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 .
Applicant's arguments filed 4/24/2026 have been fully considered but they are not fully persuasive.
Claims 1, 5, and 17 have been cancelled.
The rejection of claims 1, 3, 7, 8, 10, 11 and 16 under 35 U.S.C. 102(a)(2) as being anticipated by Tian et al. (U.S. Patent No. 12,258,419, of record) is withdrawn in view of cancellation of independent claim 1. Tian et al. does not disclose the sequence limitations of independent claim 2.
Election/Restrictions
Claim 2 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), claims 18-20, directed to the process of using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104. Claims 12-15, directed to the invention(s) of Group II is not subject to rejoinder and has NOT been rejoined.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between groups I and III as set forth in the Office action mailed on 8/28/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 12-15 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/28/2025.
Claims 2-3, 6, 7-11, and 16 are allowable. Dependent claims 6 and 9 must retain the CDRs recited in independent claim 2; otherwise, they would not be properly dependent.
Specification
The substitute specification submitted 4/24/2026 has been entered.
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.
Claim 4 is 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.
Claim 4 has been amended to recite “framework regions derived from a heavy chain template” and “framework regions derived from a light chain template.” Applicant has pointed to basis in paragraphs [0016-0017] and Example 7. Basis for “derived from” is not seen.
Paragraphs [0016] states that the antibody “may have” the named light chain and heavy chain templates. Paragraph [0017] states that particular back mutations can be made. Example 7 exemplifies particular changes to the templates.
None of these sections disclose the general concept of framework regions derived from the recited light and heavy chain templates where these derived framework can further have the recited back mutations.
Claim 4 constitutes new matter.
Claims 18-20 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 methods as discussed below, does not reasonably provide enablement for all methods encompassed by the claims. 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.
Paragraph [0111] of the specification defines “treatment” as referring to administering the claimed antibodies or antigen-binding fragments as a therapeutic agent to a subject who has had, is suspected of having, or is predisposed to having one or more diseases or symptoms thereof on which the therapeutic agent is known to have a therapeutic effect. Generally, the therapeutic agent is administered in an amount effective to alleviate one or more symptoms of the disease in the subject or population being treated, whether by inducing regression of such symptoms or inhibiting the development of such symptoms into any clinically measurable degree. Administration shall alleviate the symptoms of the disease of interest in a statistically significant number of subjects.
Paragraph [0112] defines an “effective amount” as an amount sufficient to ameliorate or prevent a symptom of a medical disorder.
Claim 18 is directed to a method for treating and/or preventing a thrombotic or thromboembolic disorder, a thrombotic or thromboembolic complication, cardiac arrhythmia, cardiogenic thromboembolism, or disseminated intravascular coagulation disease in a subject in need thereof, the method comprising: administering to the subject an effective amount of the anti-FXI/FXIa antibody or the antigen-binding fragment thereof according to claim 2. The claim does not require any particular therapeutic effect for the “treatment” embodiment. As such, all aspects of treatment as set forth above must be enabled.
Claim 19 depends upon claim 18 and lists particular disorders and complications. Claim 20 depends upon claim 18 and specifies that the subject has ischemic stroke related to atrial fibrillation and/or deep vein thrombosis.
The specification does not set forth the criteria by which one of ordinary skill in the art at the time of the effective filing date would have been able to identify a subject “suspected of having” or “predisposed to having” any of the recited diseases, complications, or symptoms. That is, the specification does not enable choosing the “subject in need” in claim 18.
Example 10 discloses inhibition of FXIa enzymatic activity by anti-FXI/FXIa antibodies in vitro.
Example 11 discloses aPTT and PT anticoagulant activity in human/monkey blood in vitro.
Example 12 discloses that administration of the 3882 antibody to cynomolgus monkeys inhibited thrombogenesis and prolonged the endogenous coagulation time but had no significant effect on the bleeding time and the exogenous coagulation time. See also Figure 5A-D.
Example 13 discloses that administration of the 3882 antibody to cynomolgus monkeys significantly prolonged the endogenous coagulation time and inhibited the activity of FXI. See also Figure 6A-B.
These results do not demonstrate preventing a thrombotic or thromboembolic disorder, a thrombotic or thromboembolic complication, cardiac arrhythmia, cardiogenic thromboembolism, or disseminated intravascular coagulation disease in a subject as recited in claim 18. The results cannot be extrapolated to predict prevention.
These results do not demonstrate preventing cardiac coronary artery disease, ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (non-STEMI), stable angina pectoris, unstable angina pectoris, reocclusion and restenosis after coronary interventions, peripheral arterial occlusive disease, pulmonary embolism, venous thromboembolism, venous thrombosis, transient ischemic attack, thrombotic stroke and thromboembolic stroke, pulmonary disease caused by chronic thromboembolic pulmonary hypertension (CTEPH), pulmonary hypertension caused by CTEPH, and a combination thereof as recited in claim 19. The results cannot be extrapolated to predict prevention.
With respect to treatment, the animal models in the examples are not art accepted animal models for the disorders, diseases, complications, and symptoms encompassed by the claims. The results cannot be extrapolated to predict all aspects of treatment (as defined by the specification) of these disorders, diseases, complications, and symptoms. At least for example, there is no evidence of record nor reason to believe that administration of the claimed antibodies would reverse cardiac tissue damage after a myocardial infarction (i.e. a complication or symptom). At least for example, there is no evidence of record nor reason to believe that administration of the claimed antibodies would reverse brain tissue damage after a thrombotic stroke (i.e. a complication or symptom). At least for example, there is no evidence of record nor reason to believe that administration of the claimed antibodies would reverse the build-up of fatty plaque in the arteries (i.e. atherosclerosis, a complication or symptom of coronary artery disease and peripheral arterial occlusive disease).
With respect to claim 20, the claim indicates that the subject has ischemic stroke related to atrial fibrillation and/or deep vein thrombosis. However, the claim does not indicate what is particularly being treated (e.g. ischemic stroke, atrial fibrillation, deep vein thrombosis, and/or other) or what therapeutic outcome must be achieved.
The scope of the claims is not enabled.
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 18-20 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.
Claim 18 is confusing in reciting “treating and/or preventing.” If the method prevents the recited disorders or complications, then there is nothing to treat. If treatment is required, then the method has not resulted in prevention. Treating “and” preventing cannot occur at the same time.
Conclusion
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 MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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