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
Filing Receipt and Priority
The filing receipt mailed 09/20/2024 states that the instant application is a 371 of PCT/EP2020/073889, filed 03/29/2022. The filing receipt also states that the instant application claims foreign benefit of EPO 21194781.7, filed 09/03/2021.
The instant claims are supported by the EPO application. Therefore, the effective filing date is 09/03/2021.
Information Disclosure Statement
The information disclosure statement submitted 11/22/2024 has been considered.
Species Election
Applicant’s election of the hydrochloride salt of the compound below is acknowledged.
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At examiner’s discretion, search and examination has been broadened to include all salts of the compound above.
Claim Objections
Claim 5 is objected against for stating “A process for preparing the compound of the formula (I)….characterized in that the…”. Here characterized takes the place of “comprising” which would be more proper. Typically characterization is used to denote features of a compound or crystal that are used to identify said compound or crystal. A method claim would better use “comprising” to denote the steps involved in the method.
Claim 6 is objected to for stating “The compound according to any of claim 1…”. The phrase “any of” is not needed.
Rejections
Use Claim
Claim Rejections - 35 USC § 101 – Use Claim
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claims 7-8 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter.
Claim Rejections - 35 USC § 112(b) – Use Claim
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 7-8 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.
Claims 7-8 are drawn to “A use” and “There use” (claim 7 and 8 respectively) for producing a medicament for the treatment and/or prophylaxis of diseases. The MPEP section 2173.05(q)I and II state:
I. A “USE” CLAIM MAY BE REJECTED UNDER 35 U.S.C 101 AND/OR 112
It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) if the facts support both rejections. For failure to recite a claim within one of the statutory classes under 35 U.S.C. 101, the appropriate form paragraph is 7.05.01. For indefiniteness under 35 U.S.C. 112(b), the appropriate form paragraph is 7.34.01.
II. BOARD HELD STEP OF “UTILIZING” WAS NOT INDEFINITE
It is often difficult to draw a fine line between what is permissible, and what is objectionable from the perspective of whether a claim is definite. In the case of Ex partePorter, 25 USPQ2d 1144 (Bd. Pat. App. & Inter. 1992), the Board held that a claim which clearly recited the step of “utilizing” was not indefinite under 35 U.S.C. 112, second paragraph. (Claim was to “A method for unloading nonpacked, nonbridging and packed, bridging flowable particle catalyst and bead material from the opened end of a reactor tube which comprises utilizing the nozzle of claim 7.”).
As claims 7 and 8 claim a use without any substantial steps, they are rejected.
Claim Rejections - 35 USC § 112(a)
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 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treatment of thrombotic or thromboembolic disorders in humans and animals in need of treatment, does not reasonably provide enablement for prevention of thrombotic or thromboembolic disorders. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The following Wands factors have been considered if not explicitly state:
(A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The term “prophylaxis” is defined on page 6 of the specification and states “”the terms ‘prevention’, ‘prophylaxis’, and ‘preclusion’ are use synonymously in the context of the present invention and refer to the avoidance or reduction of the risk of contracting, experiencing, suffering from or having a disease, a condition, a disorder, an injury, or a health problem, or a development or advancement of such states and/or the symptoms of such states.”
It is presumed “prevention” of the claimed disorders would require a method of identifying those individuals who will develop the claimed disorders before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
The factors to be considered in making an enablement rejection were summarized above. 1) As discussed above, preventing diseases requires identifying those patients who will acquire the disease before the thrombotic or thromboembolic disorder occurs. This would require extensive and potentially open-ended clinical research on healthy subjects. 2) There is no working example of such a preventive procedure in man or animal in the specification. 3) The state of the art is that no general procedure is art-recognized for determining which patients generally will suffer from thrombotic or thromboembolic disorders before the fact. 4) It is well established that "the 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). 5) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases.
Considering that applicant does not provide any working examples of the instant compounds being effective as preventative compounds and that the state of art is also silent regarding the preventative efficacy of the claimed compounds, there is a significant level of unpredictability and undue burden placed on one of ordinary skill in the art to practice the instant method within the scope as claimed.
Claim Rejections - 35 USC § 112(b)
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 6 and 8-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 states “The compound according to any of claim 1 for the treatment and/or prophylaxis of diseases.”
The term “diseases” is not explicitly defined within the specification. Exemplary diseases are not provided. The specification contemplates “small artery diseases” (p. 11, l. 14), peripheral artery disease (l. 18), vascular disorders (p. 1, l. 4), or infectious diseases caused by bacteria, viruses, and fungi (p. 3, l. 5-6). However, this discussion is only contemplative and does not limit the claim. Therefore the term “disease” is indefinite because it is not clear which specific diseases are being claimed.
Similarly, claims 8 and 10-12 are rejected for the use of “thrombotic or thromboembolic complications”.
The limitation “thrombotic or thromboembolic disorders” is defined within the specification, p. 10, l. 12-27. The limitation “thrombotic or thromboembolic complications” is not defined. The specification also does not provide a method to determine which what is and is not a thrombotic or thromboembolic complication. Because of this, the term is indefinite, making claims 8, and 10-12 indefinite.
Claims 8 and 10-12 use the term “such as”. The use of “such as” is indefinite because it is not clear if applicant is claiming the limitations following the term or if applicant is providing an example. Examiner suggests removing “such as”.
Claim 9 states “The medicament…”. This term lack antecedent basis. Additionally, claim 9 is an independent claim. The claim should instead state “A medicament…”.
Similarly, claim 12 states “The method for the treatment…” where the claim is an independent claim. Claim 12 should instead state “A method for the treatment…”.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
US Patent 11,912,692
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,912,692. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims 1-4 are drawn to a compound, shown below, and its pharmaceutically acceptable salts. The salts claimed in the reference patent include hydrochloride salt, sulfate salt, methanesulfonate, sulfonate, maleate, phosphate tartrate, and citrate salts.
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Reference claim 5 is drawn to a process for preparing a compound of the formula shown above via reacting the following compounds to achieve the final product above.
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Reference claims 7 is drawn to a pharmaceutical formulation comprising the compound I above.
Reference claims 6, 8, and 17 are drawn to methods for treatment and/or prophylaxis of thrombotic or thromboembolic disorders and/or complications and/or inflammatory disorders.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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, 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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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
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