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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-10) in the reply filed on 11/18/2025 is acknowledged.
In response to an interview with the Examiner on 12/11/2025, amended claim 1, (12/15/2025), and previously presented claims 2-3, 5-10, were submitted for examination.
Claims 4, 11-19 have been canceled.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 8/30/2024, 2/15/2024, 2/23/2023, 11/19/2021, and 7/29/2021 are in compliance with the provisions of 37 CFR 1.97 and have been considered by the examiner.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section”.
Claim rejections-35 U.S.C. 103
4. 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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
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 pre-AIA 35 U.S.C. 103(a) 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.
4a. Claims 1-3, 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over KR 10-2016-0137810 (2016) in view of Adachi et al. (2002) and Meziani et al (2018).
KR 10-2016-0137810 (2016) discloses a composition and a method for inhibiting pulmonary fibrosis comprising administering an siRNA as a M-CSF expression inhibitor (See abstract; claims 3-5; paragraph [0001]). The reference is silent with respect to administering a M-CSF antibody (as a M-CSF inhibitor) and a G-CSF antibody (as a G-CSF inhibitor) together, for treating pulmonary fibrosis.
Adachi et al. (2002) teaches administration of G-CSF causes pulmonary fibrotic diseases and therefor G-CSF is associated with pulmonary fibrotic disease (See abstract; and conclusion). The reference is silent with respect to administering a G-CSF antibody (as a G-CSF inhibitor) for treating pulmonary fibrosis.
Meziani et al (2018) teaches administering a CSF1R (M-CSFR) neutralizing antibody as inhibitor, in the prevention of radiation induced lung fibrosis (RIF) by blocking profibrotic tissue-infiltrating macrophages (IMs) (See abstract; Figure 1, page 3; Figure 7, page 10).
Therefore, it would have been obvious to a person skilled in the art at the time of the instant invention to modify the method of KR 10-2016-0137810 such that it includes administering a combination of a M-CSF inhibitor and a G-CSF inhibitor, which encompasses M-CSF antibodies and G-CSF antibodies, because KR 10-2016-0137810 teaches that M-CSF causes pulmonary fibrosis and Adachi teaches that G-CSF causes pulmonary fibrosis, and Meziani et al teaches that antibodies to MCSFR prevent RIF. Therefore, a person skilled in the art would be motivated and with a reasonable expectation of success, administer a M-CSF inhibitor (M-CSF antibodies) and a G-CSF inhibitor (G-CSF antibodies) for the treatment of pulmonary fibrosis because of the combined teachings of the references. With respect to claim 2, KR 10-2016-0137810 teaches that the pulmonary fibrosis is induced by irradiation (See paragraph [0018]; claim 4). With respect to claims 3 and 5, KR 10-2016-0137810 teaches inhibiting myofibroblast and pulmonary fibrosis of pulmonary cells (See claim 1), and inhibition of transformation of pulmonary cells into myofibroblasts (See paragraph [0018]). With respect to claim 6-10 which are pharmacological mechanisms, one of skill in the art would have expected these inhibitions because KR 10-2016-0137810 teaches that the siRNA inhibits one or more of vimentin (VIM), fibronectin (FN), versican, osteopontin (OPN), and HAS3 (See claim 5; paragraph [0019]).
Therefore, the combined teachings of KR 10-2016-0137810, Adachi et al. and Meziani et al. renders obvious claims 1-3, and 5-10.
Conclusion
No claim is allowed.
Claims 1-3, and 5-10 are rejected.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, 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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/PREMA M MERTZ/ Primary Examiner, Art Unit 1674