DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 2, 2026 has been entered.
Claims 1-8, 14, 16, 19, 20, 23 have been canceled.
Claims 9 and 27 have been amended.
Claims 32-34 have been added,
Claims 9-13, 15, 17, 18, 21, 22, and 24-34 are pending in the instant application.
Claims 11, 12, 17, and 31 stand withdrawn from consideration as being drawn to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03, for reasons of record set forth in the restriction requirement mailed February 13, 2025.
Applicant’s response and amendments received March 2, 2026 have overcome all grounds of rejection and objection as set forth in the prior office action.
Claims 9, 10, 13, 15, 18, 21, 22, 24-30, and 32-34 are allowable. Claims 11, 12, 17, and 31, previously withdrawn from consideration as a result of a restriction requirement, comprise all the limitations of an allowable claim. Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among inventions 1-3, as set forth in the Office action mailed on February 13, 2025, is hereby withdrawn and claims 11, 12, 17, and 31 are hereby rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, 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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
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 17 and 31 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 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.
Applicant has broadly claimed methods of administering a conjugate comprising blood coagulation factor IX to a subject for the purpose of “preventing” or treating a hemorrhagic disease. While claim 17 places no limits upon the nature of the hemorrhagic disorder dependent claim 31 indicates that such a disorder is to be selected from a small Markush group including congenital and acquired hemophilia B. To support such claims, the specification discloses detailed instructions for making the claimed conjugates in working examples 1 and 3, which such conjugates being tested in vitro for activity in examples 2 and 4. Working example 5 disclose in vivo half life measurements, but data concerning administration for the purpose of treating or preventing a hemorrhagic disease does not appear to be disclosed.
Notably, while the instant specification defines many terms such as on page 7, no particular definition for the terms treatment or prevention appear to be disclosed. Paragraph [0076] simply indicates that the factor IX conjugates disclosed in the specification can be administered to prevent and/or treat hemorrhagic diseases, much as is recited in instant claim 17, but without any indication of how these terms differ from one another in meaning. Administering a factor IX molecule to treat a hemorrhagic disorder is reasonably straightforward, as the subject has the condition and the drug is administered to ameliorate symptoms, and in the case of factor IX its administration to ameliorate the clinical signs and symptoms of hemorrhagic diseases including hemophilia B are extremely well known in the art. See for example US 5,621,039, US 2005/0260194, US 2005/0147618, WO 2012/006633, and US 2016/0362473. The term “prevention” is less straightforward as it could refer to when the drug is administered, such as prophylactic administration to a patient expected to develop but not presently having disease, the level of efficacy such an administration has (for example “treatment” means they get a measurable amount better while “prevention” means that all signs and symptoms are completely gone (i.e. 100% efficacy)) or some combination of timing and efficacy limitations. Dependent claim 31 indicates that for the purpose of the present discussion, “hemorrhagic disease” includes congenital deficiency of FIX, which is more commonly identified as hemophilia B in the art. Given that the lesion in the factor IX gene is present in the subject even prior to birth, their hemophilia can’t be “prevented” as it is necessarily present. It should be noted that administration of exogenous FIX polypeptide to attenuate clinical issues arising from factor IX insufficiency, such as the most obvious manifestation of excessive bleeding, is a cornerstone of hemophilia management, but such prophylactic administrations to attenuate disease severity is not identical to all of the concepts bound up in the term “prevention”. Indeed, it should be pointed out that many patients fail prophylactic therapy for a wide variety of reasons and thus the signs and symptoms of disease are unfortunately still readily apparent (Valentino, see entire document). Thus, while it appears eminently reasonable that the factor IX conjugates claimed in the instant application can readily be administered to subjects presently having hemorrhagic diseases or at risk of developing hemorrhagic disease (prophylaxis) it does not appear that such administrations can “prevent” hemorrhagic disease, especially given that as per claim 31 “hemorrhagic diseases” include hemophilia B (congenital defect) as well as surgical bleeding (and note that performing surgery in the absence of any bleeding whatsoever (i.e. “prevention”) appears unreasonable as clinical data to support such as level of efficacy does not appear to have been presented). Thus artisans would be unable to practice the full extent of the administration methods as presently claimed in the absence of performing additional unpredictable basic science research and experimentation.
Claims 9-13, 15, 18, 21, 22, 24-30, and 32-34 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
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