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 .
1. Formal Matters
A. In the response filed 6/3/26, Applicants elected, without traverse, Group IV, drawn to lung fibrosis. Therefore, this restriction is deemed proper and is made FINAL. However, upon further review, all species have been examined.
B. Claims 1-9 and 17-31 are pending. Claims 1-9 and 17-23 are withdrawn as being drawn to non-elected inventions. Claims 24-31 are the subject of this Office Action.
2. Specification
A. The specification is objected to since the Brief Description of the Figures (e.g. Figures) should be amended to initially reflect the panels. In other words, “[Fig.4]Figure 4 shows” should be amended to, for example, “[Fig 4A-B]Figure 4A shows”.
B. The listing of references on pages 1-3 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
C. The use of at least the terms LabDiet® (paragraph [0247], RNeasy® ([0250], [0256]) and Gold Bio® [0255], which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The Examiner performed a cursory review, but Applicants are urged to perform a more thorough review of the specification.
D. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors, embedded hyperlinks, or improperly referenced trademarks. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
3. Claim Objections
Claims 28-31 are objected to since they depend from withdrawn claim 6.
4. Claim Rejections - 35 USC § 103
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.
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.
A. Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Bian et al. (reference 8 on the IDS filed 1/18/24). The claims are drawn to a method of treating a fibrotic disease by administering an anti-DDR2 antibody. Bian teaches that DDR2 was increased in interstitial lung diseases, which are conditions where collagen levels accumulate (Abstract). They further state that “[o]ur investigation suggests that DDR2 might represent a major cell surface protein that mediates collagen-induced cellular effects in human ILD and, hence, is suitable for their diagnosis and therapy (Abstract). Though idiopathic pulmonary fibrosis is not taught by Bian, it would have been obvious to have considered treatment of this disease since Bian teaches that DDR2 appears to be a significant protein in collagen-induced (e.g. fibrotic) diseases.
Bian also teaches the use of a human DDR2 antibody (page 3 under “Immunohistochemical staining”). Though the anti-DDR2 antibody was not used for treatment, it would have been obvious at the time to have use any known anti-DDR2 antibody for treatment given the teachings of Bian. In addition, page 8 of Bian states “certain functions of DDR2, at least those requiring collagen binding and subsequent phosphorylation of DDR2, could be blocked by either neutralising antibody…”
B. Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (reference 29 on the IDS filed 1/18/24). The claims are drawn to a method of treating a fibrotic disease by administering an anti-DDR2 antibody. Zhao (Abstract) teaches the elucidation of a novel mechanisms by which DDR2 controls the development of (idiopathic) pulmonary fibrosis and which but also provided a candidate target for its intervention.
Zhao also teaches the use of an anti-human DDR2 antibody (last full paragraph of page 1742). Though the antibody was not used for treatment, it would have been obvious at the time to have use any known anti-DDR2 antibody for treatment given the teachings of Zhao.
C. Claims 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Borza et al. in view of either (1) Bian et al. or (2) Zhao et al.
The claims are drawn to a method of treating a fibrotic disease by administering an anti-DDR2 antibody. Borza teaches that DDR2 is a potential therapeutic target in lung fibrosis (entire document), including IFP. Borza does not teach the use of anti-DDR2 antibodies. However, both Bian and Zhou do. Given the teachings of these antibodies for the same purpose as Borza, it would have been obvious to have used them in the treatment of Borza.
5. Conclusion
A. Claims 24-27 are not allowable.
B. The antibody comprising SEQ ID NO:2, 3, 4, 6, 7 and 8 is free of the prior art.
C. Claims 28-31 are objected to, but would be allowable if rewritten to include the limitations of claim 6 from which they depend.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at 571-272-2911. 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 the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
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