DETAILED ACTION
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 .
Status of Claims
Claims 1, 3-8, and 10-13 are pending. Claims 2 and 9 are canceled.
Response to Arguments
Applicant’s arguments, see p. 7, filed 1/16/26, with respect to claims 1 and 4 have been fully considered and are persuasive. The claim objections of 10/16/25 have been withdrawn.
Applicant’s arguments, see p. 7, filed 1/16/26, with respect to claims 1, 3-8, and 10-13 have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections of 10/16/25 have been withdrawn.
Applicant’s arguments, see p. 7-12, filed 1/16/26, with respect to claims 1, 3-8, and 10-13 have been fully considered and are persuasive. The 35 U.S.C. 101 rejections of 10/16/25 have been withdrawn.
Claim Objections
Claim 4 is objected to because of the following informalities: In lines 7-8, “a size and a time change of the calcification is present” should read –whether a size and a time change of the calcification is present– or it should be rephrased so that the limitation is similar to that in claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-8, and 10-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 recites “the size of the extra-coronary calcification is equal to or greater than a predetermined value” and “the size of the extra-coronary calcification is smaller than the predetermined value”. After reviewing the specification, the specification does not disclose the above limitations or similar wording. Instead, lines 3-8 in Pg. 28 of the specification recite, “even if vascular calcification of blood vessels other than the discovered cardiovascular vessels is small, if the time change of vascular calcification is large, a patient may be judged to be at a high cardiovascular disease risk and thus the cardiovascular disease risk may be evaluated”. The specification fails to provide a written description that shows the inventor possessed the invention as recited in claim 1. Independent claim 4 recites similar limitations as claim 1. Claim 3 depends on claim 1 and is therefore also rejected under 35 U.S.C. 112(a) for the same reasons. Claims 5-8 and 10-13 depend on claim 4 and are therefore also rejected under 35 U.S.C. 112(a) for the same reasons.
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, 3-8, and 10-13 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.
The term “large” in claim 1 is a relative term which renders the claim indefinite. The term “large” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the limitation “the time change of the extra-coronary calcification” has been rendered indefinite by the use of the term “large”.
Claim 3 recites the limitation "the evaluation of the cardiovascular disease risk" in line 3. It is unclear and indefinite if this is the same as the evaluation result of the cardiovascular disease risk previously recited in the claim 1, from which claim 3 depends.
The term “large” in claim 4 is a relative term which renders the claim indefinite. The term “large” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the limitation “the time change of the extra-coronary calcification” has been rendered indefinite by the use of the term “large”.
Claims 5-8 and 10 depend on claim 4 and are therefore also rejected under 112(b).
Claim 11 recites the limitation "the evaluation result" in lines 3 and 5. It is unclear and indefinite which evaluation result is being referred to (i.e., that of the trained model, or that of the cardiovascular disease risk).
Claim 12 recites the limitation "a diagnosis result by computer-aided diagnosis" in lines 2-3. It is unclear and indefinite if this is the same as the diagnosis result of CAD previously recited in the claim 4, from which claim 12 depends.
Claim 13 recites the limitation "the evaluation result" in line 3. It is unclear and indefinite which evaluation result is being referred to (i.e., that of the trained model, or that of the cardiovascular disease risk).
Allowable Subject Matter
Claims 1, 3-8 and 10-13 are not rejected over prior art and would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Daniella M. DiGuglielmo whose telephone number is (571)272-0183. The examiner can normally be reached Monday - Friday 8:00 AM - 4:00 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, Emily Terrell can be reached at (571)270-3717. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Daniella M. DiGuglielmo/Examiner, Art Unit 2666
/EMILY C TERRELL/Supervisory Patent Examiner, Art Unit 2666
