recite “the SEQ ID NO”, it is unclear which sequence in claims 1 and 3 is referenced by “the SEQ ID NO” in claim 5. 112(d): The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 3 recites that “the modified oligonucleotide consists of at least 8 consecutive nucleobases”, while claim 1, on which claim 3 depends, recites that the “modified oligonucleotide [consists] of 12 to 30 linked nucleosides” (lines 1-2). As “consisting of” “excludes any element, step, or ingredient not specified in the claim” (see MPEP 2111.03(II)), and as claim 1 requires additional elements that claim 3 necessarily excludes (additional nucleosides), the limitations of claim 3 do not include all the limitations of claim 1 . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Amendment of “consists of” in line 2 of claim 3 to “comprises” would overcome this rejection. 112(a): The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim s 1, 3, 5, 11-18, 20-23, 47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba , B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar , 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees ., Inc., 525 U.S. 55, 68, 119 S.Ct . 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it”). According to the MPEP § 2163, "The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutsch land GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.")." The claimed invention encompasses modified oligonucleotides having a sequence at least 70% complementary to an equal-length sequence from nucleotides 1833-26789 of SEQ ID NO:2 (claim 1) and modified oligonucleotides consisting of at least 8 consecutive nucleotides which are at least 70% identical to any one of SEQ ID NOs:16-618 (claims 3, 5). This creates an enormous genus of sequences which are not sufficiently described by the disclosure. The specification only provides modified oligonucleotides 100% identical to SEQ ID NOs:16-618 (see Table 6, starting on page 100). These oligonucleotides target Exons 1-14 and Introns 1-13 of human FLCN (SEQ ID NO:2, see Table 6). The specification teaches that “mismatches or imperfect complementarity between the antisense oligonucleotide modulator and target sequence can be tolerated” (paragraph [0240]). However, the specification does not teach the number of mismatches which may be “tolerated”, nor does the specification describe the complete structure of a representative number of species of the large genus of oligonucleotides less than 100% and more than 70% complementary to SEQ ID NO:2 and/or identical to SEQ ID NOs:16-6 18, or functional equivalents thereof. Next, then, it is determined whether a representative number of species have been sufficiently described by other relevant identifying characteristics (i.e., other than nucleotide sequence), specific features, and functional attributes that would distinguish different members of the claimed genus. In the instant case, the only other identifying characteristic is that the oligonucleotides “are capable of targeting one or more transcripts of FLCN” (paragraph [0239]). Such a functional limitation cannot be an identifying characteristic for the claimed diverse genus of molecules, since by Applicant’s definition of the modified oligonucleotides, all members of the claimed genus will have that characteristic. The inventions of claims 11-18, 20-23, 47 require the use of the inventions of claims 1, 3, or 5, and therefore are likewise rejected under 35 USC 112(a), as failing to comply with the written description requirement. Claim Rejections - 35 USC § 102 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Kenyon (2016) : Claim(s) 1 , 3, 5, 47 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Kenyon (2016 , provided by Applicant with IDS filed 09/26/2025 ) . Regarding claim 1, Kenyon teaches modified oligonucleotides consisting of 25 linked nucleotides and having a nucleobase sequence at least 70% complementary to an equal length portion of nucleotides 1833-26789 of instant SEQ ID NO:2, and wherein the modified oligonucleotides comprise at least one modified internucleotide linkage (morpholino linkage) (page 10 teaches morpholino oligonucleotides targeting FLCN, see alignments to SEQ ID NO:2 below , “/c” indicates complementarity alignment ). FLCN ATG MO (this morpholino comprises a sequence of 8 consecutive nucleotides, wherein 7 of the 8 are complementary to instant SEQ ID NO:2, resulting in a percent complementarity of 87.5%): FLCN splice1 MO : FLCN splice1 MM : FLCN splice2 MO : FLCN splice2 MM : Regarding claims 3 and 5, Kenyon teaches at least one modified oligonucleotide having a sequence of at least 8 consecutive nucleotides with at least 70% identity to a sequence selected from SEQ ID NOs:16-618 (page 10; FLCN splice2 MM morpholino comprises a sequence of 12 consecutive nucleotides 83.3% identical to a sequence of 12 consecutive nucleotides of instant SEQ ID NO:18, see alignment below). Regarding claim 47, Kenyon teaches a composition comprising the modified oligonucleotide and a pharmaceutically-acceptable diluent (page 10, Kenyon teaches a solution comprising the morpholinos, used to inject the morpholinos into zebrafish eggs). 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. WO2011135396A1 : Claim (s) 1, 3, 5, 11-18, 47, 84-85 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duchateau ( WO2011135396A1 , of record ), in view of Shukla (2010) . Regarding claims 1, 3, 5, 84, and 85, Duchateau teaches a modified oligonucleotide (a “chemically modified” siRNA or other inhibitory RNA, page 42) consisting of a sequence targeting SEQ ID NO:736 (SEQ ID NO:736 comprises a sequence of 21 consecutive nucleotides 100% identical to nucleotides 12706-12726 of instant SEQ ID NO:2 and 19 consecutive nucleotides 100% complementary to instant SEQ ID NO:16 , see alignment s below) (page 45 ; claims 1-10, 17-18 ). SEQ ID NO:736 to instant SEQ ID NO:16: SEQ ID NO:736 to instant SEQ ID NO:2: Regarding claim 47, Duchateau teaches a composition comprising the modified oligonucleotide and a pharmaceutically-acceptable carrier (page 56 lines 3-6). However, Duchateau does not teach specific chemical modifications of the taught siRNAs. Shukla teaches chemical modifications of siRNA. Regarding claims 11-12, Shukla teaches that 2’-MOE and 2’-OMe modified sugars in an siRNA are common modifications and provide the benefits of improved nuclease resistance and enhanced silencing activity (page 337 ; Fig. 4b ). Regarding claim 13, Shukla teaches that bicyclic sugars (such as LNA, ENA, OXE, and ALN) are common modifications of siRNA and provide the benefit of enhanced hybridization to a target sequence (page 338; Fig. 4b). Regarding claim 14, Shukla teaches that the LNA modification consists of a 4’-CH 2 -O-2’ chemical bridge (Fig 4b). Regarding claims 15-17, Shukla teaches that phosphorothioate modifications are commonly used in siRNAs to provide “improved nuclease resistance and favorable pharmacokinetic properties” (page 336). Shukla teaches that at least one linkage in an siRNA may be so modified, rendering obvious siRNA comprising a mix of phosphorothioate and phosphodiester linkages, and siRNA comprising only phosphorothioate linkages (page 336). Regarding claim 18, Shukla teaches that siRNAs may comprise 5-methylcytidine nucleotides (inherently comprising a 5-methylcytosine base) (page 341). It would have been obvious to an artisan at the time of filing to improve the siRNA of Duchateau by adding 2’-MOE or 2’-OMe modifications, bicyclic sugars, and phosphorothioate linkages in order to provide resistance to nucleases (pages 335, 337 of Shukla), thus increasing the stability of the siRNA. Kenyon (2016) : Claim (s) 1, 3, 5, 11- 16, 20- 23, 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kenyon (2016), in view of Stanton (2012) . Regarding claim 1, Kenyon teaches modified oligonucleotides consisting of 25 linked nucleotides and having a nucleobase sequence at least 70% complementary to an equal length portion of nucleotides 1833-26789 of instant SEQ ID NO:2, and wherein the modified oligonucleotides comprise at least one modified internucleotide linkage (morpholino linkage) (page 10 teaches morpholino oligonucleotides targeting FLCN, see alignments to SEQ ID NO:2 below, “/c” indicates complementarity alignment). FLCN ATG MO (this morpholino comprises a sequence of 8 consecutive nucleotides, wherein 7 of the 8 are complementary to instant SEQ ID NO:2, resulting in a percent complementarity of 87.5%): FLCN splice1 MO : FLCN splice1 MM : FLCN splice2 MO : FLCN splice2 MM : Regarding claims 3 and 5, Kenyon teaches at least one modified oligonucleotide having a sequence of at least 8 consecutive nucleotides with at least 70% identity to a sequence selected from SEQ ID NOs:16-618 (page 10; FLCN splice2 MM morpholino comprises a sequence of 12 consecutive nucleotides 83.3% identical to a sequence of 12 consecutive nucleotides of instant SEQ ID NO:18, see alignment below). Regarding claim 47, Kenyon teaches a composition comprising the modified oligonucleotide and a pharmaceutically-acceptable diluent (page 10, Kenyon teaches a solution comprising the morpholinos, used to inject the morpholinos into zebrafish eggs). However, Kenyon does not teach the chemical modifications required by instant claims 11- 16 and 20- 23. Regarding claims 11-1 6 and 20-23, Stanton teaches antisense oligonucleotides comprising a gapmer pattern of 3-5 nucleotide LNA wings and a 10-deoxynucleotide central sequence (abstract ; Fig. 4 ) (required by claims 20-22) . Stanton teaches that common modifications of wing nucleotides in a gapmer include 2’-methoxyethyl (MOE), 2’-OMe, LNA (which comprise the chemical bridge 4’-CH 2 -O-2’ in the sugar of the nucleotide, and thus comprises a bicyclic sugar ) (page 345) (required by claims 11-14, 23) . Stanton also teaches that fully phosphorothioated backbones increase stability of antisense oligonucleotides (page 344) (required by claims 15-16). It would have been obvious to an artisan at the time of filing that the antisense oligonucleotide of Kenyon should be modified to have a gapmer structure with 3-5 nucleotide long wings comprising LNA, 2’-OMe, and/or 2’-MOE modifications and a 10-nucleotide long DNA central sequence, and to have a fully phosphorothioated backbone, as these modifications were taught by Stanton to increase stability and efficacy of the antisense oligonucleotide. Claim (s) 1, 3, 5, 11- 18 , 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kenyon (2016), in view of Scoles (2019) . Regarding claim 1, Kenyon teaches modified oligonucleotides consisting of 25 linked nucleotides and having a nucleobase sequence at least 70% complementary to an equal length portion of nucleotides 1833-26789 of instant SEQ ID NO:2, and wherein the modified oligonucleotides comprise at least one modified internucleotide linkage (morpholino linkage) (page 10 teaches morpholino oligonucleotides targeting FLCN, see alignments to SEQ ID NO:2 below, “/c” indicates complementarity alignment). FLCN ATG MO (this morpholino comprises a sequence of 8 consecutive nucleotides, wherein 7 of the 8 are complementary to instant SEQ ID NO:2, resulting in a percent complementarity of 87.5%): FLCN splice1 MO : FLCN splice1 MM : FLCN splice2 MO : FLCN splice2 MM : Regarding claims 3 and 5, Kenyon teaches at least one modified oligonucleotide having a sequence of at least 8 consecutive nucleotides with at least 70% identity to a sequence selected from SEQ ID NOs:16-618 (page 10; FLCN splice2 MM morpholino comprises a sequence of 12 consecutive nucleotides 83.3% identical to a sequence of 12 consecutive nucleotides of instant SEQ ID NO:18, see alignment below). Regarding claim 47, Kenyon teaches a composition comprising the modified oligonucleotide and a pharmaceutically-acceptable diluent (page 10, Kenyon teaches a solution comprising the morpholinos, used to inject the morpholinos into zebrafish eggs). However, Kenyon does not teach the chemical modifications required by instant claims 11-18. Scoles teaches common modifications of antisense oligonucleotides. Regarding claims 11-12, Scoles teaches that ASOs are commonly modified to comprise 2’-MOE or 2’-OMe modifications (pages 2-3). Scoles teaches that these modifications enhance binding affinity, and 2’-MOE modifications provide reduced toxicity compared to 2’-OMe modifications (pages 2-3). Regarding claims 13-14, Scoles teaches that constrained or “locked” nucleic acids are commonly comprised in antisense oligonucleotides, allowing for “increased target specificity and reduced recognition by nucleases” (page 3). Locked nucleic acids comprise a CH 2 O bridge between the 2’ carbon and 4’ carbon of the sugar (pages 3 -4, Fig. 2). Regarding claims 15-17, Scoles teaches that phosphorothioate linkages provide “resistance to a broad spectrum of nucleases, support RNase H activity, and increase protein binding, which also improves tissue uptake” (page 2). Scoles teaches that some ASOs comprise only phosphorothioate linkages, and some comprise a mixture of phosphodiester and phosphorothioate linkages “to fine tune the pharmacokinetics of the ASO”, which “can facilitate more rapid distribution into tissue while keeping the terminal elimination low” (page 3). Regarding claim 18, Scoles teaches that ASOs can comprise 5’-methycytosine modifications, increasing ASO specificity through enhanced base pairing (page 4). It would have been obvious to an artisan at the time of filing that the antisense oligonucleotide of Kenyon should be modified to comprise 2’-MOE or 2’OMe modifications, LNAs, phosphorothioate linkages (all phosphorothioate linkages or a mixture of phosphorothioate and phosphodiester linkages), and 5’-methylcytosine modifications in order to enhance binding and targeting affinity, reduce toxicity, increase resistance to nucleases (thus increasing stability), and enhancing distribution of the ASO , as taught by Scoles . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT AFRICA M MCLEOD whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-1907 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri 9:00AM-6:00PM EST . 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, FILLIN "SPE Name?" \* MERGEFORMAT Ram Shukla can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-0735 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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The form may be filed via EFS-Web using the document description Internet Communications Authorized or Internet Communications Authorization Withdrawn to facilitate processing. See MPEP 502.03(II). Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /AFRICA M MCLEOD/ Examiner, Art Unit 1635 /RAM R SHUKLA/ Supervisory Patent Examiner, Art Unit 1635