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 Election /Restrictions Applicant's election with traverse of Group I in the reply filed on 2/3/2026 is acknowledged. The traversal is on the ground(s) that there would be no undue examination and search burden for searching the biologically active material conjugate of claim 1, and a pharmaceutical composition comprising the same. This is found persuasive. Therefore, the restriction requirement has been withdrawn. Applicant’s election without traverse of SEQ ID NO: 20 (physiologically active substance), the structure B38 (biotin moiety), and the structure F11 ( fatty acid moiety) in the reply filed on 2/3/2026 is acknowledged. Applicants elected species (i.e. SEQ ID NO: 20 linked to B38 and F11) was deemed to be free of the prior art. In accordance with Markush Practice, the search was extended to the Markush group/independent claim, and a reference was discovered that anticipated it. As a result, claims 1-3, 5-7, 10-12, 14, 18 and 22-23 have been examined and claims 4, 8-9, 13, 15-17 and 19-20 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time. This is proper, as MPEP 803.02 states that, in these circumstances, the prior art search, however, will not be extended unnecessarily to cover all nonelected species ( MPEP 803.02 ) . Status of the Claims Claims 1-23 are pending in this application. Claim s 4, 8-9, 13, 15-17 and 19-20 are withdrawn from consideration as being drawn to a non-elected species. Claims 1-3, 5-7, 10-12, 14, 18 and 22-23 are presently under consideration as being drawn to the elected species. Claim Objections Claim s 1-2, 5 , 10-12, 14, 18 and 22-23 are objected to because of the following informalities: The claims should be amended as follows: Claim 1 . “A biologically active material conjugate wherein comprising a biotin moiety, a fatty acid moiety or a combination thereof is bonded to a biologically active material”. Claim 2 . “ ….the group consisting of: glucagon (Glucagon) , GLP-1…”. Claim 5 . “ .. ..wherein the biotin moiety is represented by General Formula A : General Formula A ….. where in General Formula A wherein , X is…” . Claim 10. “The biologically active material conjugate of claim 5, wherein the Z is any one of the … ……selected from the group composed consisting of…” ”. Claim 11. “…wherein the T is selected from the group composed consisting of…”. Claims 12 and 14. “The biologically active material conjugate of Claim claim 1…” Claim 18. “The biologically active material conjugate of Claim claim 14, wherein the Y’ is a direct bond…”. Claims 22-23. “…the biologically active material conjugate of Claim claim 2”. 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. Claim s 1-3, 5-7, 10-12, 14, 18 and 22-23 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 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 claims are drawn to a biologically active material conjugate wherein a biotin moiety, a fatty acid moiety or a combination thereof is bonded to a biologically active material . When referring to the biologically active material , the specification only provides a generic statement of various biologically active material s, without more, which is not an adequate written description of the genus because there is no distinguishing feature except for function. That is, the generic statement does not adequately define the species that fall within the definition since there is no structural feature commonly possessed by the member of the genus that distinguishes them from others. Accordingly , one of ordinary skill in the art cannot readily visualize or recognize the identity of the members of the genus. A genus can be described by means of reciting a representative number of species that fall within the scope of the genus or of a structural feature, which constitutes a substantial portion of the genus, that are common to the members of the genus. The specification does not provide any other structural attributes associated with the biologically active material . With respect to claim s 2 -3 , the specification does not provide any structural attributes associated with the claimed “derivatives thereof”. Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).” Based on the teachings of the specification, the biologically active material can be any agent that results in some biological response. However, the specification fails to provide a representative number of examples for such agents. The specification provides only few specific examples of biologically active material s (listed in claim 2) . This disclosure of a handful of biologically active material s does not constitute a representative number of examples for the broad genus since one of ordinary skill in the art cannot readily visualize or recognize the identity of the members of the genus. The working examples also fail to provide any insight into the broad generic since the working examples are limited to a handful of biologically active material s. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Therefore, since the specification fails to adequately describe a structural feature common to the genus of biologically active material s, and does not provide a reasonable number of examples that would reasonably convey to one of ordinary skill in the art the members of the genus, the claimed invention lacks written description. The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 2 -3 , 6 , 10 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. With respect to claim 2, the phrase s “glycolipids acting as therapeutic agents” and “derivatives thereof” are unclear. One of ordinary skill in the art would not know the compounds encompassed by said phrase s . Similarly, with respect to claims 2 -3 , 6 and 10 , the phrase “derivatives thereof” is unclear. With respect to claim 18, the variable Y is not defined. If Applicants intended to claim Y’ instead , the claim should be amended to recite so. 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- 3 , 14, 18 and 22-23 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Mogensen et al. (US 2003/0199451) . With respect to claims 1-2, Mogensen et al. teach a pharmaceutical composition comprising a glucagon like peptide-1 (GLP-1) derivative and a dual Peroxisome Proliferator-Activated Receptor- a /Peroxisome Proliferator - Activated , Receptor- g (PPAR- a /PPAR- g ) activator , wherein the GLP-1 derivative comprises a sequence wherein at least one amino acid residue of the sequence has a lipophilic substituent attached (claim s 51 -52 ). With respect to claim 3, the GLP-1 derivative of Mogensen et al. is considered a derivative of any one of instant SEQ ID NOs: 1-14 and 18-42. With respect to claim 14, Mogensen et al. teach that the e -amino group of Lys at position 26 is substituted with a lipophilic substituent optionally via a spacer (claim 59). Furthermore, it has been held that the recitation that an element is "capable of" performing a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison , 69 USPQ 138. In the instant case, the GLP-1 derivative of Mogensen et al. comprises the claimed formula X’-Y’-W, wherein X’ is the functional group linked to GLP-1, Y’ is a spacer, and W is a fatty acid. With respect to claim 1 8 , Mogensen et al. teach that the spacer is g - aminobutanoyl (i.e. an amino acid other than Cys ) (claim 59). With respect to claim 22 , it is noted that “[d] uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation “ for preventing or treating ….. " do es not appear to add any further structural differences that would distinguish the instant invention with regards to the invention of Mogensen et al. Thus, Mogensen et al. is deemed to anticipate th is claim. Furthermore, Mogensen et al. teach a method of treating or preventing metabolic syndrome, diabetes and/or obesity, comprising administering to a patient in need of such treatment a therapeutically effective amount of the pharmaceutical composition (claim 69). With respect to claim 23, Mogensen et al. teach that the pharmaceutical composition is for oral administration (claim 70). Claims 1- 3 , 5-7, 10-12 and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lau et al. (KR20100109896A ) . With respect to claims 1-2 , Lau et al. teach a conjugate comprising biotin-maleimide (depicted below ; corresponding to the elected species ) conjugated to insulin ( claims 1-5 and 17-18; compound 1 on page 11 ). Lau et al. also teach that the targeting agent is biotin-poly( ethyleneglycol )amine (claim 9). With respect to claim 3, insulin is considered a derivative of any one of instant SEQ ID NOs: 1-14 and 18-42. With respect to claims 5-7 and 10-12 , the biotin-maleimide of Lau et al. corresponds to instantly claimed General Formula A, wherein X is maleimide, Y is a spacer (i.e. C 1 ) , n is 1, Z is unsubstituted linear C 4 heteroalkylene , p is 1, m is 1 , B is Chemical Formula A-1, and T is amine . With respect to claim 22 , it is noted that “[d] uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation “ for preventing or treating ….. " do es not appear to add any further structural differences that would distinguish the instant invention with regards to the invention of Lau et al. Thus, Lau et al. is deemed to anticipate this claim. Furthermore, Lau et al. teach treating diabetes ( see “How to treat the disease” ). With respect to claim 23, Lau et al. teach a formulation for oral administration comprising the conjugate ( see “Description” ). Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claims 1-3 and 22-23 rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-17 of U.S. Patent No. 12338270 . Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same biologically active material conjugate instantly claimed . With respect to claim 1, ‘270 teaches a polypeptide of General Formula 1 covalently bound to one or more compounds selected from the group consisting of a non-peptidic polymer, a fatty acid, cholesterol, an antibody, an antibody fragment, albumin and a fragment thereof, a nucleotide, fibronectin, transferrin, an FcRn -binding material, a saccharide, elastin, and heparin (claims 1 and 3). With respect to claim s 2 -3 , the polypeptide of General Formula 1 is considered a derivative of any one of the biologically active materials claimed. With respect to claim s 22-23 , ‘270 teaches a method of preparing a pharmaceutical composition (claim 10). Furthermore, it is noted that “[d] uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation s “ for preventing or treating ….. ” and “for oral administration” do not appear to add any further structural differences that would distinguish the instant invention with regards to the invention of ‘270 Thus, ‘270 is deemed to anticipate th ese claim s . Moreover, ‘270 teaches that the pharmaceutical composition is administered orally (column 12, lines 47-67; column 13, lines 19-27) for the treatment of obesity, diabetes, and non-alcoholic fatty live r disease (column 14, lines 34-44). Please note that i t is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970). Claims 1-3, 5-7, 10-12 and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1, 3, 5-12, 14, 16-20, 22, 27 and 30-53 of copending Application No. 17/615504 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same biologically active material conjugate instantly claimed. With respect to claim s 1 , 5-7 and 10- 11 , ‘504 teaches a physiologically active substance bonded to a biotin moiety of General Formula A, wherein X is selected from the group consisting of maleimide, succinimide, N- hydroxysuccinimide and aldehyde, and wherein Y is absent, or a spacer, Z is a bonding unit that together with X or separately from X forms an amino acid , B is represented by Chemical Formula A-1, and T is amine (claim 1). With respect to claim 2, ‘504 teaches the same biologically active materials instantly claimed (claim 7). With respect to claim 3, ‘504 teaches that the biologically active material is SEQ ID NO: 1 (which corresponds to instant SEQ ID NO: 1) (claim 11 ). With respect to claim 12, ‘504 teaches the same biotin moieties instantly claimed (claim 30). With respect to claim s 22-23 , it is noted that “[d] uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation s “ for preventing or treating ….. ” and “for oral administration” do not appear to add any further structural differences that would distinguish the instant invention with regards to the invention of ‘504 Thus, ‘504 is deemed to anticipate th ese claim s . Moreover, ‘504 teaches a pharmaceutical composition comprising the biologically active material conjugate administered orally ( paras [0010] -[ 0019] ). Please note that i t is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-3, 5-7, 10-12, 14, 18 and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-27 of copending Application No. 18/039184 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same biologically active material conjugate instantly claimed. With respect to claims 1-3, 5-7, 10-12, 14, 18 and 23 , 184 teaches the same formulation for oral administration comprising a biologically active material conjugate as instantly claimed (claims 1-27). With respect to claim 22 , it is noted that “[d] uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation “ for preventing or treating ….. " do es not appear to add any further structural differences that would distinguish the instant invention with regards to the invention of ‘184. Thus, ‘184 is deemed to anticipate this claim. Furthermore, ‘184 teaches that the formulation may be used for the prevention or treatment of diabetes, obesity, fatty liver disease, irritable bowel syndrome, neurodegenerative disease, bone disease, osteoporosis, human growth hormone deficiency, anticancer or non-alcoholic fatty liver disease (para [0202]). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-3 and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-27 of copending Application No. 18/869214 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same biologically active material conjugate instantly claimed. With respect to claim 1, ‘214 teaches a triple agonist peptide or analog thereof comprising SEQ ID NO: 131 conjugated to biotin moieties or fatty acids (claims 1 and 4). With respect to claims 2-3, the triple agonist peptide or analog thereof of ‘214 is considered a derivative of any one of the biologically active materials claimed. With respect to claim 22 , it is noted that “[d] uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation “ for preventing or treating ….. " does not appear to add any further structural differences that would distinguish the instant invention with regards to the invention of ‘214. Thus, ‘ 21 4 is deemed to anticipate this claim. Furthermore, ‘ 214 teaches that the pharmaceutical formulation is administered to a subject suffering from non-alcoholic fatty liver disease ( claim 15 ). With respect to claim 23, ‘214 teaches that the pharmaceutical formulation is administered in a form selected from the group consisting of pills, capsules, tablets, liquids and suspensions (claim 21). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SERGIO COFFA whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3022 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F: 6AM-4PM . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT MELISSA FISHER can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-7430 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. FILLIN "Examiner Stamp" \* MERGEFORMAT /SERGIO COFFA Ph.D./ Primary Examiner Art Unit 1658 /SERGIO COFFA/ Primary Examiner, Art Unit 1658