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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Steinberg et al. (US 2019/0357883) in view of Kodama et al. (US 2009/0005689).
Regarding Claim 1, Steinberg discloses:
An ultrasonic attachment assembly, comprising:
an ultrasonic transducer (122) comprising:
a transducer body (body of the unit as shown in Fig. 17); and
a clip (124) configured to be removably secured to a distal end of a duodenoscope comprising an elevator channel, wherein the distal end of the duodenoscope defines a central axis, wherein the elevator channel defines an elevator channel axis that is offset from the central axis (the duodenoscope is not part of the claim; Steinberg’s clip is attached to a scope as shown in Fig. 16), and wherein the clip comprises:
a clip body (see Fig. 17 the trunk of the clip above 124); and
a cavity (distal end of the clip holding 122) formed in the clip body, wherein the cavity is configured to hold the transducer body when the clip is secured to the distal end of the duodenoscope such that the transducer lens is positioned distally with respect to the distal end of the duodenoscope (see Fig. 16 showing the clip and transducer connected at the distal end of scope 111).
Steinberg does not explicitly disclose a transducer lens comprising a field of view and wherein when attached the field of view is centered along the elevator channel axis. Kodama teaches a transducer with a lens (12a) and aligning the transducer with the tool opening that is offset from the central axis (see Fig. 3 showing the tool 24 aligned with the ultrasound transducer; see Paragraph 0034). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steingberg’s device to include Kodama’s lens and alignment. Such a modification incorporates a lens, which is common for transducers as is known in the art, and aligning the transducer with the tool centrally locates the tool within the transducer’s field of view.
Regarding Claim 6, Steinberg as modified further discloses wherein the distal end of the duodenoscope comprises a front face, wherein the front face defines a front face plane, wherein the transducer lens is positioned substantially along the front face plane when the cavity holds the transducer body, and wherein positioning the transducer lens substantially along the front face plane enables the transducer lens to acoustically couple with patient tissue when the front face of the duodenoscope is placed proximate to the patient tissue (this is functional language as the scope is not part of the claim; see Steinberg Figs. 16 and 18 showing that the clip with the transducer can be places such that the lens is along the face of the scope and distal to the scope so that it can be placed proximate patient tissue).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Steinberg et al. (US 2019/0357883) and Kodama et al. (US 2009/0005689), as applied to claim 1 above, and further in view of Surti (US 2011/0152618).
Steinberg and Kodama disclose the invention substantially as claimed as stated above.
Regarding Claim 2, they do not explicitly disclose wherein the clip further comprises a protrusion configured to extend into the elevator channel to axially and rotationally position the clip with respect to the distal end of the duodenoscope. Surti teaches includes a protrusion (142) configured to extend into the channel of a working tool (see Figs. 8-9 and Paragraph 0058) for helping secure the attachment to the main device. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg and Kodama’s device to include Surti’s protrusion. Such a modification helps secure the attachment to the main device.
Claims 7-12, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Steinberg et al. (US 2019/0357883) and Kodama et al. (US 2009/0005689), as applied to claims 1 and 6 above, and further in view of Tanaka et al. (US 6,461,304).
Steinberg and Kodama disclose the invention substantially as claimed as stated above.
Regarding Claim 7, Steinberg further discloses a spine (150) and wherein the spine extends along the transducer body and is configured to position the transducer body such that the transducer lens is positioned substantially along the front face plane when the cavity holds the transducer body (see Figs. 16 and 18), but does not explicitly disclose wherein the transducer body comprises an elastomeric material, and wherein the ultrasonic attachment assembly further comprises: a spine comprising a rigid plastic material.
Tanaka teaches using an elastic rubber material for an attachment device (see Col 13 Lines 20-22). The Examiner notes that Applicant’s disclosure does not require the spine material to be different from the elastomeric materials used for the transducer body (see Paragraph 0055 of the PGPub). Steinberg’s spine is shown as being sufficiently rigid to enter the body and maintain its shape while having some flexibility to allow for deflection. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg’s material to be elastomeric as taught by Tanaka. Such a modification allows the device to maintain its rigidity while traversing through the body and have some flexibility to deflect when desired.
Regarding Claim 8, Steinberg as modified further discloses wherein the clip comprises the rigid plastic material, and wherein the spine and the clip are formed as a single piece (see Steinberg Fig. 18 showing that the clip and spine are a single piece; see discussion above regarding the material selection). The Examiner asserts that plastic can be made with rigidity and flexibility, and plastic is commonly used in biomedical applications because of its cost and biocompatibility. The rubber material can be plastic as is known in the art. Such plastics are made with a balance between hardness and elasticity so that they have the structural integrity necessary for traversing the body while having some flexibility to allow for deflection. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg and Kodama’s device to include Tanaka’s material. Using plastic is known in the art for providing stability, and plastic is widely used in the medical field because of its cost and biocompatibility.
Regarding Claim 9, they do not explicitly disclose wherein the transducer body comprises a rigid plastic material, and wherein the transducer body is configured to position the transducer lens substantially along the front face plane when the cavity holds the transducer body. Tanaka teaches making the transducer body from rubber (Col 13 Lines 18-22). The rubber material can be plastic as is known in the art. Such plastics are made with a balance between hardness and elasticity so that they have the structural integrity necessary for traversing the body while having some flexibility to allow for deflection. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg and Kodama’s device to include Tanaka’s material. Using plastic is known in the art for providing stability, and plastic is widely used in the medical field because of its cost and biocompatibility.
Regarding Claim 10, Steinberg as modified further discloses wherein the clip comprises the rigid plastic material, and wherein the transducer body and the clip are formed as a single piece (as seen in Fig. 17 the clip 124 and the transducer 122 are part of a single piece 120).
Regarding Claim 11, Steinberg as modified further discloses wherein the clip comprises a hinge configured to removably secure the clip to the distal end of the duodenoscope, and wherein the hinge comprises at least one of: a living hinge; or a knuckle and a pin (see Figs. 16 and 18 showing the clip attached to a scope using the wings of the clip; these wings are living-hinges as is known in the art for securing around the scope).
Regarding Claim 12, Steinberg discloses:
An ultrasonic attachment assembly, comprising:
an ultrasonic transducer (122) comprising:
a transducer body (body of the unit as shown in Fig. 17); and
a means (124) configured to be positioned on a distal end of a duodenoscope by removably sliding the sleeve over the distal end of the duodenoscope, wherein the duodenoscope comprises an elevator channel, wherein the distal end of the duodenoscope defines a central axis, wherein the elevator channel defines an elevator channel axis that is offset from the central axis (the duodenoscope is not part of the claim; Steinberg’s means 124 is attached to a scope as shown in Fig. 16), wherein the means is configured to hold the transducer body when the means is positioned on the distal end of the duodenoscope such that the transducer lens is positioned distally with respect to the distal end of the duodenoscope (see Fig. 16 showing the clip and transducer connected at the distal end of scope 111) and such that that the field of view is centered along the elevator channel axis.
Steinberg does not explicitly disclose a transducer lens comprising a field of view, a sleeve and wherein when attached the field of view is centered along the elevator channel axis. Kodama teaches a transducer with a lens (12a) and aligning the transducer with the tool opening that is offset from the central axis (see Fig. 3 showing the tool 24 aligned with the ultrasound transducer; see Paragraph 0034). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg’s device to include Kodama’s lens and alignment. Such a modification incorporates a lens, which is common for transducers as is known in the art, and aligning the transducer with the tool centrally locates the tool within the transducer’s field of view.
Tanaka teaches various means for attaching an ultrasonic device to an endoscope. These include a sleeve (125 or 425) in addition to a clip assembly (25) such that the different means are considered obvious variants. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg’s device to use Tanaka’s sleeve instead of a clip. Such a modification is the simple substitution of one known element for another to yield predictable results.
Regarding Claim 14, Steinberg as modified further discloses wherein the distal end of the duodenoscope comprises a front face, wherein the front face defines a front face plane, wherein the transducer lens is positioned substantially along the front face plane when the sleeve holds the transducer body, and wherein positioning the transducer lens substantially along the front face plane enables the transducer lens to acoustically couple with patient tissue when the front face of the duodenoscope is placed proximate to the patient tissue (this is functional language as the scope is not part of the claim; see Steinberg Figs. 16 and 18 showing that the clip with the transducer can be places such that the lens is along the face of the scope and distal to the scope so that it can be placed proximate patient tissue).
Regarding Claim 15, Steinberg as modified further discloses wherein the transducer body comprises an elastomeric material (see Steinberg Fig. 18 showing how the body, clip, and neck are all the same material, and how the neck flexes (dotted line) such that this material is considered elastomeric), and wherein the ultrasonic attachment assembly further comprises: a spine (150) extending along the transducer body and configured to position the transducer body such that the transducer lens is positioned substantially along the front face plane when the sleeve holds the transducer body (holding the lens along the front face plane as shown in Fig. 18).
Regarding Claim 16, Steinberg does not explicitly disclose wherein the spine comprises a rubber material; however, Tanaka teaches making similar components from rubber (see Col 13 Lines 20-22). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg’s material to be rubber as taught by Tanaka. Such a modification incorporates a well-known material, rubber, to allow for flexibility of the device as is known in the art.
Regarding Claim 17, Steinberg does not explicitly disclose wherein the spine comprises a rigid plastic material. Tanaka teaches using an elastic rubber material for an attachment device (see Col 13 Lines 20-22). The Examiner notes that Applicant’s disclosure does not require the spine material to be different from the elastomeric materials used for the transducer body (see Paragraph 0055 of the PGPub). Steinberg’s spine is shown as being sufficiently rigid to enter the body and maintain its shape while having some flexibility to allow for deflection. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg’s material to be elastomeric as taught by Tanaka. Such a modification allows the device to maintain its rigidity while traversing through the body and have some flexibility to deflect when desired. The Examiner asserts that plastic can be made hard and elastomeric, and is commonly used in biomedical applications because of its cost and biocompatibility. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg and Kodama’s device to use a plastic material instead of rubber. Using plastic is known in the art for providing stability, and plastic is widely used in the medical field because of its cost and biocompatibility.
Regarding Claims 18-19, Steinberg as modified further discloses wherein the sleeve comprises a first elastomeric material, and wherein the transducer body comprises a second elastomeric material (Tanaka discloses making the portions of 400 other than 423 from rubber, as shown in Fig. 12); and wherein the first elastomeric mater and the second elastomeric material are the same, and wherein the sleeve and the transducer body are formed as a single piece (Tanaka and Steinberg show the transducer body and the sleeve being made from the same material, see Tanaka Fig. 12 and Steinberg Fig. 18).
Regarding Claim 20, Steinberg does not explicitly disclose wherein the transducer body comprises a rigid plastic material. Tanaka teaches making the transducer body from rubber (Col 13 Lines 18-22). The rubber material can be plastic as is known in the art. Such plastics are made with a balance between hardness and elasticity so that they have the structural integrity necessary for traversing the body while having some flexibility to allow for deflection. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg and Kodama’s device to use a plastic material. Using plastic is known in the art for providing stability, and plastic is widely used in the medical field because of its cost and biocompatibility.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Steinberg et al. (US 2019/0357883), Kodama et al. (US 2009/0005689), and Tanaka et al. (US 6,461,304), as applied to claim 12 above, and further in view of Surti (US 2011/0152618).
Steinberg, Kodama, and Tanaka disclose the invention substantially as claimed as stated above.
Regarding Claim 13, they do not explicitly disclose wherein the clip further comprises a protrusion configured to extend into the elevator channel to axially and rotationally position the clip with respect to the distal end of the duodenoscope. Surti teaches includes a protrusion (142) configured to extend into the channel of a working tool (see Figs. 8-9 and Paragraph 0058) for helping secure the attachment to the main device. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Steinberg, Kodama, and Tanaka’s device to include Surti’s protrusion. Such a modification helps secure the attachment to the main device.
Allowable Subject Matter
Claims 3-5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 3 requires a sleeve with a tab as claimed and the clip being configured to engage the sleeve and tab as claimed. While Tanaka teaches using a clip or a sleeve, there is no teaching to use both, in particular using both with a tab configuration as claimed. There being no benefit to this configuration, the Examiner considers it to be impermissible hindsight to consider such a modification obvious. Claims 4-5 depend from claim 3.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795