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 .
Response to Amendment and Arguments
2. The species election reading on proteins presented in the Requirement mailed July 21, 2025 on page 5, section 6 is moot given the amendments and cancellation to/of the claims, see Amendment to the Claims submitted February 3, 2026.
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Claims 19, 21, 23, 38, 43 and 44, drawn to non-elected species and non-elected inventions are withdrawn from examination.
Claims 24-28, 37, 38, 40 and 41 have been cancelled.
Claims12, 19, 21, 23, 38 and 39 have 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Withdrawn Objections
Drawings
5. The drawings are no longer objected to as failing to comply with 37 CFR 1.84(p)(5) because reference character(s) are now mentioned in the description: Figure 5A-Figure 5C, sections 0158, 0186 and 0188 of US Publication 2023/0184774, see Amendment to the Specification submitted February 2, 2026.
As for reference character(s), Figure 16A-Figure 16G, Figure 17A-Figure 17D and Figure 21A-Figure 21C on page 13, sections 0117, 0118 and 0122, respectively; and Figure 23A and Figure 2B on page 14, section 0124 of the Specification filed October 27, 2022. Applicant did not note them in the Remarks. However, the submitted replacement sheets reflect there are no reference characters. The changes to Figures 16, 17, 21 and 23 to align with the descriptions within the specification submitted October 27, 2022, see Amendment to the Drawings submitted February 2, 2026.
Applicant has also submitted changes to Figures 20 and 22, see Amendment to the Drawings submitted February 2, 2026.
Claim Objections
6. Claim 12 is no longer objected because the claim recites both the acronym and the full meaning, see Amendment to the Claims submitted February 3, 2026.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
7. The rejection of claims 12, 13, 29 and 39 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 is withdrawn in light of the amendment to claim 12 and cancellation of claim 41, see Amendment to the Claims submitted February 3, 2026. Claims 24-28, 40 and 41 have been cancelled.
Claim Rejections - 35 USC § 101
8. The claimed invention (claims 12, 13, 29 and 39) is no longer directed to a judicial exception and/or natural phenomenon without significantly more invention is withdrawn in light of the amendment to claims 12 and claim 39, see Amendment to the Claims submitted February 3, 2026. Claims 24-28, 40 and 41 have been cancelled.
Claim Rejections - 35 USC § 103
9. Claim(s) 12, 13, 29 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al., WO 2018/107381 A1 (published 21 June 2018/ IDS reference BA submitted September 16, 2024) and further in view Li et al. (Cellular Physiology and Biochemistry 42: 2194-2206, published online August 15, 2017/ IDS reference CE submitted February 14, 2023) is withdrawn in light of the amendment to independent claim 12 citing P-element-induced Wimpy testis like RNA-mediated gene silencing 1 (PIWIL1) and Up-Frameshift 1 (UPF1), see Amendment to the Claims submitted February 3, 2026. Claims 24, 26, 28, 40 and 41 have been cancelled.
The declaration under 37 CFR 1.132 filed February 02, 2026 is sufficient to overcome the rejection of claims 12, 13, 29 and 39 based upon the combination of teachings of Lin et al., WO 2018/107381 A1 and Li et al. cited herein.
10. The rejection of claim(s) 12, 13, 29 and 39 under 35 U.S.C. 103 as being unpatentable over Lin et al., WO 2018/107381 A1 (published 21 June 2018/ IDS reference BA submitted September 16, 2024) and further in view of Gao et al. (OncoTargets and Therapy 11: 8783-8789, 2018/ IDS reference CD submitted February 14, 2023) is withdrawn in light of the amendment to independent claim 12, see Amendment to the Claims submitted February 3, 2026. Claims 24-28, 40 and 41 have been cancelled.
The declaration under 37 CFR 1.132 filed February 02, 2026 is sufficient to overcome the rejection of claims 12, 13, 29 and 39 based upon the combination of teachings of Lin et al., WO 2018/107381 A1 and Li et al. cited herein.
New Grounds of Objection
Specification
11. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see page 11, section 0096. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
12. 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.
13. Claims 12, 13, 29 and 39 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. THIS IS A NEW MATTER REJECTION. 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.
Applicant has amended claim 12 to recite limitations not supported by Applicant’s disclosure. The wherein clause reading on “…the medicament is 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”. Applicant’s specification does not support the terminology, gene editing tool, nor macromolecular drug. Moreover, the disclosure does not support their implementation, nor the antibody in the claimed method of treating targeting the said regions. A review of the specification does cite a medicament that is a macromolecular substance, see page 4, sections 0014 and 0015. However, this broad class cannot be extrapolated to the more limiting specie, macromolecular drug.
Applicant is requested to delete the new matter or point out where in the disclosure support can be found for these limitations.
14. Claims 12, 13, 29 and 39 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.
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 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. Hence, the medicament reads on a plethora of uncharacterized and unknown compounds, antibodies and macromolecular drugs.
The specification, however, does not disclose distinguishing and identifying features of a representative number of members of the gene editing tool, an antibody or other macromolecule drug, 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 gene editing tool, an antibody or other macromolecule drug 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 compounds/antibodies/macromolecular drugs.
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 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.
In the instant case, the genus of medicaments comprise enumerable compounds, antibodies, drugs and pharmaceutical composition thereof is not adequately described in the specification, see sections 0011-00101. The genus includes a plethora of medicaments 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 compounds/antibodies/molecules 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 gene editing tool 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, which may or may not be capable of functioning in the manner suggested by the specification. These undefined gene editing tool, antibody, macromolecular drug are not commensurate scope with the established written description.
In the application at the time of filing, there is no record or description, which would demonstrate conception of any medicament that is a gene editing tool 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, 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
15. 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.
16. 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.
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, 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
15 April 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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