DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 28, 2026 has been entered.
3. Claims 12, 13, 19, 21, 23, 29, 38, 39, 43 and 44 are pending.
Claims 19, 21, 23, 38, 43 and 44, drawn to non-elected species and non-elected inventions are withdrawn from examination.
Claim 12 has been amended.
Claims 12, 13, 29 and 39 are examined on the merits with species (proteins): a. P-element Induced Wimpy testis (PIWI) protein/complex proteins.
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Withdrawn Grounds of Objection
Specification
5. The disclosure is no longer objected to because it no longer contains an embedded hyperlink and/or other form of browser-executable code, see Amendment to the Specification submitted August 28, 2026.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
6. The NEW MATTER REJECTION of claims 12, 13, 29 and 39 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of the deletion of the new matter, “…a gene editing tool that knocks out amino acid regions 251-383 and 625-758 of PIWIL1, or an antibody or other macromolecular drug that specifically binds to amino acid regions 251-383 and 625-758 of PIWIL1”., see Amendment to the Claims submitted August 28, 2026.
Claim Objections
7. Claim 12 is objected to because of the following informality: CRISPR-Cas9 technology is recited as a medicament, however it is machinery, process or practical application of a technique and not a substance, compound or composition.
Correction is required.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
8. The rejection of claims 12, 13, 29 and 39 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 is maintained.
While claim 12 has been amended to recite the medicament is either a CRISPR-Cas9 technology and a nucleic acid that silences or downregulates PIWIL1 expression.
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.
In analysis of the claims for compliance with the written description requirement of 35 U.S.C. 112, first paragraph, the written description guidelines note regarding genus/species situations that “Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed.” (See: Supplementary Examination Guidelines published in the February 9, 2011, Federal Register 76(27): 7162-7175; and
https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf.
Applicant’s claims read on a method for treating gastric cancers with expression of P-element-induced Wimpy testis (PIWI) like RNA-mediated gene silencing 1 (PIWIL1) and Up-Frameshift 1 (UPF1) comprising (i) detecting expression of PIWIL1 and UPF1, wherein a subject is determined to be a gastric cancer treatment when both, the expression of PIWIL1 is higher than that in a control subject without gastric cancer results in the diagnosis of gastric cancer and (ii) the PIWIL1 mRNA level in the tumor tissue is at least twice as high as that in the matched normal tissue from the same subject and administering a medicament or a pharmaceutical composition thereof to treat gastric cancer that blocks binding of the PIWIL1 and the UPF1 by targeting the amino acid region 251-383 and amino acid region 625-758 of PIWIL1, wherein the medicament is a CRISPR-Cas9 technology that knocks out PIWIL1 expression or a nucleic acid that silences or downregulates PIWIL1 expression targeting amino acid regions 251-383 and 625-758 of PIWIL1. Hence, the medicament reads on a process and a host of nucleic acids.
The specification, however, does not disclose distinguishing and identifying features of a representative number of members of single guide RNA (sgRNA), such as a correlation between the structure and function, so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus. Moreover, the specification fails to disclose which chemical structures are critical to the function of the nucleic acids within the pharmaceutical composition to be implemented in the in vivo method. Thus, the specification fails to adequately describe at least a substantial number of members of the genus of nucleic acids.
All of the current claims read on a method of treating gastric cancers once two criteria are met, the expression of PIWIL1 is higher than that in a control subject without gastric cancer results in the diagnosis of gastric cancer and the PIWIL1 mRNA level in the tumor tissue is at least twice as high as that in the matched normal tissue from the same subject with a medicament that is a CRISPR-Cas9 or nucleic acids that knock out, silences or downregulates amino acid regions 251-383 and 625-758 of PIWIL1.
In the instant case, the genus of medicaments comprises a technology or a nucleic acid that are not adequately described in the specification, see sections 0151-0164. The genus includes a plethora of nucleic acids for which no written description is provided in the specification. Applicant’s claims read on a genus of medicaments, which comprise hundreds of different possibilities. Here, no common element or attributes of the medicaments exist except that must either “knock out” or specifically bind the recited amino acid regions. That is, for example, the only requirement for any of the medicaments is that they must “knock out” and/or specifically bind amino acid regions 251-383 and 625-758 of PIWIL1. There are an unlimited number of nucleic acids that meet the broad scope of the claims. The specification has not identified or clearly set forth the structure of these plethora of medicaments.
It is noted in the recently decided case The Regents of the University of California v. Eli Lilly and Co. 43 USPQ2d 1398 (Fed. Cir. 1997) decision by the CAFC that
“A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169- 71,25 USPQ2d at 1605- 06 (discussing Amgen). It is only a definition of a useful result rather than a definition of what achieves that result. Many such genes may achieve that result. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521,222 USPQ 369, 372- 73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. “
In the current situation, Applicants intend to implement the medicaments in the method of treating gastric cancers. However, these medicaments lack any specific structure that has nexus with the claimed function has not been defined or assured.
It is noted that in Fiers v. Suqano (25 USPQ2d, 1601), the Fed. Cir. concluded that
"...if inventor is unable to envision detailed chemical structure of DNA sequence coding for specific protein, as well as method of obtaining it, then conception is not achieved until reduction to practice has occurred, that is, until after gene has been isolated...conception of any chemical substance, requires definition of that substance other than by its functional utility."
Also, in Vas-Cath Inc, v. Mahurkar (19 USPQ2d 1111, CAFC 1991), it was concluded that:
"...applicant must also convey, with reasonable clarity to those skilled in art, that applicant, as of filing date sought, was in possession of invention, with invention being, for purposes of "written description" inquiry, whatever is presently claimed."
The written description in this instant case seems to only set forth a “…medicament that targets NMD complex proteins [which] can be inhibitors of NMD complex protein”, see section 0095 on page 11. The written description is not commensurate in scope with the claims drawn to a method for treating gastric cancers with any medicament that is a CRISPR-Cas9 or nucleic acid that knocks out, silences or down regulates amino acid regions 251-383 and 625-758 of PIWIL1, which may or may not be capable of functioning in the manner suggested by the specification.
In the application at the time of filing, there is no record or description, which would demonstrate conception of any and all nucleic acids that knock out amino acid regions 251-383 and 625-758 of PIWIL1, which may or may not be capable of functioning in the manner suggested by the specification and the claimed method. Therefore, the claims fail to meet the written description requirement by encompassing sequences, which are not described in the specification.
Conclusion
9. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can normally be reached 8AM-8PM, Monday through Friday.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
30 September 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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