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. Claims 1-10 and 21 are pending in the instant patent application.
Claims 1-10 and 21 are under examination.
Claim Objections
2. Claims 1, 2, 7, 8 and 9 are objected to because of the following informalities:
The claims recite acronyms without first providing the full name of the terms. It is suggested that the terms be spelled out at their first use and in all independent claims so that it is clearly understood what they stand for. Appropriate correction is suggested.
Claim Rejections - 35 USC § 112
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.
3. Claims 4-9 and 21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
4. The terms “increase” and “decrease” in claim 4 are relative terms which render the claim indefinite. These terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Providing a point of reference or comparison within the claim would obviate this ground of rejection.
5. Similarly, the terms “inhibiting,” “increasing” and “decreasing” in claims 7, 8 and 9 are relative terms which render the claim indefinite. These terms are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Providing a point of reference or comparison within the claim would obviate this ground of rejection.
6. Claims 5, 6 and 21 are indefinite for being dependent from indefinite claim(s).
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.
7. Claims 1-10 and 21 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-10 and 21 specifically require possession of anti-CSF3R antibodies that are suitable for clinical administration to treat pulmonary fibrosis. Furthermore, the anti-CSF3R antibodies of the instant invention must satisfy the following functional criteria: to promote a degradation of an accumulated extracellular matrix in the lung tissue upon administration; to reduce (decrease) an expression level of Co11a1, OPN, VER, FN and Has3; to increase an expression of MMP, and specifically MMP2, MMP9 and MMP13, in the lung tissue of the patient under treatment; to decrease an expression of TIMP, and specifically TIMP-1 and TIMP-2; to inhibit a CSF3R-mediated EMT in lung cells; to decrease an expression of fibronectin, vimentin, N-cad and ZEB1 while increasing an expression of the E-cad; and to decrease a binding of STAT3 with CSF3R. The claims do not require that these antibodies possess any particular clearly disclosed structure, conserved structure or other disclosed distinguishing feature. Thus, the claims are drawn to a genus of antibodies that is defined by reference to the structure of the binding epitope—CSF3R—coupled with a specific clinical or cellular effect. However, disclosing an antigen does not satisfy the written description requirement for the antibody that binds to it. See Amgen v Sanofi, 872 F.3d 1367 (Fed.Cir.2017).
MPEP §2163(I)(A) states:
“The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. Consider the claim "A gene comprising SEQ ID NO:1." The claim may be construed to include specific structures in addition to SEQ ID NO:1, such as a promoter, a coding region, or other elements. Although SEQ ID NO:1 is fully disclosed, there may be insufficient description of other structures embraced by the claim (e.g., promoters, enhancers, coding regions, and other regulatory elements).”
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. For example, the amino acid sequence of a protein along with knowledge of the genetic code might put an inventor in possession of the genus of nucleic acids capable of encoding the protein, but the same information would not place the inventor in possession of the naturally-occurring DNA or mRNA encoding the protein. See In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993); In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) (holding that a process could not render the product of that process obvious under 35 U.S.C 103).”
MPEP 2163, II A3(a)(ii) states,
For each claim drawn to a genus:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the gen[us]”. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
In the instant case, the specification provides the description of the binding antigen; however, knowing that an antibody binds to a particular amino acid does not tell you anything at all about the structure of the antibody. Moreover, in the instant case, the disclosure of the binding epitope does not provide any information regarding the functional characteristics of the antibody.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, the only factors present in the claims is a reference to the structure of the binding substrate coupled with a requirement to perform certain physiological functions. There is no identification of any particular portion of the structure of what is actually in the claims, the recited antibodies, all suitable for clinical administration. The specification does not provide a complete structure of those anti-CSF3R antibodies that promote a degradation of an accumulated extracellular matrix in the lung tissue upon administration; reduce (decrease) an expression level of Co11a1, OPN, VER, FN and Has3; increase an expression of MMP, and specifically MMP2, MMP9 and MMP13, in the lung tissue of the patient under treatment; decrease an expression of TIMP, and specifically TIMP-1 and TIMP-2; inhibit a CSF3R-mediated EMT in lung cells; decrease an expression of fibronectin, vimentin, N-cad and ZEB1 while increasing an expression of the E-cad; and decrease a binding of STAT3 with CSF3R, and fails to provide a representative number of species within the recited genus Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited genus.
Claims 1-10 and 21 are drawn to the therapeutic use of a genus of antibodies claimed functionally but with no defined structure. The recitation of an antibody that specifically recognizes CSF3R represents a functional characteristic. Moreover, in the instant case, the antibodies of the instant claims must satisfy certain physiological functions upon administration. The instant application is lacking sufficient guidance on the structural attributes of an antibody that correlates to the functional requirements of the claimed invention. Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014, Appeal No. 13-1338 at page 26).
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
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.
8. Claim(s) 1-10 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thesis by In Yeong YUN, 02/2021, reference 5 of IDS filed on 03/06/2024.
Claims 1-10 and 21 are broadly drawn to methods for treating pulmonary fibrosis by administration of an anti-CSF3R antibody. The published YUN document fully teaches that CSF3 is a major regulator of pathology of pulmonary fibrosis and that blockade of CSF3 may reverse the fibrosis, see section IV, and, further, at section 3.5 explains the treatment by administration of CSF3R antibodies, pp. 25-26 at least. Note that claims 2-6, 8 and 9 are limited to one active step of administering anti-CSF3R antibodies while reciting various resulting effects. The results of the same procedure are reasonably expected to be the same; therefore, the disclosure of YUN fully meets the limitations of all claims.
It would have been obvious for one of ordinary skill in the art at the time of filing of the instant patent application to proceed with treatment of pulmonary fibrosis by practicing the step of administration of an anti-CSF3R antibody to a subject in need. One would have been motivated to do so because the thesis of YUN provided experimental results of practicing the treatment within an animal model for pulmonary fibrosis, bleomycin mouse model, thus supporting the expectation of successful outcome of practicing the method. This makes the instant invention fully obvious over the cited prior art.
Conclusion
9. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA N CHERNYSHEV whose telephone number is (571)272-0870. The examiner can normally be reached 9AM to 5:30PM, Monday to Friday.
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/OLGA N CHERNYSHEV/Primary Examiner, Art Unit 1675
July 8, 2026
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