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 .
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-10, 12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt et al. (US 2018/0344174; hereinafter Schmitt) in view of Dzenis et al. (US 2012/0084064; hereinafter Dzenis).
Schmitt shows a system and method for recommending a treatment of a vessel, the system for use in conjunction with an intravascular imaging system, the intravascular imaging system configured for obtaining a plurality of images of the vessel and providing information on location of each image of the plurality of images along a longitudinal length of the vessel ([0057]-[0059]), the system comprising a processor, wherein the processor is adapted to: receive a plurality of intravascular images of the vessel at respective locations along the vessel ([0057]-[0059]); determine, from the plurality of images, at least one cross sectional area of a portion of the vessel ([0076]); determine, from the plurality of images and the respective locations of the plurality of images along the vessel, a flow resistance ([0077]-[0078], [0113], [0125]-[0126], [0129]); and output a treatment recommendation based on the at least one cross sectional area of the vessel and the flow resistance ([0114]-[0117], [0119]-[0121]).
Schmitt also shows wherein the treatment recommendation is based on at least one of: the at least one cross-sectional area being within a first predetermined range (stent optimization, create arrays of area and diameter for each cross-section along the vessel; [0121]); and the flow resistance being within a second predetermined range (stent optimization, VRR; [0117]-[0121]); wherein outputting the treatment recommendation is based on a decision tree comprising an assessment of the flow resistance is within a second predetermined range (stent optimization encompasses a decision tree, as the processor decides an appropriate sized stent based on the area of the vessel and the resistance; [0121]); determine, from the plurality of images, multiple cross sectional areas of a portion of the vessel at respective locations of the plurality of images along the vessel ([0076]-[0077]); determine, from the multiple cross sectional areas and the respective locations of the images along the vessel, a cumulative flow resistance ([0078]); and output a treatment recommendation based on the cumulative flow resistance and the at least one of the multiple cross sectional areas ([0114]-[0117], [0119]-[0121]); wherein the treatment recommendation is based on a reduction of the at least one cross sectional area with respect to the cross sectional area without lesion above a predetermined threshold and based on the flow resistance (stent recommendation based on all calculated cross sectional area segments of the vessel and corresponding resistance of each segment, including both lesion and lesion free segments of the vessel; [0078], [0113]-[0114]); wherein the flow resistance is calculated as a fraction of the flow resistance of the vessel without lesion ([0078], [0113]); wherein outputting the treatment recommendation comprises recommending a stent from a plurality of stents ([0117], [0121]); wherein the intravascular imaging system comprises one or more of an intravascular ultrasound system and optical coherence tomography system ([0057]); a motorized pullback device ([0058]).
Schmitt fails to show determine whether or not the at least one cross-sectional area is within a first predetermined range for generating the treatment recommendation.
Schmitt fails to show wherein the flow resistance R is given by: R=f/x2R0, R0 where R0 is the flow resistance of the vessel without reduced cross sectional area due to lesion, f is the length of a section with reduced cross sectional area, due to lesion, as a fraction of the length of the vessel and x is the reduced cross sectional area of the vessel as a fraction of the cross sectional area of the vessel being free from lesion.
Dzenis discloses model-based systems and methods for analyzing an predicting outcomes of vascular intervention and reconstruction. Dzenis teaches determine whether or not the at least one cross-sectional area is within a first predetermined range for generating the treatment recommendation ([0076]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Schmitt to determine whether the area is within a range for generating the treatment recommendation as taught by Dzenis, as it would be within the level of one of ordinary skill in the art to account for additional known diagnostic variables to improve the overall accuracy of the treatment recommendation.
Furthermore, Schmitt teaches resistance equations which account for different lengths of the vessel including segments including a lesion and segments of the vessel being free from lesion ([0082], [0091]). Lacking further criticality or unexpected results, the equations of Schmitt are considered a suitable equivalent to the claimed equation R=f/x2R0, as the equations of Schmitt account for flow resistance along the different lengths of the vessel including both a lesion segment and lesion free segment, and provide the same end result of obtaining diagnostic values to output a treatment recommendation such as an appropriately sized stent.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt et al. (US 2018/0344174; hereinafter Schmitt) in view of Dzenis et al. (US 2012/0084064; hereinafter Dzenis) as applied to claim 9 above, and further in view of Eck et al. (US 2010/0049034; hereinafter Eck).
Schmitt fails to show an X-ray imaging system for determining a location of an intravascular imaging device of the intravascular imaging system.
Eck discloses vessel imaging techniques. Eck teaches an X-ray imaging system for determining a location of an intravascular imaging device of the intravascular imaging system ([0020]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Schmitt and Dzenis to utilize x-ray imaging to locate the intravascular imaging device as taught by Eck, in order to visualize the location of the device to thereby more accurately correlate the obtained measurement data with the corresponding vessel segment
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN CWERN whose telephone number is (571)270-1560. The examiner can normally be reached Monday - Friday, 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN CWERN/Primary Examiner, Art Unit 3797
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