DETAILED ACTION
Notice of Pre-AIA or AIA Status
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. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 23, 2026, has been entered.
Claim Disposition
3. Claims 7-8 have been cancelled. Claims 1-6 and 9-17 are pending and are under examination.
Claim Objection
4. Claims 1-6 and 9-17 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “ …wherein the Gal3C comprises [[a]] the amino acid sequence set forth in SEQ ID NO: 11, or an amino sequence that is at least 98%......”. The dependent claims hereto are also included. See also claim 15 with similar language.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
5. Claims 1-6 and 9-17 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) contain 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed invention is directed to: an agent (any) for treating cancer (any) in a subject (any), the agent comprising Gal3C that comprises at least one substituted cysteine residue in place of a solvent accessible residue, wherein the Gal3C is conjugated to a polymer (any); a method for treating a subject with cancer by administering a therapeutically effective amount of a composition comprising the agent and method of improving pharmacokinetics or thermal stability of a protein drug compound (see claims 1, 10 and 15). The claimed invention encompasses a large variable genus not adequately described because of the broad recitation of “an agent”, “ at least one substituted cysteine in ‘a sequence of SEQ ID NO: 11’. In addition, a method of treating any cancer; and any protein drug in claim 15. The claimed invention is overly broad and encompasses homologues, variants and derivatives beyond the recited position T243C with the recitation of “a sequence’. The claimed invention is not adequately described because there are no indicia as to what specific cancer, what subject, what polymer and what agent (see claim 1 and 15).
The claimed invention is not commensurate in scope with the disclosure in the specification. The claimed invention does not inform an ordinary skilled worker of the metes and bounds of the claims. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997). Thus, applicant has not demonstrated possession of the invention as claimed. Furthermore, the 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of structures, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Accordingly, the claimed invention is determined as lacking adequate written description because applicant has not demonstrated possession of the entire genus encompassed in the claims.
Response to Arguments
6. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejection of record under 112 first paragraph remains and some objections based on amendments made to the claims.
Regarding the objections note that amendments made to the claims instituted some for the reasons stated above. Applicant traverses the rejection under 112, first paragraph by stating that claims 1 and 15 have been amended and that there is adequate written description. This argument is not persuasive as the structure and function is not settled in the claims. There is no indication as to the agent and the agent is broadly recited and not described. Furthermore the structure of components of the agent still encompasses a large variable genus that is not adequately described as set forth above and that applicant did not demonstrate possession of the entire genus or a representative number of species. Thus for these reasons the rejection of record remains, albeit altered to reflect changes made to the claims.
Conclusion
7. No claims are presently allowable, however, the substitution of T243C is free of the art in SEQ ID NO: 11.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
