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 . 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.
Election/Restrictions
Applicants elected group I (method of treating sepsis and sepsis related conditions), specifically, C1q to treat pneumonia with traverse in the reply filed on 12 Jan, 2026. The traversal was found unpersuasive, and the election/restriction requirement made final in the office action of 27 Feb, 2026.
In the response of 16 April, 2026, applicants amended the claims to delete “sepsis related condition” (such as the pneumonia of the elected species), so their elected species no longer reads on the claims.
Claims Status
Claims 1-10 and 12-20 are pending.
Claims 1, 4-10, 12, and 20 have been amended.
Claims 2, 8-10, and 12-20 have been withdrawn.
Maintained/Modified Objections
Drawings
The drawings are objected to because they use color, note the heatmap of fig 1E. Applicants are required to either delete the drawing or amend it so it does not need color for interpretation. If applicants are unable to delete or amend without losing information they believe to be important, they can petition for color drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
response to applicant’s arguments
Applicants state that they have petitioned for color drawings. Once the petition is granted, the objection will be withdrawn. Note that fig 1E is given as an example – there are multiple heat maps in the drawings, all of which use color.
Withdrawn Rejections
The rejection of claims 1, 3-7, and 11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of enablement for some sepsis related disorders is hereby withdrawn due to amendment.
The rejection of claims 1, 3-7, and 11 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of written description of variants of C1q is hereby withdrawn due to amendment.
The rejection of claims 1, 3-7, and 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to what functions must be retained to be a variant of C1q is hereby withdrawn due to amendment.
Maintained/Modified Rejections
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
first rejection
Claim(s) 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Meijvis et al (J. Int. Med. (2012) 272 p25-35) in view of Bohlson et al (Front. Immunol. (2014) 5(401), cited by applicants).
Meijvis et al discuss anti-inflammatory drugs for treating pneumonia (title). Much of the discussion is in the context of pneumonia with sepsis (note abstract, p28, 2nd column, 2nd paragraph, p30, 1st column, 1st paragraph, and other portions of the document). There can be an extended inflammatory response despite treatment with appropriate antibiotics, suggesting adjuvant anti-inflammatory therapy (abstract). Patients present with inflammation upon admission to the hospital (p27, 1st column, 2nd paragraph). Lung homoeostasis is a delicate balance of pro and anti-inflammatory responses; excessive inflammation can be life threatening (p28, 1st column, 1st paragraph). While this will not be beneficial for all pneumonia patients (p33, 1st column, 2nd paragraph), the authors state that anti-inflammatory medication can be useful for a subgroup of patients with an excessive immune response (p33, 1st column, 3d paragraph).
The difference between this reference and the examined claims is that this reference does not use C1q as an anti-inflammatory agent.
Bohlson et al discuss the complement system with respect to macrophages (title). C1q stimulates enhanced phagocytosis and diminution of pro-inflammatory cytokine production (5th page, 1st column, 1st paragraph). The complement protein also induced production of anti-inflammatory cytokine production, such as IL10, and dampens transcription activity of pro-inflammatory NF-kB heterodimers (5th page, 1st column, 2nd paragraph). This reference shows that C1q is an anti-inflammatory agent, and also increases phagocytosis by macrophages (useful for a bacterial infection).
Therefore, it would be obvious to use the C1q as part of the anti-inflammatory therapy of Meijvis et al, as Meijvis et al teaches anti-inflammatory therapy is useful for some pneumonia patients, including some of those with sepsis, and Bohlson et al teaches that C1q is also anti-inflammatory. As this protein works by multiple mechanisms, and also promotes engulfment by macrophages (useful for a bacterial infection, such as sepsis), an artisan in this field would attempt this therapy with a reasonable expectation of success.
Meijvis et al et al and Bohlson et al together render obvious treatment of some sepsis patients with C1q. While neither reference discusses isolating wild type protein, if the protein was separated from blood, made by a chemist, or recombinantly produced, it will need to be isolated. Thus, the combination of references renders obvious claim 1.
Meijvis et al teaches antibiotic therapy for pneumonia, rendering obvious claim 3.
response to applicant’s arguments
Applicants argue that the claims have been amended to treat sepsis, while Meijvis et al discusses pneumonia, that applicants have discovered that anti-inflammatory markers do not reliably predict survival (which is argued that anti-inflammatory treatments would not be successful), and that Bohlson et al does not disclose the claim limitations.
Applicant's arguments filed 16 April, 2026 have been fully considered but they are not persuasive.
Applicants argue that Meijvis et al discusses pneumonia, rather than sepsis. However, as noted in the rejection (as amended), it discusses pneumonia in the context of sepsis. In other words, patients with both pneumonia and sepsis, so they read on the claim.
Applicants argue that their discovery makes it unlikely that an anti-inflammatory therapy would work for sepsis, based on their discoveries. It is not clear what this argument is; it is presumed that applicants are arguing that the logic of the rejection would not be expected to work. However, the rejection is based on what a person of skill in the art would believe as of applicant’s priority date (text of 35 USC 103). Information that was not publicly available at that time would not influence that decision.
Finally, applicants argue that the second reference does not teach the invention. While true, in combination of Meijvis et al, the claims are rendered obvious.
second rejection
Claim(s) 1, 3, and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Meijvis et al (J. Int. Med. (2012) 272 p25-35) in view of Bohlson et al (Front. Immunol. (2014) 5(401), cited by applicants) and Labris et al (Br. J. Clin. Pharmacol. (2003) 56 p588-599).
The teachings of Meijvis et al and Bohlson et al were given above, and will not be repeated here. Note that these references render obvious claims 1 and 3.
The difference between these references and the remaining claim is that these references do not disclose an administration route.
Labris et al discuss pulmonary drug delivery (title), i.e. inhalation. For treatment of respiratory disorders, such as the pneumonia of Meijvis et al, this provides several advantages over systemic administration, including high drug concentrations at disease site, minimizing systemic side effects, and smaller doses than systemic administration (table 1, p589, top of page). This reference discusses advantages of inhalation dosing for pulmonary diseases vs. systemic dosing.
Therefore, it would be obvious to use the inhalation dosing of Labris et al, to increase dosing in the lungs, minimizing systemic side effects, and to minimize the amount of drug used, as described by Labris et al. As there is extensive research and experience with inhalation dosing, an artisan in this field would attempt this administration route with a reasonable expectation of success.
response to applicant’s arguments
Applicants have repeated the same arguments for all rejections under this statue, which were answered above.
third rejection
Claim(s) 1, 3, and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Meijvis et al (J. Int. Med. (2012) 272 p25-35) in view of Bohlson et al (Front. Immunol. (2014) 5(401), cited by applicants) and Le Tourneau et al (J. Natl. Cancer Inst. (2009) 101 p708-720).
The teachings of Meijvis et al and Bohlson et al were given above, and will not be repeated here. Note that these references render obvious claims 1 and 3.
The difference between these references and the remaining claims is that these references do not discuss a dose and dose schedule.
Le Tourneau et al discusses phase I clinical trials (title). The main goal of these studies is to determine the recommended dose and dose schedule for new drugs and drug combinations (abstract). The goal is to avoid subtherapeutic doses while maintaining safety and rapid accrual (p708, 1st column, 2nd paragraph). For less toxic drugs, the occurrence of drug related biological effects can be used as an endpoint (p708, 2nd column, 1st paragraph). A number of different dose escalation methods are discussed for achieving these goals (fig 2, p711, top of page). This reference discusses how to optimize a dose and dose schedule of a drug.
Therefore, it would be obvious to optimize the dose and dose schedule of the C1q of Bohlson et al, to minimize toxicity and subtherapeutic dosing while achieving rapid accrual of the drug. As every drug used has to have the dose and dose schedule optimized, this is a common exercise in the art, leading to a reasonable expectation of success.
response to applicant’s arguments
Applicants have repeated the same arguments for all rejections under this statue, which were answered above.
Conclusion
THIS ACTION IS MADE FINAL. 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 FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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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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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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