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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 03/15/2024. Claims 1-20 are currently pending and being examined.
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 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.
Claim Objections
Claim 10 is objected to because of the following informalities: Claim 10 recites “the housing” in line 5. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a housing”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Claim 15 recites “tubing” in line 6. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a tubing”. Appropriate correction is required.
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.
Claims 1-3, 6, 7, 9-11, 13-17, 19, and 20 rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Bryan (USPAP 2017/0274182).
In reference to independent claim 1, O’Bryan discloses a system (1600, fig 3A-7) comprising: a cannula (1606); a needle (1616); a needle retraction assembly (1620); and a safety enclosure (inside of 1620) wherein the needle retraction assembly is configured to draw the needle (1616) out of the cannula (1606) and into the safety enclosure (para 0064 discloses “the actuator button 1628 may be configured to retract the needle 1616 into the needle hub 1620 such that the needle 1616 is entirely enclosed and/or trapped within the needle hub 1620 in the fluid delivery configuration”).
In reference to dependent claim 10, O’Bryan discloses a cannulation system (1600, fig 3A-7) comprising: a needle (1616) configured coaxially inside a cannula (1606); a needle retraction assembly (everything inside 1620) comprising: a spring (1602) engaged to the needle with a spring stop (attached to the rear of 1644, an inherent feature that must exist in order for the needle to retract as described in the cite below in para 0064); and a button (1628) formed on the housing (housing of 1620), the button (1628) used to release the spring (1602); and a safety enclosure (1620) wherein the needle retraction assembly is configured to draw the needle out of the cannula and into the safety enclosure when the button is operated (para 0064 discloses “the actuator button 1628 may be configured to retract the needle 1616 into the needle hub 1620 such that the needle 1616 is entirely enclosed and/or trapped within the needle hub 1620 in the fluid delivery configuration”).
In reference to dependent claim 15, O’Bryan discloses a system (1600, fig 4A-4D) comprising: a needle (1616) configured coaxially inside a cannula (figs 3A-7 show shows the needle being coaxially inside the cannula); a needle retraction assembly (everything inside 1620); a safety enclosure (1620) wherein the needle retraction assembly is configured to draw the needle (1616) out of the cannula (1606) and into the safety enclosure (para 0064 discloses “the actuator button 1628 may be configured to retract the needle 1616 into the needle hub 1620 such that the needle 1616 is entirely enclosed and/or trapped within the needle hub 1620 in the fluid delivery configuration”); and tubing connected to the cannula (para 0075 specifically discloses “the IV catheter system 1600 illustrated in any or all of FIGS. 3-7 may have components similar to those of the IV catheter systems of previous embodiments” therefore examiner takes the position that the tubing 100 of fig 1 can be added to the hub 1604).
In reference to dependent claim 2, O’Bryan discloses the system of claim 1 wherein the needle (1616) is configured to be coaxial with the cannula (figs 4A-4D show shows the needle being coaxially inside the cannula).
In reference to dependent claim 3, O’Bryan discloses the system of claim 1 further comprising: at least one support wing (1614) attached to the needle retraction assembly (seen in fig 4A).
In reference to dependent claim 6, O’Bryan discloses the system of claim 1 wherein the safety enclosure (1620) is configured to be disengaged from the needle retraction assembly (1620 can be disconnected from the hub 1604 so the needle can be discarded).
In reference to dependent claim 7, O’Bryan discloses the system of claim 1 further comprising: a connection port (para 0075 specifically discloses “the IV catheter system 1600 illustrated in any or all of FIGS. 3-7 may have components similar to those of the IV catheter systems of previous embodiments” therefore examiner takes the position that the tubing 100 of fig 1 can be added to the hub 1604, which includes the Luer lock connection port 110).
In reference to dependent claim 9, O’Bryan discloses the system of claim 1 wherein the needle retraction assembly further comprises: a spring (1602) engaged to the needle (1616) with a spring stop (attached to the rear of 1644, an inherent feature that must exist in order for the needle to retract as described in the cite below in para 0064); a housing (1620); and a button (1628) formed on the housing (1620), the button (1628) used to release the spring (para 0064 discloses “the actuator button 1628 may be configured to retract the needle 1616 into the needle hub 1620 such that the needle 1616 is entirely enclosed and/or trapped within the needle hub 1620 in the fluid delivery configuration”).
In reference to dependent claim 11, O’Bryan discloses the cannulation system of claim 10 further comprising: at least one support wing (1614a and 1614b) attached to the needle retraction assembly (shown in fig 4A).
In reference to dependent claim 13, O’Bryan discloses the cannulation system of claim 10 wherein the safety enclosure (1620) is configured to be disengaged from the needle retraction assembly (fig 4D shows 1620 being disengaged from the hub 1604).
In reference to dependent claim 14, O’Bryan discloses the cannulation system of claim 10 further comprising: a Luer lock system configured on the needle retraction assembly (para 0075 specifically discloses “the IV catheter system 1600 illustrated in any or all of FIGS. 3-7 may have components similar to those of the IV catheter systems of previous embodiments” therefore examiner takes the position that the tubing 100 of fig 1 can be added to the hub 1604, which includes the Luer lock connection port 110).
In reference to dependent claim 16, O’Bryan discloses the system of claim 15 further comprising: a joint (joint at 124) connecting the tubing (106) to the cannula (para 0075 specifically discloses “the IV catheter system 1600 illustrated in any or all of FIGS. 3-7 may have components similar to those of the IV catheter systems of previous embodiments” therefore examiner takes the position that the tubing 100 of fig 1 can be added to the hub 1604, which includes the Luer lock connection port 110).
In reference to dependent claim 17, O’Bryan discloses the system of claim 15 further comprising: a chamber (area inside 124) connecting the cannula to the tubing (106), wherein fluid can flow from the cannula through the chamber into the tubing (para 0075 specifically discloses “the IV catheter system 1600 illustrated in any or all of FIGS. 3-7 may have components similar to those of the IV catheter systems of previous embodiments” therefore examiner takes the position that the tubing 100 of fig 1 can be added to the hub 1604, which includes the Luer lock connection port 110).
In reference to dependent claim 19, O’Bryan discloses the system of claim 15 further comprising: a Luer lock system configured on the needle retraction assembly (para 0075 specifically discloses “the IV catheter system 1600 illustrated in any or all of FIGS. 3-7 may have components similar to those of the IV catheter systems of previous embodiments” therefore examiner takes the position that the tubing 100 of fig 1 can be added to the hub 1604, which includes the Luer lock connection port 110).
In reference to dependent claim 20, O’Bryan discloses the system of claim 15 wherein the needle retraction assembly further comprises: a spring (1602) engaged to the needle (1616) with a spring stop (attached to the rear of 1644, an inherent feature that must exist in order for the needle to retract as described in the cite below in para 0064); a housing (1620); and a button (1628) formed on the housing (1620), the button (1628) used to release the spring (para 0064 discloses “the actuator button 1628 may be configured to retract the needle 1616 into the needle hub 1620 such that the needle 1616 is entirely enclosed and/or trapped within the needle hub 1620 in the fluid delivery configuration”).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4, 5, 8, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over O’Bryan (USPAP 2017/0274182) in view of Howell (USPAP 2020/0330733).
In reference to dependent claim 4, O’Bryan discloses the system of claim 3, however
O’Bryan does not teach the support wing further comprises: an adhesive; and a removable cover covering the adhesive.
Howell, a similar catheter with wings, teaches the support wing (210, fig 1B) further comprises: an adhesive (128); and a removable cover covering the adhesive (para 0048 discloses “The insertion site 80 can be positioned between the distal portions of mounting wings 210 to stabilize the insertions site 80, and surrounding skin, relative to the securement device 100. The release liner 130 can then be removed by pulling on pull tab 136 in a lateral outward direction. Pulling the pull tab 136 as such peels the first portion 132 of the release liner 130 away from a laterally inner edge and allows the adhesive layer 128 to adhere to a skin surface of the patient”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the adhesive layer of Howell in the system of O’Bryan so the catheter can “adhere to a skin surface of the patient” para 0048; Howell. To be clear by using the adhesive layer the chance of the catheter being dislodged from the patient decreases.
In reference to dependent claim 5, O’Bryan discloses the system of claim 3, however
O’Bryan does not teach the support wing further comprises: a preformed slit along the support wing.
Howell, a similar catheter with wings, teaches the support wing (210, fig 1B) further comprises: a preformed slit (214 A-C, and 212A and 212B are all slits; fig 2B) along the support wing (210).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the slits of Howell in the system of O’Bryan to “provide differing malleable characteristics of the mounting wing 210” para 0053; Howell.
In reference to dependent claim 8, O’Bryan in view of Howell discloses the system of claim 5, O’Bryan further discloses a system wherein the connection port further comprises: a Luer lock system configured on the needle retraction assembly (para 0075 specifically discloses “the IV catheter system 1600 illustrated in any or all of FIGS. 3-7 may have components similar to those of the IV catheter systems of previous embodiments” therefore examiner takes the position that the tubing 100 of fig 1 can be added to the hub 1604, which includes the Luer lock connection port 110).
In reference to dependent claim 12, O’Bryan discloses the cannulation system of claim 11, however
O’Bryan does not teach the support wing further comprises: an adhesive; and a removable cover covering the adhesive.
Howell, a similar catheter with wings, teaches the support wing (210, fig 1B) further comprises: an adhesive (128); and a removable cover covering the adhesive (para 0048 discloses “The insertion site 80 can be positioned between the distal portions of mounting wings 210 to stabilize the insertions site 80, and surrounding skin, relative to the securement device 100. The release liner 130 can then be removed by pulling on pull tab 136 in a lateral outward direction. Pulling the pull tab 136 as such peels the first portion 132 of the release liner 130 away from a laterally inner edge and allows the adhesive layer 128 to adhere to a skin surface of the patient”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the adhesive layer of Howell in the system of O’Bryan so the catheter can “adhere to a skin surface of the patient” para 0048; Howell. To be clear by using the adhesive layer the chance of the catheter being dislodged from the patient decreases.
In reference to dependent claim 18, O’Bryan discloses the system of claim 15 further comprising: at least one support wing (1614a and 1614b) attached to the needle retraction assembly (shown in fig 4A), however
O’Bryan does not teach the support wing further comprising: an adhesive; a removable cover covering the adhesive; and a preformed slit along the support wing.
Howell, a similar catheter with wings, teaches the support wing (210) further comprising: an adhesive (128); a removable cover covering the adhesive (para 0048 discloses “The insertion site 80 can be positioned between the distal portions of mounting wings 210 to stabilize the insertions site 80, and surrounding skin, relative to the securement device 100. The release liner 130 can then be removed by pulling on pull tab 136 in a lateral outward direction. Pulling the pull tab 136 as such peels the first portion 132 of the release liner 130 away from a laterally inner edge and allows the adhesive layer 128 to adhere to a skin surface of the patient”); and a preformed slit along the support wing (214 A-C, and 212A and 212B are all slits preformed on the wing 210; fig 2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the adhesive layer and slits of Howell in the system of O’Bryan so the catheter can “adhere to a skin surface of the patient” para 0048; and to “provide differing malleable characteristics of the mounting wing 210” para 0053; Howell; To be clear by using the adhesive layer the chance of the catheter being dislodged from the patient decreases.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mithiue (AU 20007445000) discloses a needle with wings.
Isaacson (USPAP 2016/0008538) discloses a retractable needle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/CHARLES W NICHOLS/Examiner, Art Unit 3783
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