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
Applicants’ claim amendments render moot the anticipatory prior art rejection of record against instant claim 1.
Examiner already determined Applicants’ elected species “siRNA” (as a species of ALDH1L1 inhibitor) is free of the prior art. Thus, Applicants’ amendments to claim 1 limiting any ALDH1L1 inhibitor to “at least one ALDH1L1 siRNA that hybridizes to an ALDH1L1 mRNA” limits the “ALDH1L1 inhibitor” genus to “siRNA” (which is free of the prior art) and hence Examiner has fully extended the Markush search through the ALDH1L1 genus and determined it to be free of the prior art.
Therefore, Examiner extended the Markush search to the full scope of instant claim 1 but did not find any prior art.
Therefore, the Election of Species Requirement of 23 July 2025, as it is applied to elected Group I, is withdrawn.
Claims 60-66 and 73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention of Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 September 2025.
Non-elected Group II claims cannot be rejoined to Group I as they are drawn to a distinct objective and have different steps than Group I. Applicants are asked to cancel non-elected Group II claims in their Reply to expedite allowance.
Current Status of 17/934,277
This Office Action is responsive to the amended claims of 8 April 2026.
Claims 1, 9, 16, 56-59, 80, and 158 have been examined on the merits. Claims 1, 9, 16, 56-59, and 80 are currently amended. Claim 158 is new.
Priority
The effective filing date is 23 September 2021.
Response to Arguments
The Examiner acknowledges receipt of and has reviewed Applicants’ claim amendments and Reply of 8 April 2026.
Applicants’ claim amendments render moot the anticipatory prior art rejection of record against instant claim 1. The references ZHANG and COOK are both silent as to the amended claim 1: “at least one ALDH1L1 inhibitor comprises an ALDHIL1 small interfering RNA (siRNA) that hybridizes to an ALDH1L1 mRNA”.
Response to Amendments
Claim Rejections - 35 USC § 112
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.
Claims 1, 9, 16, 56-59, 80, and 158 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. This is a written description possession rejection.
Here. Instant claim 1 is drawn to treating or preventing eight different renal/kidney disorders (each their own genus groups) by administering to a patient in need thereof one of the following genus groups of inhibitors: ALDH1L1 inhibitor, ALDOB inhibitor, G6PC inhibitor, LRP2 inhibitor, RPL3L inhibitor, SLC25A45 inhibitor, and/or SLC7A9 inhibitor, or any combination thereof.
Each of the instant claim 1 diseases are genus groups/designations comprising the exemplary species of diseases listed within pages 26-27 of the Specification.
Claims 1 and 9 limit the ALDH1L1 inhibitor as “nucleic acid molecules that hybridizes to an ALDH1L1 nucleic acid molecule”; ALDOB inhibitor to “nucleic acid molecules that hybridizes to an ALDOB nucleic acid molecule”; and G6PC inhibitors as “nucleic acid molecules that hybridizes to an G6PC nucleic acid molecules”; and similarly, limits each of LRP2, RPL3L, SLC25A45, and SLC7A9 inhibitors as “nucleic acid molecules that hybridizes to the respective nucleic acid molecule”, etc.
Claim 16 further limits claim 9 by specifying that the inhibitory nucleic acid molecule is an antisense nucleic acid molecule that is designed to hybridize to an ALDH1L1, ALDOB, G6PC, LRP2, RPL3L, SLC25A45, or SLC7A9 mRNA.
Claim 56-57 further specify an adjuvant therapy can be added.
Claim 58 further limits claim 1 by specifying that the variant nucleic acid molecules can be missense variants, splice-site variants, stop-gain variants, start-loss variant, frameshift variant, or an in-frame indel variant, or a variant that encodes a truncated predicted loss-of-function polypeptide.
Claim 80 further defines each of the adjuvant therapies from claim 56.
Claim 158 further defines each of the adjuvant therapies from claim 57.
To satisfy the written description requirement, MPEP section 2163 states, in part, that “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.”
Moreover, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by “…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 inventor was in possession of the claimed genus.”
As used in the application, the term “nucleic acid”, “nucleic acid molecule”, “nucleic acid sequence”, “polynucleotide”, or “oligonucleotide” can comprise: a polymeric form of nucleotides of any length, can comprise DNA and/or RNA, and can be single-stranded, double-stranded, or multiple stranded. One strand of a nucleic acid also refers to its complement” (see Specification page 10).
In any of the embodiments herein, the ALDOB inhibitor can be a ALDOB (variant) nucleic acid molecule (such as a genomic nucleic acid molecule, an mRNA molecule, or a cDNA molecule produced from an mRNA molecule) encoding an ALDOB variant polynucleotide having a partial loss-of-function, a complete loss-of-function, a predicted loss-of-function, or a predicted complete loss-of-function” (page 11 of Specification). The same is true for the other inhibitors listed in instant claim 1.
Furthermore, in some embodiments, the ALDOB inhibitor comprises an inhibitory nucleic acid molecule, such as, but not limited to: antisense nucleic acid molecules, small-interfering RNAs (siRNAs), and short-hairpin RNAs (shRNAs). Such inhibitory nucleic acid molecules can be designed to target any region of an ALDOB nucleic acid molecule (page 30 of the Specification). The same is true for the other inhibitors listed in instant claim 1.
In summary, each of the inhibitors and diseases of instant claim 1 constitute genus groups comprising a wide plurality of species.
It is the Examiner’s position that the Specification provides no description that would allow one of ordinary skill in the art to identify that Applicants were in possession of the shear variability of each of the genus groups, as described, above.
Thus, instant claims 1, 9, 16, 56-59, 80, and 158 are rejected under 35 USC 112(a) written description requirement, as lacking evidence that Applicants had possession of the instantly claimed subject matter at the time the application was filed.
Conclusion
No claims are presently allowable as written.
There is no known prior art that either teaches or anticipates the method of instant claim 1.
The references ZHANG and COOK used to be considered prior art references. However, they both are silent and do not teach, suggest, or provide motivation to use a small-interfering RNA (siRNA) that hybridizes to an ALDH1L1 mRNA.
Moreover, the Written Opinion for PCT/US2022/076838 discloses numerous references that, at one time, could be considered prior art.
However, Applicants’ elected instant claim 1 is drawn to a method of using at least one of the following specific inhibitors: ALDH1L1 inhibitor, ALDOB inhibitor, G6PC inhibitor, LRP2 inhibitor, RPL3L inhibitor, SLC25A45 inhibitor, and/or SLC7A9 inhibitor, or any combination thereof, as a therapeutic moiety to treat or prevent one of the following specific diseases: kidney disease, kidney stone, chronic glomerulonephritis, nephrosis, nephronophthisis, chronic interstitial nephritis, or nephrosclerosis.
There is no known prior art reference(s) that teach, suggest, provide motivation for, or anticipate any one (or more) of these specific inhibitors being used to treat one or more of the specific diseases.
In fact, instant claim 1 is novel and non-obvious since either the concept of inhibiting most of the claim 1 targets (ALDH1L1, ALDOB, G6PC, LRP2, RPL3L, SLC25A45, and SLC7A9) to render a therapeutic outcome is not known in the art or the known art seeks rather to turn back on the target (and not inhibit/silence) it, such as with cancer therapy in which the cancer arises and/or metastasizes from a silenced target gene.
The Examiner has previously indicated (see paragraphs 19-20 of the Non-Final mailed 9 January 2026) that Applicants have provided sufficient guidance/enablement for the scope of their elected Group I instant claim 1.
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.
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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
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