DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-13 are pending.
Applicants’ election without traverse of “non-fatal myocardial infarction” as the species of “recurrent cardiovascular event” in the reply filed on 2/3/26 is acknowledged.
Claim 12 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-11 and 13 are under consideration, as they read upon the elected species.
Specification
The disclosure is objected to because of the following informalities:
---The title of the invention is not descriptive because it is directed generally to any use of canakinumab, but the claims are limited to a method of treatment by administering canakinumab. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Method for Reducing the Risk of Recurring Cardiovascular Events by Administering Canakinumab”.
Appropriate correction is required.
Claim Interpretation
The terms “approximately every 3 months” and “approximately 3 months after” and as used in each of independent claims 1, 2 and 5 has the scope as defined by the specification at ¶ 194: “[i]n another embodiment the term “approximately 3 months” includes a time period of 90 days+/−15 days or 90 days+/−10 days”. Thus, an administration “approximately every 3 months” broadly encompasses an administration every 75 to 105 days, and assessed “approximately 3 months after” broadly encompasses assessed after 75 to 105 days.
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 1-11 and 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 pre-AIA the applicant regards as the invention.
Claims 1, 2 and 5 are indefinite with regard to the recitation "about 150 mg to about 300 mg of canakinumab" (claim 1, line 3; claim 2, lines 3 and 6-7) or “about 150 mg” (claim 5, line 3) due to the use of the term "about". Per MPEP 2173.05(b)(III)(A), “In determining the range encompassed by the term “about”, one must consider the context of the term as it is used in the specification and claims of the application”. In the instant case, the specification does not provide a limiting definition of the term, only providing an exemplary definition; specifically, that “the term “about” in relation to a numerical value x means, for example, +/-10%” (page 29, lines 22-23). Thus, due to the use of the term "about", the claim is indefinite as to what degree of variation is encompassed; for example, "about 150 mg to about 300 mg" could encompass a range of 149.9 to 300.1 mg, 149 to 301 mg, 145 to 305 mg or 100 to 400 mg, to list several of the many alternate possibilities. For purposes of advancing prosecution, the term is interpreted as encompassing each of the alternate possibilities that the indefinite term reads upon.
Claims 8-11 each recites the limitation “said recurrent CV event” in line 2. There is insufficient antecedent basis for this limitation in the claim. Specifically, parent claim 1 recites “said recurrent CV events”, which is plural, and thus does not provide sufficient antecedent basis for “said recurrent CV event”, which is singular.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Note on Prior Art Rejection(s)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thuren et al, U.S. Patent Application Publication 2014/0356356, published 12/4/2014. The earliest date to which the instant application claims priority is 8/25/17.
In claim 1, the recitation of “for reducing risk of or preventing recurrent cardiovascular (CV) events” has been considered in the context of the entire claim, and is interpreted as an intended use for the method because it does not result in a manipulative difference between the method as defined by the steps and a prior art method teaching the same steps. See MPEP 2111.02. As such, this intended use does not distinguish the claimed method from a prior art method comprising the same step(s).
Furthermore, the concluding wherein clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04, which states that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited" (Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Specifically, in claim 1, the concluding wherein clause simply expresses the intended result (a reduced hsCRP level at a subsequent time point) of a process step positively recited (administration of the antibody canakinumab).
Thus, with respect to anticipation by the prior art, claim 1 encompasses a method comprising administering 150 mg of canakinumab every 3 months to a patient that has suffered myocardial infarction (MI) and has a hsCRP level of ≥ 2 mg/L at least 28 days after MI and before administration of canakinumab, and wherein the canakinumab is administered at the earliest 30 days after MI.
Thuren teaches a method of administering “about 25 mg to about 300 mg of an Ilβ binding antibody” to a patient “that has suffered a qualifying CV event” and wherein the patient “has a CRP level of ≥1 mg/L before administration of said antibody” (¶ 33). Thuren further specifies that in “one embodiment of any method of the invention, said CRP level is ≥2 mg/L” (¶ 34). Thuren further specifies that the CRP level can be the hsCRP level (¶ 37). Thuren further specifies that the amount of antibody can be 150 mg (¶ 46). Thuren further specifies that the antibody is canakinumab (e.g., ¶ 2, 31, 62). Thuren further teaches that the antibody can be administered “quarterly (every 3 months)” (¶ 41). Thuren further teaches that the term qualifying CV event includes “MI” (myocardial infarction) (¶ 148). Thuren further teaches that the antibody is administered 1 month after the CV event (¶ 39), and that that “screening will take place no earlier than” “28 days after the index MI” (¶ 255). As such, Thuren teaches a method meeting all of the limitations of instant claim 1, and thus anticipates claim 1.
Independent claim 2 encompasses a method having the same preamble as in claim 1, and as such this is interpreted as intended use for the same reasons. The concluding wherein clause is different in claim 2, reciting that the patient “will continue to receive” the same dosage of canakinumab approximately every 3 months, provided said patient has a reduced hsCRP level of <2 mg/L assessed approximately 3 months after the first administration of canakinumab. This is contingent “wherein” clause, as per MPEP 2111.04.II, “Contingent Limitations”. The method does not expressly recite a step requiring an administration or a step requiring an assessment, instead only reciting the contingency that if the patient has reduced hsCRP after 3 months, they will be administered further canakinumab. Per MPEP 2111.04.II, if the condition is not satisfied, the performance need not be carried out. As such, claim 2 broadly encompasses a method wherein a further administration is not made because the patient does not meet the intended result (i.e., hsCRP level). As such, claim 2 broadly encompasses a method comprising administering to the patient 150 mg of canakinumab, wherein said patient has a hsCRP level of ≥2 mg/L assessed at least 28 days after MI and before a first administration of canakinumab, and wherein the canakinumab is administered at earliest 30 days after MI. This method is met by the same teachings of Thuren that meet the limitations of claim 1. As such, the teachings of Thuren also anticipate claim 2.
Claims 3 and 4 encompass a method of claim 1 wherein the antibody dosage is 150 mg. The teachings of Thuren that anticipate claim 1 described above are directed to an embodiment wherein 150 mg of canakinumab is administered. As such, the teachings of Thuren also anticipate claims 3 and 4.
Independent claim 5 is directed to a method having the same limitations as claim 1, except that the dosage of canakinumab is limited to about 150 mg. The teachings of Thuren that anticipate claim 1 described above are directed to an embodiment wherein 150 mg of canakinumab is administered. As such, the teachings of Thuren also anticipate claim 5.
Claims 6-7 each encompass a method of claim 1 wherein the reduced level of hsCRP after 3 months of canakinumab administration is <1.8 mg/L (claim 6) or <1.5 mg/L (claim 7). As such, these claims further limit the concluding wherein clause of parent claim 1, and each simply expresses the intended result (a reduced hsCRP level at a certain time point) of a process step positively recited (administration of the antibody canakinumab). Therefore, claims 6 and 7 are reach anticipated by the teachings of Thuren for the same reasons as for parent claim 1.
Claims 8-11 each encompass a method of claim 1 wherein the recurrent CV event is “non-fatal MI”. The recurrent CV event is recited solely in the preamble of claim 1; as such, the further limitation of each of claims 8-11 is directed solely to the preamble of the parent claim; i.e., “for reducing the risk or preventing recurrent cardiovascular (CV) events” wherein the event is “non-fatal MI”. This recitation is interpreted as an intended use for the same reasons set forth above for parent claim 1. As such, this intended use does not distinguish the claimed method from a prior art method comprising the same step(s). Therefore, each of claims 8-11 is anticipated by the teachings of Thuren for the same reasons as for parent claim 1.
Claim 13 encompasses a method of claim 1 wherein the patient concomitantly receives standard of care treatment for reducing risk of recurrent CV event. Thuren further teaches that, “[i]n other embodiments of any method of the invention, said patient is concomitantly receiving standard of care treatment for preventing or reducing risk of experiencing recurrent CV events”. As such, the teachings of Thuren also anticipate claim 13.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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