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 Status
Claims 21-25 were canceled.
Claim 26 was added.
Claims 1-20 and 26 are pending.
Claims 1-13 stay withdrawn from further consideration.
Claims 14-20 and 26 are under consideration.
Withdrawn Rejections
Objection of specification is withdrawn. Applicant amended the specification, thereby obviating this objection.
Objections of claims 14-15 are withdrawn. Applicant amended the claims, thereby obviating this rejection/objection.
Rejection of Claims 14-20 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn. Applicant amended the claim 14, thereby obviating this rejection/objection.
Rejection of Claims 14-15 and 19-20 under 35 U.S.C. 103 as being unpatentable over Collins et al (EP0345543B1) in view of Hayasaka et al (US7803914) is withdrawn. Applicant provided a persuasive argument that Collins teaches a lyophilized composition, not a liquid composition of instant claim 14 (Response 6/16/2026, bridging paragraph at pages 7-8).
NEW - Claim Rejections - 35 USC § 112
(necessitated by amendments)
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 26 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.
Claim 26 recites “an IgM pentamer content greater than 98%”, but does not recite reference point to compare with. Does Applicant intend to recite “98% by weight of total IgM content” by “98%”?
MAINTAINED - 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 14-15 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20-23 of copending Application No. 18/672,438 (hereinafter application’438; US2024/0417445). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Regarding claim 14, claim 20 of application’438 claims “A composition comprising lyophilized IgM wherein prior to lyophilization the initial aqueous solution comprises IgM at a concentration between about 15 mg/mL (corresponds to “1.5% w/v” of instant claim 14) and about 50 mg/mL, the polyclonal IgM being at least about 90% by weight of the total protein content of the composition; further comprising amino acids selected from the group consisting of proline, glycine, alanine, valine and hydroxyproline or a mixture thereof at a final concentration of about 0.15 M to about 0.45 M; polysorbate 80 (PS80) at a concentration between about 50 and about 200 ppm; and succinic acid at a concentration between about 1 mM and about 20 mM; wherein said lyophilized composition has a content of pentameric IgM higher than about 90% of the total IgM content, a content of IgM aggregates of less than about 1.5%, and a content of IgM oligomers of less than about 7%.” Claim 22 of application’438 claims “The composition according to claim 20, wherein prior to lyophilization the pH of the initial aqueous solution comprising IgM is between about 3.8 and about 4.5”. Although application’438 does not claim the limitation “the composition is depleted of isoagglutinin A and isoagglutinin B” of instant claim 14, one of ordinary skill in the art would understand that the composition of application’438 does not contain isoagglutinin A and isoagglutinin B because application’438 does not recite that the composition comprises isoagglutinin A and isoagglutinin B. The limitation “the composition is stable in liquid form for at least 24 months when stored at 2 to 5 °C, such that the content of IgM aggregates having a molecular weight > 1200 kDa in the composition remains less than or equal to 10 % by weight of the total protein content of the composition, as determined by high performance size exclusion chromatography” of instant claim 14 is the functional characteristics of the claimed composition and because application’438 claims same composition as instant invention, the composition of application’438 will have same functional characteristics.
Regarding claim 15, claim 23 of application’438 claims “The composition according to claim 20, wherein prior to lyophilization said composition has an IgM concentration between about 15 mg/mL and about 40 mg/mL.” IgM concentration between about 15 mg/mL and about 40 mg/mL corresponds to IgM concentration between about 1.5 % w/v and about 4.0 % w/v, and therefore the range is overlapping with that of instant claim 15.
Regarding claim 20, claim 20 of application’438 encompasses a species composition comprising glycine which is claimed by instant claim 20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
In the response filed on 6/16/2026, Applicant argued at page 9-10,
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Because there is new 112 rejection for the newly added claim 26, this NSDP rejection is maintained.
Claim Objections
Claims 16-19 are objected to as being dependent from rejected base claim.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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