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 .
Status of the Application
The amendment of 2 December 2024 is entered.
Claims 1-46 have been canceled. Claims 47-59 are pending and are being examined on the merits.
Claim Observation
Claim 50 recites in the preamble “The pharmaceutical composition of claim 47”. While claim 47 does recite a pharmaceutical composition, it is suggested for clarity that claim 50 be amended to recite “The pre-filled syringe of claim 47” to match the language as found in claims 48, 49, and 51-56.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because the specification discloses SEQ ID NO: 1, but no sequence listing is present in the application as filed (see e.g. [0058], [0060], [0233]). The specification also indicates that a sequence listing is filed (see e.g. [0002]).
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
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 47-59 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.
In claim 47, the indefinite language is R5000. The claim is indefinite because it is amenable to multiple plausible interpretations: R5000 could refer to a polypeptide of SEQ ID NO: 1, but R5000 can also refer to 1-(2-chloro-5-nitrophenyl)acetone (see e.g. PubChem SID: 225162207). Ex parte Kenichi Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (precedential) “hold[s] that if a claim is amenable to two or more plausible constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.” In this instance, one of ordinary skill cannot determine based on the claim whether the intent is to claim a polypeptide or a small molecule. The dependent claims do not remedy the deficiency.
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.
1. Claims 47-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-9, 16, 23, and 24 of U.S. Patent No. 10,835,574 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘574 patent claims an overlapping composition.
The ‘574 patent claims a pharmaceutical composition comprising a polypeptide of SEQ ID NO: 1, sodium chloride at from about 25-100 mM, and sodium phosphate at about 10-100 mM (see e.g. claim 1). The ‘574 patent also claims an autoinjector pen, i.e. a prefilled syringe (see e.g. claim 8). This overlaps with instant claim 47.
With respect to claims 48 and 49, as noted above ‘574 claims 25-100 mM NaCl.
With respect to claims 50-52, as noted above ‘574 claims 10-100 mM sodium phosphate.
With respect to claim 53, ‘574 claims a pH of 6.5-7.5, which would readily be applied to the autoinjector pen formulation (see e.g. claim 3).
With respect to claims 54 and 55, ‘574 claims between 1-400 mg/ml of the polypeptide, which would readily be applied to the autoinjector pen formulation (see e.g. claim 2).
With respect to claim 56, as noted above ‘574 claims each element in ranges encompassing those instantly claimed.
With respect to claim 57, it is noted that instructions for use are not considered to be a patentable difference. See MPEP 2112.01 III.
With respect to claim 58, ‘574 claims inhibition of hemolysis via injection (see e.g. claims 9 and 16).
With respect to claim 59, ‘574 does not explicitly claim inhibition of C5 activity. However, ‘574 discloses both administration and that C5 activation is inhibited (see e.g. claims 9, 23, and 24).
2. Claims 47-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11-14, and 18 of U.S. Patent No. 11,752,190 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘190 patent claims an overlapping composition.
‘190 claims a pharmaceutical composition comprising SEQ ID NO: 1, a salt, and a buffering agent (see e.g. claim 1). ‘190 further claims that it can be prepared as an autoinjector pen, i.e. a pre-filled syringe (see e.g. claim 18). This overlaps with claim 47 as instantly claimed.
The autoinjector as claimed offers an obvious choice for preparation of the other claimed compositions for one of ordinary skill in the art before the effective filing date of the claimed invention. As the other claims refine the composition, they each would offer desirable formulations to place in the autoinjector, with a reasonable expectation of success that any could be delivered via the autoinjector.
With respect to claims 48 and 49, ‘190 claims sodium chloride at 25-100 mM (see e.g. claims 2 and 3).
With respect to claims 50-52, ‘190 claims sodium phosphate at 10-100 mM (see e.g. claims 4 and 5).
With respect to claim 53, ‘190 claims a pH of 6.5-7.5 (see e.g. claim 6).
With respect to claims 54 and 55, ‘190 claims R5000 at 1-400 mg/ml and at 40 mg/ml (see e.g. claim 7 and 11).
With respect to claim 56, ‘190 claims 40 mg/ml as noted above, 75.7 mM NaCl (see e.g. claim 12), 50 mM sodium phosphate (see e.g. claim 13), and a pH of 7.0±0.3 as noted above.
With respect to claim 57, as noted above inclusion of printed material directed to instructions for use is not considered to be a patentable difference.
With respect to claim 58, ‘190 does not explicitly claim a method of inhibiting hemolysis. However, the Federal Circuit has found that lack of an explicit claim to a method of use does not preclude a double patenting rejection if an identical use to an identical composition is disclosed in the reference patent:
A claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use (Sun Pharmaceutical. Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010)).
The ‘190 patent discloses inhibition of hemolysis (see Example 14, Table 14).
With respect to claim 59, ‘190 discloses inhibition of C5a production. It reasonably follows that one of ordinary skill would utilize this to derive a method of inhibiting C5 activity in a subject, especially since ‘190 claims a method of treating a complement-related disorder in a subject (see e.g. claim 14).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
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