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, 11, 13, 16, 18, 19, 21, 25, 28, 29, 33, 36, 43, 46, 48-51, 56, 57, 64, 74 and 75 are pending upon entry of amendment filed on 6/16/26.
Claims 1, 11, 13, 16, 18, 19, 21, 25, 28, 29, 33, 36, 43, 46, 48-51, 56, 57, 64, 74 and 75 are under consideration in the instant application.
3. Applicant’s IDS filed on 6/16/26 has been acknowledged.
4. In light of Applicant’s amendment to the claims filed on 6/16/26, the rejections under 35 U.S.C.101, 112(b) and 102(a)(1) and (2)(note see sections 6-8 and 12-14 of the office action mailed on 3/30/26) have been withdrawn.
5. The following rejections remain.
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, 11, 13, 16, 18, 19, 21, 25, 28, 29, 33, 36, 43, 46, 48-51, 56, 57, 64 and 74-75 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a protein-drug conjugate set forth in SEQ ID NO: 59-71, 106-129, 148 or 149 and method of preparing or analyzing of protein-drug conjugate, 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.
The specification of the instant application does not describe how to make and use the protein-drug conjugate as in SEQ ID NO:59-71, 106-129, 148 or 149. Although instant application describes how to make and analyze PR00020, PR000184, PR000759, PR01046, PR004432, PR004433, PR002129, PR000453, PR006345 as in tables in p. 65-66, in lack of specific conjugate moiety, the specification does not provide sufficient guidance for any unspecified antigen binding fragments, linkers and the linkers comprise Cys1 and/or Cys2 as specified in claims, 1, 7 and 9 reciting linkers derived from antibody hinge regions.
Moreover, there is insufficient guidance in the specification as filed as to how the skilled artisan would use protein-drug conjugate in treatment or prevention of cancer. The examples of instant specification disclose coupling, reduction and analysis of but the specification fails to disclose any treatment regimen required by the claims 65 and 69.
Although examples 1-13 showed coupling and analysis of various hinge regions of protein-drug conjugates, the specification fails to disclose prevention, treatment of cancer using the protein-drug conjugates. Tumor antigens are recited in claim 19 but claims 65 or 69 that is being depended on claim 1 does not recite any structurally specified tumor antigens or the specification of the instant application fails to disclose any protein-drug conjugate used in cancer treatment and prevention. As seen in WO2017/201449, the PROTAC antibodies may associated with cytotoxic activities and prepare cysteine engineered antibody, no effective cancer treatment or regimen is suggested for the cancer recited in claim 65 and 69 (see entire document).
The specification fails to provide sufficient guidance to direct a person of skilled in the art to make and achieve the intended use of the claimed invention without undue experimentation. It is unpredictable to develop antibody formulation and one exemplary formulation disclosed in the example cannot be extrapolated to various formulations encompassed by the claimed invention.
To summarize, reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view or the quantity of experimentation necessary, the limited working example, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breath of the claims, it would take undue trials and errors to practice the claimed invention.
Applicant’s responses filed on 3/30/26 and 4/30/26 have been fully considered but they were not persuasive.
Applicant has asserted that the claims are enable to the full scope of the claimed invention as the currently amended claims obviates the rejection of record. Further, the Table listed in the p. 12 of the response showed verified exemplary molecules.
Unlike Applicant’s assertion, the verified molecules in the response table is already specified as enabled embodiments and the currently amended limitations remain recite genus of linkers other than SEQ ID NO:73-105 and 145-147. Applicant is advised to limit linkers to the specific cysteine linkers with SEQ ID Nos and limit conjugates to SEQ ID NOs 59-71, 106-129, 148 or 149.
8. Claims 1, 11, 13, 16, 18, 19, 21, 25, 28, 29, 33, 36, 43, 46, 48-51, 56, 57, 64 and 74-75 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 any protein-drug conjugates with unspecified antigen binding fragments, linkers and the linkers comprise Cys1 and/or Cys2 as specified in claims, 1, 7 and 9 reciting linkers derived from antibody hinge regions.
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 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).
In The Reagents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412) 19 F.3d 1559, the court held that disclosure of a single member of a genus (rat insulin) did not provide adequate written support for the claimed genus (all mammalian insulins). In this same case, the court also noted: A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. See Fiers, 984F. 2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). It is only a definition of a useful result rather than a definition of what achieves that result. Many such genes may achieve that result. The description requirement of the patent statue requires a description of an invention, not an indication of a result that 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 outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”). Accordingly, naming the type of material generally known to exist, in the absence of knowledge as to what that material consist of, is not a description of that material”.
The court has further stated that “Adequate written description requires a precise definition such as by structure, formula, chemical name or physical properties, not a mere wish or plan for obtaining the claimed chemical invention”. Id. At 1566, 43 USPQ2d at 1404 (quoting at 1171, 25 USPQ2d at 1606). Also see (CAFC2002). Enzo-Biochem v. Gen-Probe Fiers, 984 F.2d 01-1230.
The instant claims are drawn to huge genus of any protein-drug conjugates with unspecified antigen binding fragments, linkers and the linkers comprise Cys1 and/or Cys2 as specified in claims, 1, 7 and 9 reciting linkers derived from antibody hinge. Although instant application describes how to make and analyze SEQ ID NO:59-71, 106-129, 148 or 149 as in PR00020, PR000184, PR000759, PR01046, PR004432, PR004433, PR002129, PR000453, PR006345 of tables in p. 65-66, no other conjugate is no described. This would encompass any structurally unrelated drug substance 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 and modulators exhibiting the claimed specific functions. The instant specification does not disclose a correlation between structure of the drug substances and protein drug conjugates with unspecified antigen binding fragments, linkers and the linkers comprise Cys1 and/or Cys2 with the various functions claimed. 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 protein drug conjugates. See Eli Lilly, 119 F, 3d 1559, 43, USPQ2d, 1398.
Applicant’s responses filed on 3/30/26 and 4/30/26 have been fully considered but they were not persuasive.
Applicant has asserted that the claims are enable to the full scope of the claimed invention as the currently amended claims obviates the rejection of record. Further, the Table listed in the p. 12 of the response showed verified exemplary molecules.
In light of discussion above in section 7 of this office action, the rejection is maintained.
9. No claims are allowable.
10. THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
11. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
June 22, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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