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 .
Claim 43 has been canceled. Claims 24-27, 36, 38, 40 and 44 have been amended.
Claims 24-42 and 44-48 are pending.
Acknowledgement is made of applicant’s election without traverse of the species of formula II in claim 24. Claims 24-42 and 44-48 encompass the elected species.
The requirement for a new sequence listing is withdrawn in light of applicant’s amendments deleting reference to the enumerated sequence.
The rejection of claims 24-27 and 38 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendments.
The ejection of claims 40 and 44 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of applicant’s amendment canceling “prevention”
The rejection of claims 24-42 and 44 under 35 U.S.C. 103 as being obvious over Gallo et al (WO2019/057964) in view of Zhao et al (WO2019/127607) is withdrawn in light of applicant’s statement of common ownership.
New Grounds of Rejection.
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 24, 25 and 36 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 24, 25 and 36 contains the trademark/trade names DARPin and adnectin. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe products and, accordingly, the identification/description is indefinite.
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.
Claims 24-42 and 44-48 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.
Section 2163 of the M.P.E.P. states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical 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 claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a “representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention.
Applicant has reduced to practice the amanita toxin drug linkers 71, 145, 111, 152, 153, 166, 195, 196, 213, 214, 215, 239, S-1 and S-2. It is noted that in all the examples, with the exception of “71” the core structure is identical, the diffeernc being in the linkr structures. Claim 71 differs from 145, 111, 152, 153, 166, 195, 196, 213, 214, 215, 239, S-1 and S-2 in having an R5 of OH rather than NH2 and a X of S rather than SO. However, the core strcutres claimed are highly variant encompassing R.sub.1 and R.sub.2 are independently selected from H, OH, CH.sub.2OH, CH(OH)CH.sub.2OH, CH(CH.sub.3)CH.sub.2OH, CH(OH)CH.sub.3, C.sub.1-C.sub.8 alkyl, —OR.sub.12 (ether), C.sub.2-C.sub.8 alkenyl, alkynyl, heteroalkyl, —OCOR.sub.12 (ester), —OC(═O)OR.sub.12 (carbonate), —OC(═O)NHR.sub.12(carbamate); C.sub.3-C.sub.8 aryl, heterocyclic, carbocyclic, cycloalkyl, heterocycloalkyl, heteroaralkyl, alkylcarbonyl; R.sub.3 and R.sub.4 are independently selected from H, OH, —OR.sub.12 (ether), —OCOR.sub.12 (ester), —OCOCH.sub.3 (acetate), —OCOOR.sub.12 (carbonate), —OC(═O)NHR.sub.12(carbamate), —OP(O)(OR.sub.12)(OR.sub.12′) (phosphate), OP(O)(NHR.sub.12)(NHR.sub.12′) (phosphamide), O—SO.sub.3.sup.−, or O-glycoside; R.sub.5 is selected from H, OH, NH.sub.2, NHOH, NHNH.sub.2, —OR.sub.12, —NHR.sub.12, NHNHR.sub.12, —NR.sub.12R.sub.12′, or N(H)(R.sub.12)R.sub.13CO(Aa).sub.p, (an amino acid or peptide), wherein Aa is an amino acid or a polypeptide, p represents 0-6; R.sub.6 is selected from H, OH, CH.sub.2OH, CH(OH)CH.sub.2OH, CH(CH.sub.2OH).sub.2, CH(CH.sub.3)OH, CH.sub.2CH.sub.2OH, PrOH, BuOH, C.sub.1-C.sub.8 alkyl, —OR.sub.12 (ether), C.sub.2-C.sub.8 alkenyl, alkynyl, heteroalkyl, —OCOR.sub.12 (ester); C.sub.3-C.sub.8 aryl, heterocyclic, or carbocyclic; R.sub.7, R.sub.8 and R.sub.9 are independently selected from H, OH, CH.sub.3, CH(CH.sub.3).sub.2, CH (CH.sub.3)CH.sub.2CH.sub.3, CH.sub.2OH, CH(OH)CH.sub.2OH, CH.sub.2CH(OH)CH.sub.2OH, CH(CH.sub.2OH).sub.2, CH.sub.2C(OH)(CH.sub.2OH).sub.2, CH.sub.2C(OH)(CH.sub.3)(CH.sub.2OH), CH.sub.2C(OH)(CH(CH.sub.3).sub.2)(CH.sub.2OH), CH.sub.2CH.sub.2OH, PrOH, BuOH, CH.sub.2COOH, CH.sub.2CH.sub.2COOH, CH(OH)COOH, CH.sub.2CONH.sub.2, CH.sub.2CH.sub.2CONH.sub.2, CH.sub.2CH.sub.2CH.sub.2CH.sub.2NH.sub.2, CH.sub.2CH.sub.2CH.sub.2NHC(═NH)NH.sub.2, C.sub.1-C.sub.8 alkyl, CH.sub.2Ar, CH.sub.2SH, CH.sub.2SR.sub.12, CH.sub.2SSR.sub.12, CH.sub.2SSAr, CH.sub.2CH.sub.2SCH.sub.3, —OR.sub.12(ether), C.sub.2-C.sub.8 alkenyl, alkynyl, heteroalkyl, —OCOR.sub.12 (ester); C.sub.3-C.sub.8 aryl, heterocyclic, or carbocyclic and wherein “X” is S, O, NH, SO, SO2 or CH2. Further, the linker structures represented in 71, 145, 111, 152, 153, 166, 195, 196, 213, 214, 215, 239, S-1 and S-2 do not describe thwr genus of linker structures encompassed by the claims wherein L.sub.1 and L.sub.2 are, the same or different, and are independently selected from O, NH, N, S, P, NNH, NHNH, N(R.sub.3), N(R.sub.12), N(R.sub.12)N(R.sub.12), CH, CO, C(O)NH, C(O)O, NHC(O)NH, NHC(O)O, a polyethyleneoxy unit of formula (OCH.sub.2CH.sub.2).sub.pOR.sub.12, (OCH.sub.2CH—(CH.sub.3)).sub.pOR.sub.12, NH(CH.sub.2CH.sub.2O).sub.pR.sub.12, NH(CH.sub.2CH(CH.sub.3)O).sub.pR.sub.12, N[(CH.sub.2CH.sub.2O).sub.pR.sub.12]—[(CH.sub.2CH.sub.2O).sub.pR.sub.12], (OCH.sub.2CH.sub.2).sub.pCOOR.sub.12, or CH.sub.2CH.sub.2(OCH.sub.2CH.sub.2).sub.pCOOR.sub.12, wherein p and p′ are independently an integer selected from 0 to about 1000, or a combination of two or more of above; C.sub.1-C.sub.8 alkyl; C.sub.2-C.sub.8 heteroalkyl, alkylcycloalkyl, heterocycloalkyl; C.sub.3-C.sub.8 aryl, Ar-alkyl, heterocyclic, carbocyclic, cycloalkyl, heteroalkylcycloalkyl, alkylcarbonyl, heteroaryl; or (Aa).sub.r, r=1-12 (one to 12 amino acid units), which is composed from natural or un-natural amino acids, or a same or different sequence of dipeptide, tripeptide, tetrapeptide, pentapeptide, hexapeptide, heptapeptide, octapeptide, nonapeptide, decapeptide, undecapeptide or dodecapeptide unit, or formula I-q1, wherein Q.sub.1, Q.sub.2, L.sub.1, L.sub.2, V.sub.1, or V.sub.2, can be independently absent but Q.sub.1 and Q.sub.2 are not absent at the same time; V.sub.1 and V.sub.2 are independently a spacer unit selected from O, NH, S, C.sub.1-C.sub.8 alkyl, C.sub.2-C.sub.8 heteroalkyl, alkenyl, alkynyl, C.sub.3-C.sub.8 aryl, heterocyclic, carbocyclic, cycloalkyl, alkylcycloalkyl, heterocycloalkyl, heteroaralkyl, heteroalkylcycloalkyl, or alkylcarbonyl, or (Aa).sub.r, r=1-12 (one to 12 amino acid units), which is composed from a natural or unnatural amino acid, or a same or different sequence of dipeptide, tripeptide, tetrapeptide, pentapeptide, hexapeptide, heptapeptide, octapeptide, nonapeptide, decapeptide, undecapeptide or dodecapeptide unit; or (CH.sub.2CH.sub.2O).sub.p, p is 0-1000; v.sub.1 and v.sub.2 are independently 0, 1 or 2, but v.sub.1 and v.sub.2 are not 0 at the same time; n is 1 to 30.
Written description issues may arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process (Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species; MPEP 2162.1(A)).
Further, the criteria for a “representative number of species” to be described requires that the species which are reduced to practice are representative of the entire genus. The description of the conjugates reduced to practice with only a limited number of moieties of “R” groups attached to the core structure are not representative of the compounds required in the instant claimed conjugates and thus, it cannot be concluded that the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.").
Regarding the description of the genus by partial structure combined with a specific function, the specification fails to provide such a correlation. It would be expected that the plethora of different linkers having different formats attached to different parts of the amanita molecule would provide conjugates with different properties the drug being delivered with different kinetics under different microenvironmental conditions. It would also be expected that the released linkers would not in all cases provide the free drug (Casi and Neri, Journal of Controlled Release, 2012, Vol. 161, pp. 422-428, see Table 2). Thus, the resulting drug would be modified by the residue of the linker which can affect the toxicity of the drug.
The compounds described in the specification do not provide a description of
(i) all the compounds having the numerous linkers that could be generated from all the variables recited in the instant claims pertaining to the linkers,
(i) all the modifications of the amanita toxin core encompassed by the instant claims, and
(iii) the amanita toxin -linker structures attached to the large genus of cell-binding agents, T.
Thus, the specification fails to provide adequate written description for the genus of compounds claimed and does not reasonably convey to one of skill in the art that he inventors, at the time the application was filed, had possession of the genus of conjugates, methods of making said conjugates and pharmaceutical composition comprising said conjugates.
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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