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 .
Priority
This application 17/919,711 filed on 10/18/2022 is a 371 national phase of International Application No. PCT/CN21/88478 filed on 04/20/2021, and claims the benefit of Chinese Patent Application No. 202010318352.7, filed on 04/21/2020.
Receipt of a certified copy of an English language translation of the priority document filed 09/30/2025 is acknowledged.
The priority date of claims1,4, and 7 and their dependent claims is determined to be 04/21/2020, the filing date of Chinese Patent Application No. 202010318352.7.
Status of Claims
Applicant’s amendments to claims filed 09/30/2025 in response to the Non-Final Rejection mailed 07/012/2025 are acknowledged.
Claims 2, 4-6, and 8 are amended.
Claims 9 and 10 have been canceled.
New claims 11-13 are acknowledged.
Claims 1-8 and 11-13 are pending and under examination.
Response to Remarks filed 09/30/2025
The amendments and arguments presented in the papers filed 09/30/2025 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 07/012/2025 listed below have been reconsidered as indicated.
a) Deficiencies in the information disclosure statements filed 10/18/2022 and 03/30/2023 have been remedied and objections are withdrawn in view of provided translations.
b) The objections to the specification regarding the use of trade names or marks are withdrawn in view of the amendments to the specification.
c) The 35 USC 112(b) indefiniteness rejections of claims 4-6 have been withdrawn in view of the amendments to claims 4 and 6.
d) The Double Patenting rejection of claim 3 over copending Application No. 17/919,704 in view of Jin and Rozen is withdrawn in view of amendments to the claims of copending Application No. 17/919,704.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Claim Objections - New
Claim 6 is objected to because of the following informalities: Claim 6 cites "SEQ ID NO. 2" instead of " SEQ ID NO: 2". Appropriate correction is required.
Claim Interpretation – New and Maintained
Claim 6 recites the limitation “wherein the first primer pair is capable of specifically amplifying an mRNA fragment of SEQ ID NO. 2; and the first probe is capable of specifically hybridizing to the mRNA fragment of SEQ ID NO. 2”. For the purposes of examination a sequence that aligns to SEQ ID NO: 2 is interpreted as meeting the requirement of being “capable of specifically amplifying” or “capable of specifically hybridizing” a mRNA fragment of SEQ ID NO: 2.
Claim 7 recites the limitation “an antibody for resisting an amino acid fragment of SEQ ID NO. 3”. For the purposes of examination an antibody “for resisting” is interpreted as an antibody binding and inhibiting the amino acid fragment.
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.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II.
Based upon consideration of the claims as a whole, as well as consideration of elements/steps recited in addition to the judicial exception, the present claims fail to meet the elements required for patent eligibility.
Step 1
The claimed inventions are directed to the statutory category of products.
Step 2A, Prong One
The claims are taken to be directed to natural phenomena.
Claim 4 is directed to a product (a kit) comprising “a first primer pair capable of specifically amplifying an mRNA fragment of SEQ ID NO. 2, and/or a first probe capable of specifically hybridizing to the mRNA fragment of SEQ ID NO. 2, wherein the mRNA fragment of SEQ ID NO: 2 at least contains an mRNA sequence at positions 2452-2469, 2464-2481 or 2458-2474 of SEQ ID NO: 2.”
Claim 6 is directed to reagents (products) comprising “wherein the first primer pair contains a first primer as shown in SEQ ID NO: 7 and a second primer as shown in SEQ ID NO: 8, and the sequence of the first probe contains a sequence as shown in SEQ ID NO: 9.”
Claim 6 is directed to primers and probes. Such isolated nucleic acid molecules that are identical to fragments of naturally occurring nucleic acid molecules are not patent eligible subject matter. i.e. they are judicial exceptions. See MPEP 2106.04
Step 2A, Prong Two
The claims do not include additional elements that are sufficient to amount to add significantly more than the judicial exception for the reasons that follow.
A. The courts have identified the following concepts and products as examples of laws of nature or natural phenomena:
I. Isolated DNA, Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589-91, 106 USPQ2d 1972, 1978-79 (2013);
II. Single-stranded DNA fragments known as "primers", University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755, 761, 113 USPQ2d 1241, 1244 (Fed. Cir. 2014) B. The claims encompass products that are not markedly different from products of nature for the following reasons:
Regarding claim 6, the claimed primers and probes comprising nucleotide sequences as set forth in SEQ ID NOs: 7-9 are all 100% identical to naturally occurring sequences in fragments or full length. These sequences are all directed to the MET gene as described in the specification and are identical to sequence in GenBank accession EU826570 (Homo sapiens soluble MET variant 4 (MET) mRNA, complete cds, alternatively spliced. Submitted 15-JUN-2008).
Because the naturally occurring counterpart of each of the claimed sequences and complementary nucleotide sequences thereof is a segment of a chromosome, the combination of the claimed nucleotide sequence and a complementary nucleotide sequence complementary to the claimed nucleotide sequence is not markedly different from the naturally occurring double-stranded DNA sequences found in the human genome. Alignments of each of the claimed capture sequences to their naturally-occurring counterparts follow below:
A sequence comprising SEQ ID NO: 7 (nucleotides 20-47) is 100% identical to GenBank accession EU826570:
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A sequence comprising SEQ ID NO: 8 is 100% identical to GenBank accession EU826570:
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A sequence comprising SEQ ID NO: 9 is 100% identical to GenBank accession EU826570:
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The exception is not integrated into a practical application of the exception. The claims do not recite any additional elements that integrate the exception into a practical application of the exception.
While amended claim 6 adds the limitation “wherein the first primer pair is capable of specifically amplifying an mRNA fragment of SEQ ID NO. 2; and the first probe is capable of specifically hybridizing to the mRNA fragment of SEQ ID NO. 2”, this is not an integration of the exception into a practical application. Instead these are just examples of intended use.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim does not add a specific limitation other than what is well-understood, routine, and conventional in the field.
Furthermore, the courts have recognized the following laboratory techniques as well-understood, routine, conventional activities in the life science arts when they are claimed in a merely generic manner or as insignificant extra-solution activity including:
i. Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014); and
ii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d at 1247.
For these reasons, the claims are rejected under section 101 as being directed to patent-ineligible subject matter.
Response to Arguments against Claim Rejection - 35 U.S. C § 101
The response asserts that amended claim 6 explicitly ties the primer/probe to cancer diagnostic applications by including the limitation "wherein the first primer pair is
capable of specifically amplifying an mRNA fragment of SEQ ID NO. 2; and the first probe is capable of specifically hybridizing to the mRNA fragment of SEQ ID NO. 2". The response asserts that the specification clearly records that this variant (the mRNA of SEQ ID NO: 2) is highly correlated with the malignancy of glioma and gastric adenocarcinoma. The response cites data in the specification regarding this correlation.
The response asserts the sequences of SEQ ID NO: 7-9 precisely cover the key sites in the deletion region of exon 10 of the MET gene (corresponding to positions 2452-2474 of SEQ ID NO: 2). This design is not a passive replication of natural sequences, but a functional sequence obtained through artificial screening based on research findings on tumor molecular mechanisms (p. 5).
Applicant's arguments have been fully considered but are not persuasive.
The claimed SEQ ID Nos: 7-9 are products of nature and, as shown above in the 101 rejection, lack markedly different characteristics from a naturally occurring counterpart. Applicant’s arguments are not directed to the structure of the claimed sequences, but to the design and functionality of the products, and cannot integrate a judicial exception.
The response cites Example 1 of the specification to describe the identification of SEQ ID NOs: 7-9 through screening. The response asserts that because screening considered 1) secondary structure of the target region, 2) sequence differences from the wild-type MET gene, 3) amplification efficiency and detection sensitivity, and 4) had a clear technical purpose, the probes and primer are inseparable from the prognostic
evaluation process disclosed in the specification, which clearly goes beyond the scope of natural phenomena (p. 6).
Applicant's arguments have been fully considered but are not persuasive.
The claimed SEQ ID Nos: 7-9 are products of nature and, as shown above in the 101 rejection, lack markedly different characteristics from a naturally occurring counterpart. Applicant’s arguments are not directed to the structure of the claimed sequences, but to the design and intended use of the products, and cannot integrate a judicial exception.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 11-12 remain/are rejected under 35 U.S.C. 103 as being unpatentable over EU826570 (GenBank accession EU826570. Homo sapiens soluble MET variant 4 (MET) mRNA, complete cds, alternatively spliced. Submitted 15-JUN-2008) in view of Jin et al. (Novel splice variants derived from the receptor tyrosine kinase superfamily are potential therapeutics for rheumatoid arthritis. 2008. Arthritis Res Ther. 10(4):1-16) and Rozen et al. (Primer3 on the WWW for General Users and for Biologist Programmers. 2000.In: Misener, S., Krawetz, S.A. (eds) Bioinformatics Methods and Protocols. Methods in Molecular Biology™, vol 132: 1-32).
The specification of the instant application discloses that SEQ ID NO:1 is “cDNA corresponding to a human MET gene with an exon 10 deleted” (p. 5); that “the mRNA sequence as shown in SEQ ID NO: 2 is an RNA sequence complementary to the cDNA sequence as shown in SEQ ID NO: 1” (p. 8); and that SEQ ID NO: 3 is “an amino acid sequence encoded by the mRNA sequence as shown in SEQ ID NO: 2” (p. 11).
Claims 1-6 are drawn to the cDNA (claims 1 and 2) or mRNA (claims 4 and 5) of MET as described in the specification. Claims 1, 3, 4, and 6 are further drawn to primers and probes capable of specifically amplifying (primers) or hybridizing (probes) to the recited cDNA or mRNA fragments.
The rejections of claims 11 and 12 are necessitated by claim amendments filed on 09/30/2025 including new claims 11 and 12.
Regarding claim 1, GenBank accession EU826570. teaches the complete sequence of a Homo sapiens soluble MET variant 4 (MET) mRNA which is 100% identical to SEQ ID NO:1 at positions 4057-4074 of SEQ ID NO:1.
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GenBank accession EU826570 does not teach a primer pair capable of amplifying a cDNA fragment of SEQ ID NO:1 or a probe capable of hybridizing to SEQ ID NO:1.
Jin teaches the splice variant EU826570 (Supplemental Table 1) and selecting gene-specific primers for PCR-amplification (p. 3, col 1) to identify splice variants for receptor tyrosine kinase genes, including Met (p. 1, col2). Jin also teaches the synthesis of cDNA before amplification (p 2, col. 2).
Jin does not teach the use of a probe capable of hybridizing to SEQ ID NO:1.
Rozen teaches the use of Primer3 to select primers and hybridization probes for (p. 1 Introduction) for multiple applications, including amplifying a particular sequence (p. 4). Rozen also states that “Primer3 gives users numerous options to specify which primers are acceptable and which primers are better than others” (p. 4)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of EU826570, Jin, and Rozen to arrive at the instantly claimed invention. One would have been motivated to do so for the goal of identifying the cDNA of the MET transcript variant EU826570. Jin presents primer pairs capable of amplifying different splice variants (i.e. different transcripts) of MET cDNA and the program of Rozen provides tools to select primer pairs to amplify particular positions of the transcript and hybridization probes to hybridize to MET transcripts. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 2, GenBank accession EU826570 teaches the complete sequence of a Homo sapiens soluble MET variant 4 (MET) mRNA which is 100% identical to SEQ ID NO:1, at positions 4041-4122 of SEQ ID NO:1 as shown below:
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Regarding claim 3, GenBank accession EU826570 teaches the complete sequence of soluble MET variant 4 (MET). SEQ ID NOs: 4 and 6 align 100% to GenBank accession EU826570 as shown below and SEQ ID NO: 5 aligns 46.9% to Accession EU826570:
SEQ ID NO: 4 vs EU826570:
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SEQ ID NO: 5 vs. EU826570:
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SEQ ID NO: 6 vs. EU826570:
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GenBank accession EU826570 does not teach the use of the sequence of SEQ ID NOs: 4 and 5 as primers or SEQ ID NO:6 as a probe.
Jin teaches the splice variant EU826570 (Supplemental Table 1) and selecting gene-specific primers for PCR-amplification (p. 3, col 1) to identify splice variants for receptor tyrosine kinase genes, including Met (p. 1, col2). Jin also teaches the synthesis of cDNA before amplification (p 2, col. 2).
Jin does not teach the sequences of SEQ ID NOs: 4 and 5 as primers and does not teach the use of SEQ ID NO:6 as a probe capable of hybridizing to SEQ ID NO:1.
Rozen teaches the use of Primer3 to select primers and hybridization probes for (p. 1 Introduction) for multiple applications, including amplifying a particular sequence (p. 4). Rozen also states that “Primer3 gives users numerous options to specify which primers are acceptable and which primers are better than others” (p. 4)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of EU826570, Jin, and Rozen to arrive at the instantly claimed invention. One would have been motivated to do so for the goal of identifying the cDNA of the MET transcript variant EU826570. Jin presents primer pairs capable of amplifying different splice variants (i.e. different transcripts) including the step of generating cDNA and the program of Rozen provides tools to select primer pairs to amplify particular positions of the transcript and hybridization probes to hybridize to specific MET transcripts. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Claims 4-6 are drawn to primers and probes to the mRNA sequence complementary to the cDNA sequence corresponding to a human MET gene with an exon 10 deleted as described in the instant specification.
Regarding claim 4, GenBank accession EU826570 teaches the complete sequence of soluble MET variant 4 (MET) mRNA which aligns 100% to the recited positions of 2452-2469 of SEQ ID NO. 2, as shown below:
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Jin teaches the splice variant of GenBank accession EU826570 (Supplemental Table 1) and selecting gene-specific primers for PCR-amplification (p. 3, col 1) to identify splice variants for receptor tyrosine kinase genes, including Met (p. 1, col 2).
Jin does not teach the use of a probe capable of hybridizing to SEQ ID NO:2.
Rozen teaches the use of Primer3 to select primers and hybridization probes for (p. 1 Introduction) for multiple applications, including amplifying a particular sequence (p. 4). Rozen also states that “Primer3 gives users numerous options to specify which primers are acceptable and which primers are better than others” (p. 4)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of EU826570, Jin, and Rozen to arrive at the instantly claimed invention. One would have been motivated to do so for the goal of identifying the mRNA of the MET transcript EU826570. Jin presents primer pairs capable of amplifying different splice variants (i.e. different transcripts) of the MET gene and the program of Rozen provides tools to select primer pairs to amplify particular positions of the transcript and hybridization probes to hybridize to MET transcripts. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 5, GenBank accession EU826570 teaches the complete sequence of soluble MET variant 4 (MET) mRNA which aligns 100% to positions 2416-2497 of SEQ ID NO. 2, as shown below:
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Regarding claim 6, GenBank accession EU826570 teaches the complete sequence of soluble MET variant 4 (MET) mRNA which aligns 100% to SEQ ID NOs: 8 and 9 as shown below:
SEQ ID NO: 8 vs EU826570:
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SEQ ID NO: 9 vs EU826570:
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GenBank accession EU826570 teaches the complete sequence of soluble MET variant 4 (MET) mRNA which aligns 100% to nucleotides 20-47 of SEQ ID NO: 7 as shown below:
SEQ ID NO: 7 vs EU826570:
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Jin teaches the splice variant of GenBank accession EU826570 (Supplemental Table 1) and selecting gene-specific primers for PCR-amplification (p. 3, col 1) to identify splice variants for receptor tyrosine kinase genes, including Met (p. 1, col2).
Jin does not teach the sequences of SEQ ID NOs: 4 and 5 as primers and does not teach the use of SEQ ID NO: 6 as a probe capable of hybridizing to SEQ ID NO:1.
Rozen teaches the use of Primer3 to select primers and hybridization probes for (p. 1 Introduction) for multiple applications, including amplifying a particular sequence (p. 4). Rozen also states that “Primer3 gives users numerous options to specify which primers are acceptable and which primers are better than others” (p. 4)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of EU826570, Jin, and Rozen to arrive at the instantly claimed invention. One would have been motivated to do so for the goal of identifying the mRNA of the MET transcript variant EU826570. Jin presents primer pairs capable of amplifying different splice variants (i.e. different transcripts) of the MET gene, including GenBank accession EU826570 and the program of Rozen provides tools to select primer pairs to amplify particular positions of the transcript and hybridization probes to hybridize to specific MET transcripts. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 11, GenBank accession EU826570 teaches the complete sequence of a Homo sapiens soluble MET variant 4 (MET) mRNA which is 100% identical to SEQ ID NO:1, at positions 4041-4122 of SEQ ID NO:1 as shown below:
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GenBank accession EU826570 does not teach the cDNA sequence of MET variant 4.
Jin teaches the splice variant EU826570 (Supplemental Table 1) and selecting gene-specific primers for PCR-amplification (p. 3, col 1) to identify splice variants for receptor tyrosine kinase genes, including Met (p. 1, col2). Jin also teaches the synthesis of cDNA before amplification (p 2, col. 2).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of EU826570 and Jin to arrive at the instantly claimed invention. The modification would have entailed making cDNA from the mRNA sequence of EU826570. Making cDNA is taught by Jin and was routine and well known in the art by one of ordinary skill at the tile of filing. One would have been motivated to do so for the goal of identifying the cDNA of the MET transcript variant EU826570. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 12, GenBank accession EU826570 teaches the complete sequence of a Homo sapiens soluble MET variant 4 (MET) mRNA which is 100% identical to SEQ ID NO:1, at positions 4041-4122 of SEQ ID NO:1 as shown below:
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Claims 7, 8 and 13 remain/are rejected under 35 U.S.C. 103 as being unpatentable over ACF47606.1 (GenBank Accession ACF47606.1, soluble MET variant 4. Submitted 15-JUN-2008) and Merchant et al. (Monovalent antibody design and mechanism of action of onartuzumab, a MET antagonist with anti-tumor activity as a therapeutic agent. 2013. Proc. Natl. Acad. Sci. U.S.A. 110 (32): E2987-E2996).
The rejection of claim 13 is necessitated by claim amendments filed on 09/30/2025 including new claim 13.
Regarding claim 7, GenBank Accession ACF47606.1 teaches the complete amino acid sequence of the protein for soluble MET variant 4, which is 99.6% identical to SEQ ID NO: 3, including the positions 750- 764 of SEQ ID NO: 3 as shown below:
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GenBank Accession ACF47606.1 includes the extracellular domains of MET(See ncbi.nlm.nih.gov/protein/194318436).
GenBank Accession ACF47606.1 does not teach an antibody for resisting an amino acid fragment of SEQ ID NO. 3.
Merchant teaches an antibody targeting the receptor tyrosine kinase MET (p. E2987, Abstract). Merchant further teaches the antibody binds to a MET extracellular domain fragment and blocks binding of the ligand (p. E2987, Abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of ACF47606.1 and Merchant to arrive at the instantly claimed invention. One would have been motivated to do so for the goal of identifying the presence of the peptide ACF47606.1. The peptide ACF47606.1 includes an extracellular domain and Merchant presents an antibody capable of detecting the MET extracellular domain. One skilled in the art would have been motivated to save time and money by using the existing antibody of Merchant to detect the desired peptide of ACF47606.1. There would have been a reasonable expectation of success given the underlying materials and methods are widely known, successfully demonstrated, and commonly used as evidenced by the prior art.
Regarding claim 8, GenBank Accession ACF47606.1 teaches the complete amino acid sequence of the protein for soluble MET variant 4, which is 100% identical to SEQ ID NO: 3, including the positions 722-764 of SEQ ID NO: 3 as shown below:
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Regarding claim 13, GenBank Accession ACF47606.1 teaches the complete amino acid sequence of the protein for soluble MET variant 4, which is 99.6% identical to SEQ ID NO: 3, including the positions 750-764 of SEQ ID NO: 3 as shown below:
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.
Response to Arguments against Claim Rejection - 35 U.S. C § 103
Claims 1-6
The response asserts EU826570 only discloses the nucleic acid sequence of the MET variant (Accession No. EU826570), but does not reveal its use as a disease biomarker, nor does it mention any primer or probe design for detecting this sequence. The response asserts the present invention is the first to confirm the correlation between SEQ ID NO: 1/2 (MET variant with exon 10 deletion) and cancer diagnosis, database entry (i.e., EU826570) does not provide technical inspiration for teaching how to design specific detection tools targeting the deletion region of exon 10 of the MET gene (p. 6).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's argument that Accession No. EU826570 does not reveal the use of the nucleic acid sequence as a disease biomarker, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's arguments against the references individually regarding primer or probe design, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., providing technical inspiration for teaching how to design specific detection tools targeting the deletion region of exon 10 of the MET gene) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The response asserts that Jin does not address the prognostic evaluation of glioma and/or gastric adenocarcinoma or identify an association between the MET gene exon 10 and tumor prognosis and because Jin focuses on therapies for rheumatoid arthritis, Jin cannot provide technical inspiration for the use of this MET variant in tumor prognostic evaluation. The response further asserts the MET variants in Jin and the instant application are different types, and there is an essential difference between the MET variant in Jin and SEQ ID NO: 1/2. MET-877 contains an intron retention sequence (Table 2: novel C-terminal amino acids "VRNALNTVLNHQLKLN"). SEQ ID NO:1/2 is a simple exon 10 deletion (without intron sequences) (p. 6). The response further asserts that Jin does not disclose the design of specific primers and probes targeting exon deletion breakpoints, nor does it disclose any sequences identical or similar to SEQ ID NO:4-5 (Claim 3) or SEQ ID NO:7-9 (Claim 6), thus failing to demonstrate that there is a technical basis for these specific sequences in the prior art (p. 7).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., an association between the MET gene exon 10 and tumor prognosis ) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Jin cannot provide technical inspiration for the use of this MET variant in tumor prognostic evaluation, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., SEQ ID NO:1/2 is a simple exon 10 deletion (without intron sequences) and a different type of MET variant) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the argument that Jin does not disclose sequences identical or similar to SEQ ID NO:4-5 (Claim 3) or SEQ ID NO:7-9 (Claim 6), in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The response asserts that the primer design tool disclosed by Rozen cannot solve the technical problem addressed in this application. The Primer3 software disclosed in Rozen (2000) only involves a general primer design process, is unable to identify the specific detection region related to tumor prognosis in this application, and cannot automatically generate primers and probes targeting this region. The response cites Example 1 of the application to confirm that the sequences of SEQ ID NO: 7-9 were obtained through screening via PCR verification (Figure 1) and Sanger sequencing (Figure 2).Applicant argues that their process involved experimental verification of multiple aspects such as amplification efficiency, specificity, and binding stability to the target sequence, and could not be accomplished merely through conventional software tools (p. 7).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., obtained the sequences through screening via PCR verification and Sanger sequencing) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the claimed process involved experimental verification of multiple aspects such as amplification efficiency, specificity, and binding stability to the target sequence) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Rozen is not required to identify the specific detection region or automatically generate primers and probes targeting this region. One of ordinary skill in the art would have known how to perform primer design and use the tool of Rozen to select sequences for primers and probes that are capable of specifically hybridizing to any desired region and thus meet the structural requirements of the claim.
The response asserts that the core inventive point of this application lies in the discovery that the presence of the MET gene exon 10 deletion variant (SEQ ID NO: 1/2) is highly correlated with the malignancy of glioma/gastric adenocarcinoma and that prior art did not identify this correlation, and this discovery is precisely the basis of the technical solutions of Claims 1-6, which clearly goes beyond the scope of inspiration from the prior art. The response asserts that the technical effects brought by such specific design (e.g., high sensitivity, low cross-reactivity) cannot be achieved through a simple combination of the prior art. They require in-depth understanding of the characteristics of the target sequence and extensive experimental verification. Therefore, the technical solution of this application is deemed to be non-obvious (p. 7).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the presence of the MET gene exon 10 deletion variant (SEQ ID NO: 1/2) is highly correlated with the malignancy of glioma/gastric adenocarcinoma) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claims 7 and 8
The response asserts that ACF47606.1 only discloses the complete amino acid sequence of the MET variant, but does not mention the biological significance of the "specific fragments at positions 750-764 (Claim 7) or 722-764 (Claim 8) of SEQ ID NO: 3 ", nor does it imply that these fragments can serve as targets for tumor prognosis evaluation. ACF47606.1 only relates to the MET protein sequence itself, without associating it with any tumor prognosis scenarios, and thus cannot provide inspiration for "designing antibodies targeting these specific fragments" (p. 8).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's argument that ACF47606.1 does not mention biological significance of the sequence or imply that fragments can serve as targets for tumor prognosis evaluation, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that ACF47606.1 does not associate the MET protein sequence with any tumor prognosis scenarios, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The response asserts the antibody disclosed in the Merchant reference does not involve the diagnostic use of "detecting specific amino acid fragments to evaluate tumor prognosis" and does not disclose that the antibody can bind to the fragments at positions 750-764/722-764 of SEQ ID NO: 3. The MET extracellular domain contains multiple structural regions, and the prior art fails to demonstrate or suggest that the antibody in Merchant can specifically recognize the fragments defined in the present application. Therefore, a person skilled in the art cannot directly apply it to the prognosis evaluation scenario of the present application (p. 8).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's argument that prior art does not involve the diagnostic use of "detecting specific amino acid fragments to evaluate tumor prognosis", a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the references fail to show that the antibody can bind to the fragments at positions 750-764/722-764 of SEQ ID NO: 3), it is noted that this feature is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
As written, the claim requires an antibody for resisting (i.e. binding) an amino acid fragment of SEQ ID NO. 3. The claim further requires that the amino acid fragment of SEQ ID NO. 3 at least contains an amino acid sequence at positions 750-764 of SEQ ID NO: 3 (claim 7), or at least contains an amino acid sequence at positions 722-764 of SEQ ID NO: 3 (claim 8). The claims do not require that the antibody bind to the amino acid fragment at specific positions.
The response asserts that the core function of the antibodies in Claims 7-8 of the present application is to "evaluate the prognosis of glioma/gastric adenocarcinoma patients by detecting the specific fragments of SEQ ID NO: 3", which requires meeting performance requirements such as "highly specific recognition of target fragments and low cross-reactivity" (e.g., distinguishing between wild-type MET and the SEQ ID NO: 3 variant). In contrast, the antibody in Merchant functions as a "MET antagonist to exert anti-tumor therapeutic effects". The two differ completely in design objectives and performance indicators (e.g., affinity, specific target range) (p. 8).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's argument that the core function of the antibodies in Claims 7-8 is to "evaluate the prognosis of glioma/gastric adenocarcinoma patients by detecting the specific fragments of SEQ ID NO: 3”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that the antibody of Merchant differs completely in design objectives and performance indicators, it is noted that the claim is to a product, and all that matters is the structure of the product. The argued attributes
must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The response asserts that the prior art fails to prove that the antibody in Merchant can achieve the technical effect of "prognosis evaluation". The examples of the present application show that the expression of the specific fragment of SEQ ID NO: 3 is significantly correlated with the median survival time of patients, while the antibody of Merchant has not undergone "prognosis correlation verification" and cannot be directly used in the diagnostic scenario of the present application. Thus, a person skilled in the art would need additional experiments to verify the effectiveness of the antibody for prognosis evaluation, which cannot be achieved merely by "routine combination of the prior art". (p. 8-9) The response further asserts that a person skilled in the art cannot confirm whether the antibody in Merchant exactly recognizes this homologous fragment-there is a risk of "the antibody binding to non-target regions". This requires extensive experimental screening and verification (e.g., epitope mapping to locate the antibody binding site), and this process involves creative work that cannot be "directly derived from the prior art" (p. 9).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's argument that Merchant fails to achieve the technical effect of "prognosis evaluation" and cannot be directly used in a diagnostic scenario, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., ) that expression of the specific fragment of SEQ ID NO: 3 is significantly correlated with the median survival time of patients) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding the argument that “a person skilled in the art would need additional experiments to verify the effectiveness of the antibody for prognosis evaluation”, or “extensive experimental screening and verification”, one of ordinary skill in the art would have been able to verify effectiveness of an antibody. Experimentation for optimizing results is considered to be routine and known in the art. Further, these steps are not necessary to have arrived at the claimed products.
The response asserts that the antibody of the present application needs to be adapted to "clinical detection scenarios for glioma/gastric adenocarcinoma samples" and must meet clinical requirements. In contrast, the antibody in Merchant is only optimized for "anti-tumor therapy" and does not involve performance adaptation for clinical sample detection. A person skilled in the art would need to modify the antibody (e.g., adjusting affinity, labeling methods), and these optimization steps go beyond the routine teachings of the prior art, resulting in no "reasonable expectation of success" (p. 9).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's argument that “the antibody of the present application needs to be adapted to "clinical detection scenarios for glioma/gastric adenocarcinoma samples" and must meet clinical requirements”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding the argument that a person skilled in the art would need to modify the antibody (e.g., adjusting affinity, labeling methods), optimization steps are considered to be routine and known in the art.
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.
(I). (i). Claims 1-5, 7, 8, and 11-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 6, 12, and 13 of copending Application No. 17/919,704.
These are new or modified rejections updated to reflect amended claims for copending Application ‘704.
The rejections of claims 11-13 are necessitated by claim amendments filed on 09/30/2025 including new claims 11-13.
Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to kits directed to sequences from MET genes.
Regarding instant claim 1, copending claim 2 requires SEQ ID NO: 3, “a cDNA sequence of the MET gene with an exon 10 deleted”. SEQ ID NO: 3 of copending Application No. 17/919,704 is identical to “the cDNA fragment of SEQ ID NO: 1” in the instant application.
Regarding instant claim 2, copending claim 2 requires SEQ ID NO: 3, “a cDNA sequence of the MET gene with an exon 10 deleted”. SEQ ID NO: 3 of copending Application No. 17/919,704 is identical to “the cDNA fragment of SEQ ID NO: 1” in the instant application.
Regarding instant claim 3, copending claim 1 requires a primer pair that consists of SEQ ID NO: 19 and SEQ ID NO: 20 and a probe that consists of SEQ ID NO: 21. SEQ ID NO: 19 of copending Application No. 17/919,704 is identical to the “first primer as shown in SEQ ID NO: 4” in the instant application; SEQ ID NO: 20 of copending Application No. 17/919,704 is identical to the “second primer as shown in SEQ ID NO: 5” in the instant application; and SEQ ID NO: 21 of copending Application No. 17/919,704 is identical to “the sequence of the first probe -- as shown in SEQ ID NO:6” in the instant application.
Regarding instant claim 4, copending claim 6 requires “an mRNA sequence as shown in SEQ ID NO: 9”. SEQ ID NO: 9 of copending Application No. 17/919,704 is identical to “the cDNA fragment of SEQ ID NO: 2” in the instant application.
Regarding instant claim 5, copending claim 6 requires “an mRNA sequence as shown in SEQ ID NO: 9”. SEQ ID NO: 9 of copending Application No. 17/919,704 is identical to “the cDNA fragment of SEQ ID NO: 2” in the instant application.
Regarding instant claim 7, copending claim 6 requires SEQ ID NO: 15, an “amino acid sequence”. SEQ ID NO: 15 of copending Application No. 17/919,704 is identical to “the amino acid fragment of SEQ ID NO:3” in the instant application.
Regarding instant claim 8, copending claim 6 requires SEQ ID NO: 15, an “amino acid sequence”. SEQ ID NO: 15 of copending Application No. 17/919,704 is identical to “the amino acid fragment of SEQ ID NO:3” in the instant application.
Regarding instant claim 11, copending claim 2 requires SEQ ID NO: 3, “a cDNA sequence of the MET gene with an exon 10 deleted”. SEQ ID NO: 3 of copending Application No. 17/919,704 is identical to “the cDNA fragment of SEQ ID NO: 1” in the instant application.
Regarding instant claim 12, copending claim 6 requires “an mRNA sequence as shown in SEQ ID NO: 9”. SEQ ID NO: 9 of copending Application No. 17/919,704 is identical to “the cDNA fragment of SEQ ID NO: 2” in the instant application
Regarding instant claim 13, copending claim 6 requires SEQ ID NO: 15, an “amino acid sequence”. SEQ ID NO: 15 of copending Application No. 17/919,704 is identical to “the amino acid fragment of SEQ ID NO:3” in the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(ii). Claim 6 remains/is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 6, 12, and 13 of copending Application No. 17/919,704 in view of Jin et al. (Novel splice variants derived from the receptor tyrosine kinase superfamily are potential therapeutics for rheumatoid arthritis. 2008. Arthritis Res Ther. 10(4):1-16) and Rozen et al. (Primer3 on the WWW for General Users and for Biologist Programmers. 2000.In: Misener, S., Krawetz, S.A. (eds) Bioinformatics Methods and Protocols. Methods in Molecular Biology™, vol 132: 1-32).
Regarding instant claim 6, the claims of the ‘704 application do not require “the second primer pair contains a third primer as shown in SEQ ID NO: 7 and a fourth primer as shown in SEQ ID NO: 8, and the sequence of the second probe contains a sequence as shown in SEQ ID NO: 9 “ (instant claim 6).
The teachings of Jin and Rozen as they relate to these claims are given previously in this office action and are fully incorporated here.
Response to Arguments against Double Patenting
The applicant traversed the double patenting rejection over pending application 17/919,704. The response asserts the technical solutions of this application and application 17/919,704 are substantially different and cites the prognostic evaluation and survival prediction of glioma and/or gastric adenocarcinoma using the kits of the instant application. Applicant points to the instant specification for support of this use malignancy of tumors can be determined by detecting SEQ ID NO:1/2 (the MET variant with only exon 10 deletion), and its core value lies in providing a basis for predicting patient survival in clinical practice. Applicant asserts that the teaching of application 17/919,704 is the screening of MET inhibitor sensitivity, with its core being to determine the responsiveness of tumors to inhibitors by detecting specific MET variants. That teaching belongs to a completely different clinical application scenario from the prognostic evaluation of the present application (p. 9).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's argument that the kits of the instant application provide
prognostic evaluation and survival prediction of glioma and/or gastric adenocarcinoma, and determine the responsiveness of tumors to inhibitors by detecting specific MET variants, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that malignancy of tumors can be determined by detecting SEQ ID NO:1/2) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The response further asserts that the target sequences SEQ ID NO:1/2 of the present application only involve the deletion of exon 10 of the MET gene, without deletions of other exons, while the target sequences of 17/919,704 involve the MET variant with double deletions of exons 10+19, and the primers and probes are designed for the deletion region of exons 10+19. Therefore, the primers and probes of the two applications are also different (p. 10).
Applicant's arguments have been fully considered but are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the deletion of exon 10 of the MET gene, without deletions of other exons) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that SEQ ID NOs:1 and 2 only involve the deletion of exon 10 of the MET gene, without deletions of other exon, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The indicated sequences of the copending application are identical to SEQ ID NOs:1 and 2 claimed in the instant application.
The response also requests that the Examiner withdraw the provisional rejection of Claims 1-8 of the present application, at least until otherwise patentable subject matter is identified in both applications, at which time the need for a terminal disclaimer can be re-considered (p.10) .
Applicant's arguments have been fully considered but are not persuasive.
No terminal disclaimer has been filed and it is the Examiner’s position that the copending application and supporting references do disclose said claim limitations as outlined in the rejections provided above
Thus, for the reasons stated above, and those already of the record, the rejection is maintained.
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 JESSICA GRAY whose telephone number is (571)272-0116. The examiner can normally be reached Monday-Friday 8-5 with second Fridays off.
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/JESSICA GRAY/Examiner, Art Unit 1682
/WU CHENG W SHEN/Supervisory Patent Examiner, Art Unit 1682
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