DETAILED ACTION
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 .
Response to Amendment
The 2026 February 3 RCE amendment is acknowledged and considered. Newly amended claims 1, 3, 5-12, 14, 16-20, 22, 27, and 30-53 are pending. The claim objections of 2025 November 3 are overcome because claim 30 now has legible images. The 35 U.S.C. 112 (a) and (b) rejections are overcome for the following reasons: the new matter is no longer present for variables Z and T; the claims now recite how a physiologically active substance binds to a biotin compound of [general formula a]; the term “respective derivative” is no longer recited in the examined claims; and the relationship between trioxa-containing group and PEG is now clear. Claim 30 now recites compounds with at least two biotin parts. The 35 U.S.C. 102(a) rejection under WILBUR (US 7141676, issued 2006 November 20) is no longer prior art because variable X cannot be an isothiocyanate group.
Claims 1, 3, 30, 31, and 32 contain allowable subject matter with regard to a compound of [general formula a]. The restriction requirement among groups I-III, as set forth in the Office action mailed on 2024 December 12, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 2024 December 12 is partially withdrawn. Claims 5-12, 14, 16-20, 22, 27, and 33, directed to subject matter of the claimed invention are no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim. However, claims 34-53, directed to non-elected subject remain withdrawn from consideration because they do not require all the limitations of the allowable claims. Consequently, claims 1, 3, 5-12, 14, 16-20, 22, 27, and 30-33 are examined on the merits.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 34-53 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2024 December 12.
Claim Objections
Claim 7 recites the term “exending-4”. YAP (Basic & Clinical Pharmacology & Toxicology, 2019, 513-527) describes the exendin-4 can treat type II diabetes mellitus (abstract). In claim 7, should the term “exending-4” be written as --exendin-4--?
Claim 32 recites instructions for administering a physiologically active substance. These instructions do not carry patentable weight according to the following teaching.
With regards to the ‘label’ and ‘instructions’, The MPEP states, “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed.). See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983)("Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability …. [T ]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate.").” (MPEP § 2112.01).
This objection is maintained because the written instructions do not distinguish the invention from prior art. If the art taught a kit of claim 32, the instructions would not be considered when evaluating the prior art.
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, 14, 16-20, 22, 27, and 30-33 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of written description.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claims 1, 14, 16-20, 22, 27, and 30-33 are drawn to a physiologically active substance bound to a biotin moiety of [general formula A].
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Level of skill and knowledge in the art:
WILBUR (US 7141676, issued 2006 November 20) describes compound 83, a conjugate that can bind to streptavidin (column 126; column 35, lines 10-58).
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(2) Partial structure:
The specified claims do not provide any structural metes and bounds to a physiologically active agent. The only guidance provided is that the substance is physiologically active, a functional characteristic.
(3) Physical and/or chemical properties and (4) Functional characteristics:
Examined claims 3 and 5-12 recites different chemical properties of a physiologically active agent. Examined claim 3 limits the physiologically active agent to a polypeptide, protein, or polysaccharide. Examined claim 5 states the physiologically active agent has an exposed NH3+ or NH2 group. Examined claim 6 states the physiologically active agent has an N-terminal bound to a biotin group. Examined claim 7 recites various agents or classes of agents. Examined claims 8-12 recite polypeptide sequences which are physiologically active.
(5) Method of making the claimed invention:
Embodiments 1-9 describe how a complex is formed (specification, page 31, line 4 to page 33, last line).
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claim(s) , 14, 16-20, 22, 27, and 30-33 is/are broad and generic, with respect to all possible compounds encompassed by the claims. The possible structural variations are limitless to any physiologically active substance that can bind to a biotin moiety of [general formula a]. Although the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond those compounds specifically disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus. While having written description of a physiologically active substance recited in the specified claims and compounds identified in the specification tables and/or examples, the specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
The description requirement of the patent statue 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 rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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 applicant regards as his invention.
Claims 1, 3, 5-12, 14, 16-20, 22, 27, and 30-33 is / 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.
Claims 1, 7, 14, 16-20, 22, 27, and 30-33 is / are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01.
The omitted elements are: the structural elements of a physiologically active substance and method in which heparin is modified to be considered a heparin analogue.
Claims 1, 14, 16-20, 22, 27, and 30-33 only define the substance functionally, physiologically active. Without structural metes and bounds, the structural requirements of a physiologically active substance are unclear.
Claim 7 fails to define how heparin is modified to be considered a heparin analogue. THOMAS (British Journal of Hematology, 1984, 58, 385-390) describes multiple heparin analogues SSHA and pentosan polysulphate (page 387, paragraph 2 to page 388, paragraph 3). The examined specification does not define the metes and bounds of a heparin analogue. Do the intended claims encompass heparin derivatives SSHA and pentosan polysulphate?
Claims 3 and 5-12 recites various embodiments of a physiologically active substance. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not recite the structural metes and bounds of a physiologically active substance.
Conclusion
Claims 1, 3, 5-12, 14, 16-20, 22, 27, and 30-33 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: WILBUR (US 7141676, issued 2006 November 20) describes compound 83, a conjugate that can bind to streptavidin (column 126; column 35, lines 10-58). This compound does not anticipate or render obvious a compound of amended [general formula a] because variable X cannot be an isothiocyanate group.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 9:00 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
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