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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 2/23/26, amended claim(s) 1 and 10, and new claim(s) 21 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
Claim(s) 12 is/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.
For claim 12, the claim language “the pressure parameter further includes a pressure variation of the subset of the plurality of pressure measurements” is ambiguous. Claim 1, from which claim 12 depends, already recites this limitation. Therefore, it is unclear whether this language provides any further limitation or whether it is a typo. The claim is examined under the latter interpretation.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-12 and 21 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receiving a plurality of pressure measurements from the pressure sensor during advancement of the elongate medical device along the vasculature,” “determining a trend of a pressure parameter of the plurality of pressure measurements with respect to positioning of the distal end within the vasculature during advancement, wherein the pressure parameter includes a pressure variation of a subset of the plurality of pressure measurements, the pressure variation caused by cardiac pressure pulses,” and “determining a position of the distal end within the vasculature based on the trend of the pressure parameter.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “an elongate medical device configured for advancement along a vasculature of a patient, the elongate medical device comprising a pressure sensor coupled with the elongate medical device, wherein the pressure sensor is configured to determine a pressure adjacent a distal end of the elongate medical device,” and “a system module including a console coupled with the pressure sensor, the console including a processor and a memory having logic stored thereon that, when executed by the processor, performs operations.” However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0002] of U.S. Patent Application Publication No. 20240399106 to Haller et al. (hereinafter “Haller”) (also see Figs. 1-2 of EP 1 970 001 B1) and Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 5-12 and 21 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Dependent claim 2 does not recite “significantly more” in view of para [0002] of Haller (also see para [0002] of EP 1 970 001 B1). Dependent claim 3 does not recite “significantly more” in view of para [0022] of U.S. Patent Application Publication No. 20150272698 to Rolfes et al. (hereinafter “Rolfes”). Dependent claim 4 does not recite “significantly more” in view of para [0002] of Haller (also see Figs. 1-2 of EP 1 970 001 B1). Thus, claim(s) 1-12 and 21 is/are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 4-7, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0080762 to Kassab et al. (hereinafter “Kassab”).
For claim 1, Kassab discloses a medical system (Abstract), comprising:
an elongate medical device (100) (Fig. 1) (para [0087]) configured for (Examiner’s Note: functional language, i.e., capable of) advancement along a vasculature of a patient (para [0087]), the elongate medical device comprising a pressure sensor (850) (Fig. 8A) (para [139]) coupled with the elongate medical device (as can be seen in Fig. 8A), wherein the pressure sensor is configured to (Examiner’s Note: functional language, i.e., capable of) determine a pressure adjacent a distal end of the elongate medical device (para [0139]); and
a system module including a console (902) (Fig. 9A) (para [129]) coupled with the pressure sensor (para [0107]), the console including a processor and a memory having logic stored thereon that, when executed by the processor, performs operations (“personal computer (PC),” para [0129]) that include:
receiving a plurality of pressure measurements from the pressure sensor during advancement of the elongate medical device along the vasculature (para [0139]);
determining a trend of a parameter of the plurality of pressure measurements with respect to positioning of the distal end within the vasculature during advancement (para [0141], see “gradient” and “stepwise changes,”), wherein the parameter includes a variation of a subset of the plurality of measurements (para [0141], see “phasic measurements,” “peak to a minimum,” and “pulsatility or phasic changes,”), the variation caused by cardiac pressure pulses (para [0141], see “subclavian vein” and “heart”); and
determining a position of the distal end within the vasculature based on the trend of the parameter (para [0141]).
Kassab does not expressly disclose that the parameter at para [0141] is a pressure parameter and that the variation is a pressure variation. Instead, Kassab teaches that the parameter at para [0141] is conductance or voltage.
However, Kassab teaches that pressure may be a measured parameter in addition to or alternatively to conductance/voltage for the same purpose of providing feedback regarding location (para [0139]).
Therefore, it would have been obvious to a skilled artisan to modify Kassab such that the parameter is pressure parameter and the variation is a pressure variation, in view of the teachings of Kassab, because such a modification is the simple substitution of the type of parameter that is being measured/analyzed that would lead to the same predictable result detecting the location of the device in the patient’s vasculature.
For claim 2, Kassab further discloses wherein the pressure sensor is located adjacent the distal end of the elongate medical device (as can be seen in Fig. 8A).
For claim 4, Kassab further discloses wherein the elongate medical device is a central catheter (para [0087]).
For claim 5, Kassab further discloses wherein the vasculature includes a vein (para [0141]).
For claim 6, Kassab further discloses wherein advancement includes advancement toward a heart of the patient (para [0141]).
For claim 7, Kassab further discloses wherein the position of the distal end within the vasculature includes a cavoatrial junction (para [0039] and [0041]).
For claim 10, Kassab further discloses wherein: the subset is received with the distal end disposed at a location within the vasculature (para [0141]), and the trend includes an increase in the pressure variation as the distal end is advanced along the vasculature away from the location (para [0141]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kassab in view of U.S. Patent Application Publication No. 2023/0052862 to Lau et al. (hereinafter “Lau”).
For claim 3, Kassab does not expressly disclose wherein: the elongate medical device includes an optical fiber extending therealong, and the pressure sensor includes a fiber optic Bragg grating.
However, Lau teaches wherein: the elongate medical device includes an optical fiber extending therealong (para [0101]), and the pressure sensor includes a fiber optic Bragg grating (para [0101]).
It would have been obvious to a skilled artisan to modify Kassab wherein: the elongate medical device includes an optical fiber extending therealong, and the pressure sensor includes a fiber optic Bragg grating, in view of the teachings of Lau, because a fiber optic Bragg grating is a suitable structure to measure pressure to obtain the pressure data that is disclosed in Kassab.
Claim(s) 8-9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kassab in view of U.S. Patent Application Publication No. 2022/0338753 to Gershi et al. (hereinafter “Gershi”).
For claim 8, Kassab does not expressly disclose wherein: the pressure parameter includes an average pressure of a subset of the plurality of pressure measurements, and the trend includes a decrease in the average pressure.
However, Gershi teaches wherein: the pressure parameter includes an average pressure of a subset of the plurality of pressure measurements (para [0114]), and the trend includes a decrease in the average pressure (para [0120]).
It would have been obvious to a skilled artisan to modify Kassab wherein: the pressure parameter includes an average pressure of a subset of the plurality of pressure measurements, and the trend includes a decrease in the average pressure, in view of the teachings of Gershi, because such a modification would be the simple substitution of pressure data processing step(s) for another data processing step(s) that would lead to the predictable result of being able to determine the location of the medical device.
For claim 9, Kassab, as mofiied, further discloses wherein determining a position of the distal end within the vasculature based on the trend includes determining a minimum of the average pressure in accordance with the trend (para [0160] of Gershi).
For claim 12, Kassab further discloses the pressure parameter further includes a pressure variation of the subset of the plurality of pressure measurements (para [0141]), the trend further including an increase in the pressure variation (para [0141]).
Kassab does not expressly disclose wherein: the pressure parameter includes an average pressure of a subset of the plurality of pressure measurements, the trend including a decrease in the average pressure; and determining the position of the distal end within the vasculature based on the trend includes determining a minimum of the average pressure in combination with determining a maximum of the pressure variation.
However, Gershi teaches wherein: the pressure parameter includes an average pressure of a subset of the plurality of pressure measurements (para [0114]), and the trend includes a decrease in the average pressure (para [0120]).
It would have been obvious to a skilled artisan to modify Kassab wherein: the pressure parameter includes an average pressure of a subset of the plurality of pressure measurements, the trend including a decrease in the average pressure; and determining the position of the distal end within the vasculature based on the trend includes determining a minimum of the average pressure in combination with determining a maximum of the pressure variation, in view of the teachings of Gershi, because such a modification would be the simple substitution of pressure data processing step(s) for another data processing step(s) that would lead to the predictable result of being able to determine the location of the medical device.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kassab in view of U.S. Patent Application Publication No. 2025/0261861 to Sonck et al. (hereinafter “Sonck”).
For claim 11, Kassab, as modified, further discloses wherein determining a position of the distal end within the vasculature based on the trend includes determining a maximum of the pressure variation in accordance with the trend (see the top, flat, plateu in time window 42 of the graph in Fig. 5).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kassab in view of U.S. Patent Application Publication No. 2023/0309844 to Jang et al. (hereinafter “Jang”).
For claim 21, Kassab does not expressly disclose wherein the pressure variation includes a standard deviation of the subset of the plurality of pressure measurements.
However, Jang teaches wherein a pressure variation includes a standard deviation of pressure measurements (para [0057]).
It would have been obvious to a skilled artisan to modify Kassab wherein the pressure variation includes a standard deviation of the subset of the plurality of pressure measurements, in view of the teachings of Jang, because standard deviation is an objective measure of variation in a parameter.
Response to Arguments
Applicant’s arguments filed 2/23/26 have been fully considered.
With respect to the 112 rejection(s), Applicant’s amendments and arguments are persuasive and thus the rejection(s) is/are withdrawn.
With respect to the 101 rejection(s), Applicant’s arguments do not appear commensurate in scope with the claim language. The arguments focus on the claimed subject matter being too complex for the human mind to calculate “on the fly” and are more complex than the subject matter in Ambry or Grams. However, there is no recitation in the claim language that the calculations be performed on the fly. Additionally, claim terms such as “plurality of pressure measurements” is broad enough to encompass two pressure measurements. Are two pressure values too complex for the human mind? The examiner understands that if thousands of pressure values were required to be computed in a matter of seconds, then such a task would be too complex for the human mind. But the claim language is not that limited.
With respect to the 102/103 rejections, Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 2/23/26. With respect to claim 3, Lau discloses that the sensor may be a “pressure sensor” (para [0021]). With respect to claim 9, para [0114] of Gershi is relied upon as well in the rejection. Therefore, solely arguing para [0160] doesn’t address the entire rejection of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791