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 .
Claims 1, 4-6, 8, 9-11, 23, 26-30, 36, 43 and 45-47 are presented for examination.
Claim 44 is withdrawn for examination.
Election/Restriction
Applicant’s election without traverse of Group I, claims 1, 4-6, 8, 9-11, 23, 26-30, 36, 43 and 45-47 and species of Compound Formula IA-4 in the reply filed on 05/06/2026 is acknowledged.
Claim 44 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/06/2026.
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.
Claims 1, 6, 9, 26, 27 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 1 and 36 are indefinite as to the phrases “an initiation residue”. Claim 1 is also indefinite as to the phrase “an organic residue”. Such phrases fail to set forth bounds and metes of the claimed invention.
Claim 6 and 36 are indefinite as to the phrase “discrete number”. Such phrase fails to set forth bounds and metes of the claimed invention.
Claim 9-11 and 36 are indefinite in failing to set forth the definition of X1 and X2. The phrases “a divalent covalent linking moiety” in claim 36 is indefinite, since the claim fails to set forth what kind of components are covered under such broad phrase.
Claim 26 is indefinite as to the phrase “Trop-2targeting fragment”. Such phrase fails to set forth the intended meaning. Claim 26 is also indefinite as to the phrase “the composition of claim 1 any one of the preceding claims”. The phrase fails to set forth if the composition is dependent. There are no preceding claims to claim 1.
Claim 27 is indefinite as to the phrase ”DUPA”. Such phrase fails to set forth the intended meaning.
Claims dependent on the rejected claims are also rejected, since they have all the limitations of the rejected claims.
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.
Claims 1, 4-6, 8-11, 22, 2627-30, 36, 43 and 45-47 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 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 courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v.American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). ("The description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.")- Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California V. Eli Lilly & Co., 43 USPQ2d 1398. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of Califormia V. Eli Lilly & Co. the court stated:.
"A written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ") Regents of the University of Califormia V. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP states that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. The Guidelines for Examination of Patent Applications Under 35 USC 112, first, "Written Description" Requirement (Federal Register, Vol. 66, No. 4, pg. 1105, column 3), in accordance with MPEP § 2163, specifically state that for each claim drawn to a genus the written description requirement may be satisfied through sufficient description of a representative number of species by a) actual reduction to practice; b) reduction to drawings or structural chemical formulas; c) disclosure of relevant, identifying characteristics (i.e. structure) by functional characteristics coupled with a known or disclosed correlation between function and structure. The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated possession of the claimed invention (Federal Register, Vol.66, No. 4, p. 1105, 3rd column, 3rdparagraph). In the instant case the claimed scope is extremely broad with a variety of distinct variables encompass essentially billions of compounds. A correlation between structure and function, for instantly claimed genus of compounds, is neither known in the art nor disclosed in the specification. Thus, it is not understood what specific structures for the claimed variables will lead to compounds that have the instantly claimed activity. It is the examiner's position that substantial structural variation exists in the genus/subgenus embraced by the instant claims and the disclosure of species supporting genus is limited to compounds reduced to practice, which their scope is not commensurate in scope with the genus/subgenus as claimed herein. Furthermore, common structural attributes of the claimed genus/subgenus, combined with a correlation between structure and function, is neither disclosed in the instant application nor commonly known in the art. The claims of the instant application are drawn to the composition of Formula I or pharmaceutically acceptable “ solvate”, “hydrate”, “tautomer” or “enantiomer”. The claims are also drawn to “X1 is a divalent covalent linking moiety”, “X2 is a divalent covalent linking moiety”, “L is a targeting fragment”, “L is selected from an EGFR targeting fragment; a PSMA targeting fragment; an anti-HER2 peptide; folic acid; a somatostatin receptor-targeting fragment; an integrin-targeting fragment, a low pH insertion peptide; an ASGPr targeting fragment; an insulin-receptor targeting fragment; a mannose-6- phosphate receptor targeting fragment; a mannose-receptor targeting fragment; a Sialyl Lewis antigen targeting fragments,; a sigma-2 receptor agonist, sphingolipid- derived amine, and/or steroid; a p32-targeting ligand, a Trop-2 targeting fragment, insulin-like growth factor 1; vascular endothelial growth factor; platelet-derived growth factor; and fibroblast growth factor”, “a polyanion”. The instant specification describes a few compounds within the scope of what is claimed. It is the examiner's position that substantial structural variation exists in the genus/subgenus embraced by the instant claims and the disclosure of species supporting genus is limited to compounds reduced to practice, which their scope is not commensurate in scope with the genus/subgenus as claimed herein. Furthermore, common structural attributes of the claimed genus/subgenus, combined with a correlation between structure and function, is neither disclosed in the instant application nor commonly known in the art. Thus, the specification fails to provide adequate written description for the genus of compounds claimed and does not reasonably convey to one skilled in the art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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, 4-6. 8-11, 22, 26-30, 36, 43 and 45-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-11, 20-23, 25-28, 35 and 45 of copending Application No. 19/127,651 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap. The claims of the instant application are drawn to a composition comprising a conjugate of formula I.
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The claims of the copending application are drawn to
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The composition of the copending application has the m being an integer of 25-100, which falls between the scope of m being 1-200 of the instant application. There are other differences in repeating numbers of the polymers, which all fall within the scope of each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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, 4-6, 8-11, 22, 26-30, 36, 43, 45-47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9,006,406. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap. The claims of the U.S. Patent are drawn to a pharmaceutical composition for systemic administration comprising a pharmaceutically acceptable carrier and an EGFR-homing vector selected from the group consisting of a vector comprising polyinosinic-polycytidylic acid double stranded RNA; unbranched polyethyleneimine covalently linked to polyethylene glycol; and mEGF (pIC/PPE) and a vector comprising polyinosinic-polycytidylic acid double stranded RNA; unbranched polyethyleneimine covalently linked to polyethylene glycol; and peptide GE11 (pIC/PPGE11). The claims of the instant application are drawn to a vector of polyinosinic-polycytidylic acid double stranded RNA; unbranched polyethyleneimine covalently linked to polyethylene glycol; and mEGF (pIC/PPE) and a vector comprising polyinosinic-polycytidylic acid double stranded RNA; unbranched polyethyleneimine covalently linked to polyethylene glycol; and peptide GE11 (pIC/PPGE11). The claims of the instant application comprise a polyethyleneimine covalently linked to polyethylene glycol with a specific chemical structure. The polymers of the instant application fall within the scope of the polymers taught by the U.S. Patent.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
