DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-15, 18 and 19 are pending in the instant invention. According to the Amendments to the Claims, filed June 12, 2024, claims 1-11, 13, 14 and 18 were amended and claims 16 and 17 were cancelled.
Status of Priority
This invention is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/CN2022/138449, filed December 12, 2022, which claims priority under 35 U.S.C. § 119(a-d) to International Application No. PCT/CN2021/137553, filed December 13, 2021.
Restrictions / Election of Species
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The forthcoming first Office action and prosecution on the merits includes (1) claims 1-15, drawn to substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), shown to the right, and/or a pharmaceutical composition thereof; and (2) claims 18 and 19, drawn to a method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I), shown to the right above, respectively.
Thus, a first Office action and prosecution on the merits of claims 1-15, 18 and 19 is contained within.
Specification Objection - Disclosure
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the inventor’s or joint inventor’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility invention should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase Not Applicable should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR
DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A
COMPACT DISC.
(f) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art (including information disclosed under 37 CFR 1.97
and 1.98).
(g) BRIEF SUMMARY OF THE INVENTION.
(h) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(i) DETAILED DESCRIPTION OF THE INVENTION.
(j) CLAIM OR CLAIMS (commencing on a separate sheet).
(k) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(l) SEQUENCE LISTING (See MPEP § 2424 and 37 CFR 1.821-1.825).
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(b) above and 37 CFR 1.77(c). Revisions should particularly include and/or address: a) section headings (b-i), where applicable; and b) bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests identifying the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I).
The following title is suggested: SUBSTITUTED [1,2,3]TRIAZOLO[4,5-d]PYRIMIDINES AS P2Y12 RECEPTOR ANTAGONISTS.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A compound of Formula (I):
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(I)
or a pharmaceutically acceptable salt thereof,
wherein:
(i) E represents H, F, C(O)R11, C(O)OR11, OH, OR11, or OC(O)R11; and
R11 represents H, C1-8 alkyl, CH2-phenyl, C3-8 alkenyl, C3-8 alkynyl, C3-8 cycloalkyl, heterocyclyl, or aryl;
wherein the C1-8 alkyl, CH2 of CH2-phenyl, C3-8 alkenyl, or C3-8 alkynyl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, CN, NO2, C(O)OH, C(O)OC1-6 alkyl, OH, OC1-3 alkyl, and OC(O)OC1-6 alkyl; and
wherein the phenyl of CH2-phenyl, C3-8 cycloalkyl, heterocyclyl, or aryl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, CN, NO2, C1-3 alkyl, C(O)OH, C(O)OC1-6 alkyl, OH, OC1-3 alkyl, and OC(O)OC1-6 alkyl; or
(ii) E represents:
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G1,
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G2, or
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G3;
A represents a single bond, -CH2-, -CHF-, -CF2-, -CH2CH2-, -C(O)-, -O-, or -S-;
R7 represents H, F, C1-3 alkyl, CH2C(O)OH, CH2OH, or CH2CH2OH;
R12 represents H; or
R7 and R12, taken together with the carbon atom to which they are bonded, form -C(O)-;
R1 represents H, CN, C1-3 alkyl, C1-3 haloalkyl, CH2C(O)OC1-8 alkyl, CH2C(O)phenyl, or CH2OH, CH2CH2OH, wherein the CH2C(O)OC1-8 alkyl or CH2C(O)phenyl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, C(O)OH, and C(O)OC1-6 alkyl;
X represents -O-, -S-, -S(O)-, or -S(O)2-;
R2 represents H, CN, C1-3 alkyl, C1-3 haloalkyl, CH2C(O)OH, CH2C(O)OC1-6 alkyl, CH2OH, CH2CH2OH, CH2CH2CH2OH, C(O)OH, or OC1-3 alkyl;
R3 represents H, CN, C1-3 alkyl, C1-3 haloalkyl, CH2C(O)OH, CH2C(O)OC1-6 alkyl, CH2OH, CH2CH2OH, CH2CH2CH2OH, C(O)OH, or OC1-3 alkyl; or
R2 and R3, taken together with the carbon atom to which they are bonded, form a C3-5 carbocyclyl, wherein the C3-5 carbocyclyl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, C1-3 alkyl, OH, and OC1-3 alkyl;
R4 represents H, halogen, CN, C1-3 alkyl, C1-3 haloalkyl, CH2C(O)OC1-6 alkyl, CH2OH, CH2CH2OH, CH2CH2CH2OH, C(O)OH, C(O)OC1-6 alkyl, NH2, NH(alkyl), N(alkyl)2, OH, or OC1-3 alkyl;
R5 represents H, halogen, CN, C1-3 alkyl, C1-3 haloalkyl, CH2C(O)OC1-6 alkyl, CH2OH, CH2CH2OH, CH2CH2CH2OH, C(O)OH, C(O)OC1-6 alkyl, NH2, NH(alkyl), N(alkyl)2, OH, or OC1-3 alkyl; or
R4 and R5, taken together with the carbon atom to which they are bonded, form a C3-5 carbocyclyl, wherein the C3-5 carbocyclyl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, C1-3 alkyl, OH, and OC1-3 alkyl;
R6 represents H, CN, C1-3 alkyl, CH2OH, or CH2CH2OH;
R8 represents H, C1-6 alkyl, C(O)NHC1-3 alkyl, C(O)N(C1-3 alkyl)2, or C(O)OC1-6 alkyl, wherein the C1-6 alkyl, C(O)NHC1-3 alkyl, C(O)N(C1-3 alkyl)2, or C(O)OC1-6 alkyl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, OH, and OC1-3 alkyl;
Y represents H, C1-8 alkyl, C1-6 alkylene-OC1-6 alkyl, C1-6 alkylene-SC1-6 alkyl, C1-3 alkylene-C3-8 cycloalkyl, C1-3 alkylene-phenyl, C1-3 alkylene-4- to 10-membered heterocyclyl, C3-8 cycloalkyl, C3-8 cycloalkylene-4- to 10-membered heterocyclyl, C3-8 cycloalkylene-phenyl, or 4- to 10-membered heterocyclyl;
wherein the C1-8 alkyl, C1-6 alkylene-OC1-6 alkyl, C1-6 alkylene-SC1-6 alkyl, C1-3 alkylene of C1-3 alkylene-C3-8 cycloalkyl, C1-3 alkylene of C1-3 alkylene-phenyl, and C1-3 alkylene of C1-3 alkylene-4- to 10-membered heterocyclyl is optionally and independently substituted by one or more substituents independently selected from the group consisting of halogen, CN, NO2, NH2, NH(alkyl), N(alkyl)2, OH, OC1-3 alkyl, and C3-6 cycloalkyl; and
wherein the C3-8 cycloalkyl of C1-3 alkylene-C3-8 cycloalkyl, phenyl of C1-3 alkylene-phenyl, 4- to 10-membered heterocyclyl of C1-3 alkylene-4- to 10-membered heterocyclyl, C3-8 cycloalkyl, C3-8 cycloalkylene-4- to 10-membered heterocyclyl, C3-8 cycloalkylene-phenyl, or 4- to 10-membered heterocyclyl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, CN, NO2, C1-3 alkyl, C1-3 haloalkyl, C1-3 alkylene-OC1-3 alkyl, C2-6 alkenyl, C2-6 alkynyl, NH2, NH(alkyl), N(alkyl)2, OH, OC1-3 alkyl, and C3-6 cycloalkyl;
Z represents a single bond, -NH-, -NR10-, -O-, or -S-;
R10 represents C1-6 alkyl; and
R9 represents H, halogen, C1-6 alkyl, alkylene-4- to 6-membered heterocyclyl, aralkyl, C2-8 alkenyl, C2-8 alkynyl, C(O)C1-8 alkyl, C3-8 cycloalkyl, 4- to 6-membered heterocyclyl, or aryl, wherein the C1-6 alkyl, alkylene-4- to 6-membered heterocyclyl, aralkyl, C2-8 alkenyl, C2-8 alkynyl, C(O)C1-8 alkyl, C3-8 cycloalkyl, 4- to 6-membered heterocyclyl, or aryl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, CN, NO2, NH2, NH(alkyl), N(alkyl)2, OH, OC1-3 alkyl, and SC1-3 alkyl;
with the provisos that:
(1) if R8 represents H, then Y does not represent H;
(2) if Y represents H, then R8 does not represent H; and
(3) if Z represents a single bond, then R9 does not represent H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 2 is objected to because of the following informalities: for brevity, clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt thereof, wherein:
X represents -O-; and
R6 represents H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 3 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt thereof, wherein:
R12 represents H;
R1 represents H;
X represents -O-;
R6 represents H;
R8 represents H; and
Z represents -S-.
Appropriate correction is required. See MPEP § 2173.02.
Claim 4 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt thereof, wherein:
R7 represents H;
R12 represents H;
R1 represents H;
X represents -O-;
R6 represents H;
R8 represents H;
Y represents cyclopropylene-4- to 10-membered heterocyclyl or cyclopropylene-phenyl, wherein the 4- to 10-membered heterocyclyl of C3-8 cycloalkylene-4- to 10-membered heterocyclyl or phenyl of C3-8 cycloalkylene-phenyl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, CN, NO2, C1-3 alkyl, NH2, NH(alkyl), N(alkyl)2, OH, OC1-3 alkyl, and C3-6 cycloalkyl;
Z represents -S-; and
R9 represents C1-5 alkyl, C3-8 cycloalkyl, or phenyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 5 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt thereof, wherein:
A represents a single bond or -O-,
R7 represents H;
R12 represents H;
R1 represents H;
X represents -O-;
R6 represents H;
R8 represents H;
Y represents cyclopropylene-4- to 10-membered heterocyclyl or cyclopropylene-phenyl, wherein the 4- to 10-membered heterocyclyl of C3-8 cycloalkylene-4- to 10-membered heterocyclyl or phenyl of C3-8 cycloalkylene-phenyl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, CN, NO2, C1-3 alkyl, NH2, NH(alkyl), N(alkyl)2, OH, OC1-3 alkyl, and C3-6 cycloalkyl;
Z represents -S-; and
R9 represents C1-5 alkyl, C3-8 cycloalkyl, or phenyl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 6 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt thereof, wherein:
R12 represents H;
R4 represents H, F, or OH; and
R5 represents H, F, or OH.
Appropriate correction is required. See MPEP § 2173.02.
Claim 7 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt thereof, wherein:
(i) E represents H, C(O)R11, or OR11; and
R11 represents C1-8 alkyl, CH2-phenyl, heterocyclyl, or phenyl;
wherein the C1-8 alkyl or CH2 of CH2-phenyl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, C(O)OH, C(O)OC1-6 alkyl, OH, OC1-3 alkyl, and OC(O)OC1-6 alkyl; and
wherein the phenyl of CH2-phenyl, heterocyclyl, or phenyl is optionally substituted by one or more substituents independently selected from the group consisting of halogen, C1-3 alkyl, C(O)OH, C(O)OC1-6 alkyl, OH, OC1-3 alkyl, and OC(O)OC1-6 alkyl;
A represents a single bond or -O-;
R12 represents H;
R1 represents H;
R3 represents H;
R6 represents H;
R8 represents H; and
Z represents -S-.
Appropriate correction is required. See MPEP § 2173.02.
Claim 8 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt thereof, wherein:
R12 represents H;
R2 represents CH2OH; and
R3 represents H.
Appropriate correction is required. See MPEP § 2173.02.
Claim 9 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The compound according to claim 1, or a pharmaceutically acceptable salt thereof, wherein Y represents cyclopropylene-phenyl, wherein the phenyl of cyclopropylene-phenyl is substituted by one, two, three, or four F substituents.
Appropriate correction is required. See MPEP § 2173.02.
Claim 10 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b) and/or 35 U.S.C. § 112(d), the existing recitation should be replaced with the following recitation:
The compound according to claim 1, wherein the compound is selected from the group consisting of:
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8,
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19,
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27,
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32,
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39a,
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39b,
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42,
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43,
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49,
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54,
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56,
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60,
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63, and
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or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 11 is objected to because the recitation of an intended use for a pharmaceutical composition must result in a further structural limitation in the pharmaceutical composition in order to be further limiting. In the instant claim, the intent is to use the pharmaceutical composition comprising a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I), for the treatment, amelioration, or prevention of a platelet-mediated thrombotic disease, disorder, or condition. Consequently, since the intended use of the pharmaceutical composition comprising a substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), for the treatment, amelioration, or prevention of a platelet-mediated thrombotic disease, disorder, or condition, (1) fails to result in a further structural limitation to the pharmaceutical composition comprising a substituted [1,2,3]triazolo-[4,5-d]pyrimidine of the Formula (I), and/or (2) fails to include all the limitations of the pharma-ceutical composition comprising a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I), it is not given patentable weight.
The examiner suggests amending the claim, particularly as stated directly below, to overcome this rejection.
Claim 11 is further objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising at least one pharmaceutically acceptable carrier or excipient and a therapeutically effective amount of a compound according to claim 1, or a pharmaceutically acceptable salt thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 12 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
The pharmaceutical composition according to claim 11, wherein the pharmaceutical composition further comprises at least one additional therapeutic agent selected from the group consisting of an antiplatelet agent, an anticoagulant agent, and an antifibrinolytic agent, or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 18 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(a) and/or 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation(s):
18. A method for antagonizing P2Y12 receptor activity in a subject in need thereof, wherein the method comprises administering to the subject a therapeutically effective amount of a compound according to claim 1, or a pharmaceutically acceptable salt thereof.
20. The method according to claim 18, wherein the subject suffers from a platelet-mediated thrombotic disease, disorder, or condition selected from the group consisting of angina, myocardial infarction, peripheral vascular disease, a thrombotic stroke, and a transient ischemic attack.
21. The method according to claim 20, wherein the angina is unstable angina.
Appropriate correction is required. See MPEP § 2173.02.
Claim 19 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
22. The method according to claim 18, wherein the method further comprises administering to the subject a therapeutically effective amount of at least one additional therapeutic agent selected from the group consisting of an antiplatelet agent, an anticoagulant agent, and an antifibrinolytic agent, or a combination thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112:
(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.
Scope of Enablement - Prodrugs of substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I)
Claims 1, 2 and 10 are rejected under 35 U.S.C. § 112(a) because the specification, while being enabling for substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), does not reasonably provide enablement for prodrugs of substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I). 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/or use the invention commensurate in scope with these claims. Prodrugs of substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), as recited in claims 1, 2 and 10, respectively, have not been adequately enabled in the specification to allow any person having ordinary skill in the art, at the time this invention was made, to make and/or use prodrugs of substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the instant invention, are summarized as follows:
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(a) Breadth of the claims - the breadth of the claims includes substituted [1,2,3]triazolo-[4,5-d]pyrimidines of the Formula (I), shown to the right below, as well as the myriad of potential prodrugs formulated from these substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), shown to the right, respectively;
(b) Nature of the invention - the nature of the invention is evaluation of substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), shown to the right above, and/or prodrugs thereof, and the pharmacokinetic behavior of these substances as P2Y12 receptor antagonists;
(c) State of the prior art - Nature Reviews: Drug Discovery offers a snapshot of the state of the drug development art. Herein, drug development is stated to follow the widely accepted Ehrlich model which includes: (1) development of a broad synthetic organic chemistry program; (2) subsequent testing of compounds in an appropriate laboratory model for the disease to be treated; and (3) screening of compounds with low toxicity in prospective clinical trials (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205). Moreover, WO 23/108363 provides a synthesis of the instantly recited substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I) {Zhang, et al. WO 23/108363, 2023};
(d) Level of one of ordinary skill in the art - the artisans synthesizing the inventor’s or joint inventor’s substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), and/or prodrugs thereof, would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience;
(e) Level of predictability in the art - Synthetic organic chemistry is quite unpredictable (See In re Marzocchi and Horton 169 USPQ at 367 ¶3). Similarly, it is unclear based on the combination of the instant specification and Zhang, et al. in WO 23/108363, respectively, whether the instantly recited prodrugs of substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), are enabled. Moreover, the following excerpt is taken from Burger’s, with respect to the synthesis of prodrugs of [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I) {Wolff, Manfred E., Ed. Burger’s Medicinal Chemistry and Drug Discovery - Fifth Edition, Volume 1: Principles and Practice, New York: John Wiley & Sons, 1994, 975-977}:
The design of prodrugs in a rational manner requires that the underlying causes which necessitate or stimulate the use of the prodrug approach be defined and clearly understood. It may then be possible to identify the means by which the difficulties can be overcome. The rational design of the prodrug can thus be divided into three basic steps: (1) identification of the drug delivery problem; (2) identification of the physiochemical properties required for optimal delivery; and (3) selection of a prodrug derivative that has the proper physiochemical properties and that will be cleaved in the desired biological compartment.
The difficulty of extrapolating data from animal to humans encountered during toxicokinetic and toxicologic studies with drugs is amplified with prodrugs, since not only metabolism of the active moiety might differ, but also its availability from the prodrug. As a matter of fact, there is presently no published rational for the conduct of animal and human pharmacokinetic programs during prodrug research and development.
(f) Amount of direction provided by the inventor - the invention lacks direction with respect to making and/or using prodrugs of substituted [1,2,3]triazolo[4,5-d]-pyrimidines of the Formula (I);
(g) Existence of working examples - the inventor or joint inventor has provided sufficient guidance to make and/or use substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I); however, the disclosure is insufficient to allow extrapolation of the limited examples to enable the instantly recited prodrugs of substituted [1,2,3]-triazolo[4,5-d]pyrimidines of the Formula (I). The specification lacks working examples of prodrugs of substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I).
Within the specification, [A]t least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP § 608.01(p) and MPEP § 2173.05.
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(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure - predicting whether a recited compound, and/or a prodrug thereof, is in fact one that produces a desired physiological effect at a therapeutic concentration and with useful kinetics, is filled with experimental uncertainty, and without proper guidance, would involve a substantial amount of experimentation (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205-213). Similarly, the specification, as originally filed, including any references incorporated therein, fails to provide the necessary support required by 35 U.S.C. § 112(a) to enable the instantly recited prodrugs of substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I). Thus, it is unclear, based on the guidance provided by the specification, whether a prodrug of a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I), such as a prodrug of ((2R,3R,4R,5S)-3-(7-(1R,2S)-2-(3,4-diluorophenyl)cyclo-propyl)amino)-5-(propylthio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-4-hydroxy-tetrahydrofuran-2,5-diyl)dimethanol, shown to the left above, is either synthetically feasible or possesses utility as a P2Y12 receptor antagonist.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the invention was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor or joint inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that the inventor or joint inventor is insufficiently enabled for making and/or using prodrugs of substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), is clearly justified.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Enablement - Method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo-[4,5-d]pyrimidine of the Formula (I)
Claims 18 and 19 are rejected under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement because the claims contain subject matter, particularly a method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I), which was not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use (perform) the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor or joint inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. {See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986); and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988)}.
The above factors, regarding the present invention, are summarized as follows:
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(a) Breadth of the claims - the breadth of the claims includes a method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I), shown to the right;
(b) Nature of the invention - the nature of the invention is performance of a method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I), shown to the right above;
(c) State of the prior art - Nature Reviews: Drug Discovery offers a snapshot of the state of the drug development art. Herein, drug development is stated to follow the widely accepted Ehrlich model which includes: (1) development of a broad synthetic organic chemistry program; (2) subsequent testing of compounds in an appropriate laboratory model for the disease to be treated; and (3) screening of compounds with low toxicity in prospective clinical trials (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205). Similarly, no single drug has been discovered that is effective in treating the myriad of platelet-mediated thrombotic diseases, disorders, or conditions in a subject…, including, but not limited to, angina, myocardial infarction, peripheral vascular disease, a thrombotic stroke, and/or a transient ischemic attack {See In re Hokum, 226 USPQ 353 (ComrPats 1985)}. Moreover, WO 23/108363 illustrates the synthesis of substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), and/or methods of use thereof { Zhang, et al. WO 23/108363, 2023};
(d) Level of one of ordinary skill in the art - the artisans performing the inventor’s or joint inventor’s method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I) would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience;
(e) Level of predictability in the art - Synthetic organic chemistry is quite unpredictable (See In re Marzocchi and Horton 169 USPQ at 367 ¶3). Similarly, it is well established that [T]he scope of enablement varies inversely with the degree of unpredictability of the factors involved, and physiological activity is generally considered to be an unpredictable factor {See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970)}.
Moreover, the following excerpt is taken from Hackam, et al., with respect to the poor replication of animal research in human clinical trials {Hackam, et al. JAMA, 296(14), 2006, 1731-1732}:
Only about a third of highly cited animal research translated at the level of human randomized trials. This rate of translation is lower than the recently estimated 44% replication rate for highly cited human studies. Nevertheless, we believe these findings have important implications. First, patients and physicians should remain cautious about extrapolating the findings of prominent animal research to the care of human disease. Second, major opportunities for improving study design and methodological quality are available for preclinical research. Finally, poor replication of even high-quality animal studies should be expected by those who conduct clinical research.
(f) Amount of direction provided by the inventor - the invention lacks direction with respect to making and/or using (performing) a method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I);
(g) Existence of working examples - the disclosure is insufficient to allow extrapolation of the limited examples to enable performing the instantly recited method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo-[4,5-d]pyrimidine of the Formula (I).
Similarly, according to the specification, substituted [1,2,3]triazolo[4,5-d]-pyrimidines of the Formula (I) are capable of treating a variety of platelet-mediated thrombotic diseases, disorders, or conditions in a subject…, including, but not limited to, angina, myocardial infarction, peripheral vascular disease, a thrombotic stroke, and/or a transient ischemic attack; however, the specification fails to set forth any convincing in vitro and/or in vivo assays corroborating the alleged activity in association with any platelet-mediated thrombotic diseases, disorders, or conditions in a subject…, including, but not limited to, angina, myocardial infarction, peripheral vascular disease, a thrombotic stroke, and/or a transient ischemic attack. There is insufficient disclosure to reasonably conclude that the method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I), as recited, would contribute to treatment of any platelet-mediated thrombotic diseases, disorders, or conditions in a subject…, including, but not limited to, angina, myocardial infarction, peripheral vascular disease, a thrombotic stroke, and/or a transient ischemic attack. Furthermore, the combination of the instant specification and Zhang, et al. in WO 23/108363, respectively, lacks adequate credible evidence to support the assertion that a method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I), as recited, would contribute to the prophylaxis of any platelet-mediated thrombotic diseases, disorders, or conditions in a subject…, including, but not limited to, angina, myocardial infarction, peripheral vascular disease, a thrombotic stroke, and/or a transient ischemic attack, since the inventor or joint inventor has neither provided convincing data for any subject population, nor indicated any art recognized correlation between the disclosed data and the breadth of the claims.
Within the specification, [A]t least one specific operative embodiment or example of the invention must be set forth. The example(s) and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP § 608.01(p) and MPEP § 2173.05.
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(h) Quantity of experimentation needed to make and/or use (perform) the invention based on the content of the disclosure - predicting whether a recited compound is in fact one that produces a desired physiological effect at a therapeutic concentration and with useful kinetics, is filled with experimental uncertainty, and without proper guidance, would involve a substantial amount of experimentation (Jordan, V. C. Nature Reviews: Drug Discovery, 2, 2003, 205-213). Furthermore, it is unclear, based on the guidance provided by the specification, whether a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I), such as ((2R,3R,4R,5S)-3-(7-(1R,2S)-2-(3,4-diluorophenyl)cyclopropyl)amino)-5-(propyl-thio)-3H-[1,2,3]triazolo[4,5-d]pyrimidin-3-yl)-4-hydroxytetrahydrofuran-2,5-diyl)-dimethanol, shown to the left above, possesses utility as a therapeutic agent, useful in a method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I). Thus, one of ordinary skill in the art, at the time this invention was made, would have an unreasonable expectation of success and undue experimentation in transferring the in vitro and/or in vivo method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo-[4,5-d]pyrimidine of the Formula (I), wherein the platelet-mediated thrombotic disease, disorder, or condition in a subject, includes, but is not limited to, angina, myocardial infarction, peripheral vascular disease, a thrombotic stroke, and/or a transient ischemic attack, to any subject population.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the invention was filed, would not have taught one skilled in the art how to make and/or use (perform) the full scope of the claimed invention without undue experimentation. {See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (See In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor or joint inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that the inventor or joint inventor is insufficiently enabled for making and/or using (performing) a method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition… in a subject… comprising administering… a substituted [1,2,3]triazolo[4,5-d]pyrimidine of the Formula (I) is clearly justified.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 1-6, 8, 9, 11-15, 18 and 19 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 1 recites the limitations, H, with respect to A, where the limitation is implausible, resulting in an incomplete valence. Claims are unduly speculative where they define only a portion of a substituted [1,2,3]triazolo[4,5-d]-pyrimidine of the Formula (I). Consequently, since incomplete valences are not permitted in the structure of the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), an essential portion of the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I) is indefinite and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I). {See Ex parte Pedlow and Miner, 90 USPQ 395 (Bd. Pat. App. & Int. 1951)}.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 11 and 12 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 11 recites the limitation, A pharmaceutical composition for the treatment, amelioration or prevention of a platelet-mediated thrombotic disease, disorder, or condition including…, in lines 1-2 of the claim.
Similarly, the inventor or joint inventor should further note that MPEP § 2111.03 states the transitional term, comprising, which is synonymous with including, containing, or characterized by, is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. {See Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004); Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948); and Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005)}.
Likewise, the inventor or joint inventor should further note that [A] Markush group must be definite and complete as to its membership. A Markush group is indefinite, and claims are rejected, where the Markush group is defined as comprising. {See Ex parte Morrell, 100 USPQ 317 (Bd. Pat. App. & Int. 1953)}.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this rejection.
Claims 18 and 19 are further rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 18 recites the limitation, A method for the treatment or prevention of a platelet-mediated thrombotic disease, disorder, or condition including…, in lines 1-2 of the claim.
Similarly, the inventor or joint inventor should further note that MPEP § 2111.03 states the transitional term, comprising, which is synonymous with including, containing, or characterized by, is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. {See Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004); Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948); and Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005)}.
Likewise, the inventor or joint inventor should further note that [A] Markush group must be definite and complete as to its membership. A Markush group is indefinite, and claims are rejected, where the Markush group is defined as comprising. {See Ex parte Morrell, 100 USPQ 317 (Bd. Pat. App. & Int. 1953)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Next, the inventor or joint inventor should further note that a broad limitation together with a narrow limitation that falls within the broad limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c), MPEP § 2173.05(h), and/or Eli Lilly & Co. v. Teva Parenteral Meds., 845 F.3d 1357, 1371, 121 USPQ2d 1277, 1287 (Fed. Cir. 2017).
Then, the inventor or joint inventor should further note that claim 18 independently recite the broad limitation, angina, and the claim also recites unstable angina, which is the narrower statement of the limitation.
Moreover, the inventor or joint inventor should further note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), pertaining to where broad language is followed by such as and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and consequently, not required, or (b) a required feature of the claim.
Furthermore, the inventor or joint inventor should also note the explanation given by the Board of Patent Appeals and Interferences in the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
Also, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Claim Rejections - 35 U.S.C. § 112(d)
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
(d) REFERENCE IN DEPENDENT FORMS. Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 13 is rejected under 35 U.S.C. § 112(d) because the recitation of an intended use for a compound must result in a further structural limitation in the compound, in order to be further limiting. In the instant dependent claim, the intent is to use the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), as recited in claim 1, for therapy. Consequently, since the intended use of the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), as recited in claim 1, for therapy, fails to result in a further structural limitation to the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), as recited in claim 1, and/or fails to include all the limitations of the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claim, (2) amend the dependent claim to place the dependent claim in proper dependent form, (3) rewrite the dependent claim in independent form, or (4) present a sufficient showing that the dependent claim complies with the statutory requirements, to overcome this rejection.
Claims 14 and 15 are rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The inventor or joint inventor should note that claim 14 is rejected under 35 U.S.C. § 112(d) because the recitation of an intended use for a compound must result in a further structural limitation in the compound, in order to be further limiting. In the instant dependent claim, the intent is to use the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), as recited in claim 1, for the treatment, amelioration, or prevention of a platelet-mediated thrombotic disease, disorder, or condition. Consequently, since the intended use of the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), as recited in claim 1, for the treatment, amelioration, or prevention of a platelet-mediated thrombotic disease, disorder, or condition, fails to result in a further structural limitation to the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), as recited in claim 1, and/or fails to include all the limitations of the substituted [1,2,3]triazolo[4,5-d]pyrimidines of the Formula (I), as recited in claim 1, it is not given patentable weight and thus, renders the instant dependent claim, and any additional dependent claims therefrom, improperly dependent under 35 U.S.C. § 112(d). {See MPEP § 2111.02; and 37 CFR 1.75(c)}.
Similarly, the inventor or joint inventor should further note that the U.S. Court of Appeals for the Federal Circuit indicated that although the requirements of 35 U.S.C. § 112(d) are related to matters of form, non-compliance with 35 U.S.C. § 112(d) renders the claim unpatentable just as non-compliance with other subsections of 35 U.S.C. § 112 would. {See Pfizer, Inc. v. Ranbaxy Labs., Ltd., 457 F.3d 1284, 1291-92 (Fed. Cir. 2006)}.
Moreover, the inventor or joint inventor should further note that if a dependent claim does not comply with the requirements of 35 U.S.C. § 112(d) the dependent claim should be rejected under 35 U.S.C. § 112(d) as unpatentable rather than objecting to the claim. {See also MPEP § 608.01(n), Section III, Infringement Test for dependent claims}.
The examiner suggests the inventor or joint inventor (1) cancel the dependent claims, (2) amend the dependent claims to place the dependent claims in proper dependent form, (3) rewrite the dependent claims in independent form, or (4) present a sufficient showing that the dependent claims comply with the statutory requirements, to overcome this rejection.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
Prosecution Insights