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
This action is in response to the papers filed June 1, 2026.
Claim Amendments
Applicant’s amendment to the claims filed 06/01/2026 is acknowledged.
Claims 46-47 have been cancelled.
Claims 44, 54-56 are amended.
Claims 44-45, 48-60 are pending and under examination.
Election/Restrictions
The following is a summary of the restriction/election requirements in the present application. See, the Requirement for Restriction/Election mailed 09/19/2025.
In the reply filed 11/19/2025, applicant elected without traverse a Cas9 nuclease and cancer cells, as the type of cells having sequence variation.
Priority
The instant application 17/911,018 was filed on 09/12/2022. This application is a national stage of international application PCT/KR2021/003109 filed 03/12/2021, claiming priority based on Korean patent application KR10-2020-0030473 filed 03/12/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. While a certified copy of the foreign patent application is provided with the instant application, a certified English translation of said foreign patent application has not been provided.
Withdrawal of Prior Rejections/Objections
Rejections and/or objections not reiterated from the previous Office action mailed 02/10/2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
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 44-45, 48-60 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.
This rejection is newly applied, necessitated by amendment.
Claim 44 has been amended to further recite “wherein the subject comprises a first cancer cell and a second cancer cell, and wherein the number of mutated sequences in the first cancer cell is three or fewer, and the number of mutated sequences in the second cancer cell is six or more; ... whereby death of the second cancer cell is induced, while death of the first cancer cell is not induced.” The amendment is considered new matter. In this case, the specification as originally filed describes that the cells having sequence variation may have broadly any number of sequence variations ranging from 4 to 30. See, paragraphs 122-123. The specification is not found to specifically describe a subject having a first cancer cell with 3 or less sequence variations and a second cancer cell with 6 or more variations. In remarks field 06/01/2026, applicant asserts written support for the amendment is found in Examples 5-3 to 5-5 (paragraphs 529-537) of the specification. However, the experiments performed in Examples 5-3 to 5-5 report the apoptosis of osteosarcoma cells was achieved by targeting 5, 10 or 30 DNA sequences with a saCas9 endonuclease in U2OS cells, but cell death was not achieved when only 3 DNA sequence were targeted with a saCas9 endonuclease. Examples 5-3 to 5-5 do not describe the specific limitations introduced by the amendment, i.e., the combination of a first cancer cell and a second cancer cell possessing the ranges of 3 or less and 6 or more sequence mutations, respectively. For these reasons, the amendment filed 06/01/2026 is found to have introduced new matter into the claims. Dependent claims are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 44-45, 48-60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0114413 A1 to Hahn et al.
This rejection is newly applied, necessitated by amendment.
Hahn relates to compositions and methods for targeting cancer-specific DNA sequences, such as copy number amplifications and other types of cancer-specific variations, such as cancer-specific polymorphisms, insertions or deletions, and methods of treating cancer by administration of such sequence-specific DNA targeting agents. See Abstract.
The method of treating cancer in a subject comprises:
preparing a DNA targeting agent by identifying a cancer cell-specific sequence variation from sequencing a tumor sample obtained from the subject, wherein the DNA targeting agent is a CRISPR/Cas system comprising a Cas nuclease and guide RNA (gRNA); and
administering at least one composition comprising the DNA targeting agent to the subject.
See, e.g., paragraphs 14, 31-33, 38-39, 44-45, 72-76, 79-80, 83-84, 98, 123-125, 132.
The cancer-specific sequence variation refers to a DNA sequence which is specific for cancer cells and does not occur in non-cancerous cells (par. 125, 132), and the DNA targeting agent generates double-strand breaks which may induce cell cycle arrest or cell death, such as apoptosis (par. 123-124). Hahn suggests that targeting cancer-specific sequences may lead to an intolerable level of DNA damage burden in cancer cells, resulting in mitotic catastrophe with resultant cell cycle arrest or cell death (par. 11).
Accordingly, with respect to claim 44, Hahn is found to teach or fairly suggest a method for treating a cancer of a subject, comprising:
obtaining a sample form the subject, wherein the sample comprises at least cancer cells of the subject;
obtaining sequencing information from the sample;
identifying multiple mutated sequences of the cancer cell which are not found in a normal cell from the sequencing information;
selecting at least a part of the identified mutated sequences;
preparing a composition comprising a Cas protein and a guide RNA, wherein the guide RNA is complementary to the selected mutated sequences; and
administering the composition to the subject, whereby the Cas protein and guide RNA induces double strand breaks in the genomic DNA of the cancer cells, resulting in selective death of the cancer cells.
Claim 44 further recites that the composition comprises 6-30 guide RNAs, wherein each of the multiple guide RNAs is complementary to the selected multiple mutated sequences.
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)) (emphasis in original) (Claims to titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and 0.2-0.4% molybdenum (Mo) were held anticipated by a graph in a Russian article on Ti-Mo-Ni alloys because the graph contained an actual data point corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni and this composition was within the claimed range of compositions.). "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
In this case, Hahn teaches that the subject may be administered two or more compositions, wherein each composition targets a different cancer-specific DNA sequence variation. The method may involve a multiplexed DNA targeting agent, wherein at least 2, 3, 4, 5, 6, 7, 8, 9, 10 or more different DNA targeting agents, each targeting a different cancer-specific sequence variation, is used. See paragraphs 73, 143. Therefore, since the DNA targeting agent is a CRISPR/Cas system comprising a Cas nuclease and guide RNA, Hahn is found to teach or fairly suggest the composition comprises, at least, 6, 7, 8, 9 or 10 different guide RNAs, each complementary to different mutated sequences. Accordingly, the claimed range of 6-30 guide RNAs, as claimed in claim 44, is anticipated by Hahn.
Claim 44 further recites that the subject possesses a first cancer cell having 3 or less sequence variations and a second cancer cell having 6 or more sequence variations, whereby the claimed composition induces cell death in the second cancer cell but not the first cancer cell.
"[T]he 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). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). See, MPEP 2112.
In this case, the limitation wherein the composition induces cell death in cancer cells having 6 or more sequence variations but not in cancer cells having 3 or less sequence variations describes an intended result or functional property of administering the claimed composition to a subject having cancer. A recitation of an intended result or functional property of the claimed process must result in a manipulative difference between the claimed process and the cited prior art in order to patentably distinguish the claimed process from the cited prior art. If the prior art process is capable of performing the intended result, or if the functional property naturally flows from the prior art process, then the prior art reads on the intended result or functional property recitation. There is no requirement that the cited prior art expressly teach or suggest the intended result or functional property recitation, but only that the subject matter is, in fact, present in the cited prior art. As outlined above, the manipulative actions positively recited by the claims are anticipated by the cited prior art. In particular, Hahn sequences a tumor sample obtained from the subject, identifies the multiple mutated sequences of the cancers cells which are not in normal cells, and administers the claimed composition to the subject having cancer, as claimed in claim 44. Therefore, the intended result or functional property of inducing cell death in cancer cells having 6 or more sequence variations but not in cancer cells having 3 or less sequence variations would have naturally flowed from performing the process steps taught by Hahn. Indeed, the limitation indicates that only cancer cells possessing a sufficient number of the identified multiple mutated sequences are eliminated by the claimed composition, and Hahn recognizes that targeting cancer-specific sequences may lead to an intolerable level of DNA damage burden in cancer cells, resulting in cell death (par. 11). Accordingly, absent evidence to the contrary, the intended result or functional property recitations are not found to patentably distinguish the claimed invention from the cited prior art.
For these reasons, Hahn anticipates the process of claim 44.
Regarding dependent claims 2-5, the claims further recite the organoids comprise lung epithelial, mesenchymal and immune cells (claim 2); the epithelial cells comprise E-cadherin+ epithelial cells, SFTPC+ AT2 cells, KRT5+ basal cells, SCGB1A1+ club cells, tubulin+ cilia cells, and HT1-56+ AT1 cells (claim 3); the immune cells comprise CD4+ T cells, CD8+ T cells, B cells, and macrophages (claim 4); and the mesenchymal cells are vimentin+ mesenchymal cells (claim 5).
These limitations describe intended results or functional properties that naturally flow from performing the process steps (manipulative actions) positively recited in claim 1. Therefore, for the same reasons provided above with regards to claim 1, the intended result or functional property recitations of dependent claims 2-5 are not found to patentably distinguish the claimed invention from the cited prior art.
For these reasons, claim 44 is anticipated by Hahn.
Regarding dependent claim 45, Hahn teaches or fairly suggests that the sequencing information is obtained by performing next-generation sequencing on the sample. See, e.g., par. 90, 126, and fig. 1A.
Regarding dependent claims 54, 57-60, Hahn is found to teach or fairly suggest the composition comprises, at least, 6, 7 or 8 different guide RNAs, each complementary to different mutated sequences, as discussed above. See paragraphs 73, 143. Further, as discussed above, cell death of the cancer cell is induced by double strand breaks generated by the CRISPR/Cas system, as claimed in claim 54. See paragraphs 11, 123-124.
Regarding dependent claims 48-49, Hahn teaches or fairly suggests that the Cas protein is a Cas9 protein derived from Streptococcus thermophilus or pyogenes. See, e.g., par. 14, 49, 176.
Regarding dependent claims 50-53, and 55, Hahn teaches or fairly suggests the composition comprises a Cas protein complexed with the guide RNA, the Cas protein and/or guide RNA is encoded by a nucleic acid, and/or the CRISPR/Cas system is delivered to the subject via a viral vector or nanoparticle. See, e.g., paragraphs 217, 256, 278, 296-297.
Regarding dependent claim 56, Hahn teaches or fairly suggests the cancer is sarcoma, colon cancer or lung cancer. See paragraph 80.
For these reasons, dependent claims 45, 48-60 are also anticipated by Hahn.
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 44-45, 48-56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending U.S. Application No. 19/288,975 (reference to claim listing filed 08/01/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This rejection is newly applied, necessitated by amendment.
The reference claims recite a method of treating cancer of a subject comprising:
obtaining a sample from the subject, wherein the sample comprises at least cancer cells of the subject;
obtaining sequencing information from the sample;
identifying multiple mutated sequences of the cancer cell which are not found in a normal cell from the sequencing information;
selecting at least a part of the identified multiple mutated sequences;
preparing a composition comprising a Cas9 protein or a nucleic acid encoding the Cas9 protein, and multiple guide RNAs or nucleic acid encoding the multiple guide RNAs, wherein each of the multiple guide RNAs is complementary to the selected multiple mutated sequences; and
administering the composition to the subject, whereby the Cas protein and the multiple guide RNAs induce multiple double strand breaks in a genomic DNA of the cancer cells, which selectively induce death of the cancer cell. See claim 1.
The reference claims further recite that the cancer cell is a lung cancer cell, colon cancer cell or osteosarcoma cell (claim 2); the sequencing information is obtained by performing next-generation sequencing on the sample (claim 3); the cancer cell comprises at least ten mutated sequences, the number of the selected multiple mutated sequences that are targeted by the multiple guide RNAs is at least ten, the number of multiple guide RNAs is at least ten, and cell death is induced by at least ten double strand breaks in the genomic DNA of the cancer cell (claims 4-5, 13-14); the Cas9 protein is derived from Streptococcus pyogenes, Streptococcus thennophilus, Staphylococcus aureus, or Campylobacter jejuni (claim 6); the composition comprises a ribonucleoprotein (RNP) in which the Cas9 protein is complexed with each of the multiple guide RNAs (claim 7); the Cas9 protein and/or multiple guide RNAs is encoded by a nucleic acid (claims 8-10); the composition is delivered via a viral vector or nanoparticles (claims 11-12, 15).
Instant claim 44 further recites that the subject possesses a first cancer cell having 3 or less sequence variations and a second cancer cell having 6 or more sequence variations, whereby the claimed composition induces cell death in the second cancer cell but not the first cancer cell.
"[T]he 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). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). See, MPEP 2112.
In this case, the limitation wherein the composition induces cell death in cancer cells having 6 or more sequence variations but not in cancer cells having 3 or less sequence variations describes an intended result or functional property of administering the claimed composition to a subject having cancer. A recitation of an intended result or functional property of the claimed process must result in a manipulative difference between the claimed process and the cited reference in order to patentably distinguish the claimed process from the cited reference. If the reference process is capable of performing the intended result, or if the functional property naturally flows from the reference process, then the reference reads on the intended result or functional property recitation. There is no requirement that the cited reference expressly teach or suggest the intended result or functional property recitation, but only that the subject matter is, in fact, present in the cited reference. As outlined above, the manipulative actions positively recited by the claims are anticipated by the cited reference. In particular, the reference claims recite obtaining sequencing information from a sample comprising cancer cells taken from the subject, identifying the multiple mutated sequences of the cancers cells which are not in normal cells, and administering the claimed composition to the subject having cancer, as instantly claimed in claim 44. Therefore, the intended result or functional property of inducing cell death in cancer cells having 6 or more sequence variations but not in cancer cells having 3 or less sequence variations would have naturally flowed from performing the process steps of the cited reference. Indeed, the limitation indicates that only cancer cells possessing a sufficient number of the identified multiple mutated sequences are eliminated by the claimed composition, and reference claim 1 states that cell death is induced by causing multiple double stranded breaks in the genomic DNA of the cancer cells. Accordingly, absent evidence to the contrary, the intended result or functional property recitations are not found to patentably distinguish the claimed invention from the reference claims.
For these reasons, the reference claims anticipate instant claims 44-45, 48-56.
Claim 57-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending U.S. Application No. 19/288,975, as applied to claims 44-45, 48-56 above, because the instant claims would have been prima facie obvious over the reference claims.
This rejection is newly applied, necessitated by amendment.
The reference claims recite the cancer cell comprises at least ten mutated sequences, the number of the selected multiple mutated sequences that are targeted by the multiple guide RNAs is at least ten, the number of multiple guide RNAs is at least ten, and cell death is induced by at least ten double strand breaks in the genomic DNA of the cancer cell (claims 4-5, 13-14).
The reference claims do not recite that the composition comprises 6, 7 or 8 guide RNAs with different sequences or nucleic acids encoding the guide RNAs, as instantly claimed in claims 57-60.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, the instant claims recite a composition comprising 6, 7 or 8 different guide RNAs, and the reference claims recite a composition comprising at least 10 different guide RNAs. The guide RNAs target the cancer-specific mutations for Cas nucleases to induce double-strand breaks, resulting in cell death or apoptosis. Accordingly, one of ordinary skill in the art would have recognized that the number of guide RNAs is a result-effective variable influencing the amount of damage made to the genomic DNA of the cancer cells, which causes the desired cell death. Therefore, prior to the effective filing date of the instantly claimed invention, one of ordinary skill in the art would have been led to modify the number of guide RNAs through routine optimization in order to improve upon the invention of the reference claims, e.g., by making a more efficient composition while maintaining an effective level of genomic DNA damage.
For these reasons, the limitations of instant claims 57-60 would have been prima facie obvious over the reference claims.
Incomplete response:
In remarks field 06/01/2026, applicant requests that the nonstatutory double patenting (NSDP) rejections be held in abeyance until the claims of the present application are in condition for allowance. As instructed by MPEP 804, a complete response to a NSDP rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims or the filing of a terminal disclaimer in accordance with 37 CFR 1.321. Such a response is required even when the nonstatutory double patenting rejection is provisional. Accordingly, applicant’s reply is not in compliance with 37 CFR 1.111(b), which requires a complete reply to every ground of objection and rejection set forth in the prior Office action. Applicant is respectfully reminded to provide a complete reply to every ground of objection and rejection, as required by 37 CFR 1.111(b), in order to avoid delays prosecution.
Conclusion
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 JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
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 D 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.
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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
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