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 .
Information Disclosure Statement
Five information disclosure statements (IDS) submitted: one on January 11th, 2023; one on February 13th, 2023; one on September 12th, 2023; one on February 8th, 2024; and one on July 15th, 2024. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The listing of references in the specification [0016] 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.
Specification
The use of the term TICE® BCG, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Nucleotide and/or Amino Acid Sequence Disclosures
While Applicant has provided appropriate SEQ ID NO. for nucleotide sequences 1-10, Applicant has failed to provide a SEQ ID NO. for peptide sequence found in [0276], page 113 of the specification.
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.
The Specification discloses a peptide sequence on page 113, para. [0276].
For compliance with sequence rules, it is necessary to include the sequence in the “Sequence Listing” and identify them with SEQ ID NO. In general, any sequence that is disclosed and/or claimed as a string of particular bases or amino acids, and that otherwise meets the criteria of CFR 1.821(a), must be set forth in the “Sequence Listing.” See MPEP 2422.03.
While the Examiner has made every attempt to check the Specification for sequence compliance, Applicant is required to carefully check the entire Specification for any and all issues regarding sequence compliance.
For the response to this Office Action to be complete, Applicant is REQUIRED to comply with the Requirements for Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Failure to comply with the Requirements will be considered nonresponsive.
Status of the Claims
Claims 1-8 and 10-17 are pending in this application. Claims 9 and 18-19 have been cancelled by applicant.
Claim Interpretation
Claim 13 recites the limitation “a kit preparation…” The specification, however, does not define the term “kit,” and so it is being interpreted to encompass any collection of reagents that includes all of the elements of claims 1 and 11. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation of on the claimed subject matter.
Claim Objections
Claim 1 objected to because of the following informalities: Claim recites the limitation “an other antitumor agent” in the last line. This should read “another antitumor agent.” Appropriate correction is required.
Claims 12, 14, and 16-17 objected to because of the following informalities: Claim recites the limitation “treatment of tumor.” This should read “treatment of a tumor.” 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.
Claims 3-4 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 regards as the invention.
Claim 3-4 recite the limitation "…represented by the formula (II)." There is insufficient antecedent basis for this limitation in the claim, as formula (II) is not mentioned in claim 1, upon which the claims depend.
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.
Claims 1-8 and 10-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-19 of U.S. Patent No. US 11,078,207 B2 (US ‘207).
Regarding instant claims 1-8 and 10-17, US ‘207 claims the compounds of Formulas I and II below (US ‘207 claims 1-2). US ‘207 also speaks to a pharmaceutical composition formulated for oral administration comprising these compounds, and a method of treating a tumor in a subject comprising administration of these compounds (US ‘207 claims 12-16).
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(Formula I)
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(Formula II)
Regarding coadministration of the compounds of Formula I and II with another antitumor agent, as recited in the instant claims, applicant is advised the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” See MPEP2144.06. It is therefore obvious to provide a mixture of the two agents for the treatment of a tumor in a subject.
MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, counsel's mere arguments cannot take the place of evidence in the record.
Claims 1-8 and 10-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 24-48 of copending Application No. 18/016,103 (Copending ‘103).
Regarding instant claims 1-8 and 10-17, Copending ‘103 claims a method of treating a disease associated with EGFR (reading on cancers and tumors) comprising administration of the compounds of Formula I and II below (Copending ‘103 claims 23-25):
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(Formula II)
Regarding coadministration of the compounds of Formula I and II with another antitumor agent, as recited in the instant claims, applicant is advised the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. It is therefore obvious to provide a mixture of the two agents for the treatment of a tumor in a subject.
Applicant is reminded, the arguments of counsel cannot take the place of evidence in the record.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8 and 10-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-35 of copending Application No. 18/563,058 (Copending ‘058).
Regarding instant claims 1-8 and 10-17, Copending ‘058 claims a method of treating cancer (reading on a tumor) comprising administration of the compound I below:
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Regarding coadministration of the compounds of Formula I and II with another antitumor agent, as recited in the instant claims, applicant is advised the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. It is therefore obvious to provide a mixture of the two agents for the treatment of a tumor in a subject.
Applicant is reminded, the arguments of counsel cannot take the place of evidence in the record.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached at (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/Robert T. Crow/Supervisory Patent Examiner Trainer, OPT
Prosecution Insights