DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims Status
Claim 1 is pending in the application.
Claim Rejections - 35 USC § 112
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.
Claim 1 is 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. The instant claim 1 is confusing an unclear as the compound having the structure
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has specific bonding sites between the subunits p,q,r and s and therefore it is unknown how the subunits associated with elements p,q,r and s may be in any order. Therefore, the Markush structure contains many possible variations so that the metes and bounds of the claim can not be determined or identified.
Claim 1 is rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) the species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The claim is directed to a the compound having the structure
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wherein the subunits associated with elements p,q,r and s may be in any order. The compound encompasses many different chemical structures comprising a combination of chelators, fluorescent dyes, azide, alkynes, etc. with various linker moiety chains, triazole linkers, etc. Further, the subunits associated with elements p,q,r and s may be in any order and therefore, the number of structures are vast. There is nothing of record to show a common chemical core that is specifically tied to a function in the almost unlimited breadth of the claimed compounds.
It is duly noted that the compounds do not contain a common core but comprise a wide variety of
structures. Thus, there is no common core consistent with the claimed compounds since the claims embrace species from various different chemical classes.
Applicant attention is directed to the third paragraph of MPEP 803.02 which discloses:
“Since the decisions in In re Weber, 580 F.2d 455, 198 USPQ 328 (CCPA 1978) and In re Haas, 580 F.2d 461, 198 USPQ 334 (CCPA 1978), it is improper for the Office to refuse to examine that which Applicants regard as their invention, unless the subject matter in a claim lacks unity of invention. In re Harnisch, 631 F.2d 716, 206 USPQ 300 (CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int. 1984). Broadly, unity of invention exists where compounds included within a Markush group (1) share a common utility, and (2) share a substantial structural feature essential to that utility.”
In the instant case, if it is asserted that the claims share a common utility, it is noted the only shared structure is the DUPA moiety but it is bound to a plethora of different and distinct chemical moieties. In addition, the wide variety of structures formed by the combination of chelators, fluorescent dyes, azide, alkynes, etc. with various linker moiety chains, triazole linkers, etc. wherein the subunits associated with elements p,q,r and s may be in any order does not allow the genus to have an art recognized classification. Hence, the Markush grouping is improper.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 1 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Pomper et al. (US 2011/0064657A1).
Pomper et al. (US 2011/0064657A1) teaches of PSMA imaging and therapy agents (abstract), such as a.)
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(p11, [0225]) that anticipates the compounds of the instant claims when G is
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; Ch is a metal chelating moiety; V is -NRC(S)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is -CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH;
b.)
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(p12, [0225]) that
anticipates the compounds of the instant claims when G is
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; Ch is a metal chelating moiety; V is -C(O)-; p is 0; R2 is CO2H; -(CH2)n- wherein n is 4; R3 is H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH;
c.)
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(p12, [0225]) that anticipates the compounds of the instant claims when G is
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; Ch is a metal chelating moiety; V is -C(O)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH.
Claim(s) 1 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Pomper et al. (US 2015/0246144A1).
Pomper et al. (US 2015//0246144A1) teaches of PSMA imaging and therapy agents (abstract), such as a.)
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(p12, [0223]) that anticipates the compounds of the instant claims when G is
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; when G is
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; Ch is a metal chelating moiety; V is -NRC(S)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is -CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH;
b.)
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(p12, [0223]) that anticipates the compounds of the instant claims when G is
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; Ch is a metal chelating moiety; V is -C(O)-; p is 0; R2 is CO2H; -(CH2)n- wherein n is 4; R3 is H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH;
c.)
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(p12, [0223]) that anticipates the compounds of the instant claims when G is
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; Ch is a metal chelating moiety; V is -C(O)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,056,841B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compound of U.S. Patent No. 9,056,841B2 having a structure
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wherein Z is CO2H; R is H or C1-C4 alkyl; W is -NRC(O)-; Y is C(O); a is 1-4; m is 1-6; n is 1-6; q is 1; s is 1 and R3 is H, CO2H encompasses the compounds
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of the instant claims optionally chelated to a metal when G is
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; p is 0 and r is 0; Z is CO2H; R is H or C1-C4 alkyl; W is -NRC(O)-; Y is C(O); a is 1-4; m is 1-6; n is 1-6; q is 1; s is 1 and R3 is H, CO2H.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 9,694,091B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of U.S. Patent No. 9,694,091B2, such as a.)
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b.)
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c.)
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encompass the compounds of the instant claims
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optionally chelated to a metal when a.) G is
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; Ch is a metal chelating moiety; V is -NRC(S)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is -CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH; b.) when G is
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; Ch is a metal chelating moiety; V is -C(O)-; p is 0; R2 is CO2H; -(CH2)n- wherein n is 4; R3 is H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH and c.) when G is
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; Ch is a metal chelating moiety; V is -C(O)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH, respectively.
The method of imaging of U.S. Patent No. 9,694,091B2 can be used with the compounds of the instant claims.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9,776,977B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of U.S. Patent No. 9,776,977B2
having a structure
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, such as
a.)
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b.)
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that encompass the compounds of the instant claims
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optionally chelated to a metal when a.) G is
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; Ch is a metal chelating moiety; V is -C(O)-; p is 1; R1 is phenyl; R is H; R2 is H; -(CH2)n- wherein n is 4; R3 is H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH and b.) Ch is a metal chelating moiety; V is -NRC(S)-; p is 1; R1 is phenyl; R is H; R2 is H; -(CH2)n- wherein n is 4; R3 is -CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH, respectively.
The method of imaging of U.S. Patent No. 9,776,977B2 can be used with the compounds of the instant claims.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-13 of U.S. Patent No. 9,884,132B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compound
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of U.S. Patent No. 9,884,132B2 encompasses the compounds of the instant claims
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optionally chelated a metal when G is
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; Ch is a metal chelating moiety; V is -NRC(S)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH.
The method of imaging of U.S. Patent No. 9,884,132B2 can be used with the compounds of the instant claims.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,717,750B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compound
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of U.S. Patent No. 10,717,750B2 encompasses the compounds of the instant claims
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optionally chelated to a metal when G is
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; Ch is a metal chelating moiety; V is -NRC(S)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is -CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH.
The method of imaging of U.S. Patent No. 10,717,750B2 can be used with the compounds of the instant claims.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,021,450B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of U.S. Patent No. 11,021,450B2 having the structure
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, such as
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b.)
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encompass the compounds of the instant claims
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when a.) G is
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; FG is a fluorescent dye moiety; V is -NRC(S)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is -CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH and b.) G is
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; FG is a fluorescent dye moiety; V is -C(O)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is -CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH, respectively.
The methods of imaging, sorting cells and intraoperative tumor mapping of U.S. Patent No. 11,021,450B2 can be used with the compounds of the instant claims.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,661,402B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compound of U.S. Patent No. 11,661,402B2
having the structure
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, such as
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b.)
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that encompasses the compounds of the instant claims
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when a.) G is
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; Ch is a metal chelating moiety; V is -C(O)-; R1 is phenyl; R is H; p is 1; R2 is CO2H; -(CH2)n- wherein n is 4; R3 is H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH and b.) G is
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; Ch is a metal chelating moiety; V is -NRC(S)-; R1 is phenyl; R is H; p is 1; R2 is H; -(CH2)n- wherein n is 4; R3 is -CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH, respectively.
The methods of imaging and treating a tumor of U.S. Patent No. 11,661,402B2 can be used with the compounds of the instant claims.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,065,413B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of U.S. Patent No.
12,065,413B2 having the structure
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, such as
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encompass the compounds of the instant claims
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when a.) G is
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; FG is a fluorescent dye moiety; V is -C(O)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is -CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH and b.) G is
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; FG is a fluorescent dye moiety; V is -C(O)-; p is 0; R2 is H; -(CH2)n- wherein n is 4; R3 is -CO2H; W is -NRC(O)-; q is 1; r is 0; -(CH2)m- wherein m is 6; Y is -C(O)-; s is 1; –(CH2)a- wherein a is 4 and Z is COOH, respectively.
The methods of imaging, sorting cells and intraoperative tumor mapping of U.S. Patent No. 12,065,413B2 can be used with the compounds of the instant claims.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of copending Application No. 18/479,900 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of copending Application No. 18/479,900 having the structure
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wherein G is
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; FG is a fluorescent dye moiety; V is -C(O)-, -NRC(O)-, -NRC(S), etc.; p is 0-3; R1,R’ and R are H, alkyl, aryl, etc.; R2 is H, alkyl, -CO2H, etc. ; -(CH2)n- wherein n is 1-6; R3 is H, alkyl, -CO2H, etc.; W is -NRC(O)-, C(O)O, -C(O)NR-, etc.; q is 0 or 1; r is 0 or 1; -(CH2)m- wherein m is 1-6; Y is -C(O)-, -NRC(O)-, -NRC(S)NR-, etc.; s is 0 or 1; –(CH2)a- wherein a is 1-6 and Q is H that encompass the compounds of the instant claims
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when a.) G is
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; FG is a fluorescent dye moiety; V is -C(O)-, -NRC(O)-, -NRC(S), etc.; p is 0-3; R1 is H, alkyl, aryl, etc.; R is H or alkyl; R2 is H, alkyl, -CO2H, etc. ; -(CH2)n- wherein n is 1-6; R3 is H, -CO2H, etc.; W is -NRC(O)-, C(O)O, -C(O)NR-, etc.; q is 0 or 1; r is 0 or 1; -(CH2)m- wherein m is 1-6; Y is -C(O)-, -NRC(O)-, etc.; s is 0 or 1; –(CH2)a- wherein a is 1-4; Z is CO2H and Q is H.
The compounds copending Application No. 18/479,900 encompass the compounds of the instant claims, have the same properties and are capable of the same functions, such as may be administered in the unit doses, lyophilized, contained within a sterile container with a machine detectable identifier and comprise excipients.
The use and method for visualization of tissue expressing PSMA of copending Application No. 18/479,900 can be used with the compounds of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed at this time.
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/MELISSA J PERREIRA/ Examiner, Art Unit 1618
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