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 .
Election/Restrictions
Applicant’s response to the unity of invention requirement in the reply filed on 11/04/2025 is acknowledged.
Response to Amendment
This office action is responsive to the amendment filed on 11/04/2025. As directed by the amendment: claims 1, 13, 16-18, 21 and 23 have been amended. Claims 14, 15, and 22 have been cancelled.
Thus, claims 1-13, 16-21 and 23-25 are pending in this application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Reference numbers 5 and 12 in figure 2 are not in the description.
Reference number 270 in figure 17 is not in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 abstract of the disclosure is objected to because it is not presented on a separate sheet.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 9, 10, 12, 13, 16, 17 and 21 are objected to because of the following informalities:
Claims 9 and 10, line 1, “the display” should read “the touch display”.
Claim 12, line 2, “a trocar” should read “the trocar”.
Claim 13, line 13, “wherein in the feet” should read “wherein the feet”.
Claim 16, line 1, “the feet” should read “the plurality of feet”.
Claim 17, line 1, “the feet” should read “the plurality of feet”.
Claim 21, line 21, “wherein in the feet” should read “wherein the 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 1, 7, 18-20 and 23 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.
Claim 1 recites the limitation "the fluid" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the phrase "wherein the feet and shafts are configured to move 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" renders the claim indefinite because it is unclear how the feet and shafts are configured to move the elongate body to an expanded position away from the elongate body and wherein in the feet releasably grasp the tissue surface. See MPEP § 2173.05(d).
For the purpose of compact prosecution, examiner is interpreting the limitation as “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
Claim 7 recites the limitation "the treatment" in line 2. There is insufficient antecedent basis for this limitation in the claim.
By virtue of dependency, claims 2-12 are also rejected.
Claim 18 recites the limitation "the engagement components" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 19 and 20 recite the limitation "the elongate shaft" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the stabilizing means" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a fluid delivery mechanism” in claim 1 .
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Presumption is rebutted because no structure is recited that can perform the limiting function. The word “mechanism” is a generic placeholder that does not denote a sufficient structure to deliver fluid through injection needle.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Flom et al (US 5817062 A).
Regarding claim 13, Flom et al disclose a trocar (2D, figs 14-15), comprising: an elongate body (120) having proximal and distal ends (fig 15); a lumen (lumen of 120) extending from the proximal end to the distal end therethrough (figs 14-15); and a stabilizing mechanism (116) on a distal portion of the elongate body configured to stabilize the distal end of the elongate body relative to a tissue surface (col 1, lines 59-65 and col 2, lines 1-7), the stabilizing mechanism comprising: a plurality of feet (118); 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 (col 6, lines 20-65), wherein in the feet releasably grasp the tissue surface in the expanded position (col 8, lines 25-28).
Regarding claim 16, Flom et al disclose the trocar of claim 13, wherein the feet have micro-hooks thereon ( col 2, lines 34-39 and col 6, lines 39-42).
Regarding claim 17, Flom et al disclose the trocar of claim 13, wherein the feet include at least one of adhesive, suction, and pinchers (col 6, lines 62-63).
Regarding claim 18, Flom et al disclose the trocar of claim 13, further comprising a removable stylet (6, fig 1) configured to extend through the lumen of the elongate body, the stylet being configured to actuate the engagement components upon removal (col 1, lines 44-58 and col 3, lines 30-38).
Regarding claim 19, Flom et al disclose the trocar of claim 13, wherein at least part of the elongate shaft is configured to translate distally and proximally parallel to a longitudinal axis of the elongate shaft (figs 17-18, col 7, lines 18-24).
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 Flom et al (US 5817062 A).
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), 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 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, Flom et al disclose a trocar (2F, fig 20) which provides a path for surgical instruments into a patient (col 1, lines 12-14) comprising an elongate body (158) having proximal and distal ends (see fig 19-21); a lumen (lumen of 158 receiving cannula 166) extending from the proximal end to the distal end therethrough (see figs 20-21); and a stabilizing mechanism (150) on a distal portion of the elongate body (figs 20-21) configured to stabilize the distal end of the elongate body relative to a tissue surface (col 1, lines 59-65 and col 2, lines 1-7), the stabilizing mechanism comprising: a plurality of feet (157, fig 20); and a plurality of shafts (figs 20-21) 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 (160) at another end, wherein the feet and shafts are configured to move the elongate body to an expanded position away from the elongate body by the hinged points when the trocar is in use (col 7, lines 54-64), wherein in the feet releasably grasp the tissue surface in the expanded position (col 8, lines 25-28).
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 Flom et al 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 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. 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 injection needle can pass through its lumen without binding (col 1, lines 10-15 and col 8, lines 8-11).
Regarding claim 2, Piehl et al in view of Flom et al 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 Flom et al 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 Flom et al disclose the device of claim 8,
Piehl et al further teach wherein the 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 Flom et al disclose the device of claim 8,
Piehl et al further teach wherein the 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 Flom et al 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 Flom et al 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 a trocar (valve 31 can be engaged with trocar 2 of Flom et al).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Piehl et al (US 20170319783 A1) in view of Flom et al (US 5817062 A) and further in view of Stearns et al (US 20120065618 A1).
Regarding claim 3, Piehl et al in view of Flom et al 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 Flom et al to 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 Flom et al 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 Flom et al (US 5817062 A) and further in view of Buckley et al (US 20170000594 A1).
Regarding claim 5, Piehl et al in view of Flom et al 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 Flom et al to 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 Flom et al 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 Flom et al (US 5817062 A) and further in view of Kurokawa et al (US 20110282324 A1).
Regarding claim 7, Piehl et al in view of Flom et al 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 the 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 Flom et al to 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 20 is rejected under 35 U.S.C. 103 as being unpatentable over Flom et al (US 5817062 A).
Regarding claim 20, Flom et al disclose the limitations of claim 13 but fail 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.
Flom et al disclose at least part of the elongate shaft is configured to translate (figs 18-19, col 7, lines 18-24).
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 Flom et al 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, 24-25 allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior are Piehl et al (US 20170319783 A1) in view of Flom et al (US 5817062 A).
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.
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.”
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /DUNG T ULSH/Examiner, Art Unit 3783