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 .
Claims 1-22 are pending and examined upon their merits.
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.
Claims 1-22 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.
The term “reducing” the level of free IL-18 in a subject in claim 1 is a relative term which renders the claim indefinite. The term “reducing” is not defined by the claim, nor does the specification provide a standard for ascertaining the requisite degree. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This affects the scope of all depending claims, claims 2-22.
Claims 4-7, 13-18 and 20 are further indefinite wherein they recite the method wherein the subject has abnormal levels relative to levels in healthy controls. However, none of these claims recite active steps whereby levels in either the subject or healthy controls are assessed. Absent positively recited active steps, it is unclear whether or not assessing the levels is required for direct infringement of the invention. Alternatively, the claims may be interpreted as merely reciting inherent properties of the subject on which the method is performed. For purposes of applying prior art, these claims will be interpreted as inherent properties of the subject. This rejection may be obviated by rolling the limitations of instant claim 19, which positively states the active method steps for assessing levels, into these claims.
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.
Claims 12 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.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. Claim 12 recites, “a functional variant” of the IL-18BP of SEQ ID NO:7. The claim does not require that the “variant” possess any particular structure or other distinguishing feature. Therefore, the claims are drawn to a genus of variant molecules.
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 MPEP 2163(II)(3)(a)( i)(A), reduction to drawings MPEP 2163(II)(3)(a) (i)(B), 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 MPEP 2163(II)(3)(a) (i)(C). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
In the instant case, regarding the variants of the claims, the specification provides only the sequence of SEQ ID NO:7 but goes on to state that variants encoding the IL-18BP may have a sequence identity of 80%, 85%, 90%, 91%, 92%, 93%, 94%,95%, 96%, 97%, 98%, 99% or 100% to the sequence depicted in SEQ ID NO: 7 (paragraph [0086]). However, there is no guidance within the disclosure as to which, for example, 20% of SEQ ID NO:7 residues may be altered while maintaining function. Therefore, there is no structure-to-function correlation such that the variants that fall within the claimed genus can be readily identified.
Additionally, Claim 21 recites a genus of “IL-18 associated” diseases or disorders. Claim 22 lists species within this genus, however, the disclosure as filed does not provide sufficient description of the relevant, identifying characteristics of “IL-18 associated” diseases or disorders such that a person having ordinary skill in the art could at once envisage those diseases or disorders that are encompassed by the claimed genus.
Thus, the specification fails to provide adequate description for the genera of variants and “IL-18 associated” diseases or disorders encompassed by the claims. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
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).
Claims 1-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of COPD comprising administering the IL-18BP of SEQ ID NO:7 (specification pg. 83, at (B); and Figure 5), does not reasonably provide enablement for reducing the level of free IL-18 comprising administering any other IL-18 inhibitor or IL-18 binding protein, nor for treating any other disease listed in claim 22. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure would require undue experimentation include:
A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01.
With respect to claim breadth, the standard under 35 U.S.C. §112, first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing the scope of enablement, the claims are analyzed with respect to the teachings of the specification and are to be “given their broadest reasonable interpretation consistent with the specification.” See MPEP 2111 [R-5]; Phillips v. AWH Corp., 415 F.3d 1303, 75 USPQ2d 1321 (Fed. Cir. 2005); and In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).
The breadth of the claims encompasses all methods of reducing the level of free IL-18 comprising administering any IL-18 binding protein inhibitor. In contrast with the breadth of the claims, the specification discloses a single specific IL-18BP consisting of the amino acid sequence of SEQ ID NO:7. While the specification discloses making monoclonal antibodies that bind IL-18 there is no guidance or direction that these antibodies function to reduce the level of free IL-18, as claimed. Therefore, the specification does not enable the full scope of the IL-18 inhibitors encompassed.
Regarding the method of treating, the specification provides only enabling guidance for treating COPD in an art-accepted animal model that is predictive of treatment (pg. 83 at B). Specifically, administration of the IL-18BP of SEQ ID NO: 7 leads to inhibition of neutrophil infiltration in the lung airway space, inhibition of G-CSF, and mitigated weight loss in this COPD animal model (pg. 85). There is no direct evidence that administration results in a reduction in the level of free IL-18, but treatment is enabled nonetheless. There is no enabling guidance for the treatment of any of the other diseases/conditions listed in Claim 22. Thus, a skilled artisan would not know how to use the method with a reasonable expectation of success based solely on what is disclosed in the specification.
The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. In the decision of Genentech, Inc, v. Novo Nordisk, 42 USPQ 2d 1001, (CAFC 1997), the court held that:
"[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable" and that "[t]ossing out the mere germ of an idea does not constitute enabling disclosure". The court further stated that "when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art", "[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement".
The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the claimed method, commensurate in scope with the breadth of the claims, without first making a substantial inventive contribution. Given that the nature of the invention is in vivo treatment, a person having ordinary skill in the art would have to perform multiple further experiments, in either human clinical trials or in animal models that are predictive of treating the IL-18 associated diseases listed within claim 22, in order to demonstrate use of the method with a reasonable expectation of success. The amount of experimentation required for enabling guidance, goes beyond what is considered ‘routine’ within the art, and constitutes undue further experimentation in order to make other IL-18 inhibitors and/or use those with a reasonable expectation of successfully treating any “IL-18 associated disease or disorder”.
Therefore, Claims 1-22 are rejected under 35 U.S.C. 112, first paragraph, for failing to meet the enablement requirement.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2, 4, 7, and 9-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,858,426 issued 8 December 2020. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented (reference) claims are directed to a method of determining the amount of free IL-18 in a sample or in situ comprising detecting the specific binding of IL-18 binding protein (IL-18BP) to free IL-18 protein in the sample or in situ which includes the steps of: a) bringing a sample or a specific body part or body area suspected to contain free IL-18 into contact with the IL-18BP, which specifically binds to free IL-18, but not to IL-18 bound in a complex and functions as the capturing molecule for free IL-18; b) allowing the IL-18BP to bind to free IL-18; c) detecting the binding of IL-18 to the IL-18BP, and determining the amount of free IL-18 in the sample; wherein the IL-18 binding protein (IL-18BP) prevents binding of free IL-18 to IL-18 receptor; and wherein the IL-18BP is a full length IL-18BP or functional equivalent thereof; wherein the IL-18 receptor is IL-18Rα; wherein the IL-18BP is SEQ ID NO: 7 or a functional equivalent thereof; wherein the IL-18BP is SEQ ID NO: 7.
The patented claims read upon the method of the instant claims comprising detecting abnormal levels of free IL-18 and/or abnormal ratio of free IL-18/IL-18BP in the body fluids compared to the levels in the body fluids of a healthy control subject have been determined by a method comprising the steps of: a) bringing a sample or a specific body part or body area suspected to contain free IL-18 into contact with an IL-18 binding molecule, which specifically binds to free IL-18, but not to IL-18 bound in a complex; b) allowing the IL-18 binding molecule to bind to free IL-18; c) detecting the binding of IL-18 to the IL-18 binding molecule and determining the amount of free IL-18 and/or the ratio of free IL-18/IL-18BP in the sample. Depending claims recite the IL-18BP is SEQ ID NO: 7, which is the same IL-BP of the patented claims.
Therefore, the reference claims would either anticipate or render obvious the claims of the instant application.
Claims 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No.11,530,263 issued 20 December 2020. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented (reference) claims are directed to a method for treating an IL-18 associated disease or disorder in a subject, wherein the IL-18 associated disease or disorder is selected from chronic obstructive pulmonary disease (COPD), which is listed in instant claim 22, comprising administering to said subject a therapeutically effective amount of an IL-18 inhibitor, wherein the IL-18 inhibitor is an IL-18 binding protein (IL-18BP). Depending claims state: the subject has abnormal levels of free IL-18 and/or an abnormal ratio of free IL-18/IL-18 binding protein (IL-18BP) in the body fluids compared to the levels in the body fluids of a healthy control subject; said abnormal level of free IL-18 in the body fluids exceeds the level in body fluids of a healthy control subject by 5%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, or more than 100%; said abnormal levels of free IL-18 are elevated levels of free IL-18, wherein the elevated levels of free IL-18 are ≥5 pg/mL; and wherein the body fluid is serum; and the hIL-18BP is a recombinant hIL-18BP. Thus, the reference claims anticipate the subject matter of the instant claims, particularly in view what is enabled by the disclosure as filed (COPD see rejection above).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STACEY NEE MACFARLANE whose telephone number is (571)270-3057. The examiner can normally be reached M-F 7:30-5 (EST) & Sat. A.M..
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, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STACEY N MACFARLANE/Examiner, Art Unit 1675
Prosecution Insights