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 .
DETAILED ACTION
Applicant's amendments and remarks filed on March 14, 2026 are acknowledged. Claims 5, 10, 11, 13, 21, 22, and 24-26 were canceled. Claims 1-4, 6, 9, 12, 20, and 23 were amended. Claims 1-4, 6-9, 12, 14-20, 23, 27, and 28 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5, 9-15, and 20-28) and the following species (small interfering RNA and SEQ ID NO: 3) in the reply filed on July 11, 2025 is acknowledged.
Claims 6-8 and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 July 11, 2025.
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 11, 2025.
Claims 1, 2, 4, 9, 12, 14, 15, 20, 23, 27, and 28 are examined on the merits herein.
Priority
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Withdrawn Objections
In view of Applicant’s amendments and response, the claim objections are withdrawn.
Withdrawn Rejections
In view of Applicant’s amendments and response, the 35 U.S.C 112(b), 35 U.S.C. 112(a) written description, and 35 U.S.C. 102 rejections are withdrawn.
Specification
It is noted that the amendment to the specification filed on March 14, 2026 does not comply with the requirements of 37 CFR 1.121(b) because the amendment does not include clear instructions. Therefore, the amendment to the specification has not been entered. Specifically, the amendment to the specification indicates to amend the paragraph beginning on page 6, line 4; however, the paragraph that Applicant is referring to begins on page 6, line 3 of the specification filed on June 9, 2022.
The disclosure is objected to because of the following informality:
Page 6, line 6 reads in part “FIG. 22B”. It appears this is a typographical error and Applicant may have intended “FIG. 22C” because a description already exists for FIG. 22B and there is no description for FIG. 22C.
Appropriate correction is required.
Response to Arguments
Applicant's arguments filed March 14, 2026 have been fully considered but they are not persuasive.
It is noted that the amendment to the specification filed on March 14, 2026 does not comply with the requirements of 37 CFR 1.121(b) because the amendment does not include clear instructions. Therefore, the amendment to the specification has not been entered. Specifically, the amendment to the specification indicates to amend the paragraph beginning on page 6, line 4; however, the paragraph that Applicant is referring to begins on page 6, line 3 of the specification filed on June 9, 2022.
Therefore, the Examiner is maintaining the objection to the specification.
Claim Objections
Claims 2, 4, 12, and 23 are objected to because of the following informalities:
Claim 2 recites in part “consisting of the nucleotide sequence selected from the group consisting of SEQ ID NOS: 3-37 or a combination thereof” and should recite “consisting of a nucleotide sequence selected from the group consisting of SEQ ID NOS: 3-37 and a combination thereof” (emphasis added).
Claim 4 is missing a period at the end of the claim.
Claim 12 recites in part “the nucleic acid” and should recite “the nucleic acid-based inhibitor”
Claim 12 has a comma after “(siRNA)” and is missing a period at the end of the claim.
Claim 23 recites in part “wherein the nucleic acid-based” and should recite “wherein the nucleic acid-based inhibitor” (emphasis added).
Claim 23 is missing a period at the end of the claim.
Appropriate correction is required.
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.
This following is a new rejection, necessitated by the amendment to the claims in the reply filed March 14, 2026.
New Matter
Claims 1, 2, 4, 9, 12, 14, 15, 20, 23, 27, and 28 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.
Claims 1 and 2 are reproduced below:
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The reply filed 3/14/2026 asserts that support for the amendment can be found in original claims 3 and 5, and in the specification at pages 8-9, Table 1 and Table 2 and on page 10, lines 11-15.
Original claim 5 did recite in part “wherein the inhibitor is an siRNA comprising at least one nucleotide sequence selected from the group consisting of SEQ ID NOS: 3-45”. The specification discloses that some embodiments of the invention may consist of or consist essentially of one or more elements [page 7, lines 8-9]. Table 2 on pages 8-9 of the specification discloses siRNA sequences for reducing Xv1 levels designated as SEQ ID NOS: 3-42. The specification discloses that the sequence of the nucleic acid is selected from the first exon of Xv1 and its flanking region in the genome DNA sequence or mRNA sequence of Xv1. In one aspect, the inhibitor is a nucleic acid, or nucleic acid-based inhibitor that contains nucleotide sequences derived from the first exon of Xv1 and its flanking region (Table 1, SEQ ID NOS: 1-2) in the genomic DNA sequence or cDNA sequence. In another aspect the nucleic acid sequence of the inhibitor mRNA sequence of Xv1 (Table 2, SEQ ID NOS: 3-42 and Table 3, SEQ ID NOS: 43-45) [page 8]. However, the specification does not provide support for a nucleic acid-based inhibitor consisting of a nucleotide sequence selected from the group consisting of SEQ ID NOS: 3-42 and a combination thereof (claim 1). The specification also does not provide support for a nucleic acid-based inhibitor consisting of a nucleotide sequence selected from the group consisting of SEQ ID NOS: 3-37 and a combination thereof (claim 2). The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). However, the transitional phrase "consisting of" excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("consisting of" defined as "closing the claim to the inclusion of materials other than those recited except for impurities ordinarily associated therewith").
Therefore, claims 1 and 2 recite new matter. Claims 4, 9, 12, 14, 15, 20, 23, 27, and 28 are included in the rejection because the claims depend from a rejected claim (claim 1) without addressing the issue in claim 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 (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.
Claims 1, 2, 4, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Klar et al. (WO 2020/011909; reference previously cited by the Examiner). This is a new rejection, necessitated by the amendment to the claims in the reply filed March 14, 2026.
Regarding claims 1, 2, and 4, Klar et al. teaches an oligonucleotide comprising 12 to 20 nucleotides that hybridizes with a nucleic acid sequence of the X-box binding protein 1 (XBP1) wherein the oligonucleotide inhibits at least 50% of the XBP1 expression [abstract]. Klar et al. SEQ ID NO: 69 (designated as Db) has a 100% match to instant SEQ ID NO: 3 (designated as Qy) as shown in the alignment below. Klar et al. SEQ ID NO: 69 is the human pre-mRNA of XBP1 [page 23].
Query Match 100.0%; Score 19; Length 6013;
Best Local Similarity 89.5%;
Matches 17; Conservative 2; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GGAUCCGCCACGCUGGGAA 19
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Db 451 GGATCCGCCACGCTGGGAA 469
Regarding claims 9 and 12, Klar et al. teaches a pharmaceutical composition comprising an oligonucleotide and a pharmaceutically acceptable carrier [page 5, first paragraph] wherein the pharmaceutical composition is for use in a method of treating a disorder such as cancer [page 5, third paragraph].
Although Klar et al. does not explicitly teach a siRNA of instant SEQ ID NO: 3, it would have been obvious to try because Klar et al. taught that an agent effective in inhibiting the function or expression of an intracellular mediator of immunosuppression and tumorigenic functions like XBP1 would be an important improvement for the treatment of patients suffering from diseases or conditions affected by the activity of this suppressive factor [page 2, third full paragraph]. Specifically, targeting XBP1 expression in cancer cells, myeloid progenitors, eosinophils and/or other immune cells on mRNA-level by antisense-oligonucleotides is a promising state-of-the-art approach to develop and improve immunotherapies against different cancers and therapies against inflammatory and immune diseases [page 2, last paragraph bridging to page 3]. Therefore, one of ordinary skill in the art would be motivated to design a siRNA for inhibiting XBP1 expression capable of treating cancers or inflammatory and immune diseases. One of ordinary skill in the art would have had a reasonable expectation of success designing a siRNA because Klar et al. taught oligonucleotides comprising 12 to 20 nucleotides wherein at least one of the nucleotides is modified and the oligonucleotide hybridizes with a nucleic acid sequence of the X-box binding protein 1 (XBP1) of SEQ ID NO: 69 [page 3, first full paragraph] and the sequence of the target is known.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Klar et al. (WO 2020/011909; reference previously cited by the Examiner) as applied to claims 1, 2, 4, 9, and 12 above, and further in view of Fitzgerald et al. (US 2009/0275638; reference previously cited by the Examiner).
Regarding claims 14 and 15, the teachings of Klar et al. are discussed above.
However, Klar et al. does not teach that the pharmaceutically acceptable carrier is a biologically compatible inert solvent. Klar et al. also does not teach that the pharmaceutically acceptable carrier is a liposome.
Fitzgerald et al. teaches compositions containing double-stranded ribonucleic acid (dsRNA) capable of inhibiting the expression of an XBP-1 gene in a cell or mammal. Further, Fitzgerald et al. teaches compositions capable of treating pathological conditions and diseases caused by the expression of XBP-1 gene, such as cancer [0006]. Fitzgerald et al. also teaches pharmaceutical compositions containing the XBP-1 dsRNA and a pharmaceutically acceptable carrier [0029] such as inert diluents [0053]. Fitzgerald et al. teaches suitable topical formulations include those in which the dsRNA are in admixture with a topical delivery agent such as liposomes [0097].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pharmaceutical composition of Klar et al. wherein the pharmaceutically acceptable carrier is an inert diluent or a liposome as taught by Fitzgerald et al. because both Klar et al. and Fitzgerald et al. taught a pharmaceutical composition comprising an oligonucleotide capable of inhibiting XBP1 expression and a pharmaceutically acceptable carrier for the purposes of treating cancer. One of ordinary skill in the art would have been motivated to do so because it would have amounted to combining known prior art elements to yield predictable results.
Claims 20, 23, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Klar et al. (WO 2020/011909; reference previously cited by the Examiner) as applied to claims 1, 2, 4, 9, and 12 above, and further in view of Ahern (The Scientist 1995; reference previously cited by the Examiner) and Glimcher et al. (US 2017/0240903; reference previously cited by the Examiner).
Regarding claim 20, the clause “for targeting an X-box binding protein 1 variant (Xv1)” is the preamble and is interpreted as intended use of the invention while the body of the claim sets forth all the limitations. See MPEP 2111.02(II).
Regarding claims 20, 23, 27, and 28, the teachings of Klar et al. are discussed above.
However, Klar et al. does not teach a kit comprising an antibody for detecting the Xv1 protein and instructions for using the kit.
Ahern teaches that more researchers are buying premade reagents and kits because they are convenient and they save time. Further, investigators can purchase a kit that supplies all of the necessary reagents for a particular research application and even provides detailed instructions to follow [page 5, third paragraph]. Ahern also teaches that the major advantage of purchasing products that come already prepared is that it enables investigators to save time and money [page 4, second paragraph].
Glimcher et al. teaches kits for carrying out screening assays, modulatory methods or diagnostic assays [0157]. Glimcher et al. also teaches immunodetection of complexes using antibodies reactive with XBP-1 [0156]. In addition, Glimcher et al. teaches that a specific pattern of detectable signals such as signals generated by hybridization of mRNAs in a sample to mRNA nucleic acid probes is indicative of gene expression in a sample [0131].
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to package the oligonucleotide of Klar et al. in a kit because Klar et al. taught that it is within the skill of the art to use oligonucleotides to inhibit XBP1 expression, Ahern taught kits with reagents and instructions for use, and Glimcher et al. taught kits for diagnostic assays. One would have made such a substitution in order to achieve the predictable result of inhibiting XBP1 expression and to package reagents in kits to detect Xv1 protein because Ahern taught that it is convenient, saves time, and saves money and because Glimcher et al. taught immunodetection using antibodies and in situ hybridization probes.
Response to Arguments
Applicant's arguments filed March 14, 2026 have been fully considered but they are not persuasive.
With regard to Applicant’s arguments directed to the rejections under 35 U.S.C. 103, the arguments are directed to Fitzgerald et al. in view of Klar et al. However, amendments to the claims necessitated the new 35 U.S.C. 103 rejections as discussed above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHRISTINA TRAN whose telephone number is (571)270-0550. The examiner can normally be reached M-F 7:30 - 5:00pm.
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, Jennifer Dunston can be reached at (571) 272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T./
Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
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