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 .
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.
Claim 18 is 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 18 recites “which optionally is aligned with a major axis of the retrieval funnel such that an orientation of the retrieval funnel is indicative of an orientation of the coude bend.” The claim never introduces a “retrieval funnel.” Claim 1 introduces a “receiving funnel,” but it is not clear whether “retrieval funnel” is intended to denote that component or a different component. The claim should read “receiving funnel” if that is the intended antecedent. As written, the claim fails to particularly point out and distinctly claim the subject matter because the referenced funnel lacks antecedent basis and creates uncertainty about the claimed orientation relationship.
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.
Claim 1, 3, 4, 5, 17, 18, 19, 20, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Boyko et al. (US 2011/0202036A1; hereinafter “Boyko”) in view of Yin et al. (US2018/0104444A1; hereinafter “Yin”) and Buckberg (US 5,226,427).
In relation to claim 1, this claim recites: an inserter assembly for deploying an intravesical device into a bladder, including a placement catheter with a lumen and exit opening, a receiving funnel, a removable stylet with a body that drives the device, and a proximal paddle engageable with the funnel. Claim 1 has been rejected in the following manner:
An inserter assembly for deploying an intravesical device into a urinary bladder of a patient.
Boyko discloses the claimed intravesical deployment setting. Specifically, Boyko discloses: “The deployment system generally includes a deployment instrument, such as a catheter, that can be used to deploy an implantable device through the urethra into the bladder or another genitourinary site.” (Boyko, ¶ [0047].)
A placement catheter defining a lumen … to an exit opening.
Boyko discloses an internal lumen and an exit opening. Specifically, Boyko discloses: “The deployment instrument also includes at least one internal passageway or lumen extending along its longitudinal length that permits passing a device through the interior of the instrument[.]” (Boyko, ¶ [0054].) Boyko further discloses: “At least one exit opening in communication with the internal passageway permits releasing the device from the internal passageway into the bladder or other implantation site.” (Boyko, ¶ [0057].)
A receiving funnel secured to the placement catheter at the proximal catheter end.
Boyko does not expressly call its proximal entry structure a “receiving funnel.” Yin fills that gap by disclosing: “The handle 102 may have a funnel-like shape 106 on the proximal end thereof, and may be adapted to connect to drain bags, extension tubes, and/or the like.” (Yin, ¶ [0035].) Boyko independently teaches a widened proximal entry for receiving a stylet: “The wider entry opening 618 facilitates easy insertion of the device, the stylet, or the fluid source.” (Boyko, ¶ [0069].)
A stylet body … dimensioned to drive the intravesical device … and a paddle fixed to the stylet body about the proximal stylet end.
Boyko discloses the stylet-driving function, stating: “In some embodiments, driving the implantable device into the bladder in block 3206 comprises driving the implantable device with a stylet.” (Boyko, ¶ [0129].) Boyko does not expressly disclose the claimed paddle. Buckberg fills that gap by disclosing: “A stylet 10 provides a handle 12 which is located at a proximal end 13 of a stylet rod 14. A means for placement of a finger extending outwardly from handle 12 takes the form of a finger loop 16 which is used in conjunction with a thumb rest 18 to manipulate the stylet[.]” (Buckberg, col. 4, ll. 34–39 (approx.).)
Wherein the paddle is engageable with the receiving funnel.
Boyko does not expressly disclose the claimed engagement by a paddle and funnel. Buckberg fills the gap by disclosing: “A luer connector 32 stops handle 12 from being inserted further into catheter 30.” (Buckberg, col. 4, ll. 47–49 (approx.).)
Motivation to combine.
A person of ordinary skill in the art would have been motivated to employ Yin’s proximal funnel-like catheter handle and Buckberg’s proximal stylet handle in Boyko’s intravesical deployment catheter to facilitate insertion, controlled advancement, and a positive proximal stop. The combination applies known catheter-access and stylet-control structures to Boyko’s expressly disclosed bladder-deployment instrument and would have predictably improved clinician handling.
In relation to claim 3, this claim depends from claim 1 and further recites a curved thumb rest and, optionally, a curved finger rest opposing the thumb rest. Claim 3 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
A curved thumb rest … and optionally … a curved finger rest opposing the curved thumb rest.
Boyko does not expressly disclose those ergonomic stylet-handle features. Buckberg fills the gap by disclosing: “The handle of the inventive stylet provides a thumb rest located on the proximal end and a finger loop extending outward from one side of the handle.” (Buckberg, col. 3, ll. 42–44 (approx.).) Buckberg further discloses: “One preferred embodiment … provides for an additional finger loop projecting from the other side of the handle for additional control.” (Buckberg, col. 3, ll. 47–49 (approx.).)
Motivation to combine.
A person of ordinary skill in the art would have used Buckberg’s opposed digit-support structures on the claim 1 stylet paddle to improve grip and directional control during advancement of Boyko’s deployment device.
In relation to claim 4, this claim depends from claim 1 and further recites a grip surface on the paddle. Claim 4 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
The paddle comprises a grip surface.
Boyko does not expressly disclose a grip surface on a paddle. Yin fills the gap by disclosing: “The handle 102 includes ridges 112 to provide a gripping surface for easier gripping and handling.” (Yin, ¶ [0036].)
Motivation to combine.
A person of ordinary skill in the art would have added Yin’s ridged grip surface to Buckberg’s proximal stylet handle in the claim 1 combination to improve handling of the device during advancement and withdrawal.
In relation to claim 5, this claim depends from claim 1 and further recites that the paddle is dimensioned to be received within the receiving funnel. Claim 5 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
The paddle is dimensioned to be received within the receiving funnel.
The base combination does not expressly describe that dimensional relationship using the claimed terms. Buckberg fills the gap by disclosing: “A luer connector 32 stops handle 12 from being inserted further into catheter 30.” (Buckberg, col. 4, ll. 47–49 (approx.).) Yin further supplies the funnel-like proximal structure: “The handle 102 may have a funnel-like shape 106 on the proximal end thereof[.]” (Yin, ¶ [0035].)
Motivation to combine.
A person of ordinary skill in the art would have dimensioned the Buckberg handle and Yin funnel-like proximal opening for cooperative receipt and stopping to provide a known insertion-depth stop in Boyko’s deployment instrument.
In relation to claim 17, this claim depends from claim 1 and further recites a transparent or translucent placement catheter for visually determining the position of the intravesical device or stylet. Claim 17 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
The placement catheter is transparent or translucent.
The base combination does not expressly specify transparency. Yin fills the gap by disclosing: “In one embodiment, the catheter 100 will be at least partially transparent to an unaided eye.” (Yin, ¶ [0035].)
Motivation to combine.
A person of ordinary skill in the art would have used Yin’s transparent catheter material in Boyko’s deployment instrument to enable direct visual observation of the inserted device or stylet where practicable.
In relation to claim 18, this claim depends from claim 1 and further recites a rounded atraumatic tip and/or a coude bend, optionally aligned with a major axis of the retrieval funnel. Claim 18 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
A rounded atraumatic tip, and/or a coude bend.
Boyko expressly discloses: “In embodiments, the distal end portion includes one or more of a coude tip, a council tip, and an inflatable balloon.” (Boyko, ¶ [0058].) Boyko also discloses: “The distal end 622 also has a rounded exterior surface that facilitates driving the deployment instrument forward without causing trauma to the surrounding anatomy[.]” (Boyko, ¶ [0072].) Boyko does not expressly disclose the stated alignment with a “retrieval funnel”; that phrase is also indefinite for the separate § 112(b) reason stated above.
Motivation to combine.
A person of ordinary skill in the art would have used Boyko’s expressly disclosed coude and rounded atraumatic tip in the claim 1 assembly to facilitate passage through the urethra while reducing trauma.
In relation to claim 19, this claim depends from claim 1 and further recites depth markings indicative of insertion depth and exit-opening orientation. Claim 19 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
The placement catheter comprises depth markings indicative of insertion depth and exit opening orientation.
Boyko discloses: “The deployment instrument may have markings along its length, such as graduated markings that indicate dimensions or relative positions.” (Boyko, ¶ [0064].) The primary reference does not expressly use the exact phrase “exit opening orientation”; the claimed use of Boyko’s disclosed graduated markings to communicate the known relative position of the exit opening is an ordinary application of the disclosed markings.
Motivation to combine.
A person of ordinary skill in the art would have calibrated Boyko’s graduated markings to the exit opening to provide reproducible insertion-depth and orientation information during deployment.
In relation to claim 20, this claim depends from claim 1 and further recites a catheter length from 10 cm to 40 cm and/or an outer diameter from 5 Fr to 30 Fr. Claim 20 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
A length of from 10 cm to 40 cm, and/or an outer diameter of from 5 Fr to 30 Fr.
Boyko discloses a urethra-to-bladder deployment instrument “in the range of about 30 cm to about 45 cm” and an outer diameter “in the range of about 12 to 18 Fr.” (Boyko, ¶ [0061].) Yin fills the remaining size-selection gap by disclosing: “the catheter may be sold and packaged in sizes ranging in diameter from 8 Fr to 24 Fr … with a length L of greater than 155 mm[.]” (Yin, ¶ [0037].)
Motivation to combine.
A person of ordinary skill in the art would have selected a catheter length and French size from Boyko’s and Yin’s overlapping disclosed urinary-catheter ranges based on patient anatomy and device dimensions, a routine optimization of known variables.
In relation to claim 23, this claim depends from claim 1 and further recites a paddle with a central body portion, a proximal thumb rest, and laterally extending wing portions. Claim 23 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
A central body portion surrounding the proximal stylet end, a thumb rest … and a pair of wing portions extending laterally.
Boyko does not expressly disclose the claimed paddle geometry. Buckberg fills the gap by disclosing: “A stylet 10 provides a handle 12 which is located at a proximal end 13 of a stylet rod 14. A means for placement of a finger extending outwardly from handle 12 takes the form of a finger loop 16 which is used in conjunction with a thumb rest 18 to manipulate the stylet[.]” (Buckberg, col. 4, ll. 34–39 (approx.).) Buckberg also discloses an “additional finger loop projecting from the other side of the handle for additional control.” (Buckberg, col. 3, ll. 47–49 (approx.).)
Motivation to combine.
A person of ordinary skill in the art would have implemented Buckberg’s opposed digit-support features as laterally extending handle portions around the proximal stylet body of the claim 1 assembly to obtain enhanced control during insertion.
In relation to claim 25, this claim recites a kit comprising the inserter assembly of claim 1 and an intravesical device suited for bladder introduction using the inserter assembly. Claim 25 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
A kit of parts comprising an inserter assembly of claim 1 and an intravesical device suited for introduction into a patient’s bladder using the inserter assembly.
Boyko discloses: “The deployment instrument may be provided as a kit. In some embodiments, the deployment instrument further includes at least one package that houses one or more of the instrument, a stylet, a syringe, and the implantable device.” (Boyko, ¶ [0123].) Boyko does not expressly name the claim 1 funnel/paddle configuration; that gap is supplied by the claim 1 combination of Yin and Buckberg.
Motivation to combine.
A person of ordinary skill in the art would have packaged Boyko’s intravesical device and deployment instrument together with the claim 1 proximal funnel-and-paddle assembly to provide the known convenience, sterility, and readiness benefits of a procedural kit.
Claim 2, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Boyko et al. (US 2011/0202036A1; hereinafter “Boyko”) in view of Yin et al. (US2018/0104444A1; hereinafter “Yin”) and Buckberg (US 5,226,427), as discussed above for claim 1, and in further view of Long (US 3,867,945).
In relation to claim 2, this claim depends from claim 1 and further recites that the paddle is over-molded about the stylet body at the proximal stylet end, or integral with the stylet body. Claim 2 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
The paddle is over-molded about the stylet body … or is integral with the stylet body.
The Boyko/Yin/Buckberg combination does not expressly disclose the recited manufacture. Long fills the gap by disclosing: “While the rod 12 and handle 14 are shown as being formed in two separate pieces, it should be understood that the stiffener and former 10 can be formed unitarily in one piece through conventional plastic molding practices.” (Long, col. 2, ll. 47–51 (approx.).)
Motivation to combine.
A person of ordinary skill in the art would have incorporated Long’s unitary molding teaching into the proximal stylet handle of the claim 1 combination to reduce part count and provide a durable, predictable stylet/handle connection.
In relation to claim 11, this claim depends from claim 1 and further recites that the receiving funnel is over-molded about, or integral with, the proximal catheter end. Claim 11 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
The receiving funnel is over-molded about … or integral with the placement catheter.
The base combination does not expressly state a unitary funnel/catheter manufacture. Long fills the gap by disclosing: “the stiffener and former 10 can be formed unitarily in one piece through conventional plastic molding practices.” (Long, col. 2, ll. 47–51 (approx.).)
Motivation to combine.
A person of ordinary skill in the art would have applied Long’s unitary molding teaching to Yin’s funnel-like proximal handle and Boyko’s catheter to reduce joints, part count, and potential leakage sites.
In relation to claim 16, this claim depends from claim 1 and further recites a solid cross-section along the entirety of the stylet body. Claim 16 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
The stylet body has a solid cross-section along an entirety of the stylet body.
The base combination does not expressly specify a solid entire-body cross-section. Long fills the gap by disclosing: “Rod 12 is preferably formed from selected plastic materials[.]” (Long, col. 2, ll. 35–36 (approx.).) Long also describes the stylet as “a rod 12.” (Long, col. 2, ll. 24–30 (approx.).)
Motivation to combine.
A person of ordinary skill in the art would have used Long’s rod-stock stylet body in the claim 1 assembly to obtain the known rigidity and pushability of a catheter stylet.
Claim 6-10, 12, 13, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Boyko et al. (US 2011/0202036A1; hereinafter “Boyko”) in view of Yin et al. (US2018/0104444A1; hereinafter “Yin”) and Buckberg (US 5,226,427), as discussed above for claim 1, and in further view of Sage et al. (US 2011/0270230A1).
In relation to claim 6, this claim depends from claim 1 and further recites a fitting lockably engageable with the receiving funnel to removably secure the stylet to the placement catheter. Claim 6 is rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
A fitting being lockably engageable with the receiving funnel to removably secure the stylet to the placement catheter.
The base combination does not expressly disclose a lockable removable fitting. Sage fills the gap by disclosing: “The surface 126 may be generally perpendicular to the longitudinal axis to provide positive latching (e.g., a ratcheting or snap-fit connection) of the collet to the body 103.” (Sage, ¶ [0053].)
Motivation to combine.
A person of ordinary skill in the art would have added Sage’s positive latching fitting to the claim 1 proximal interface to temporarily retain the stylet during use and permit deliberate release thereafter.
In relation to claim 7, this claim depends from claim 6 and further recites that the fitting is engageable with an interior surface of the receiving funnel. Claim 7 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 6 is incorporated herein.
The fitting is engageable with an interior surface of the receiving funnel.
The base combination does not expressly identify that internal engagement. Sage fills the gap by disclosing: “The end of the sleeve is received within the annular space 138 … formed between the inner ring and the outer ring 134 of the collet.” (Sage, ¶ [0054].)
Motivation to combine.
A person of ordinary skill in the art would have used Sage’s internal annular engagement at the claim 6 fitting/funnel interface to obtain a compact removable lock without increasing the external profile.
In relation to claim 8, this claim depends from claim 6 and further recites that one or both of the fitting and receiving funnel comprises at least one clip securable to the other. Claim 8 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 6 is incorporated herein.
At least one clip securable to the other of the fitting and the receiving funnel.
The base combination does not expressly disclose a clip. Sage fills the gap by disclosing: “The outer ring 134 may also define a series of openings, e.g., first and second openings 142 and 144. These openings may interact with the tabs 124 and 128 as further described below.” (Sage, ¶ [0045].)
Motivation to combine.
A person of ordinary skill in the art would have substituted Sage’s tab-and-opening retention structure for the claim 6 latching interface because it provides a known, compact, removable securing mechanism for catheter components.
In relation to claim 9, this claim depends from claim 6 and further recites a circumferential ridge on the fitting and a mating circumferential channel on the receiving funnel. Claim 9 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 6 is incorporated herein.
A circumferential ridge … and a circumferential channel dimensioned to matingly engage the circumferential ridge.
The base combination does not expressly use the claimed ridge/channel nomenclature. Sage fills the gap by disclosing “one or more radially protruding, circumferential barbs 117” on a connector pin (Sage, ¶ [0037].) and that “the end of the sleeve is received within the annular space 138 … formed between the inner ring and the outer ring 134 of the collet.” (Sage, ¶ [0054].)
Motivation to combine.
A person of ordinary skill in the art would have used Sage’s circumferential projection and annular receiving engagement at the claim 6 removable lock to obtain a circumferential retention interface with predictable engagement and release behavior.
In relation to claim 10, this claim depends from claim 6 and further recites audible and/or tactile feedback during engagement. Claim 10 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 6 is incorporated herein.
The fitting is configured to generate audible and/or tactile feedback during engagement.
The base combination does not expressly disclose that feedback. Sage fills the gap by disclosing: “Such positive latching may be indicated, for example, by tactile, audible, or visual cues.” (Sage, ¶ [0053].)
Motivation to combine.
A person of ordinary skill in the art would have provided Sage’s audible or tactile latch indication in the claim 6 fitting to confirm successful stylet retention and reduce uncertainty during a clinical deployment procedure.
In relation to claim 12, this claim depends from claim 1 and further recites an oval profile and/or an oval perimeter of the receiving funnel. Claim 12 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
The receiving funnel has one or both of an oval profile and an oval perimeter.
The base combination does not expressly state an oval funnel. Sage fills the gap by disclosing: “Any suitable cross-sectional shape could be utilized (e.g., octagonal, elliptical, oval, etc.).” (Sage, ¶ [0030].)
Motivation to combine.
A person of ordinary skill in the art would have selected Sage’s expressly disclosed oval cross-sectional form for Yin’s funnel-like proximal entry to provide a known profile adapted to the desired handling envelope.
In relation to claim 13, this claim depends from claim 1 and further recites that the receiving funnel extends asymmetrically transverse to the stylet body. Claim 13 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
The receiving funnel extends asymmetrically in a direction transverse to the stylet body.
The base combination does not expressly identify the stated asymmetric orientation. Sage fills the gap by teaching that “Any suitable cross-sectional shape could be utilized (e.g., octagonal, elliptical, oval, etc.).” (Sage, ¶ [0030].) Yin provides the proximal “funnel-like shape 106.” (Yin, ¶ [0035].)
Motivation to combine.
A person of ordinary skill in the art would have selected a noncircular, transversely extending profile for Yin’s funnel-like handle to suit gripping and clearance constraints. This is a predictable choice among Sage’s expressly disclosed alternative connector profiles.
In relation to claim 22, this claim depends from claim 1 and further recites that one or more of the catheter, paddle, funnel, and stylet are formed of the same or different polymeric material. Claim 22 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
One or more … are formed of the same or different polymeric material.
The base combination does not expressly list all four claimed parts. Sage fills the gap by disclosing: “Each catheter 102 may be of conventional construction, e.g., an elastomeric tubular body made from a polymer (pure or blended), silicone, or the like.” (Sage, ¶ [0032].) Yin independently discloses: “The catheter shaft 104 is made from a silicone material.” (Yin, ¶ [0035].)
Motivation to combine.
A person of ordinary skill in the art would have selected known medical polymers for the catheter and proximal components in the claim 1 combination to meet flexibility, manufacturability, and biocompatibility requirements.
In relation to claim 24, this claim depends from claim 23 and further recites a thumb rest with a concave surface facing away from the central body, an oval shaped periphery, or both. Claim 24 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 23 is incorporated herein.
The thumb rest has … an oval shaped periphery.
The claim is satisfied by its alternative oval-periphery limitation. Buckberg supplies the thumb rest, disclosing: “The handle of the inventive stylet provides a thumb rest located on the proximal end[.]” (Buckberg, col. 3, ll. 42–43 (approx.).) The base combination does not expressly state an oval thumb-rest periphery. Sage fills that gap by disclosing: “Any suitable cross-sectional shape could be utilized (e.g., octagonal, elliptical, oval, etc.).” (Sage, ¶ [0030].)
Motivation to combine.
A person of ordinary skill in the art would have selected Sage’s oval profile for Buckberg’s thumb-rest surface as an obvious alternative ergonomic profile within the claim 23 handle arrangement.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Boyko et al. (US 2011/0202036A1; hereinafter “Boyko”) in view of Yin et al. (US2018/0104444A1; hereinafter “Yin”) and Buckberg (US 5,226,427), as discussed above for claim 1, and in further view of Norton et al. (US 3,726,281).
In relation to claim 14, this claim depends from claim 1 and further recites a funnel lumen transferring lubricant to the placement-catheter lumen, optionally receiving at least 1 mL lubricant. Claim 14 has been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
A funnel lumen configured to transfer lubricant from the receiving funnel to the placement-catheter lumen.
The base combination does not expressly disclose a dedicated lubricant funnel lumen. Norton fills the gap by disclosing: “The third lumen 19 extends from the eye 20 … to the funnel 21 … and is also equipped with a lubricant flow restrainer 23, securely lodged in the lumen at approximately the point where the funnel 21 attains its least diameter.” (Norton, col. 2, ll. 21–27 (approx.).) Boyko also discloses: “The fluid may comprise a lubricant, such as Surgilube brand lubricant[.]” (Boyko, ¶ [0098].)
Optionally … dimensioned to receive at least 1 mL of lubricant.
The base combination does not expressly state the claimed one-milliliter minimum. Norton fills the gap by disclosing: “3 to 5cc.” (Norton, col. 2, ll. 42–43 (approx.).)
Motivation to combine.
A person of ordinary skill in the art would have incorporated Norton’s funnel-associated lubricant reservoir and lumen into Boyko’s deployment instrument because both references address urinary-catheter introduction and lubricant delivery; the resulting arrangement would have facilitated controlled lubrication while retaining Boyko’s stylet deployment function.
In relation to claim 15, this claim depends from claim 14 and further recites that the receiving funnel is shaped to facilitate lubricant transfer from a packet into the placement-catheter lumen. Claim 15 have rejected in the following manner:
Base rejection incorporated.
The rejection of claim 14 is incorporated herein.
The receiving funnel is shaped to facilitate transfer of lubricant from a packet into the lumen of the placement catheter.
The base combination does not expressly state that transfer is from a packet. Norton fills the gap by disclosing: “In the first method a packet of sterile lubricant is torn open and the content is squeezed onto the catheter surface.” (Norton, col. 1, ll. 10–13 (approx.).) Norton also discloses a catheter “terminating proximally in the funnel 14.” (Norton, col. 2, ll. 10–16 (approx.).)
Motivation to combine.
A person of ordinary skill in the art would have configured the claim 14 funnel to receive the packet-supplied lubricant identified by Norton so that the lubricant could be directed through the known lubricant lumen rather than applied externally, thereby improving handling and sterility control.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Boyko et al. (US 2011/0202036A1; hereinafter “Boyko”) in view of Yin et al. (US2018/0104444A1; hereinafter “Yin”) and Buckberg (US 5,226,427), as discussed above for claim 1, and in further view of Lee et al. (US 6,520,934B1; hereinafter “Lee”).
In relation to claim 21, this claim depends from claim 1 and further recites a radio marker in the placement catheter and/or the stylet. Claim 21 have been rejected in the following manner:
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
One or both of the placement catheter and the stylet include a radio marker.
The base combination does not expressly disclose a radio marker. Lee fills the gap by disclosing: “The radiopaque coil marker may be wound directly onto the catheter shaft under tension to form a flexible radiopaque marker that is embedded into the catheter shaft.” (Lee, col. 3, ll. 37–41 (approx.).) Lee further discloses that such markers “may be used with any type of catheter assembly or any type of medical device where visibility under a fluoroscope is desired.” (Lee, col. 5, ll. 40–43 (approx.).)
Motivation to combine.
A person of ordinary skill in the art would have incorporated Lee’s radiopaque marker into Boyko’s deployment catheter or stylet to provide fluoroscopic visibility of the device during placement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted.
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
