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. The Amendment filed on February 24, 2026, has been received and 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, “ An agent comprising galectin 3C (Gal3C)…..…. place of a [[rationally-selected and/or]] solvent accessible……..residue, and wherein the Gal3C…SEQ ID NO: 11, or [[a variant thereof comprising]] a sequence that is at least 98% [[sequence identity therewith,]] to SEQ ID NO: 11 that comprises a ….”. The dependent claims hereto are also included. See also claim 15 with similar language.
For clarity and precision of claim language it is suggested that claim 10 is amended to read, “ A method of treating cancer in a subject, comprising:
administering a therapeutically ……”. The dependent claims hereto are also included.
For clarity it is suggested that claim 16 is amended to recite, “….wherein the conjugating…….and wherein the maleimide….”.
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 comprising Gal3C with at least one substituted cysteine residues and conjugated to a polymer; a method for treating a subject with cancer by administering a composition with the agent and method of improving pharmacokinetics or thermal stability of a protein drug. 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 rationally-selected place with a variant thereof and no recitation of an activity for said agent. 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. The claimed invention is not adequately described because there are no indicia as to what specific structure or activity is assigned to the protein (see claim 1).
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claim(s) 1 and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hudalla et al. (US Patent No. 11,603394, 23/30/17).
Hudalla et al. teach a composition for cancer treatment having an effective amount of N-terminally truncated galectin-3 or its homologue, in a pharmaceutically acceptable carrier. Also provided by the present invention is a method of treating disease by administering (intravenously) to a patient in need of such treatment an effective amount, such as cancer. Hudalla et al. discloses that provided are targeted effector fusion proteins, complexes thereof, and uses thereof. The targeted effector fusion proteins can include an effector protein that can be linked to a targeting moiety. Monomer targeted effector fusion proteins can form homogeneous or heterogeneous complexes. The targeted effector fusion proteins and complexes thereof can be formulated as pharmaceutical formulations. The targeted effector fusion proteins, complexes thereof, and formulations thereof can be administered to a subject in need thereof (see abstract and paragraphs 3, 92, 116 and 193).The full length structure of SEQ ID NO:11 is taught by the reference. Therefore, the limitations of the claims are met by the reference.
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.
7. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claim(s) 1-3, 9-11 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over John et al. (US20050032673, 2/10/05) in view of University of Florida (Hudalla et al., US Patent No. 11,603,394, 10/4/16).
John et al. teach a composition for anti-cancer or anti-inflammatory treatment having an effective amount of N-terminally truncated galectin-3 or its homologues, antibodies to galectin-3 carbohydrate binding sites, or a nucleic acid sequences encoding N-terminally truncated galectin-3 or its homologues, in a pharmaceutically acceptable carrier. Also provided by the present invention is a method of treating disease by administering (intravenously) to a patient in need of such treatment an effective amount of N-terminally truncated galectin-3, its homologues, antibody to galectin-3 carbohydrate binding sites, or a nucleic acid sequence encoding N-terminally truncated galectin-3 in a pharmaceutically acceptable carrier. Further, there is provided a disease treatment having an effective amount of N-terminally truncated galectin-3 or its homologues, antibodies to galectin-3 carbohydrate binding sites, or a nucleic acid sequences encoding N-terminally truncated galectin-3 or its homologues, in a pharmaceutically acceptable carrier (see abstract). John et al. at paragraph [0109], discloses a PEGylated N-terminally truncated galectin-3 or antibody that is administered, which is utilized in the composition of the present invention, is present in a sufficient amount to at least reduce tumor size. Alternatively, the composition can prevent or reduce metastasis of a tumor. The tumors being treated can include breast cancer, prostate cancer, colon cancer, lung cancer, and all additional solid and liquid forms of cancer.
The reference also discloses at paragraph [0110], that the compound of the present invention can be useful in preventing tumor growth. In such an example, by maintaining the titers of sustained release form or PEGlated N-terminally truncated galectin-3 or antibodies to galectin-3 saccharide in the body of an individual, the composition can prevent tumor growth by preventing tumors from forming in the first place. Further, the reference discloses mutations involving cysteine residues see paragraph [0111], “The present invention provides a method of treating cancer in a patient by administering to a patient in need of such treatment an effective amount of N-terminally truncated galectin-3 that has been derivatized with one or more molecules of polyethylene glycol (PEG). A second method of treating cancer in a patient is provided that includes administering to a patient an effective amount of N-terminally truncated galectin-3 to which there has been added one or more cysteine residues and that has been derivatized with PEG. A third method of treating cancer in a patient is provided that includes administering to a patient an effective amount of an antibody that binds to complex saccharide ligands of galectin-3. A fourth method of treating cancer in a patient is provided that includes administering to a patient an effective amount of N-terminally truncated galectin-3 that has been formulated for sustained release using methodologies that are well known to those skilled in the art.
John et al. discloses cancer treatment see paragraphs [0112 and 0188] below with the claimed composition.
[0112] The "effective amount" for purposes herein is thus determined by such considerations as are known in the art of cancer treatment…and, in a preferred embodiment, complete recovery of the patient without the presence of cancer cells.
[0188] Treatment with galectin-3C reduced the percentage of animals with metastases from 55% ({fraction (11/20)}) in the control group to 20% ({fraction (4/20)}) in the treated group, a decrease of 2.75-fold. None of the animals in the treated group with small tumors less than 1500 mm.sup.3 in size (0/15) had metastases, whereas 62.5% (5/8) of the control group that had tumors this size had metastases. Only one animal in the treated group had a tumor larger than 1500 mm.sup.3 that had not metastasized compared to 6 animals in the control group that had tumors of this size that had no metastases.
John et al. does not expressly teach the structure of SEQ ID NO:11, however, discloses Gal3C and mutations (the structure is simply another property of the known protein). In addition, John et al. renders obvious the claimed method to improve pharmacokinetics with the disclosure of improvements in cancer treatment with the composition. The secondary reference provides the structure of SEQ ID NO:11 reads on the variant thereof as claimed (see the below alignment and abstract).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because the combined teaching of the references renders the claimed invention as obvious (John et al. provides a medicament for cancer treatment that is stable or can be construed as improving pharmacokinetics). One of ordinary skill in the art would be motivated to combine the references because they are analogous art. Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Response to Arguments
9. 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 rejections of record under 112 first paragraph and art rejection remains and some objections based on amendments made to the claims.
Regarding the objections note that amendments made to the claims instituted some and others are maintained that were not addressed in remarks or via amendments. 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 indicia as to the activity of 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 dd 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. Note that the art rejection is maintained for reasons stated above and here. Applicant states that the claims have been amended to recite the point mutation of cysteine residue at position 243, however the claim is written in the alternative and the art discloses full length SEQ ID NO:11 thus not novel and obvious to combine as stated above.
Conclusion
10. No claims are presently allowable, however, the substitution of T243C is free of the art in SEQ ID NO: 11.
11. Applicant’s amendment necessitated the new/modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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