12(b)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 is a CIP of PCT/CN2020/119255 filed on 09/30/2020 which claims foreign priority to CN201910939688.2 filed on 09/30/2019 and CN201910939677.4 filed on 09/30/2019.
Election/Restrictions
Applicant's election with traverse of group II (claims 2-4 and 6:product(s) for detecting activities of RNAs or DNAs or c-Kit protein in a sample from an addict) in the reply filed on 01/04/2025 is acknowledged.
The traversal is on the ground(s) that Applicants deems Groups I to IV as being drawn to a process and an apparatus or means specifically designed for carrying out the said process, and hence, the group of inventions do not lack unity of invention.
This argument is not found persuasive because the groups when considered together are found to lack a special technical feature linking the claims of the groups over the art as the prior art reference of Li Yan-qin et al. (CN105974131A; hereinafter "Li") already teach a product for “monitoring” c-Kit protein activities in imatinib treated rats.
Claim 2 currently recites “a product for reflecting a substance or behavioral addiction state by tracing or detecting and monitoring various RNA, DNA or c-Kit protein activities and related metabolites of c-Kit in an addicted patient”.
Concerning claim 2 and the limitation “addicted patient” of claim 2, the scope for the addictive substance consumed by the patient, stage of addiction of the patient, and/or the manner of administration/ingestion of the addictive substance to the patient, are unknown since no limitations are directed to these features in the claims. Furthermore, the scope of the limitations that are recited are too broadly drawn and do encompass the teachings of Li Yan-qin et al. (CN105974131A).
Claim 2 thus is construed as being directed to a product for tracing or detecting and monitoring RNA, DNA, or c-Kit protein in a patient.
Accordingly, the Office maintains that the cited teachings from Li Yan-qin et al. (CN105974131A; hereinafter "Li") teach a special technical feature that links the claims of the groups.
The requirement is still deemed proper and is therefore made FINAL.
Concerning the species election requirement in the paper of 08/13/2025: Applicant was required to elect one choice for species group A and one choice for species group B and one choice for species group C and one choice for species group D.
Concerning species group A: Sample type to inform diagnosis or screening:
Applicant elects: (3) c- Kit RNA.
Concerning species group B: Assay:
Applicant elects: (6) fluorescent real-time quantitative PCR.
Concerning species group C: Patient sample to be analyzed
Applicant elects: (13) blood.
Concerning species group D and species group Bb: Diagnosis focus and abuse type:
Applicant elects: (19) behavior abuse.
Applicant further elects: (n) behavior abuse is an eating addiction.
Concerning species Group Cc: Treatment for Behavior abuse selected in species group Bb:
Applicant elects: (v) a derivative of imatinib (imatinib mesylate).
Concerning species Group E: Product type to inform addiction diagnosis or screening:
Applicant elects: (21) Kit.
Claims 1, 5 and 7-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/04/2025.
Status of the claims
Claims 1-10 are pending. Claims 2-4 and 6 are under review.
Specification Objection
Nucleotide and/or Amino Acid Sequence Disclosures
The specification discloses on pages 12-13, at paragraph [0066], the nucleotide sequences of SEQ ID NOS:1-4.
According to the specification, SEQ ID NO: 1 consists of 5’-CGCAGCTTCCTTATGACCAC-‘3 and SEQ ID NO: 2 consists of 5'-AGTGGCCTCAACTACCTTCC-‘3.
The objections below are made because no accompanying sequence listing was found for these aforementioned sequences.
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 fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
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) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
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 of SEQ ID NOS: 1-4 are located para [0066] of the specification on pages -12-13, paragraphs [0066].
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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-4 and 6 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 2-4 and 6 are considered genus claims that encompass a wide array of compositions/product(s) that are identifiable only by function, rather than by any limitation directed to structural features. The specification fails to set forth a representative number of examples in order to reasonably verify possession of such a potentially enormous number of items/compositions/products for tracing or detecting and monitoring c-KIT RNA, c-KIT DNA, or c-Kit protein, or activated c-KIT protein/gene, or metabolites of c-KIT gene.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that the claims are broad generics, with respect to all products for tracing or detecting and monitoring c-KIT RNA, c-KIT DNA, or c-Kit protein, or activated c-KIT protein/gene, or metabolites of c-KIT gene. The possible variations of products for tracing or detecting and monitoring c-KIT RNA, c-KIT DNA, or c-Kit protein, or activated c-KIT protein/gene or metabolites of c-KIT gene are limitless with potentially millions of types of products for tracing or detecting and monitoring c-KIT RNA, c-KIT DNA, or c-Kit protein, or activated c-KIT protein/gene, or metabolites of c-KIT gene.
The purpose of the written description requirement is to ensure that the invention had possession, as of the filing date of the application, of the specific subject matter later claimed by him or her. A patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention. Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, no that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention."
The specification lacks sufficient variety of species of products for tracing or detecting and monitoring c-KIT RNA, c-KIT DNA, or c-Kit protein, or metabolites of c-KIT gene, or activated c-KIT protein to reflect this variance in the genus since the specification does not provide any examples of such products for tracing or detecting and monitoring c-KIT RNA, c-KIT DNA, or c-Kit protein, or metabolites of c-KIT gene, or activated c-KIT protein.
Accordingly, the specification fails to provide adequate written description for the genus of “products for tracing or detecting and monitoring c-KIT RNA, c-KIT DNA, or c-Kit protein, or activated c-KIT protein/gene, or metabolites of c-KIT gene and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed had possession of the entire scope of the claimed invention. Moreover, the specification neither describes the complete structure of a representative number of species, nor describes a representative number of species in terms of partial structure and relevant identifying characteristics. Absent of such teachings and guidance as to the structure and function of these products for tracing or detecting and monitoring c-KIT RNA, c-KIT DNA, or c-Kit protein, or activated c-KIT protein/gene, or metabolites of c-KIT gene, the specification does not describe the claimed products for tracing or detecting and monitoring c-KIT RNA, c-KIT DNA, or c-Kit protein, or metabolites of c-KIT gene, or activated c-KIT protein in such full, clear, concise and exact terms so as to indicate that applicant had possession of these products for tracing or detecting and monitoring c-KIT RNA, c-KIT DNA, or c-Kit protein, or activated c-KIT protein/gene, or metabolites of c-KIT gene at the time of filing of the present application. Thus, the written description requirement has not been satisfied.
Claim Interpretation
Prior to analysis of the art, the claims must be construed. As noted in MPEP 2111, citing Phillips v. AWH Corp., 415 F.3d l303, 75 USPQ2d l321 (Fed. Cir. 2005), "During patent examination, the pending claims must be 'given their broadest reasonable interpretation consistent with the specification.' ".
The instant claims 2-4 and 6 currently recites:
2. (Original) A product for reflecting a substance or behavioral addiction state by tracing or detecting and monitoring various RNA, DNA or c-Kit protein activities and related metabolites of c-Kit in an addicted patient.
3. (Original) The product of claim 2, wherein the substance comprises narcotic drugs, psychotropic drugs, alcohol, tobacco, and volatile organic solvents; the narcotic drugs comprise opioids, cocaine, cannabis and other drugs; the psychotropic drugs comprise sedative- hypnotics, anxiolytics, central stimulants, hallucinogens and the like; and the behaviors comprise internet addiction, gambling addiction and other behaviors.
4. (Original) The product of claim 2, wherein the product comprises test strips, kits, chips, high-throughput sequencing platforms or imaging and other in vivo or in vitro diagnostic products.
6. (Original) The product of claim 2, wherein a purpose of detecting activities of c-Kit gene, RNA and protein is achieved by the product based on various methods comprising reverse transcription PCR, fluorescent real-time quantitative PCR, immunoassay, in-situ hybridization, chip, high-throughput sequencing platform or brain functional magnetic resonance and omics.
In view of Applicant’s elections from above:
Claim 2 is construed as being drawn to a product for detecting and monitoring c-Kit RNA expression level of a patient with behavioral abuse addiction.
Claim 3 is construed as being drawn to said behavioral abuse addiction is an eating abuse addiction.
Claim 4 is construed as being drawn to the instant product which is a kit.
Claim 6 is construed as being directed to the instant product providing detection of c-Kit RNA expression by fluorescent real-time quantitative PCR.
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 2-4 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 2-4 and 6 are construed as being directed to nucleotide sequences that appear to encompass natural product (s) which falls within the law of nature exception.
Furthermore, claims 2-4 and 6 do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (June 13, 2013) - “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated”, and “Myriad’s DNA claim falls within the law of nature exception”.
The following 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, article of manufacture, or composition of matter?
Yes- the claims are clearly directed to nucleotide sequences/nucleic acids as products for detecting and monitoring c-Kit RNA expression level of a patient with behavioral abuse addiction. The nucleotide sequences/nucleic acids are a composition of matter.
Step 2A, prong one. Does the claim recite a law of nature, a natural phenomenon, or an abstract idea (recognized judicial exceptions)?
Yes- the claims encompass primers and/or probe(s) nucleotide sequences within a kit/package, the primers and/or probe(s) each comprise sequences (i.e. SEQ ID NO: 1 consisting of 5’-CGCAGCTTCCTTATGACCAC-‘3 and SEQ ID NO: 2 consisting of 5'-AGTGGCCTCAACTACCTTCC-‘3) that are not markedly different naturally occurring sequence(s) of GenBank Accession No. D12524.1 at nucleotides 1771-1790 and at nucleotides 1871-1852, respectively.
The claimed nucleotide sequences have no functional differences relative to their naturally occurring counterparts since both the claimed and naturally occurring molecules hybridize to complementary nucleic acids.
MPEP 2106.04(b)(i) identifies nucleic acid sequence(s) having no structural or functional differences from naturally occurring nucleic acids as an example of a patent-ineligible natural product.
In addition, as discussed in MPEP 2016.04(b)(II), “[P]roduct of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.” See Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244.
Step 2A, prong two. Does the claim as a whole integrate the recited judicial exception into a practical application of the exception?
No - This evaluation is performed by identifying whether there are any additional elements recited in the claim beyond the judicial exception, and evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application.
In the instant case, the claims do not appear to recite any additional elements beyond those that may reasonably be consider part of a naturally occurring nucleotide sequence(s) (wildtype or mutant Rattus norvegicus mRNA for c-kit receptor tyrosine kinase).
The polynucleotides (claimed primers and probe(s)) of the composition are not required to include a label or non-naturally occurring nucleotides, nor do they have functions not possessed by naturally occurring nucleic acids.
Step 2B. Does the claim recite additional elements that amount to significantly more than the judicial exception?
No- In the instant case, as detailed above, the claims are PCR primers/probe encompassing partial or full-length sequence(s) of naturally occurring DNA sequences.
This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05.
Concerning claims are drawn to nucleic acids that encompass a product that is naturally occurring (i.e.: the claimed primer pair/probe may be the same as a portion of a natural genome), it is noted that in Association for Molecular Pathology et al v. Myriad Genetics, Inc. et al, (569 U. S.(2013)), the Supreme Court provides:
Myriad did not create or alter either the genetic information encoded in the BCRA1 and BCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry. See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U. S. 127. Finding the location of the BRCA1 and BRCA2 genes does not render the genes patent eligible “new . . . composition[s] of matter,” §101. Myriad’s patent descriptions highlight the problem with its claims: They detail the extensive process of discovery, but extensive effort alone is insufficient to satisfy §101’s demands. Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs the chemical bonds that bind gene molecules together.
Further, the nucleotide sequence(s) encompassed by the claimed product/within claimed kit possess no structural or functional difference and do not have any markedly different characteristic as a collection than each primer/probe nucleotide sequence has individually.
In view of the foregoing, claims 2-4 and 6 are rejected under 35 U.S.C. 101 for being directed to ineligible subject matter.
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 2-3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rezai et al. (2007, BMC pharmacology, 7(1), 13, pp. 1-10).
Regarding claims 2-3 and 6, Rezai et al. teach c-KIT upper primer consisting 5'-AAGCAGATTTCAGAGAGCACCA-‘3 for detecting Human c-kit proto-oncogene mRNA oligonucleotide having the GenBank Accession No. X06182 at nucleotides 2797-2818 (see page 3, 1st and 2nd paragraphs of section entitled Evaluation of c-kit mRNA expression and pg 3, right col., 1st, 2nd and 3rd paragraphs).
Rezai et al. teach c-KIT lower primer consisting 5'-GCTGCCGACAGAATTGATCC-‘3 for detecting Human c-kit proto-oncogene mRNA oligonucleotide having the GenBank Accession No. X06182 at nucleotides 2909-2888 (see page 3, 1st and 2nd paragraphs of section entitled Evaluation of c-kit mRNA expression and pg 3, right col., 1st, 2nd and 3rd paragraphs).
Rezai et al. teach c-KIT probe consisting 5'-ACTCCAACTTAGCAAACTGCAGCCCCAA-‘3 for detecting Human c-kit proto-oncogene mRNA oligonucleotide having the GenBank Accession No. X06182 at nucleotides 2828-2855 (see page 3, 1st and 2nd paragraphs of section entitled Evaluation of c-kit mRNA expression and pg 3, right col., 1st, 2nd and 3rd paragraphs).
The instant claims 2-3 and 6 are anticipated by Rezai et al. who teach primer/probe nucleotide sequence(s) that detects cKIT RNA of human tumor sample recovered from xenografted in mice intraperitoneal injected with Etoposide (VP16), or Fluconazole, or sodium chloride.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rezai et al. (2007, BMC pharmacology, 7(1), 13, pp. 1-10) in view of Polasky (US 2004/0023207).
The teachings of Rezai et al. as it relates to claim 2 are stated above.
Regarding claim 4, Rezai et al. do not teach a kit comprising the product(s) of claim 2.
Polansky (US 2004/0023207) taught (paragraph [0919]): “Well known advantages of commercial kits include convenience and reproducibility due to manufacturing standardization, quality control and validation procedures”.
It would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the invention, to combine products known in the prior art for detecting and monitoring c-KIT RNA of a patient such as those taught by Rezai et al., into a kit since Polasky teach advantages of making kits to include convenience and reproducibility due to manufacturing standardization, quality control and validation procedures. In view of all of the teachings of the cited references, the instant claim 4 is prima facie obvious.
Conclusion
No claims are currently allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLAYINKA A OYEYEMI whose telephone number is (571)270-5956. The examiner can normally be reached Monday -Thursday: 9:00 am - 5:00 pm, EST.
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OLAYINKA A. OYEYEMI
Examiner
Art Unit 1681
/OLAYINKA A OYEYEMI/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681