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
Additionally, Fig. 1-4B of the application use solid black shading. New corrected
drawings in compliance with 37 CFR 1.121(d) are required in this application because
solid black shading areas are not permitted, except when used to represent bar graphs
or color. No new matter should be entered. See MPEP 608.02.
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
Claim 12 is objected to because of the following informalities:
The preamble of claim 12 should read “The [[A]] system of claim 1”
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.
Claims 9-11, 14, 15-17 and 19-20 are 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.
Regarding claims 9, 11, 14 and 16, the term “optionally” renders the claim indefinite because it is unclear whether the limitation following the phrase is part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitations following the term “optionally” within in each claim have been interpreted as not being required by the claim.
Claim 10 is similarly rejected by virtue of its dependency from claim 9.
Regarding claim 15, it is unclear if recitations of “a tube”, “a tube channel”, “a first flow channel”, “a second flow channel”, “a connector”, “at least two syringe outlets” are intended to introduce new structure to the system or are intended to refer back to similarly named structures in claim 1. As best understood, based on the specification and figures, there is not an arrangement of the invention that includes multiple tubes, each having first and second flow channels and a connector. For examination purposes, the structures recited in claim 15 have been interpreted as being the same structures recited in claim 1.
It is noted that if the structure recited in claim 15 does refer to the structure introduced in claim 1, it is unclear how the subject matter of claim 15 would further limit the subject matter of claim 1.
If the structure recited in claim 15 refers to additional structure, it is noted that the drawings will be objected to for failing to show the claimed subject matter (i.e., a system comprised of multiples tubes, each having a first and second flow channel and a connector).
Claims 16-17, are similarly rejected by virtue of their dependency from claim 15.
Regarding claim 19, there is a lack of antecedent basis for the limitation “The system of claim 18” in the preamble of the claim. For examination purposes, “The system of claim 18” has been interpreted as “The kit of claim 18.”
Additionally, in claim 19, the term “optionally” renders the claim indefinite because it is unclear whether the limitation following the phrase is part of the claimed invention. For examination purposes, the limitation following the phrase optionally has been interpreted as not being required by the claim.
Claim 20 is similarly rejected by virtue of its dependency from claim 19.
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.
Claims 1-2, 11-12, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bright (US 2016/0317621).
Regarding claims 1 and 15, Bright discloses a system for delivering a haemostatic agent (see Fig. 3 and 7A-7B), comprising: a minimally invasive surgical (MIS) instrument comprising a tube channel (the catheter 100 can be delivered to a treatment site via insertion through a tuohy needle, see [0540] and Fig. 7A-7B); and a tube (100, see Fig. 3) receivable in the tube channel (the catheter 100 is capable of being received in the channel of a tuohy needle), the tube comprising: a first flow channel (110); a second flow channel (112), fluidically separated from the first flow channel; and a connector, at a proximal end of the tube (a luer connector can connect the outlets of the syringe 116 with the proximal end of the catheter 100, see [0358]), connectable to at least two syringe outlets, a first one of the at least two syringe outlets being connectable to the first flow channel, and a second one of the at least two syringe outlets being connectable to the second flow channel, so that efflux from the at least two syringe outlets is prevented from combining before reaching a distal end of the tube (the outlets of the syringe chambers 102 and 104 are connectable to the first and second flow channels 110 and 112, respectively, and their contents are prevented from mixing before reaching the distal end of the catheter 114, see Fig. 3 and [0358]).
Regarding claim 2, Bright discloses the system of claim 1, wherein the tube when received within the tube channel is movable between a first configuration, in which a distal end of the tube is contained within the tube channel, and a second configuration, in which the distal end of the tube projects from a distal end of the tube channel (at some point as the catheter 100 is inserted through the needle, the catheter is in a first configuration where the distal end is contained within the channel until is pushed out through the other end to extend beyond the tip of the needle as disclosed in [0540] of Bright).
Regarding claim 11, Bright discloses the system of claim 1, wherein the MIS instrument comprises, at a distal end, a surgical tool (the sharp pointed end of the needle at its distal end is considered a surgical tool, see [0540]). Regarding the limitation “and optionally wherein the surgical tool comprises a pair of jaws”, as discussed above with reference to the rejection of the claim under 35 U.S.C. 112(b), the limitation following the term “optionally” has been interpreted as not being required by the claim.
Regarding claim 12, Bright discloses the system according claim 1, wherein the tube is separable from the MIS instrument (the catheter is disclosed as being separable from the needle since it is disclosed as being inserted through it, see [0540]).
Regarding claim 13, Bright discloses the system of claim 1, wherein: the tube channel extends substantially along a longitudinal axis of the MIS instrument (the lumen of the disclosed touhy needle would extend along its longitudinal axis); and the connector is a Luer lock connector (the connector between the syringe 116 and catheter 100 is a luer lock connector, see [0358]).
Regarding claim 14, Bright discloses the system of claim 1, further comprising a syringe (116, see Fig. 3), the syringe comprising: a first chamber (102) having a first fluid outlet coupled to the first flow channel (110), the first chamber containing a first constituent (102A); and a second chamber (104) having a second fluid outlet coupled to the second flow channel (112), the second chamber containing a second constituent (104B), wherein the first constituent and second constituent, when combined, form a haemostatic agent; and optionally wherein the first constituent comprises at least one of: fibrinogen, aprotinin, fibronectin, plasminogen, factor XIII, thrombin, calcium, serum albumin, glutaraldehyde; and wherein the second constituent comprises at least one of: fibrinogen, aprotinin, fibronectin, plasminogen, factor XIII, thrombin, calcium, serum albumin, glutaraldehyde (the chambers of the syringe can contain a variety of constituents including fibrinogen, thrombin, glutaraldehyde, calcium, see [0404]-[0405], [0380] and [0405]).
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 3-10, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bright (US 2016/0317621) in view of Ryan et al. (US 2021/0059654).
Regarding claims 3 -5, 7 and 16, Bright discloses the system of claims 2 and 15, but fails to expressly teach the system comprises a limiter as claimed. However, it is note that Bright discloses an intention to control the distance that the catheter extends beyond the needle (the catheter is inserted through the needle to extend 1 to 2 cm beyond its tip, see [0540]).
Ryan, in the same field of art, teaches a related system comprised of a tube (4, see Fig. 2A-2E) receivable in a tube channel of a MIS instrument (2) and a limiter (positioning mechanism 8, see Fig. 3A) configured so that the distal end of the tube projects from the distal end of the tube channel by a distance, X (the positioning mechanism is used to control relative movement between the tube and the MIS instrument which thereby controls the distance the tube projects from the distal end of the tube channels, see [0208]). Ryan additionally teaches with respect to claim 4, the limiter is configured so that the distance X is adjustable (the components of the positioning mechanism disclosed by Ryan are adjustable and therefor the distance X would be adjustable, see [0208] of Ryan). With respect to claim 5, 7 and 16, Ryan teaches the tube comprises the limiter (the positioning mechanism 8 of Ryan is comprised of a part 17 which is on the needle 4 so it can be said that the needle comprises the limiter, see Fig. 3a of Ryan), and the limiter is configured to engage with a proximal end of the tube channel upon the tube being in the second configuration (the distal end of the part 17 is configured to engage with the proximal end of the MIS instrument, see [0208] and Fig. 4C of Ryan).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Bright to include a limiter, as taught by Ryan, since doing would allow a user to have control over how much distance the tube extends beyond the distal end of the tube channel.
Regarding the limitation “optionally wherein the tube is configured to project, distally, from a tube channel of the MIS instrument when the limiter engages a proximal end of a tube channel of the MIS instrument” recited in claim 16, this limitation has been interpreted as not being required by the claim.
Regarding claim 6, 8 and 17, the combination of Bright and Ryan teaches the system of claims 5, 7 and 16. Ryan further teaches the limiter comprises a flange having a diameter greater than a diameter of the tube channel (the part 17 is considered to be a flange because it is a protruding collar around the needle 4 and it has an outer diameter that is greater than the inner diameter of the cannula 2, see Fig. 4C of Ryan).
Regarding claim 9, the combination of Bright and Ryan teaches the system of claim 8. Bright further teaches the MIS instrument comprises, at a distal end, a surgical tool (the sharp pointed end of the needle at its distal end is considered a surgical tool, see [0540] of Bright). Regarding the limitation “and optionally wherein the surgical tool comprises a pair of jaws”, as discussed above with reference to the rejection of the claim under 35 U.S.C. 112(b), the limitation following the term “optionally” has been interpreted as not being required by the claim.
Regarding claim 10, the combination of Bright and Ryan teaches the system of claim 9. Bright further teaches in the second configuration, the distal end of the tube extends distally beyond the surgical tool (in the second configuration in which the catheter extends beyond the needle, the catheter is understood to extend beyond the sharp pointed end, see [0540] of Bright).
Regarding claim 18, Bright substantially teaches the limitations of claim 18, as described above with reference to claims 1 and 14.
Bright simply fails to expressly teach the claimed components being a part of a kit.
Ryan teaches providing the constituent components of a related system as a part of a kit so that the components can be packaged in way that is suitable for sterilization separately (see [0109]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Bright so that the components were provided as part of a kit, as taught by Ryan, since doing so would allow the components to be packaged and sterilized separately.
Regarding claim 19, the combination of Bright and Ryan teaches the kit of claim 18. Bright fails to expressly a limiter as claimed.
Ryan teaches a related system comprised of a tube (4, see Fig. 2A-2E) receivable in a tube channel of a MIS instrument (2) and a limiter (positioning mechanism 8, see Fig. 3A) configured to engage with a proximal end of the tube channel upon the tube being in the second configuration (the distal end of the part 17 of the positioning mechanism is configured to engage with the proximal end of the MIS instrument, see [0208] and Fig. 4C of Ryan).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Bright to include a limiter, as taught by Ryan, since doing would allow a user to have control over how much distance the tube extends beyond the distal end of the tube channel. Regarding the limitation “optionally wherein the tube is configured to project, distally, from a tube channel of the MIS instrument when the limiter engages a proximal end of a tube channel of the MIS instrument” recited in claim 19, this limitation has been interpreted as not being required by the claim.
Regarding claim 20, the combination of Bright and Ryan teaches the kit of claim 19. Bright further teaches wherein the first constituent comprises at least one of: fibrinogen, aprotinin, fibronectin, plasminogen, factor XIII, thrombin, calcium, serum albumin, glutaraldehyde; and wherein the second constituent comprises at least one of: fibrinogen, aprotinin, fibronectin, plasminogen, factor XIII, thrombin, calcium, serum albumin, glutaraldehyde (the chambers of the syringe can contain a variety of constituents including fibrinogen, thrombin, glutaraldehyde, calcium, see [0404]-[0405], [0380] and [0405]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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