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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/22/2026 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
New Grounds of Rejection
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 1-10 and 24-27 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. The application does not adequately describe the genus of cancer that “has been determined to overexpress exportin-1.” There is no standard across the scope of “cancer” in the prior art of what level exportin-1 expression needs to be to be considered “over-expressed,” nor has the application described what level exportin-1 expression needs to be to be considered “overexpressed” within the meaning of the invention, nor description of the properties or other characterstics a cancer needs to have to be qualified as overexpression within the meaning of “been determined.” The recitation “been determined” lacks sufficient written description as there is no description of what practitioner is doing the determining and what criteria is being used in order for the overexpression to have “been determined,” and no description of what analysis is done and what criteria are required in a cancer to meet the limitation “been determined” to overexpress exportin-1. There is insufficient written description for the recitation in claim 1 “wherein the cancer has been determined to overexpress exportin-1, the method comprising administering to the subject having the cancer determined to overexpress exportin-1.”
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 1-10 and 24-27 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 recitation “determined to overexpress exportin-1” renders the claims indefinite. The level of expression that constitutes Exportin-1 (XPO1/CRM1) overexpression is not a singular, fixed standard level across all research or clinical settings, but rather a relative, heightened state defined in comparison to normal tissue or control cells. Whether or not the level of expression of exportin-1 in a particular cancer constitutes “overexpression” depends on the opinion and working frame of the practionier. One practionier may have a different standard for what level of expression constitutes overexpression than the next, as there is no standard art-recognized definition of the term “overexpression” in the field of cancers. The artisan would not know which practitioner’s opinion falls under the scope of the claim.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s argument that “determined to” is clear, the examiner’s response is that the level of expression that constitutes Exportin-1 (XPO1/CRM1) overexpression is not a singular, fixed standard level across all research or clinical settings, but rather a relative, heightened state defined in comparison to normal tissue or control cells, and as practionier may have a different standard for what level of expression constitutes overexpression than the next, as there is no standard art-recognized definition of the term “overexpression” in the field of cancers. The artisan would not know which practitioner’s opinion falls under the scope of the claim.
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.
The declaration of Salim Iqbal Khako under 37 CFR 1.132 filed 1/22/2025 is insufficient to overcome the rejection of claim 1-10 and 24-27 based upon WO 20151570123 A2 to Khakoo as set forth in the last and present Office action for the reason set forth below.
Claims 1-10 and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over WO 20151570123 A2 to Khakoo (IDS filed 12/5/2023). Khakoo teaches methods of NK cell activation and NK cell mediated immunity, immunogenic peptides, compositions and complexes; and associated methods of treatment or prophylaxis of cancer, wherein hepatocellular carcinoma (a cancer that overexpresses exportin-1) is one embodiment (page 1, lines 3-14) by carrying out a method comprising administration of: a peptide capable of activating NK cell-mediated immunity to cancer cells that overexpress exportin-1 comprising or consisting of the amino acid sequence XIIAX-2X1, corresponding to applicant’s peptide, or administration of one or more of a nucleic acid encoding the peptide; an immunogenic composition comprising the peptide; a complex comprising the peptide; a vesicle comprising the peptide or nucleic acid encoding the peptide; a dendritic cell comprising the peptide and/or comprising nucleic acid encoding the peptide; an activated NK cell, that has been activated by the peptide; or a virus or virus like particle comprising the peptide and/or comprising nucleic acid encoding the peptide” (page 7, line 15 to page 9, line 35). Khakoo further teaches administration of an MHC class I molecule provided as a complex with the peptide, wherein the MHC class I molecule comprises MHC class I truncated at the stem region of the a3 domain or alternatively HLA-C (page 5, lines 1-16; page 7, line 9; claim 18).
Khakoo fails to expressly use hepatocellular carcinoma in its method.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to treat hepatocellular carcinoma across the scope of hepatocellular carcinoma with the method of Khakoo. The motivation for this is that hepatocellular carcinoma is taught as a cancer that falls under the scope of Khakoo’s invention, and by applying the method of Khakoo to treat hepatocellular carcinoma, the cancer will be treated.
Applicant’s arguments and the arguments presented in the declaration have been fully considered but are not found persuasive. Regarding applicant’s argument that Khakoo does not appreciate that hepatocellular carcinoma is a cancer that overexpresses exportin-1, the examiner’s response is that overexpression of exportin-1 is an inherent characteristic of the majority of hepatocellular carcinomas, and thus treatment of this cancer across the scope of HCC is treatment of a cancer that overexpresses exportin 1. Regarding applicant’s argument that XPO-1 expression is frequently seen in HCC, but is not an inherent feature of HCC, the examiner’s response is that the data presented by applicant suggests that XPO-1 is expressed or overexpressed in the majority of HCC cases, and it would have been obvious to treat HCC across the scope of HCC, which includes those that do and do not overexpress XPO-1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
March 19, 2026