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.
Claims 1-20 are pending.
Claims 1-13 were withdrawn from further consideration (see below).
Claims 14-20 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 14-20) in the reply filed on 11/26/2025 is acknowledged.
Claim(s) 1-13 were/was withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/26/2025.
Applicant’s election without traverse of species I (claims 16-17) in the reply filed on 11/26/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Because no art was identified for the elected species, the search has been extended and the species are rejoined.
Specification
The abstract of the disclosure is objected to because “(c)” in line 3 must be deleted and “between 5 (w/v) and 11% (w/v)” in last line should read “between 5% (w/v) and 11% (w/v)”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 14 is objected to because of the following informalities: (A) “about 1.5% to about 5% w/v” in line 2 should read “about 1.5% w/v to about 5% w/v” because it is unclear whether 1.5% means 1.5% w/v or 1.5% w/w. (B) “valine, or hydroxyproline” in line 5 should read “valine, hydroxyproline” (i.e. conjunction “or” must be deleted) because proper Markush group format is “selected from the group consisting of A, B, C, and D”. (C) “a surfactant selected between” should read “a surfactant selected from the group consisting of” for proper Markush group. See MPEP 2173.05(h) for proper Markush group format. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: “about 2% to about 3% w/v” in line 2 should read “about 2% w/v to about 3% w/v” because it is unclear whether 2% means 2% w/v or 2% w/w.
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 14-20 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 14 recites “wherein the composition is substantially depleted of”. The term “substantially depleted of” is a relative term which renders the claim indefinite. The term “substantially depleted of” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what level of isoagglutinin is allowed by the term “substantially depleted of”.
Claim 14 recites “total protein (immunoglobulin)” in second from last line, which is exemplary claim language and it is unclear the content in parenthesis is limiting or merely exemplary.
Dependent claims are also rejected because they depend from claim 14 and therefore contain same claim limitation as claim 14.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 14-15 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Collins et al (EP0345543B1; 12/16/2022 IDS) in view of Hayasaka et al (US7803914; PTO-892).
Regarding claim 14 and 19-20, Collins teaches “Protective antibody compositions comprising at least 33% by weight of antibodies of the IgM type and substantially free of homologous isoagglutinins are highly active against gram negative pathogens in mammals” (abstract). Collins teaches “An intravenously administrable lyophilized IgM concentrate substantially free of isoagglutinins, derived from a plasma source” (claim 1). Collins teaches that composition free of anti-A antibodies and anti-B antibodies (claims 4-5). The anti-A antibodies and anti-B antibodies are alternative names for isoagglutinin A and isoagglutinin B. Collins teaches “Fraction III was obtained from a blood type A specific pool of plasma (i.e. from donors having type A blood) and processed as in Example 1 through the caprylic acid precipitation, clarification and filtration steps. The filtrate was adjusted to 0.16 M sodium potassium phosphate at pH 6.5 and the IgM adsorbed on an anion exchanger such as Q Sepharose® equilibrated with the same pH 6.5 buffer. The adsorbed IgM was washed with equilibration buffer. IgM was eluted from the exchanger with 0.3 M sodium potassium phosphate at pH 6.5. Virus inactivation is achieved by application of tri-n-butyl phosphate and Tween® 80. The virus-free solution is adjusted to 0.025 M sodium acetate, 0.2 M glycine (corresponds to instant claim 14(ii)), 0.05 M sodium chloride, pH 4.8 (corresponds to instant claim 14(iii)). The IgM thus prepared has a globulin composition by weight of 96% IgM (corresponds to instant claim 14(i)), 1.3% IgG, 2.1% IgA (corresponds to “IgA is less than 3% by weight of the toral protein” of claim 19), and a saline titer of less than 1 anti A” [0022]. Because Virus inactivation is achieved by Tween 80 and then the virus-free solution is adjusted to a new buffer condition, this composition will still comprise Tween 80 (corresponds to instant claim 14(iv)). Tween 80 is alternative name for polysorbate 80.
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 (immunoglobulin) content of the composition, as determined by high performance size exclusion chromatography” of instant claim 14 is the functional characteristics of the claimed composition. As shown below, because the instant composition is obvious, this functional limitation is also obvious.
Collins teaches “In liquid form suitable for IV administration, the IgM concentration is at least 5 mg per ml” [0011]. 5 mg/ml corresponds to 0.5% w/v. Therefore, IgM concentration range of Collins is overlapping with the range 1.5% to 5% of instant claim 14(i).
The difference between prior art and the instant invention is that although IgM concentration range of Collins is overlapping with the range of instant claim 14(i), Collins does not teach more specific narrower range from 2% to 3% recited by instant claim 14(i) and claim 15.
Regarding claims 14-15, Hayasaka teaches “The present inventors examined use of citric acid buffers for suppressing cryoprecipitation of IgM at a pH range and salt concentration suitable for storing IgM” (abstract). Hayasaka teaches “solution comprising the IgM at a concentration of 20 mg/ml or greater” (claim 1). 20 mg/ml corresponds to 2% w/v. Hayasaka teaches that the concentration of the IgM in the second solution is 25 mg/ml or greater (claim 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adjusted IgM concentration to 2.5% (w/v) (corresponding to 25 mg/ml as taught by Hayasaka) because Hayasaka teaches that composition comprising 2.5% w/v IgM is stable. One of ordinary skill in the art would envision that higher IgM concentration in the composition is beneficial because less volume of the composition can be infused into the patient. For example, Collins teaches “The minimum IgM concentration was 50 mg/kg of animal treated” [0025]. If the patient has weight of 60 kg, then the patient must be infused with 3,000 mg IgM. If IgM concentration is 0.5% w/v (5 mg/ml) as taught by Collins, 600 ml of the composition needs to be infused to the patient for the required 3,000 mg IgM. In contrast, if IgM concentration is 2.5% w/v (25 mg/ml) as taught by Hayasaka, 120 ml of the composition needs to be infused to the patient for the required 3,000 mg IgM. Therefore, one of ordinary skill in the art would understand that 2.5% w/v as taught by Hayasaka is beneficial because less volume of the composition can be infused to the patient. Therefore, one of ordinary skill in the art would be motivated to adjust IgM concentration to 2.5% w/v as taught by Hayasaka because IgM at 2.5% w/v is stable and 2.5% w/v is more beneficial than 0.5% w/v. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because Hayasaka teaches that IgM composition at 2.5% w/v IgM concentration is stable. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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; PTO-892). 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 substantially 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 (immunoglobulin) 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.
Conclusion
No claim is allowed.
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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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645