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
The amendment filed on 2/12/2026 has been entered. Claims 21-40 remain pending in the application.
Response to Arguments
Applicant’s arguments, see page 8, filed 2/12/2026, with respect to the drawing objection, have been fully considered and are not persuasive in light of Applicant’s amendments.
The applicant argues that the amendments to claims 32 and 38 address the drawing objection such that the objection can be withdrawn. Examiner respectfully disagrees. In Figures 1-3 of Applicant’s specification, a y-connector is used to couple the first tube and the second tube. Therefore, the drawings do not show a “second channel that is independent of the first channel.”
Accordingly, the objection to the drawings as set forth in the Non-Final Office Action mailed 11/13/2025 stands. Please see section Drawings below for further explanation.
Applicant’s arguments, see pages 9-10, filed 2/12/2026, with respect to the rejections under 35 USC § 112(d) of Claims 22, 34, and 39, have been fully considered and are not persuasive in light of Applicant’s amendments.
The applicant argues that the “agent” and “fluid” are positively recited in independent claims 21 and 35. Examiner respectfully disagrees. Functional language does not positively recite the elements upon which the function is performed. For example, in “the agent delivery device is configured to store and deliver an agent,” the “agent” is not positively recited as a structural or required element of the claim, and thus the claim only clearly recites the agent delivery device.
Accordingly, the rejections under 35 USC § 112(d) of Claims 22, 34, and 39 as set forth in the Non-Final Office Action mailed 11/13/2025 stand. Please see section 35 USC § 112 below for further explanation.
Applicant’s arguments, see pages 10-11, filed 2/12/2026, with respect to the rejections under 35 USC § 102 of Claims 21, 35, and 40, have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 102 rejections identified in the non-final dated 11/13/2025 moot, and require a new ground of rejection.
Therefore, the 102 rejections previously identified in the non-final action dated 11/13/2025 have been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 102 below for further explanation.
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 “second channel that is independent of the first channel” in claim 32 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 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 limitations are:
“the agent delivery device is configured to store and deliver an agent towards the medical device and into the catheter” in claims 21 and 35 as described in Para. [24 and 33] of Applicant’s specification.
“the fluid delivery device is configured to store and deliver a fluid towards the medical device and into the catheter” in claims 21 and 35 as described in Para. [35] of Applicant’s specification.
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.
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 § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 22, 34, and 39 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regards to claim 22, the claim reads “wherein the agent is a multi-component agent that includes a first component agent and a second component agent.”
Claim 21 does not positively recite the agent as it merely claims that the agent delivery device is “configured to store and deliver an agent.” Therefore, claim 22 is not drawn to any element defined in independent claim 21.
In regards to claims 34 and 39, the claim reads “wherein the fluid is configured to propel the agent through the medical device and out of the catheter for delivery at the target site.”
Claims 21 and 35 do not positively recite the fluid as they merely claim that the fluid delivery device is “configured to store and deliver a fluid.” Therefore, claims 34 and 39 are not drawn to any element defined in independent claims 21 and 35.
As such, claims 22, 34, and 39 are improperly dependent as they fail to limit claims 21 and 35 from which they depend.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 21-26 and 31-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Appl. Publ. No. 2009/0281486 A1 to Ducharme (“Ducharme”).
Regarding claim 21, Ducharme discloses a system (system 20; Fig. 1, paragraph 0023) comprising:
a medical device including a catheter (a working channel 161 extends through the distal end surface of the endoscope 150; Fig. 3, paragraph 0051);
an agent delivery device positioned outside of the medical device (container 30; Fig. 1, paragraph 0023) and fluidly coupled to the catheter (the catheter 90 then may be advanced through the working lumen 161 of the endoscope 150; Fig. 3, paragraph 0052), the agent delivery device is configured to store and deliver an agent towards the medical device and into the catheter (container 30 that is configured to hold a therapeutic agent 38; Fig. 1, paragraph 0023-0024); and
a fluid delivery device positioned outside of the medical device (pressure source 50; Fig. 1, paragraph 0027) and fluidly coupled to the catheter (the catheter 90 then may be advanced through the working lumen 161 of the endoscope 150; Fig. 3, paragraph 0052), the fluid delivery device is configured to store and deliver a fluid towards the medical device and into the catheter (the pressure source 50 may comprise a pressurized fluid, such as a liquid or gas; Fig. 1, paragraph 0027);
wherein, the medical device is configured so that, when a distal end of the catheter is positioned at a target site, the medical device can deliver a mixture of the agent received from the agent delivery device and the fluid received from the fluid delivery device towards the target site via the catheter (the catheter 90 further comprises a distal end 94 that may facilitate delivery of the therapeutic agent 38 to a target site; Figs. 1 and 3, paragraphs 0032 and 0051), wherein the mixture of the agent and the fluid is formed prior to receipt by the medical device (the therapeutic agent 38 may be carried through the outlet port 76 of the connecting member 70 by the pressurized fluid, and subsequently through the catheter 90, thereby delivering the therapeutic agent 38 to the target site at a desired pressure; Fig. 1, paragraph 0038).
Regarding claim 22, Ducharme discloses the system according to claim 21. Ducharme further discloses wherein the agent is a multi-component agent that includes a first component agent and a second component agent (the therapeutic agent 38 employed also may comprise an antithrombogenic bioactive agent … Additionally, or alternatively, the therapeutic agent 38 may include thrombolytic agents; Fig. 1, paragraph 0023 and 0047-0048).
Regarding claim 23, Ducharme discloses the system according to claims 21-22. Ducharme further discloses wherein the agent delivery device is configured to house each of the first component agent and the second component agent (the therapeutic agent 38 employed also may comprise an antithrombogenic bioactive agent … Additionally, or alternatively, the therapeutic agent 38 may include thrombolytic agents; paragraph 0023 and 0047-0048).
Regarding claim 24, Ducharme discloses the system according to claims 21-23. Ducharme further discloses wherein the agent delivery device is configured to mix the first component agent and the second component agent with one another to generate the multi-component agent within the agent delivery device (the therapeutic agent 38 employed also may comprise an antithrombogenic bioactive agent … Additionally, or alternatively, the therapeutic agent 38 may include thrombolytic agents; paragraph 0023 and 0047-0048). As disclosed by Ducharme, one or more medications may be mixed together in the agent delivery device (paragraphs 0047-0048).
Regarding claim 25, Ducharme discloses the system according to claims 21-24. Ducharme further discloses wherein the agent delivery device is configured to deliver the multi-component agent to the medical device upon mixing the first component agent with the second component agent (the catheter 90 then may be advanced through the working lumen 161 of the endoscope 150; Fig. 3, paragraph 0052) (the catheter 90 further comprises a distal end 94 that may facilitate delivery of the therapeutic agent 38 to a target site; Figs. 1 and 3, paragraphs 0032 and 0051).
Regarding claim 26, Ducharme discloses the system according to claim 21. Ducharme further discloses wherein the agent delivery device includes a container configured to store the agent (the user simply may load the desired therapeutic agent into the reservoir 32; Fig. 1, paragraph 0039) and an actuator configured to selectively release the agent from the container for delivery out of the agent delivery device (in addition to the automatic withdrawal of the therapeutic agent 38 from the container 30 in accordance with Bernoulli’s principle, a user may manually actuate the proximal handle 43 of the plunger 40 to dispense the therapeutic agent 38; Fig. 1, paragraph 0040).
Regarding claim 31, Ducharme discloses the system according to claims 21 and 26. Ducharme further discloses wherein the container includes a cylindrical portion (cylindrical portion of reservoir 32; Fig. 1) and a funnel portion positioned downstream from the cylindrical portion (funnel portion on the distal side of the reservoir 32; Fig. 1), the cylindrical portion is configured to store the agent (the container may comprise any suitable size and shape for holding a therapeutic agent 38; Fig. 1, paragraph 0024), and the funnel portion is configured to receive the agent from the cylindrical portion via gravity (if properly set up the container 30 could operate such that the agent from the cylindrical portion enters the funnel portion via gravity; Fig. 1).
Regarding claim 32, Ducharme discloses the system according to claim 21. Ducharme further discloses wherein the catheter is fluidly coupled to the agent delivery device via a first tube that includes a first channel (the container 30 further may comprise a distal region 36 that is configured to be coupled to a first inlet port 72 associated with the connecting member 70, thereby enabling fluid communication between the container 30 and the connecting member 70; Fig. 1, paragraph 0025) and to the fluid delivery device via a second tube that includes a second channel that is independent of the first channel (fluid from the pressure source 50 flows through the tubing 60, through the second inlet port 74 of the connecting member 70, and then through the outlet port 76 of the connecting member 70 and through a lumen of the catheter 90; Fig. 1, paragraph 0037).
Regarding claim 33, Ducharme discloses the system according to claim 21 and 32. Ducharme further discloses wherein the agent delivery device is fluidly coupled to the first channel of the first tube such that the medical device is configured to receive the agent from the agent delivery device through the first channel (the container 30 further may comprise a distal region 36 that is configured to be coupled to a first inlet port 72 associated with the connecting member 70, thereby enabling fluid communication between the container 30 and the connecting member 70; Fig. 1, paragraph 0025).
Regarding claim 34, Ducharme discloses the system according to claim 21. Ducharme further discloses wherein the fluid is configured to propel the agent through the medical device and out of the catheter for delivery at the target site (the therapeutic agent 38 may be carried through the outlet port 76 of the connecting member 70 by the pressurized fluid, and subsequently through the catheter 90, thereby delivering the therapeutic agent 38 to the target site at a desired pressure; Fig. 1, paragraph 0038).
Regarding claim 35, Ducharme discloses a system (system 20; Fig. 1, paragraph 0023) comprising:
a medical device including a catheter (a working channel 161 extends through the distal end surface of the endoscope 150; Fig. 3, paragraph 0051);
an agent delivery device (container 30; Fig. 1, paragraph 0023) fluidly coupled to the medical device via a first tube that is in fluid communication with the catheter (the catheter 90 then may be advanced through the working lumen 161 of the endoscope 150; Fig. 3, paragraph 0052), the agent delivery device includes an agent stored therein (container 30 that is configured to hold a therapeutic agent 38; Fig. 1, paragraph 0023-0024), wherein, upon actuation, the agent delivery device is configured to deliver the agent towards the medical device and into the catheter via the first tube (the container 30 further may comprise a distal region 36 that is configured to be coupled to a first inlet port 72 associated with the connecting member 70, thereby enabling fluid communication between the container 30 and the connecting member 70; Fig. 1, paragraph 0025); and
a fluid delivery device (pressure source 50; Fig. 1, paragraph 0027) fluidly coupled to the medical device via a second tube that is in fluid communication with the catheter (the catheter 90 then may be advanced through the working lumen 161 of the endoscope 150; Fig. 3, paragraph 0052), the fluid delivery device includes a fluid stored therein (the pressure source 50 may comprise a pressurized fluid, such as a liquid or gas; Fig. 1, paragraph 0027), wherein, upon actuation, the fluid delivery device is configured to deliver the fluid towards the medical device and into the catheter via the second tube (fluid from the pressure source 50 flows through the tubing 60, through the second inlet port 74 of the connecting member 70, and then through the outlet port 76 of the connecting member 70 and through a lumen of the catheter 90; Fig. 1, paragraph 0037);
wherein the medical device is configured to receive a mixture of the agent and the fluid prior to reaching the medical device and guide the mixture of the agent and the fluid towards a target site via the catheter (the therapeutic agent 38 may be carried through the outlet port 76 of the connecting member 70 by the pressurized fluid, and subsequently through the catheter 90, thereby delivering the therapeutic agent 38 to the target site at a desired pressure; Fig. 1, paragraph 0038).
Regarding claim 36, Ducharme discloses the system according to claim 35. Ducharme further discloses wherein the agent stored in the agent delivery device is a multi-component agent that includes at least a first component agent and a second component agent and wherein the agent delivery device is configured to mix the first component agent with the second component agent to generate and deliver the multi-component agent towards the medical device and into the catheter via the first tube (the therapeutic agent 38 employed also may comprise an antithrombogenic bioactive agent … Additionally, or alternatively, the therapeutic agent 38 may include thrombolytic agents; paragraph 0023 and 0047-0048). As disclosed by Ducharme, one or more medications may be mixed together in the agent delivery device (paragraphs 0047-0048).
Regarding claim 37, Ducharme discloses the system according to claim 35. Ducharme further discloses wherein the first tube and the second tube are fluidly coupled to a connector (at least one connecting member 70 may be placed in fluid communication with the container 30 and the pressure source 50; Fig. 1, paragraph 0023), and the connector is fluidly coupled to the medical device via a third tube (the tube member may comprise a catheter 90 having a proximal end 92 that may be placed in fluid communication with the outlet port 76 of the connecting member 70 using a suitable coupling mechanism or arrangement; Figs. 1 and 3, paragraph 0032); and wherein the agent received at the connector from the first tube and the fluid received at the connector from the second tube are each delivered from the connector towards the medical device via the third tube (the container 30 further may comprise a distal region 36 that is configured to be coupled to a first inlet port 72 associated with the connecting member 70, thereby enabling fluid communication between the container 30 and the connecting member 70; Fig. 1, paragraph 0025) (a distal end 64 of the tubing 60 may be coupled to the second inlet port 74 of the connecting member 70 using any suitable coupling mechanism; Fig. 1, paragraph 0030).
Regarding claim 38, Ducharme discloses the system according to claim 35. Ducharme further discloses wherein the catheter is fluidly coupled to the agent delivery device via a first tube that includes at least a first channel (the container 30 further may comprise a distal region 36 that is configured to be coupled to a first inlet port 72 associated with the connecting member 70, thereby enabling fluid communication between the container 30 and the connecting member 70; Fig. 1, paragraph 0025) and to the fluid delivery device via a second tube that includes a second channel (fluid from the pressure source 50 flows through the tubing 60, through the second inlet port 74 of the connecting member 70, and then through the outlet port 76 of the connecting member 70 and through a lumen of the catheter 90; Fig. 1, paragraph 0037);
wherein the first tube is fluidly coupled to the first channel of the first tube such that the medical device is configured to receive the agent from the agent delivery device through the first channel (the container 30 further may comprise a distal region 36 that is configured to be coupled to a first inlet port 72 associated with the connecting member 70, thereby enabling fluid communication between the container 30 and the connecting member 70; Fig. 1, paragraph 0025).
Regarding claim 39, Ducharme discloses the system according to claim 35. Ducharme further discloses wherein the fluid is configured to propel the agent through the medical device and out of the catheter for delivery at the target site (the therapeutic agent 38 may be carried through the outlet port 76 of the connecting member 70 by the pressurized fluid, and subsequently through the catheter 90, thereby delivering the therapeutic agent 38 to the target site at a desired pressure; Fig. 1, paragraph 0038).
Regarding claim 40, Ducharme discloses a method for delivering an agent and a fluid to a target tissue through a medical device, the method comprising:
coupling an agent delivery device (container 30; Fig. 1, paragraph 0023) to the medical device (the catheter 90 then may be advanced through the working lumen 161 of the endoscope 150; Fig. 3, paragraph 0052), the agent delivery device storing the agent (container 30 that is configured to hold a therapeutic agent 38; Fig. 1, paragraph 0023-0024);
coupling a fluid delivery device (pressure source 50; Fig. 1, paragraph 0027) to the medical device (the catheter 90 then may be advanced through the working lumen 161 of the endoscope 150; Fig. 3, paragraph 0052), the fluid delivery device storing the fluid (the pressure source 50 may comprise a pressurized fluid, such as a liquid or gas; Fig. 1, paragraph 0027);
positioning a catheter of the medical device at the target tissue (the endoscope 150 may be advanced through a bodily lumen such as the alimentary canal to a position proximate the target location. The catheter 90 then may be advanced through the working channel lumen 161 of the endoscope 150; Fig. 3, paragraph 0052); and
actuating the agent delivery device to guide the agent towards the catheter and the fluid delivery device to guide the fluid towards the catheter, thereby delivering a mixture of the agent and the fluid towards the target tissue via the medical device (the catheter 90 further comprises a distal end 94 that may facilitate delivery of the therapeutic agent 38 to a target site; Figs. 1 and 3, paragraphs 0032 and 0051), wherein the mixture of the agent and the fluid is formed prior to receipt by the medical device (the therapeutic agent 38 may be carried through the outlet port 76 of the connecting member 70 by the pressurized fluid, and subsequently through the catheter 90, thereby delivering the therapeutic agent 38 to the target site at a desired pressure; Fig. 1, paragraph 0038).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Ducharme in view of U.S. Patent Appl. Publ. No. 2022/0053995 A1 to Knollman et al. (“Knollman”).
Regarding claim 27, Ducharme discloses the system according to claims 21 and 26. However, Ducharme does not explicitly disclose wherein the medical device includes a handle, a port on the handle, and the catheter extending distally from the handle and wherein the port is in fluid communication with the catheter.
Knollman teaches wherein the medical device includes a handle (the ureteroscope 100 includes a catheter 104 and a handpiece 110; Fig. 1A, paragraph 0022), a port on the handle (the handpiece 110 also includes a working channel port 118; Fig. 1A, paragraph 0040), and the catheter extending distally from the handle (catheter 104; Fig. 1A, paragraph 0022) and wherein the port is in fluid communication with the catheter (the handpiece 110 also includes a working channel port 118 and a working channel 107 that provides fluid communication between the working channel port 118 and the distal end 105 of the catheter 104; Fig. 1A-B, paragraph 0040).
Knollman is considered to be analogous to the claimed invention because it is in the same field of endoscopes with a working channel capable of delivering fluids and instruments. As the reference is not limited to any specific example of an endoscope and as a handle with a port in fluid connection with a working channel is well known in the art at the time the invention was made, as evidenced by Knollman, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use a handle with a working channel port. Said combination would amount to use of a known element for its intended use in a known environment to an accomplish entirely expected result.
Regarding claim 28, Ducharme, as previously modified by Knollman, discloses the system according to claims 21 and 26-27. Ducharme, as modified by Knollman, further discloses wherein each of the agent delivery device and the fluid delivery device is fluidly coupled to the port on the handle via a connector (at least one connecting member 70 may be placed in fluid communication with the container 30 and the pressure source 50; Fig. 1, paragraph 0023).
Regarding claim 29, Ducharme, as previously modified by Knollman, discloses the system according to claims 21 and 26-28. Ducharme further discloses wherein the connector includes a Y-connector (the alternative system 220 comprises a generally Y-shaped connecting member 270; Fig. 5, paragraph 0054), wherein the agent delivery device is fluidly coupled to the Y-connector via a first tube (the container 30 further may comprise a distal region 36 that is configured to be coupled to a first inlet port 72 associated with the connecting member 70, thereby enabling fluid communication between the container 30 and the connecting member 70; Figs. 1 and 5, paragraph 0025), the fluid delivery device is fluidly coupled to the Y-connector via a second tube (a distal end 64 of the tubing 60 may be coupled to the second inlet port 74 of the connecting member 70 using any suitable coupling mechanism or arrangement; Fig. 1 and 5, paragraph 0030), and the medical device is fluidly coupled to the Y-connector via a third tube (the tube member may comprise a catheter 90 having a proximal end 92 that may be placed in fluid communication with the outlet port 76 of the connecting member 70 using a suitable coupling mechanism or arrangement; Figs. 1 and 5, paragraph 0032).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Ducharme in view of Knollman, as applied to claims 1 and 26-28 above, and further in view of U.S. Patent Appl. Publ. No. 2019/0328412 A1 to Mazhar et al. (“Mazhar”).
Regarding claim 30, Ducharme, as previously modified by Knollman, discloses the system according to claims 21 and 26-28. Ducharme further discloses wherein the agent delivery device includes a syringe (the container may comprise a syringe; Fig. 1, paragraph 0024), and the medical device includes an endoscope (endoscope 150; Fig. 3, paragraph 0051). However, Ducharme, as modified by Knollman, fails to explicitly disclose wherein the fluid delivery device includes a syringe.
Mazhar teaches wherein the fluid delivery device includes a syringe (the irrigation fluid source 112 is a syringe containing the irrigation fluid supply 112B; Fig. 1, paragraph 0068).
Mazhar is considered to be analogous to the claimed invention because it is in the same field of endoscopes connected to fluid and medication supply devices. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted the fluid delivery device of Ducharme with the syringe of Mazhar, because the substitution of art recognized equivalents as shown by Mazhar is within the level of ordinary skill in the art. In addition, the substitution of one fluid delivery device for another is likely to be obvious when it does no more than yield predictable results.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLIVIA GRACE STARKEY/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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