Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Election/Restrictions
1. Applicant's election of Group I, claims 1-19, without traverse, filed June 22, 2026 is acknowledged and has been entered. Applicant further elected Species SEQ ID NO. 24 recited in claim 7. Claims 5, 11, 14, 20-24, 34, 38-47 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected invention and species. Accordingly, claims 1-24, 34, and 38-47 are pending. Claims 1-4, 6-10, 12, 13, and 15-19 which read on the elected species are under examination.
Priority
2. Acknowledgment is made of Applicant's possible claim for foreign priority based on an application filed in European Patent Office (EPO) on11/30/2020. It is noted, however, that Applicant has not filed a certified copy of EPO 20210641.5 application as required by 37 CFR 1.55.
3. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 111(a) and 37 C.F.R 1.53(b) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a continuation of PCT/EP2021/069405 filed 07/13/2021, which claims the benefit of Provisional Application Number 63/051,596 filed 07/14/202020. Applicant may also be eligible to claim benefit for foreign priority under 35 U.S.C. 119 (a)-(d) or (f), 365(a) or (b) or 386(a) based on EPO 20210641.5 file 11/30/2020. Based on the filing receipt, the effective filing date of this application is July 14, 2020 which is the filing date of Provisional Application Number 63/051,596 from which the benefit of domestic priority is claimed.
Information Disclosure Statement
4. The listing of references in the specification in pages XXX is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
5. Claim 3 is objected to in reciting “the binding of an antibody binding to HER2 extracellular subdomain II” because the recitation appears redundant. It should recite “the binding of an antibody to HER2 extracellular subdomain II.” Appropriate correction is required.
6. Claim 9 is objected to in reciting “the binding of an antibody binding to HER2 extracellular subdomain IV” because the recitation appears redundant. It should recite “the binding of an antibody to HER2 extracellular subdomain IV.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 1-4, 6-10, 12, 13, and 15-19 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.
Claim 1, step a) is indefinite in reciting, “ECD”. Acronyms or abbreviations should be fully defined and recited at least one time in a given set of claims.
Claim 1, step b) lacks antecedent basis in reciting “the sample.”
Claim 1, step b) is also ambiguous in reciting “detectable antibody” because it fails to clearly define in the method what component between the FDC and the capture reagent the detectable antibody should bind to. See also step c).
Claim 1, step c) lacks clear antecedent basis in reciting “the level of antibody bound to the capture reagent” because it is unclear which recitation of antibody the Applicant intends to refer back to, because the preamble recites two anti-HER2 antibodies; whereas step b) also recites “a detectable antibody.”
Claim 1, step c) is vague and indefinite in reciting “the level of antibody bound to the capture reagent” because it fails to clearly define in the method what component between the FDC and the capture reagent the detectable antibody should bind to. See also step c).
Claim 1, step c) is also confusing in reciting “quantifying the level of antibody bound to the capture reagent” because the preamble and step a) recite that the FDC is composed of a combination of two anti-Her2 antibodies. Accordingly, it is unclear which one of the combination of two anti-HER2 antibodies that may have bound to the capture reagent, is being detected. It is further unclear, therefore, how the FDC of two anti-HER2 antibodies is quantified based on the one detectable antibody, which is encompassed in the claimed invention.
Claim 3 is vague and indefinite in reciting “wherein the binding of an antibody binding to HER2 extracellular subdomain II is quantified” because the preamble and step a) of claim 1 from which the instant claim depends recites “FDC of two anti-Her2 antibodies” and claim 2 recites that the FDC binds to each one of HER2 extracellular domain II and HER2 extracellular domain IV. Accordingly, it is unclear how the HER2 extracellular domain IV portion of the FDC is detected, as claimed.
Claim 8 is indefinite in reciting “wherein the capture reagent does not comprise a HER2 subdomain IV” because the preamble and step a) of claim 1 from which the instant claim ultimately depends recites “FDC of two anti-Her2 antibodies” and claim 2 recites that the FDC binds to each one of HER2 extracellular domain II and HER2 extracellular domain IV. Accordingly, it is unclear, as recited, what the antibody binding to HER2 subdomain IV of the FDC of two anti-Her2 antibodies should bind to.
Claim 9 is vague and indefinite in reciting “wherein the binding of an antibody binding to HER2 extracellular subdomain IV is quantified” because the preamble and step a) of claim 1 from which the instant claim depends recites “FDC of two anti-Her2 antibodies” and claim 2 recites that the FDC binds to each one of HER2 extracellular domain II and HER2 extracellular domain IV. Accordingly, it is unclear how the HER2 extracellular domain IV portion of the FDC is detected, as claimed.
Claim 12 is indefinite in reciting “wherein the capture reagent does not comprise a HER2 subdomain II” because the preamble and step a) of claim 1 from which the instant claim ultimately depends recites “FDC of two anti-Her2 antibodies” and claim 2 recites that the FDC binds to each one of HER2 extracellular domain II and HER2 extracellular domain IV. Accordingly, it is unclear, as recited, what the antibody binding to HER2 subdomain II of the FDC of two anti-Her2 antibodies should bind to.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claims 1-4, 6, 8-10, 12, 13, and 15-19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Tamaskovic et al. (US 2015/0284463 A1).
Tamaskovic et al. disclose a binding assay for a fixed dose combination (FDC) of two anti-HER2 antibodies comprising: a. contacting the two anti-HER2 FDC antibodies with a capture reagent comprising a modified (truncated) HER2 ECD (extracellular domain) subdomain; b. contacting the mixture of a) with a detectable antibody (secondary anti-human antibody coupled to alkaline phosphatase); and c. quantifying the amount (level) of antibody bound to the capture reagent using a detection means (ELISA plate reader) that detects a binding signal (color reaction) from the detectable antibody ([0234, 0287, 0311]; Example 15). The capture reagent comprising modified HER2 ECD subdomain is coated on ELISA microtiter plate ([0234, 0287, 0311]; Example 15). Tamaskovic et al. shows the detectable antibody targeting the F(ab')2 portion of the anti-HER2 antibody [0333]. Tamaskovic et al. specifically teach that the FDC anti-HER2 antibodies comprise Pertuzumab and Trastuzumab; wherein Pertuzumab is the antibody directed against (binds to) HER2 ECD subdomain II and Trastuzumab is the antibody directed against HER2 ECD subdomain IV [0011, 0021, 0210]. Pertuzumab is a HER2 dimerization inhibitor that acts by blocking complex formation, prevents growth stimulating effects and cell survival signals activated by ligands of HER1, HER2, and HER4 [0011, 0021, 0210]. Tamaskovic et al. teach quantifying Pertuzumab (PER, 2C4) binding to HER2 ECD subdomain II and Trastuzumab (TT, 4D5) binding to HER2 ECD subdomain IV, individually (Figure 13b) or in combination (i.e. FDC) (Figure 13a) ([0011, 0021, 0210, 0232, 0309]; Figure 13).
Tamaskovic et al. teach that the capture reagent comprises recombinant HER2 ECD II subdomains I, II, III and does not comprise HER2 ECD subdomain IV. The capture reagent may also comprise recombinant HER2 ECD subdomain IV or recombinant HER2 ECDs I, III, IV and domain II of EGFR or does not comprise HER2 ECD subdomain II [0005, 0287, 0307]. Tamaskovic et al. show using the method to analyzes the potency of Trastuzumab [0327].
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
9. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tamaskovic et al. (US 2015/0284463 A1) in view of XU et al. (US 2023/0017515 A1).
Tamaskovic et al. is discussed supra. Tamaskovic et al. differ from the instant invention in failing to teach that the capture reagent comprises SEQ ID NO. 24
XU et al. teach assaying for two FDC anti-HER2 antibodies wherein the two anti-HER2 FDC antibodies are Pertuzumab and Trastuzumab. Xu et al. further teach using a capture reagent comprising a modified HER2 ECD which is SEQ ID NO. 24 (SEQ ID NO. 78) [0167, 0248-0250, 0252, 0309].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the capture reagent of Tamaskovic with SEQ ID NO. 4 as taught by XU because XU provides SEQ ID NO. 4 as an alternate modified HER2 ECD for use in FDC binding assays for immunotherapeutic screening studies. One of ordinary skill would have had reasonable expectation of success in combining the teaching of XU with Tamaskovic because both of Tamaskovic and XU teach analogous art.
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. 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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/GAILENE GABEL/Primary Examiner, Art Unit 1678
July 21, 2026
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