DETAILED ACTION
Response to Amendments/Arguments
Applicant’s response with respect to the drawing objection has been considered but is not fully accepted. The addition of a needle and syringe (fig. 6) are accepted. However, these drawings also contain subject matter not supported by the as-filed specification. Specifically, element 120 has been added in fig. 5, and this is also present in fig. 6. This is, as best understood, a tensioning ring. The as-filed specification contains no support for such a restraining element. The only discussion of any specific structure for a restraining element appears to be in [0022] as originally filed. This passage states: "Alternatively, a crosswise thin bridge may be used to hold a low-strength adhesive to keep the membrane 112 from rising to indicate pressure until pressure exceeds a small amount to prevent a very minimal pressures from causing a visible false deformation in the membrane 112. The false deformation may lead to erroneous indication of pressure of the fluid." In order to overcome the drawing objection, it is this structure that must be shown in the figures.
Applicant’s response with respect to the 35 U.S.C. 112(b) rejection of claim 12 has been fully considered and is accepted. The 35 U.S.C. 112(b) rejection of claim 12 has been withdrawn.
Applicant’s arguments with respect to claim 1 as rejected by Edwards, and all claims depending therefrom, have been considered but 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.
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 restraining element (claim 1), as supported by the original specification, 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 amendment filed 20 January 2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the specific ring configuration of element 120 in fig. 5 and 6. The as-filed specification contains no support for such a restraining element. The only discussion of any specific structure for a restraining element appears to be in [0022] as originally filed. This passage states: "Alternatively, a crosswise thin bridge may be used to hold a low-strength adhesive to keep the membrane 112 from rising to indicate pressure until pressure exceeds a small amount to prevent a very minimal pressures from causing a visible false deformation in the membrane 112. The false deformation may lead to erroneous indication of pressure of the fluid."
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
Claims 1-4, 6-7, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,866,648 to Hadzic et al. (hereinafter referred to as Hadzic) and US 10,145,748 to Lucchina et al. (hereinafter referred to as Lucchina; previously cited).
With regards to claim 1, Hadzic teaches a device (pressure indicating device 20; see fig. 1, 2, etc.) for indicating a pressure of a fluid (anesthetic solution), the device comprising:
a) a first end (end 26) having a cross-section and being configured to receive a flow of the fluid (from syringe 10), wherein the first end is integral with a needle (needle 60);
b) a pressure indicator (at least membrane 36, spring 34) configured to indicate the pressure of the flow, wherein the pressure indicator comprises:
a membrane (membrane 36) configured to indicate a level of the pressure of the flow (col. 7, ll. 10-22);
a restraining element (spring 34) attached to at least one of an upper surface or a lower surface of the membrane (see fig. 2), the restraining element being configured to prevent deformation of the membrane from a resting position until the pressure of the fluid exceeds a predetermined threshold value (col. 6, ll. 41-49); and
c) a second end (end 22) opposite the first end (see fig. 1, 2), the second end configured to couple the device to a syringe (see fig. 1), such that a fluid path is established from the needle through the device to the syringe (to deliver the solution; col. 5, ll. 35-56).
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Hadzic does not expressly teach:
the device indicating pulsatility, the needle being configured to puncture a blood vessel and to deliver the fluid into the device, wherein the device is configured to indicate pressure of blood in blood vessels, or
the pressure indicator comprising:
a base plate having a first thickness, the base plate being configured for receiving the membrane therewithin;
a dome shaped element made of a transparent material, the dome shaped element is configured to cover the membrane, wherein the dome shaped element comprises a cylindrical wall configured to reduce optical distortion; and
Lucchina teaches the feature of providing a pressure indicator with:
a base plate (base 2) having a first thickness (see fig. 4, 5, etc.), the base plate being configured for receiving the membrane therewithin (membrane 3; see fig. 1, 4, 5);
a dome shaped element (bell 4) made of a transparent material (col. 9, ll. 4-9), the dome shaped element is configured to cover the membrane (see fig. 1, 4, 5, etc.), wherein the dome shaped element comprises a cylindrical wall (clear from at least fig. 1) configured to reduce optical distortion (as a result of being cylindrical).
Hadzic and Lucchina both belong to the field of pressure indicators, and it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hadzic such that the pressure indicator comprises a mating base plate and transparent dome shaped element with a cylindrical wall, as in Lucchina. One of ordinary skill in the art would be motivated to do so in order to provide a good seal between the device body parts and the membrane using, e.g., press fitting, allow for easy assembly or disassembly, and allow for easy visual confirmation that the device is operating correctly. One could also close the housing and adopt the indicia-based indicator technique of Lucchina (col. 9, ll. 34-38) for monitoring fluid pressure if so desired, in order to simplify device construction by eliminating the indicator pole of Hadzic. Moreover, in this combination the individual pieces of each reference would continue to function in the same way, and the result of this combination would thus be predictable to one of ordinary skill in the art. This combination accordingly amounts to no more than the predictable use of prior-art elements according to their established functions, and would further be obvious for this reason.
As for the language requiring that the device indicating pulsatility, the needle being configured to puncture a blood vessel and to deliver the fluid into the device, wherein the device is configured to indicate pressure of blood in blood vessels, this language relates to how the apparatus set forth in the claim is intended to be used. The instant claim is an apparatus claim, and an apparatus claim is to cover what a device is, not how a device is to be used. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex Parte Masham, 2 USPQ F.2d 1647 (1987). The aforementioned limitations relating to the intended use of the claimed apparatus do not define positive limitations on the apparatus itself, and have accordingly not been given patentable weight. As the applied combination of references teach all of the structural limitations in this claim, said combination anticipates the claim.
With regards to claim 2, the combination of Hadzic and Lucchina teaches the device of claim 1. Hadzic and Lucchina both further teach the membrane being configured to be deformed from a resting position to a deformed position corresponding to the level of the pressure of the fluid (in Hadzic, these positions correspond to those in fig. 2A and 2B; in Lucchina, the membrane is flat when resting as in fig. 4-5, and deformed when fluid pressure acts therein as in fig. 1).
With regards to claim 3, the combination of Hadzic and Lucchina teaches the device of claim 2. Hadzic and Lucchina both further teach the membrane being configured to be deformed from the resting position to a plurality of deformed positions (in both references, the membrane is fluidly, i.e., not in discrete steps, between positions corresponding to maximum and minimum pressures).
With regards to claim 4, the combination of Hadzic and Lucchina teaches the device of claim 3. Hadzic and Lucchina both further teach the membrane being configured to be deformed from the resting position to a first deformed position on detection of a first pressure of the fluid, thereby indicating a first level of pressure of the fluid, and is configured to be deformed to a second deformed position on detection of a second pressure of the fluid, thereby indicating a second level of pressure of the fluid (in Hadzic, this corresponds to the green, yellow, and red levels in fig. 2B; in Lucchina a plurality of marks 9 may be provided to indicate any desired number of pressure levels corresponding to membrane deformation, see col. 9, ll. 24-38).
With regards to claim 6, the combination of Hadzic and Lucchina teaches the device of claim 1. This combination further teaches the base plate configured to have a top surface, a bottom surface (the top and bottom surfaces are shown in profile view in fig. 4-5 of Lucchina), and an aperture (element 7 in Lucchina, corresponding to opening 40 in Hadzic), wherein the aperture extends from the top surface to the bottom surface (col. 4, ll. 60-65, Lucchina; col. 6, ll. 21-23, Hadzic), and wherein the membrane is configured to cover the aperture on the top surface (see fig. 2 of Hadzic and fig. 1, 4, 5, of Lucchina).
With regards to claim 7, the combination of Hadzic and Lucchina teaches the device of claim 1. This combination further teaches the base plate comprises a top surface having an annular ring (in Lucchina, base 2 has a annular ring corresponding to the closed contour 6 where the membrane 3 is secured to base 2 via bell 4; see col. 4, ll. 44-51 and fig. 1, 4, 5), the annular ring being configured to receive the dome shaped element (see fig. 1, 4, 5 of Lucchina).
With regards to claim 11, the combination of Hadzic and Lucchina teaches the device of claim 1. This combination further teaches the membrane is configured to have a membrane thickness for facilitating displacement thereof in presence of the fluid (the membrane has a given thickness, and this ability to displace is shown in the figures of both Hadzic and Lucchina).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hadzic and Lucchina as applied to claim 7 above, and further in view of US 11,931,500 to Kawajiri et al. (hereinafter referred to as Kawajiri).
With regards to claim 9, the combination of Hadzic and Lucchina teaches the device of claim 7. Lucchina further teaches the dome shaped element comprising a vent hole (hole 8). However, this combination does not teach the vent hole configured to be covered by a filter.
Kawajiri teaches the feature of covering a vent hole in a pressure detector with a filter (see hydrophobic membrane B in fig. 14, 15, etc., and at least col. 10, ll. 24-43). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Edwards such that it similarly comprises a filter over the vent hole. Kawajiri teaches that, among other things, providing such a filter prevents leakage of the fluid for which pressure is measured from leaking to the outside of the pressure detector while still allowing gas to pass through for membrane operation (col. 10, l. 35-43).
With regards to claim 10, the combination of Hadzic, Lucchina, and Kawajiri teaches the device of claim 9. In this combination, the filter is a hydrophobic filter (the filter taught by Kawajiri is a hydrophobic filter; see at least col. 10, ll. 24-43 of Kawajiri).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10,739,218 to Schmidt et al. discloses pressure sensor with tensioned membranes, the tensioning being for precisely configuring the operating range of the sensor.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Split whose telephone number is (571)270-1524. The examiner can normally be reached Monday to Friday, 9:00 to 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Judy Nguyen can be reached at (571)272-2258. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JS/Examiner, Art Unit 2858
/JUDY NGUYEN/Supervisory Patent Examiner, Art Unit 2858