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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the gripper member comprises two semi-circular wings sandwiching at least the distal portion of the needle housing that encloses the distal section of the fluid diverter must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Objections
Claims 1 and 17 are objected to because of the following informalities:
Claim 1, line 1 recites “Apparatus comprising” but should read “An apparatus comprising” due to the lack of an article.
Claim 17, line 1 recites “Apparatus, comprising” but should read “An apparatus comprising” due to the lack of an article.
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 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 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 2-3, 5-9, and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US 20200222671 A1) in view of Brown (US 4772267 A).
Regarding claim 1, Burkholz discloses an apparatus (200) comprising: a needle housing (202) having a needle hub (202c) with a passageway (Interior of 202c), a needle (202a) having a sharp distal end and a proximal end connected to the needle hub (Figs. 4 and 8C), the needle having a lumen extending from the sharp distal end to the proximal end in alignment with the passageway of the needle hub (Figs. 4 and 8C-8D, Paragraph [0043]), a rear chamber (210) in the needle housing proximal the needle hub adapted to receive fluid that enters the distal end of the needle (Figs. 4 and 8C, Paragraph [0038]), and a fluid diverter (800) in fluid communication with the needle hub for receiving the fluid incoming from the lumen and redirecting the fluid to flow to a distal section of the fluid diverter (Fig. 8D, Paragraph [0055]).
Burkholz is silent regarding
the fluid diverter… redirecting the fluid to flow to the distal section of the fluid diverter viewable through a distal portion of the housing.
In analogous art, Brown teaches a needle housing (12), the needle housing defining a flashback chamber (20), wherein the needle housing is made of a clear or transparent plastic material (Col 2, lines 55-57).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the needle housing of Burkholz to incorporate the teachings of Brown to incorporate being made of a clear or transparent plastic material in order to allow an observer to observe blood (Col 2, lines 52-57). The modification of Burkholz in view of Brown would teach a fluid diverter (800, Burkholz) in fluid communication with the needle hub for receiving the fluid incoming from the lumen and redirecting the fluid to flow to a distal section of the fluid diverter (Fig. 8D, Paragraph [0055], Burkholz) viewable through a distal portion of the housing (The housing of Burkholz as modified by Brown teaches it being made of a clear or transparent plastic material which would allow one of ordinary skill in the art to be able to view through a distal portion of the housing).
Regarding claim 2, Burkholz in view of Brown disclose the apparatus of claim 1, wherein the fluid diverter is further configured to guide the fluid from the distal section to the rear chamber (Fig. 8D, Burkholz), the rear chamber being a flashback chamber (210, Burkholz) that enables a user to see the fluid (The housing (which includes the flashback chamber) of Burkholz as modified by Brown teaches it being made of a clear or transparent plastic material which would enable a user to see the fluid).
Regarding claim 3, Burkholz in view of Brown disclose the apparatus of claim 1, wherein the needle housing is an elongate tubular member having an open proximal end (Fig. 2, Burkholz), the needle hub integrally formed at the distal portion inside the elongate tubular member (Fig. 8C, Burkholz), the open proximal end fitted with a flash plug (210a/800b, Burkholz) that allows air to pass but prevents the fluid from passing (Paragraphs [0038] and [0052], Burkholz).
Regarding claim 5, Burkholz in view of Brown disclose the apparatus of clam 1, wherein the needle housing is transparent or translucent such that the presence of fluid can been observed at the distal portion and the rear chamber of the needle housing (The housing (which includes the rear/flashback chamber) of Burkholz as modified by Brown teaches it being made of a clear or transparent plastic material, therefore the presence of fluid can be observed at the distal portion and the rear chamber of the needle housing).
Regarding claim 6, Burkholz in view of Brown disclose the apparatus of claim 1, wherein the fluid diverter is configured to reroute the fluid in the distal section to the rear chamber of the needle housing (Figs. 8C-8D, Burkholz).
Regarding claim 7, Burkholz in view of Brown disclose the apparatus of claim 1, wherein the fluid diverter comprises an enclosure (801, Burkholz) having a bore (801a, Burkholz) in fluid communication with the needle hub such that the incoming fluid is directed to the bore (Fig. 8C, Burkholz), the bore leads to a distal direction fluid path that redirects the incoming fluid to flow in a distal direction to the distal section of the enclosure (Fig. 8D, Burkholz), the fluid diverter further having at least one proximal direction fluid path in fluid communication with the distal section such that the fluid at the distal section is rerouted in a proximal direction to the rear chamber (Fig. 8D, Burkholz), the rear chamber being a flashback chamber (210, Figs. 8C-8D, Burkholz).
Regarding claim 8, Burkholz in view of Brown disclose the apparatus of claim 7, wherein the distal direction fluid path is separated into two proximal direction fluid paths (801a1, Burkholz) at the distal section for rerouting the fluid to the flashback chamber (Figs. 8B-8D, Burkholz).
Regarding claim 9, Burkholz in view of Brown disclose the apparatus of claim 7, wherein the fluid diverter has a distal surface in abutment with a proximal surface of the needle hub such that the passageway of the needle hub is in alignment with the bore of the fluid diverter (Fig. 8C, Burkholz).
Regarding claim 11, Burkholz in view of Brown disclose the apparatus of claim 1, further comprising:
a catheter hub (What 201 is pointing to in Fig. 3, Burkholz) having a distal end and an open proximal end (Fig. 3, Burkholz), an internal cavity defined between the distal end and the open proximal end of the catheter hub (Fig. 3, Burkholz);
wherein the distal portion of the needle housing includes a coupler for connecting to the open proximal end of the catheter hub (Fig. 3, Paragraph [0035], Burkholz) such that the needle extends through the catheter hub and a catheter (201a, Burkholz) extending from the distal end of the catheter hub with the distal end of the needle extending beyond a distal end of the catheter (Fig. 3, Burkholz).
Regarding claim 12, Burkholz discloses a method of establishing blood flow in a needle housing (202), comprising the steps of:
providing a needle housing (202) including a distal portion (Figs. 4 and 8C);
attaching a proximal end of a needle (202a) having a lumen and a sharp distal end to a needle hub (202c) integrally formed inside a distal portion of the needle housing such that the lumen of the needle is in alignment with a passageway of the needle hub to establish a fluid passage for receiving blood that enters the distal end of the needle when the needle is placed into a vein or artery of a patient (Figs. 4 and 8C-8D, Paragraphs [0039] and [0043]);
providing a flashback chamber (210) in the needle housing proximal the needle hub (Figs. 4 and 8C, Paragraph [0038]); and
positioning a fluid diverter (800) adjacent the needle hub for receiving the blood output from the passageway (Fig. 8D, Paragraph [0055]), the fluid diverter redirecting the blood to flow in a distal direction (Fig. 8D, Paragraph [0055]).
Burkholz is silent regarding
the needle housing including the distal portion having a transparent or translucent viewing part and the fluid diverter redirecting the blood to flow in the distal direction to the transparent or translucent viewing part of the distal portion of the housing where the user can observe the blood flow.
In analogous art, Brown teaches a needle housing (12), the needle housing defining a flashback chamber (20), wherein the needle housing is made of a clear or transparent plastic material (Col 2, lines 55-57).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the needle housing of Burkholz to incorporate the teachings of Brown to incorporate being made of a clear or transparent plastic material in order to allow an observer to observe blood (Col 2, lines 52-57). The modification of Burkholz in view of Brown would teach a needle housing including a distal portion having a transparent or translucent viewing part and the fluid diverter redirecting the blood to flow in a distal direction to the transparent or translucent viewing part of the distal portion of the housing where a user can observe the blood flow (The housing of Burkholz as modified by Brown teaches it being made of a clear or transparent plastic material which would allow one of ordinary skill in the art to be able to observe the blood flow).
Regarding claim 13, Burkholz in view of Brown disclose the method of claim 12, further comprising the step of:
configuring the fluid diverter to guide the blood from the distal portion of the needle housing to the flashback chamber where the user can see the blood (The housing (which includes the flashback chamber) of Burkholz as modified by Brown teaches it being made of a clear or transparent plastic material which would enable a user to see the blood, see Fig. 8D, Burkholz).
Regarding claim 14, Burkholz in view of Brown disclose the method of claim 12, wherein the needle housing is an elongate tubular member having an open proximal end (Fig. 2, Burkholz), further comprising the step of:
fitting a flash plug (210a/800b, Burkholz) that allows air to pass but prevents the fluid from passing to the proximal open end of the elongate tubular member (Paragraphs [0038], and [0052], Burkholz).
Regarding claim 15, Burkholz in view of Brown disclose the method of claim 12, further comprising the steps of:
configuring the fluid diverter to have an enclosure (801, Burkholz) having a bore (801a, Burkholz) in fluid communication with the passageway of the needle hub such that blood from the needle flows into the bore (Fig. 8C, Burkholz); and
configuring the bore to have a distal direction fluid path that redirects the blood from the passageway to flow in a distal direction to a distal section of the fluid diverter (Figs. 8C-8D, Burkholz), the distal section in fluid communication with at least one proximal direction fluid path such that the blood at the distal section of the fluid diverter is rerouted in a proximal direction to the flashback chamber (Figs. 8C-8D, Burkholz).
Regarding claim 16, Burkholz in view of Brown disclose the method of claim 16, further comprising the step of:
separating the distal direction fluid path into two proximal direction fluid paths (801a1, Burkholz) at the distal section for rerouting the fluid to the flashback chamber (Figs. 8B-8D, Burkholz).
Regarding claim 17, Burkholz discloses an apparatus (200) comprising:
a needle housing (202) including a proximal portion, a distal portion and a flashback chamber (210) at the proximal portion (Figs. 4 and 8C);
a needle (202a) having a lumen, a sharp distal end and a proximal end attached to a needle hub (202c) integrally formed inside a distal portion of the needle housing such that the lumen of the needle is in alignment with a passageway of the needle hub to establish a fluid passage for receiving blood that enters the distal end of the needle when the needle is placed into a vein or artery of a patient (Figs. 4 and 8C-8D, Paragraphs [0043]); and
a fluid diverter (800) positioned adjacent the needle hub for receiving the blood output from the fluid passage (Fig. 8D, Paragraph [0055]), the fluid diverter redirecting the blood to flow in a distal direction to a distal section of the fluid diverter.
Burkholz is silent regarding
the needle housing including the distal portion having a transparent or translucent viewing part and the fluid diverter redirecting the blood to flow in a distal direction to a distal section of the fluid diverter located in the transparent or translucent viewing part of the distal portion of the housing where a user can observe the blood flow.
In analogous art, Brown teaches a needle housing (12), the needle housing defining a flashback chamber (20), wherein the needle housing is made of a clear or transparent plastic material (Col 2, lines 55-57).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the needle housing of Burkholz to incorporate the teachings of Brown to incorporate being made of a clear or transparent plastic material in order to allow an observer to observe blood (Col 2, lines 52-57). The modification of Burkholz in view of Brown would teach a needle housing (202, Burkholz) including a distal portion having a transparent or translucent viewing part and a fluid diverter redirecting the blood to flow in a distal direction to a distal section of the fluid diverter (Fig. 8D, Paragraph [0055], Burkholz) located in the transparent or translucent viewing part of the distal portion of the housing where a user can observe the blood flow (The housing of Burkholz as modified by Brown teaches it being made of a clear or transparent plastic material which would allow one of ordinary skill in the art to be able to view through a distal portion of the housing).
Regarding claim 18, Burkholz in view of Brown disclose the apparatus of claim 17, wherein the fluid diverter is configured to reroute the fluid in the distal section to the flashback chamber (Figs. 8C-8D, Burkholz).
Regarding claim 19, Burkholz in view of Brown disclose the apparatus of claim 17, wherein the fluid diverter comprises an enclosure (801, Burkholz) having a bore (801a, Burkholz) in fluid communication with the needle hub such that the incoming fluid is directed to the bore (Fig. 8C, Burkholz), the bore leads to a distal direction fluid path that redirects the incoming fluid to flow in a distal direction to the distal section of the enclosure (Fig. 8D, Burkholz), the fluid diverter further having at least one proximal direction fluid path in fluid communication with the distal section such that the fluid at the distal section is rerouted in a proximal direction to the flashback chamber (Fig. 8D, Burkholz).
Regarding claim 20, Burkholz in view of Brown disclose the apparatus of claim 19, wherein the distal direction fluid path is separated into two proximal direction fluid paths (801a1, Burkholz) at the distal section for rerouting the fluid to the flashback chamber (Figs. 8B-8D).
Claims 4 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US 20200222671 A1) in view of Brown (US 4772267 A) further in view of Khalaj et al. (US 20220265313 A1).
Regarding claim 4, Burkholz in view of Brown disclose the apparatus of claim 3, wherein a gripper member (202b) adapted to be gripped by a user integrally extends from the distal portion of the needle housing (Figs. 3-4, Burkholz).
Burkholz in view of Brown are silent regarding wherein a gripper member adapted to be gripped by a user integrally and semi-circumferentially extends from a distal portion of a needle housing.
In analogous art, Khalaj teaches a gripper member (154) adapted to be gripped by a user integrally extends from the distal portion of the needle housing (130, Figs. 1 and 8-9).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the needle housing of Burkholz in view of Brown to incorporate the teachings of Khalaj to incorporate a gripper member adapted to be gripped by a user integrally and semi-circumferentially extends from the distal portion of the needle housing in order to improve the ability for a user to maintain a grip on the housing (Paragraph [0040]).
Regarding claim 10, Burkholz in view of Brown further in view of Khalaj disclose the apparatus of claim 4, wherein the gripper member comprises a semi-circular wing (202b, Burkholz) arranged at the distal portion of the needle housing that encloses the distal section of the fluid diverter (Fig. 4, Burkholz), the needle housing being transparent or translucent so that the user may, based on observation of fluid flowing into the distal section of the fluid diverter, determine that the distal sharp tip of the needle is correctly placed into the vein or artery of a patient (The housing (which includes the flashback chamber) of Burkholz as modified by Brown teaches it being made of a clear or transparent plastic material which would enable a user to see the fluid, also see Paragraph [0008] of Burkholz).
Burkholz in view of Brown further in view of Khalaj are silent regarding
wherein the gripper member comprises two semi-circular wings sandwiching at least the distal portion of the needle housing that encloses the distal section of the fluid diverter.
However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the gripper member of Burkholz to incorporate a second semi-circular wing since it has been held that mere duplication of essential working parts of a vice involves only routine skill in the art In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Further, it would have been obvious to one of ordinary skill in the art to incorporate the second semi-circular wing at the opposite side of the housing relative to the first semi-circular wing to allow for it to correspond with the wing 201c of the catheter adapter 201. This modification would teach two semi-circular wings sandwiching at least the distal portion of the needle housing that encloses the distal section of the fluid diverter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG-VAN N TRINH whose telephone number is (571)272-8039. The examiner can normally be reached Thursday-Thursday 12-8 ET.
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/HONG-VAN N TRINH/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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