DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-19 and 23-25 are pending upon entry of amendment filed on 4/28/26.
Applicant’s election of group I, claims 1-10 and 15 without traverse in the reply filed on 4/28/26 has been acknowledged.
Accordingly, claims 11-14, 16-18 and 23-25 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 1-10 and 15 are under consideration in the instant application.
3. Applicant’s IDS filed on 1/19/25 and 4/28/26 have been acknowledged.
4. The oaths filed on 5/23/25 have been acknowledged.
5. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
6. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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.
7. Claims 1-10 and 15 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for an antibody that binds to Guanylyl cyclase C (GCC) having CDRs set forth in SEQ ID NO:9-19 and VH set forth in SEQ ID NO:1, 20-21 and 26-28, does not reasonably provide enablement for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use of the invention commensurate in scope with these claims.
The specification does not enable one of skill in the art to practice the invention as claimed without undue experimentation. Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
There is insufficient guidance in the specification as filed as to how the skilled artisan would make and use GCC binding agent other than single domain antibody, VH or antibody related structures. The binding agent comprises any chemically or physically unrelated structures to the GCC.
Examples 1-3 showed single domain antibody that binds GCC or design of chimeric antigen receptors to GCC. No examples disclose any other binders encompassed by the claimed invention other than antibody related structures as in claim 6 in part. Further, the claims comprise less than 90-95% of the binding agent sequences set forth in SEQ ID NO:1,20-21,26-28. Minor structural differences among structurally related compounds or compositions can result in substantially different or deleterious biological activities. As is evidenced in the instant application, no guidance is present where to make various additions, substitutions or deletions without changing the range of activities of the binding agent to GCC. Ngo et al teach that the amino acid positions within the polypeptide/protein that can tolerate change such as conservative substitution or no substitution, addition or deletion which are critical to maintain the protein’s structure will require guidance (see Ngo et al., 1994, The Protein Folding Problem and Tertiary Structure Prediction, pp. 492-495 in particular).
In re Fisher, 166 USPQ 18 indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Since the amino acid sequence of a polypeptide determined its structural property, predictability of which amino acid fragment can retain the functional capabilities of the GCC binding agent less than 100% of the binding agent requires knowledge of, and guidance with regard to, which segments in the polypeptide’s sequence contribute to its function.
Therefore, there is insufficient direction as to how to make and to use any binding agent other than antibody of less than 100% of SEQ ID NO:1, 20-21 and 26-28 and its functional equivalent molecules which can be used as to whether such a desired effect can be achieved or predicted, as encompassed by the claims.
In view of the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
8. Claims 1-10 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, there is insufficient written description to demonstrate that Applicant was in possession of the claimed genus of compositions comprising low molecular weight find-me molecules and tolerance promoting immune modulators.
The guidelines of the Examination of Patent Applications Under the 35 U.S.C. 112, §1 “Written Description” Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of 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 genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see specially page 1106 column 3).
The instant claims are drawn to a huge genus of structurally distinct binding agent molecules. This would encompass any structures that function in any part of binding to any portion of GCC. Thus, claims would encompass structurally unrelated binding molecules including small molecules, nucleic acids, antibodies, peptides, lipids and more. There is no art recognized correlation between structure and function of such classes of the molecules exhibiting the claimed specific functions. For example, the specification discloses chimeric antigen receptor or single domain antibody may work as binding agent for GCC (note p. 80 of the specification). The instant specification does not disclose a correlation between structures and function of structurally distinct binding agents. Further, the disclosed species are not sufficiently representative of the huge genus encompassed by the present claims. Thus, one of skilled in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus of the claimed pharmaceutical compositions. See Eli Lilly, 119 F, 3d 1559, 43, USPQ2d, 1398.
The guidelines of the Examination of Patent Applications Under the 35 U.S.C. 112, §1 “Written Description” Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of 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 genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see specially page 1106 column 3, MPEP2163).
The instant specification does not disclose a correlation between structure defined by “90% sequence identity” to the antibody set forth in SEQ ID NO:1, 20, 21 and 26-28. Further, the disclosed species are not sufficiently representative of the huge genus encompassed by the present claims. Thus, one of skilled in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus of the claimed pharmaceutical compositions. See Eli Lilly, 119 F, 3d 1559, 43, USPQ2d, 1398.
9. No claims are allowable.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
June 10, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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