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 .
Election/Restrictions
Applicant's election with traverse of Group II, species A1 and species B3 (claims 15, 16, 19-22 and 25-33) in the reply filed on 3/9/2026 is acknowledged. The traversal is on the ground(s) that it is unclear how the office actions accounts for “a signal generator configured to transmit a signal that causes a pressure of a fluid associated with the vein of the patent to fluctuate... the second portion of the IV catheter comprises the pressure sensor configured to detect the pressure of the a fluid associated with the second portion of the IV catheter” as recited in claim 1. More specifically, at the top of page 5 “Applicant notes that it is unclear how the office action accounts for the distinct features of a signal generator, an IV catheter, and a pressure sensor, with the further detail in claim 1” is not found persuasive because ¶176 discusses a needleless connector (which from the rest of the specification is clear attaches to a catheter, especially peripheral IV catheter mentioned in the restriction), directly mentions a pressure sensor and states that the sensor detects a flush (and one of ordinary skill in the art would recognize that it is a very basic principal of physics, Newton’s first law, that a generator is necessary to create the flush; the examiner specifically stated that the flushing event causes a pressure fluctuation).
Applicant also argues that ¶82 does not mention a smart device 104. It does not need to, the examiner stated that the flushing device may be started by smart device 104, which is supported by the specification (such as ¶233).
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 32 is objected to because of the following informalities: on the third to last line, “determining” isn’t grammatically correct. “determine” is suggested. Appropriate correction is required.
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 19 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.
In claim 19, Applicant claims “wherein, when the first portion of the IV catheter is inserted into the vein of the patient and the second portion of the IV catheter is configured to be in fluid communication with the first portion of the IV catheter and vein of the patient”. Yet there is no follow-up to the “when”. It is treated as “wherein, when the first portion of the IV catheter is inserted into the vein of the patient, portion of the IV catheter is configured to be in fluid communication with the first portion of the IV catheter and vein of the patient”.
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) 15, 16, 19, 20 and 25-33 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brand et al (WO 2020/163297).
Regarding claim 15, Brand discloses a system, comprising: an intravenous (IV) catheter (peripheral IV catheter, ¶155) comprising a first portion configured to be inserted into a vein of a patient (fig 7) and a second portion configured to remain outside a patient when the first portion is inserted into the patient (fig 7); a pressure sensor configured to detect a pressure of a fluid associated with the vein of the patient (sensor 254, ¶176 and ¶183 among others); and a signal generator (structure which cause flushing event or a med-administration such as 102/214 or 104, which is a pressure fluctuation - ¶82; med-administration may be provided by IV bags or syringes 102 - ¶144, ¶156, ¶229 via the needleless connector 214 - ¶156; smart device 104 may generate a flush - ¶184) configured to transmit a signal that causes a pressure of a fluid associated with the vein of the patient to fluctuate (as stated above, the structure which causes flushing or medication delivery causes a pressure of a fluid associated with vein of the patient to fluctuate), wherein the second portion of the IV catheter comprises the signal generator configured to transmit the signal that causes a pressure of a fluid associated with the IV catheter to fluctuate (fig 7 – 104/214 are part of second portion, the portion external to the vein).
Regarding claim 16, wherein the signal generator is disposed within a lumen of the second portion of the IV catheter (when a syringe is used with the needleless connector 214, the syringe is inserted into the connector and thus into a lumen of the second portion of the IV catheter).
Regarding claim 19, wherein, when the first portion of the IV catheter is inserted into the vein of the patient, the second portion of the IV catheter is configured to be in fluid communication with the first portion of the IV catheter and the vein of the patient (fig 7).
Regarding claim 20, wherein the signal that the signal generator is configured to transmit is configured to cause the pressure of the fluid in the vein of the patient to fluctuate when the first portion of the IV catheter is inserted into the vein of the patient (pressure fluctuation is measured within flow path, ¶176, as per fig 7 that flow path is in fluid communication with the fluid in the vein of the patient such that the pressure fluctuation generated by the signal is also transmitted to the fluid in the vein of the patient).
Regarding claim 25, wherein the pressure sensor is configured to detect the pressure of the fluid associated with the vein of the patient when the pressure sensor is disposed along a portion of the patient (¶183, fig 7).
Regarding claim 26, wherein the pressure sensor is configured to detect the pressure of the fluid associated with the vein of the patient when the pressure sensor is positioned within a first predetermined distance from the vein of the patient and when the pressure sensor is positioned within a second predetermined distance from the signal generator (fig 7; said predetermined distances being those such that the device is assembled as in fig 7).
Regarding claim 27, wherein the pressure sensor is configured to detect the pressure of the fluid associated with the vein of the patient when the pressure sensor is within a third predetermined distance to the signal generator along a fluid path between the pressure sensor and the signal generator (fig 7, similar to claim 26, the distance being one in which the device is assembled).
Regarding claim 28, wherein the device includes at least one processor programmed or configured to: transmit a control signal to cause the signal generator to generate the signal that causes pressure of fluid included in the vein of the patient to fluctuate (¶184 – device may automatically flush a lumen, which will cause a fluctuation in pressure of the lumen and the fluid in the vein of the patient), receive data associated with the pressure of the fluid associated with the vein of the patient (¶183, ¶221), and determine whether the first portion of the IV catheter is inserted into the vein of the patient based on the pressure of the fluid associated with the vein of the patient (¶216, ¶222).
Regarding claim 29, when receiving the data associated with the pressure of the fluid associated with the vein of the patient, the at least one processor is further programmed or configured to: receive the data associated with the pressure of the fluid associated with the vein of the patient based on transmitting the control signal to cause the signal generator to generate the signal that causes pressure of fluid associated with the vein of the patient to fluctuate (device is constantly monitoring pressure and is thus will also detect data associated with the fluctuation caused by transmitting the control signal, in allowable area below the examiner suggests a small tweak to make this claim allowable).
Regarding claim 30, wherein, when determining whether the IV catheter is inserted into the vein of the patient based on the pressure of the fluid associated with the vein of the patient, the at least one processor is programmed or configured to: determine that the pressure of the fluid associated with the vein of the patient detected by a pressure sensor satisfies a pressure threshold, and determine whether the first portion of the IV catheter is inserted into the vein of the patient based on determining that the pressure of the fluid associated with the vein of the patient detected by the pressure sensor satisfies the pressure threshold (¶216 – threshold pressure variation associated with heartbeat of patient).
Regarding claim 31, wherein the data associated with the pressure of the fluid associated with the vein of the patient comprises: data associated with a first pressure of the fluid associated with the vein of the patient (actual pressure), and data associated with a second pressure of the fluid associated with the vein of the patient (pressure of blood vessel), and wherein, when determining whether the IV catheter is inserted into the vein of the patient based on the pressure of the fluid associated with the vein of the patient, the at least one processor is programmed or configured to: compare the first pressure of the fluid associated with the vein of the patient to the second pressure of the fluid associated with the vein of the patient, and determine whether the IV catheter is inserted into the vein of the patient based on comparing the first pressure of the fluid associated with the vein of the patient to the second pressure of the fluid associated with the vein of the patient (¶216 – compares actual pressure variations to those associated with heartbeat of patient to determine if within vein of patient or elsewhere).
Regarding claim 32, wherein, when comparing the first pressure of the fluid associated with the vein of the patient to the second pressure of the fluid associated with the vein of the patient, the at least one processor is programmed or configured to: determine a measured deviation between the first pressure of the fluid associated with the vein of the patient and the second pressure of the fluid associated with the vein of the patient; compare the measured deviation to a permitted deviation threshold associated with placement of the IV catheter in the vein of the patient; and determine that the measured deviation satisfies the permitted deviation threshold, and wherein, when determining whether the IV catheter is inserted into the vein of the patient based on comparing the first pressure of the fluid associated with the vein of the patient to the second pressure of the fluid associated with the vein of the patient, the at least one processor is programmed or configured to: determining whether the IV catheter is inserted into the vein of the patient based on determining that the measured deviation satisfies the permitted deviation threshold (similar to claim 31, ¶216 – actual pressure variation is compared to heartbeat pressure variation and deviation between the two is used to determine whether in vein or not).
Regarding claim 33, further comprising: a display configured to output an image indicating whether the IV catheter is inserted into the vein of the patient, wherein the at least one processor is further programmed or configured to: output, via the display, the image indicating whether the IV catheter is inserted into the vein of the patient based on determine whether the IV catheter is inserted into the vein of the patient (¶219 – pattern of light being an image).
Allowable Subject Matter
Claims 21 and 22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The examiner did not find a teaching or objective to modify Brand such that the signal that the signal generator is configured to transmit is configured to forego causing the pressure of the fluid in the vein of the patient to fluctuate beyond a fluctuation threshold when the first portion/distal end of the IV catheter is not inserted into the vein of the patient, absent impermissible hindsight.
Claims 29 would be allowable if it tied transmitting the control signal in claim 28 to detecting the result of that fluctuation (as in claim 29) and uses that detection to determine whether the device is located within the vein of the patient (at the end of claim 28; currently the processor need only be capable of doing the things listed in 28 individually, the received data is not necessarily a result of the control signal nor is the determination necessarily based on the received data). Such is considered allowable as the system uses the pressure fluctuations associated with a heartbeat of a user to determine whether the device is located within the vein of the patient, not an artificially generated pressure fluctuation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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