Prosecution Insights
Last updated: April 19, 2026
Application No. 18/004,895

CANCER CELL PROLIFERATION INHIBITOR AND HEALTH FOOD

Final Rejection §101§102§112§DP
Filed
Jan 10, 2023
Examiner
KIM, TAEYOON
Art Unit
1631
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Fordays Co. Ltd.
OA Round
2 (Final)
52%
Grant Probability
Moderate
3-4
OA Rounds
3y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allow Rate
450 granted / 874 resolved
-8.5% vs TC avg
Strong +51% interview lift
Without
With
+51.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
74 currently pending
Career history
948
Total Applications
across all art units

Statute-Specific Performance

§101
4.8%
-35.2% vs TC avg
§103
34.9%
-5.1% vs TC avg
§102
15.4%
-24.6% vs TC avg
§112
29.2%
-10.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 874 resolved cases

Office Action

§101 §102 §112 §DP
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 . Applicant’s amendment and response filed on 12/29/2025 has been received and entered into the case. Election/Restrictions Newly submitted claims 9-12 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the newly added claims 9-12 are directed to a method of using the product. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 9-12 have been withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention. Claim 6 have been canceled, claims 7-12 are newly added, claims 9-12 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-5 and 7-8 have been considered on the merits. All arguments have been considered. Claim Objections Claim 1 is objected to because of the following informalities: The term “ascites carcinoma cell proliferation inhibitor” is awkward. It is suggested to use “a proliferation inhibitor for ascites carcinoma cell”. The term “Rb” in line 6 would be more appropriate as “retinoblastoma (Rb)”. 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. Claims 1-5 and 7-8 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. The instant claims are directed to an ascites carcinoma cell proliferation inhibitor comprising a torula yeast-derived RNA as an active component. The claimed product of an RNA extracted from torula yeast is disclosed to have a function to inhibit progression from a G1 phase to an S phase in a cycle of a cancer cell. While the amendment claims disclose an intended purpose of inhibiting proliferation of ascites carcinoma cells, however, as the claims disclose that the function of the inhibitor is to inhibit the phase transition of ANY cancer cell, the scope of the cancer cell as claimed would be extremely broad. Thus, the claims disclose that the yeast RNA would necessarily and sufficiently inhibit the proliferation of any cancer cells. While the claims disclose that the RNA extracted from torula yeast would inhibit any cancer cell proliferation, however, the instant specification fails to show any example that the RNA extract of torula yeast is capable of carrying out the claimed feature. There are two examples in vitro utilizing 3T3-L1 fibroblasts or hepatocytes as a normal cell and it appears that there is no effect of the RNA in 3T3-L1 fibroblasts but it rather increases the cell number in hepatocytes (Fig. 3 and 4). Figure 6 shows an apparent effect of RNA at different concentration on mouse-derived Ehrlich ascites tumor cells (EATC). While the data shown in the specification appear to show the effect of the RNA extract inhibiting cell cycle and thus cell proliferation in EATC, however, the EATC does not represent all the cancer cells. Furthermore, as claims 4-6 are intended to inhibit cancer cell proliferation in vivo, there is no sufficient written description supporting the in vivo efficacy of the claimed product as claimed. M.P.E.P. §2163 recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, 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 applicant was in possession of the claimed genus…when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” Applicant is advised to amend “a cancer cell” in line 4 of claim 1 to “an ascites carcinoma cell” to overcome the rejection. 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 1-5 and 7-8 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. Claim 1 discloses a phrase “to inhibit progression from a G1 phase to an S phase in a cycle of a cancer cell”. This phrase refers to “a cancer cell” whereas the product is disclosed as “ascites carcinoma cell proliferation inhibitor” which would be understood as to limit only to the carcinoma in ascites. The scope of the claimed inhibitor is not clear if the function of the inhibitor is limited to ascites carcinoma cell or it is for any cancer cell. Clarification is required. Applicant is advised to replace “a cancer cell” with “an ascites carcinoma cell” instead. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-5 and 7-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, a product of nature, without significantly more. The claim(s) recite(s) a yeast-derived RNA or RNA extracted from torula yeast as an active component of the ascites carcinoma cell proliferation inhibitor. There is no additional ingredient in the product. The RNA extracted from torula yeast is considered a nature-based product as torula yeast exists in nature and their RNA would be naturally occurring. The nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state. There is no indication in the specification that the claimed naturally occurring product has any characteristics (structural, functional or otherwise) that are different from naturally occurring counterparts. Thus, the claimed invention does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. There is no indication in the claims that the RNA is transformed or changed in any way different from the naturally occurring counterpart. The claims disclose other limitations directed to the intended purpose of inhibiting cancer cell or a mechanism how it would inhibit the cancer cell proliferation. There is no additional element that makes Thus, the claims are directed to a naturally occurring product, a judicial exception (STEP 2A Prong One: YES). This judicial exception is not integrated into a practical application because there is no additional element that would integrate the judicial product into any improvement in their function or the use of a particular treatment or applying or using the judicial exception in some other meaningful way. It is noted that the intended purpose or use, “ascites carcinoma cell proliferation inhibitor”, “health food” or “sweetener, an acidulant or a vitamin”, does not constitute as an integration into a practical application. MPEP2106.04(d)(2) states “…it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.” Thus, the judicial exception is not integrated into a practical application (STEP 2A Prong Two: NO). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no additional element other than intended purpose of the claimed product. These elements do not add significantly more to the judicial exception as the claims merely disclose a product of extracted RNA per se. Again, the intended purpose/use does not add significantly more to the nature-based product (STEP 2B: NO). Based on the above discussion, the claimed product of RNA extracted from torula yeast cannot be considered as an eligible subject matter under 35 U.S.C. 101. Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1-4 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yeast RNA (2013, Ambion). Ambion teaches yeast RNA purified from Torulla yeast. It appears the term “Torulla” is a typo of “Torula”. Claims 1-4 are interpreted as a torula yest-derived RNA. The intended use or purpose of “an ascites carcinoma cell proliferation inhibitor” or “a health food” does not provide any patentable weight in determining the patentability of the claimed product as they do not provide any structure to the product. Regarding the limitations directed to the inhibitor inhibiting progression from a G1 phase to an S phase in the cell cycle of a cancer cell and the inhibitor suppressing phosphorylation of Rb protein enabling a proportion of low-phosphorylated Rb protein relative to high-phosphorylated Rb protein to be increased in an amount, these limitations are directed to the property or characteristics inherent to the RNA when it is utilized for an intended purpose of inhibiting ascites carcinoma cell proliferation, and it does not add any structure to the RNA. M.P.E.P. §2112 states that “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that “just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel.” Regarding claims 2-3 and 7 directed to the inhibitor increasing an expression level of cyclin E protein, p21 protein or p53, these limitations do not provide any additional structure to the claimed product. Rather they are directed to the results of the claimed product when it is used in a method. As the product of Ambion is identical to the claimed product, the results or characteristics of the product is expected the same. Regarding claim 8 directed to the cancer cell being Ehrlich ascites tumor cell, the cancer cell does not provide any structure to the claimed product. Rather it is the property or characteristics of the claimed product when it is used in the method, and the same product is expected to produce the same results. Thus, the yeast RNA purified from Torula yeast taught by Ambion would anticipate the claimed product. Claim(s) 1-5 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takahashi et al. (US 2014/0302171) Takahashi et al. teach a health drink comprising Torula yeast (para. 43-47). Claims 1-4 are interpreted as a composition comprising a RNA of torula yeast. The intended use or purpose of “an ascites carcinoma cell proliferation inhibitor” or “a health food” does not provide any patentable weight in determining the patentability of the claimed product as they do not provide any structure to the product. Regarding the limitations directed to the inhibitor inhibiting progression from a G1 phase to an S phase in the cell cycle of a cancer cell and the inhibitor suppressing phosphorylation of Rb protein enabling a proportion of low-phosphorylated Rb protein relative to high-phosphorylated Rb protein to be increased in an amount, these limitations are directed to the property or characteristics inherent to the RNA when it is utilized for an intended purpose of inhibiting ascites carcinoma cell proliferation, and it does not add any structure to the RNA. Regarding claims 2-3 and 7 directed to the inhibitor increasing an expression level of cyclin E protein, p21 protein or p53, these limitations do not provide any additional structure to the claimed product. Rather they are directed to the results of the claimed product when it is used in a method. As the product of Takahashi et al. is identical to the claimed product, the results or characteristics of the product is expected the same. Regarding claims 4-5, as discussed above, Takahashi et al. teach a health drink (para. 43), and they also teach that the drink contain sweeteners (para. 65). Regarding claim 8 directed to the cancer cell being Ehrlich ascites tumor cell, the cancer cell does not provide any structure to the claimed product. Rather it is the property or characteristics of the claimed product when it is used in the method, and the same product is expected to produce the same results. Thus, the reference anticipates the claimed invention. Claim(s) 1-5 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tkachuk (US 2012/0232129) as evidenced by Buerth et al. (supra) Tkachuk teaches a yeast RNA extracted and purified from Candida utilis (para. 97; p.20, claim 24). It is known in the art that Candida utilis is torula yeast according to Buerth et al. (p.6981, 2nd col.). The intended use or purpose of “ascites carcinoma cell proliferation inhibitor” or “a health food” does not provide any patentable weight in determining the patentability of the claimed product as they do not provide any structure to the product. Regarding the limitations directed to the inhibitor inhibiting progression from a G1 phase to an S phase in the cell cycle of a cancer cell and the inhibitor suppressing phosphorylation of Rb protein enabling a proportion of low-phosphorylated Rb protein relative to high-phosphorylated Rb protein to be increased in an amount, these limitations are directed to the property or characteristics inherent to the RNA when it is utilized for an intended purpose of inhibiting ascites carcinoma cell proliferation, and it does not add any structure to the RNA. Regarding claims 2-3 and 7 directed to the inhibitor increasing an expression level of cyclin E protein, p21 protein or p53, these limitations do not provide any additional structure to the claimed product. Rather they are directed to the results of the claimed product when it is used in a method. As the product of Tkachuk et al. is identical to the claimed product, the results or characteristics of the product is expected the same. Regarding claims 4-5, as discussed above, “health food” is considered as an intended purpose. Regarding the “sweetener” of claim 5, Tkachuk et al. teach a combination of RNA extract with sugar (para. 63), and the sugar is considered to meet the sweetener. Regarding claim 8 directed to the cancer cell being Ehrlich ascites tumor cell, the cancer cell does not provide any structure to the claimed product. Rather it is the property or characteristics of the claimed product when it is used in the method, and the same product is expected to produce the same results. Thus, the reference anticipates the claimed invention. Claim(s) 1-5 and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yasumatsu et al. (US2014/0234526) Yasumatsu et al. teach a yeast extract comprising RNA and used for a food, and the yeast includes Candida utilis, i.e. torula yeast (paras. 31 and 49; claims 1-8). The intended use or purpose of “ascites carcinoma cell proliferation inhibitor” or a “health food” does not provide any patentable weight in determining the patentability of the claimed product as they do not provide any structure to the product. Regarding the limitations directed to the inhibitor inhibiting progression from a G1 phase to an S phase in the cell cycle of a cancer cell and the inhibitor suppressing phosphorylation of Rb protein enabling a proportion of low-phosphorylated Rb protein relative to high-phosphorylated Rb protein to be increased in an amount, these limitations are directed to the property or characteristics inherent to the RNA when it is utilized for an intended purpose of inhibiting ascites carcinoma cell proliferation, and it does not add any structure to the RNA. Regarding claims 2-3 and 7 directed to the inhibitor increasing an expression level of cyclin E protein, p21 protein or p53, these limitations do not provide any additional structure to the claimed product. Rather they are directed to the results of the claimed product when it is used in a method. As the product of Yasumatsu et al. is identical to the claimed product, the results or characteristics of the product is expected the same. Regarding claims 4-5, as discussed above, Yasumatsu et al. teach a food or drink comprising a yeast extract of Candida utilis, and they also teach the sweet food and the sweetness derived from sweetener (para. 22). Regarding claim 8 directed to the cancer cell being Ehrlich ascites tumor cell, the cancer cell does not provide any structure to the claimed product. Rather it is the property or characteristics of the claimed product when it is used in the method, and the same product is expected to produce the same results. Thus, the reference anticipates the claimed invention. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 1-5 and 7-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/262,759 (reference application) in view of Yasumatsu et al. (supra) and Takahashi et al. (supra) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘759 application discloses a drug or a health food comprising a yeast extract comprising RNA, and the yeast is a torula yeast. The intended purpose or use of the instant application is based on the property of the product inherent to the product. Thus, the RNA in the yeast extract from torula yeast of the ‘759 application is identical to the RNA extracted from the torula yeast of the instant application. One skilled in the art would expect the same property for the product of the ‘759 application as the claimed product of the instant application. Regarding the limitations directed to the inhibitor inhibiting progression from a G1 phase to an S phase in the cell cycle of a cancer cell and the inhibitor suppressing phosphorylation of Rb protein enabling a proportion of low-phosphorylated Rb protein relative to high-phosphorylated Rb protein to be increased in an amount, these limitations are directed to the property or characteristics inherent to the RNA when it is utilized for an intended purpose of inhibiting ascites carcinoma cell proliferation, and it does not add any structure to the RNA. Regarding claims 2-3 and 7 directed to the inhibitor increasing an expression level of cyclin E protein, p21 protein or p53, these limitations do not provide any additional structure to the claimed product. Rather they are directed to the results of the claimed product when it is used in a method. As the product of Takahashi et al. is identical to the claimed product, the results or characteristics of the product is expected the same. Regarding claims 4-5, while the claims of the ‘759 application disclose heath food, however, they do not disclose other component such as sweetener or vitamin, however, it is known in the art that torula RNA extract can be combined with sweeteners. For example, Yasumatsu et al. teach the yeast extract comprising RNA and used for a food, and the yeast includes Candida utilis, i.e. torula yeast, and the yeast extract is combined with sweet food that contains sweeteners (para. 22). Takahashi et al. also teach a health drink (para. 43), and they also teach that the drink contain sweeteners (para. 65). Regarding claim 8 directed to the cancer cell being Ehrlich ascites tumor cell, the cancer cell does not provide any structure to the claimed product. Rather it is the property or characteristics of the claimed product when it is used in the method, and the same product is expected to produce the same results. Thus, the claims of the ‘759 application in view of Yasumatsu et al. and Takahashi et al. render the claims of the instant application obvious. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Response to Arguments Applicant’s arguments with respect to the 112(a) rejection have been fully considered and are persuasive in view of the instant amendment. The claim rejection has been withdrawn. However, the instant amendment has raised the same issue with regard to the scope of cancer types in inhibiting proliferation as discussed above. Regarding to the 101 rejection, applicant argues that there is no disclosure that the torula yeast-derived RNA is used as an ascites carcinoma cell proliferation inhibitor. The inquiry of the 101 rejection is whether the torula RNA is naturally occurring product. The analysis presented above maintains the examiner’s position that the claimed product is not significantly different from the naturally occurring torula yeast RNA. With regard to the method claims, as indicated above, the method claims have been withdrawn. Regarding the 102 rejections, it is noted that the 102 rejections presented above have been modified to address the newly added limitations and claims. Applicant’s argument is directed to the instant amendment reciting the integration of the active ingredient into a health food for an administration method (orally) to a subject for selectively inhibiting progression of G1 to S phase in a cycle of an Ehrlich ascites tumor cells. The argument is not persuasive as these limitations do not add any structure to the claimed product and they are structurally not different from the product taught by the cited references. As discussed, “health food” is directed to the intended use, and the products of the cited references are capable of being used as a food or drink, thus, the intended use does not distinguish the prior art product from the claimed product. The function of the claimed torula RNA and the results obtainable from the use of the product is considered inherent to the prior art product as they are identical in structure to the claimed product. Thus, it is the Examiner’s position that the prior art product comprising torula RNA would have the same property in inhibiting proliferation of Ehrlich ascites tumor cells as they are the same as the claimed product. Regarding the double patenting rejection, applicant indicated a TD would be filed when the claims are in condition for allowance. Thus, the rejection is maintained. 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 TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-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, JAMES SCHULTZ can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TAEYOON KIM/ Primary Examiner, Art Unit 1631
Read full office action

Prosecution Timeline

Jan 10, 2023
Application Filed
Jul 30, 2025
Non-Final Rejection — §101, §102, §112
Dec 29, 2025
Response Filed
Mar 11, 2026
Final Rejection — §101, §102, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
52%
Grant Probability
99%
With Interview (+51.1%)
3y 11m
Median Time to Grant
Moderate
PTA Risk
Based on 874 resolved cases by this examiner. Grant probability derived from career allow rate.

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