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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because a computer program is considered a signal per se. It is suggested to amend the claim in the format of a non-transitory computer readable medium type claim, comprising the program.
Claim Rejections - 35 USC § 112
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 5-6 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.
In claim 5, the limitation “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” renders the claim indefinite. It is unclear what is meant by the term “reduction”. It is unclear what is meant by the phrase “area without lesion above a predetermined threshold”. The term “the cross sectional area without lesion” lacks antecedent basis.
In claim 6, the limitation “wherein the flow resistance is calculated as a fraction of the flow resistance of the vessel without lesion” renders the claim indefinite. It is unclear what is meant by the phrase “calculated as a fraction”. It is unclear what mathematical formula is set forth.
Claim Rejections - 35 USC § 102
(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.
Claim(s) 1-6, 8-10, and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schmitt et al. (US 2018/0344174; hereinafter Schmitt).
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 whether the at least one cross-sectional area is within a first predetermined range and 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]).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt et al. (US 2018/0344174; hereinafter Schmitt).
Schmitt shows the invention substantially as described in the 102 rejection above.
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.
However, 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 Eck et al. (US 2010/0049034; hereinafter Eck).
Schmitt shows the invention substantially as described in the 102 rejection above.
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 invention of Schmitt 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
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Fonte (US 2015/0272448) provides similar teaching as Schmitt, such as blood flow resistance calculations for patient treatment planning such as for stents ([0125]-[0126], [0152]-[0153], [0291], [0325]-[0328]).
Haase (US 2020/0390345) describes flow estimation techniques (abstract).
Spencer (US 2016/0007947) describes vessel modeling techniques (abstract).
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN CWERN/Primary Examiner, Art Unit 3797