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 Objections
Claim 2 is objected to because of the following informalities:
Claim 2 recites “wherein the needle comprised a curved needle.” The past-tense verb “comprised” creates grammatical ambiguity regarding the temporal scope of the limitation. The claim should read “wherein the needle comprises a curved needle.” As written, the claim fails to particularly point out and distinctly claim the subject matter because the past tense creates uncertainty about whether the needle is presently curved or was curved at some prior time.
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.
Claim 1 [and dependent claims] 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 1 recites “an actuatable toggle movably coupled with the handle.” The term “the handle” lacks antecedent basis. The claim previously introduces “a hand piece configured for grasping by a user” but does not introduce a “handle.” The claim should read “an actuatable toggle movably coupled with the hand piece.” As written, the claim fails to particularly point out and distinctly claim the subject matter because a person of ordinary skill in the art cannot determine with reasonable certainty whether “the handle” refers to the “hand piece” or to some other unrecited element.
Claim 1 further recites “upon actuation of the toggle.” The term “the toggle” lacks antecedent basis. The claim previously introduces “an actuatable toggle” but subsequently refers to it as “the toggle” without a prior definite introduction of the bare term “toggle.” The claim should read “upon actuation of the actuatable toggle.” As written, the claim fails to particularly point out and distinctly claim the subject matter because it is unclear whether “the toggle” is the same as “the actuatable toggle.”
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)(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.
Claims 1, 14 and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Oberkircher et al. (US 2015/0223977A1; hereinafter “Oberkircher”).
In relation to independent claim 1, this claim recites: a surgical instrument for fluid injection, the surgical instrument comprising: a hand piece configured for grasping by a user, the hand piece comprising: a first lumen disposed therein; and an actuatable toggle movably coupled with the handle; a cannula coupled to the hand piece and configured to be introduced into an eye, the cannula comprising a second lumen extending therethrough; and a needle movably disposed within the second lumen and coupled with the actuatable toggle, the needle configured to extend from and retract into the second lumen at a distal end of the cannula upon actuation of the toggle.
A surgical instrument for fluid injection;
Oberkircher discloses an apparatus for delivering therapeutic agent to an eye. Specifically, Oberkircher discloses: “A first embodiment of the invention includes an apparatus for delivering therapeutic agent to an eye. The apparatus comprises a body, a cannula, a hollow needle, and an actuation assembly.” (Oberkircher ¶ [0011].)
a hand piece configured for grasping by a user;
Oberkircher discloses a body configured to be grasped by an operator. Specifically, Oberkircher discloses: “body (40) is generally shaped as an elongate rectangle with a curved distal end. The particular shape of body (40) that is shown is configured to be grasped by an operator.” (Oberkircher ¶ [0149].)
a first lumen disposed therein;
Oberkircher discloses a supply tube (lumen) disposed within the body. Specifically, Oberkircher discloses: “supply tube (64) connects to the fluid coupling member of body engagement portion (50), extends proximally through body engagement portion (50), proximally through actuation member (62), and proximally out through the proximal end of actuation member (62). Thus, supply tube (64) defines a conduit through actuation member (62) to needle (30) such that fluid may be injected via supply tube (64) through needle (30) to an injection site.” (Oberkircher ¶ [0154].)
and an actuatable toggle movably coupled with the handle;
Oberkircher discloses an actuation member movably coupled with the body. Specifically, Oberkircher discloses: “Actuation member (62) is secured to the proximal end of body engagement portion (50) of advancement member (46)… The shape of actuation member (62) is configured for grasping by an operator. As will be described in greater detail below, actuation member (62) is configured to translate relative to body (40) to actuate advancement member (46) within body (40) to thereby advance needle (30) distally through cannula (20).” (Oberkircher ¶ [0153].)
a cannula coupled to the hand piece and configured to be introduced into an eye, the cannula comprising a second lumen extending therethrough;
Oberkircher discloses a cannula extending from the body with a lumen configured to receive the needle. Specifically, Oberkircher discloses: “Cannula (20) extends distally from body (40) and has a generally rectangular cross section. Cannula (20) is generally configured to support a needle (30) that is slidable within cannula (20).” (Oberkircher ¶ [0126].) Furthermore, Oberkircher discloses: “Cannula (20) defines three lumens (22, 24) extending longitudinally through cannula (20) and terminating at a beveled distal end (26)… central lumen (24) is configured to receive needle (30).” (Oberkircher ¶ [0134].)
and a needle movably disposed within the second lumen and coupled with the actuatable toggle, the needle configured to extend from and retract into the second lumen at a distal end of the cannula upon actuation of the toggle.
Oberkircher discloses a needle slidably disposed within the cannula lumen and actuated by the actuation member. Specifically, Oberkircher discloses: “needle (30) is slidably disposed within central lumen (24) such that needle (30) may be advanced distally from beveled distal end (26).” (Oberkircher ¶ [0136].) Furthermore, Oberkircher discloses: “actuation member (62) may be moved or translated relative to body (40) to advance needle (30) relative to cannula (20).” (Oberkircher ¶ [0157].)
In relation to claim 14, this claim depends from claim 1 and further recites: the surgical instrument of claim 1, wherein the actuatable toggle is lockable such that the needle may be fixed in either an extended or retracted position.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the actuatable toggle is lockable such that the needle may be fixed in either an extended or retracted position.
Oberkircher discloses a locking member for the actuation assembly. Specifically, Oberkircher discloses: “Locking member (66) is removably attachable to body engagement portion (50), between body (40) and actuation member (62). As will be described in greater detail below, locking member (66) fills a space between body (40) and actuation member (62) to prevent actuation member (62) from being advanced distally relative to body (40). However, locking member (66) can be removed to selectively permit actuation member (62) to be advanced distally relative to body (40).” (Oberkircher ¶ [0155].) The locking member prevents advancement of the actuation member, thereby fixing the needle in the retracted position. After removal of the locking member and advancement of the needle, the needle may be fixed in the extended position by the physical stop of the actuation member contacting the body.
In relation to claim 15, this claim depends from claim 1 and further recites: the surgical instrument of claim 1, further comprising: a first flexible tubing fluidically coupled at a distal end of the first flexible tubing to the actuatable toggle or needle in the first lumen, the first flexible tubing further fluidically coupled at a proximal end of the first flexible tubing to a connector disposed at a proximal end of the hand piece, wherein the connector is further configured to fluidically couple to a second flexible tubing external to the first lumen.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
a first flexible tubing fluidically coupled at a distal end of the first flexible tubing to the actuatable toggle or needle in the first lumen, the first flexible tubing further fluidically coupled at a proximal end of the first flexible tubing to a connector disposed at a proximal end of the hand piece, wherein the connector is further configured to fluidically couple to a second flexible tubing external to the first lumen.
Oberkircher discloses a supply tube (first flexible tubing) extending from the needle through the actuation member and terminating at a connector (luer fitting) at the proximal end of the body. Specifically, Oberkircher discloses: “supply tube (64) connects to the fluid coupling member of body engagement portion (50), extends proximally through body engagement portion (50), proximally through actuation member (62), and proximally out through the proximal end of actuation member (62). Thus, supply tube (64) defines a conduit through actuation member (62) to needle (30) such that fluid may be injected via supply tube (64) through needle (30) to an injection site. In the present example, the proximal end of supply tube (64) connects to a fluid source such as a syringe, an automated or semi-automated injector, or any other suitable fluid source. It should be understood that the proximal end of supply tube (64) may include a luer fitting and/or any other suitable kind of fitting to enable supply tube (64) to be releasably coupled with a fluid source.” (Oberkircher ¶ [0154].) The luer fitting at the proximal end of the body is the connector that fluidically couples to a second flexible tubing (the external supply line from the fluid source) external to the first lumen.
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 2, 3, 4, 5, 6, 7, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Oberkircher et al. (US 2015/0223977A1; hereinafter “Oberkircher”) in view of Meyer et al. (US 2017/0258988A1; hereinafter “Meyer”).
In relation to claim 2, this claim depends from claim 1 and further recites: the surgical instrument of claim 1, wherein the needle comprised a curved needle; wherein a curvature of the needle increases as it is extended from the second lumen; and wherein a curvature of the needle decreases as it is retracted into the second lumen.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the needle comprised a curved needle; wherein a curvature of the needle increases as it is extended from the second lumen; and wherein a curvature of the needle decreases as 0068
it is retracted into the second lumen.
Oberkircher discloses a needle but does not expressly disclose a curved needle whose curvature progressively increases upon extension and decreases upon retraction. Meyer fills this gap by disclosing a needle with a preformed curved portion that is constrained to a substantially straight configuration when retracted within the cannula and whose curvature progressively increases as it is extended. Specifically, Meyer discloses: “As shown in FIGS. 9A-9C, needle (200) is slidably disposed in needle guide (60) within cannula (50)… as needle (200) begins to exit cannula (50) via lateral opening (56), the distally protruding portion of needle (200) is oriented along a first exit axis (EA1)… the now longer protruding portion of needle (200) is oriented along a second exit axis (EA2). Second exit axis (EA2) defines an angle with the longitudinal axis (LA) that is larger than the angle defined between first exit axis (EA1) and the longitudinal axis (LA)… the now longer protruding portion of needle (200) is oriented along a third exit axis (EA3). Third exit axis (EA3) defines an angle with the longitudinal axis (LA) that is larger than the angle defined between second exit axis (EA3) and the longitudinal axis (LA). Thus, the further needle (200) is advanced, the larger the angle defined between the exit axis (EA) and the longitudinal axis (LA).” (Meyer ¶ [0068]–[0069].) Furthermore, Meyer discloses: “When needle (200) is in a proximal position as shown in FIG. 11A, distal tip (202) of needle (200) is fully contained within lumen (410). At this stage, insert (408) constrains needle (200) such that needle (200) is held under stress in a substantially straight configuration.” (Meyer ¶ [0074].)
Motivation to combine.
It would have been obvious to combine Oberkircher with Meyer because Meyer is directed to the same field of subretinal administration of therapeutic agents and explicitly teaches that a curved needle provides a progressively increasing exit angle that allows the needle to penetrate the choroid more consistently across patients with varying anatomies. A person of ordinary skill in the art would have been motivated to incorporate Meyer’s curved needle into Oberkircher’s instrument to improve the reliability of choroidal penetration and reduce the risk of retinal perforation.
In relation to claim 3, this claim depends from claim 2 and further recites: the surgical instrument of claim 2, wherein the needle is formed of an elastic material.
Base rejection incorporated.
The rejection of claim 2 is incorporated herein.
wherein the needle is formed of an elastic material.
Meyer discloses a needle formed of nitinol, which is a well-known elastic, shape-memory alloy. Specifically, Meyer discloses: “In the present example, needle (200) is formed of nitinol, though it should be understood that any other suitable material(s) (e.g., stainless steel, etc.) may be used.” (Meyer ¶ [0065].) The elastic nature of nitinol is what enables the needle to be resiliently biased to assume its curved configuration upon extension and to be constrained to a straight configuration upon retraction.
Motivation to combine.
It would have been obvious to combine the base combination of Oberkircher and Meyer because Meyer explicitly teaches the use of nitinol as the needle material to enable the preformed curved configuration. A person of ordinary skill in the art would have been motivated to use an elastic material such as nitinol to allow the needle to be constrained in a straight configuration within the cannula and to resiliently assume its curved shape when extended, thereby achieving the functional benefits described by Meyer.
In relation to claim 4, Claim 4 depends from claim 1 and further recites: the surgical instrument of claim 1, further comprising: an annular insert disposed in the second lumen at the distal end of the cannula, the annular insert circumscribing at least a portion of the needle within the second lumen, wherein extension of the needle from the second lumen and through the annular insert increases a flexibility of the needle, and wherein retraction of the needle into the second lumen and through the annular insert increases a stiffness of the needle.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
an annular insert disposed in the second lumen at the distal end of the cannula, the annular insert circumscribing at least a portion of the needle within the second lumen, wherein extension of the needle from the second lumen and through the annular insert increases a flexibility of the needle, and wherein retraction of the needle into the second lumen and through the annular insert increases a stiffness of the needle.
Oberkircher discloses a guide member (36) within the cannula lumen but does not expressly disclose an annular insert that increases needle flexibility upon extension and increases stiffness upon retraction. Meyer fills this gap by disclosing an insert positioned within the cannula that constrains the needle when retracted and releases it when extended. Specifically, Meyer discloses: “An insert (408) is positioned within cannula (400). Insert (408) may be secured within cannula (400) by a press or interference fit, by adhesives, by mechanical locking mechanisms, and/or in any other suitable fashion… Needle (200) is slidably disposed in a lumen (410) defined by insert (408). When needle (200) is in a proximal position as shown in FIG. 11A, distal tip (202) of needle (200) is fully contained within lumen (410). At this stage, insert (408) constrains needle (200) such that needle (200) is held under stress in a substantially straight configuration. When needle (200) is in a distal position as shown in FIG. 11B, distal tip (202) of needle is positioned distally of cannula (400). At this stage, curved portion (214) is exposed such that the distal portion (212) of needle (200) is oriented along an exit axis that is oblique to the longitudinal axis of cannula (400).” (Meyer ¶ [0074].) When the needle is retracted within insert (408), the insert constrains and stiffens the needle; when extended beyond the insert, the needle’s elastic curvature is released, increasing flexibility.
Motivation to combine.
It would have been obvious to combine Oberkircher with Meyer because Meyer teaches that an insert within the cannula can be used to constrain a curved needle in a straight configuration during retraction, thereby providing stiffness for navigation, and to release the needle’s curvature upon extension, thereby providing flexibility for penetration. A person of ordinary skill in the art would have been motivated to incorporate Meyer’s insert into Oberkircher’s cannula to guide and control the needle during both extension and retraction.
In relation to claim 5, this claim depends from claim 1 and further recites: the surgical instrument of claim 1, wherein the needle comprises: a first proximal portion having a first outer diameter; and a second distal portion comprising a second outer diameter.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the needle comprises: a first proximal portion having a first outer diameter; and a second distal portion comprising a second outer diameter.
Oberkircher discloses a needle with an outer diameter range and contemplates different needle configurations. Specifically, Oberkircher discloses: “the outer diameter of needle (30) may fall within the range of 27 gauge to 45 gauge; or more particularly within the range of 30 gauge to 42 gauge; or more particularly within the range of 32 gauge to 39 gauge.” (Oberkircher ¶ [0138].) While Oberkircher does not expressly disclose a needle with distinct proximal and distal portions having different outer diameters, it would have been obvious to a person of ordinary skill in the art to configure the needle with a stepped or tapered diameter profile to optimize fluid flow through the proximal portion while minimizing the penetration profile at the distal tip, as such stepped needle configurations were well known in the art.
Motivation to combine.
It would have been obvious to a person of ordinary skill in the art to configure the needle of Oberkircher with different proximal and distal diameters because stepped needle designs were well known in the art for optimizing both fluid delivery capacity and tissue penetration characteristics.
In relation to claim 6, this claim depends from claim 5 and further recites: the surgical instrument of claim 5, wherein the first proximal portion has a gauge of 38 or smaller, and wherein the second distal portion has a gauge of 37 or larger.
Base rejection incorporated.
The rejection of claim 5 is incorporated herein.
wherein the first proximal portion has a gauge of 38 or smaller, and wherein the second distal portion has a gauge of 37 or larger.
Oberkircher discloses a needle with a gauge range that encompasses the claimed values. Specifically, Oberkircher discloses: “the outer diameter of needle (30) may fall within the range of 27 gauge to 45 gauge; or more particularly within the range of 30 gauge to 42 gauge; or more particularly within the range of 32 gauge to 39 gauge.” (Oberkircher ¶ [0138].) The claimed gauge values of 38 or smaller for the proximal portion and 37 or larger for the distal portion fall squarely within the range disclosed by Oberkircher. It would have been obvious to select gauge values within the disclosed range to achieve the desired balance of fluid flow capacity and tissue penetration.
Motivation to combine.
It would have been obvious to a person of ordinary skill in the art to select the specific gauge values claimed, as they fall within the range expressly disclosed by Oberkircher, and the selection of specific values within a known range is a matter of routine optimization.
In relation to claim 7, this claim depends from claim 5 and further recites: the surgical instrument of claim 5, wherein the first proximal portion has a gauge of 41 or smaller, and wherein the second distal portion has a gauge of 40 or larger.
Base rejection incorporated.
The rejection of claim 5 is incorporated herein.
wherein the first proximal portion has a gauge of 41 or smaller, and wherein the second distal portion has a gauge of 40 or larger.
Oberkircher discloses a needle gauge range that encompasses the claimed values. Specifically, Oberkircher discloses: “the outer diameter of needle (30) may fall within the range of 27 gauge to 45 gauge; or more particularly within the range of 30 gauge to 42 gauge; or more particularly within the range of 32 gauge to 39 gauge.” (Oberkircher ¶ [0138].) The claimed gauge values of 41 or smaller for the proximal portion and 40 or larger for the distal portion fall within the broader range of 27 to 45 gauge disclosed by Oberkircher. It would have been obvious to select gauge values within the disclosed range to achieve the desired balance of fluid flow capacity and tissue penetration.
Motivation to combine.
It would have been obvious to a person of ordinary skill in the art to select the specific gauge values claimed, as they fall within the range expressly disclosed by Oberkircher, and the selection of specific values within a known range is a matter of routine optimization.
In relation to claim 8, this claim depends from claim 1 and further recites: the surgical instrument of claim 1, wherein the needle comprises a beveled distal tip, the beveled distal tip comprising a distal endface disposed at a non-normal and non-zero angle relative to a major longitudinal axis of the needle.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the needle comprises a beveled distal tip, the beveled distal tip comprising a distal endface disposed at a non-normal and non-zero angle relative to a major longitudinal axis of the needle.
Oberkircher discloses a needle with a beveled distal tip. Specifically, Oberkircher discloses: “The distal end (32) is formed by first grinding or laser cutting a first bevel (31) in needle (30), at an oblique angle relative to the longitudinal axis (LA) of needle (30). By way of example only, first bevel (31) may be oriented at an angle of approximately 30° relative to the longitudinal axis (LA) of needle (30).” (Oberkircher ¶ [0139].) An angle of approximately 30° relative to the longitudinal axis is both non-normal (not 90°) and non-zero, satisfying the claimed limitation.
Motivation to combine.
It would have been obvious to combine Oberkircher’s teachings as the reference explicitly discloses a beveled distal tip at a non-normal, non-zero angle relative to the longitudinal axis of the needle to facilitate tissue penetration.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Oberkircher et al. (US 2015/0223977A1; hereinafter “Oberkircher”) in view of in view of Meyer et al. (US 2017/0258988A1; hereinafter “Meyer”), as discussed above, and in further view of Crawford (US 4,894,052).
In relation to claim 9, this claim depends from claim 8 and further recites: the surgical instrument of claim 8, wherein the needle further comprises a port disposed in a side wall thereof and adjacent the beveled distal tip.
Base rejection incorporated.
The rejection of claim 8 is incorporated herein.
wherein the needle further comprises a port disposed in a side wall thereof and adjacent the beveled distal tip.
Oberkircher discloses various needle tip configurations but does not expressly disclose a port disposed in the side wall of the needle adjacent the beveled distal tip. Crawford fills this gap by disclosing an access port in the side wall of a needle adjacent the beveled tip. Specifically, Crawford discloses: “A port provided through the wall of the needle is preferably located within the catheter adjacent the seal. Blood from the penetrated vessel, enters the hollow needle bore, flows into the needle, through the port and fills an annular cavity.” (Crawford col. 3, ll. 17–21.) Furthermore, Crawford discloses: “In the preferred embodiment, the port and needle bevel are open outwardly in a direction normal to the bore.” (Crawford col. 3, ll. 23–25.)
Motivation to combine.
It would have been obvious to combine the base combination of Oberkircher with Crawford because Crawford teaches that a side-wall port adjacent the beveled tip permits fluid communication between the needle bore and the exterior, which is a well-known needle design feature for controlling fluid flow. A person of ordinary skill in the art would have been motivated to incorporate Crawford’s side-wall port into Oberkircher’s needle to provide an additional fluid exit pathway adjacent the beveled distal tip.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Oberkircher et al. (US 2015/0223977A1; hereinafter “Oberkircher”) in view of in view of Crawford (US 4,894,052).
In relation to claim 10, this claim depends from claim 1 and further recites: the surgical instrument of claim 1, wherein the needle comprises an annular sealing element circumscribing a portion of the needle at a distal end thereof.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the needle comprises an annular sealing element circumscribing a portion of the needle at a distal end thereof.
Oberkircher does not expressly disclose an annular sealing element on the needle. Crawford fills this gap by disclosing an annular sealing arrangement between a catheter and a needle. Specifically, Crawford discloses: “The cavity may be annular extending from a relatively tight seal or interference fit between the distal end of the catheter and the outside surface of the needle.” (Crawford col. 3, ll. 14-16.) Furthermore, Crawford discloses: “The interference fit of catheter end 15 with the outer diameter of the elongate tubular hollow needle wall 13 circumscribes and holds end 15 against the outside of wall 13 of the needle 11 to form a seal.” (Crawford col. 4, ll. 57–60.)
Motivation to combine.
It would have been obvious to combine the base combination of Oberkircher with Crawford because Crawford teaches that an annular sealing element circumscribing the needle at its distal end prevents fluid from escaping between the needle and the surrounding structure. A person of ordinary skill in the art would have been motivated to incorporate an annular sealing element into Oberkircher’s needle assembly to prevent leakage of therapeutic agent during subretinal injection.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Oberkircher et al. (US 2015/0223977A1; hereinafter “Oberkircher”) in view of Pryce Lewis et al. (US 2014/0135708A1; hereinafter “Pryce Lewis”).
In relation to claim 11, this claim depends from claim 1 and further recites: the surgical instrument of claim 1, wherein the needle comprises a polymeric coating formed on an inner wall thereof for reducing fluidic resistance through the cannula.
Base rejection incorporated.
The rejection of claim 1 is incorporated herein.
wherein the needle comprises a polymeric coating formed on an inner wall thereof for reducing fluidic resistance through the cannula.
Oberkircher does not expressly disclose a polymeric coating on the inner wall of the needle. Pryce Lewis fills this gap by disclosing a polymeric fluorocarbon coating on the inner surface of a medical article to reduce friction. Specifically, Pryce Lewis discloses: “contacting the inner surface of a barrel with the reactive species to form a fluorocarbon layer.” (Pryce Lewis ¶ [0041].) Furthermore, Pryce Lewis discloses: “PTFE coatings may be particularly well-suited to providing advantages to medical articles including increasing lubricity (e.g., by reducing coefficient of friction of article surface), reducing the adherence of chemicals on article surfaces, enhancing chemical resistance, and lowering surface energy of medical articles.” (Pryce Lewis ¶ [0028].)
Motivation to combine.
It would have been obvious to combine the base combination of Oberkircher with Pryce Lewis because Pryce Lewis teaches that polymeric fluorocarbon coatings on the inner surfaces of medical articles reduce friction and improve fluid flow. A person of ordinary skill in the art would have been motivated to apply Pryce Lewis’s polymeric coating to the inner wall of Oberkircher’s needle to reduce fluidic resistance and ensure smooth, consistent delivery of therapeutic agents through the small-gauge needle.
In relation to claim 12, this claim depends from claim 11 and further recites: the surgical instrument of claim 11, wherein the polymeric coating is further disposed on an inner wall of the cannula.
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the polymeric coating is further disposed on an inner wall of the cannula.
Pryce Lewis discloses coating the inner surfaces of medical articles including tubes and catheters. Specifically, Pryce Lewis discloses: “A variety of medical articles may be suitable for use in connection with the embodiments described herein including syringe assemblies (including syringe barrels, plungers or pistons, and plunger seals or piston seals), drug cartridges, needleless injectors, liquid dispensing devices, liquid metering devices, metered dose inhalers and components thereof, dry powder inhalers and components thereof, catheters, and shunts.” (Pryce Lewis ¶ [0021].) Extending the coating to the inner wall of the cannula is a straightforward application of the same coating technique to an adjacent surface.
Motivation to combine.
It would have been obvious to combine the base combination of Oberkircher and Pryce Lewis to also coat the inner wall of the cannula because Pryce Lewis teaches that such coatings reduce friction on all internal surfaces of medical articles through which fluids pass. A person of ordinary skill in the art would have been motivated to extend the coating to the cannula inner wall to further reduce fluidic resistance along the entire fluid pathway.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Oberkircher et al. (US 2015/0223977A1; hereinafter “Oberkircher”) in view of Pryce Lewis et al. (US 2014/0135708A1; hereinafter “Pryce Lewis”), as disclosed above, and in further view of Kampa (US 2007/0043333A1; hereinafter “Kampa”).
In relation to claim 13, this claim depends from claim 11 and further recites: the surgical instrument of claim 11, wherein the polymeric coating comprises at least one of poly (ethylene oxide) (PEO), poly (methyl methacrylate) (PMMA), poly (hydroxyethyl methacrylate) (PHEMA), polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), perfluoroalkoxy (PFA), chlorotrifluoroethylene (E-CTFE), or polyether ether ketone (PEEK).
Base rejection incorporated.
The rejection of claim 11 is incorporated herein.
wherein the polymeric coating comprises at least one of poly (ethylene oxide) (PEO), poly (methyl methacrylate) (PMMA), poly (hydroxyethyl methacrylate) (PHEMA), polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), perfluoroalkoxy (PFA), chlorotrifluoroethylene (E-CTFE), or polyether ether ketone (PEEK).
Pryce Lewis discloses PTFE as a polymeric coating for medical articles. Specifically, Pryce Lewis discloses: “In some embodiments, the coatings comprise a fluorocarbon. Suitable fluorocarbons can include fluorinated hydrocarbon species such as fluorosurfactants, fluorinated monomers, fluorinated oligomers, fluorinated polymers, fluorinated copolymers, and fluorinated polymer blends. Examples of fluorinated polymers include fluorinated polyacrylates, fluorinated polyalkylacrylates, fluorinated polymethacrylates, fluorinated polyalkylmethacrylates, poly(vinyl fluoride), poly(vinylidene fluoride), and poly(tetrafluoroethylene). Poly(tetrafluoroethylene) is also referred to as PTFE.” (Pryce Lewis ¶ [0028].) To the extent Pryce Lewis does not expressly disclose PEO, PMMA, PHEMA, ETFE, PFA, E-CTFE, or PEEK, Kampa fills this gap. Specifically, Kampa discloses: “Some examples of suitable water soluble polymers include: polyvinyl alcohol, polyethyleneoxide, polyethyleneglycol, polyvinylpyrrolidone, carboxymethylcellulose, hydroxyethylcellulose, and the like, and mixtures or combinations thereof.” (Kampa ¶ [0021].) Polyethyleneoxide (PEO) is listed therein. Furthermore, Kampa discloses a list of outer layer polymers including: “polytetrafluoroethylene (PTFE), polyether-ether ketone (PEEK)… perfluoro(propyl vinyl ether) (PFA).” (Kampa ¶ [0039].)
Motivation to combine.
It would have been obvious to combine the base combination of Oberkircher and Pryce Lewis with Kampa because Kampa is directed to the same field of polymeric coatings for medical device lumens and explicitly teaches a wide range of polymers suitable for inner lumen coatings. A person of ordinary skill in the art would have been motivated to select from the polymers taught by Pryce Lewis and Kampa to achieve the desired reduction in fluidic resistance through the needle and cannula, as these polymers were well known in the art for their lubricious properties.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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