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 .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15, drawn to a medical device, classified in A61M5/158
II. Claims 16-20, drawn to a method, classified in A61M5/16854
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, Invention II appears to require inserting the distal end of the needle into both a closed space and an open space (in order to carry out the two determining steps, i.e., “determining that the distal end of the needle is inserted into a closed space… and determining that the distal end of the needle is inserted into an open space…”) whereas Invention II does not require introduction percutaneously, let alone into both a closed space and an open space. Further, Invention I does not require any structure for determining a differential of the first pressure and the second pressure.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Different search terms and/or different classification/subclassification areas.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Kirk Nuzum, Applicant’s attorney, on 01/30/2026 a provisional election was made without traverse to prosecute the invention of Invention I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5, 6 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho (U.S. Pat. 6,981,960 B2, hereinafter “Cho”).
Regarding claim 1, Cho discloses a medical device comprising:
an injection unit (Y-shaped portion 24 and fluid line 28; see Fig. 1) configured to be connected to a drug container that is configured to contain a drug, the injection unit including a channel (interior lumen defined by the Y-shaped portion 24) that allows passage of the drug;
and a first measurement unit 30 (see Fig. 1) configured to measure a pressure at a first part in a distal end side of the channel (using sensor 34) and at a second part closer to a proximal end side of the channel than the first part (using sensor 32, which is proximal to sensor 34).
Regarding claim 5, Cho discloses the medical device according to claim 1, wherein the first measurement unit includes a first sensor 34 disposed in the first part in the channel and a second sensor 32 disposed in the second part in the channel.
Regarding claim 6, Cho discloses the medical device according to claim 1, wherein the first measurement unit is fixed to the channel (first measurement unit is located within sensing module 36, which is fixed within the channel when the flange 38 of the sensing module 36 attaches to the Y-site connector 26).
Regarding claim 9, Cho discloses the medical device according to claim 1, further comprising: a visual alert unit 46 (see Fig. 1) that visually displays a measured value associated with the pressure measured by the first measurement unit (see col. 7, line 58 to col. 8, line 20).
Regarding claim 10, Cho discloses the medical device according to claim 1, further comprising: a notification unit 46 that notifies a user when a value measured by the first measurement unit satisfies a specific condition (see col. 7, line 58 to col. 8, line 20; notification unit 46 is a display that notifies a user of the pressure measurement).
Regarding claim 11, Cho discloses a medical device comprising:
a drug container configured to contain a drug (see “RESERVOIR” in Fig. 1); an injector (Y-shaped portion 24 and fluid line 28; see Fig. 1) configured to be connected to the drug container;
a first sensor 34 configured to measure a pressure at a first part in a distal end side of a lumen of the injector; and a second sensor 32 configured to measure a pressure at a second part closer to a proximal end side of the lumen of the injection than the first part in the distal end of the lumen measured by the first sensor (sensor 32 is proximal to sensor 34).
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 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn (U.S. Pub. 2015/0025363 A1) in view of Robinson (U.S. Pub. 2014/0350512 A1, hereinafter “Robinson”).
Regarding claim 1, Hulvershorn discloses an injection unit 100 (see Fig. 2) configured to be connected to a drug container 50 (see Fig. 1) that is configured to contain a drug (a syringe is known to be designed to contain drugs), the injection unit including a channel that allows passage of the drug (see para [0059] disclosing that fluid or substance can flow through the passage, including drug that is located in the drug container 50; a portion of the channel is shown as 132, but the entire channel extends from the drug container 50 to the distal tip of the needle 24);
and a first measurement unit configured to measure a pressure at a second part closer to a proximal end side (see, e.g., pressure transducer 144 located in the channel 132).
Hulvershorn does not appear to disclose that the first measurement unit is also configured to measure a pressure at a first part in a distal end side of the channel.
Robinson discloses a similar unit in the analogous art to the claimed invention (a medical device capable of obtaining information about pressure in a drug delivery channel), comprising a measurement unit configured to measure a pressure at first part in a distal end side of a channel 300 (see pressure sensor 310 in Fig. 3) a second part closer to a proximal end side (see pressure sensor 320 in Fig. 3) of the channel.
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hulvershorn, so that the first measurement unit is also configured to measure a pressure at a first part in a distal end side of the channel, according to the teaching in Robinson, in order to permit generation of both a first signal corresponding to proximal pressure and a second signal corresponding to distal pressure, for the purpose of comparing the signals and optimally adjusting the delivery of fluid based on the difference between the signals (see Robinson at para [0016], [0035], [0036]; for example, Robinson teaches that a higher pressure at the distal sensor causing a controller to deliver more fluid to the site, while sensing a decreased or a decreasing pressure at the site may cause the controller to deliver less fluid to the site).
Regarding claim 5, Hulvershorn, in view of Robinson, discloses that the first measurement unit includes a first sensor disposed in the first part in the channel (the first sensor of Hulvershorn) and a second sensor disposed in the second part in the channel (the second sensor of Robinson).
Regarding claim 6, Hulvershorn, in view of Robinson, discloses that the first measurement unit is fixed to the channel (in Hulvershorn, the measurement unit is fixed to the channel, otherwise, it would not be able to properly operate).
Regarding claim 7, Hulvershorn discloses that he channel has an elongated shape, but does not appear to disclose that the second part provided with the second sensor is larger than the first part provided with the first sensor in cross section intersecting with a longitudinal direction.
But it is taught in Hulvershorn and Robinson that the size of the tubular body where the two sensors are located may vary depending on intended use (see Hulvershorn at para [0098] and Robinson at para [0043]). Therefore, it does not appear that either Hulvershorn or Robinson places any limitations on the size and shape of the pressure sensors, and an artisan would have the skill necessary to determine the appropriate size of a sensor based on the area on the device where it is located. Therefore, a skilled artisan would have found it a matter of obvious engineering choice to modify the sizes of the first and second part provided with the respective first and second sensors, as may be required when affixing the first and second sensors to systems of different sizes, with a reasonable expectation of success.
Regarding claim 8, Hulvershorn discloses a switching unit 116 (see Fig. 2) configured to switch between a connection with an instrument configured to make a pressure of the channel negative (such as a suction device attached to 116) and a disconnection from the instrument (i.e., 116 is used to attach or detach instruments to the channel to vary its pressure).
Regarding claim 9, Hulvershorn discloses a visual alert unit 182/184 (see Fig. 2) that visually displays a measured value associated with the pressure measured by the first measurement unit (see LCD display that provides notification signals; see para [0071]).
Regarding claim 10, Hulvershorn discloses a notification unit 182/184 (see Fig. 2) that notifies a user when a value measured by the first measurement unit satisfies a specific condition (see para [0071]).
Regarding claim 11, Hulvershorn discloses a medical device comprising:
a drug container 50 (see Fig. 1) that is configured to contain a drug (a syringe is known to be designed to contain drugs); an injector 100 configured to be connected to the drug container;
a first sensor (see, e.g., pressure transducer 144 located in the channel 132).configured to measure a pressure at a first part in a side of a lumen of the injector.
Hulvershorn does not appear to disclose a second sensor configured to measure a pressure at a second part closer to a proximal end side of the lumen of the injection than the first part in the distal end of the lumen measured by the first sensor.
Robinson discloses a similar unit in the analogous art to the claimed invention (a medical device capable of obtaining information about pressure in a drug delivery channel), comprising a measurement unit configured to measure a pressure at first part in a distal end side of a channel 300 (see pressure sensor 310 in Fig. 3) a second part closer to a proximal end side (see pressure sensor 320 in Fig. 3) of the channel.
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hulvershorn, so that the first measurement unit is also configured to measure a pressure at a first part in a distal end side of the channel, according to the teaching in Robinson, in order to permit generation of both a first signal corresponding to proximal pressure and a second signal corresponding to distal pressure, for the purpose of comparing the signals and optimally adjusting the delivery of fluid based on the difference between the signals (see Robinson at para [0016], [0035], [0036]; for example, Robinson teaches that a higher pressure at the distal sensor causing a controller to deliver more fluid to the site, while sensing a decreased or a decreasing pressure at the site may cause the controller to deliver less fluid to the site).
Regarding claim 15, Hulvershorn discloses a switch 116 (see Fig. 2) configured to switch between a connection with an instrument configured to make a pressure of the channel negative (such as a suction device attached to 116) and a disconnection from the instrument (i.e., 116 is used to attach or detach instruments to the channel to vary its pressure).
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn in view of Robinson, further in view of Leonardi et al (U.S. Pub. 2019/0321566 A1, hereinafter “Leonardi”).
Regarding claims 2 and 12, Hulvershorn discloses a needle provided with the channel and configured to puncture a body of a patient (see Hulvershorn, needle 20, Fig. 2);
a connecting member (e.g., the actual housing 100 of the injection unit, along with 116 and 112; see Fig. 2) provided with the channel and connected to the needle member in a proximal end side of the needle member, and the injection unit includes the connecting member having a first part connected to the drug container (see Fig. 2).
But Hulvershorn, in view of Robinson, does not appear to disclose that the first measurement unit is configured to measure the pressure while being connected to a wire; and the injection unit includes a second part that guides the wire from the first measurement unit.
Leonardi discloses an injection unit and a needle therewith, comprising a pressure measurement unit 6 (see Fig. 6) located in a channel where drug is intended to be delivered, the pressure measurement unit being connected to a wire 7 (see Fig. 6); the wire is connected to a second part that guides the wire from the first measurement unit (see para [0059] disclosing that the cable can be fixed to a hub at the proximal end of the needle, leaving a part of the wire within the needle itself).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hulvershorn, in view of Robinson, so that the first measurement unit is configured to measure the pressure while being connected to a wire, and the injection unit includes a second part that guides the wire from the first measurement unit, as taught in Leonardi, as a well-known way to transmit the pressure value to a controller (see Leonardi at para [0042]) with a reasonable expectation of success.
Claims 3 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn in view of Robinson, further in view of Shachar et al (U.S. Pub. 2017/0325685 A1, hereinafter “Shachar”).
Regarding claims 3 and 13, it is noted that Hulvershorn discloses that the injection unit has a tubular shape provided with the channel, but does not appear to disclose that the tubular shape has a closed distal end, the tubular shape having a lateral surface provided with an outlet for releasing the drug from the drug container.
Shachar discloses a device for providing drugs into a target site of a patient, comprising a tubular shaped injection unit with a closed distal end and lateral surfaces provided with an outlet for releasing the drug from the drug container (see Fig. 2, showing injection unit 10 with a closed distal end and a lateral surface with an outlet 8 for releasing drug from a drug container; see also para [0038]).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hulvershorn, in view of Robinson, so that the tubular shape has a closed distal end, the tubular shape having a lateral surface provided with an outlet for releasing the drug from the drug container, as taught in Shachar, as a well-known way for supplying drug away from the distal tip of the passage, as may be necessary, with a reasonable expectation of success.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hulvershorn in view of Robinson, further in view of Moskowitz et al (U.S. Pub. 10,004,450 B2, hereinafter “Moskowitz”).
Regarding claims 4 and 14, it is noted that Hulvershorn, in view of Robinson, does not appear to disclose a sensor/second measurement unit configured to measure a pressure of a fluid existing around the injector in contact with the fluid, the sensor being disposed outside the injector.
Moskowitz discloses a sensor configured to measure a pressure of a fluid existing around an injector in contact with a fluid in the body, the sensor being disposed outside the injector (see col. 39, line 65 to col. 40, line 7).
A skilled artisan would have found it obvious at the time of the invention to modify the device of Hulvershorn, in view of Robinson, to provide a sensor configured to measure a pressure of a fluid existing around the injector in contact with the fluid, the sensor being disposed outside the injector, as taught in Moskowitz, in order to monitor pressure of the fluid around the injector in real time (see Moskowitz at col. 39, line 65 to col. 40, line 7), with a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 02/03/2026