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 .
Applicant's amendment and remarks, filed 6/11/26, are acknowledged.
Claims 2-3, 6, 8-10, 12 have been amended.
Claims 13-15 have been added.
Claims 2-10 and 12-15 are pending.
Claims 2-5 and 13-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 6-10 and 12 are being acted upon.
The 35 U.S.C. 112b, 112d, and the 112a enablement rejection are withdrawn in view of Applicant’s claim amendments.
The prior art rejections are withdrawn in view of Applicant’s claim amendments. However, Applicant’s arguments relevant to the new prior art rejections will be addressed below.
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 6-10 and 12 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 SAA inhibitors.
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 methods employing an extremely large genus of structurally distinct molecules. For example, the claims encompass antibody inhibitors, small molecule inhibitors, nucleic acids, or peptides. Furthermore, SAA consists of a family of proteins that has pleiotropic functions and despite more than fifty years since its discovery, its true biological functions remain enigmatic (See Ji, 2025). Thus, there is not an art recognized correlation between structure and function. Regarding antibody inhibitors, the claims encompass methods employing a broad genus of structurally different antibodies. For example, the claims encompass bispecific antibodies, monoclonal antibodies, antibody mimetics or antibodies derived from different species, such as human, mouse, or rat that would have different VH and VL sequences. Furthermore, the claims encompass a genus of antibodies that bind to different epitope regions of a genus of SAA proteins, or those with different affinities or pharmokinetic properties. The state of the art is such that antibody based therapy is extremely complex and requires a deep understanding of protein-engineering techniques, mechanisms of action and resistance, and the interplay between the immune system. Furthermore, the development of candidate antibodies involves a complex process of clinical and preclinical evaluation that include identification of the physical and chemical properties of the antibody (see Scott et al, pages 278-279, of record). Antibodies have a wide range of pharmacokinetics, effector functions, size and immunogenicity, affinities and avidities, all of which effect the function of each antibody in vivo (see Scott et al., 2012, page 278, in particular). Additionally, antibody variable regions are composed of a heavy and light chain, each involved in providing for binding specificity. Variability in the antigen binding site is achieved by V(D)J recombination via heavy and light chain pairing, with the most diverse regions being the 6 CDR regions in the heavy and light chain. For example Janeway, teaches that the antibody repertoire in humans is at least 1011, with a large degree of diversity in both heavy and light chains. See, for example, Rabia, 2018, which teaches that the maximal chemical diversity of antibody CDRs is unimaginably large and is extremely challenging to define the sequence determinant of antibody specificity (see page 4). The specification does not provide a correlation between structure and function for the inhibitors as broadly claimed. The only species of inhibitors specifically disclosed by the instant specifical is HDL and mc1 and mc29 monoclonal antibodies. It is noted that Mc1 and Mc29 are disclosed in the prior art as being detrimental and reducing survival from sepsis (see US 2015/0023957). The specification does not provide any guidance regarding what types of inhibitors are to be used in each of the distinct disease encompassed by the present claims. No species of bispecific peptides, antibody mimetics or small molecule inhibitors are disclosed by the instant specification. The disclosed species are not sufficiently representative of the broad genus of inhibitors that function in the genus of disease 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 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. 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.
Applicant’s arguments filed 6/11/26 have been fully considered, but they are not persuasive.
Applicant argues that the amendment to claim 12 to remove the treating of disease is remedial. The claims still encompass a large genus of inhibitors of any structure (i.e. peptide, nucleic acid, antibody, small molecule) that function to inhibit SAA. The specification does not disclose a correlation between structure and function, nor does it disclose a representative number of species for the reasons set forth above.
The following are new grounds of rejection necessitated by Applicant’s claim amendments.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitation “means” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The claim passes the three prong test since the claim recites a function of inducing normal temperature or hypothermia, uses the term “means” and the claim is not modified by sufficient structure, material, or acts for performing the claimed function.
However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The specification on page 6 discloses that means for actively inducing hyperthermia are not particularly limited and are known in the art. This is not sufficient disclosure of the corresponding structure, material, or acts for performing the claimed function of inducing hyperthermia. Nor is it sufficient for performing the entire claimed function, since nothing is mentioned regarding means for inducing normal temperature, as recited in the present claims. For the purposes of applying prior art, the claim is being interpreted to encompass any means for inducing normal temperature, other than administration of the SAA inhibitor.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 6-10 and 12 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.
The claims lack written description for the “means” for inducing hyperthermia or normal temperature because the specification fails to disclose the corresponding structure, material, or acts for performing the claimed function for the same reasons set forth above.
Claims 6-10 and 12 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. This is a new matter rejection.
The specification and the claims as originally filed do not provide support for the invention as now claimed, specifically:
A) A method wherein an SAA inhibitor is administered before, concurrently with, or after actively inducing normal temperature or hypothermia in said subject by means “other than administration of said inhibitor of SAA” (Claim 12, and dependent claims 6-10).
B) A method comprising administering to a subject an inhibitor of SAA (Claim 12 and dependent claims 6-7, 9-10).
It is noted that applicant has not cited any support for the new limitation in the specification. A review of the specification fails to reveal support for the new limitations.
Regarding A), any negative limitation or exclusionary proviso must have basis in the original disclosure. The mere absence of a positive recitation is not basis for an exclusion. Applicant does not cite any support for the negative limitation. The specification on page 6 discloses that means for actively inducing hyperthermia are not particularly limited and are known in the art. This does not provide any basis for the negative limitation of the instant claims.
Regarding B), the specification discloses using SAA inhibitors to treat conditions and diseases characterized by dysregulation and excessive inflammation in a subject in need thereof. The present claims (other than dependent claim 8) are much broader than what is disclosed in the instant specification and encompass administration of an SAA inhibitor to any subject, such as a healthy subject or a subject with a non-inflammatory condition.
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.
Claims 6-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0023957 (of record, see 11/17/22 IDS), in view of US 20160333081 (of record, see 892 mailed 2/11/26).
The ‘957 publication teaches a method of treating sepsis in a subject comprising administering to the subject an antibody inhibitor of SAA (See pages 2, 11-12, in particular). The ‘957 publication teaches treating human subjects (see page 11, in particular). The ‘957 publication teaches giving repeated doses of the antibodies (see paragraph 60 and 121, in particular). The ‘957 publication teaches SAA neutralizing antibodies that bind to various epitopes within SAA1 or SAA2 (see Table 2, in particular). The ‘957 publication teaches said antibody inhibitor as part of a pharmaceutical composition with a pharmaceutically acceptable carrier (see page 11, in particular).
The reference differs from the claimed invention in that it does not explicitly teach actively inducing normal temperature in the subject by means other than administration of said SAA inhibitor.
The ‘081 publication teaches that fever is a well-known symptom of sepsis, and that treatment methods for sepsis can comprise administration of secondary agents that include NSAIDs, anti-infectives, or antibiotics (See paragraph 15 and 35, 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, that other treatments could be provided, as taught by the ‘081 publication, in the method of treating sepsis of the ‘957 publication. For example, it would also be obvious that the sepsis patient treated in the method of the ‘957 publication would have fever, since it is a well-known symptom of sepsis, and that it would be obvious to concurrently further administer secondary agents, such as NSAID, anti-infectives, or antibiotics (i.e. means for inducing normal temperature other than administration of said inhibitor of SAA), to further treat sepsis and actively resolve the fever and return body temperature to normal for a human patient, i.e. 37 degrees C.
Applicant’s arguments filed 6/11/26 have been fully considered, but they are not persuasive.
Applicant argues that the ‘957 publication discloses methods of treating sepsis using PAD inhibitors and antibodies directed against citrullated histones, and does not teach or suggest inhibition of SAA.
The teachings of the ‘957 publication relate to the use of antibody SAA Inhibitors to treat sepsis, and not to PAD inhibitors as argued by Applicant.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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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