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
The following claims are objected to because of the following informalities and should recite:
Claim 1: “An ultrasonic surgical holder comprising an assembly portion,
wherein at least a part of the assembly portion is connected to at least one operating portion having an end extending in a direction, and an operating space is configured between the assembly portion and the at least one operating portion,
wherein the assembly portion is detachably assembled with an ultrasonic probe so that an irradiating end of the ultrasonic probe corresponds to the operating space and forms an irradiating plane extending along the direction,
wherein the at least one operating portion comprises at least one module that is detachably assembled with a surgical device and a module assembly structure for detachably assembling the [emphasis added] at least one module,
wherein, when the at least one module is assembled with the surgical device and disposed in the module assembly structure, an operating end of the surgical device is horizontally aligned with the irradiating plane, and is perpendicular to the direction.”
Appropriate indenting and spacing is needed for ease of reading. Appropriate correction is needed.
Claim 2: line 7, “an[[the] outer diameter.
Proper antecedent basis is needed.
Claim 8:
line 2, “-section”.
lines 4-5, “[[the]]a minimum diameter of the polygon cross-section of the projection is greater than or equal to [[the]]a maximum diameter of [[the]]a cross-section of the rotating shaft”.
Proper antecedent basis and consistent claim language is needed.
Claim 9: line 1, “polygon cross-section is a quadrilateral”.
Appropriate correction is needed.
Claim 10: line 2, “[[a]]the spring”.
Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 3-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3: recites:
lines 3-4, “the module assembly structure includes an assembly hole corresponding to the operating space and penetrating through the two operating portions.”,
The claims are rejected under 35 U.S.C. 112(a) for lack of written description. The specification does not provide adequate written description for a singular modular assembly structure to include a singular assembly hole correspond to the operating space and penetrating through two operating portions.
The specification states, at ¶0022 “an assembly hole 1221 corresponding to the operating space 13 and penetrating through the operating portion 12.”.
Because the specification uses the singular form of “the operating portion” and never explicitly describes a singular assembly hole penetrating through both or the two operating portions simultaneously, there is no written description in the specific limitation recited in claim 3 as identified above (i.e., penetrating through the two operating portions). Consequently, one of ordinary skill in the art would not deem the instant specification having sufficient detail so that they could understand how the inventor intended to achieve said aforementioned claimed feature. Since the instant specification fails to provide written description for the phrase above in claim 3 fails to meet the written description requirement under 35 U.S.C. 112(a).
The dependent claims of the above rejected claims are rejected due to their dependency.
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.
Claims 2-6, 8-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 2:
lines 1-2, “rod-like”. It is unclear what constitutes as “rod-like”. For examination purposes, the Examiner assumes a collar defined by an opening. Appropriate correction is required.
Claim 3:
lines 3-4, “the module assembly structure includes an assembly hole corresponding to the operating space and penetrating through the two operating portions.”, renders the claim indefinite. The phrase is physical contradictory and ambiguous and provides unclear linkage with respect to the two operating portions in light of omitted features. It is unclear if the assembly hole is penetrating through both operating portions or one operating portion. Based on the 35 USC § 112(a), the assembly hole penetrates through one operating portion (i.e. a singular operating portion) not two based on, See ¶0022 of the instant specification, “an assembly hole 1221 corresponding to the operating space 13 and penetrating through the operating portion 12.”. For examination purposes, the Examiner assumes the module assembly structure includes an assembly hole corresponding to the operating space and penetrating through the operating portion. Appropriate correction is required.
Claim 4:
line 2, “the module”. It is unclear if the term refers to or is separate from the at least one module or the module assembly structure. For examination purposes, the Examiner assumes the at least one module. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 5:
line 5, “a surgical needle”. The anteceding claims refer to the surgical device, as such it is unclear if the “surgical needle” refers to or is separate from the “surgical device” (i.e., an additional surgical instrument). For examination purposes, the Examiner assumes “a surgical needle” refers to the surgical device. Consistent claim language is required when referring to the same term. Appropriate correction is required.
Claim 6:
“the assembly hole”-line 3, & “the needle holding hole”-line 6. There is insufficient antecedent basis for these limitations in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes “an assembly hole” & “a needle holding hole” respectively. Accordingly, proper antecedent basis is required.
Claim 8:
lines 1-3, “a projection having a regular polygon cross section along a longitudinal direction at both ends of the assembly portion”, renders the claim indefinite. It is unclear if the projection or the polygon cross-section is at both ends along a longitudinal direction of the assembly portion. The claim is recited such that there is only a single projection with a polygon shape at its ends. The specification, similarly recites the same, ¶0029. For examination purposes, the Examiner assumes a projection with a polygon cross section at both ends. Clarity is needed.
line 6, “the connecting position”. There is not step provides to introduce a connecting position. There is insufficient antecedent basis for this limitation in the claim, as required by MPEP 2173.05(e). For examination purposes, the Examiner assumes the connection between the assembly portion to at least one operating portion as defined in line 2 of claim 1. Consistent claim language is required when referring to the same term. Accordingly, proper antecedent basis is required.
line 12-13: “the spring urges the projection”, renders the claim indefinite. It is unclear what a spring urging the projection to a position in the assembly recess means, in the context of the claim. Specifically, its unclear what provides the spring to “urge[s]” the projection to a position (i.e., mechanical force). For examination purposes, the Examiner assumes the spring pushes via an elastic recovery force the projection to a position in the assembly recess. Appropriate correction is required.
The dependent claims of the above rejected claims are rejected due to their dependency.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 & 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guju et al (US20230301627A1).
Claim 1: Guju discloses, An ultrasonic surgical holder (¶Abstract, FIG. 1) comprising an assembly portion (coupling body 110, FIG. 1 - ¶Abstract, ¶0033, ¶0036),
wherein at least a part of the assembly portion is connected to at least one operating portion (See FIG. 3 Highlighted Below) having an end extending in a direction (See FIG. 3 Highlighted Below),
PNG
media_image1.png
678
993
media_image1.png
Greyscale
and an operating space (The physical region defined by the scanning surface 192 of the ultrasound probe and the resulting scanning plane 196 where the ultrasonic beam is emitted, FIG. 1) is configured between the assembly portion and the at least one operating portion (The defined operating space is configured between the assembly portion and the at least one operating portion, FIG. 1. Specifically, this corresponds to the functional area defined between the coupling body and the holder support where the procedure takes place, ¶0035-0036),
wherein the assembly portion is detachably assembled with an ultrasonic probe (ultrasound probe 190, FIG. 1) so that an irradiating end (The end of scanning plane 196) of the ultrasonic probe corresponds to the operating space and forms an irradiating plane (scanning plane 196) extending along the direction (The irradiating end of the scanning plane 196 of the ultrasound probe 190 extends along the previously defined vertical direction, FIG. 1),
-The coupling body uses a resiliently biased latch to quickly couple to an decouple from the ultrasound probe 190, ¶0039.
wherein the at least one operating portion comprises at least one module (needle holder portion 150, FIG. 1) that is detachably assembled with a surgical device (needle) and a module assembly structure (holder support 140) for detachably assembling at least one module,
-The holder support’s 140 acts as the module assembly structure, ¶0041. The needle holder portion 150 (i.e., module) is designed to be removable coupled by disposing it within this holder support, ¶0044. This needle holder portion contains a needle opening designed to hold a needle (i.e., the surgical device of varying gauges, ¶0043. Thus, the module (i.e., the needle holder portion 150) is detachable assembled with the surgical device (i.e., the needle) by means of a specifically sized needle opening defined within the body of the module. The needle is detachable assembled simply by fitting into or being disposed within this opening.
wherein, when the at least one module is assembled with the surgical device and disposed in the module assembly structure, an operating end (needle tip of the needle, ¶0043) of the surgical device is horizontally aligned with the irradiating plane, and is perpendicular to the direction.
-Guju discloses that “The needle holder portion has a rotational axis and defines a needle opening having an opening central axis extending perpendicularly to the rotational axis.”, ¶Abstract, ¶0043. The device of Guju is configured so that when the coupling body is attached to the ultrasound probe, this opening central axis 166 and thus the path of the needle and its tip (i.e., the operating end) is disposed within the scanning plane (i.e., aligned with the irradiating plane) across all variable positions, ¶0045-“ For the device 100 shown in FIGS. 1-4 , the opening central axis 166 is disposed at a 0-degree angle relative to the scanning surface plane 194 in the first position, and the opening central axis 166 is disposed at a 90-degree angle relative to the scanning surface plane 194 in the second position.”. This ensures that the needle tip remains safely in the field of view of the ultrasound beam during the procedure. 0-degree angle relative to the scanning plane, means the needle is lying flat or parallel to the physical face of the ultrasound probe and thus horizontally aligned with the irradiating plane.
Claim 7: Guju discloses all the elements above in claim 1, Guju discloses, wherein the at least one operating portion is pivoted relative to the assembly portion and away from the irradiating plane (See FIG. 1 Highlighted Below).
PNG
media_image2.png
766
932
media_image2.png
Greyscale
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Guju et al (US20230301627A1).
Claim 2: Guju discloses all the elements above in claim 1, Guju discloses, wherein the assembly portion is rod-like (FIG. 3 & 4, coupling body 110 is a collar 112 defined by an opening 114) and includes
Guju discloses in an implementation (also note ¶0055 – embodiments are not mutually exclusive and can be combined):
a first assembly (first portion 454 - FIG. 8) and a second assembly (second portion 456 - FIG. 8), wherein a first recess (The groove of the needle opening 464 of first portion 454) is recessed in one side of the first assembly (FIG. 8), and a second recess (The groove of the needle opening 464 of the second portion 456) is recessed in one side of the second assembly (FIG. 8), wherein two ends of the first assembly are assembled with two ends of the second assembly respectively (FIG. 8), and the first recess is aligned with the second recess that a through hole (space of the needle opening 464, FIG. 8) extending in the direction is formed between the first recess and the second recess (FIG. 8, ¶0049), and a size of the through hole (the size of the space of needle opening 464 going through from one side to the other) corresponds to at least a part of the outer diameter of the ultrasonic probe (The needle opening does correspond to the ultrasound probe via a functional, geometric or system relationship because its orientation, alignment and function are dependent on the probe and thus at least a correspondence to at least a part of the outer diameter of the ultrasound probe).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the module of Guju in view of the implementation of device 400 of Guju because Guju established at ¶0055 any subset or combination of these components is are not mutually exclusive. The motivation to do this yield predictable results such as providing an alternative mechanisms for securing the needle to allow for a variable selection of needle insertion angles, as suggested by Guju, ¶0006.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Guju et al (US20230301627A1), as applied to claim 2, in further view of Sonek (US 4899756 A).
Claim 3: Modified Guju discloses all the elements above in claim 2, Guju discloses in an implementation (also note ¶0055 – embodiments are not mutually exclusive and can be combined),
wherein the at least one operating portion (See FIG. 3 Highlighted Below)
PNG
media_image3.png
678
993
media_image3.png
Greyscale
is implemented as two operating portions (the two identified operating portions in FIG. 10, See FIG. 10 Highlighted below) provided at two ends of the assembly portion (FIG. 10 both holder supports are at two ends of the assembly portion. See FIG. 10 Highlighted Below),
PNG
media_image4.png
862
996
media_image4.png
Greyscale
the module assembly structure includes the through hole corresponding to the operating space and penetrating through the operating portion (FIG. 1, 3, & 10).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the operating portion of modified Guju such that the operating portion is implemented as two operating portions provided at two ends of the assembly portion in view of the implementation of device 1000 of Guju because Guju established at ¶0055 any subset or combination of these components is are not mutually exclusive. The motivation to do this yield predictable results such as providing an alternative mechanisms for securing the needle to allow for a variable selection of needle insertion angles, as suggested by Guju, ¶0006.
Based on the 35 USC § 112(a) and 112(b), the phrase, “the module assembly structure includes an assembly hole corresponding to the operating space and penetrating through the two operating portions.”, is interpreted under the broadest reasonable interpretation in light of the specification, the module assembly structure includes an assembly hole corresponding to the operating space and penetrating through the operating portion.
However, Sonek in the context of articulated needle guidance for ultrasound imaging using a needle mount moveable in substantial alignment with the plane of the ultrasound beam, ¶Abstract, discloses, the module assembly structure (extending flange 28) includes an assembly hole (sterile, disposable, synthetic resin sleeve 29) corresponding to the operating space (FIG. 10, the element 29 is in the operating space) and penetrating through the operating portion (FIG. 1 operating portion (i.e., area) of the guide 19).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify module assembly structure of modified Guju to include such that it includes an assembly hole (i.e., a resin sleeve 29), as taught by Sonek. The motivation to do this yield predictable results such as to maintain the sterility of the biopsy needle as it is guided through the mount, as suggested by Sonek, [Col 2. l.48-56].
Claim 4: Guju as modified discloses all the elements above in claim 3, Guju discloses, wherein the at least one module (needle holder portion 150, FIG. 1) is proportional to an inner diameter of the through hole (FIG. 1, 3, & 8, the needle holder portion is proportional to an inner diameter of the through hole because there is a physical and geometrical proportionality with respect to each size), the module being (needle holder portion 150, FIG. 1) arranged along the direction to penetrate at least one holding hole (The needle holder portion 150 penetrates the gap or cavity defined by the space between the two arms 142, ¶0041, the two arms hold the needle holder portion 150.) parallel to the irradiating plane (The needle holder portion 150 is arrange along the direction to penetrate at least one holding hole parallel to the irradiating plane, FIG. 1) for holding a laser calibrator.
Regarding the limitations of claim 4 - “for holding a laser calibrator" directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the invention modified Guju is capable of performing the functions as set forth by applicant, see MPEP 2114
Guju fails to disclose the assembly hole
However, Sonek in the context of articulated needle guidance for ultrasound imaging using a needle mount moveable in substantial alignment with the plane of the ultrasound beam, ¶Abstract, discloses, the assembly hole (sterile, disposable, synthetic resin sleeve 29)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the through hole of modified Guju to include such that it includes an assembly hole (i.e., a resin sleeve 29), as taught by Sonek. The motivation to do this yield predictable results such as to maintain the sterility of the biopsy needle as it is guided through the mount, as suggested by Sonek, [Col 2. l.48-56]. The modified combination would still disclose the at least one module being proportional to an inner diameter of the assembly hole.
Claim 5: Guju as modified discloses all the elements above in claim 3, Guju discloses, wherein the at least one module (needle holder portion 150, FIG. 1) is proportional to an inner diameter of the through hole, (FIG. 1, 3, & 8, the needle holder portion is proportional to an inner diameter of the through hole because there is a physical and geometrical proportionality with respect to each size)
As established above: Guju discloses in an implementation (also note ¶0055 – embodiments are not mutually exclusive and can be combined), said implementation of Guju discloses the at least two operating portions, where the at least one module would comprise the needle holder portion 150 and needle holder portion 1500.
Accordingly, it would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the at least one module of modified Guji such that it includes needle portion 150 and needle portion 1500 provided at two ends of the assembly portion in view of the implementation of device 1000 of Guji because Guji established at ¶0055 any subset or combination of these components is are not mutually exclusive. The motivation to do this yield predictable results such as providing an alternative mechanisms for securing the needle to allow for a variable selection of needle insertion angles, as suggested by Guju, ¶0006.
Accordingly, such a modification would disclose,
a plurality of needle holding holes is arranged in the at least one module (needle portion 150 and needle portion 1500, FIG. 10) along the direction (the needle openings, FIG. 10, are arranged on the needle holder portion ), and
the plurality of needle holding holes is aligned with the irradiating plane (the needle openings, FIG. 10, are arranged on the needle holder portion, ¶0047, “in the implementation shown in FIG. 10 , the device 1000 is similar to device 100 shown in FIGS. 1-4 but includes a second holder support 1400 and a second needle holder portion 1500 that are spaced apart along the circumference of the collar 112 from the other holder support 140′ and needle holder portion 150′.”),
As established above: Guju discloses in an another implementation (also note ¶0055 – embodiments are not mutually exclusive and can be combined), accordingly, Guju disclose in the another implementation, the plurality of needle holding holes is applied for holding a needle holding member (protrusions 368 to provide support to a needle disposed within the needle openings, ¶0048) to guide a surgical needle (the needle).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the plurality of needle holding holes of modified Guju to include a needle holding member to guide the surgical device as taught by Guju because Guji established at ¶0055 any subset or combination of these components is are not mutually exclusive. The motivation to do this yield predictable results such as providing an alternative mechanisms for securing the needle to allow for a variable selection of needle insertion angles, as suggested by Guju, ¶0006.
Modified Guju fails to disclose the assembly hole
However, Sonek in the context of articulated needle guidance for ultrasound imaging using a needle mount moveable in substantial alignment with the plane of the ultrasound beam, ¶Abstract, discloses, the assembly hole (sterile, disposable, synthetic resin sleeve 29)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the through hole of modified Guju to include such that it includes an assembly hole (i.e., a resin sleeve 29), as taught by Sonek. The motivation to do this yield predictable results such as to maintain the sterility of the biopsy needle as it is guided through the mount, as suggested by Sonek, [Col 2. l.48-56]. The modified combination would still disclose the at least one module being proportional to an inner diameter of the assembly hole.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Guju et al (US20230301627A1), as applied to claim 1, in further view of Cermak et al (US20200060721A1).
Claim 6: Guju discloses all the elements above in claim 1, Guju fails to disclose,
wherein a first notch is recessed in a edge of the at least one operating portion, and extends toward the operating space, and the first notch is connected to the assembly hole, and
a second notch is recessed in the at least one module aligning to the first notch, and extends toward the operating space, when the at least one module is assembled with the at least one module assembly structure, the second notch is connected to the first notch and the needle holding hole.
However, Cermak in the context of needle guide system’s for use with ultrasound probes discloses, (FIGS. 18-24) wherein a first notch (slot 136) is recessed in a edge of the at least one operating portion (FIG. 18), and extends toward the operating space (the slot extends parallel to its central longitudinal axis from top to bottom extending toward the operating space, ¶0093, FIG. 18-24), and the first notch (slot 136) is connected to the assembly hole (interior of the tubular barrel member 132 designed so that the elongated insert (needle holder 134) can be disposed within it, ¶0094), and a second notch (slot 142) is recessed in the at least one module (needle holder 134) aligning to the first notch (¶0097, “At that time the slot 142 of the insert will be aligned with the slot 136 of the barrel member,”), and extends toward the operating space (the insertion allows a needle to be inserted laterally from the outside environment (i.e., the operating space), when the at least one module is assembled with the at least one module assembly structure (base member 126), the second notch is connected to the first notch and the needle holding hole (circular inner end of the slot 142, ¶0094). See FIG 18-24 demonstrating when the at least one module is assembly with the at least one module assembly structure, the second notch connected to the first notch and the needle holding hole)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the holder support of Guju such that it configured as the mountable member, ¶0017 of Cermak. The motivation to do this yield predictable results such as improving the securing and releasing of the needle guide onto the assembly, as suggested by Cermak, Claim 1, & ¶0017.
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the needle holder portion of modified Guju such that it configured as the needle guide device of Cermak that teaches wherein a first notch is recessed in a edge of the at least one operating portion, and extends toward the operating space, and the first notch is connected to the assembly hole, and a second notch is recessed in the at least one module aligning to the first notch, and extends toward the operating space, when the at least one module is assembled with the at least one module assembly structure, the second notch is connected to the first notch and the needle holding hole. The motivation to do this yield predictable results such as providing an improved needle guide that is disposable and can be securely mounted on a transducer with a cover and dismounted therefrom and without breaching or otherwise degrading the transducer's cover's integrity, with both of such actions being accomplished easily with minimal effort, as suggested by Cermak, ¶0006.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Guju et al (US20230301627A1), as applied to claim 7, in further view of Park et al (US 2007/0276253 A1) in view of Sonek (US 4,899,756).
Claim 8: Guju discloses all the elements above in claim 7, Guju fails to disclose: wherein the assembly portion has a projection having a regular polygon cross section along a longitudinal direction at both ends of the assembly portion, and an end face of the projection has a rotating shaft projected along the longitudinal direction, the minimum diameter of the cross-section of the projection is greater than or equal to the maximum diameter of the cross-section of the rotating shaft; an assembly recess corresponding to the projection is recessed at the connecting position of the at least one operating portion and the assembly portion, and a rotating shaft hole corresponding to the rotating shaft is pierced through the assembly recess, the rotating shaft is rotatably pierced in the rotating shaft hole; and a spring is a compression spring placed between the assembly portion and the at least one operating portion, wherein, when the assembly portion is assembled with the operating portion, the spring urges the projection to a position in the assembly recess; and when the spring is compressed, the projection is separated from the assembly recess so that the rotating shaft rotates relative to the rotating shaft hole, and the projection is angularly misaligned with the assembly recess.
However, Park in the context of needle guides for ultrasound guidance system’ discloses,
wherein the assembly portion (sheath 10 & shell 2, FIG. 1 & 4) has a projection (-The shape of extension 8) having a regular polygon cross section along a longitudinal direction at both ends of the assembly portion (FIG. 4), and
an end face of the projection has a rotating shaft (shaft 49) projected along the longitudinal direction (FIG. 10),
the minimum diameter of the cross-section of the projection is greater than or equal to the maximum diameter of the cross-section of the rotating shaft; (FIG. 10)
an assembly recess (-opening 8b) corresponding to the projection (FIG. 10) is recessed at the connecting position of the at least one operating portion and the assembly portion (FIG. 9-10), and a rotating shaft hole (opening for which the element 49 occupies, FIG. 10) corresponding to the rotating shaft (rotatable shaft 49) is pierced through the assembly recess, the rotating shaft is rotatably pierced in the rotating shaft hole (-The passage 8a of rotatable shaft 49 is equated to the rotating shaft hole, FIG. 10); and
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the assembly portion of Guju such that it has a regular polygon cross section along a longitudinal direction at both ends of the assembly portion, and an end face of the projection has a rotating shaft projected along the longitudinal direction, the minimum diameter of the cross-section of the projection is greater than or equal to the maximum diameter of the cross-section of the rotating shaft; an assembly recess corresponding to the projection is recessed at the connecting position of the at least one operating portion and the assembly portion, and a rotating shaft hole corresponding to the rotating shaft is pierced through the assembly recess, the rotating shaft is rotatably pierced in the rotating shaft hole as taught by Park. The motivation to do this yield predictable results such as improving sterility and sealing as suggested by Park, ¶0010.
Modified Guju fails to disclose:
a spring is a compression spring placed between the assembly portion and the at least one operating portion, wherein, when the assembly portion is assembled with the operating portion, the spring urges the projection to a position in the assembly recess; and
when the spring is compressed, the projection is separated from the assembly recess so that the rotating shaft rotates relative to the rotating shaft hole, and the projection is angularly misaligned with the assembly recess.
However, Sonek in the context of a articulating needle guide for ultrasound imaging, discloses:
a spring (spring 138) is a compression spring placed between the assembly portion and the at least one operating portion, wherein, (FIG. 3-5, Fig. 7)
when the assembly portion is assembled with the operating portion, the spring urges the projection to a position in the assembly recess; and ([Col. 3 l.34-41], ‘as indicated in FIG. 7, a pin 137A, B, C may be provided on the descending arm 123. An enlarged head 137A and a spring 138 may be provided to bias the shaft 137B in a direction which forces the enlarged shank or collar 137C into the keyhole slot 130 in the mounting block 124. Thus positioned, the collar 137C prevents the block 124 and link 123 from separating.’)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the assembly portion of modified Guju such that it includes a spring as taught by Sonek. The motivation to do this yields predictable results such as providing a secure connection, [Col. 3 l.34-41].
Regarding the limitations of claim 8 - “when the spring is compressed, the projection is separated from the assembly recess so that the rotating shaft rotates relative to the rotating shaft hole, and the projection is angularly misaligned with the assembly recess." directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the invention modified Guju is capable of performing the functions as set forth by applicant, see MPEP 2114
Claim 9: Guju as modified discloses all the elements above in claim 8, Guju fails to disclose: wherein the regular polygon cross section is a regular quadrilateral.
However, Park is relied upon above discloses, wherein the regular polygon cross section is a regular quadrilateral. (FIG. 4)
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the regular polygon cross section of modified Guju such that it a regular quadrilateral as taught by Park because it has been held that “The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.”. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) . see MPEP 2144.04 IV B - Changes in Shape. Further, the applicant places no criticality on the shape claimed. One of ordinary skill in the art would be able to obtain such a configuration through routine experimentation.
Claim 10: Guju as modified discloses all the elements above in claim 9, Guju fails to disclose: wherein an end of the rotating shaft is provided with a resting member,
However, Park discloses, wherein an end of the rotating shaft (rotating shaft 49) is provided with a resting member (ring 24),
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the assembly portion of modified Guju such that wherein an end of the rotating shaft is provided with a resting member as taught by Park. The motivation to do this yield predictable results such as improving sterility and sealing as suggested by Park, ¶0010.
Guju in view of Park fails to disclose: and a spring is sleeved at the end of the rotating shaft and placed between the at least one operating portion and the resting member.
However, Sonek is relied upon above discloses:: a spring is sleeved at the end of the rotating shaft (spring 138) and placed between the at least one operation portion and the resting member, (FIG. 3-5, & 7).
It would have been obvious to one of ordinary skilled in the art before the effective filing date of the claimed invention to modify the assembly portion of modified Guju such that it includes a spring at the end of the rotating shaft that is placed between an operation portion and a resting member as taught by Sonek. The motivation to do this yields predictable results such as providing a secure connection, [Col. 3 l.34-41]. The modified combination of modified Guju in view of Sonek would disclose the spring of Sonek is sleeved at the end of the rotating shaft of Guju and placed between the operating portion and the resting member of Guju.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Robinson whose telephone number is (571)272-9019. The examiner can normally be reached M-F 9:00AM-5:00PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.A.R./Examiner, Art Unit 3798
Prosecution Insights