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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/2/2026 has been entered.
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 outputting a portion of the intravascular imaging data to a display, 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 2 - 3 and 19 - 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 to output to the display 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 claim 1 is suggested by reference claims 8 - 9.
Instant claims 2 - 3 and 19 - 20 are suggested by reference claims 2 - 3.
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 - 4, 7, and 11 - 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).
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]); and
provide, to a display in communication with the processor, an output for a user associated with the user controlling an expansion of the stent during the stent placement procedure, wherein the output comprises at least a portion of the intravascular imaging data and a graphical representation based, at least in part, on the comparison (“… 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) indicating a probability of restenosis occurring after the stent placement procedure is complete (implicit: the features of the data/graphics displayed on the GUI are necessarily in some way ‘indicative of a probability of restenosis’, as the data/graphics reflect the physiological state of the patient’s tissue/stent, and corresponding natural probability of restenosis).
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 claims 2 - 3, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows
identify, based on the imaging data, a gap between the stent and the vessel, and that the graphical representation is further based on the gap; and that a visualization of the gap is displayed(“… areas of malapposition, perpendicular distances … text, arrows, color coding, highlighting, contour lines, … indicia…”, [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 providing the output with the graphical representation as 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 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 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 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 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 claims 19 - 20, the combined invention of Elbasiony and Schmitt discloses the claimed invention substantially as noted above. Elbasiony further shows the graphical representation comprises an indication to the user of a stent positioning, a stent expansion, and the stent apposition (“… 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 with respect to the claim(s) have been considered but they are not persuasive or 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.
Applicant’s comments on page 7 regarding the double patenting rejections are acknowledged. The rejections are deemed proper and are maintained.
In response to applicant's arguments on page 9 against Elbasiony individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Elbasiony is not cited to teach the claimed percentage.
Applicant’s arguments on page 9 against Gopinathan are moot in view of the new grounds of rejection in view of Schmitt.
Conclusion
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.
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, 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.
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.
/AMELIE R DAVIS/Primary Examiner, Art Unit 3798