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 .
Response to Amendment
This office action is responsive to the amendment filed on 05/11/2026. As directed by the amendment: claims 1, 7, 9, 10, 12, 13, 16-19, 21 and 23 have been amended.
Claims 14, 15, and 22 were cancelled.
Thus, claims 1-13, 16-21 and 23-25 are pending in this application.
Applicant’s amendments to the claims, drawings, specification, and abstract have overcome each and every objection previously set forth in the Non-final Office Action mailed on 02/09/2026.
Claim Objections
Claims 1, 13 and 21 are objected to because of the following informalities:
Claim 1, line 15, “wherein the feet and shafts” should read “wherein the plurality of feet and the plurality of shafts”.
Claim 1, line 17, “wherein the feet” should read “wherein the plurality of feet”.
Claim 13, lines 10-11, “wherein the feet and shafts” should read “wherein the plurality of feet and the plurality of shafts”.
Claim 13, line 13, “wherein the feet” should read “wherein the plurality of feet”.
Claim 21, line 14-15, “wherein the feet and shafts” should read “wherein the plurality of feet and the plurality of shafts”.
Claim 21, line 17, “wherein the feet” should read “wherein the plurality of feet”.
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 19 and 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.
Claims 19 and 20 recite the limitation "the elongate shaft" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Examiner is unsure whether the elongate shaft is referring to “the elongate body of the trocar” or “the plurality of the shafts of the stabilizing mechanism” recited in claim 13.
Clarification is required.
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 13, 16, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reznik (US 20110040154 A1).
Regarding claim 13, Reznik discloses a trocar (4) comprising: an elongate body (body of 4) having proximal (8) and distal ends (20); a lumen (18) extending from the proximal end to the distal end therethrough (fig 4); and a stabilizing mechanism (6) on a distal portion of the elongate body configured to stabilize the distal end of the elongate body relative to a tissue surface (fig 13 and para 0041 and 0047), the stabilizing mechanism comprising: a plurality of feet (12); and a plurality of shafts (6) each coupled to a corresponding foot of the plurality of feet on a first end (figs 7a-d) and coupled to the elongate body by corresponding hinged points at another end (see annotated figure below), wherein the feet and shafts are configured to move along the elongate body to an expanded position away from the elongate body by the hinged points when the trocar is in use (figs 7a-b, fig 13), wherein in the feet releasably grasp the tissue surface in the expanded position (fig 13 and 0047).
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Regarding claim 16, Reznik discloses the trocar of claim 13, wherein the plurality of feet have micro-hooks thereon ((12), figs 7a-b and para 0047).
Regarding claim 18, Reznik discloses the trocar of claim 13, further comprising a removable stylet ((22), fig 6) configured to extend through the lumen of the elongate body, the stylet being configured to actuate engagement components upon removal (fig 13, para 0040 and 0049).
Regarding claim 19, Reznik discloses wherein at least part of the elongate shaft is configured to translate distally and proximally parallel to a longitudinal axis of the elongate shaft (cannula 4 have to translate distally for the wings 6 to be in closed position as shown in figure 3 and translate proximally for wings to expand as shown in fig 2)
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.
Claims 1, 2 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Piehl et al (US 20170319783 A1) in view of Reznik (US 20110040154 A1).
Regarding claim 1, Piehl et al disclose a pharmaceutical fluid formulation delivery device ((10), fig 1), comprising: a body (body of device 10) having an actuator (37), a fluid receiver (62 receiving syringe 48), and a fluid delivery mechanism (56 or 156); a detachable injection needle (109, para 0171) extending distally from the body (fig 17), wherein the fluid delivery mechanism is configured to deliver the fluid through the injection needle (para 0014, 0045 and 0160).
Piehl et al fail to teach said device comprises a trocar comprising: an elongate body having proximal and distal ends; a lumen extending from the proximal end to the distal end therethrough; and a stabilizing mechanism on a distal portion of the elongate body configured to stabilize the distal end of the elongate body relative to a tissue surface, the stabilizing mechanism comprising: a plurality of feet; and a plurality of shafts each coupled to a corresponding foot of the plurality of feet on a first end and coupled to the elongate body by corresponding hinged points at another end, wherein the feet and shafts are configured to move along the elongate body to an expanded position away from the elongate body by the hinged points when the trocar is in use, wherein in the feet releasably grasp the tissue surface in the expanded position.
Piehl et al disclose said device comprises a dual check valve which provides a variety of different connection methods to the inlet tubing, outlet tubing, as well as the syringe (para 0158) and further disclose by using universal connectors such as male/female Luer connection, a wide variety of devices may be connected to the tubing (para 0238).
However, Reznik discloses a trocar (4) comprising: an elongate body (body of 4) having proximal (8) and distal ends (20); a lumen (18) extending from the proximal end to the distal end therethrough (fig 4); and a stabilizing mechanism (6) on a distal portion of the elongate body configured to stabilize the distal end of the elongate body relative to a tissue surface (fig 13 and para 0041 and 0047), the stabilizing mechanism comprising: a plurality of feet (12); and a plurality of shafts (6) each coupled to a corresponding foot of the plurality of feet on a first end (figs 7a-d) and coupled to the elongate body by corresponding hinged points at another end (see annotated figure above), wherein the feet and shafts are configured to move along the elongate body to an expanded position away from the elongate body by the hinged points when the trocar is in use (figs 7a-b), wherein in the feet releasably grasp the tissue surface in the expanded position (fig 13 and 0047).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Piehl et al and incorporate the teachings of Reznik to have said device comprising a trocar comprising: an elongate body having proximal and distal ends; a lumen extending from the proximal end to the distal end therethrough; and a stabilizing mechanism on a distal portion of the elongate body configured to stabilize the distal end of the elongate body relative to a tissue surface, the stabilizing mechanism comprising: a plurality of feet; and a plurality of shafts each coupled to a corresponding foot of the plurality of feet on a first end and coupled to the elongate body by corresponding hinged points at another end, wherein the feet and shafts are configured to move along the elongate body to an expanded position away from the elongate body by the hinged points when the trocar is in use, wherein the feet releasably grasp the tissue surface in the expanded position. This would provide the benefit of having a trocar as a variety of device that can be attached to said device via the dual check valve and to be placed within a patient and provide access to an internal tissue site so that the injection needle can pass through its lumen without binding (para 0010 and 0041).
Regarding claim 2, Piehl et al in view of Reznik disclose the device of claim 1,
Piehl et al further disclose wherein the fluid delivery mechanism includes an electromechanical system having a central processing unit (158) and a pump (para 0163-64 and fig 11).
Regarding claim 8, Piehl et al in view of Reznik disclose the device of claim 1,
Piehl et al further teach said device comprising a touch display (90) configured to control operation of the device (fig 9, para 0162).
Regarding claim 9, Piehl et al in view of Reznik disclose the device of claim 8,
Piehl et al further teach wherein the touch display is configured to set one or more parameters for delivery of the fluid, including at least one of pressure and volume (para 0162).
Regarding claim 10, Piehl et al in view of Reznik disclose the device of claim 8,
Piehl et al further teach wherein the touch display is configured to provide real-time dispensing information of the fluid during delivery (para 0162 and 0217).
Regarding claim 11, Piehl et al in view of Reznik disclose the device of claim 1,
Piehl et al further teach wherein the actuator is one of a trigger (37), a plunger, a switch, or a button (see fig 1).
Regarding claim 12, Piehl et al in view of Reznik disclose the device of claim 1,
Piehl et al further teach said device comprising an engagement feature (31) on a distal end of the body configured to detachably engage the trocar (valve 31 can be engaged with trocar of Reznik).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Piehl et al (US 20170319783 A1) in view of Reznik (US 20110040154 A1) and further in view of Stearns et al (US 20120065618 A1).
Regarding claim 3, Piehl et al in view of Reznik disclose the limitations of claim 1 but fail to teach said device further comprising a valve configured to translate proximally and distally parallel to the injection needle during placement of the device and delivery of the fluid.
However, Stearns et al disclose a delivery device (100) comprising an injection needle (102) and a valve (108) configured to translate proximally and distally parallel to the injection needle (102) during placement of the device and delivery of fluid (para 0026, figs 4-5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Piehl et al in view of Reznik and incorporate the teachings of Stearns et al to have said device further comprising a valve configured to translate proximally and distally parallel to the injection needle during placement of the device and delivery of the fluid. This would provide the benefit of providing a fitting for said injection needle to ensure its rigid operation allowing steadier delivery of fluid to a target delivery site and proximal retraction of the injection needle from the target site during fluid delivery (para 0031).
Regarding claim 4, Piehl et al in view of Reznik and Stearns et al disclose the limitations of claims 1 and 3 but fail to expressly teach the valve is configured to translate about 2 cm distally and proximally.
Stearns et al disclose said valve is configured is configured to translate (para 0031).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the valve of Stearns et al to have the valve configured to translate about 2 cm distally and proximally since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the valve of Stearns et al would not operate differently with the claimed dimension. Further, applicant places no criticality on the dimension claimed, indicating simply that the valve 120 can translate distally and proximally up to about 2 cm (specification pp [0079]).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Piehl et al (US 20170319783 A1) in view of Reznik (US 20110040154 A1) and further in view of Buckley et al (US 20170000594 A1).
Regarding claim 5, Piehl et al in view of Reznik disclose the limitations of claim 1 and further teach wherein the fluid receiver is configured to removably and replaceably receive a fluid reservoir therein that includes a known dosage of a fluid (para 0155-56) but fail to teach said fluid reservoir comprises at least one cartridge.
However, Buckley et al disclose a dosing apparatus (19, fig 4) comprising a fluid receiver (67) configured to removably and replaceably receive a fluid reservoir (11) therein and the fluid reservoir comprises at least one cartridge (11) that includes a known dosage of a fluid (para 0056).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Piehl et al in view of Reznik and incorporate the teachings of Buckley et al to have said fluid reservoir comprises at least one cartridge. This would provide the benefit of using a cartridge for precise preselected doses and providing enhanced safety and convenience (para 0056).
Regarding claim 6, Piehl et al in view of Reznik and Buckley et al disclose the device of claim 5,
Buckley et al further disclose wherein the fluid receiver is configured to receive a plurality of cartridges concurrently (fig 4, para 0058).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Piehl et al (US 20170319783 A1) in view of Reznik (US 20110040154 A1) and further in view of Kurokawa et al (US 20110282324 A1).
Regarding claim 7, Piehl et al in view of Reznik disclose the limitations of claim 1 and further disclose said device deliver the fluid (abstract, para 0002) but fail to teach said fluid includes therapeutic cells or products thereof for treatment of kidney disease.
However, Kurokawa et al disclose a therapeutic Cell applicator instrument (fig 1) comprising delivering fluid wherein the fluid includes therapeutic cells (para 0074).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the fluid of Piehl et al in view of Reznik and incorporate the teachings of Kurokawa et al to have said fluid includes therapeutic cells. This would promote and improve tissue healing in patients aim to add active biological components (para 0074).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Reznik (US 20110040154 A1) in view of Kelleher (US 20050075654 A1).
Regarding claim 17, Piehl et al disclose the trocar of claim 13 but fail to teach wherein the plurality of feet include at least one of adhesive, suction, and pinchers.
Kelleher discloses a tissue penetrating device (28) comprising an anchoring element (30) with a plurality of feet (38) and wherein an adhesive may be incorporated into the anchoring device (para 0016).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the feet of Reznik and incorporate the teachings of Kelleher to have said plurality of feet include an adhesive. This would provide the benefit of having an adhesive to serve to attach the plurality of feet to the tissue, but also to induce scarification of the tissue around the stabilizing mechanism (para 0016).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Reznik (US 20110040154 A1).
Regarding claim 20, Reznik discloses the limitations of claim 13 but fails to expressly teach the at least part of the elongate shaft is configured to translate about 2 cm distally and proximally parallel to a longitudinal axis of the elongate shaft.
Reznik discloses at least part of the elongate shaft is configured to translate (figs 1-3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause at least part of the elongate shaft is configured to translate about 2 cm distally and proximally parallel to a longitudinal axis of the elongate shaft since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the shaft of Reznik would not operate differently with the claimed dimension. Further, applicant places no criticality on the dimension claimed, indicating simply that at least part of the elongate shaft can translate distally and proximally up to about 2 cm (specification pp [0084]).
Allowable Subject Matter
Claims 21, 23-25 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior arts are Piehl et al (US 20170319783 A1) in view of Reznik (US 20110040154 A1).
Regarding claim 21, the cited prior arts fail to disclose/teach among all the limitations or render obvious a method of delivering a pharmaceutical fluid formulation to tissue, comprising: attaching an injection device to a trocar, the trocar having a lumen therethrough and a stylet positioned therein; connecting a fluid source to the injection device; advancing the injection device and trocar through an outer tissue surface of a patient and penetrating an inner tissue target site; removing the stylet from the trocar and disengaging the injection device and the trocar; deploying a stabilizing mechanism on a distal portion of the trocar to stabilize the distal end of the trocar relative to the tissue target site, wherein the stabilizing mechanism comprises a plurality of feet and a plurality of shafts each coupled to a corresponding foot of the plurality of feet on a first end and coupled to the elongate body by corresponding hinged points at another end, wherein the feet and shafts are configured to move along the elongate body to an expanded position away from the elongate body by the hinged points when the trocar is in use, wherein in the feet releasably grasp the tissue surface in the expanded position; attaching an injection needle to the injection device; inserting the injection needle through the trocar to the tissue target site; and actuating the injection device to deliver a continuous flow or boluses of a fluid from the fluid source through the injection needle and to the tissue target site in combination with the total structure and function as claimed. No combination of prior art was found to teach or suggest each and every element of claim 21.
Claims 23-25 are allowed for incorporating the above limitations due to their respective dependencies on the independent claim 21.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments, see Remarks, filed 05/11/2026, with respect to the rejections of claims 1-13 and 16-20 have been fully considered and are persuasive. The rejections of claims 1-13 and 16-20 have been withdrawn.
Conclusion
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/FATIMATA SAHRA DIOP/ Examiner, Art Unit 3783
/BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783
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