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
Restriction/Election
1. Applicant’s election without traverse of Group I (claims 1, 10-11, 18, 22-23, 30-31, 33, 37-38, and 40-41) in the reply filed on 07/22/2026 is acknowledged. In response to species election requirement, Applicant elected the following species: (i) head and neck squamous cell carcinoma; (ii) STIM003; and (iii) atezoliumab.
2. Claims 1, 10-11, 18, 22-23, 30-31, 33, 37-38, and 40-41 are pending and currently under consideration.
Information Disclosure Statement
3. The information disclosure statement filed on 02/02/206 has been considered by the Examiner and an initialed copy of the form PTO-1449 is attached to this communication.
Drawings
4. The drawings filed on 11/15/2023 are accepted by the examiner.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (a)
5. The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 1, 10-11, 18, 30-31, 33, 37-38, and 40-41 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor at the time the application was filed, had possession of the claimed invention.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Claims 1, 10-11, 18, 30-31, 33, and 37-38 are drawn to a method of treating cancer in a patient, wherein the patient has a PD-L1 negative tumour or a tumour with low PD-L1 expression, comprising administering to the patient a modulator of ICOS. The claims do not require that the modulator of ICOS possess any particular conserved structure nor other disclosed distinguishing feature. Claim 40 is drawn to a random combination of six CDRs from various antibodies recited in claim 40 or variations thereof with 1-5 amino acid alterations, whereas claim 41 is drawn to a random combination of VH domains and VL domains from various antibodies recited in claim 41 or variations thereof with 90% identical to the antibody VH domain sequences or VL domain sequences. Thus, the claims encompass a genus of modulators of ICOS without definitive structures
For each claim drawn to a genus, MPEP §2163 II.A.3(a) ii) (page 2100-189) states, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”. In the instant case, the specification discloses modulators of ICOS, anti-ICOS antibodies. Other than anti-ICOS antibodies, the specification does not disclose any other types of modulators of ICOS. With respect to claims 40-41, all disclosed anti-ICOS antibodies comprise a particular set of six CDRs, three CDRs in the heavy chain variable region and three CDRs in the light chain variable region, or a particular pair of a heavy chain variable region and a light chai variable region. The instant disclosure is insufficient to support the broad genus of modulators of ICOS or anti-ICOS antibodies.
It is well established in the art that the formation of an intact antigen binding site of an antibody routinely requires the association of the complete heavy and light chain variable regions of a given antibody. It is expected that proper association of heavy and light chain variable regions is required in order to form a functional antigen binding site (Paul, Fundamental Immunology, 3rd Edition, 1993, pages 292-295; in particular page 293, column 1, lines 3-8; column 1, line 31 to column 2, line 9; column 2, lines 27-30). Vajdos et al. teach that amino acid sequence and conformation of each of the CDRs of the heavy and light chains is critical for maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin (J. Mal. Biol. 320:415-428, 2002; in particular page 416).
Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other modulators of ICOS or anti-ICOS antibodies might be. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of modulators of ICOS or anti-ICOS antibodies, and thus the method of using the same.
Claim Rejections[Symbol font/0xBE]35 USC § 112 (b)
7. The following is a quotation of the second paragraph of 35 U.S.C. 112:
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.
8. Claims 1, 10-11, 18, 22-23, 30-31, 33, 37-38, and 40-41 are rejected under 35 U.S.C. 112(b) 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.
Claims 1 and 37 are indefinite for the following reasons:
(i). it recites the abbreviation “ICOS”. It is suggested that the full name for the abbreviation be provided in the first independent claim.
(ii). it recites “wherein the patient has a PD-L1 negative tumour or a tumour with low PD-L1 expression”. Neither the art nor the specification provides an unambiguous definition for “a tumour with low PD-L1 expression”. It is unclear what type of tumor is, rendering the claims indefinite.
Claims 10-11, 18, 22-23, 30-31, 33, 38, and 40-41 are rejected as dependent claims from claim 1 or claim 37.
Claim Objection
9. Claim 37 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Conclusion
10. No claims are allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ruixiang Li whose telephone number is (571) 272-0875. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa Ford, can be reached on (571) 272-0857. The fax number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/RUIXIANG LI/Primary Examiner, Art Unit 1674
September 21, 2026
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