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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Applications No. 63/125,513, 63/158,176, 63/197,816, 63/250,117, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. A claim by claim analysis indicated lack of support for any of the instant claims formulas in PRO applications 63/125,513, 63/158,176, 63/197,816. Claims 1-10 thus received a priority date of 09/29/2021. A claim by claim analysis indicated lack of support for the specific groups of E1, E2, the SEQ ID NO:135, and specific structures of claims 19, 22 and 56 in PRO applications 63/125,513, 63/158,176, 63/197,816, 63/250,117. Thus claims 11-26 and 56 were given a priority date of 12/15/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/08/2023 is being considered by the examiner.
Claim Interpretation
As no specific structure other than the instant formula is taught to accomplish the specific biological activities of the dependent claims the claims are interpreted so that any structure of the instant claim is understood to inherently possess that biological activity. For example since no definition is given for the structure function relation to treated DM1 gene and [0050] says provided herein are compounds that reduce expression of the disease-causing DM1 gene it is interpreted to mean all compounds covered by the instant application have this activity inherently. To say otherwise, would mean the disclosure is not enabling as a person of ordinary skill in the art would not know which compounds of the disclosure would provide such activity.
Drawings
The drawings are objected to because figures 16 and 18 have white bars on a white background and thus are difficult to interpret. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 56 is objected to because of the following informalities: poor image resolution. Appropriate correction is required.
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 7, 11-26 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.
The parentheses used around the phrases "(SEQ ID NO: 135)" renders the claims 16 indefinite because it is not clear if this limitation is part of the claim or not. It is unclear what part of the claim SEQ ID NO: 135 is referring to as it could be the biologically-active agent or the mRNA sequence. It is especially unclear because the ID appears after integer numbers 1-100 and SEQ ID is not an indicator of integer number. Thus the scope of claim 16 is indefinite. Appropriate correction is required.
The term “biologically-active agent” in claims 11-26 is a relative term which renders the claim indefinite. The term “biologically-active agent” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A person of ordinary skill in the art opinion on what is biological active can differ. For instants a person may consider all compounds biological active as they can all interact with biology while other may consider some chemicals inert. For instance N2 is generally considered an inert gas but it can displace O2 in a room and cause a person to suffocate. Would one then consider it to be biological active as it did interact a living organism and cause an effect?
The term “oligonucleotide analogue” in claim 17 is a relative term which renders the claim indefinite. The term “oligonucleotide analogue” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A no definition is given in the claim one of ordinary skill in the art would not know how close in structure and/or function an agent would need to be to be considered a oligonucleotide analogue.
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.
Claim(s) 1, 2, 5, 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 1373444-74-6 CAS Registry File from STN, entered into STN 11 May 2012.
The reference CAS 1373444-74-6 teaches the following compound, wherein R1=H,R2=NH,R3=H, R4=H, n=3, R5=alkyl substituted, E1=chemical moiety, E2= chemical moiety, p=1.
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This anticipates claims 1, 2, 5 and 7.
Claim(s) 1, 2, 5, 7 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Niu (Niu et al., Mol. Pharmaceutics 2012, 9, 5, 1529–1534).
The reference CAS 1373444-74-6 teaches the following compound, wherein R1=H,R2=NH,R3=H, R4=H, n=3, R5=alkyl substituted, E1=biologically-active agent, E2= biologically-active agent, p=1.
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This anticipates claims 1, 2, 5, 7 and 11.
Claim(s) 11-12, 17, 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 2721422-90-6 CAS Registry File from STN, entered into STN 29 Oct 2021.
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The reference CAS 2721422-90-6 teaches the following compound, wherein R1=H,R2=NH,R3=H, R4=H, n=4, R5=alkyl substituted, E1=H, E2= PNA/ oligonucleotide analogue., p=5.
This anticipates claims 11-12, 17, 18.
Claim(s) 11-16 is/are rejected under 35 U.S.C. 102((a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ly (Ly et al., WO 2021/202621 A2, 07 October 2021).
The reference Ly teaches the following compound [078], wherein R1=H,R2=NH,R3=H, R4=H, n=4, R5=alkyl substituted, E1=H, E2= PNA/ oligonucleotide analogue(Title/abstract)., p=5. This anticipates claims 11-12
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The reference Ly teaches “The present disclosure describes the use of a compound and methods to treat conditions or genetic disease, including trinucleotide repeat disorders. The method can comprise administering to the subject a therapeutically-effective amount of a compound of the disclosure. In some embodiments, the genetic disease is a polyglutamine (polyQ) disease. Polyglutamine diseases include trinucleotide repeat disorders involving genes that comprise an abnormally high number of CAG repeats. In some embodiments, the poly glutamine disease is SCA1 (Spinocerebellar ataxia Type 1), SCA2 (Spinocerebellar ataxia Type 2), SCA3 (Spinocerebellar ataxia Type 3 or Machado-Joseph disease), SCA6 (Spinocerebellar ataxia Type 6), SCA7 (Spinocerebellar ataxia Type 7), SCA12 (Spinocerebellar ataxia Type 12), SCA17 (Spinocerebellar ataxia Type 17), DRPLA (Dentatorubropallidoluysian atrophy), SBMA (Spinal and bulbar muscular atrophy), or Huntington’s disease” [149] and “Compounds of the disclosure can be systemically administered to a subject in need thereof as a therapeutically-effective amount of a compound that binds to a repeat codon. ...”[153]. The reference also teaches “Embodiment 235. The method of any one of embodiments 221-234, wherein the compound binds a CAG repeat sequence in a nucleic acid molecule[940]”. Additionally, the reference teaches “[039] The present disclosure relates to compounds useful for the detection or modulation of target nucleic acids, including DNA and RNA. The present disclosure further relates to methods for treatment of trinucleotide repeat disorders, which can include administration of oligonucleotide analogues that can bind pathogenic nucleotide repeats in DNA or RNA. In some embodiments, compounds of the disclosure bind CAG repeats within the mutant mHTT transcript present in Huntington’s disease, thereby modulating expression of mHTT protein.”
As no specific structure other than the instant formula is defined to accomplish the specific biological activities of the dependent claims the claims are interpreted so that any structure of the instant claim is understood to inherently possess that biological activity. For example since no definition is given for the structure function relation to treated DM1 gene and [0050] says provided herein are compounds that reduce expression of the disease-causing DM1 gene it is interpreted to mean all compounds covered by the instant application have this activity inherently. To say otherwise, would mean the disclosure is not enabling as a person of ordinary skill in the art would not know which compounds of the disclosure would provide such activity.
This anticipates claims 13, 14, 15 and 16.
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.
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) 1, 2, 5, 6, 7 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niu (Niu et al., Mol. Pharmaceutics 2012, 9, 5, 1529–1534).
The reference Niu teaches the following cell penetrating peptide , wherein R1=H,R2=NH,R3=H, R4=H, n=3, R5=alkyl substituted, E1=chemical moiety, E2= chemical moiety, p=1 and its biological uses (abstract).
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This helps to teach claims 1, 2, 5, 6, 7 and 11.
The reference Niu does not teach n=4 (claim 6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Niu to get the compound of instant claim 6 because it only differs slightly in structure by one CH2 unit. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Thus one would have reasonable expectation of success to make the compound of Niu with one additional CH2 unit and for that compound to have similar properties and similar uses because the change in structure is minor. Thus one would be motivated to do so to produce additional cell-penetrating peptides for carrying drugs.
Claim(s) 1, 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ly (Ly et al., WO 2021/202621 A2, effective filing date 3/3/2020).
The reference Ly has been discussed supra.
The reference Ly teaches (pages 215):
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The reference Ly does not specifically teach a compound of claim 8-10 wherein p=6-8 but instead requires picking and choosing from a generic formula.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Ly to get the compound of instant claim 8-10 because it only differs in the number of repeating units. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Thus one would have reasonable expectation of success to make the compound of Ly with additional units and for that compound to have similar properties and similar uses because the change in structure is minor. Thus one would be motivated to do so to produce additional compounds for treating the same disease taught by Ly.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-4 and 6-18 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 110-141 of copending Application No. 18/873,193 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because :
The application ‘193 claims:
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This anticipates claims 1-4 and 6-18.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claim 56 is objected to.
Claims 1-26 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR SALAMATIAN whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627