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 .
Election/Restrictions
Applicant’s election without traverse of claims 3-13 in the reply filed on June 15, 2026 is acknowledged.
Status of Claims
Claims 1-18 are currently pending in the instant application. Claims 1-2 and 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, claims 3-13 are under examination on the merits in the instant 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.
Claims 3-13 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.
Claim 3 recites that the composition comprises a PEGylated aptamer, “wherein the aptamer comprises the sequence of SEQ ID NO:1”. The claim simultaneously recites “more than 92% of the aptamer in the composition is full length aptamer”, thereby requiring that some (e.g., 6-7%) aptamers are shorter than the full/entire length of SEQ ID NO:1. It is unclear how the aptamer that “comprises” the entire length of sequence of SEQ ID NO:1 can be shorter than SEQ ID NO:1 because the shorter aptamer cannot “comprise” SEQ ID NO:1 as required by the claim. Accordingly, claim 3 and all dependent claims thereof recite structurally conflicting, impossible limitations pertaining to the aptamer, thereby rendering the claims indefinite.
For examination purpose, the 100% of the aptamer included in the claimed composition will be interpreted as comprising the entire length of SEQ ID NO:1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 3-7, 10, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Epstein et al. (US 2009/0269356 A1, applicant’s citation).
Epstein teaches making “an ocular pharmaceutical composition” comprising the following PEGylated aptamer (“ARC1905”) “or a salt thereof” and a pharmaceutically acceptable carrier/excipient. See paragraphs 0132-0137. See the structure of “ARC1905” comprising the sequence of SEQ ID NO:4 in Figure 22 as reproduced below.
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It is noted that Epstein’s aptamer sequence of SEQ ID NO:4 is 100% identical to SEQ ID NO:1 claimed in the instant case.
Since all structural limitations set forth in the rejected claims are fully satisfied by Epstein’s composition comprising “ARC1905” or a salt thereof, it necessarily follows that Epstein’s composition inherently possesses all of the properties recited in the instant claims (e.g., “4.74% of the composition is RRT 2”; “at least 5% more potent at inducing a complement cascade as measured by ELISA, as compared to a control composition”; “has an osmolarity between 350 mOsM/kg to 500 mOsM/kg”), absent objective evidence to the contrary. Note that “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
Accordingly, the subject matter of claims 3-7, 10, and 13 is described by Epstein et al.
Claims 3-7, 10, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rezaei (WO 2021/091718 A1, applicant’s citation).
Rezaei discloses a pegylated aptamer, ARC1905 in paragraph 0025 as reproduced below.
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Rezaei teaches making a pharmaceutical composition and a salt thereof comprising ARC1905 at a concentration of “about 20 mg/mL” and a pharmaceutically acceptable carrier/excipient that is “sterile” “sodium phosphate” buffer solution, “in which the pH of the composition is about 6.8 to about 7.8.” See paragraphs 0025-0026 and 0056-0060.
Since all structural limitations set forth in the rejected claims are fully satisfied by Rezaei’s pharmaceutical composition comprising “ARC1905” and sodium salt thereof at the concentration of 20 mg/mL in a sterile solution at a pH of about 6.8-7.8, it necessarily follows that Rezaei’s composition inherently possesses all of the properties recited in the instant claims (e.g., “4.74% of the composition is RRT 2”; “at least 5% more potent at inducing a complement cascade as measured by ELISA, as compared to a control composition”; “has an osmolarity between 350 mOsM/kg to 500 mOsM/kg”), absent objective evidence to the contrary. Note that “[f]rom the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing.” In re Papesch, 315 F.2d 381, 391 (CCPA 1963).
Accordingly, the subject matter of claims 3-13 is described by Rezaei.
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 3-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-26 of copending Application No. 18/877,396.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by and overlap in scope with the ‘396 claims that are drawn to and require a pegylated anti-C5 agent satisfying the instantly claimed structure.
Claims 3-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-22 of copending Application No. 19/126,129.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by and overlap in scope with the ‘129 claims that are drawn to and require the instantly claimed structure.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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