DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment of 4/16/26 has been entered in full. Claims 21-25, 28-33, 37, 39 are amended. New claims 41-43 are added. Claims 21-43 are pending.
The elections of (1) an antibody with the VH/VL of SEQ ID NO: 25/26 as the species of CD14 antagonist antibody, and (2) aspirin as the species of ancillary agent, were previously acknowledged. Claims 35 and 36 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 21-34 and 37-43 are under consideration, as they read upon the elected species
Information Disclosure Statement
The Information Disclosure Statement of 4/16/26 has been considered.
Withdrawn Objections and/or Rejections
The following page numbers refer to the previous Office Action (1/22/26).
The objection to the specification at page 2 is withdrawn in view of the amendments to the title.
The objections to claims 31 and 37 at page 3 are withdrawn in view of the amendments to the claims.
The rejection of claims 21-40 at pages 8-11 under 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Application Publication 2022/0249610, and further in view of Nolan (2011) is withdrawn in view of the amendments to the claims, and further in view of Applicants’ persuasive arguments at pages 11-14 of the 4/16/26 reply.
Maintained Objections and/or Rejections
Claim Rejections - 35 USC § 112(a), written description
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 21-27, 30, 32-34 and 37-43 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection was set forth previously at pages 3-7 of the 1/22/26 Office Action for claims 21-27, 30, 32-34 and 37-40; the addition of new claims 41-43 necessitate the addition of these claims.
Applicants indicate that the claims have been amended to change “a CD14 antagonist antibody” to “an anti-CD14 antibody”, wherein “the anti-CD14 antibody comprises means for binding CD14 and inhibiting binding of lipopolysaccharide to CD14” (page 10).
The amendments to the claims have been fully considered, and the newly recited language is held to invoke 35 U.S.C. 112(f) in accord with MPEP 2181.I. The function of the recited means is two-fold: (1) to bind CD14 and (2) to inhibit its binding to lipopolysaccharide (LPS). The specification describes this activity in ¶ 118 (published application), where the methods of identifying antagonist antibodies are described:
“The methods for identifying suitable antagonist antibodies for use in accordance with the present disclosure may assess the agonist activity of CD14. For example, such a method may be carried out using peripheral blood mononuclear cells. Such cells will produce cytokines such as IL-1α, IL-6, TNF-α, IFN-β, IL-1β, IL-17 and IL-8 on response to stimulation with, for example, LPS. Methods may therefore comprise combining peripheral blood mononuclear cells with the antibody or a vehicle and adding LPS. The cells may then be incubated for an amount of time (e.g., 24 hours) to allow the production of pro-inflammatory mediators such as cytokines. The level of cytokines such as IL-1α, IL-6, TNF-α, IFN-β, IL-1β, IL-17 and IL-8 produced by the cells in that time period can then be assessed. If the antibody has anti-CD14 properties, then the production of such cytokines should be reduced compared to the vehicle-treated cells”
The specification further teaches that the “28C5 and 23G4 antibodies that inhibit binding of LPS and suppress production of pro-inflammatory cytokines, and the 18E12 antibody that partly inhibits binding of LPS and suppresses production of pro-inflammatory cytokines” (¶ 82). The 28C5 and 18E12 antibodies represent examples that were acknowledged in the rejection of record to be examples of “monoclonal antibodies that bind CD14, antagonize the protein function and are defined by their amino acid sequences” (page 6 of the 1/22/26 Office action). With respect to the amended claims, these two antibodies are determined to be examples of structures that correspond to the newly claimed function of “binding CD14 and inhibiting binding of lipopolysaccharide to CD14”. However, for the reasons set forth in detail at pages 3-7 of the rejection of record, the two species of antibodies are not representative of a genus of antibodies that are defined by function, i.e., binding CD14 and inhibit its binding to LPS. As such, it is maintained that the only a method of claim 21 wherein the antibody is selected from the group recited in claim 28, 29 or 31, but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112(a).
At page 10, Applicants further argue that the “Federal Circuit has held that means-plus function language satisfies § 112(a) written description requirement where the specification discloses and links corresponding structure to the claimed function”, pointing to the decision in Biomedino, LLC v. Waters Techs. Corp. (2007).
This argument has been fully considered but is not found to be persuasive. Applicants do not quote or point to a specific portion of the decision of Biomedino. MPEP 2181.II.A, cites Biomedino as stating that “"[a] bare statement that known techniques or methods can be used does not disclose structure" in the context of a means plus function limitation. Biomedino, LLC v. Waters Technology Corp., 490 F.3d 946, 952, 83 USPQ2d 1118, 1123 (Fed. Cir. 2007)”. In the instant case, the statement that antibodies that bind CD14 and inhibit its binding to LPS can be identified as described in ¶ 118 of the specification is not sufficient to describe the structure of such antibodies. Furthermore, the instant specification does not describe how the structure of the disclosed species of antibodies that are encompassed by the genus of antibodies to be used in the claimed method allows the identification of the structure of other antibodies that will bind CD14 and inhibit its binding to LPS, and thus the instant specification does not link structure and the requisite function.
At page 10, Applicants further argue that the “PTAB has held that a functionally defined antibody claim drafted in means-plus-function form encompasses the antibodies disclosed in the specification and their equivalents, and that the written description requirement is satisfied where such corresponding structure is provided, without requiring express description of all equivalents”, pointing to Ex Parte Chamberlain, Appeal No. 2022-001944. Applicants further argue that the “USPTO has issued patents reciting antibodies in means-plus-function format”, pointing to four U.S. Patents.
These arguments have been fully considered but are not found to be persuasive. While it is acknowledged that the claims have been amended to include the phrase “means for”, and that such invokes 35 U.S.C. 112(f), per MPEP 2181.II.A:
“[t]he invocation of 35 U.S.C. 112(f) does not exempt an applicant from compliance with 35 US.C. 112(a) and 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, first and second paragraphs. See Donaldson, 16 F.3d at 1195, 29 USPQ2d at 1850; In re Knowlton, 481 F.2d 1357, 1366, 178 USPQ 486, 493 (CCPA 1973) ("[The sixth paragraph of section 112] cannot be read as creating an exception either to the description requirement of the first paragraph … or to the definiteness requirement found in the second paragraph of section 112. Means-plus-function language can be used in the claims, but the claims must still accurately define the invention.").”
This in accord with the decision in Ex Parte Chamberlain, Appeal No. 2022-001944 (cited by Applicants in the response), which held that a claim directed to “an anti-C5 antibody comprising a) means for binding human C5 protein” (as set forth on page 3 of Chamberlain), both invoked 112(f) (page 28) but also “lacks written description under 35 U.S.C. § 112(a) and is further indefinite under 35 U.S.C. § 112(b)” (page 29 of Chamberlain). Furthermore, it is acknowledged that the USPTO has issued other patents with claims reciting antibodies containing means-plus-function language, but this does not obviate the need for the instant specification to provide a written description for instant claims.
New rejections necessitated by Applicants’ amendment
Claim Rejections - 35 USC § 112(b)
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 21-27, 30, 32-34 and 37-43 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 pre-AIA the applicant regards as the invention.
Claim 21 is indefinite with respect to the newly added recitation of “means for binding CD14 and inhibiting binding of lipopolysaccharide to CD14”. This limitation is held to invoke 35 U.S.C. 112(f). Per MPEP 2181.III, “[o]nce the examiner determines that a claim limitation is a means-plus-function limitation invoking 35 U.S.C. 112(f) … the examiner should determine the claimed function and then review the written description of the specification to determine whether the corresponding structure, material, or acts that perform the claimed function are disclosed”. Per MPEP 2181.III, “A rejection under 35 U.S.C. 112(b) … is appropriate … if there is no disclosure (or insufficient disclosure) of structure, material, or acts for performing the claimed function. Donaldson, 16 F.3d at 1195, 29 USPQ2d at 1850”. In the instant case, there is insufficient disclosure of structure corresponding to the antibodies comprising “means for binding CD14 and inhibiting binding of lipopolysaccharide to CD14” as set forth above in the section “Claim Rejections - 35 USC § 112(a), written description”. As such, rejection of the claim under 35 U.S.C. 112 (b) is appropriate.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Conclusion
Claims 28-29 and 31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 extension fee 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 ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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