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 .
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 7-9, 12, and 16-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by JP2012189909A to Kato et al. (hereinafter Kato).
Concerning claim 1,
Kato discloses a vascular lesion model comprising: a tubular vascular model (0013, 0048, Figure 2); and
a lesion model arranged in a lumen of the vascular model (0013, 0050, Figure 2),
the lesion model including a plurality of lesions arranged along a longitudinal direction of the vascular model (0030-0036, 0050, Figure 2, lesions 2a-b),
the plurality of lesions including a first lesion (lesion 2b) formed of a first polymeric material and a second lesion (lesion 2a) formed of a second polymeric material, different from the first polymeric material (0030-0036, 0050, Figure 2), and
at least a first end of the lesion model in the longitudinal direction being fixed to an inner peripheral surface of the vascular model to restrict movement of the lesion model along the longitudinal direction (0050-0055, Figure 2).
Concerning claim 2,
Kato discloses the lesion model further includes a fixation portion that fixes the first end to the inner peripheral surface of the vascular model (0050-0055, Figure 2), and
the fixation portion is formed of a third polymeric material, and is harder than both the first lesion and the second lesion (0050-0055, Figure 2).
Concerning claim 3,
Kato discloses the first lesion (lesion 2b) is harder than the second lesion (lesion 2a) (0013-0014, 0050).
Concerning claim 7,
Kato teaches the third polymeric material is different from both the first polymeric material and the second polymeric material (0050-0055, Figure 2).
Concerning claim 8,
Kato discloses the first polymeric material (lesion 2b) is harder than the second polymeric material (lesion 2a) (0013-0014, 0030-0036, 0050).
Concerning claim 9,
Kato discloses the first lesion (lesion 2b) is harder than the second lesion (lesion 2a) (0013-0014, 0030-0036, 0050).
Concerning claim 12,
Kato discloses an outer peripheral surface of the lesion model, which faces the vascular model, is fixed to the inner peripheral surface of the vascular model to further restrict movement of the lesion model along a circumferential direction (0026-0029, 0048, Figure 2).
Concerning claim 16,
Kato discloses an outer peripheral surface of the lesion model, which faces the vascular model, is fixed to the inner peripheral surface of the vascular model to further restrict movement of the lesion model along a circumferential direction (0026-0029, 0048, Figure 2).
Concerning claim 17,
Kato discloses a second end of the lesion model in the longitudinal direction is fixed to the inner peripheral surface of the vascular model to further restrict movement of the lesion model along the longitudinal direction (0050-0055, Figure 2).
Concerning claim 18,
Kato discloses a fixation portion that fixes the first end to the inner peripheral surface of the vascular model (0050-0055, Figure 2), and
a space between the fixation portion and part of the inner peripheral surface of the vascular model (0050-0055, Figure 2).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2012189909A to Kato et al. in view of US Publication 2008/0076101 A1 to Hyde et al. (hereinafter Hyde).
Concerning claim 4,
Kato does not disclose in the lesion model, a plurality of the first lesions and a plurality of the second lesions are alternately arranged along the longitudinal direction of the vascular model.
Hyde teaches in the lesion model, a plurality of the first lesions and a plurality of the second lesions are alternately arranged along the longitudinal direction of the vascular model (0046-0051).
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the lesion configuration of Hyde in the vascular model of Kato. Varying of the configuration of the lesions would allow for more effective surgical practice by someone training off a vascular model.
Claim(s) 5-6, 10-11, and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2012189909A to Kato et al. in view of US Publication 2008/0076101 A1 to Hyde et al.
Concerning claim 5,
Kato does not disclose at least one of the first lesion and the second lesion includes a granular calcified portion harder than both the first polymeric material and the second polymeric material.
Hyde teaches at least one of the first lesion and the second lesion includes a granular calcified portion harder than both the first polymeric material and the second polymeric material (0058-0059).
A datasheet of an exemplary cyanoacrylate adhesive. used in the simulation of a granular calcified portion in Hyde, that demonstrates that it is harder than the polymeric material described in Kato is included in the office action.
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the granular calcified portion in the simulated lesions as described in Hyde in the vascular model of Kato in order to more faithfully simulate the dynamics of an in vivo lesion and improve the practice that can be obtained from the model.
Concerning claim 6,
Kato discloses an outer peripheral surface of the lesion model, which faces the vascular model, is fixed to the inner peripheral surface of the vascular model to further restrict movement of the lesion model along a circumferential direction (0026-0029, 0048, Figure 2).
Concerning claim 10,
Kato does not disclose in the lesion model, a plurality of the first lesions and a plurality of the second lesions are alternately arranged along the longitudinal direction of the vascular model.
Hyde teaches in the lesion model, a plurality of the first lesions and a plurality of the second lesions are alternately arranged along the longitudinal direction of the vascular model (0046-0051).
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the lesion configuration of Hyde in the vascular model of Kato. Varying of the configuration of the lesions would allow for more effective surgical practice by someone training off a vascular model.
Concerning claim 11,
Kato does not disclose at least one of the first lesion and the second lesion includes a granular calcified portion harder than both the first polymeric material and the second polymeric material.
Hyde teaches at least one of the first lesion and the second lesion includes a granular calcified portion harder than both the first polymeric material and the second polymeric material (0058-0059).
A datasheet of an exemplary cyanoacrylate adhesive. used in the simulation of a granular calcified portion in Hyde, that demonstrates that it is harder than the polymeric material described in Kato is included in the office action.
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the granular calcified portion in the simulated lesions as described in Hyde in the vascular model of Kato in order to more faithfully simulate the dynamics of an in vivo lesion and improve the practice that can be obtained from the model.
Concerning claim 13,
Kato does not disclose in the lesion model, a plurality of the first lesions and a plurality of the second lesions are alternately arranged along the longitudinal direction of the vascular model.
Hyde teaches in the lesion model, a plurality of the first lesions and a plurality of the second lesions are alternately arranged along the longitudinal direction of the vascular model (0046-0051).
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the lesion configuration of Hyde in the vascular model of Kato. Varying of the configuration of the lesions would allow for more effective surgical practice by someone training off a vascular model.
Concerning claim 14,
Kato does not disclose at least one of the first lesion and the second lesion includes a granular calcified portion harder than both the first polymeric material and the second polymeric material.
Hyde teaches at least one of the first lesion and the second lesion includes a granular calcified portion harder than both the first polymeric material and the second polymeric material (0058-0059).
A datasheet of an exemplary cyanoacrylate adhesive. used in the simulation of a granular calcified portion in Hyde, that demonstrates that it is harder than the polymeric material described in Kato is included in the office action.
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the granular calcified portion in the simulated lesions as described in Hyde in the vascular model of Kato in order to more faithfully simulate the dynamics of an in vivo lesion and improve the practice that can be obtained from the model.
Concerning claim 15,
Kato does not disclose both the first lesion and the second lesion include the granular calcified portion.
Hyde teaches both the first lesion and the second lesion include the granular calcified portion (0058-0059).
A datasheet of an exemplary cyanoacrylate adhesive. used in the simulation of a granular calcified portion in Hyde, that demonstrates that it is harder than the polymeric material described in Kato is included in the office action.
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the granular calcified portion in the simulated lesions as described in Hyde in the vascular model of Kato in order to more faithfully simulate the dynamics of an in vivo lesion and improve the practice that can be obtained from the model.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP2012189909A to Kato et al. in view of JP2019192698A to Suzuki et al. (hereinafter Suzuki).
Concerning claim 19,
Kato does not disclose at least one of the first lesion and the second lesion includes a central portion harder than a main portion.
Suzuki teaches at least one of the first lesion and the second lesion includes a central portion harder than a main portion.
It would have been obvious for one with ordinary skill in the art before the effective filing date of the claimed invention to incorporate the lesion with a gradient of hardness as described in Suzuki in the vascular model of Kato in order to more faithfully simulate the dynamics of an in vivo lesion and improve the practice that can be obtained from the model.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 6517354 B1 and US 6062866 A.
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/I.S./Examiner, Art Unit 3715
/DMITRY SUHOL/Supervisory Patent Examiner, Art Unit 3715