DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's election with traverse of Group II (claims 4-6) and the species of (i) a Mps1 inhibitor and (ii) a compound in the reply filed on 8/24/2026 is acknowledged. The traversal is on the ground(s) that unity of invention does exist between Groups I and II and III, because there is a technical relationship that involves the same special technical feature. It is this technical feature that defines the contribution which each of the groups, taken as a whole, makes over the prior art. A search of all the claims would not impose a serious burden on the Office.
This is not found persuasive. As indicated in the previous office action, even though the inventions of these groups require the technical feature of an antibody for confirming whether threonine at position 1010 from NCAPG2 is phosphorylated, wherein the antibody binds to SEQ ID NO:1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Kim et al. (US 2015/0197548A1, pub. date: 7/16/2015). Kim et al. teaches NCAPG2 pThr1010 antibody made in rabbit with VLSpTL-containing peptide as antigen. Kim et al. further teaches detecting phosphorylated T1010-NCAPG2 by western blotting ([0019]). Instant SEQ ID NO:1 (HRGVLSTLIAGPV) comprises VLSpTL. An antibody which binds to VLSpTL and specifically to threonine at position 1010 of NCAPG2 would bind instant SEQ ID NO:1. Applicant’s arguments of no burdensome search are not persuasive because the instant case is a national stage filing of an international application (i.e. 35 U.S.C. 371) and as such the standard of burdensome search is not applied.
Therefore, the requirement is still deemed proper and is therefore made FINAL.
Note that the species election does not apply to the elected group.
3. Claims 1, 2, 4-9 and 17 are pending. Claims 3 and 10-16 are canceled. Claims 1, 2 and 7-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/24/2026.
4. Claims 4-6 and 17 are under examination.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 5/22/2025 has been considered by the examiner.
The information disclosure statement filed 11/24/2023 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered as it pertains to the foreign prior arts 10-1903838 B1 which is in Korea.
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:
6. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). see pages 9, 10, 13, 30, 32, 33 and 35, for example.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, 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.
7. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. See Figures 1A, 2B and 2C.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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.
Abstract
8. The abstract of the disclosure is objected to because it exceeds 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
9. Claims 4-6 and 17 are objected to because of the following informalities:
(i) Claims 4-6 and 17 are objected to for being dependent from a withdrawn claim.
(ii) Claims 4-6 and 17 are objected to for the recitation of the term “represented by”. The term “represented by” implies a genus of sequences, which genus is represented by SEQ ID NO:1 or SEQ ID NO:2. To avoid ambiguity, the term “comprising” or “consisting of” should be used.
(iii) Claims 6 recites “wherein the higher the degree of phosphorylation of the threonine at position 1010 from the N terminus of the amino acid sequence of NCAPG2, the lower the degree of differentiation of tumor cells”. The position 1010 is either phosphorylated or non-phosphorylated. The higher the degree of phosphorylation can only be used in the context of a sample or a population of tumor cells, not in the context of 1010 position.
Claim Rejections - 35 USC § 112
10. 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.
11. Claims 4-6 and 17 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.
The claims are indefinite for reciting “threonine at position 1010 from the N terminus of the amino acid sequences of NCAPG2”. NCAPG2 in different species has different amino acid sequences, as evidenced by Exhibit A. The amino acid at position 1010 from the N terminus of the amino acid sequences of NCAPG2 varies depending on the NCAPG2 sequence. Therefore, the metes and bounds of the claimed invention cannot be determined and the claim is indefinite.
Amending the claims to recite SEQ ID NO:2 would overcome the rejection.
Claim Rejections - 35 USC § 101
12. 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.
13. Claims 4-6 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a law of nature.
According to the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019, the claims meet step 1 as the instant claims are drawn to a process. The claims also meet prong one of step 2A because the claims recite the following law of nature or natural phenomenon: a correlation between phosphorylation of threonine at position 1010 from the N-terminus of the amino acid sequence of NCAPG2 and cancer (claims 4-6 and 17), and a correlation between a higher degree of phosphorylation of threonine at position 1010 from the N-terminus of the amino acid sequence of NCAPG2 in tumor cells and the lower the degree of differentiation of tumor cells (claim 6). The claims do not meet prong two of step 2A because the combination of additional elements fails to integrate the judicial exception into practical application. The additional elements (beyond the judicial exceptions) are confirming whether threonine at position 1010 from the N terminus of the amino acid sequence of NCAPG2 is phosphorylated by reacting NCAPG2-expressing cells with the antibody of claim 1. These elements do not apply, rely on or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
According to 2019 PEG updates, limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
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625
657
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Limitations that are not indicative of integration into a practical application when recited in a claim with a judicial exception include:
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656
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In the instant case, reacting NCAPG2-expressing cells with the antibody of claim 1 are insignificant extra-solution activity. Data gathering steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity. The claims also fail to apply or use a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition, or improve to the functioning of a compute or any other technology or technical field.
The claims also fail to meet step 2B because the additional elements were well known and conventional in the art as evidenced by Kim et al. (US 2015/0197548A1, pub. date: 7/16/2015). Kim et al. teaches NCAPG2 pThe1010 antibody made in rabbit with VLSpTL-containing peptide as antigen. Kim et al. further teaches detecting phosphorylated T1010-NCAPG2 by western blotting ([0019]). Instant SEQ ID NO:1 (HRGVLSTLIAGPV) comprises VLSpTL. An antibody which binds to VLSpTL would bind instant SEQ ID NO:1. Therefore, the additional steps/elements do not add significantly more to the judicial exception.
Since the claims as a whole do not include additional elements that are sufficient to amount to significantly more than the judicial exception, the claims are not directed to eligible subject matter under 35 U.S.C 101.
Claim Rejections - 35 USC § 102
14. 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.
15. Claim 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 2015/0197548A1, pub. date: 7/16/2015, PTO 892 dated 6/24/2026).
Claim 4 is interpreted as a method of providing information for cancer diagnosis, comprising: confirming whether threonine at position 1010 from the N terminus of the amino acid sequence of NCAPG2 is phosphorylated by reacting NCAPG2-expressing cells with an antibody, wherein the amino acid sequence of NCAPG2 consists of SEQ ID NO:2, wherein the antibody recognizes a peptide consisting of the amino acid sequence of SEQ ID NO: 1, and specifically binds to threonine at position 1010 from the N terminus of SEQ ID NO:2.
Kim et al. teaches NCAPG2 pThr1010 antibody made in rabbit with VLSpTL-containing peptide as antigen. Kim et al. further teaches detecting phosphorylated T1010-NCAPG2 in NCAPG2-expressing cells by western blotting ([0019] and [0026]). Instant SEQ ID NO:1 (HRGVLSTLIAGPV) comprises VLSpTL. An antibody which binds to VLSpTL and specifically to phosphorylated threonine at position 1010 of NCAPG2 would bind instant SEQ ID NO:1.
Kim et al. teaches the active step of claim 4.
The limitation “providing information for cancer diagnosis” in the preamble is intended use of the method and is not given patentable weight.
Claim Rejections - 35 USC § 103
16. 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.
17. Claims 4-6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 2015/0197548A1, pub. date: 7/16/2015, PTO 892 dated 6/24/2026), in view of Wallweber et al. (US 2016/0041171A1, pub. date: 2/11/2016).
The teachings of Kim et al. have been set forth above as they apply to claim 4.
Regarding claim 5, Kim et al. teaches that the expression of NCAPG2 in human cancer cells was significantly increased compared to the expression in normal cell ([0062]) and NCAPG2 and PLK1 tend to increase together in various carcinomas ([0063]). Kim et al teaches that our immunoprecipitation and in vitro binding assay data indicated that NCAPG2 and PLK1 directly interact with each other in a phosphorylation-dependent manner at Thr1010 (FIGS. 8b and 8c) ([0026]). The phosphorylated 7-mer peptide 1006GVLS-pT-LI1012 interacts strongly with PBD of PLK1 in contrast to the unphosphorylated peptide 1006GVLSTLI1012 (SEQ ID NO: 8) (FIG. 8C) ([0030]). The phosphorylation of amino acid residue 1010 of SEQ ID NO: 7 has a critical role in NCAPG2 or PLK1 function (FIG. 8E) ([0030]). The phosphorylation inhibitor can show anti-tumor activity by suppressing the activity of PLK1 by inhibiting the interaction between NCAPG2 and PLK1 ([0030]).
Kim et al. does not teach detecting NCAPG2 pThr1010 in a sample of a subject for cancer diagnosis.
Wallweber et al teaches that upregulation of HER3 is commonly seen in various malignancies such as breast cancer, colorectal carcinoma, squamous cell carcinoma of the head and neck (SCCHN), uveal melanoma, and gastric, ovarian, prostate, and bladder cancers ([0006]). Wallweber et al teaches a method of measuring the amount of activated HER3 in a tumor for facilitating diagnosis, the method comprising: (a) measuring in a tumor sample the amount of total HER3 and the amount of phosphorylated HER3 in the sample; and (b) determining the ratio of phosphorylated HER3 to total HER3 protein ([0009], [0010]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have detected NCAPG2 pThr1010 in a sample of a subject for facilitating cancer diagnosis in view of Wallweber et al. One of ordinary skill in the art would have been motivated to do so because Kim et al. teaches NCAPG2 and PLK1 tend to increase together in various carcinomas ([0063]), and NCAPG2 and PLK1 directly interact with each other in a phosphorylation-dependent manner at Thr1010 (FIGS. 8b and 8c) ([0026]), and Wallweber et al teaches detecting both HER3 and phosphorylated HER3 in a sample for diagnosis of cancer. One of ordinary skill in the art would have had a reasonable expectation of success because Kim et al. teaches detecting NCAPG2 pThr1010 using an antibody that binds specifically to NCAPG2 pThr1010.
Regarding claim 6, the combination of Kim and Wallweber teaches detecting NCAPG2 pThr1010 in a tumor sample for cancer diagnosis as discussed above. The limitation “wherein the higher the degree of phosphorylation of the threonine at position 1010 from the N terminus of the amino acid sequence of NCAPG2 in tumor cells, the lower the degree of differentiation of tumor cells” is considered an inherent property of tumor cells expressing NCAPG2 pThr1010.
Regarding claim 17, Kim et al. teaches NCAPG2 pThr1010 antibody made in rabbit with VLSpTL-containing peptide as antigen ([0018]). Instant SEQ ID NO:1 (HRGVLSTLIAGPV) comprises VLSpTL. An antibody which binds to VLSpTL and specifically to phosphorylated threonine at position 1010 of NCAPG2 would bind instant SEQ ID NO:1.
In claim 17, the antibody is defined by a process of making. The steps of making the antibody are not considered affirmative steps of the claimed method. However, the product by process language does limit the identity of the antibody.
In the instant case, the antibody in claim 17 is not limited to a polyclonal antibody raised against an antigen consisting of SEQ ID NO:1, which would be different from a polyclonal antibody raised against VLSpTL containing antigen. However, the antibody in claim 17 broadly encompasses any monoclonal antibodies that can be generated using the antigen consisting of SEQ ID NO:1, which may include the antibody of Kim because VLSpTL is a subsequence of SEQ ID NO:1
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the antibody of the prior art is not the same as the claimed antibody. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed antibody is different from that taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Conclusion
18. No claims are allowed.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG SANG/Primary Examiner, Art Unit 1646
