DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Application
Claims 42-48 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 12/04/2025 are acknowledged. Claims 42 and 44 are amended and new claims 46-48 are added. Claim 44 is no longer withdrawn due to Applicant’s amendments. Claims under consideration in the instant office action are claims 42-48.
Applicants' arguments, filed 12/04/2025, have been fully considered and they are deemed to be persuasive. The rejection of claims 1-8, 13-18, 22-31, 35-41, and 42 under 35 USC 102 and 103 are withdrawn due to Applicant’s amendments. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
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 42-44 and 46-48 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 the diagnosis of multiple myeloma patients or patients with MGUS, does not reasonably provide enablement for the diagnosis of any cancer or disease. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, "Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue', not 'experimentation'" (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations" (Wands, 8 USPQ2d 1404). Among these factors are: (i) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method of diagnosing a cancer or disease comprising the use of an antibody comprising a heavy chain selected from IgG, IgA, IgM, IgD, and IgE. The breadth of the claims thus covers that any antibody comprising the recited heavy chains is capable of diagnosing any given cancer or disease, which have completely different etiologies.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
The state of the art as shown by Fritz et al. teaches “the methods involve evaluation, e.g., cytogenetic screening, of biological tissue sample from a subject, e.g., a patient who has been diagnosed with or is suspected of having cancer (e.g., presents with symptoms of cancer) to detect one or more alteration in RAS ( e.g., one or more of H-Ras, N-Ras, or K-Ras), EGFR, PIK3CA, RAF (e.g., one or more of A-Raf, B-Raf(BRAF) orC-Raf), PTEN, AKI, TP53 (p53), CTNNBl (beta-catenin), APC, KIT, JAK2, NOTCH, FLT3, MEK, ERK, RSK, EIS, ELK-1, or SAP-1.” (paragraph 0318). However, Fritz et al. is silent as to the use of the recited antibodies for the diagnosis of any cancer or disease.
Within the scope of cancers, which does not cover the full breadth of the claimed invention, Simone (Introduction: Oncology) teaches that for all cancers, "each specific type has unique biologic and clinical features that must be appreciated for proper diagnosis, treatment and study” (pg. 1004). Furthermore, different types of cancers affect different organs and have different methods of growth and harm to the body. Thus, it is beyond the skill of oncologists today to provide a diagnosis using the recited antibodies for a wide range of cancers.
(5) The relative skill of those in the art:
Those of relative skill in the art are those with a level of skill of the authors of the references cites to support the examiner’s position (MD’s or those with advanced degrees and the requisite experience in medicine).
(6) The amount of direction or guidance presented and (7) the presence of absence of working examples:
The specification provides working examples only for the diagnosis of multiple myeloma or patients with MGUS comprising the use of an antibody comprising a heavy chain selected from IgG, IgA, IgM, IgD, and IgE. Thus, the specification has only provided working examples with two cancers, but not for the diagnosis of any given cancer or disease.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Fritz et al. and Simone above, and the high unpredictability in the art as evidenced therein, and the lack of guidance provided by the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Conclusion
Claims 42-44 and 46-48 are rejected.
Claim 45 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691