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 .
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 13-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim 13 recites “At least one machine readable storage device”. However, the usage of this phrase encompasses both "non-transitory" and "transitory" recording mediums. The specification further explicitly does not limit the utilization of a non-transitory machine readable storage devices. Therefore, when the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter). Therefore, claims 12 and 13 are non-statutory. A suggestion is made that the Applicant amend the claims to recite a non-transitory machine-readable storage device.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1, 4, 5, 6, 11, 13, 16, 18, 19, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 5, 6, 1, 14, 12, 1, 17, 18, and 22, respectively of copending Application No. 18/466,587 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches generating graphical component comprising an indication of calcium in the vessel while the instant claims are directed to generating graphical components comprising an indication of the plaque burden. The term “plaque burden” is a generic term than encompasses indications of calcium in the vessel because plaque burden is partly determined by or otherwise includes calcified deposits within the plaque burden in the vessel. Moreover, the invention is directed to graphical user interfaces for displaying data using graphical components such that it 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 to have modified the reference application’s claimed generating graphical components comprising an indication of the calcium in the vessel and receive indications of an amount of calcium in the vessel to apply to the more generic generating graphical components comprising an indication of the plaque burden and to
receive indications of plaque burden in the vessel because the more specific calcium in the vessel teaches or at least suggests the generic plaque burden, because there is a reasonable expectation of success, and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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)(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.
(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.
Claims 1-5, 13-15, and 18-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sakaguchi (US 2023/0245307 A1).
Claim 1
In regards to claim 1, Sakaguchi discloses a computing apparatus for a medical device, comprising:
a processor {see Figs. 1, 2, 3 including server 1 and control units 11, 21, [029]-[0030], [0037]-[0042]};
an interface coupled to the processor, the interface to couple to an intravascular ultrasound (IVUS) device {Fig. 1, 2, 3 including communication unit 13, 23, Network N and diagnostic imaging device 2 which is an IVUS device as per [0032]-[0033]}; and
a memory coupled to the processor, the memory comprising instructions executable by the processor {Figs. 1-3 including main storage unit 12, [0038]-[0039] including memory and software}, which when executed the processor cause the computing apparatus to:
receive a series of IVUS images of a vessel of a patient from the IVUS device, the series of IVUS images comprising a plurality of frames {see Fig. 4 illustrating IVUS image frame being received by the calculation model 51 residing in the processor as per [0044]-[0045]. Device 2 includes IVUS as further discussed in [0032]-[0033]. Further as to series of IVUS images see [0045], [0050] processing each of the plurality of IVUS frames},
receive, for each of the plurality of frames, an indication of plaque burden in the vessel {Fig. 4 calculation model extracts a feature amount that includes plaque burden that is used/received by device 2 as per [0045]-[0051]},
generate a graphical component comprising an indication of the plaque burden respective to a threshold amount {see Figs. 5-9 illustrating graphical presentations including graphical components (gradation bar 6) indicating the plaque burden as further discussed in [0052]-[0058]. As to threshold amounts, note that the color, lightness, hue saturation of the gradation bar 6 may be used to indicate degree of plaque burden including relative to a threshold (e.g. 50%) with a warm/orange color indicating above threshold and white for below threshold
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generate a GUI comprising a longitudinal view of the vessel and the graphical component configured to indicate the detected plaque burden along a longitudinal axis of the vessel, and render the GUI for display on a display {Figs. 5-9, [0052]-[0058] and explanation above clearly disclosing longitudinal view and graphical components along longitudinal axis as claimed}.
Claim 2
In regards to claim 2, Sakaguchi discloses wherein the graphical component is a first graphical component, the instructions, when executed by the processor further cause the computing apparatus to:
generate a second graphical component comprising the longitudinal view of the vessel; and generate the GUI comprising the first graphical component and the second graphical component {Figs. 5-9, [0052]-[0058] including particularly longitudinal tomographic image 5, [0052]-[0053]}.
Claim 3
In regards to claim 3, Sakaguchi discloses the instructions, when executed by the processor further cause the computing apparatus to
overlay the first graphical component over a portion of the second graphical component to indicate the plaque burden along the longitudinal axis of the vessel component {Figs. 5-9, [0052]-[0058] including particularly overlay of gradation bar 6 over a portion of longitudinal tomographic image 5 to indicate plaque burden as claimed, [0052]-[0053]}.
Claim 4
In regards to claim 4, Sakaguchi discloses wherein the first graphical component comprises a line disposed along a portion of the longitudinal axis of the vessel {Figs. 5-9 illustrate such lines including the the gradation bar 6 itself and the lines in the central part of the vessel}.
Claim 5
In regards to claim 5, Sakaguchi discloses the instructions, when executed by the processor further cause the computing apparatus to:
identify, for each of the plurality of frames, whether the plaque burden is less than a threshold level {Fig. 4 calculation model extracts a feature amount that includes plaque burden that is used/received by device 2 as per [0045]-[0051]. Further as to threshold see [0055]-[0057], [0061]-[0064]};
overlay the line over portions of the second graphical component associated with the ones of the plurality of frames where the plaque burden is less than the threshold level
{See Figs. 5-9, [0052]-[0058]. As to threshold amounts, note that the overlayed color, lightness, hue, saturation, etc. of the gradation bar 6 may changed to indicate degree of plaque burden including relative to a threshold (e.g. 50%) with a warm/orange color overlay indicating above threshold and white overlay color for below threshold and that this graphical element (gradation bar 6)}.
Claims 13-15; and 18-20
The rejection of apparatus claims 1, 2+3, 4+5; and 1, 2, and 3 above applies mutatis mutandis to the corresponding limitations of machine-readable storage device claims 13-15 and method claims 18-20, respectively while noting that the rejection above cites to both device and method disclosures. For the computer readable storage medium storing program limitations of claim 10 see Sakaguchi’s Figs. 1-3 including main storage unit 12, [0038]-[0039] including memory and software executed by processors (server 1 and control units 11, 21, [029]-[0030], [0037]-[0042])}. The notation above, e.g. “2+3”, indicates that claim 14 is a combination of parallel claims 2 and 3 written in a different claim format.
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.
Claims 6-9, 10, 12, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sakaguchi and Tu (US 2021/0298706 A1).
Claim 6
In regards to claim 6, Sakaguchi discloses wherein the second graphical component comprises an indication of a distal bracket, a proximal bracket, a minimum region, a vessel profile view, and
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}
Sakaguchi is not relied upon to disclose displaying a graphical component that includes a mirror of the vessel profile view.
Tu is analogous art from the same field of IVUS image processing and generating graphical displays of vessels. See abstract, Figs. 1-4, 11, [0001], [0086],
Tu also teaches displaying a graphical component that includes a mirror of the vessel profile view {see Figs. 7-10, [0149], [0156]}.
It 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 to have modified Sakaguchi’s graphical user interface which already includes a graphical component comprises an indication of a distal bracket, a proximal bracket, a minimum region, a vessel profile view, and wherein the vessel profile view comprises a graphical representation of a vessel border and a lumen border of the vessel along the longitudinal axis such that the graphical component also includes and a mirror of the vessel profile view as taught by Tu because Tu motivates such a graphical presentation in order to present a display which provides vial feature information of the two dimensional sections of the blood vessel in a mutual fusion manner, and where the display simulates the shape of the two-dimensional section of the blood vessel so that the specifications of the blood vessel can be displayed more intuitively as described by Tu ([0149]) and that modifying Sakaguchi’s graphical user interface to include different forms for displaying the plaque/calcium in relation to the blood vessel, including by using a mirrored format of the diagnostic information would similarly benefit; because there is a reasonable expectation of success; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Claim 7
In regards to claim 7, Sakaguchi discloses wherein the distal bracket comprises one of a plurality of bracket graphical representations selected based on the location of the distal bracket relative to the plaque burden and the threshold level {see above mappings {See Figs. 5-9, [0052]-[0058] while noting that the color, lightness, hue, saturation, etc. of the gradation bar 6 is selected based on and to indicate degree of plaque burden including relative to a threshold (e.g. 50%)}.
Claim 8
In regards to claim 6, Sakaguchi discloses the instructions, when executed by the processor further cause the computing apparatus to:
identify a location of the distal bracket; determine whether the distal bracket is associated with a frame of the plurality of frames where the plaque burden is less than the threshold level; and select a first one of the plurality of bracket graphical representations based on a determination that the distal bracket is associated with a frame of the plurality of frames where the plaque burden is less than the threshold level; or select a second one of the plurality of bracket graphical representations based on a determination that the distal bracket is not associated with a frame of the plurality of frames where the plaque burden is less than the threshold level.
{See Figs. 5-9, [0052]-[0058] in which for each (identified) location/segment of the gradation bar 6, the method determines whether to change the display color (select graphical representation) based on and to indicate degree of plaque burden for that corresponding longitudinal image 5 with a warm/orange color indicating above threshold (second graphical representation) and white for below threshold (first graphical representation)}
Claim 9
In regards to claim 9, Sakaguchi discloses wherein the proximal bracket comprises one of a plurality of graphical representations selected based on the location of the proximal bracket relative to the plaque burden and the threshold level {See Figs. 5-9, [0052]-[0058] while noting that the color, lightness, hue, saturation, etc. of the gradation bar 6 is selected based on and to indicate degree of plaque burden including relative to a threshold (e.g. 50%)}.
Claim 10
In regards to claim 10, Sakaguchi discloses the instructions, when executed by the processor further cause the computing apparatus to:
identify a location of the proximal bracket; determine whether the proximal bracket is associated with a frame of the plurality of frames where the plaque burden is less than the threshold level; and select a first one of the plurality of bracket graphical representations based on a determination that the proximal bracket is associated with a frame of the plurality of frames where the plaque burden is less than the threshold level; or selecting a second one of the plurality of bracket graphical representations based on a determination that the proximal bracket is not associated with a frame of the plurality of frames where the plaque burden is less than the threshold level.
{See Figs. 5-9, [0052]-[0058] in which for each (identified) location/segment of the gradation bar 6, the method determines whether to change the display color (select graphical representation) based on and to indicate degree of plaque burden for that corresponding longitudinal image 5 with a warm/orange color indicating above threshold (second graphical representation) and white for below threshold (first graphical representation)}
Claim 12
In regards to claim 12, Sakaguchi discloses the IVUS imaging device {Device 2 includes IVUS as further discussed in [0032]-[0033]}.
Claims 16-17
The rejection of apparatus claims 6 and 7+8 above applies mutatis mutandis to the corresponding limitations of machine-readable storage device claims 16-17, respectively while noting that the rejection above cites to both device and method disclosures. For the computer readable storage medium storing program limitations of claims 16-17 see Sakaguchi’s Figs. 1-3 including main storage unit 12, [0038]-[0039] including memory and software executed by processors (server 1 and control units 11, 21, [029]-[0030], [0037]-[0042])}. The notation above, e.g. “7+9”, indicates that claim 17 is a combination of parallel claims 7 and 8 written in a different claim format.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sakaguchi and Gopinath (US 20240057870 A1).
Claim 11
In regards to claim 12, Sakaguchi discloses inputting cross-section views of each of the frames to generate the longitudinal view of the vessels, Sakaguchi is not relied upon to disclose the graphical components related to these cross-section views as recited in claim 11.
Gopinath is analogous art from the same field of generating GUIS for IVUS images, see [0015] in which the disclosure applies and ingests image data from various related modalities including OCT, IVUS, OFDI and others and includes GUI elements including calcium, proximal and distal brackets, lumen boundary, angiography images and co-registration indication as per [0024].
Gopinath also teaches the instructions, when executed by the processor further cause the computing apparatus to:
generate a third graphical component comprising a cross-section view of a one of the plurality of frames; and generate the GUI comprising the first graphical component, the second graphical component, and the third graphical component, wherein the GUI comprises an angiographic image of the vessel
{see [0024]-[0028], Fig. 3C (copied below), [0002]-[0008], [0024]-[0026], [0036], [0045]-[0049], [0054], [0058]-[0062], [0087]-[0091], [0104]-[0107], [0127], [0135]. See also Fig. 2F, 4A-C, 5B}
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It 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 to have modified Sakaguchi’s graphical user interface which already includes a graphical component comprises an indication of a distal bracket, a proximal bracket, a minimum region, a vessel profile view, and wherein the vessel profile view comprises a graphical representation of a vessel border and a lumen border of the vessel along the longitudinal axis such that the graphical component also generate a third graphical component comprising a cross-section view of a one of the plurality of frames; and
generate the GUI comprising the first graphical component, the second graphical component, and the third graphical component, wherein the GUI comprises an angiographic image of the vessel as taught by Gopinath because Gopinath motivates such a graphical presentation helps a user visualize the artery relative to angiography that is co-registered and help deploy a stent or balloon and that modifying Sakaguchi’s graphical user interface to include an cross-section view and a GUI that includes an angiographic image of the vessel would similarly benefit; because there is a reasonable expectation of success; and/or because doing so merely combines prior art elements according to known methods to yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cohen (US 20230190227 A1) is a highly relevant publication that anticipates (e.g. X type reference) many of the claimed features including generating a graphical component comprising an indication of the plaque burden respective to a threshold amount and generating a GUI comprising a longitudinal view of the vessel and the graphical component configured to indicate the detected plaque burden along a longitudinal axis of the vessel, and render the GUI for display on a display. See Figs. 8, 10, copied below, and corresponding disclosure in the specification.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael R Cammarata whose telephone number is (571)272-0113. The examiner can normally be reached M-Th 7am-5pm EST.
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, Matthew Bella can be reached at 571-272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ROBERT CAMMARATA/ Primary Examiner, Art Unit 2667