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
This Office action is responsive to Applicant's preliminary amendment filed April 14, 2025. As filed, claim 32 is pending in the instant application. Claims 1-31, 33-53 are cancelled.
Priority
This application filed 01/17/2025 is a Continuation of 18302682 , filed 04/18/2023, now abandoned 18302682 is a Continuation of 17470723 , filed 09/09/2021, now abandoned 17470723 is a Continuation of 16417958 , filed 05/21/2019 ,now U.S. Patent # 11148997; 16417958 is a Continuation of 15527811 , filed 05/18/2017 ,now U.S. Patent # 10343979;15527811 is a National Stage entry of PCT/US2015/061427 , International Filing Date: 11/18/2015 PCT/US2015/061427 Claims Priority from Provisional Application 62081515 , filed 11/18/2014.
Information Disclosure Statement
Applicants' information disclosure statements (IDS) have been considered except where lined through. Please refer to Applicants' copy of the 1449 submitted herewith.
Claim Objections
1.Claim 32 is objected to because of the following informalities: claim 1 should be amended to recite “the method comprising” instead of “comprising”.
2.Claim 32 is objected to for being written in improper Markush format: the recitation in claim 1for definition of variable R2 of Markush formula (A) “is” should be changed to “is selected from the group consisting of” See MPEP 2173.05(h). "When materials recited in a claim are so related as to constitute a proper Markush group, they may be recited in the conventional manner, or alternatively.
3.Claim 32 is objected to for inconsistent claim terminology: treprostinil prodrug is referred to as of having the “formula” and “Formula (A)”.
Appropriate correction is required.
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.
Claim 32 is 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 32 is drawn to a method for making a treprostinil prodrug having the formula reproduced below:
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, comprising mixing, in the presence of an acid catalyst a compound of Formula (A) with a compound of formula R2-OH, wherein R2 is a linear or branched C5-C18 alkyl, a linear C2-C18 alkenyl or a branched C3-C18 alkenyl, aryl, aryl-C1-C18 alkyl, an amino acid or a peptide, incubating the mixture for a sufficient period of time to form the compound of Formula (A).
However, it is not clear how the product of formula (A) could be produced upon reaction of a substrate of the same chemical Formula (A) with alcohol of the formula R2-OH wherein the R2 group in formula (A) remains unchanged during the synthetic method as claimed. The claims are inconsistent with the specification. The reaction of instant disclosure Fig 1 shown below and Scheme 1 on [0123] show reaction of Treprostinil as substrate, derivatized at carboxyl group with alcohol substrates:
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The specific examples of the method of making treprostinil derivative of the according to the reaction of scheme 1 yielded products resulted by reacting R2OH with treprostinil which is not encompassed within the scope of claimed formula A as reactant. As such, the specification fails to set forth a clear boundary in the claims.
The claims are indefinite because is not clear what is the reactive group of formula (A) which makes possible producing a derivative as claimed; or if formula (A) is incorrectly recited in the claim as starting material; alternatively if formula (A) is incorrectly recited in the claim as final product; and the specification fails to set forth a clear boundary in the claims.
Therefore, the claims are indefinite because the boundaries of the protected subject matter are not clearly delineated and the scope is unclear.
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 32 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 32 is drawn to a method for making a treprostinil prodrug having the formula reproduced below:
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, comprising mixing, in the presence of an acid catalyst a compound of Formula (A) with a compound of formula R2-OH, wherein R2 is a linear or branched C5-C18 alkyl, a linear C2-C18 alkenyl or a branched C3-C18 alkenyl, aryl, aryl-C1-C18 alkyl, an amino acid or a peptide, incubating the mixture for a sufficient period of time to form the compound of Formula (A).
ln the compound of formula R2-OH the variable R2 is defined as a linear or branched Cs-C1s alkyl, a linear C2-C18 alkenyl or a branched C3-C18 alkenyl, aryl, aryl-C1-C1s alkyl, an amino acid or a peptide, which read of any peptide chemical group and derivatives thereof.
However, the specification shows only products resulted upon esterification reactions of treprostinil derivates with alcohol R2OH in which the carboxyl group of treprostinil are derivatized as shown on Scheme 1 and examples [0123]-[0139].
Therefore, the claim cover method of producing treprostinil prodrug for which the extent of generalization is broader and different compared to the supported reaction conditions of the examples in the specification.
Furthermore, there are no examples provided on the original disclosure of making a treprostinil prodrug of formula (A) by reacting a compound of formula (A) with a compound of formula R2-OH, as required by instant process of clam 32.
By contrast, the nature and scope of the invention described in the Specification limited to preparation of treprostinil derivative amide of the example 1 and scheme on [0123] and table 6:
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in which products are formed by reacting Treprostinil with alcohol to derivates of treprostinil.
As such a person skilled in the art would not recognize the written description of the invention as providing adequate support for the entire scope of the claimed invention.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163.
The specification, then, is considered absent of sufficiently detailed, relevant, identifying characteristics demonstrating that Applicant was in possession of the genus as claimed, i.e., additional complete or partial structures, other physical and/or chemical properties, functional characteristics coupled with a known or disclosed correlation between function and structure, demonstrating possession of the entirety of the claimed genus.
Applicants have not disclosed a correlation between the claimed functional requirement and the structures that meet that requirement. As such, the claims lack adequate written description for the claimed method of making treprostinil derivative of formula (A).
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
1.Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,343,979. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims generically overlap with Applicants’ instantly claimed invention: “a method for making a treprostinil prodrug having formula (A) comprising mixing, in the presence of an acid catalyst, an alcohol of the formula R2-OH”.
2.Claim 32 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11148997. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims generically overlap with applicants’ instantly claimed invention: “a method for making a treprostinil prodrug having formula (A) comprising mixing, in the presence of an acid catalyst, an alcohol of the formula R2-OH”.
Conclusion
Claim 32 is rejected.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to:
Ana Muresan
(571) 270-7587 (phone)
(571)270-8587 (fax)
Ana.Muresan@uspto.gov
The examiner can normally be reached Monday - Friday (9:00AM - 5:30PM).
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/ANA Z MURESAN/Primary Examiner, Art Unit 1692
