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
The election without traverse filed September 4, 2025, is acknowledged and has been entered. Applicant has elected Group 2.
The amendment filed September 4, 2025, is acknowledged and has been entered. Claims 1-22 have been amended. Claims 23-24 have been canceled. Claim 25 has been newly added.
Claims 1-22 and 25 are pending.
Claims 20-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-19, 22 and 25 are under examination.
Information Disclosure Statement
The information disclosure statements have been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In this case, claim 22 is a method claim and depends from claim 20 which is a product claim such that claim 22 fails to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-18 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anonymous: (Clinicaltrials.Gov: "History of Changes for Study: NCT03324113 Evaluation of SAR408701 in Combination With Other Anti-tumor Drug in JapanesePatients With Advanced Malignant Solid Tumors", 15 January 2019, IDS) as evidenced by WO 2024/180192 A1, IDS (Bauchet et al) and WO 2014/079886 A1, IDS (Berne et al).
As evidenced by Bauchet et al, SAR408701 is an immunoconjugate combining the huMAb2-3 (anti-CEACAM5) antibody and the maytansinoid derivative 4 (DM4), a potent antimitotic agent that inhibits microtubule assembly. DM4 is covalently bound to huMAb2-3 through an optimized linker SPDB [N-succinimidyl 4-(2-pyridyldithio)-butyrate] that is stable in plasma and cleavable inside cells. Thus SAR408701 is also known as huMAb2-3-SPDB-DM4 (see ¶¶ 43, 44 and 46) and comprises the huMAb2-3 antiboy sequences set forth in the instant claims (see instant claims 2-4 and in particular 12 which references huMAb2-3). Then, as evidenced by Berne et al, huMAb2-3-SPDB-DM4 ahs a DAR of 3.8 or 3.9 (see page 99).
Anonymous discloses in the Study Description method of treating solid colorectal cancer by administering SAR408701 (huMAb2-3-SPDB-DM4) in combination with TAS-102 components (trifluridine and tipiracil).
Anonymous discloses at page 3, table, second row "Experimental: SAR408701 + TAS-102 combination", SAR408701 is administered in multiple cycles intravenously (i.v.) once every two weeks, which is combined with treatment with TAS-102 (being trifluridine and tipiracil) given orally as a tablet, i.e. they are in the form of two separate pharmaceutical compositions, one comprising the immunoconjugate (i.v. formulation) and one comprising TAS-102 (oral formulation) which also encompasses simultaneous administration because there are times when both would be administered at the same time.
Accordingly, Anonymous anticipates the claims absent a showing otherwise.
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.
Claims 1-16, 18, 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Anonymous: (Clinicaltrials.Gov: "History of Changes for Study: NCT03324113 Evaluation of SAR408701 in Combination With Other Anti-tumor Drug in JapanesePatients With Advanced Malignant Solid Tumors", 15 January 2019, IDS) as evidenced by WO 2024/180192 A1, IDS (Bauchet et al) and WO 2014/079886 A1, IDS (Berne et al).
The disclosure of Anonymous is set forth above. Anonymous does not teach SAR408701 + TAS-102 in the same composition as set forth in claim 22.
In this case, it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to place SAR408701 + TAS-102 in the same composition and then administer the composition in methods of treating solid cancer as suggested by Anonymous because a single composition could be administered together which would be easier for the medical provider and patient. Notably, "It 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." See logic of In re Kerkhoven, 626 F.2d 848, 850, 205 USPQ 1069, 1072, (CCPA 1980) and MPEP § 2144.06.
Accordingly, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference.
Claims 1-19 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Anonymous: (Clinicaltrials.Gov: "History of Changes for Study: NCT03324113 Evaluation of SAR408701 in Combination With Other Anti-tumor Drug in JapanesePatients With Advanced Malignant Solid Tumors", 15 January 2019, IDS) as evidenced by WO 2024/180192 A1, IDS (Bauchet et al) and WO 2014/079886 A1, IDS (Berne et al) in view of Yoshino et al (Lancet Oncol, 13:993-1001, 2012) and WO 2020/161214 A1 (Allard et al).
The disclosure of Anonymous is set forth above. Anonymous does not teach a dose of SAR408701 as set forth in claim 19 or a dose of TAS-102 in claim 19.
Yoshino et al disclose that TAS-102 comprises trifluridine and tipiracil as a molar ratio of 1:0.5 and administering 35 mg/m² to treat cancer (see abstract and page 993).
Allard et al disclose treating cancer with immunoconjugate huMAb2-3-SPDB-DM4 as doses of 60, 80, 100, 120, 150, 180, or 210 mg/ m² based on the body surface area of the subject (see page 5). Allard et al disclose optimizing the amount of immunoconjugate based on the age and the size of the subject as well as the route of administration and other factors well known to those of ordinary skill in the art (see pages 54-55).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to treat cancers including solid colorectal cancers by administering SAR408701 + TAS-102 at the schedule Anonymous at the doses of Yoshino et al and Allard et al because the art taught that these components can be used at such doses to treat cancer.
Notably, with respect to the dosages and timing, the art taught that the skilled artisan can readily determine the proper dosages and timing as evidenced by the prior art, so these treatments also have been considered obvious, absent a showing otherwise. Notably, as evidenced by the references, and treatment schedules and doses were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, any optimization of dosages and timing of administration would be seen as routine optimization, absent a showing otherwise, because one would see these limitations as combining prior art elements according to known methods to yield predictable results.
Accordingly, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner works a flexible schedule.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
October 30, 2025