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 .
DETAIL ACTION
This office action is a response to the following:
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As filed, claims 1-56 are pending.
Election/Restrictions
Regarding the election of species requirement, the Applicant made their election, which is shown below, with traverse. The traversal is on the ground(s) that the Office has not provided any reasons or examples to support a conclusion that the species are indeed patentably distinct, and the Examiner has not shown a burden in a search and a search has not been extended. Therefore, the election of species requirement is improper and should be withdrawn.
This is not found persausive because the species of myocardial infarction for advserse cardiovascular event, for instance, is patentably distinct from the species of death, and the species of a subject having a previous coronary revascularization procedure, for instance, is patentably distinct from the species of a subject has type II diabetes There would be a serious search and examination burden because each species require a different field of search (e.g. employing different search queries, etc.); and the prior art applicable to one species would not be applicable to other species.
Accordingly, the election of species requirement is still deemed proper and is therefore made FINAL.
Regarding the election of species requirement, Applicant elected the species of myocardial infarction for the instantly claimed Adverse Cardiovascular Event; and the species of the subject having a previous coronary revascularization procedure for the instantly claimed subject in need thereof, which can be found in paragraphs 0016 and 0031 of the instant specification, respectively. The claims, which read on the elected species, are instant claims 1-8, 10, 13, 15, 16, 41, and 53-56, according to Applicant’s reply filed on 7/16/2026.
Claims 9, 11, 12, 14, 17-40, and 42-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does not make a contribution over the prior art.
According to MPEP 803.02: should the elected species appear non-allowable, the search of the Markush-type claim will not be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/1/2024 and 9/4/2024 has been considered by the Examiner.
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 1-8, 10, 13, 15, 16, 41, and 53-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Rationale and Design of Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy with Pitavastatin in Coronary Artery Disease (REAL-CAD) Trial”, hereinafter Miyauchi (see IDS filed 8/1/2024), as evidenced by “High-Dose Versus Low-Dose Pitavastatin in Japanese Patients With Stable Coronary Artery Disease (REAL-CAD)”, hereinafter Taguchi (see IDS filed 8/1/2024).
Regarding claims 1-8, 10, 13, 15, 16, 41, and 53-56, Miyauchi, for instance, teaches the prevention of adverse cardiovascular event, such as myocardial infarction, in a subject with stable coronary artery disease who had a previous coronary revascularization procedure via the subject taking an initial dosage of 1 mg/day of pitavastatin. When the subject reached an LDL-C concentration less than 120 mg/dL, the subject increased the dosage of pitavastatin to 4 mg/day, which reduced LDL-C level to approximately 80 mg/dL.
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(pg. 316, right column 3rd paragraph)
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(pg. 317, Figure)
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(pg. 315, summary)
Although Miyauchi did not explicitly teach increase in HDL-C level in the subject or decrease in TG level/hs-CRP level in the subject, the Examiner finds the resulting dosage of pitavastatin at 4 mg/day should increase the HDL-C level in the subject and/or decrease the TG level/hs-CRP level in the subject. This is supported by evidentiary reference Taguchi (see data below), which shows that pitavastatin at 4 mg/day reduced the level of LDL, TG, and hsCRP level when compared to pitavastatin at 1 mg/day, as well as increase the HDL level when compared to pitavastatin at 1 mg/day.
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(Taguchi, pg. 2002, Figure 2)
Claims 1-8, 10, 13, 15, 16, 41, and 53-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by READ-CAD Program Information from https://www.csp.or.jp/Id/real-cad/sitemap/index.html., hereinafter REAL-CAD (see IDS filed 8/1/2024), as evidenced by Taguchi (see IDS 8/1/2024).
Regarding claims 1-8, 10, 13, 15, 16, 41, and 53-56, REAL-CAD, for instance, teaches the prevention of adverse cardiovascular event, such as myocardial infarction, in subject having a previous coronary revascularization procedure via the subject taking an initial dosage of 1 mg/day of pitavastatin. When the subject reached an LDL-C concentration less than 120 mg/dL, the subject increased the dosage of pitavastatin to 4 mg/day.
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(pg. 3 of the document)
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(pg. 4 of the document)
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(pg. 4 of the document)
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(pg. 4 of the document)
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(pg. 7 of the document)
Although REAL-CAD did not explicitly teach increase in HDL-C level in the subject or decrease in TG level/hs-CRP level in the subject, the Examiner finds the resulting dosage of pitavastatin at 4 mg/day should increase the HDL-C level in the subject and/or decrease the TG level/hs-CRP level in the subject. This is supported by evidentiary reference Taguchi (see data below), which shows that pitavastatin at 4 mg/day reduced the level of LDL, TG, and hsCRP level when compared to pitavastatin at 1 mg/day, as well as increase the HDL level when compared to pitavastatin at 1 mg/day.
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(Taguchi, pg. 2002, Figure 2)
Conclusion
Claims 1-8, 10, 13, 15, 16, 41, and 53-56 are rejected.
Claims 9, 11, 12, 14, 17-40, and 42-52 are withdrawn.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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, Clinton Brooks can be reached on (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
