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 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 using injected SEQ ID 1 to treat ANCA associated vasculitis associated with extracellular traps with traverse in the reply filed on 20 Dec, 2022 and the phone call with Donald Prather, applicant’s representative, on 3 Jan, 2023.
Claims Status
Claims 1-7 and 13-24 are pending.
Claims 1, 3, 17, and 20 have been amended
Claims 7, 13, 15, and 24 have been withdrawn from consideration due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claims 1-6, 14, and 16-21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to the addition of new matter is hereby withdrawn due to amendment.
The rejection of claims 3 and 20 are under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is hereby withdrawn due to amendment.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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-6, 14, and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kessenbrock et al (Nat. Med. (2009) 15(6) p623-625) in view of Gregory et al (US 20110182914, cited by applicants).
Kessenbrock et al discusses testing for NETs in patients with small vessel vasculitis (SVV) and deterioration of kidney function (2nd page, 4th paragraph). Note that SVV is linked to antineutrophil cytoplasm autoantibodies (ANCAs) (abstract), so this is ANCA associated vasculitis. These NETs were found in close proximity to neutrophil infiltrates in affected glomeruli in many biopsies (2nd page, 4th paragraph).
The difference between this reference and the examined claims is that this reference does not discuss treatment of the SVV.
Gregory et al discusses methods of modulating granulocyte activation and migration by modulating lactoferrin concentrations (abstract), which can be used to treat inflammatory disorders (paragraph 1), such as vasculitis (paragraph 19). In other words, this is an immunosuppressive and anti-inflammatory therapy. Lactoferrin itself is considered a modulator of lactoferrin concentration (paragraph 33). An example is given of an in-vivo model of peritonitis, where mice were injected with human lactoferrin (paragraph 126). While this reference discusses both increasing and decreasing lactoferrin concentrations at the site of disorder, it is clear from the text of the reference that lactoferrin is an inhibitor of granulocyte migration, and hence an inhibitor of inflammation (note examples 2-5 and 7, paragraphs 142-148 and 150). The dosage to be used will vary depending on several factors, and will be at the discretion of the physician (paragraph 85). Experiments show that the material inhibits neutrophil activation (example 5, paragraph 148). Note that the experiments used human lactoferrin (paragraph 126, 145, 150). This reference teaches that lactoferrin has an anti-inflammatory effect that can be used to treat vasculitis, a genus that includes the ANCA associated vasculitis described by Romeo et al.
Therefore, it would be obvious to treat the patients of Kessenbrock et al suffering from SVV with the lactoferrin of Gregory et al, as Gregory et al states that this therapy will provide a benefit to patients with vasculitis. As Gregory et al shows at least some of the immune effects of this therapy, an artisan in this field would attempt this therapy with a reasonable expectation of success.
Kessenbrock et al discuss testing patients with ANCA associated vasculitis (applicant’s elected patient population) for NETs (a patient in need thereof). Gregory et al renders obvious treating these patients with lactoferrin. Thus, the combination of references renders obvious claims 1, 3, 16-18, and 20.
While the reference does not discuss the same dosages described by applicants, it states that these are to be determined by the doctor. The MPEP states that “Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or working ranges by routine experimentation" In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”) (MPEP2144.05.II). Thus, it would be obvious to optimize the dosage of the lactoferrin to achieve optimal results, rendering obvious claims 2 and 19.
Gregory et al discuss human lactoferrin (SEQ ID 1 of applicants), rendering obvious claims 4 and 21.
Kessenbrock et al discuss neutrophil extracellular traps (NETs), rendering obvious claims 5, 6, 22, and 23.
response to applicant’s arguments
Applicants argue that neither reference cited discusses using lactoferrin to treat ANCA associated vasculitis, that lactoferrin is found in NETs, and claim the unexpected result that lactoferrin suppresses the formation of NETS.
Applicant's arguments filed 24 Oct, 2025 have been fully considered but they are not persuasive.
Applicants argue that neither reference discusses using lactoferrin to treat ANCA associated vasculitis. While true, it is not clear how this overcomes the rejection, as Gregory et al discusses using lactoferrin to treat vasculitis, a genus that includes ANCA associated vasculitis, as discussed in the rejection.
Applicants argue that NETs contain lactoferrin, which means that a person of skill in the art would not administer this compound. The logic between the facts and the conclusion is lacking. Applicants have not explained such scenarios as desiring to increase the activity of the material by increasing the amount in the bloodstream, for example, such as in hormone replacement therapy. Given that Gregory et al explicitly discusses using lactoferrin to treat vasculitis, this is not an unreasonable proposition.
Finally, applicants claim the alleged unexpected results that lactoferrin suppresses the formation of NETs. The burden is on applicants to show that alleged unexpected results are of practical significance (MPEP 716.02(b)(I)). Applicants have not stated what the practical significance of this discovery is, beyond what the prior art would suggest.
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.
Examiner interviews are available via telephone and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/FRED H REYNOLDS/Primary Examiner, Art Unit 1658