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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01 September 2026 has been entered.
Response to Amendment
The amendment filed 01 September 2026 has been entered. Claim(s) 1-23 and 32 are pending in the application; claims 24-31 are canceled.
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 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.
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 1-2, 4-7, 10-11, 14-15 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz (US 20160317132) (Fig 1) in view of Keady (US 20160331405 A1).
Regarding claim 1, Markowitz discloses a device for collecting a biological sample in an esophagus of a patient (paragraph 0023-0024), the device comprising:
a swallowable collection portion (12/112) for collecting a sample at a collection site in the esophagus (paragraph 0023);
a catheter (20) having a fluid tight connection at its distal end with the collection portion and having a connector at its proximal end (paragraph 0025, 0036-0037); and
wherein the collection portion is placed into a back of a throat of the patient for swallowing (Paragraph 0036).
Markowitz is silent regarding a stylet having a proximal end and a distal end being relatively more flexible than the remainder of the stylet, the stylet further having a length that (1) when fully inserted along the catheter, allows the stylet to remain entirely within the length of the catheter such that the distal end of the stylet is adjacent to the distal end of the catheter and is spaced proximally from the collection portion and (2) is removable from the catheter, the stylet designed to a) be manipulated to place the collection portion into a back of a throat of the patient for swallowing and b) minimize compromising a structural integrity of the collected portion.
Keady, in analogous art of a guiding structure for use with biopsy device (Paragraph 0006-0007), discloses a stylet having a proximal end and a distal end being relatively more flexible than the remainder of the stylet (Paragraph 0016-- reduced removal force may be provided by enhanced flexibility along at least a length of a metallic stylet body portion…and providing a more flexible, lower friction polymeric distal tip member along or defining a distalmost length of the stylet body, as is described below; paragraph 0020-- a "more flexible" length will be coilable and bendable around smaller/ tighter radii of curvature than will a "less flexible" length…; paragraph 0027--a distalmost length of the wire is malleable and more highly flexible than a proximal-most length… Such an embodiment may have a general external appearance similar or even identical to the stylet of FIG. 1, but will have the novel flexibility differences based upon the martensitic properties of selected and identified length(s) of the single-wire body; paragraph 0030, 0036, 0040-- Most of the distalmost end length 304 has a third outer circumference less than the first and second outer circumferences...As such, the unoccupied distal-most length of the polymeric distal tip member 306 preferably will be even more flexible than the martensitic phase contacting/ immediately-adjacent length of the single-wire body 302, which will further provide for decreasing likelihood of binding/ increased retraction force attributable to stylet stiffness through certain lengths of a needle lumen (or other lumen) during use),
the stylet further having a length that (1) when fully inserted along the catheter, allows the stylet to remain entirely within the device (Paragraph 0016-- A stylet for within an endoscopy needle is described, including features that provide reduced removal force as compared to a standard stainless steel, nitinol, or other standard stylet. The phrase “within an endoscopy/endoscopic needle” should be understood as meaning that all or substantially all of the stylet length fits within and, when in use will, at some time, be disposed within the lumen of a needle, including that the distal end terminus of the stylet will not extend beyond the distal needle end terminus; paragraph 0033-0034-- A stylet according to any embodiment herein described (including variants that combine or exchange features of separately described embodiments) is provided through the needle lumen, occupying the entire length thereof without extending substantially past the distal terminal needle tip)
such that the distal end of the stylet is adjacent to the distal end of the catheter and is spaced proximally from the collection portion (Paragraph 0005, 0016, 0033-0034--the needle is introduced with a stylet disposed through the entire length or nearly the entire length of its longitudinal needle lumen…all or substantially all of the stylet length fits within and, when in use will, at some time, be disposed within the lumen of a needle, including that the distal end terminus of the stylet will not extend beyond the distal needle end terminus; paragraph 0023, 0032--As such, for use in a needle system, the absolute dimensions of the stylet body with its polymeric distal tip member will be determined by the needle selected. For example, a 19-gauge needle including a central longitudinal needle lumen that is 170 cm long preferably will receive and contain...The combined length of the single-wire body and its polymeric distal tip member for such a needle will be about 170 cm)
(2) is removable from the device (Paragraph 0006—in a biopsy procedure, the stylet will be removed from…the needle lumen; paragraph 0008, 0042—a stylet structure that provides for reduced removal force…), and
the stylet designed to a) be manipulated to place the collection portion into a back of a throat of the patient for swallowing (Paragraph 0005-0006, 0032, 0038-0039, 0042—describe benefits of the stylet in pushability and navigation when used together with a collection device such as a needle through which the stylet is disposed “The stylet provides columnar strength while the needle is being directed to a target site, as well as minimizing the likelihood that an open distal tip and/or side aperture of, for example, a biopsy needle will collect tissue en route to the actual site being targeted” and “Each of the above embodiments may be useful in methods for accessing a target site via a tortuous passage”) and b) minimize compromising a structural integrity of the collected portion (Paragraph 0028--The distal end terminus of the polymeric distal tip member 206 is shown as having a blunt flat end, although this embodiment and all others may have any number of end-terminal shapes, including by way of non-limiting example, hemispherical or otherwise rounded, flat, beveled, conical, or otherwise singly or multiply pointed, or convex).
It is noted that as Keady discloses that the length of the stylet may be nearly the entire length of the needle lumen and additionally discloses of a stylet having a length that is about the same as the needle lumen length while emphasizing that the stylet will not extend beyond the distal needle tip (see paragraph 0033-0034), Keady may be seen to disclose a stylet length with is some amount shorter than the exact length of the needle lumen, such that when provided in the needle lumen in its entirety, the stylet would be spaced proximally by some amount from the distalmost end of the needle lumen, which would correspond to being spaced proximally from the distal collection portion when combined with Markowitz.
It is additionally noted that as the stylet of Keady is described as providing strength for improved ability to direct a collection device to a target site and Markowitz describes a collection device which is placed in the patient’s throat for swallowing, it may be seen that such a combination would result in a collection device including a stylet which may be used to manipulate the collection portion of the collection device into a back of a throat of the patient for swallowing.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Markowitz to include the stylet structure as described by Keady in order to predictably improve control and precision over the positioning of the end of the device at particular target tissue without disrupting or compromising the collection portion or gathering undesired material (see Keady, paragraph 0005, 0042-- stylet provides columnar strength while the needle is being directed to a target site, as well as minimizing the likelihood that an open distal tip and/or side aperture of, for example, a biopsy needle will collect tissue en route to the actual site being targeted) and the particular flexibility of the stylet is described by Keady as an improvement over other stylets which allows for improved retraction ability (see paragraph 0007-0008, 0016 of Keady).
Regarding claim 2, the combination of Markowitz and Keady disclose the device for collecting a biological sample as set forth in claim 1. Markowitz additionally discloses wherein a catheter is connected to the collection portion (paragraph 0025). However, Markowitz is silent regarding the stylet extending through the connector along the catheter toward the collection portion.
Keady teaches the stylet extends through a connector along the device toward a collection portion (Paragraph 0023—stylet embodiments may have different lengths; paragraph 0039—"a needle or other device through which the stylet is disposed is positioned through an endoscope contorted through a tortuous passage” demonstrates that it is known in the art for a stylet to be positioned in a needle through an endoscope such that it is known for a stylet to pass through a handheld connector or device portion). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Markowitz by including a stylet as taught by Keady predictably improve control and precision over the positioning of the end of the device at the target tissue.
Regarding claim 4, the combination of Markowitz and Keady disclose the device for collecting a biological sample as set forth in claim 1. Markowitz additionally discloses wherein the collection portion (12) includes a first axial end portion (14) and a second axial end portion (16), the second axial end portion having a collapsed position and an expanded position (paragraph 0026), the second axial end portion moving in an axial direction relative to the first axial end portion when the second axial end portion moves between the collapsed position and the expanded position, the second axial end portion extending axially into the first axial end portion and having a concave shape when the second axial end portion is in the collapsed position (paragraph 0027).
Regarding claim 5, the combination of Markowitz and Keady disclose the device for collecting a biological sample as set forth in claim 4. Markowitz additionally discloses wherein the second axial end portion (16) has an outer surface (32) facing radially outwardly when the second axial2ACTIVE 64141163v1Attorney Docket No. 189573-010202/USUSSN 16/610,115 end portion (16) is in the expanded position, the outer surface facing radially inwardly when the second axial end portion is in the collapsed position (paragraph 0030; Fig 2 and 3).
Regarding claim 6, the combination of Markowitz and Keady disclose the device for collecting a biological sample as set forth in claim 4. Markowitz additionally discloses wherein the second axial end portion (16) includes a plurality of tissue collecting projections (40) extending from an outer surface (32) of the second axial end portion (paragraph 0031; Fig 4).
Regarding claim 7, the combination of Markowitz and Keady disclose the device for collecting a biological sample as set forth in claim 6. Markowitz additionally discloses wherein a first side wall (54) of the tissue collecting projection of the plurality of tissue collecting projections extends generally perpendicular to the outer surface of the second axial end portion and a second wall (56) of the tissue collecting projection tapers (paragraph 0033) toward the first side wall as the side walls extend radially outward from the outer surface when the second axial end portion is in a non-inflated position between the collapsed and expanded positions (paragraph 0033; Fig 5).
Regarding claim 10, the combination of Markowitz and Keady disclose the device for collecting a biological sample as set forth in claim 6. Markowitz additionally discloses the second axial end portion has a lower durometer (paragraph 0024, 0028). However, Markowitz is silent regarding wherein the second axial end portion has a durometer between 5 -90 Shore A. It would have been obvious to one of ordinary skill in the art at the time of the invention to have wherein the second axial end portion has a durometer between 5 and 90 Shore A, since where the general conditions of the claim are disclosed in the prior art (distal proximal end has a lower durometer than proximal axial end, paragraph 0024), discovering the optimal or workable ranges involves only routine skill in the art. The motivation for doing so would be to offer a material of proper flexibility to allow the end portion to expand and contract.
Regarding claim 11, the combination of Markowitz and Keady disclose the device for collecting a biological sample as set forth in claim 6. Markowitz additionally discloses the second axial end portion has a lower durometer (paragraph 0024, 0028). However, Markowitz is silent regarding a device for collecting a biological sample as set forth in claim 6 wherein the second axial end portion has a durometer between 20-70 Shore A. It would have been obvious to one of ordinary skill in the art at the time of the invention to have wherein the second axial end portion has a durometer between 5 and 90 Shore A, since where the general conditions of the claim are disclosed in the prior art (distal proximal end has a lower durometer than proximal axial end, paragraph 0024), discovering the optimal or workable ranges involves only routine skill in the art. The motivation for doing so would be to offer a material of proper flexibility to allow the end portion to expand and contract.
Regarding claim 14, the combination of Markowitz and Keady disclose a device for collecting a biological sample as set forth in claim 4. Markowitz additionally discloses wherein the second axial end portion includes a plurality of tissue collecting projections extending from an outer surface of the second axial end portion, each of the projections having a V-shape connected to an adjacent V-shaped projection (paragraph 0031, 0034; Fig 1 and 4).
Regarding claim 15, the combination of Markowitz and Keady disclose a device for collecting a biological sample as set forth in claim 4. Markowitz additionally discloses further including a cap (“cap or cover”) extending over the second axial end portion when the second axial end portion is in the collapse position to retain the second axial end portion in the collapsed position (paragraph 0036).
Regarding claim 32, Markowitz discloses a device for collecting a biological sample in an esophagus of a patient (paragraph 0023-0024), the device comprising:
a swallowable collection portion (12/112) for collecting a sample at a collection site in the esophagus (paragraph 0023);
a catheter (20) having a fluid tight connection at its distal end with the collection portion and having a connector at its proximal end (paragraph 0025, 0036-0037); and
Markowitz is silent regarding a stylet having a length measurably shorter than the catheter to permit the stylet to be disposed entirely within the catheter, the stylet further having a proximal end and a distal end that is configured to advance the collection portion toward the back of a throat of the patient for swallowing.
Keady, in analogous art of a guiding structure for use with biopsy device (Paragraph 0006-0007), discloses a stylet having a length measurably shorter than the catheter to permit the stylet to be disposed entirely within the catheter (Paragraph 0016-- A stylet for within an endoscopy needle is described, including features that provide reduced removal force as compared to a standard stainless steel, nitinol, or other standard stylet. The phrase “within an endoscopy/endoscopic needle” should be understood as meaning that all or substantially all of the stylet length fits within and, when in use will, at some time, be disposed within the lumen of a needle, including that the distal end terminus of the stylet will not extend beyond the distal needle end terminus; paragraph 0033-0034-- A stylet according to any embodiment herein described (including variants that combine or exchange features of separately described embodiments) is provided through the needle lumen, occupying the entire length thereof without extending substantially past the distal terminal needle tip), the stylet further having a proximal end and a distal end that is configured to advance the collection portion toward the back of a throat of the patient for swallowing (paragraph 0005, 0042-- stylet provides columnar strength while the needle is being directed to a target site, as well as minimizing the likelihood that an open distal tip and/or side aperture of, for example, a biopsy needle will collect tissue en route to the actual site being targeted),
the stylet designed to a) be manipulated to place the collection portion into a back of a throat of the patient for swallowing (Paragraph 0005-0006, 0032, 0038-0039, 0042—describe benefits of the stylet in pushability and navigation when used together with a collection device such as a needle through which the stylet is disposed “The stylet provides columnar strength while the needle is being directed to a target site, as well as minimizing the likelihood that an open distal tip and/or side aperture of, for example, a biopsy needle will collect tissue en route to the actual site being targeted” and “Each of the above embodiments may be useful in methods for accessing a target site via a tortuous passage”) and b) minimize compromising a structural integrity of the collected portion (Paragraph 0028--The distal end terminus of the polymeric distal tip member 206 is shown as having a blunt flat end, although this embodiment and all others may have any number of end-terminal shapes, including by way of non-limiting example, hemispherical or otherwise rounded, flat, beveled, conical, or otherwise singly or multiply pointed, or convex).
It is noted that as Keady discloses that the length of the stylet may be nearly the entire length of the needle lumen and additionally discloses of a stylet having a length that is about the same as the needle lumen length while emphasizing that the stylet will not extend beyond the distal needle tip (see paragraph 0033-0034), Keady may be seen to disclose a stylet length with is some amount shorter than the exact length of the needle lumen, such that when provided in the needle lumen in its entirety, the stylet would be spaced proximally by some amount from the distalmost end of the needle lumen, which would correspond to being spaced proximally from the distal collection portion when combined with Markowitz.
It is additionally noted that as the stylet of Keady is described as providing strength for improved ability to direct a collection device to a target site and Markowitz describes a collection device which is placed in the patient’s throat for swallowing, it may be seen that such a combination would result in a collection device including a stylet which may be used to manipulate the collection portion of the collection device into a back of a throat of the patient for swallowing.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Markowitz to include the stylet structure as described by Keady in order to predictably improve control and precision over the positioning of the end of the device at the target tissue (see Keady, paragraph 0005, 0042-- stylet provides columnar strength while the needle is being directed to a target site, as well as minimizing the likelihood that an open distal tip and/or side aperture of, for example, a biopsy needle will collect tissue en route to the actual site being targeted).
Claims 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz (US 20160317132) (Fig 1) in view of Keady (US 20160331405 A1), further in view of Benning (US 20170112477).
Regarding claim 3, the combination of Markowitz and Keady disclose the device for collecting a biological sample as set forth in claim 2. However, Markowitz is silent regarding wherein the connector is a Y-fitting, the stylet being insertable within a first branch of the connector, the first branch of the connector extending at an angle to a second branch of the connector, the second including a stopcock.
Benning teaches device including a stylet in an interior area of the collection portion (14) into the back of a throat of a patient for swallowing (20) (paragraph 0052, 0060-0061, 0064, 0066-0067), the device including a connector (paragraphs 0066-0067), where the stylet extends through the connector and along the catheter from the stylet toward the collection portion (paragraph 0066-0067). Therefore Benning teaches wherein the connector is a Y-fitting (Fig 1, ports 7 of hub 27 are a y shape), the stylet being insertable within a first branch of the connector (Fig 1 shows wherein the shaft 12 and elongate shaft 22 is connected at a proximal end 28 to port 6), the first branch of the connector extending at an angle to a second branch of the connector, the second including a stopcock (hub 27 to facilitate connection to other medical devices e.g. syringe, stopcock, paragraph 0067). Therefore, it would have been obvious at the time of the invention to modify Markowitz to include a y-fitting connector, and stopcock as taught by Benning for the purpose of allowing other instruments to access the catheter lumen and thereby facilitate the procedure.
Claims 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz (US 20160317132) (Fig 1) in view of Keady (US 20160331405 A1) in view of Lonky (US 20130267870).
Regarding claim 8, the combination of Markowitz and Keady disclose the device for collecting a biological sample as set forth in claim 7.
However, Markowitz is silent regarding wherein a lip extends from a radially outer surface of the tissue collecting projection toward the first side wall of the tissue collecting projection when the second axial end portion is in the expanded position.
Lonky, in the same field of endeavor of a device for obtaining a biological sample, teaches wherein a lip extends from a radially outer surface of the tissue collecting projection (Fig 5B shows wherein abrasive material 110 has a curved tip that serves as a lip, paragraph 0140) toward the first side wall of the tissue collecting projection when the second axial end portion is in the expanded position (Figs 1A-B and 5B wherein the hooks are curved towards both proximal and distal directions when head 120 is deployed). It would have been obvious at the time of the invention to modify Markowitz to include a lip as taught by Lonky as to predictably improve the ability of the device to collect tissue by providing rigid hooks which may abrade tissue and thereby loosen the tissue for collection.
Regarding claim 9, the combination of Markowitz, Keady, and Lonky disclose the device for collecting a biological sample as set forth in claim 8. Markowitz additionally discloses wherein at least one of the plurality of tissue collecting projections has a V-shape, the first side wall facing in a proximal direction and forming an inner wall of the V-shape, the second side wall facing in a distal direction and forming an outer wall of the V-shape (paragraph 0031, 0034; Fig 1 and 4).
Claims 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz (US 20160317132) (Fig 1) in view of Keady (US 20160331405 A1), further in view of Markowitz (Fig 12).
Regarding claim 12, the combination of Markowitz (Fig. 1) and Keady disclose the device for collecting a biological sample as set forth in claim 4. However, Markowitz (Fig. 1) is silent regarding a sleeve configured to be axially inserted into the first axial end portion, the sleeve configured to provide hoop strength to prevent the axial end portion from collapsing under vacuum. Markowitz (Fig. 12) teaches a sleeve in the first axial end portion configured to be axially inserted into the first axial end portion (wherein a first axial end portion 622 overlaps the proximal axial end portion 614, paragraph 0078; Fig 12), the sleeve configured to provide hoop strength to prevent the axial end portion from collapsing under vacuum (Paragraph 0025-- support 20 resists collapsing when a vacuum is applied to the support member and resists stretching during withdrawal of the collection device 10 from the collection site, it is noted that the cited sleeve portion includes the analogous structure of the support 20 and may thus be configured to provide the same strength against collapse; see also Figs. 1-3 and 12 wherein support 20 is analogous to the axial end portions 622 and 614). It would have been obvious at the time of the invention to modify Markowitz (Fig 1) to further include a sleeve as taught by Markowitz (Fig 12) to predictably improve the device by providing a smooth outer surface to allow for easier movement of the collection portion (paragraph 0077-0078).
Regarding claim 13, the combination of Markowitz (Fig. 1), Keady, and Markowitz (Fig. 12) disclose the device for collecting a biological sample as set forth in claim 12. Markowitz (Fig. 12) teaches wherein the sleeve is held in the first axial end portion by an undercut rim within the first axial end portion (first axial end portion 622 engages a shoulder 624 on the proximal axial end portion 614, paragraph 0078) (Fig 12). It would have been obvious at the time of the invention to modify Markowitz (Fig 1) to further include a sleeve which is held in the first axial end portion by an undercut rim as taught by Markowitz (Fig 12) to allow a junction without any protrusions and thereby predictably improving the device by providing a smooth surface and easier movement of the collection portion (paragraph 0077-0078).
Claims 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz (US 20160317132) (Fig 1) in view of Keady (US 20160331405 A1), further in view of Rachlin (US 20150289752)
Regarding claim 16, the combination of Markowitz and Keady disclose the device for collecting a biological sample as set forth in claim 4. However, Markowitz is silent regarding a weight connected to the first axial end portion. Rachlin, in the same field of endeavor of a device having a lumen which is insertable into the throat of a patient, teaches a weight connected to the first axial end portion (weight may be added to the capsule…circularly symmetric set of beads 1603-1605, paragraph 0138) (Fig 16). It would have been obvious at the time of the invention to modify Markowitz to include a weight connected to the first axial portion as taught by Rachlin for the purpose of predictably improving the ease of use of the device by allowing a user to utilize gravity to assist in moving the capsule through the lumen easily (Rachlin, paragraph 0138, 0142).
Claims 17-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Markowitz (US 20160317132) (Fig 1) in view of Markowitz (Fig 12) in view of Keady (US 20160331405 A1).
Regarding claim 17, Markowitz (Fig 1) discloses a device for collecting a biological sample in an esophagus of a patient (abstract), the device comprising:
a collection portion (12/112) having a first axial end portion (14/114) and a second axial end portion (16/116), the second axial end portion having a collapsed position and an expanded position (paragraph 0026, 0041), the second axial end portion moving in an axial direction relative to the first axial end portion when the second axial end portion moves between the collapsed position and the expanded position, the second axial end portion extending axially into the first axial end portion and having a concave shape when the second axial end portion is in the collapsed position (paragraph 0027, 0042); and
a catheter (20) having a fluid tight connection at its distal end with the collection portion and having a connector at its proximal end (paragraph 0025, 0036-0037).
However, Markowitz (Fig 1) is silent regarding a sleeve in the first axial end portion.
Markowitz (Fig 12) teaches a sleeve in the first axial end portion (wherein a first axial end portion 622 overlaps the proximal axial end portion 614, paragraph 0078) (Fig 12). It would have been obvious at the time of the invention to modify Markowitz (Fig 1) to further include a sleeve as taught by Markowitz (Fig 12) to predictably improve the ease of use of the device by providing a smooth outer surface and allow for easier movement of the collection portion (paragraph 0077-0078).
However, Markowitz (Fig. 1) is silent regarding a stylet having a proximal end and a distal end being relatively more flexible than the remainder of the stylet, the stylet further having a length that (1) when fully inserted along the catheter, allows the stylet to remain entirely within the length of the device such that the distal end of the stylet is adjacent to the distal end of the catheter and is spaced proximally from the collection portion for placing the collection portion into the back of a throat of a patient for swallowing and (2) is removable from the catheter.
Keady, in analogous art of a guiding structure for use with biopsy device (Paragraph 0006-0007), discloses a stylet having a proximal end and a distal end being relatively more flexible than the remainder of the stylet (Paragraph 0016-- reduced removal force may be provided by enhanced flexibility along at least a length of a metallic stylet body portion…and providing a more flexible, lower friction polymeric distal tip member along or defining a distalmost length of the stylet body, as is described below; paragraph 0020-- a "more flexible" length will be coilable and bendable around smaller/ tighter radii of curvature than will a "less flexible" length…; paragraph 0027--a distalmost length of the wire is malleable and more highly flexible than a proximal-most length… Such an embodiment may have a general external appearance similar or even identical to the stylet of FIG. 1, but will have the novel flexibility differences based upon the martensitic properties of selected and identified length(s) of the single-wire body; paragraph 0030, 0036, 0040-- Most of the distalmost end length 304 has a third outer circumference less than the first and second outer circumferences...As such, the unoccupied distal-most length of the polymeric distal tip member 306 preferably will be even more flexible than the martensitic phase contacting/ immediately-adjacent length of the single-wire body 302, which will further provide for decreasing likelihood of binding/ increased retraction force attributable to stylet stiffness through certain lengths of a needle lumen (or other lumen) during use),
the stylet further having a length that (1) when fully inserted along the catheter, allows the stylet to remain entirely within the device (Paragraph 0016-- A stylet for within an endoscopy needle is described, including features that provide reduced removal force as compared to a standard stainless steel, nitinol, or other standard stylet. The phrase “within an endoscopy/endoscopic needle” should be understood as meaning that all or substantially all of the stylet length fits within and, when in use will, at some time, be disposed within the lumen of a needle, including that the distal end terminus of the stylet will not extend beyond the distal needle end terminus; paragraph 0033-0034-- A stylet according to any embodiment herein described (including variants that combine or exchange features of separately described embodiments) is provided through the needle lumen, occupying the entire length thereof without extending substantially past the distal terminal needle tip)
such that the distal end of the stylet is adjacent to the distal end of the catheter and is spaced proximally from the collection portion (Paragraph 0005, 0016, 0033-0034--the needle is introduced with a stylet disposed through the entire length or nearly the entire length of its longitudinal needle lumen…all or substantially all of the stylet length fits within and, when in use will, at some time, be disposed within the lumen of a needle, including that the distal end terminus of the stylet will not extend beyond the distal needle end terminus; paragraph 0023, 0032--As such, for use in a needle system, the absolute dimensions of the stylet body with its polymeric distal tip member will be determined by the needle selected. For example, a 19-gauge needle including a central longitudinal needle lumen that is 170 cm long preferably will receive and contain...The combined length of the single-wire body and its polymeric distal tip member for such a needle will be about 170 cm)
(2) is to be removed from the device by withdrawing the stylet from and relative to the collection portion and the catheter (Paragraph 0006—in a biopsy procedure, the stylet will be removed from…the needle lumen; paragraph 0008, 0042—a stylet structure that provides for reduced removal force…),
the stylet designed to a) be manipulated to place the collection portion into a back of a throat of the patient for swallowing (Paragraph 0005-0006, 0032, 0038-0039, 0042—describe benefits of the stylet in pushability and navigation when used together with a collection device such as a needle through which the stylet is disposed “The stylet provides columnar strength while the needle is being directed to a target site, as well as minimizing the likelihood that an open distal tip and/or side aperture of, for example, a biopsy needle will collect tissue en route to the actual site being targeted” and “Each of the above embodiments may be useful in methods for accessing a target site via a tortuous passage”) and b) minimize compromising a structural integrity of the collected portion (Paragraph 0028--The distal end terminus of the polymeric distal tip member 206 is shown as having a blunt flat end, although this embodiment and all others may have any number of end-terminal shapes, including by way of non-limiting example, hemispherical or otherwise rounded, flat, beveled, conical, or otherwise singly or multiply pointed, or convex).
It is noted that as Keady discloses that the length of the stylet may be nearly the entire length of the needle lumen and additionally discloses of a stylet having a length that is about the same as the needle lumen length while emphasizing that the stylet will not extend beyond the distal needle tip (see paragraph 0033-0034), Keady may be seen to disclose a stylet length with is some amount shorter than the exact length of the needle lumen, such that when provided in the needle lumen in its entirety, the stylet would be spaced proximally by some amount from the distalmost end of the needle lumen, which would correspond to being spaced proximally from the distal collection portion when combined with Markowitz.
It is additionally noted that as the stylet of Keady is described as providing strength for improved ability to direct a collection device to a target site and Markowitz describes a collection device which is placed in the patient’s throat for swallowing, it may be seen that such a combination would result in a collection device including a stylet which may be used to manipulate the collection portion of the collection device into a back of a throat of the patient for swallowing.
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the system of Markowitz to include the stylet structure as described by Keady in order to predictably improve control and precision over the positioning of the end of the device at the target tissue (see Keady, paragraph 0005, 0042-- stylet provides columnar strength while the needle is being directed to a target site, as well as minimizing the likelihood that an open distal tip and/or side aperture of, for example, a biopsy needle will collect tissue en route to the actual site being targeted) and the particular flexibility of the stylet is described by Keady as an improvement over other stylets which allows for improved retraction ability (see paragraph 0007-0008, 0016 of Keady).
Regarding claim 18, the combination of Markowitz (Fig. 1), Markowitz (Fig. 12) and Keady disclose the device for collecting a biological sample as set forth in claim 17. However, Markowitz (Fig 1) is silent regarding the sleeve is held in the first axial end portion by an undercut rim on the first axial end portion. Markowitz (Fig 12) teaches wherein the sleeve is held in the first axial end portion by an undercut rim on the first axial end portion (first axial end portion 622 engages a shoulder 624 on the proximal axial end portion 614, paragraph 0078) (Fig 12). Therefore, it would have been obvious at the time of the invention to modify Markowitz (Fig 1) to further include a sleeve which is held in the first axial end portion by an undercut rim as taught by Markowitz (Fig 12) to allow a junction without any protrusions and thereby providing a smooth surface and easier movement of the collection portion (paragraph 0077-0078).
Regarding claim 19, the combination of Markowitz (Fig. 1), Markowitz (Fig. 12) and Keady disclose the device for collecting a biological sample as set forth in claim 17. However, Markowitz (Fig 1) is silent regarding wherein the second axial end portion extends axially into the sleeve when the second axial end portion is in the collapsed position. Markowitz (Fig 12) teaches wherein the second axial end portion extends axially into the sleeve when the second axial end portion is in the collapsed position (paragraph 0078-0079) (Fig 12). It would have been obvious at the time of the invention to modify Markowitz (Fig 1) to further include a sleeve as taught by Markowitz (Fig 12) to predictably improve the ease of use of the device by providing a smooth outer surface and allowing for easier movement of the collection portion (paragraph 0077-0078).
Regarding claim 20, the combination of Markowitz (Fig. 1), Markowitz (Fig. 12) and Keady disclose the device for collecting a biological sample as set forth in claim 17. Markowitz (Fig. 1) additionally discloses wherein the collection portion is swallowable (12/112; paragraph 0023).
Regarding claim 21, the combination of Markowitz (Fig. 1), Markowitz (Fig. 12) and Keady disclose the device for collecting a biological sample as set forth in claim 17. Markowitz (Fig. 1) additionally discloses wherein the second axial end portion has an outer surface facing radially outwardly when the second axial end portion is in the expanded position, the outer surface facing radially inwardly when the second axial end portion is in the collapsed position (paragraph 0030).
Regarding claim 22, the combination of Markowitz (Fig. 1), Markowitz (Fig. 12) and Keady disclose the device for collecting a biological sample as set forth in claim 17. However, Markowitz (Fig 1) does not expressly disclose wherein the second axial end portion has a durometer between 5 -90 Shore A. It would have been obvious to one of ordinary skill in the art at the time of the invention to have wherein the second axial end portion has a durometer between 5 and 90 Shore A, since where the general conditions of the claim are disclosed in the prior art (distal proximal end has a lower durometer than proximal axial end, paragraph 0024, 0028), discovering the optimal or workable ranges involves only routine skill in the art. The motivation for doing so would be to offer a flexible material to allow the end portion to expand and contract.
Regarding claim 23, the combination of Markowitz (Fig. 1), Markowitz (Fig. 12) and Keady disclose the device for collecting a biological sample as set forth in claim 17. However, Markowitz (Fig 1) does not expressly disclose wherein the second axial end portion has a durometer between 20-70 Shore A. It would have been obvious to one of ordinary skill in the art at the time of the invention to have wherein the second axial end portion has a durometer between 5 and 90 Shore A, since where the general conditions of the claim are disclosed in the prior art (distal proximal end has a lower durometer than proximal axial end, paragraph 0024, 0028), discovering the optimal or workable ranges involves only routine skill in the art. The motivation for doing so would be to offer a flexible material to allow the proximal end portion to maintain its shape when the distal end is collapsing or expanding or collapse itself due to any outside influence.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-23 and 32 have been considered but are not persuasive.
The applicant argues that a person having ordinary skill in the art would not have been motivated to combine the device of Markowitz with the stylet of Keady because the device of Markowitz is disclosed to be swallowed or intubated by the patient without disrupting the collection portion such that "the device is already capable of providing" positioning functionality without Keady and it "is not clear why, in view of the Office Action, a POSITA would introduce a stylet". However, the ability of Markowitz to generally position the device at a broad area does not mean that Markowitz is capable, unmodified, of positioning the device at a particular portion of that broad area (such as a particular area of the back of the throat), which would be enabled by combination with a stylet as described by Keady. Applicant additionally argues that the citation of paragraph 0005/0042 of Keady which recites providing columnar strength while the needle is being directed to a target site would destroy the functionality of the primary reference Markowitz which does not involve the use of a needle. Keady is cited as disclosing a stylet present in a catheter which has a collection portion, where the collection portion is a needle. Markowitz, as the primary reference being modified, includes a collection portion which is not a needle, where the collection portion itself is not modified and is as a result not destroyed, as a needle is not added to Markowitz. The stylet of Keady as described in the office action additionally provides columnar strength to the collection portion being delivered in Markowitz.
With respect to applicant’s arguments in response to the advisory action, the applicant argues that “Markowitz already provides the functionality relied upon by the Office without the stylet disclosed in Keady” such that a person having ordinary skill in the art would not have been motivated to modify Markowitz with the stylet disclosed in Keady.
However, while Markowitz discloses positioning the device at a collection site in the esophagus and describes placement in a collection site via swallowing of the collection end in a collapsed position, Markowitz does not described an invention with the same functionality as provided by the stylet of Keady. Namely, Markowitz provides no ability to target a specific location of the esophagus (such as to target a specific area of the esophagus to obtain samples from a lesion or tumor) beyond a general depth indicator, whereas a more precise location targeting functionality would be provided through the inclusion of a stylet which provides columnar strength and maneuverability to such a device, which would improve the ability of the device to be used in collecting samples for specific condition monitoring such as biopsies for cancerous cells at specific areas of concern. Additionally, regarding the useful of the stylet in navigating tortuous passages to access a target site, while applicant argues that Markowitz “does not involve advancing a device through such a tortuous pathway” such that this added functionality would be unnecessary, the capability provided by Keady, in addition to allowing exact placement at particular sites, would enable the navigation and placement of the collection device through tortuous pathways which may be present in the mouth, throat, and/or esophagus due to injury, medical condition, or other unique anatomy of a patient requiring the collection of a sample, whereas Markowitz could not be utilized in such a patient due to the inability to steer the collection portion through such an area to the collection site.
Furthermore, Markowitz describes that the device in some embodiments may be held in the collapsed position by including a removable cover of some kind which is disengaged upon reaching the target location (Paragraph 0036), where it is not stated but may be seen that this cover would enable a reduction in incidental sample collection during placement of the device, as Figs. 1-3 of Markowitz demonstrate that even in a collapsed configuration, the collection portion of Markowitz otherwise includes an open end which may unintentionally gather material during swallowing. As Keady provides an ability to steer a collection portion and thus avoid collecting tissue en route to a target site (see Keady, paragraph 0005, 0042-- stylet provides columnar strength while the needle is being directed to a target site, as well as minimizing the likelihood that an open distal tip and/or side aperture of, for example, a biopsy needle will collect tissue en route to the actual site being targeted), the inclusion of a stylet may additionally be seen as a modification to Markowitz which may function in embodiments which do not include a cap/cover and enables the same avoidance of incidental sample collection while improving the safety of the device by providing the functionality without requiring a component which is removed from the device within the body lumen which could cause choking or other complications.
The claims remain rejected under 35 U.S.C. 103.
Conclusion
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/ANNA ROBERTS/Examiner, Art Unit 3791
