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 .
Applicant filed a Preliminary Amendment on March 30, 2022, in which claims 1-17 were canceled, leaving claims 18-20 pending. It is noted that the claims filed on March 30, 2022 did not include status identifiers or underlines/strikeouts showing amendments to the claims. This, however, does not preclude examination.
In addition, Applicant received Notices of Incomplete Application on May 3, 2022 and September 7, 2022, to which Applicant responded on May 18, 2022 and September 30, 2022, respectively, along with Petitions relying on 37 C.F.R. § 1.57(b) in order to submit omitted material. The Petition was ultimately granted on March 23, 2023 (after being dismissed January 24, 2023 and refiled February 6, 2023). It is noted that the claim set filed May 18, 2022 was the original claim set. It is believed that, because this application was filed as a divisional application and the claims are directed to the remaining unexamined Group from the original Restriction Requirements in U.S. Patent Application Nos. 16/267,653 and 15/464,520 (now U.S. Patent Nos. 11,319,601 and 10/208,357, respectively), Applicant intends claims 18-20 to be examined in the instant Application.
Therefore, claims 18-20 are deemed to be pending in this application, and are under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of 35 U.S.C. 112 (pre-AIA ). See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 15/464,520 and 16/267,653, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112 (pre-AIA ), first paragraph for one or more claims of this application. The application fails to provide support for the claims under examination, since there is no disclosure therein of the claimed assay cell comprising: “a stably integrated HER2 expression construct,” “a double knockout of HEW1 and HER2” or “a stably integrated JNK signal expression construct. Therefore, the effective filing date of claims 18-20 is deemed to be March 20, 2022, the filing date of the instant application. Thus, the instant application could be considered to be a continuation-in-part application, rather than a divisional application.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
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 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.
It is noted that the Sequence Listing Incorporation by Reference paragraph lists the size of the ASCII text file as 9,203 bytes. However, the ASCII text file itself lists the size as 9,343 bytes.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 18, part a) recites “a stably integrated HER2 expression construct.”
Claim 18, part b) recites “a double knockout of HEW1 and HER2.”
Claim 18, part c) recites “a stably integrated JNK signal expression construct.
The specification does not provide antecedent bases for any of these three claim limitations. The originally filed claims do recite each of “a stably integrated HER3 expression construct,” “ a double knockout of HER1 and HER2,” and “a stably integrated JNK signal expression construct comprising a reporter gene cDNA linked to at least one AP-1 sequence.” The specification should be amended to include each of these terms.
Claim Interpretation
Because the claims recite limitations that are neither present in the specification nor the claims as originally filed, claims 18-20 are being examined both as being drawn to originally filed claims 18-20 and to the claims including the recitation of HEW1 for prior art purposes.
Claim Objections
At claim 18, line 2, “HER2” should be changed to HER3.”
At claim 18, line 3, “HEW1” should be changed to “HER1.”
At claim 18, line 5, “AP-1” should be changed to “activator protein 1 (AP-1).”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-20 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.
At claim 18, line 3, it is not clear to what gene “HEW1” refers. Is this recitation intended to refer to a specific gene?
Claims 19-20 depend from claim 18, and are therefore included in this rejection.
Claim 20 recites the limitation "the parent cell" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
While the prior art does disclose that HER2 can have mutations that impact the sensitivity of cells to HER2 inhibitors, that HER2 and HER3 are able to form dimers, and that HER2 mediates AP-1 activation (see Amler et al. (U.S. Patent No. 7,981,418, issued July 19, 2011 and Yuan et al. 318 Molecular and Cellular Biochemistry 73-79 (2008)); the prior art does fail to disclose or suggest an assay cell that has each of the following characteristics:
a stably integrated HER3 expression construct,”
“ a double knockout of HER1 and HER2,” and
“a stably integrated JNK signal expression construct comprising a reporter gene cDNA linked to at least one AP-1 sequence.”
In addition, the prior art fails to disclose or suggest an assay cell that comprises “a double knockout of HEW1 and HER2.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANCY J LEITH whose telephone number is (313)446-4874. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NEIL HAMMELL can be reached at (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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NANCY J. LEITH
Primary Examiner
Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636