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 .
Claims 175-190 are currently pending in this Application.
Priority
CONTINUING DATA
This application is a CON of 17/056,572 11/18/2020 ABN
17/056,572 is a 371 of PCT/US2019/033625 05/22/2019
PCT/US2019/033625 has PRO 62/674,968 05/22/2018
Information Disclosure Statement
Applicant’s Information Disclosure Statements, filed on 10/26/2023; 01/30/2025; 03/17/2025; 10/03/2025; and 10/27/2025 have been considered. Please refer to Applicant’s copies of the 1449 submitted herewith.
Response to Restriction
Applicants’ election, without traverse, claims 175-190, drawn to a method for modulating transcription of a gene comprising a trinucleotide repeat sequence GAA the method comprising contacting a cell comprising the gene with an agent having a first terminus, a second terminus, and an oligomeric backbone and the following species:
PNG
media_image1.png
222
888
media_image1.png
Greyscale
wherein:
PNG
media_image2.png
583
869
media_image2.png
Greyscale
, in response filed on April 08, 2026 is acknowledged.
Therefore, the restriction requirement is considered proper and is maintained.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a petition under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Claim Rejections- Improper Markush
Claims 175-190 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and a common use that flows from the substantial structural feature for the following reasons: The claims are directed to a large multitude of different polyamide structures and protein binding amino acid sequences. Although the polyamide are DNA binding moieties, they do not share any significant structural similarity. Likewise, although the protein binding moieties are made of amino acids, they do not share any significant sequence similarity.
When the Markush grouping is for alternatives of chemical compounds, they shall be regarded as being of a similar nature where the following criteria are fulfilled:
(A) All alternatives have a common property or activity; and
(B) (1) A common structure is present, i.e., a significant structural element is shared by all of the alternatives; or
(B) (2) In cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains.
In paragraph (B)(1), above, the words "significant structural element is shared by all of the alternatives" refer to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity. The structural element may be a single component or a combination of individual components linked together.
In paragraph (B)(2), above, the words "recognized class of chemical compounds" mean that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved. In order for the members of the Markush group to belong to "recognized class of chemical compounds" there must be an expectation that the members of the class will behave in the same way in the context of the claimed invention. In other words, each member of the class could be substituted one for the other with the expectation that the same intended result would be achieved. In the instant case, activity of any specific DNA binding moiety is dependent upon the specific type and structure and any protein binding moiety is depended on the specific amino acid sequence. There is no expectation that any one of the DNA binding moieties or protein biding moieties as claimed can be substituted for any of the other with the expectation of the same activity.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. 134 and 37 CFR 41.31(a)(1).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 175-190 are rejected under 35 U.S.C. 103(a) as being unpatentable over Ansari et al (WO 2017172914 A1), Melander et al (US 2006270727), Will et al (US 20170166953), JP 2016108249.
Regarding claim 175, Ansari et al. teach methods of modulating expression of a gene comprising a repeat sequence GAA using an agent comprising a first terminus comprising DNA-binding polyamide that binds to the repeat sequence and is linked to an oligomeric backbone that is linked to a second terminus comprising a protein-binding moiety (0004-0006). Ansari et al. teach the methods of modulation is a decrease in transcription (0135).
Regarding claim 177, Ansari et al. teach the repeat sequence comprises at least 30 to 200 repeats (see 0012).
Regarding claim 184, Ansari et al. teach the linker has about 10 to 50 atoms (0052-0053).
Ansari et al. do not teach the DNA- binding moiety is a hairpin polyamide, the linker has a length measured in angstroms, the gene is FXN and methods of treating a disease mediated a GAA repeat sequence in FXN such as Friedreiech’s Alaxia.
Regarding claim 176, Melander et al. teach polyamide DNA binding moieties that bind DNA repeat sequences that cause disease to modulate transcription of a gene (see 0004-0008, 0013). Melander et al. teach the target gene can be a neurological gene such as SCA8, SCA10 and SCA12 which are associated with spinocerebellar ataxia (0016). Melander et al. teach the polyamide is a hairpin polyamide (0065).
Regarding claim 184, Will et al. teach using linkers that are measured in angstroms of less than about 50 angstroms that join two moieties together (0059).
Regarding claims 185-190, Ansari et al teach Friedreich's ataxia (FA or FRDA) is an autosomal recessive neurodegenerative disorder caused by mutations in the FXN gene, which encodes the protein frataxin.
It would have been obvious to one of ordinary skill in the art to use the method of Ansari et al. to target a GAA repeat sequence to modulate expression of the FXN gene in methods of treating a disease mediated by GAA such as Friedreich's ataxia (FA or FRDA). It would have been obvious to try given there is a need because there is no cure for ataxias as taught by JP249, Ansari et al. teach an efficient method for targeting pentanucleotide repeat sequences of spinocerebellar ataxias.
Further it would have been obvious to use an oligonucleotide linker to connect the first and second terminus wherein the linker is measure in angstroms or chain atoms which are known in the art to measure linker length.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing 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. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function "would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art." 596 F.2d at 1022, 201 USPQ at 661.); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991). See MPEP 2145, Section II. "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Accordingly, claims 175-190 are rendered obvious in view of the references above. Applicant might consider providing evidence of unexpected results to overcome the rejection.
Claim Objections
Claims 175-190 are objected to for containing non-elected subject matter.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMAL A SAEED whose telephone number is (571) 272-0705.
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, Adam C Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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
/Kamal A Saeed/
Primary Examiner, Art Unit 1626
Prosecution Insights