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 .
Priority
The examiner notes that the application claims benefit to multiple parent applications; specifically, 16/577962 (CON), 17/819580 (CIP), and 17/000240 (CIP).
Of these three parent applications, it is noted that support for the claimed limitation of “instructions that, when executed, cause a user interface to display a representation of the sensor data and a change between the first flow rate and the second flow rate” is not present.
As such, the instant application is given a priority date of 08/09/2023.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 08/09/2023, has been considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “user interface to display a representation of the sensor data and a change between the first flow rate and the second flow rate” (as recited in claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The claimed subject matter of “at least one pressure sensor configured to generate sensor data corresponding to a change between a first pressure and a second pressure distal to the balloon” or “instructions that, when executed, cause a user interface to display a representation of the sensor data and a change between the first flow rate and the second flow rate” is not disclosed in the originally filed specification.
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 1 is 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] The claim recites the limitation of “at least one pressure sensor configured to generate sensor data corresponding to a change between a first pressure and a second pressure distal to the balloon” in the 4th and 5th lines of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if this limitation refers to when the measurement is taken or where the measured pressures must be located. Furthermore, if the limitation refers to a location of measured pressure, it is unclear if both the “first pressure” and the “second pressure” must be “distal to the balloon,” or if only the “second pressure” is required to be “distal to the balloon.” For purposes of examination, it is interpreted that the limitation refers to a location of measured pressures and that both measured pressures are to be “distal to the balloon.”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schwartz et al. (PGPub 2017/0189654).
[Claim 1] Schwartz teaches a system (figure 1, item 10) for analyzing flow resistance in a blood vessel (paragraph [0041]), the system comprising:
a catheter (figure 1, item 20) comprising a distal region, a proximal region, and a balloon (figure 1, item 22) disposed at the distal region (figure 1), the distal region of the catheter (figure 1, item 20) sized and shaped to be positioned in a blood vessel (figure 6);
at least one pressure sensor (figure 6, items 100/102) configured to generate sensor data corresponding to a change between a first pressure and a second pressure distal to the balloon (see 112b interpretation above) (figure 1, item 22) (figure 6; paragraphs [0105], [0107]);
a pump assembly (figure 1, item 40) coupled to the proximal region of the catheter (figure 1, item 20) (figure 1), the pump assembly (figure 1, item 40) comprising at least one reservoir (figure 1, item 44) containing injectate (paragraph [0097]), the pump assembly (figure 1, item 40) configured to pump injectate from the at least one reservoir (figure 1, item 44) through the catheter (figure 1, item 20) at a first flow rate and a second flow rate (paragraphs [0036], [0050], [0058], [0098]); and
instructions that, when executed, cause a user interface (figure 14; “sample data lab displays”) to display a representation of the sensor data (figure 14, item “Pd”) and a change between the first flow rate and the second flow rate (figure 14, item “Q”) (figure 14; paragraphs [0064], [0066], [0146], [0147]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 02/10/2026