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 .
Election/Restrictions
1. Applicant’s election without traverse of Group II in the reply filed on May 07, 2026 is acknowledged.
2. Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention(s), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 07, 2026.
Claims 15 and 16 are under examination.
Claim Objections
3. Claims 15 and 16 are objected to because of the following informalities:
The claims recite “HERV-W ENV” without first providing the full name of the term. It is suggested that the term be spelled out at its first use and in all independent claims so that it is clearly understood what it stands 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.
4. Claims 15 and 16 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.
5. Claim 15 is vague and ambiguous for reasons that follow. First, the claim is indefinite insofar as it employs the term “psychotic disease” as a limitation. This term is not known in the relevant prior art of record as being associated with well-defined genus of pathological. Moreover, because the instant specification does not identify that property or combination of properties which is unique to and, therefore, definitive of a “psychotic disease”, an artisan cannot determine if a disease which meets all of the other limitations of a claim would then be included or excluded from the claimed subject matter by the presence of this limitation.
6. Second, the claim recites the limitation “a patient diagnosed with a psychotic disease belongs to a subgroup of patients suffering from psychotic disease,” which renders the claimed subject matter indefinite because the difference between being diagnosed and belonging to a subgroup is not clear from the claim or the specification as filed.
7. Third, it is not obvious and cannot be determined from the claim or the specification as filed who or what pathology is “characterized with a high level of a cytokine in a body fluid sample.”
8. Finally, the term “high” in claim 15 is a relative term which renders the claim indefinite. The term “high” is 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.
9. Applicant is advised that one of the purposes of the 112, second paragraph is to provide a clear warning to others as to what constitutes infringement of the patent (see, e.g., Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The test for definiteness under 35 U.S.C. § 112, second paragraph, is whether “those skilled in the art would understand what is claimed when the claim is read in light of the specification.” Orthokinetics, Inc. v. Safety Travel Chairs, Inc., 806 F .2d 1565 (Fed. Cir. 1986) (citations omitted).
In precedential decision Ex parte Kenichi Miyazaki, Appeal 2007-330, BPAI stated “In particular, rather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amendable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph.”
Further, the federal Circuit stated in Halliburton Energy Servs.:
When a claim limitation is defined in purely functional terms, the task of determining whether that limitation is sufficiently definite is a difficult one that is highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the relevant art area). We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiner demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
Halliburton Energy Servs. V. M-ILLC 514 F .3d 1244, 1255 (Fed. Cir. 2008) (emphasis added).
10. Similar to claim 15, claim 16 is indefinite insofar as it employs the term “psychotic disease” as a limitation see reasons of record earlier, section 5.
11. Next, claim 16 recites limitations “characterized with” and “HERV-W ENV detected in a body fluid sample” set forth in a passive voice. This renders the claim indefinite because it is not clear if the characterization and detection are part of the invention.
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.
12. Claims 15 and 16 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 15 and 16 specifically require possession of cytokines that are specifically associated with a subgroup of psychotic diseases. Claims 15-16 further require possession of anti-HERV-Q ENV antibodies suitable for clinical administration to treat the patients who belong to a subgroup of psychotic diseases characterized with a high level of cytokine(s) in a body fluid sample. The claims do not require that the cytokines and antibodies possess any particular conserved structure or other disclosed distinguishing feature. Thus, the claims are drawn to a genus of cytokines that is defined only by reference to the term, “a cytokine,” and a genus of antibodies that is defined by the binding epitope. However, the instant specification fails to describe the entire genus of cytokines and genus of antibodies, which are encompassed by these claims.
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).”
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, with respect to the use of a cytokine, the only factor present in the claims is a requirement to be present in high level during pathology of psychotic disease. With respect to anti-HERV-W ENV antibody, the only written description present within the claims defines the binding epitope of the antibody. The specification does not provide a complete list of cytokines that are present at high levels in a body fluid during psychotic disease or the structure of those anti-HERV-W ENV antibodies suitable for clinical administration and immediate benefit to treat a psychotic disease, or a subgroup thereof. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited genus of cytokines and recited genus of antibodies.
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). 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).
13. Claims 15 and 16 are further rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 15 and 16 are broadly directed to methods of diagnosis and treatment of a subgroup of psychotic diseases characterized by high levels of a cytokine in a body fluid sample obtained from a patient under testing by administration of an anti-HERV-W ENV antibody. However, the specification does not provide sufficient guidance to enable practice the full scope of the claimed invention without undue experimentation.
The enablement requirement is met when one skilled in the art, having read the specification, could practice the invention without “undue experimentation.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d at 1336 (Fed. Cir. 2013). The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and, (8) the breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The specification discloses presence of HERV-W ENV, and different, elevated, levels of IL-1β, IL-6 and TNF-α in serum samples obtained from patients suffering from schizophrenia and bipolar disorder, Fig 14a and 14d, p. 58-59. There appears to be no further information disclosed within the specification as originally filed, to provide guidance for the claimed methods, such as any other group of cytokines, or other psychotic disorders, described in such detail so to support the invention, as claimed.
The nature of the invention involving biological molecules and their effect on a physiological system is complex and unpredictable. As was found in Ex parte Hitzeman, 9 USPQ2d 1821 (BPAI 1987), a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology", Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991).
The prior art recognizes association of HERV-W ENV with pathology of multiple sclerosis and in particular of schizophrenia and bipolar disorder, see US published patent application 2017/0101461 (cited as US 2019/0263895, reference 2 of IDS of 11/25/2022), and Perron et al. Trans Psychiatry, 2012, 2, e201. However, finding of high levels of cytokines or presence of HERV-W ENV in general in every psychotic condition has not been reported.
With respect to claim breadth, the standard under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing the enablement scope of the claims, the teachings of the specification are to be taken into account because the claims are to be given their broadest reasonable interpretation that is consistent with the specification (see MPEP 2111 [R-1], which states that claims must be given their broadest reasonable interpretation. “During patent examination, the pending claims must be "given *>their< broadest reasonable interpretation consistent with the specification." 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).”
As such, the broadest reasonable interpretation of the claimed methods is that they allow treatment of any psychotic disease characterized by an elevated level of any cytokine, as determined in any body fluid sample, by administration of any anti-HERV-W ENV antibody. Thus, the claims encompass an unreasonable number of pathological conditions, characterized by altered levels of different cytokines and not necessarily associated with HERV-W ENV expression or even its presence whatsoever, which the skilled artisan would not know how to evaluate. As opposed to the claims, what is disclosed about the claimed method is narrow: a set of experiments limited to two diseases and three cytokines and no other obvious specific examples of psychotic pathologies, disclosure of specific levels of particular cytokines, or examples, real or prophetic, of meaningful treatment, as currently claimed.
Applicant has left those skilled in the art with too much experimentation to research and discover for themselves what psychotic diseases belong to a subgroup of the psychotic diseases that are specifically associated with altered levels of specific cytokines and the effect, if any, of administration of an anti-HERV-W ENV antibody to a patient suffering from the identified subgroup of pathologies. The art does not teach that elevated levels of cytokines in general are directly associated with psychotic pathology. The specification does not teach how to make decisions about the choice of cytokines, critical “high” levels, effective doses of the antibody, specific routes and regimes of administration, or how to determine when the antibody is actually targeting HERV-W ENV, especially if HERV-W ENV is not present or expressed during the diagnostic stpe of the claimed method. As such, Applicant has merely provided a starting point for research and experimentation and not a meaningful enabling disclosure of how to practice the claimed invention. Therefore, the claimed methods of diagnosis and treatment clearly lack enablement, as disclosed. In fact, the specification does not describe a single embodiment that satisfies the claim limitations.
A mere wish or plan of obtaining the claimed invention is not sufficient. The standard of an enabling disclosure is not the ability to make and test if the invention worked 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. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. In the decision of Genentec, Inc, v. Novo Nordisk, 42 USPQ 2d 100, (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 and practice the claimed methods without first making a substantial inventive contribution to perfect the method and complete the invention.
Conclusion
14. 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.
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.
/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
June 10, 2026
Prosecution Insights