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
RESPONSE TO ELECTION/RESTRICTION
Applicant’s election without traverse of the elected species of Formula I in the reply filed on 5/27/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
An action on the merits of claims 1,8,11,13-16 and 18-24 is contained herein.
Priority
This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent App No. 63/242,425, filed 9/9/2021. Benefit for the provisional application is not accorded since subject matter disclosed within the instant application is not supported (e.g. the treatment of myelofibrosis specifically). The claims in a U.S. application are entitled to the benefit of a foreign priority date or the filing date of a provisional application if the corresponding foreign application or provisional application supports the claims in the manner required by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Ziegler, 992 F.2d 1197, 1200, 26 USPQ2d 1600, 1603 (Fed. Cir. 1993); Kawaiv.Metlesics, 480 F.2d 880, 178 USPQ 158 (CCPA 1973); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989).
Information Disclosure Statement
The examiner has considered the references cited in the information disclosure statement filed of record.
Specification
Applicant is reminded of the proper content of an Abstract of the Disclosure, see MPEP 608.01(b).
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., "The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics." Exemplification of a species could be illustrative of members of the class. For processes, the type reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
It is recommended that the structure of Formula I be inserted into the abstract to accurately illustrate the claimed invention. Additionally the abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1,8,11,13-16 and 18-24 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 6-8 of US Patent 12,115,153. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The instant claims and claims of ‘153 are drawn to the treatment of myelofibrosis using the compound of formula I or a salt thereof. The recitation in the instant claims “dependent on l-myc gene” does not distinguish between the two methods since one skilled in the art would have viewed that such patients with myelofibrosis would have inherently expressed dependency on that particular gene. Other dependent limitations such as dosing, modes of administration, etc. would have been considered routine experimentation. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Additionally there is no evidence provided of record suggesting whether a patient being treated previously or not with immunotherapy or possess certain protein proliferation rates has any bearing on the overall method of treatment upon administration with the compound of formula I. Thus the claims are not independent or distinct from each other.
Claims 1,8,11,13-16 and 18-24 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 5-6 of US Patent 12,268,681. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The instant claims and claims of ‘681 are drawn to the treatment of myelofibrosis using the compound of formula I or a salt thereof. The recitation in the instant claims “dependent on l-myc gene” does not distinguish between the two methods since one skilled in the art would have viewed that such patients with myelofibrosis would have inherently expressed dependency on that particular gene. Other dependent limitations such as dosing, modes of administration, etc. would have been considered routine experimentation. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Additionally there is no evidence provided of record suggesting whether a patient being treated previously or not with immunotherapy or possess certain protein proliferation rates has any bearing on the overall method of treatment upon administration with the compound of formula I. Thus the claims are not independent or distinct from each other.
Claims 1,8,11,13-16 and 18-24 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 3-6 of US Application 18/690,554. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The instant claims and claims of the copending application are drawn to the treatment of myelofibrosis using the compound of formula I or a salt thereof. The recitation in the instant claims “dependent on l-myc gene” does not distinguish between the two methods since one skilled in the art would have viewed that such patients with myelofibrosis would have inherently expressed dependency on that particular gene. Other dependent limitations such as dosing, modes of administration, etc. would have been considered routine experimentation. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Additionally there is no evidence provided of record suggesting whether a patient being treated previously or not with immunotherapy or possess certain protein proliferation rates has any bearing on the overall method of treatment upon administration with the compound of formula I. Thus the claims are not independent or distinct from each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1,8,11,13-16 and 18-24 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 92-101 of US Application 18/898,634. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The instant claims and claims of the copending application are drawn to the treatment of myelofibrosis using the compound of formula I or a salt thereof. The recitation in the instant claims “dependent on l-myc gene” does not distinguish between the two methods since one skilled in the art would have viewed that such patients with myelofibrosis would have inherently expressed dependency on that particular gene. Other dependent limitations such as dosing, modes of administration, etc. would have been considered routine experimentation. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Additionally there is no evidence provided of record suggesting whether a patient being treated previously or not with immunotherapy or possess certain protein proliferation rates has any bearing on the overall method of treatment upon administration with the compound of formula I. Thus the claims are not independent or distinct from each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1,8,11,13-16 and 18-24 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 5-6 of US Application 19/005,807. Although the conflicting claims are not identical, they are not patentably distinct from each other because there is significant overlap between the two applications.
The instant claims and claims of the copending application may be drawn to the treatment of myelofibrosis using the compound of formula I or a salt thereof. The pending application requires an additional therapeutic which simply falls within the scope of the generic instant claims. The recitation in the instant claims “dependent on l-myc gene” does not distinguish between the two methods since one skilled in the art would have viewed that such patients with myelofibrosis would have inherently expressed dependency on that particular gene. Other dependent limitations such as dosing, modes of administration, etc. would have been considered routine experimentation. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Additionally there is no evidence provided of record suggesting whether a patient being treated previously or not with immunotherapy or possess certain protein proliferation rates has any bearing on the overall method of treatment upon administration with the compound of formula I. Thus the claims are not independent or distinct from each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
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.
Claims 20-23 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 pre-AIA the applicant regards as the invention.
The claims recite indefinite language such as “fragments, conjugates, biosimilars, or variants thereof” wherein the specification or the art in general provides no guidance regarding the explicit chemical structures that may be obtained from the aforementioned modifications of the parent compounds. In respect to the latter, one skilled in the art could not readily interpret the metes and bounds of the claims. Thus the claims are rejected for indefiniteness. Correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1,8,11,13-16 and 18-24 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2019/213074.
The instant claims is drawn to the treatment of myelofibrosis using the compound of formula I or a salt thereof. WO 2019/213074 teaches this method of treatment using the same Formula I (see page 138, claims 1 and 6). Dosage amounts are described at page 26 along with modes of administration at page 86 of the document as well. The recitation in the instant claims “dependent on l-myc gene” does not distinguish between the two methods since one skilled in the art would have viewed that such patients with myelofibrosis would have inherently expressed dependency on that particular gene. Other dependent limitations such as dosing, modes of administration, etc. would have been considered routine experimentation. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Additionally there is no evidence provided of record suggesting whether a patient being treated previously or not with immunotherapy or possess certain protein proliferation rates has any bearing on the overall method of treatment upon administration with the compound of formula I. Thus the claimed method of treatment would have been considered obvious to one skilled in the art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/Primary Examiner, Art Unit 1624
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