DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement filed 12/13/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. It appears that wrong reference number is used to refer to a foreign document.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
236 in figure 16A
S524 in figure 35A
S528 in figure 35C
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. 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 disclosure is objected to because of the following informalities:
Paragraph 0001 needs to be updated to include the updated status of the Application 17/161107 to include the patent number 12,059,538.
Paragraph 0001 needs to be updated to include the updated status of the Application 16/219606 to include the patent number 10,905,858.
Paragraph 0001 needs to be updated to include the updated status of the Application 14/299872 to include the patent number 10,159,818.
Paragraph 0001 needs to be updated to include the updated status of the Application 13/111,716 to include the patent number 8,814,833.
Regarding paragraph 0028, line 10, it appears that “the extended position of 134 of the sheath” needs to be updated to recite “the extended position 134 of the sheath” to resolve grammatical error.
Reference character 212 has been used to refer to “the needle mount” in paragraph 0045 and “a needle” in paragraph 0045.
Reference character 238 has been used to refer to “a catch portion” in paragraph 0053 and “the catch” in paragraph 0053.
Reference characters S522 and S526 are both used to refer to the medical device in paragraph 0076.
Reference character S522 has been used to refer “the sheath” in paragraph 0076 and “the medical device” in paragraph 0076.
Reference character S530 has been used to refer “the medical device” in paragraph 0078 and “steps” in paragraph 0078.
Reference character S540 has been used to refer “the extended position” in paragraph 0078 and “Steps” in paragraph 0078.
Reference character S550 has been used to refer to “the extended position” in paragraph 0079 and “the sheath” in paragraph 0079.
Reference characters “S550” and “S556” are both used to refer to “the sheath”.
Applicant is requested that if reference characters starting with letter “S” is used to indicate steps then the entire specification needs to be updated to clearly indicate the step with the reference character instead of using the reference character starting with letter “S” to indicate features such as needle, sheath, medical device etc.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-6, 8, 10 and 11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brimhall (US 2001/0041871 A1) in view of Woehr et al. (US 2005/0027263 A1).
Regarding claim 2, Brimhall discloses a method of inserting and securing a catheter comprising:
providing a vascular delivery system 10 (figure 1) adapted to be placed about a catheter insertion site (site where element 40 is inserted) on a patient, the vascular delivery system 10 comprising:
a catheter 20, a frame (see “F” in figure 1 below) with a catheter hub 21 configured to provide a first anchoring point (anchoring point can be construed as a point where element 21 could be hold tight using a finger or hand), a stabilization hub 51 configured to provide a second anchoring point (anchoring point can be construed as a point where element 51 can be hold tight using finger or hand), and at least one lateral member 50 extending distally from the catheter hub 21 and connecting the catheter hub 21 and the stabilization hub 51;
wherein the frame (see “F” in figure 1 below) is configured to operate in a folded configuration (configuration shown in figure 2 where elements 31 and 25 are connected to one another) in which the stabilization hub 51 is positioned adjacent the catheter hub 21 and an unfolded configuration (configuration shown in figure 3 where elements 31 and 25 are separated from one another), the at least one lateral member 50 being bendable such that the stabilization hub 51 is movable relative to the catheter hub 21;
providing a safety needle system (system formed by elements 31, 41, 29, 40 and features associated with those elements) operable with the vascular delivery system, the safety needle system comprising:
a needle 40 extending through both the catheter 20 and the catheter hub 21 wherein a proximal end (end of element 40 exposed in figure 7) of the needle is exposed beyond an end (end of element 20 from where element 40 extends) of the catheter 20; and
inserting (paragraph 0026, lines 1-10) the proximal end of the needle 40 and the catheter 20 into the catheter insertion site on the patient with the frame in the folded configuration;
withdrawing (paragraph 0027, lines 1-12) the needle from the vascular delivery system;
transitioning (paragraph 0026, lines 16-29, paragraph 0027, lines 9-11, in order to move element 40 with respect to element 20, element 31 has to be moved out of contact with element 25 thereby transitioning from folded to unfolded configuration) the frame of the vascular delivery system from the folded configuration to the unfolded configuration. Brimhall is silent regarding a needle catch configured to engage a portion of the needle to capture the proximal end of the needle when the needle is removed from the vascular delivery system and withdrawing the needle from the vascular delivery system such that the needle is separate from the vascular delivery system and the proximal end of the needle is captured by the needle catch securing the vascular delivery system in the unfolded configuration to the patient such that the catheter insertion site is positioned between the first and second anchoring points.
However, Woehr teaches a design of a spring clip safety (figure 10A) comprising a needle catch 120 configured to engage a portion of the needle 16 to capture the proximal end 18 of the needle 16 when the needle 16 is removed from the vascular delivery system (see figure 10B) and withdrawing the needle 16 from the vascular delivery system such that the needle 16 is separate from the vascular delivery system and the proximal end of the needle is captured by the needle catch 120 securing the vascular delivery system (paragraph 0004, lines 10-13) for the purpose of preventing accidental needle stick (paragraph 0005) and to securely hold the catheter on the patient’s skin (paragraph 0004, lines 10-13).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the method of Brimhall at the time the invention was made to incorporate a needle catch configured to engage a portion of the needle to capture the proximal end of the needle when the needle is removed from the vascular delivery system and withdrawing the needle from the vascular delivery system such that the needle is separate from the vascular delivery system and the proximal end of the needle is captured by the needle catch securing the vascular delivery system to the patient as taught by Woehr for the purpose of preventing accidental needle stick (paragraph 0005) and to securely hold the catheter on the patient’s skin (paragraph 0004, lines 10-13).
Additionally, Brimhall modified in view of Woehr will result in having securing the vascular delivery system in the unfolded configuration to the patient such that the catheter insertion site is positioned between the first and second anchoring points because Brimhall already discloses the withdrawal of the needle which will require the frame to transition into the unfolded configuration and the catheter insertion site will be located between the first and second anchoring points since the claim does not require any specific positioning of the first and second anchoring points such as being on opposite sides.
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Regarding claim 3, Brimhall is silent regarding wherein the needle catch comprises a spring clip.
However, Woehr teaches wherein the needle catch 120 comprises a spring clip (paragraph 0072, lines 1-5) for the purpose of covering the needle under the radial force (paragraph 0075) thereby preventing accidental needle stick (paragraph 0005) and to securely hold the catheter on the patient’s skin (paragraph 0004, lines 10-13).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made to have modified the vascular delivery system of Brimhall to incorporate wherein the needle catch comprises a spring clip as taught by Woehr for the purpose of covering the needle under the radial force (paragraph 0075) thereby preventing accidental needle stick (paragraph 0005) and to securely hold the catheter on the patient’s skin (paragraph 0004, lines 10-13).
Regarding claim 4, Brimhall is silent regarding wherein the spring clip comprises a first arm and a second arm and during the withdrawing step the first and second arms move relative to each other to enclose the proximal end of the needle.
However, Woehr teaches wherein the spring clip 120 comprises a first arm 124 and a second arm 122 and during the withdrawing step the first and second arms move relative to each other to enclose the proximal end of the needle (see figure 10B) for the purpose of covering the needle under the radial force (paragraph 0075) thereby preventing accidental needle stick (paragraph 0005) and to securely hold the catheter on the patient’s skin (paragraph 0004, lines 10-13).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified the vascular delivery system of Brimhall to incorporate wherein the spring clip comprises a first arm and a second arm and during the withdrawing step the first and second arms move relative to each other to enclose the proximal end of the needle as taught by Woehr for the purpose of covering the needle under the radial force (paragraph 0075) thereby preventing accidental needle stick (paragraph 0005) and to securely hold the catheter on the patient’s skin (paragraph 0004, lines 10-13).
Regarding claim 5, Brimhall is silent regarding wherein the first arm is longer than the second arm.
However, Woehr teaches wherein the first arm 124 is longer (see figure 10B where element 124 is extending longer longitudinally thereby being longer) than the second arm 122 for the purpose of covering the needle under the radial force (paragraph 0075) thereby preventing accidental needle stick (paragraph 0005) and to securely hold the catheter on the patient’s skin (paragraph 0004, lines 10-13).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified the vascular delivery system of Brimhall to incorporate wherein the first arm is longer than the second arm as taught by Woehr for the purpose of covering the needle under the radial force (paragraph 0075) thereby preventing accidental needle stick (paragraph 0005) and to securely hold the catheter on the patient’s skin (paragraph 0004, lines 10-13).
Regarding claim 6, Brimhall is silent regarding wherein each of the first arm and the second arm comprises a curved portion.
However, Woehr teaches wherein each of the first arm 124 and the second arm 122 comprises a curved portion (integrated structure formed by elements 128, 130, 132) for the purpose of covering the needle under the radial force (paragraph 0075) thereby preventing accidental needle stick (paragraph 0005) and to securely hold the catheter on the patient’s skin (paragraph 0004, lines 10-13).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have modified the vascular delivery system of Brimhall to incorporate wherein each of the first arm and the second arm comprises a curved portion as taught by Woehr for the purpose of covering the needle under the radial force (paragraph 0075) thereby preventing accidental needle stick (paragraph 0005) and to securely hold the catheter on the patient’s skin (paragraph 0004, lines 10-13)
Regarding claim 8, Brimhall discloses wherein in the folded configuration the stabilization hub 51 is coupled to the catheter hub 21.
Regarding claim 10, Brimhall discloses wherein the vascular delivery system further comprises a septum 29 having a first seal (see “FS” in figure 8 below), a second seal (see “SS” in figure 8 below) and a cavity (paragraph 0028, portion comprising gel) between the first and the second seals.
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Regarding claim 11, Brimhall discloses wherein the withdrawing step (see figures 7-8) comprises moving the needle 40 relative to the catheter 20 and the septum 29.
Allowable Subject Matter
Claims 7, 9 and 12-14 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 following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Brimhall (US 2001/0041871 A1) in view of Woehr et al. (US 2005/0027263 A1) is silent regarding wherein in the folded configuration, the stabilization hub is positioned above the catheter hub in combination with other claimed limitations of claim 7.
The closest prior art of record, Brimhall (US 2001/0041871 A1) in view of Woehr et al. (US 2005/0027263 A1), is silent regarding wherein the transitioning step further comprises uncoupling the stabilization hub from the catheter hub in combination with other claimed limitations of claim 9.
The closest prior art of record, Brimhall (US 2001/0041871 A1) in view of Woehr et al. (US 2005/0027263 A1), is silent regarding wherein the securing step positions the first and second anchoring points on opposite sides of the catheter insertion site in combination with other claimed limitations of claim 12.
Claim 13 being dependent on claim 12 is also indicated allowable.
The closest prior art of record, Brimhall (US 2001/0041871 A1) in view of Woehr et al. (US 2005/0027263 A1), is silent regarding wherein the securing step forms at least a partial perimeter around the catheter insertion site with the frame in combination with other claimed limitations of claim 14.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Simon (US 5,279,591): discloses a design of a needle protector comprising a spring clip to cover the needle when the needle is removed from the catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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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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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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