Prosecution Insights
Last updated: April 19, 2026
Application No. 17/919,118

cDNA, mRNA, PROTEIN, AND KIT AND SYSTEM FOR EVALUATING GLIOMA PROGNOSIS

Final Rejection §101§102§112§DP
Filed
Oct 14, 2022
Examiner
BAUSCH, SARAE L
Art Unit
1699
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Beijing Neurosurgical Institute
OA Round
2 (Final)
29%
Grant Probability
At Risk
3-4
OA Rounds
4y 0m
To Grant
72%
With Interview

Examiner Intelligence

Grants only 29% of cases
29%
Career Allow Rate
170 granted / 593 resolved
-31.3% vs TC avg
Strong +44% interview lift
Without
With
+43.6%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
59 currently pending
Career history
652
Total Applications
across all art units

Statute-Specific Performance

§101
21.2%
-18.8% vs TC avg
§103
20.4%
-19.6% vs TC avg
§102
22.8%
-17.2% vs TC avg
§112
28.2%
-11.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 593 resolved cases

Office Action

§101 §102 §112 §DP
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 . Claim Status Currently, claims 1-4, 7-8, and 11-13 are pending in the instant application. Claims 5-6 and 9-10 have been canceled. Claims 1-2, 4, and 7 has been amended while claims 11-13 have been added. This action is written in response to applicant' s correspondence submitted 10/30/2025 and supplemental filed 11/13/2025 and 11/21/2025. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is FINAL. Claims 1-4, 7 (as it reads on nucleic acids), 8 and 11-13 is under examination. Withdrawn Rejections The rejection of claims 1, 3-4 and 7 under 35 U.S.C. 102(a)(1) as being anticipated by NM_000245.4 .(GenBank, NCBI Reference sequence NM_000245.4 submitted May 31, 2019) is withdrawn in view of the amendment to the claims. Specifically claim 1 requires that the sequence does not contain exon 19 of MET gene and the NM_000245.4 comprises exon 19 of MET gene. The double patenting rejection of claims 1, 3, 4 and 7 over claim 1, 2, 4, 5, 7, and 8 of copending Application No. 17919711 is withdrawn due to the amendment to the claims. Nucleotide and/or Amino Acid Sequence Disclosures REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825. The sequence disclosures are located figure 2, para 56, 62, 69 and 70.. Required response – Applicant must provide: A "Sequence Listing" part of the disclosure, as described above in item 1); as well as An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2); A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4). If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter; If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide: A replacement CRF in accordance with 1.825(b)(6); and Statement according to item 2) a) or b) above. Response to Arguments The response traverses and asserts the sequence listing was provided on 2/23/23 with a substitute specification. The response asserts that the sequence listing has been validated on 2/23/23. This response has been reviewed but not found persuasive. While a substitution specification was submitted on 2/23/23 the specification does not contain SEQ ID for the sequences recited in figure 2, para 56, 62, 69 and 70. None of these sequences are in the sequence listing. The sequence listing submitted on 11/21/2025 and 11/13/2025 contained errors and does not address these deficiencies. Applicant is required to provide a sequence listing containing the sequences that do not have a SEQ ID NO in the specification. Claim Objections Claim 11 is objected to because of the following informalities: “claim1”. There should be a space between claim and 1. Appropriate correction is required. New Grounds of Rejections, Necessitated by Amendment to the Claims Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-4, 7-8, 11-13 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. This rejection was previously presented and has been rewritten to address the amendment to the claims. Claim 1 recites the cDNA corresponds to the human MET gene. The recitation of corresponds to the human MET gene renders the claim indefinite. Corresponding is not an art recognized term to describe the relationship between two nucleic acid sequences. It is not clear as to whether a corresponding nucleic acid consists of, comprises the human MET gene or shares some unstated level of complementarity or identity with MET gene. Because the term “corresponds” has not been clearly defined in the specification and there is no art recognized definition for the term as it relates to nucleic acid sequences, one of skill in the art cannot determine the metes and bounds of the claimed subject matter. Claim 2-3 and 7 are indefinite over the recitation of “according to claim 1”. Claim 1 is indefinite for the reasons addressed above. Claims 2-3 and 7 are indefinite because it is not clear what part of claim 1 is required for the cDNA, mRNA or primer pair and probe of claims 2-3 and 7. The claims do not further limit specific embodiments of claim 1 and merely require according to claim 1. It is unclear which fragment of claim 1 is required for claims 2-3 and 7 and what the structural features of the claims entail. Are the structural requirements of claim 2 the fragment at position 2588-2687 or the position 2635-2652 or some other embodiment of claim 1. Because claim 1 is indefinite and it is not clear the structural requirements of the claims, the metes and bounds of the claims are indefinite. Claim 11 recites the limitation "the DNA of claim 1" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 2-4, 7-8, 11-13 depend from claim 1 and are indefinite for the reasons applied to claim 1. Response to Arguments The response traverses the rejection on page 5. The response asserts the claims have been amended to remove preferably and the rejection is now moot. As addressed in the rejection above the claims are indefinite for the recitation of corresponds to a human MET gene. It is unclear what is encompassed by or required for a sequence to correspond to a human MET gene, for these reasons and reasons of record this rejection is maintained. 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 1-4, 7-8, 11-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a natural phenomenon, law of nature. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. This rejection was previously presented and has been rewritten to address the amendment to the claims. The following three inquiries are used to determine whether a claim is drawn to patent-eligible subject matter: Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? Yes, all of the claims are directed to a composition of matter. Step 2. Is the claim directed to a law of nature, a natural phenomenon or an abstract idea (judicially recognized exception) and does the claim recite additional elements that integrate the judicial exception into a practical application? The claims are drawn to a composition of matter, which is a law of nature. Claim 1 recites a cDNA sequence wherein a sequence of the cDNA contains a fragment of SEQ ID NO 1. Claim 2 recites the cDNA according to claim 1 wherein the cDNA is single-stranded DNA Claim 3 recites a mRNA that is a reverse transcription for claim 1. Claim 4 requires the sequence of mRNA contains a fragment of SEQ ID NO 2. SEQ ID NO 7 comprises a kit comprising primer pairs and probes. Claim 8 recites primer pairs comprise SEQ ID NO 4-6 and 7-9. Claims 11 recite the fragment of SEQ ID NO 1 contains a sequence at position 2588-2687 of SEQ ID NO 1. Claims 12-13 recite a mRNA that comprises a fragment of SEQ ID NO 2 or the sequence of SEQ ID NO 2. Each of these sequences are naturally occurring sequences. The specification teaches identifying the sequences from human subjects with glioma (see table 2). The recitation of a cDNA, mRNA, primer, probe and kit does not result in a markedly different sequence and each of the claimed sequences encompass naturally occurring sequences. There is no recitation within the claims that indicate that the nucleic acid claimed have any structural or functional characteristics that differ from the naturally occurring nucleic acids. Additionally the recitation of kit comprising a primer and probe does not structurally change the naturally occurring sequence. Thus the recitation of a kit encompasses naturally occurring nucleic acids contained within or associated by any means with a container. There is no indication in the specification that the nucleic acids claimed here have any structural or functional characteristics that differ from the naturally occurring nucleic acids. Additionally the claims reciting a cDNA or mRNA does not result in any structural difference and the sequences convey the naturally occurring sequence. The claimed nucleic acids do not display markedly different characteristic compared to the naturally occurring counterpart, the recitation of cDNA or mRNA including fragments does not change or alter the sequence. Because SEQ ID NO 1-2 and 4-8 are naturally occurring, as evidence by the specification and the prior art there the claims encompass a natural phenomenon. There is no indication that the kit comprising primers or probes results in changing the structure, function or other properties of the naturally occurring nucleic acid. According the nucleic acids are a product of nature exception and the claim is directed to at least one exception. This judicial exception is not integrated into a practical application because the claims recite probes or primers that are naturally occurring and the probes and primers detect naturally occurring sequences. The recitation of cDNA, mRNA, probe or primer is nothing more than an attempt to generally link the product of nature to a technological environment and is a nominal extra solution component of the claim and does not structurally change the nucleic acid sequence. Many cited prior art references in this record demonstrate the probes and primers are naturally occurring sequences. Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? No. Herein the claims as a whole are not considered to recite any additional elements that amount to significantly more than the naturally occurring nucleotide sequences. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Besides the nucleic acids, the claims recite a kit in the preamble. At the time the invention was made, a kit or combination of reagents was well-established, routine and conventional. Additionally where a composition such as a kit is recited at such a high level of generality it does not meaningfully limit the claim. Thus the claims as a whole does not amount to significantly more than each “product of nature” by itself and the claims do not qualify as eligible subject matter. Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter. Response to Arguments The response traverses the rejection on page 5-6 of the remarks mailed 10/30/2025. The response asserts the cDNA defined in claim 1 has non-natural structural characteristics, it explicitly requires that it does not contain exon 19 of the human MET gene whereas naturally occurring MET gene cDNA includes exon 19. This response has been reviewed but not found persuasive. The claim encompasses a cDNA that contains a sequence at position 2635-2652, 2623-2640, or 2627-2645 of SEQ ID NO 1. The claim requires that the sequence does not contain exon 19 of SEQ ID NO 1. The claim does not require that the sequence comprises the sequence of SEQ ID NO 1. The claim recites “a” sequence and encompasses a fragment. The recited fragments in the claim do not contain exon 19. The recitation of corresponds to MET gene does not require that the fragment or sequence is a MET gene but merely corresponds in some way to MET gene, which could encompass any level of similarity to MET gene, including only two nucleotides in similarity. Because the claim encompasses cDNA that comprises a fragment and the fragment comprising position 2635-2652, 2623-2640, or 2627-2645 of SEQ ID NO 1 is naturally occurring the claims are directed to natural product. For example position 2635-2652 of SEQ ID No 1 is the same sequence found in Xerocrassa montserratensis, position 2623-2640 of SEQ ID NO 1 is the same sequence found in Salix pentandra, and position 2627-2645 of SEQ ID NO 1 is the same sequence round in Amara familiaris. The RNA sequence of claims 3-4 are naturally occurring as described in the instant specification. The specification teaches that 12 cases of human subjects with glioma had mRNA sequence of SEQ ID NO 2, which indicates that SEQ ID NO 2 is naturally occurring sequence. The response asserts that since the mutation does not universally occur is it not naturally occurring. The response further asserts that the fragment intervals are based on applicants screening results and not random fragments of natural sequences. This response has been reviewed but not found persuasive. The frequency of the mutation found in nature is not the requirement for a sequence that is naturally occurring. Any sequence that occurs in nature, regardless of the frequency or occurrence is a naturally occurring sequence. There is no structural different between the fragments and mRNA and the naturally occurring sequence. Additionally the discovery of a naturally occurring sequence does not make a sequence non-naturally occurring. There is no markedly different sequence that results in the discovery of the sequence. The sequence claimed are the same structure as the naturally occurring sequence, regardless of the frequency or discovery. The response addresses the prognostic marker and the sequences exhibit a specific function of indicating poor prognosis and fall outside the scope of natural product. This responses has been reviewed but not found persuasive. A natural product is a sequence that occurs in nature. The criteria for a sequence to be non-naturally occurring is that it has a markedly different characteristic, such as a fluorescent label that would not occur in nature. The discovery that the MET lacking exon 19 has a poor prognosis does not result in a markedly different structure from the naturally occurring MET lacking exon 19. The discovery of the MET gene lacking exon 19 in a human subject does not result in a different characteristic of the naturally occurring MET gene lacking exon 19. The claims encompass fragments and sequences that are naturally occurring and none of the sequences encompass a markedly different sequence or characteristic that would distinguish the sequence from a natural product. For these reasons and reasons of record this rejection is maintained. 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. Claims 1, 3-4, 7, 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by anticipated by Reeve et al (U.S. Patent No. 6,399,364; 04 June 2002). Reeve et al teach compositions comprising all possible "N mer" oligonucleotides or subsets thereof "where N is preferably from 5 to 10, particularly 8 or 9" (see, e.g., col. 2, lines 62-67; claims 11 and 12; quotation from col 2, lines 63-65). Reeve et al teach that each of the 5 to 10 N-mers is labeled with a detectable moiety that is a detected by fluorescence, and particularly detectable moieties that are fluorophores (see, e.g., col. 2, lines 62-67; col. 3, lines 18-21; col. 10, line 1). Given that Reeve teaches compositions comprising all possible 5-10mers, it is a property of at least one of the nucleic acids will comprise a fragment of SEQ ID NO 1 that comprises a sequence of 2635-2652, 2623-2640, 2627-2645, a mRNA that comprises a fragment that has a sequence of 3820-3837, 3832-3849, 3827-3845 of SEQ ID NO 2, and primers and probe sequences that are capable of hybridizing to SEQ ID NO 1 and SEQ ID NO 2. It is noted that the claims recite “a” sequence which encompasses any two more nucleotides as such the 10mers of Reeve anticipate the claims. Response to Arguments The response traverses the rejection on page 7 of the remarks mailed 10/30/2025. The response asserts that Reeve only discloses 5-10mer oligonucleotides while the fragments of claim 1 are 18-19 nucleotides in length. The response further asserts there is no overlap in technical features between Reeve and the instant application. The response asserts that the fragment length and specific positions in claim 1 are specification sequences determined by the applicant screening in Example 2. The response asserts the technical purpose and application of the two are completely different. This response has been reviewed but not found persuasive. Reeves anticipates claim 1 because Reeves teaches every possible 10mer oligonucleotides which is encompassed by claim 1, 3-4, 7, 11-12. Specifically claim 1 recites wherein “a” sequence of the cDNA contains “a” fragment of SEQ ID NO 1, wherein the fragment of SEQ ID NO 1 at least contains “a” sequence at position 2635-2640, 2623-2640, 2627-2645 of SEQ ID NO 1. The recitation of a fragment contains a sequence encompasses any two or more nucleotides at position 2635-2640, 2623-2640, 2627-2645 of SEQ ID NO 1. The claims are not limited to a specific fragment length and do not require a specific fragment as each of the claims recite “a” sequence not the sequence of SEQ ID NO 1, for example for claim 1. The intended use of the product does not result in a structurally different product and the traversal with regard to the use of the oligonucleotides is not found persuasive, as the oligonucleotides of Reeve encompass the oligonucleotides claimed and will have the same use as the structure is identical to the claimed invention. For these reasons and reasons of record this rejection is maintained. 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 1-4,7-8, and 11-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 and 12-13 of copending Application No. 17919704 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This rejection was previously presented and has been rewritten to address the amendment to the claims. Claim 4 and 12-13 of ‘704 recites a kit comprising SEQ ID NO 4 . Claim 12 recites a nucleotide sequence of SEQ ID NO 6 which is a cDNA sequence of the MET gene with exon 19 deleted. SEQ ID NO 6 is identical to instant SEQ ID NO 1. SEQ ID NO 4 is identical to nucleotides 2607-2666 of instant SEQ ID NO 1. Claim 13 recites a mRNA sequence of SEQ ID NO 12 which is a MET sequence without exon 19 and identical to SEQ ID NO 2. Therefore claims 4, 12-13 of ‘704 are entirely within the scope of claims 1-4,7-8, and 11-14. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Response to Arguments The response traverses the rejection on pages 8 of the remarks mailed 10/30/2025. The response asserts ‘704 involves the sequence of the MET gene with exon19 deleted but all of the claim focus is on evaluating a patient’s sensitivity to MET inhibitors and there is no mention of prognostic evaluation. The response asserts that claim 1 recites specific fragments and lacking exon 19 which narrows the scope and this limitation is not disclosed in ‘704. This response has been reviewed but not found persuasive. The scope of ‘704 falls entirely within the scope of the instant claims. Specifically claim 2 recites the cDNA is the sequence as shown in SEQ ID NO 1, as such claim 2 encompasses the entire cDNA sequence which is identical to SEQ ID NO 6. While the intended use might be slightly different in scope, the structure of the nucleic acid sequences is identical and thus are not different inventive contributions. For these reasons and reasons of record the rejection is maintained. Conclusion No claims are allowable. 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 SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p. 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, Fereydoun Sajjadi can be reached at 571-272-3311. 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. /SARAE L BAUSCH/ Primary Examiner, Art Unit 1699
Read full office action

Prosecution Timeline

Oct 14, 2022
Application Filed
Aug 23, 2025
Non-Final Rejection — §101, §102, §112
Oct 30, 2025
Response Filed
Feb 19, 2026
Final Rejection — §101, §102, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
29%
Grant Probability
72%
With Interview (+43.6%)
4y 0m
Median Time to Grant
Moderate
PTA Risk
Based on 593 resolved cases by this examiner. Grant probability derived from career allow rate.

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