DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed 2/18/26 in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/21/26 has been entered.
Claims 3-5, 24-27, 32, 38 are pending and are under examination.
The rejections under 35 U.S.C. 103 are withdrawn in view of Applicant’s remarks.
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.
Claim 5 is 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.
Claim 5 is indefinite since it recites a list of options i)-iv) in the alternative, wherein option iv) recites that “the neutropenia is not associated with a fever”. The only antecedent basis for the neutropenia is in options i)-iii). The claim is indefinite because it is not clear what is encompassed when option iv) is selected from alternatively recited list, since it appears to only define the scope of “the neutropenia’ in the preceding options i)-iii). For example, would selecting option iv) encompass a method wherein administration of the antibody does not induce neutropenia associated with a fever (in other words, any amount of neutropenia could be induced, so long as it not associated with a fever). Or does the claim intend that the limitations of part iv) only modify the preceding neutropenia. For example, administration of the antibody induces grade 2 or grade 3 neutropenia, wherein the neutropenia is not associated with a fever. The scope of the claim is unclear and indefinite.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 3-5, 24-27, 32, 38 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is insufficient written description to demonstrate that applicant was in possession of the claimed genus of antibodies that bind to G-CSFR comprising a VH and VL comprising “an” amino acid sequence set forth in SEQ ID NO: 2-5 or a heavy chain and light chain comprising “a” sequence set for in SEQ ID NO: 14/15 or 14/16.
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, reduction to drawings, 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 MPEP 2163.
The instant claims are directed to a method of treating hidradenitis suppurative (HS) or palmoplantar pustulosis (PPP) comprising administering an antibody that binds to G-CSFR, wherein the antibody comprises a VH comprising “an” amino acid sequence set forth in SEQ ID NO: 2 or 4, and a VL comprising “an” amino acid sequence set forth in SEQ ID NO: 3 or 5. For example, a single CDR would be “an amino acid sequence” set forth in SEQ ID NO: 4. Thus the claims would encompass antibodies comprising as little as a single CDR region of the VH and VL domain of SEQ ID NOs: 4 and 5, for example. The state of the art is such that the 6 CDRs of an antibody are critically involved in antigen binding, that even single amino acid changes can alter antigen specificity of binding, and that CDR mutations are unpredictable in terms of affinity, specificity, and solubility, and are also context dependent (see Hall, 1992, and Rabia, 2018). The specification discloses antibodies having a VH comprising SEQ ID NO: 4 and a VL comprising SEQ ID NO: 5, or antibodies having a VH comprising SEQ ID NO: 2 and a VL comprising SEQ ID NO: 3. The specification discloses using antibodies having the three CDRs of said VH and VL. This is not sufficiently representative of the genus of antibodies encompassed by the present claims.
The instant application has not provided a sufficient description showing possession of the necessary 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 genus of antibodies and inhibitors encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002).
In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "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.)
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning – i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims.
Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
Amendment to recite that the VH comprise “the” amino acid sequence set forth in SEQ ID NO: 4 and the VL comprises “the” amino acid sequence set forth in SEQ ID NO: 5, for example, would be remedial.
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.
Claim(s) 3-5, 24-27, 32, 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 9,193,793 (of record), in view of Kurokawa, 2004 and Iwata, 2017.
The ‘793 patent discloses a method of treating a G-CSF associated condition in a subject comprising administering an antibody that binds to hG-CSFR (see column 13-14, and 38-39, in particular). The ‘793 patent teaches a method of treating a G-CSF mediated condition in a subject, and a method of reducing the number of neutrophils in a subject without inducing neutropenia, comprising administering an antibody that binds to hG-CSFR (see column 13, in particular). The ‘793 patent teaches treating human subjects (See column 24, in particular). The ‘793 patent teaches administering an amount of the antibody sufficient to reduce the number of neutrophils without inducing moderate or severe neutropenia (see column 14, in particular). The ‘793 patent teaches administration of amounts between 0.5 mg/kg and 2 mg/kg, such as 0.5 mg/kg or 1 mg/kg, or a dose of 0.1 mg/kg (see column 14 and 41, in particular). The ‘793 patent teaches administration of multiple doses of the antibody such as every 14 or 21 days (see columns 41-42, in particular). The ‘793 patent teaches that the antibody neutralizes G-CSF signaling (see column 2, in particular). The ‘793 patent teaches that the antibodies comprise a VH and VL having SEQ ID NO: 4 and 5, which are identical to SEQ ID NO: 4 and 5 of the present application (see column 5, in particular). The ‘793 patent further teaches that the antibodies comprise a heavy and light chain as set forth in SEQ ID NO: 64/68 and 65, which are identical to SEQ ID NO: 14/16 and SEQ ID NO: 15 of the instant application (See column 14, in particular). The ‘793 patent discloses that moderate neutropenia is an ANC greater than or equal to 500 and less than 1000 cells per microliter, while severe neutropenia is an ANC of less than 500 cells per microliter (see column 23-24, in particular). The instant specification on page 15 discloses that grade 3 neutropenia is ANC of greater than 500 and less than 1000 cells per microliter (i.e. the same as the “moderate” neutrophil as taught in the ‘793 patent). The instant specification defines grade 4 neutropenia as less than 500 cells/ul, i.e. the same as the severe neutropenia described in the ‘793 patent. Since the ‘793 patent teaches that the method does not induce moderate or severe neutropenia (i.e. grade 3 or 4 neutropenia), it would meet the limitation of “without causing sustained grade 3 or grade 4 neutropenia for greater than 7 consecutive days” as recited in the claims. The ‘793 patent discloses that the methods include treating any inflammatory condition that is caused by or exacerbated by G-CSF in a subject, and that G-CSF associated conditions include those associated with administration of G-CSF (see columns 23 and 38-39, in particular).
The reference differs from the claimed invention in that it does not explicitly teach treating palmoplantar pustulosis (PPP).
Kurokawa teaches that G-CSF administration can cause skin disorders and that G-CSF exacerbates PPP.
Iwata teaches that G-CSF causes and/or exacerbates PPP (see page 1223 and 1225, in particular).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to treat PPP as taught by Kurokawa and Iwata, as the condition exacerbated by G-CSF in the method of treatment taught in the ‘793 patent. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because Kurokawa and Iwata teach that PPP is exacerbated by G-CSF and the ‘793 patent teaches that the anti-G-CSFR antibodies are useful for treating any inflammatory conditions that is caused by or exacerbated by G-CSF in a subject.
No claim is allowed. The claimed method of treating HS is free of the prior art. Kelly, 2015, teaches that IL-17 and IL1 are elevated in HS lesions, and suggest that anti-IL-1 or anti-IL17 therapies may be effective in HS. Kelley does not teach anything regarding the role of G-CSF in HS. Wolk, which is published in 2021 (after the filing date of the claimed invention) teaches that no data demonstrating the function of G-CSF in HS were previously available, and that their study for the first time demonstrates an abundance of G-CSF in diseased HS skin. Thus, given that a role of G-CSF in causing or exacerbating HS was not recognized at the time the invention was made, it would not have be obvious to treat HS as the G-CSF mediated condition int the method of the ’793 patent.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY E JUEDES whose telephone number is (571)272-4471. The examiner can normally be reached on M-F from 7am to 3pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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