DETAILED ACTION
This office action is in response to the communication received on 11/20/2025 concerning application no. 18/466,640 filed on 09/13/2023.
Claims 1-20 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/20/2025 has been entered.
Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed 10/21/2025 have been fully considered but they are not persuasive.
Regarding the 112(a) rejection, Applicant argues that “For example, the Specification teaches "during some medical interventions (e.g., pre-percutaneous coronary intervention (pre-PCI), it may be desirable to measure and/or monitor the blood pressure within a blood vessel." See Specification, 47 (emphasis added). Further, the Specification teaches that "the present disclosure provides advantages over prior or conventional pressure measurement systems in that the pressure ratio and trend lines are generated in real time and can be displayed during a pre-PCI procedure in a mechanism that is more easily digestible or interpretable than conventional pressure measurements." See Specification, 49 (emphasis added). Therefore, one of ordinary skill in the art would find it reasonable clear that the Specification teaches to "generate, during the medical intervention, a trend line comprising the identified maximum FFR values" as recited in the claims. Thus, Applicant was in possession of the claimed invention and Applicant requests withdrawal of the 35 U.S.C. § 112(a) rejection of claims 1-20.”
Examiner respectfully disagrees. As established in the prior action, filed 07/21/2025, “While…paragraph 0047 discloses ‘During some medical interventions (e.g., pre-percutaneous coronary intervention (pre-PCI)’1, the specification fails to disclose the teaching that the calculation of the slope, the mean, and the plurality of FFR values, the identification of the regions and the maximum of a set of FFR values, and the generation of the trendline is performed during the medical intervention. Rather, as the specification discloses the medical intervention has the “first time period” as noted in paragraphs 0007 and 0022 where the reception of the indications of the first and second pressures is performed. The subject matter, at the time of filing, did not disclose that the calculation steps, identification steps, and the generation steps are performed during the medical intervention.” (emphasis added). That is, the specification does not teach the “calculate, during the medical intervention, a slope”, “calculate, during the medical intervention, a mean”, “identify, during the medical intervention, one or more regions”, “calculate, during the medical intervention, a plurality of FFR values”, “identify, during the medical intervention for each of the plurality of FFR values, a maximum of a set of FFR values”, and “generate, during the medical intervention, a trend line” to be performed during the medical procedure. Nowhere in the specification is it established that it is performed during the medical intervention. Rather, the specification establishes that the medical intervention is during the receptions of the indications of the first and second pressures as disclosed in paragraph 0007 and 0022. Additionally, paragraph 0047 clearly states that it is for pre-PCI. The instant claims are claiming that the medical intervention is PCI and resulting in further 112(a) issues.
Examiner respectfully maintains the rejection.
Applicant's arguments filed 10/21/2025 have been fully considered but they are not persuasive.
Regarding the 101 rejection, Applicant argues that the determination of the FFR in absence of a hyperemic agent and during PCI is and improved method and meets Step 2A, Prong 2. Applicant argues that the claims read as a whole result in an actual machine that operates the calculation. Applicant argues that “[T]his is similar to Example 4 from the USPTO 101 Eligibility Guidance. Example 4 relates to a GPS device performing mathematical operations. However, despite reciting an abstract idea, the claims are patentable under 35 U.S.C. § 101 as the claimed "combination of elements impose meaningful limits in that the mathematical operations are applied to improve an existing technology (global positioning) by improving the signal-acquisition sensitivity of the receiver to extend the usefulness of the technology into weak-signal environments and providing the location information for display on the mobile device. All of these features, especially when viewed in combination, amount to significantly more than the judicial exception." See Example 4 of the USPTO 2014 Interim Eligibility Guidance.” Applicant argues that the claims are addressing the plotting of trends during a PCI and highlighting measurements.
Examiner respectfully disagrees. The determination is based on the reception and calculation steps that are assess in Step 2A, Prong 1 rather than Step 2A, Prong 2. Additionally, Applicant’s arguments rely on language solely recited in preamble recitations in claim 1. When reading the preamble in the context of the entire claim, the recitation of determination of the FFR in absence of a hyperemic agent is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. Furthermore, the Applicant’s argument that it results in an improvement is without support. MPEP 716.01(c) establishes “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” As noted in the rejection, the Step 2A Prong 2 assesses the additional elements. Furthermore, while the claim establishes that the medical procedure is PCI, a PCI procedure is broad and does not preclude the performance of a calculation and identification as claimed. The application of the mental processes in a machine is not significantly more. As established in the prior action, filed 07/21/2025, “[C]alculations, identifications, and generations of the data are mental processes that are assessed in Step 2A Prong 1. Furthermore, MPEP 2106.04(a)(1) establishes that the “courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."); Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1139, 120 USPQ2d 1473, 1474 (Fed. Cir. 2016) (holding that claims to a mental process of "translating a functional description of a logic circuit into a hardware component description of the logic circuit" are directed to an abstract idea, because the claims "read on an individual performing the claimed steps mentally or with pencil and paper").” MPEP 2106.05(I)(A) establishes that “Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include: i. Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)); ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d))”. The implementation of a computational system in the performance of the mental processes is not significantly more.” Regarding Example 4, the instant claim is not similar to the Guidance Example 4. That is regarding a GPS device and the instant claim is regarding a system for FFR calculation with “a processor coupled to the memory device, the processor configured to execute the instructions, which when executed cause the system to” perform a series of mental processes. The use of the memory and processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception as established in MPEP 2106.05(I)(A). Furthermore, the instant claim is not showing an improvement to an “existing technology (global positioning) by improving the signal-acquisition sensitivity of the receiver to extend the usefulness of the technology into weak-signal environments and providing the location information for display on the mobile device” as Example 4 is established to do. Nowhere in the specification is there disclosure that the operation of the steps is during PCI and will highlight the measurements during PCI as claimed by Applicant. As noted above, MPEP 716.01(c) establishes “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” Mere allegation of similarity to an undisclosed example is insufficient.
Examiner respectfully maintains the rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “calculate, during the medical intervention, a slope”, “calculate, during the medical intervention, a mean”, “identify, during the medical intervention, one or more regions”, “calculate, during the medical intervention, a plurality of FFR values”, “identify, during the medical intervention for each of the plurality of FFR values, a maximum of a set of FFR values”, and “generate, during the medical intervention, a trend line”. While paragraphs 0007 and 0022 each discloses “the first time period is during the medical intervention” and the paragraph 0047 discloses “During some medical interventions (e.g., pre-percutaneous coronary intervention (pre-PCI)”2, the specification fails to disclose the teaching that the calculation of the slope, the mean, and the plurality of FFR values, the identification of the regions and the maximum of a set of FFR values, and the generation of the trendline is performed during the medical intervention. Rather, as the specification discloses the medical intervention has the “first time period” as noted in paragraphs 0007 and 0022 where the reception of the indications of the first and second pressures is performed. The subject matter, at the time of filing, did not disclose that the calculation steps, identification steps, and the generation steps are performed during the medical intervention. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 1 recites “wherein the medical intervention is a percutaneous coronary intervention (PCI)”. The specification does not disclose the operation during PCI. Rather, the specification discloses that the disclosure is regarding “an improved method to derive, plot, and present pressure rations for interpretation by a physician prior to placing a stent as part of a PCI” (Paragraph 0004 of the specification) (emphasis added). Even paragraphs 0047-49 establishes that the medical intervention is before PCI. Paragraph 0047 establishes “During some medical interventions (e.g., pre-percutaneous coronary intervention (pre-PCI), it may be desirable to measure and/or monitor the blood pressure within a blood vessel.” (emphasis added). Paragraph 0048 establishes that it is a system that is “for measuring Pd and Pa during a pre-PCI procedure” (emphasis added). Paragraph 0049 discloses “The present disclosure provides advantages over prior or conventional pressure measurement systems…during a pre-PCI procedure... Further, often during a pre-PCI procedure,….” (emphasis added). Similarly, paragraphs 0058-60 and 0064-65 disclose operation pre-PCI. The suffix “pre-” refers to “earlier than : prior to : before” or “preparatory or prerequisite to”3. Therefore, upon review of the specification, one with ordinary skill in the art would realize the disclosure is regarding a procedure that occurs prior to or earlier than the PCI procedure. Nowhere in the specification is there disclosure of the operation of the claimed method during the PCI procedure as instantly claimed. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 16 recites “calculate, during the medical intervention, a slope”, “calculate, during the medical intervention, a mean”, “identify, during the medical intervention, one or more regions”, “calculate, during the medical intervention, a plurality of FFR values”, “identifying, during the medical intervention for each of the plurality of FFR values, a maximum of a set of FFR values”, and “generate, during the medical intervention, a trend line”. While paragraphs 0007 and 0022 each discloses “the first time period is during the medical intervention” and the paragraph 0047 discloses “During some medical interventions (e.g., pre-percutaneous coronary intervention (pre-PCI)”4, the specification fails to disclose the teaching that the calculation of the slope, the mean, and the plurality of FFR values, the identification of the regions and the maximum of a set of FFR values, and the generation of the trendline is performed during the medical intervention. Rather, as the specification discloses the medical intervention has the “first time period” as noted in paragraphs 0007 and 0022 where the reception of the indications of the first and second pressures is performed. The subject matter, at the time of filing, did not disclose that the calculation steps, identification steps, and the generation steps are performed during the medical intervention. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 16 recites “wherein the medical intervention is a percutaneous coronary intervention (PCI)”. The specification does not disclose the operation during PCI. Rather, the specification discloses that the disclosure is regarding “an improved method to derive, plot, and present pressure rations for interpretation by a physician prior to placing a stent as part of a PCI” (Paragraph 0004 of the specification) (emphasis added). Even paragraphs 0047-49 establishes that the medical intervention is before PCI. Paragraph 0047 establishes “During some medical interventions (e.g., pre-percutaneous coronary intervention (pre-PCI), it may be desirable to measure and/or monitor the blood pressure within a blood vessel.” (emphasis added). Paragraph 0048 establishes that it is a system that is “for measuring Pd and Pa during a pre-PCI procedure” (emphasis added). Paragraph 0049 discloses “The present disclosure provides advantages over prior or conventional pressure measurement systems…during a pre-PCI procedure... Further, often during a pre-PCI procedure,….” (emphasis added). Similarly, paragraphs 0058-60 and 0064-65 disclose operation pre-PCI. The suffix “pre-” refers to “earlier than : prior to : before” or “preparatory or prerequisite to”5. Therefore, upon review of the specification, one with ordinary skill in the art would realize the disclosure is regarding a procedure that occurs prior to or earlier than the PCI procedure. Nowhere in the specification is there disclosure of the operation of the claimed method during the PCI procedure as instantly claimed. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 19 recites “calculating, during the medical intervention, a slope”, “calculating, during the medical intervention, a mean”, “identifying, during the medical intervention, one or more regions”, “calculating, during the medical intervention, a plurality of FFR values”, “identifying, during the medical intervention for each of the plurality of FFR values, a maximum of a set of FFR values”, and “generating, during the medical intervention, a trend line”. While paragraphs 0007 and 0022 each discloses “the first time period is during the medical intervention” and the paragraph 0047 discloses “During some medical interventions (e.g., pre-percutaneous coronary intervention (pre-PCI)”6, the specification fails to disclose the teaching that the calculation of the slope, the mean, and the plurality of FFR values, the identification of the regions and the maximum of a set of FFR values, and the generation of the trendline is performed during the medical intervention. Rather, as the specification discloses the medical intervention has the “first time period” as noted in paragraphs 0007 and 0022 where the reception of the indications of the first and second pressures is performed. The subject matter, at the time of filing, did not disclose that the calculation steps, identification steps, and the generation steps are performed during the medical intervention. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 20 recites “wherein the medical intervention is a percutaneous coronary intervention (PCI)”. The specification does not disclose the operation during PCI. Rather, the specification discloses that the disclosure is regarding “an improved method to derive, plot, and present pressure rations for interpretation by a physician prior to placing a stent as part of a PCI” (Paragraph 0004 of the specification) (emphasis added). Even paragraphs 0047-49 establishes that the medical intervention is before PCI. Paragraph 0047 establishes “During some medical interventions (e.g., pre-percutaneous coronary intervention (pre-PCI), it may be desirable to measure and/or monitor the blood pressure within a blood vessel.” (emphasis added). Paragraph 0048 establishes that it is a system that is “for measuring Pd and Pa during a pre-PCI procedure” (emphasis added). Paragraph 0049 discloses “The present disclosure provides advantages over prior or conventional pressure measurement systems…during a pre-PCI procedure... Further, often during a pre-PCI procedure,….” (emphasis added). Similarly, paragraphs 0058-60 and 0064-65 disclose operation pre-PCI. The suffix “pre-” refers to “earlier than : prior to : before” or “preparatory or prerequisite to”7. Therefore, upon review of the specification, one with ordinary skill in the art would realize the disclosure is regarding a procedure that occurs prior to or earlier than the PCI procedure. Nowhere in the specification is there disclosure of the operation of the claimed method during the PCI procedure as instantly claimed. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(a) are also rejected because they inherit the deficiencies of the claims they respectively depend upon.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a system for determining fractional flow reserve (FFR) in the absence of administering a hyperemic agent and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “calculate, during the medical intervention, a slope of a plot of the second pressure over the first time period; calculate, during the medical intervention, a mean of the second pressure over the first time period; identify, during the medical intervention, one or more regions within the first time period where the second pressure is less than or equal to the mean of the second pressure and where the slope of the plot of the second pressure is less than or equal to zero; calculate, during the medical intervention, a plurality of FFR values as the ratio of the first pressure over the second pressure during the one or more regions; identify, during the medical intervention for each of the plurality of FFR values, a maximum of a set of FFR values comprising the FFR value and n prior FFR values of the plurality of FFR values, where n is greater than one; and generate, during the medical intervention, a trend line comprising the identified maximum FFR values; wherein the medical intervention is a percutaneous coronary intervention (PCI)”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the calculation of a slope and mean for pressure information, the identification of regions according to a comparison to the numerical slope and mean information, the calculation of a ratio, the identification of a maximum FFR value and the generation of the trendline. These calculations and determinations can be performed during a medical intervention that is claimed to be PCI. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “a memory device comprising instructions; and a processor coupled to the memory device, the processor configured to execute the instructions, which when executed cause the system to: receive an indication of a first pressure from a pressure sensing guidewire coupled to the system for a first time period, wherein the first time period is during a medical intervention and wherein the first pressure is measured within a vessel of a patient; receive an indication of a second pressure from a pressure sensing medical device different from the pressure sensing guidewire for the first time period, wherein the second pressure is measured within the vessel of the patient”. The reception of the pressure indications is a data-gathering steps is a form of a pre-solution insignificant activity. The use of a processor and memory does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 1 is ineligible.
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein n is greater than or equal to 3”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the consideration of an n value that is greater than or equal to 3. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 2 is ineligible.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein n is greater than or equal to 3 and less than or equal to 5”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the consideration of an n value that is greater than or equal to 3 and less than or equal to 5. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 3 is ineligible.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “scale the mean by a factor to generate a scaled mean; and identify the one or more regions within the first time period where the second pressure is less than or equal to the scaled mean”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the identification of regions where the pressure is less than or equal to a factor of the mean and the scaling of a meany by a factor to generate a scaled mean. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “the memory device further comprising instructions that when executed by the processor cause the system to identify”. The use of the memory and processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 4 is ineligible.
Claim 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the factor is between 0.75 and 0.85”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the consideration of the factor. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 5 is ineligible.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a system and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein the factor is 0.8”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the consideration of the factor. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 6 is ineligible.
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 7 recites the following elements: “wherein the pressure sensing guidewire comprises an optical pressure sensor”. This claim element is a mere data-gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 7 is ineligible.
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 8 recites the following elements: “wherein the pressure sensing medical device comprises a catheter with a pressure sensor”. This claim element is a mere data-gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 8 is ineligible.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 9 recites the following elements: “wherein the pressure sensing guidewire and/or the pressure sensing medical device are wirelessly coupled to the system”. This claim element is a mere data-gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 9 is ineligible.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 10 recites the following elements: “comprising the pressure sensing medical device and the pressure sensing guidewire”. This claim element is a mere data-gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 10 is ineligible.
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 11 recites the following elements: “wherein the pressure sensing guidewire is configured to be disposed in the vessel distal of an intravascular lesion”. This claim element is a mere data-gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 11 is ineligible.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 11 rejection.
Claim 12 recites the following elements: “wherein the pressure sensing medical device is configured to be disposed in the vessel proximal of the intravascular lesion”. This claim element is a mere data-gathering step which amounts to a pre-solution insignificant activity. This pre-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 12 is ineligible.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 1 rejection.
Claim 1 recites the following elements: “the memory device further comprising instructions that when executed by the processor cause the system to generate a graphical user interface comprising a graphical representation of the trend line”. This claim element is a mere displaying step which amounts to a post-solution insignificant activity. This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 13 is ineligible.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 13 rejection.
Claim 14 recites the following elements: “memory device further comprising instructions that when executed by the processor cause the system to render the graphical user interface for display on a display”. This claim element is a mere displaying step which amounts to a post-solution insignificant activity. This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 14 is ineligible.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 and Step 2A, Prong 1, Judicial Exception are discussed above in the claim 14 rejection.
Claim 15 recites the following elements: “comprising the display”. This claim element is a mere displaying step which amounts to a post-solution insignificant activity. This post-solution insignificant activity does not integrate the judicial exception into a practical application nor does it contain an inventive step. In light of above, claim 15 is ineligible.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite at least one non-transitory machine readable storage device and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “calculate, during the medical intervention, a slope of a plot of the second pressure over the first time period; calculate, during the medical intervention, a mean of the second pressure over the first time period; identify, during the medical intervention, one or more regions within the first time period where the second pressure is less than or equal to the mean of the second pressure and where the slope of the plot of the second pressure is less than or equal to zero; calculate, during the medical intervention, a plurality of FFR values as the ratio of the first pressure over the second pressure during the one or more regions; identifying, during the medical intervention for each of the plurality of FFR values, a maximum of a set of FFR values comprising the FFR value and n prior in time FFR values of the plurality of FFR values, where n is greater than one; and generate, during the medical intervention, a trend line comprising the identified maximum FFR values, wherein the medical intervention is a percutaneous coronary intervention (PCI)”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the calculation of a slope and mean for pressure information, the identification of regions according to a comparison to the numerical slope and mean information, the calculation of a ratio, the identification of a maximum FFR value and the generation of the trendline. These calculations and determinations can be performed during a medical intervention that is claimed to be PCI. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “comprising a plurality of instructions that in response to being executed by a processor of a hemodialysis machine cause the processor to: receive, during a medical intervention, an indication of a first pressure from a pressure sensing guidewire coupled to the hemodialysis machine for a first time period, wherein the first time period is during a medical intervention and wherein the first pressure is measured within a vessel of a patient; receive, during the medical intervention, an indication of a second pressure from a pressure sensing medical device different from the pressure sensing guidewire for the first time period, wherein the second pressure is measured within the vessel of the patient”. The reception of the pressure indications is a data-gathering steps is a form of a pre-solution insignificant activity. The use of a processor and memory does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 16 is ineligible.
Claim 17 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite at least non-transitory machine readable storage device and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “scale the mean by a factor to generate a scaled mean; and identify the one or more regions within the first time period where the second pressure is less than or equal to the scaled mean, wherein the factor is between 0.75 and 0.85”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the identification of regions where the pressure is less than or equal to a factor of the mean and the scaling of a meany by a factor to generate a scaled mean. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “wherein the plurality of instructions, in response to being executed by the processor of the hemodialysis machine further cause the processor to”. The use of a processor does not integrate the judicial exception into a practical application as it is merely used to perform the judicial exception.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 17 is ineligible.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite at least one non-transitory machine readable storage device and therefore, is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein n is greater than or equal to 3”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the consideration of an n value that is greater than or equal to 3. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 18 is ineligible.
Claim 19 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “calculating, during the medical intervention, a slope of a plot of the second pressure over the first time period; calculating, during the medical intervention, a mean of the second pressure over the first time period; identifying, during the medical intervention, one or more regions within the first time period where the second pressure is less than or equal to the mean of the second pressure and where the slope of the plot of the second pressure is less than or equal to zero; calculating, during the medical intervention, a plurality of FFR values as the ratio of the first pressure over the second pressure during the one or more regions; identifying, during the medical intervention for each of the plurality of FFR values, a maximum of a set of FFR values comprising the FFR value and n prior in time FFR values of the plurality of FFR values, where n is greater than one; and generating, during the medical intervention, a trend line comprising the identified maximum FFR values, wherein the medical intervention is a percutaneous coronary intervention (PCI)”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the calculation of a slope and mean for pressure information, the identification of regions according to a comparison to the numerical slope and mean information, the calculation of a ratio, the identification of a maximum FFR value and the generation of the trendline. These calculations and determinations can be performed during a medical intervention that is claimed to be PCI. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements: “receiving, during a medical intervention, an indication of a first pressure from a pressure sensing guidewire coupled to a hemodialysis machine for a first time period, wherein the first time period is during a medical intervention and wherein the first pressure is measured within a vessel of a patient; receiving, during the medical intervention, an indication of a second pressure from a pressure sensing medical device different from the pressure sensing guidewire for the first time period, wherein the second pressure is measured within the vessel of the patient”. The reception of the pressure indications is a data-gathering steps is a form of a pre-solution insignificant activity.
These additional elements, taken individually or in combination, merely amount to insignificant pre/post-solution activities and do not integrate the judicial exception into a practical application. This claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No - Similarly to Step 2A Prong 2, the additional claim elements merely recite insignificant extra-solution activities, which do not amount to significantly more than the judicial exception. For these reasons, there is no inventive concept in the claim. In light of the above, claim 19 is ineligible.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite a method and therefore, is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim recites the limitation “wherein n is greater than or equal to 3”.
This limitation, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it is regarding a concept relating to the consideration of an n value that is greater than or equal to 3. That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim does not contain additional elements. Therefore, the claim does not integrate the judicial exception into a practical application.
Step 2B, Inventive Concept: No - Similar to Step 2A Prong 2, the claim does not contain additional elements. For these reasons, there is no inventive concept in the claim. In light of the above, claim 20 is ineligible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tochterman et al. (PGPUB No. US 2016/0007866): Teaches the trendline assessment of a vessel and FFR measurements.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 Note the term “some” and “e.g.” indicates that the pre-PCI intervention that is exemplary and is not limited to one embodiment.
2 Note the term “some” and “e.g.” indicates that the pre-PCI intervention that is exemplary and is not limited to one embodiment.
3 Link: https://www.merriam-webster.com/dictionary/pre-
4 Note the term “some” and “e.g.” indicates that the pre-PCI intervention that is exemplary and is not limited to one embodiment.
5 Link: https://www.merriam-webster.com/dictionary/pre-
6 Note the term “some” and “e.g.” indicates that the pre-PCI intervention that is exemplary and is not limited to one embodiment.
7 Link: https://www.merriam-webster.com/dictionary/pre-