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 .
DETAILED ACTION
The Amendment filed 8/4/2026 in response to Office Action of 2/5/2026, is acknowledged and has been entered. Claims 1, 14-20, 22, 23, 26, 28 and 29 are now pending. Claims 1, 16 and 26 are amended. Claims 27 and 28 are new.
Previous Rejections cited in Office Action dated 2/5/2026:
112(a) WD is withdrawn due to amendments
112a enablement regarding prophylaxis is withdrawn due to amendments
103 rejection is withdrawn in view of arguments and amendments
Claims 1, 14-20, 22, 23, 26, 28 and 29 are under prosecution.
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 16, 26 and 29 remain 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 combination of rituximab and blinatumomab for treatment of a hyperproliferative disorder, does not reasonably provide enablement for (1) the combination of an “anti-cancer antibody” wherein the anticancer antibody is one of the following: margetuximab, naxitamab, tafasitamab, isatuximab, mogamuizumab, olaratumab, daratumumab, elotuzumab, necitumumab, dinutuximab, ramucirumab, obinutuzumab, pertuzumab, ofatumumab. panitumumab, cetuximab, alemtuzumab, trastuzumab, or edrecolomab; and (2) wherein the T-cell activating agent is catumaxomab, for the treatment of a hyperproliferative disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
BREADTH OF THE CLAIMS: Claim 16 recites a method for maintaining long-term natural killer (NK) cell antibody-dependent cellular cytotoxicity (ADCC) in the treatment of a hyperproliferative disorder in a mammal in need thereof comprising, administering to the mammal a combination of (a) an anti-cancer antibody, wherein the anti-cancer antibody is a monospecific antibody, and wherein the monospecific antibody is margetuximab, naxitamab, tafasitamab, isatuximab, mogamuizumab, olaratumab, daratumumab, elotuzumab, necitumumab, dinutuximab, ramucirumab, obinutuzumab, pertuzumab, ofatumumab. panitumumab, cetuximab, alemtuzumab, trastuzumab, rituximab, or edrecolomab, and (b) a T cell activating agent, wherein the T cell activating agent is blinatumomab or catumaxomab, and wherein the T cell activating agent is administered as an intermittent dosage, for the therapeutic treatment of the hyperproliferative disorder. Claim 26 recites A kit comprising a T cell activating agent, a container, and a package insert or label indicating the administration rituximab and the intermittent administration of blinatumomab or catumaxomab for treating a hyperproliferative disorder.
STATE OF THE ART: It is well known that the art of anti-cancer therapy is highly unpredictable, for example, Gura (Science, 1997, 278:1041-1042) teaches that researchers face the problem of sifting through potential anticancer agents to find ones promising enough to make human clinical trials worthwhile and teach that since formal screening began in 1955, many thousands of drugs have shown activity in either cell or animal models that only 29 have actually been shown to be useful for chemotherapy See p. 1041, see 1st and 2nd para. Furthermore, Kaiser (Science, 2006, 313: 1370) teaches that 90% of tumor drugs fail in patients. See 3rd col., 2nd to last para. Additionally, Chames et al (British J. of Pharmacology, 2009, 157, 220-233) teach that there are several challenges to development therapeutic antibodies. These challenges include functional limitations such as inadequate pharmacokinetics, tissue accessibility and impaired interactions with the immune system (Abstract). Additionally, Chames teaches several limitations of therapeutic antibodies such as affinity between the antibody and its antigen, competition with patient’s IgG, and efficiency issues in triggering the immune response (pages 224-225).
PRESENCE OR ABSENCE OF EXAMPLES: The instant specification discloses the following: Example 1 describes the use of rituximab, an anti-CD20 monoclonal antibody, and the long-term effects on Natural Killer cell responses and effects of T-cells. Example 2 describes use of rituximab or trastuzumab to determine effects on NK cells. Thus, Examples 1 and 2 demonstrate the effects of just an anti-cancer antibody. Example 3 demonstrates use of a bispecific antibody, blinatumomab and rituximab, these agents were cultured in target Raji cells for one week and the results demonstrate that small numbers of T cells activated by blinatumomab enhanced RTX-mediated ADCC and NK cell number. No other examples in the specification are disclosed that demonstrate the claimed method of other anti-cancer antibodies and T-cell activating agents.
PREDICTABILITY: The specification lacks the critical steps necessary in presenting some type of predictable response in a population of hosts deemed necessary to treat hyperproliferative disorders with any anti-cancer antibody and any T-cell engaging agent. The amount of experimentation required to formulate such guidance would be enormous; one would have to demonstrate the efficacy of the combination in several models across several different types of cancers and determine the appropriate regimen (doses and frequency) for use of the combination or composition in a treatment setting.
Thus, considering the high level of skill in the art, the state of the art, the level of predictability, and the guidance and examples provided, the experimentation required to enable the full scope of the claimed invention would not be reasonable.
QUANTITY OF EXPERIMENTATION: Undue experimentation would be required to determine what anti-cancer antibody and what T-cell activating agent predictably treat a hyperproliferative disease as claimed. MPEP 2164.01 recites that “The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976)”. The experimentation needed to practice this method is undue and unreasonable as it requires determining whether the claimed agents treat what hyperproliferative disorder. A person skilled in the art will not be able to use the invention without undue experimentation. (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988))
Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Response to Arguments
Applicant argues that claim 16 has been amended to recite that element (a) an anti-cancer antibody, is rituximab, and element (b) a T cell activating agent, is blinatumomab (or blinatumomab or catumaxomab, in claim 26).
No other arguments for the claim is provided. The rejection for these claims is maintained as the specification only provides enablement for the combination of rituximab and blinatumomab.
Allowable Subject Matter
Claims 1, 14, 15, 17-20, 22, 23, and 28 and are allowed.
The following is an examiner’s statement of reasons for allowance: The claims have been amended to recite a method for treating a hyperproliferative disorder in a mammal in need thereof comprising, administering to the mammal a combination of (a) an anti-cancer antibody, wherein the anti-cancer antibody is a monospecific antibody, and wherein the monospecific antibody is rituximab, and (b) a T cell activating agent, wherein the T cell activating agent is blinatumomab, and wherein the T cell activating agent is administered as an intermittent dosage, for the prophylactic or therapeutic treatment of the hyperproliferative disorder.
The closest prior art made of record is d'Argouges et al (Combination of rituximab with blinatumomab (MT103/MEDI-538), a T cell-engaging CD19-/CD3-bispecific antibody, for highly efficient lysis of human B lymphoma cells. Leuk Res. 2009 Mar;33(3):465-73, of record), and Oak et al (2015). (Blinatumomab for the treatment of B-cell lymphoma. Expert Opinion on Investigational Drugs, 24(5), 715–724, of record). d'Argouges teaches a method for treating a hyperproliferative disorder, cancer, comprising administering a combination of (a) an anti-cancer antibody, rituximab, and (b) a T-cell activating agent, for the treatment of cancer, blinatumomab. Oak teaches a method for treating cancer, B-cell lymphoma, comprising administering blinatumomab. However, a search of relevant art demonstrates that teaches away from administration blinatumomab intermittently. The art demonstrates that blinatumomab has a short half life (~2 hours) and that intermittent or short-term dosing has not been demonstrated to be effective and only demonstrates continuous administration of the agent. [see Oak pg 719, Pharmacokinetics and metabolism]
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 SARAH A ALSOMAIRY whose telephone number is (571)272-0027. The examiner can normally be reached Monday-Friday 7:30 AM to 5:30 PM.
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/SARAH A ALSOMAIRY/ Examiner, Art Unit 1646
/Zachariah Lucas/ Supervisory Patent Examiner, Art Unit 1600
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