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 1/30/26, amended claim(s) 5-8 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) 5 and 7 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 5, the claim language “wherein the first pressure is defined in accordance with a venous pressure of the patient, the venous pressure being a pressure that transitions the first valve to an opened state while the second valve remains in the normally closed state” is ambiguous. It is unclear what pressure values are included with this limitation and what values are not since the claim is defined by a result to be achieved (i.e., the pressure being in accordance with a venous pressure that transitions the first valve to an opened state while the second valve remains in the normally closed state of a patient) without any guidance or scope on what the boundaries of this function imposes to the “first pressure” itself. The claim is examined as meaning between 4 mmHg and 40 mm Hg.
For claim 7, the claim language “wherein the second pressure is defined in accordance with an arterial pressure of the patient, the arterial pressure being a pressure that transitions the first valve and the second valve from the normally closed state to the opened state” is ambiguous. It is unclear what pressure values are included with this limitation and what values are not since the claim is defined by a result to be achieved (i.e., the pressure being in accordance with an arterial pressure that transitions the first valve and the second valve from the normally closed state to the opened state of a patient) without any guidance or scope on what the boundaries of this function imposes to the “second pressure” itself. The claim is examined as meaning greater than 40 mmHg.
Claim Rejections - 35 USC § 102
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(s) 1-4 and 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2019/0365303 to Bullington et al. (hereinafter “Bullington”).
For claim 1, Bullington discloses a medical device (Abstract), comprising:
a third chamber (213) (Fig. 2) (para [0073]) including a fluid port (212) (Fig. 2) (para [0071]);
a first chamber (254) (Fig. 2) (para [0072]) fluidly coupled with the third chamber via a first valve (222) (Fig. 2) (para [0075]); and
a second chamber (224) (Fig. 2) (para [0072]) fluidly coupled with the third chamber via a second valve (221) (Fig. 2) (para [0075]),
wherein:
the first valve is configured to transition from a normally closed state to an opened state in response to a first pressure across the first valve (para [0075]),
the second valve is configured to transition from a normally closed state to an opened state in response to a second pressure across the second valve (para [0075]), the second pressure different from the first pressure (para [0076]), and
the fluid port is configured to receive a body fluid from a patient (para [0024] and [0093]).
For claim 2, Bullington further discloses wherein the body fluid is blood (para [0024] and [0093]).
For claim 3, Bullington further discloses wherein the fluid port is configured to couple with a vascular access device (para [0071]).
For claim 4, Bullington further discloses wherein the fluid port includes a Luer lock connector (para [0044]).
For claim 7, Bullington further discloses wherein the second pressure is defined in accordance with an arterial pressure of the patient (para [0077]).
For claim 8, Bullington further discloses wherein the second pressure is greater than about 40 mmHg (para [0077]).
For claim 9, Bullington further discloses wherein: the first valve includes a first septum extending across an opening between the first chamber and the third chamber (as can be seen in Fig. 2), and the second valve includes a second septum extending across an opening between the second chamber and the third chamber (as can be seen in Fig. 2).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bullington in view of U.S. Patent Application Publication No. 2011/0270183 to Miyasaka.
For claim 5, Bullington does not expressly disclose discloses wherein the first pressure is defined in accordance with a venous pressure of the patient.
However, Miyasaka teaches wherein a first pressure is defined in accordance with a venous pressure of the patient (para [0013] and [0053]).
It would have been obvious to a skilled artisan to modify Bullington wherein the first pressure is defined in accordance with a venous pressure of the patient, in view of the teachings of Miyasaka, for the obvious advantage of having the valve open when the catheter disclosed in Bullington enters a vein of a patient.
For claim 6, Bullington does not expressly disclose wherein the first pressure is between about 4 mmHg and 40 mmHg.
However, Miyasaka teaches wherein the first pressure is between about 4 mmHg and 40 mmHg (para [0048]) (also see para [0013] and [0053]).
It would have been obvious to a skilled artisan to modify Bullington wherein the first pressure is between about 4 mmHg and 40 mmHg, in view of the teachings of Miyasaka, for the obvious advantage of having the valve open when the catheter disclosed in Bullington enters a vein of a patient.
Claim(s) 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bullington in view of DE 92 08 103 to Braun.
For claim 10, Bullington does not expressly disclose wherein: the first chamber includes a first vent configured to define an atmospheric pressure within the first chamber, and the second chamber includes a second vent configured to define the atmospheric pressure within the second chamber.
However, Braun teaches a first vent configured to define an atmospheric pressure within a chamber (Fig. 2) (para [0021]), and a second vent configured to define the atmospheric pressure within a chamber (Fig. 2) (para [0021]).
It would have been obvious to a skilled artisan to modify Bullington wherein: the first chamber includes a first vent configured to define an atmospheric pressure within the first chamber, and the second chamber includes a second vent configured to define the atmospheric pressure within the second chamber, in view of the teachings of Braun, for the obvious advantage of venting any air bubbles in the fluid that is introduced into Bullington’s device.
For claim 11, Bullington, as modified, further discloses wherein the first and second vents include a hydrophobic membrane configured to inhibit passage of a liquid therethrough (see Fig. 2 and para [0021] of Braun).
For claim 12, Bullington does not expressly disclose wherein: the first chamber includes a first exterior wall having a first window, and the second chamber includes a second exterior wall having a second window.
However, Braun teaches disclose wherein: the first chamber includes a first exterior wall having a first window (Fig. 2) (para [0009]-[0011]), and the second chamber includes a second exterior wall having a second window (Fig. 2) (para [0009]-[0011]).
It would have been obvious to a skilled artisan to modify Bullington wherein: the first chamber includes a first exterior wall having a first window, and the second chamber includes a second exterior wall having a second window, in view of the teachings of Braun, for the obvious advantage of confirming venous and/or arterial access.
For claim 13, Bullington, as modified, further discloses a device body including: the first exterior wall; the second exterior wall; and an interior wall disposed between the first chamber and the second chamber (see Fig. 2 and para [0009]-[0011] of Braun).
For claim 14, Bullington, as modified, further discloses wherein the first and second exterior walls define a cylindrical circumference of the device body (see Figs. 1-2 and para [0021] of Braun).
For claim 15, Bullington, as modified, further discloses wherein during use, fluid communication between a vein of the patient and the fluid port causes blood to flow into the first chamber, the blood within the first chamber visible through the first window (para [0011] of Braun) (also see para [0009]-[0010] of Braun).
For claim 16, Bullington, as modified, further discloses wherein, during use, fluid communication between an artery of the patient and the fluid port causes blood to flow into the second chamber, the blood within the second chamber visible through the second window (para [0011] of Braun) (also see para [0009]-[0010] of Braun).
Response to Arguments
Applicant’s arguments filed 1/30/26 have been fully considered.
With respect to the 112 rejections, some of the rejections are withdrawn in view of Applicant’s amendments and arguments. With respect to the rejections that remain, they are still being defined based on a result to be achieved.
With respect to the 102/103 rejections, the arguments will be treated in the order presented. With respect to the first argument, this argument does not appear to be commensurate in scope with the claim language. The term “chamber” needs to be construed under the broadest, reasonable interpretation. Applicant’s specification does not give an explicit definition for the term “chamber,” and therefore extrinsic evidence will be consulted. Merriam-Webster defines “chamber” as the following:
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Some of these definitions don’t really apply to the instant application (i.e., such as “a legislative or judicial body”), but among the definitions, many of them refer to a negative space that is surrounded by a positive structure (such as a “room” or “hall” or “bore”). Such a construction would be consistent with Applicant’s own written description in that the chambers disclosed in Applicant’s specification also encompass negative spaces surrounded by positive structures. Bullington also teaches negative spaces that are surrounded by positive structures at elements 213, 224, and 254. Therefore, the response appears to be arguing a narrower scope than the broadest, reasonable interpretation of the claim language. With respect to the second argument, this argument is a straw man. The rejection does not state that overlapping portions of 213, 224, and 254 are required to read on the claim language. Instead, separate portions of the negative space, that are defined by reference numerals 213, 224, and 254, read on the different claimed chambers. Nothing in Bullington requires that both chambers are required to be filled with fluid simultaneously and the rejection does not purport such a modification (the rejection is a 102 rejection after all, not a 103 rejection). Once again, each of cited references is a different negative space within the device of Bullington, as shown by the arrows and reference numerals shown in Fig. 2 of Bullington.
Conclusion
THIS ACTION IS MADE FINAL. 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 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