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 § 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 1, 3 - 18, and 20 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.
Claim 1 is indefinite because it is unclear what is meant by “an output for a user
associated with indicating a probability of restenosis occurring after the stent placement procedure is complete and controlling an expansion of the stent during the stent placement procedure”. It is unclear whether (1) the output, or (2) the user, must be “associated with indicating a probability of restenosis occurring after the stent placement procedure is complete and controlling an expansion of the stent during the stent placement procedure”. For the purposes of examination, the limitation will be interpreted as intending that the output is ‘associated with indicating a probability of restenosis’, and the user controls the expansion.
Claims 3 - 18 and 20 are indefinite by virtue of dependency.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1 - 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 16 of U.S. Patent No. 10,772,599 (reference claims). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed towards a system for determining a probability of restenosis based on imaging data obtained from intravascular imaging catheter regarding a stent deployed at a site of a lesion.
Instant claim 1 is suggested by reference claims 1, 5 and/or 11. It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of the reference claims to include identifying a gap and providing output as recited, in order to help the clinician visualize the patient’s anatomy and understand the quality of the stent positioning within the vessel. It also would have been obvious to have modified the invention of the reference claims to have the ‘comparison’ comprise a percentage, in order to use a well-known mathematical comparison technique to evaluate the relative sizes of the vessel and stent. Further, it would have been obvious to have modified the invention of the reference claims to combine the features of reference claim 5 and 11, in order to facilitate evaluating the stent expansion.
Instant claims 3 and 20 are suggested by reference claims 7 - 9 and/or 13. It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of the reference claims have the output comprise a visualization of the gap, in order to further help the clinician visualize and understand the quality of the stent positioning within the vessel.
Instant claim 4 is suggested by reference claim 4.
Instant claims 5 - 6 are suggested by reference claims 7 - 9 and/or 13.
Instant claims 7 and 12 - 18 are suggested by reference claim 15. It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of the reference claims to have the qualitative value comprise a color, in order to further help the clinician visualize and understand the quality of the stent positioning within the vessel.
Instant claim 8 - 9 are suggested by reference claim 5. Any displayed data indicating the probability of restenosis is interpreted as an “alert”.
Regarding claim 10, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of the reference claims to cause a speaker to provide an audio notification to the user based on the probability of restenosis, in order to communicate results in an auditory fashion, as is well-understood and conventional in the art.
Regarding claim 11, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of the reference claims to have the vessel diameter comprise an average diameter, in order to select an appropriate numeric value for the stent diameter for mathematical calculations.
Claims 1 - 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 12 of U.S. Patent No. 12,089,990 (reference claims). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed towards a system for determining a probability of restenosis based on imaging data obtained from intravascular imaging catheter regarding a stent deployed at a site of a lesion.
Instant claims 1 - 3 and 19 - 20 are suggested by reference claims 2 - 3. It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of the reference claims to include identifying a gap and providing output as recited, in order to help the clinician visualize the patient’s anatomy and understand the quality of the stent positioning within the vessel.
Instant claim 4 is suggested by reference claim 4.
Instant claims 5 - 6 are suggested by reference claims 5 - 6.
Regarding claims 7 - 9 and 12 - 18 are suggested by reference claim 8 and/or 9. Any displayed data indicating the probability of restenosis is interpreted as an “alert”. It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of the reference claims to have the graphical representation comprise a numeric value, a qualitative value, and/or a color, in order to help the clinician visualize and understand the quality of the stent positioning within the vessel using known visualization techniques.
Regarding claim 10, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of the reference claims to cause a speaker to provide an audio notification to the user based on the probability of restenosis, in order to communicate results in an auditory fashion, as is well-understood and conventional in the art.
Regarding claim 11, it would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified the invention of the reference claims to have the vessel diameter comprise an average diameter, in order to select an appropriate numeric value for the stent diameter for mathematical calculations.
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.
Claims 1, 3 - 4, 7, 11 - 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Elbasiony (US 2014/0257087, of record) in view of Schmitt et al. (US 2015/0297373, of record).
Regarding claim 1, Elbasiony shows a system, comprising:
an intravascular imaging catheter (catheter 20, [0046] and figs. 1A - 1B) configured to obtain intravascular imaging data after a stent has been deployed within a vessel to provide treatment to a lesion during a stent placement procedure (“… views of a blood vessel … stent deployment …”, [0054]), wherein the intravascular imaging catheter comprises an optical fiber for optical coherence tomography (OCT) (“optical fiber … OCT data sets”, [0042]) or an ultrasound transducer for intravascular ultrasound (IVUS) (ultrasound, [0047]), wherein the stent comprises a proximal end and a distal end (implicit); and
a processor (computing device 40, [0050] - [0051] and fig. 1B) configured for communication with the intravascular imaging catheter, wherein the processor is configured to:
determine, using the intravascular imaging data, a stent measurement (detected stent strut position, [0052]) for a proximal or distal portion of the lesion;
determine, using the intravascular imaging data, a vessel measurement (“lumen border … detected points …”, [0108]) for the proximal or distal portion of the lesion;
calculate, during the stent placement, using the stent measurement and the vessel measurement, a stent expansion amount for at least one of the proximal portion of the lesion or the distal portion of the lesion (“distance measurement … used to represent … under inflation …”, [0086]), wherein the stent expansion amount is distinct from stent apposition (implicit by definition, as the distance measurement is a numerical value, whereas stent apposition is a state of stent contact with a vessel. Also refer to discussion of “… another stent state such as under inflation …”, [0086]);
perform, during the stent placement procedure, a comparison between the stent
expansion amount and a threshold (“compare a distance threshold… with a distance measured from the vessel wall to a stent strut”, [0090]);
perform, based on the intravascular imaging data, identification of a gap between
the stent and the vessel (“… areas of malapposition…”, [0052] and fig. 1B; degree of stent malapposition, [0056]; calculate regions of significant malapposition, [0090]), wherein the gap is indicative of the stent apposition (implicit. Also refer to [0052]; [0056]; [0090]); and
provide, to a display (display 46, [0052] and fig. 1B) in communication with the processor, an output for a user associated with indicating a probability of restenosis occurring after the stent placement procedure is complete and controlling an expansion of the stent during the stent placement procedure, wherein the output comprises:
an intravascular image based on the intravascular imaging data (“… cross-sectional and longitudinal views of a blood vessel generated using collected OCT data… displayed …”, [0052] and fig. 1B);
a first graphical representation (“… information 47 can include… areas of malapposition …”, [0052] and fig. 1B; “regions of significant malapposition”, [0090]); associated with the stent expansion amount and based, at least in part, on the comparison ([0090]); and
a second graphical representation associated with the stent apposition and based at least in part on the identification of the gap (“… perpendicular distances measured relative to a automatically detected lumen border and a perpendicular distance extending from the lumen border to a detected stent strut position …identify stent struts and malapposition levels (such as based on a threshold and measured distance comparison) …. with text, arrows, color coding, highlighting, contour lines, [0052] and fig. 1B),
wherein the first graphical representation and the second graphical representation are distinct from one another ([0052]: the displayed “ areas of malapposition” are distinct from displayed “perpendicular distances … stent struts and malapposition levels …. with text, arrows, color coding, highlighting, contour lines).
Elbasiony fails to show calculating the stent expansion amount as a percentage.
Schmitt discloses stent placement procedures. Schmitt teaches calculating a stent expansion amount as a percentage (“quality of stent expansion after implantation… judge whether the stent has been expanded properly”, [0040]; “… percentage difference between the computed stent profile area and the current lumen area is calculated,” [0075]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date, to have modified Elbasiony’s invention to include calculating the stent expansion amount as a percentage, as taught by Schmitt, in order to facilitate judging whether the stent has been expanded properly, as suggested by Schmitt ([0040]).
Regarding claim 3, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows
The second representation comprises a visualization of the gap (“… areas of malapposition, …”, [0052] and fig. 1B).
Regarding claim 4, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows determining, based on the intravascular imaging data, a location of the stent within the vessel ([0052]).
Regarding claim 7, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows the first graphical representation comprises a color (“malapposition scores … color scale”, [0025]; color coding, [0052]; [0055]; [0059]; [0080] - [0081]; [0087] - [0088], inter alia) when the stent expansion amount is below the threshold (“malapposition distance threshold”, [0021] - [0023]; [0052]; [0057], inter alia).
Examiner note: in the combined invention of Elbasiony and Schmitt, the “stent expansion amount” is the “stent expansion percentage”, as explained in the art rejection of claim 1.
Regarding claim 11, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows the vessel diameter comprises an average diameter (mean diameter, [0082]).
Regarding claim 12, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows the first graphical representation comprises a numerical value (distance measurements, [0052]).
Regarding claims 13 - 14, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows the first graphical representation comprises a qualitative description comprising color (color, [0025]; [0052]; [0055]; [0059]; [0080] - [0081]; [0087] - [0088], inter alia).
Regarding claim 15, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows the first graphical representation comprises an indication to the user of a stent expansion (“…diameter graphs, image masks, shadow regions, stents, areas of malapposition, lumen border, perpendicular distances … images or representations of a blood vessel … text, arrows, color coding, highlighting, contour lines, … indicia…”, [0052] and fig. 1B. Note that the displayed data are necessarily in some way ‘indicative’ of the expansion of the stent).
Regarding claims 16 - 18, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows the first graphical representation comprises a numerical value (distance measurements, [0052]) and a color (color, [0025]; [0052]; [0055]; [0059]; [0080] - [0081]; [0087] - [0088], inter alia), wherein the color is based at least in part, on the comparison (“malapposition distance threshold”, [0021] - [0023]; [0052]; [0057], inter alia).
Regarding claim 20, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows the output comprises an indication to the user of a stent positioning (“… views of a blood vessel generated using collected OCT data …GUI … diameter graphs, image masks, shadow regions, stents, areas of malapposition, lumen border, perpendicular distances … images or representations of a blood vessel … text, arrows, color coding, highlighting, contour lines, … indicia…”, [0052] and fig. 1B. Note that the displayed data are necessarily in some way ‘indicative’ of the positioning and expansion of the stent).
Response to Arguments
Applicant's arguments filed 6/25/2026 have been fully considered but they are not persuasive.
Applicant’s comments on page 6 regarding the double patenting rejections are acknowledged. The rejections are deemed proper and are maintained.
Applicant argues on pages 7 - 8 that the prior art does not teach the amended features of the claims.
Examiner respectfully disagrees for reasons explained in the art rejections above.
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 AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
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