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 .
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 5-7, and 10-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the opposing fingers coupled to the probe holder must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “36” in Fig. 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “35” has been used to designate both the friction (elastomeric) material in Fig. 3 and the screw in Fig. 1. Additionally reference character “36” has been used to designate both the ramp in Fig. 3 and it is also used as a designation in a prior art device shown in Fig. 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "32" and "44" have both been used to designate the pinch trigger. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 16, and 17 are objected to because of the following informalities:
Lines 8-9 of claim 1 recite “wherein squeezing the pinch trigger spreads the opposing fingers to release the ring of elastomeric material and allow repositioning”. However this should be read as “wherein squeezing the pinch trigger spreads the opposing fingers to release the ring of elastomeric material and allows repositioning”. Appropriate correction is required.
Claim 16 recites “a separation distance between the probe and a patient's head”. However this should be read as “a separation distance between the probe and the patient's head”. Appropriate correction is required.
Claim 17 recites “a coupling component inserted between the probe and the head of a patient”. However this should be read as “a coupling component inserted between the probe and the patient's head”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5-7, and 10-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, claim 1 recites “opposing fingers coupled to the probe holder, and a ramp mechanism actuated by a pinch trigger, wherein squeezing the pinch trigger spreads the opposing fingers to release the ring of elastomeric material”. It’s unclear if the opposing fingers are being spread from each other or being spread from the elastomeric material. The amended specification discloses in [0019] “Pinch trigger 32 is squeezed to release probe holder 28 from a clutch mechanism comprising clutch pressure plate 33, clutch brake 34, friction (elastomeric) material 35, ramp 36, and back stop 37. The clutch pressure plate 33 allows opposing fingers, coupled to the probe holder 28, to engage with the friction (elastomeric) material 35. The ramp mechanism 36 is coupled to the pinch trigger 32 to separate the opposing fingers from the elastomeric material 35 when squeezed”. In light of the specification the it is unclear how the pinch trigger is spreading the opposing fingers of the probe holder. For examination purposes in light of the specification the limitation will be interpreted as “opposing fingers coupled to the probe holder, and a ramp mechanism actuated by a pinch trigger, wherein squeezing the pinch trigger separates the opposing fingers from the elastomeric material”. Dependent claims are also rejected due to their dependency.
Regarding claim 2, claim 2 recites “wherein the probe attaches to a fixed ring”. It is unclear if this is the same fixed ring defined in claim 1 or a different fixed ring. For examination purposes the claim will be interpreted as “wherein the probe attaches to the fixed ring”.
Regarding claim 5, claim 5 recites “wherein the brake assembly employs”. A brake assembly has not been previously defined therefore it is unclear if the brake assembly is the compressible brake defined in claim 1 or a different brake assembly. For examination purposes the claim will be interpreted as “wherein the compressible brake employs”. Claim 6 is also rejected due to its dependency.
Regarding claim 11, claim 11 recites “wherein releasing a pinch trigger enables”. It is unclear if this is the pinch trigger defined in claim 1 or a different pinch trigger. For examination purposes the claim will be interpreted as “wherein releasing a pinch trigger enables”. Claim 12 is also rejected due to its dependency.
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 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.
Claims 1, 3, 10-12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1) and further in view of Zhang (US 20110251489), Baumann (US 20230063412), and Schafer (US 20210361975).
Regarding claim 1, Seip discloses a cranial probe assembly (Abstract – “A head frame is configured for the head of a medical patient. It includes support for an ultrasound probe (102) for imaging and/or therapy”) comprising:
an ultrasound transducer packaged in a probe (pg. 6 lines 17-18 – “the ultrasound transducer of the probe 102”); and
a probe holder positioned on a patient's head (Abstract – “a probe holder (108)”, pg. 4 lines 6-8 – “keep the probe 102 held by the probe holder 108 in place against a temporal bone window 120 of the head 102”, Fig. 1), wherein the position of the probe relative to the position of the patient's head can be adjusted with five degrees of freedom (pg. 5 lines 32-33 – “allowing smooth probe angulation and rotation by the user”, pg. 6 lines 15-16 – “full horizontal and vertical (X-Y) positioning flexibility is afforded”, pg. 10 line 34 – “allow for Z positioning”, pg. 10 lines 2-3 – “The probe 102 can be manipulated with one hand in all degrees of freedom in order to find its required position on the patient's temporal bone”);
a clutch mechanism […] allow repositioning of the probe holder in x and y degrees of freedom along a fixed ring (Figs. 2 and 3, pg. 3 lines 30-32 – “X-Y positioning probe holder 108…The probe holder 108 has, at one end, a circular or round opening or orifice 112 for the probe 102”, Pg. 6 lines 14-16 – “because of the slot 114 in the probe holder 108, and the single axis attachment of the probe holder to the headpiece 106, full horizontal and vertical (X-Y) positioning flexibility is afforded”); and
an angular adjustment mechanism including a ball joint (pg. 5 lines 30-31 – “The spherical mating of the adaptor 144 to the probe holder 108 allows the probe 102 to be rotated into a targeted, or optimal, orientation”), the ball joint including a compressible brake […] to resist angular adjustment in the θ and φ degrees of freedom (pg. 5 line 33 – pg. 6 line 1 – “As a desired probe orientation is obtained, the knob 118 is tightened, pressing the regions surrounding the clam-shell sections 146 against them, firmly locking the probe 102 in place”, by locking the orientation by pressing the regions surrounding the clam-shell sections 146 against them a compressible brake is formed that would resist all angular adjustment).
Conversely Seip does not teach a clutch mechanism including a ring of elastomeric material, opposing fingers coupled to the probe holder, and a ramp mechanism actuated by a pinch trigger, wherein squeezing the pinch trigger spreads the opposing fingers to release the ring of elastomeric material and allow repositioning of the probe holder in x and y degrees of freedom […]; and
[…] the ball joint including a compressible brake compressed by a spring […].
However Zhang discloses a clutch mechanism including a ring of […] material, […], and a ramp mechanism actuated by a pinch trigger, wherein squeezing the pinch trigger […] release the ring of […] material and allow repositioning of the probe holder in x and y degrees of freedom ([0052] – “The interior dimension(s) of probe mounts 62A, 62B are preferably adjustable using clamping mechanisms 68A, 68B. In one embodiment, squeezing the projections of clamping mechanisms 68A, 68B toward one another enlarges the interior dimension(s) of the probe mount(s)… Releasing the adjustment mechanisms clamps and stably holds the probe interface component and probe housing within housing 62A, 62B”, one with ordinary skill in the art would recognize that by enlarging the interior dimensions of the probe mount repositioning of the probe holder in x and y degrees of freedom would be allowed, the ramp mechanism is shown below in Fig. 6C) […]; and
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The disclosure of Zhang is an analogous art considering it is in the field of a probe holding mechanism to be used on the head of a patient.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the pinch trigger of Zhang to achieve the same results. One would have motivation to combine because it would allow for easy adjustment and removal of the probe.
Conversely Seip and Zhang do not teach […] a ring of elastomeric material, opposing fingers coupled to the probe holder, […] spreads the opposing fingers to release the ring of elastomeric material […]; and
[…] the ball joint including a compressible brake compressed by a spring […].
However Baumann discloses […] a ring of elastomeric material, opposing fingers coupled to the probe holder, […] spreads the opposing fingers to release the ring of elastomeric material […]; and (Abstract – “a ring-like fastening region for fastening the attachment to the ultrasound probe”, [0078] – “The attachment 10 is manufactured integrally from silicone”, [0015] – “Various fastening means can be used within the scope of the invention, e.g… geometries for creating a bayonet connection”, Abstract – “A replaceable attachment”, one with ordinary skill in the art would recognize that one way to separate the probe from the bayonet connection of the elastomeric material of the attachment 10 would be to spread elastomeric material from the fingers of the bayonet connection).
The disclosure of Baumann is an analogous art considering it is in the field of a probe holder.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the ring with a fastening attachment that requires fingers coupled to the probe of Baumann to achieve the same results. One would have motivation to combine because it would provide a more secure attachment.
Conversely Seip, Zhang, and Baumann do not teach […] the ball joint including a compressible brake compressed by a spring […].
However Schafer discloses […] the ball joint including a compressible brake compressed by a spring ([0032] – “thereby hold the transducer in the desired position. In some embodiments, the locking elements of the transducer may be spring-loaded”, based on the shape of the transducer shown in Figs. 5 and 6 the rotational joint can be interpreted to be a ball joint) […].
The disclosure of Schafer is an analogous art considering it is in the field of an ultrasound transducer holder placed on the head.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the orientation adjustment with a compressible brake of Schafer to achieve the same results. One would have motivation to combine because it allows “the transducer holder 100 to hold the transducer 300 to the transducer holder 100 at a desired angle” (Schafer [0063]).
Regarding claim 3, Seip, Zhang, Baumann, and Schafer discloses all the elements of the claimed invention as cited in claim 1.
Seip further discloses wherein the five degrees of freedom comprise cartesian coordinates x and y, axis z normal to the probe, and two orientation angles orthogonal to axis-z (pg. 5 lines 32-33 – “allowing smooth probe angulation and rotation by the user”, pg. 6 lines 15-16 – “full horizontal and vertical (X-Y) positioning flexibility is afforded”, pg. 10 line 34 – “allow for Z positioning”, pg. 10 lines 2-3 – “The probe 102 can be manipulated with one hand in all degrees of freedom in order to find its required position on the patient's temporal bone”).
Regarding claim 10, Seip, Zhang, Baumann, and Schafer disclose all the elements of the claimed invention as cited in claims 1 and 3.
Conversely Seip does not teach wherein each of the two orientation angles has an adjustment range of 10 degrees.
However Schafer discloses wherein each of the two orientation angles has an adjustment range of 10 degrees ([0063] – “the first angle may be 0 degrees, the second angle may be 2.5 degrees, and/or the third angle may be 5 degrees”, 5 degrees to the left of the z axis and 5 degrees to the right of the z axis would be a total of 10 degrees, the Schafer reference does not limit the orientation adjustment to a certain axis therefore it can be interpreted each of the two orientation angles has an adjustment range of approximately 10 degrees).
The disclosure of Schafer is an analogous art considering it is in the field of an ultrasound transducer holder placed on the head.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the orientation adjustment range of Schafer to achieve the same results. One would have motivation to combine because an angle too large may cause distortions due to the skull.
Regarding claim 11, Seip, Zhang, Baumann, and Schafer disclose all the elements of the claimed invention as cited in claim 1.
Conversely Seip does not teach wherein releasing a pinch trigger enables a compressible braking action.
However Zhang discloses wherein releasing a pinch trigger enables a compressible braking action (Figs. 6C and 6D, [0052] – “Releasing the adjustment mechanisms clamps and stably holds the probe interface component and probe housing within housing”, therefore providing compressible braking).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the clamps of Zhang to achieve the same results. One would have motivation to combine because it would allow for easy adjustment and removal of the probe.
Regarding claim 12, Seip, Zhang, Baumann, and Schafer disclose all the elements of the claimed invention as cited in claims 1 and 11.
Conversely Seip does not teach wherein the compressible braking action comprises engagement of compressible material with a spherical surface of a housing, wherein the compressible material is backed by a spring.
However Zhang discloses wherein the compressible braking action comprises engagement of compressible material with a spherical surface of a housing ([0052] – “Releasing the adjustment mechanisms clamps and stably holds the probe interface component and probe housing within housing 62A, 62B, with the acoustically emissive probe face positioned for carrying out an ultrasound protocol”, [0033] – “The frame member may be constructed from a variety of resilient materials…polymeric materials”, it is interpreted the adjustment mechanism clamps of the probe housing 62A are part of the frame member and therefore made of a compressible material such as a polymeric material, [0016] – “the probe mount has at least one curved, at least partially spherical surface adapted to contact a curved surface of a probe housing”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the braking action of Zhang to achieve the same results. One would have motivation to combine because it would allow for easy adjustment and removal of the probe while also provide secure attachment of the probe to stably hold the probe in the correct position.
Conversely Seip and Zhang do not teach wherein the compressible material is backed by a spring.
However Schafer discloses wherein the compressible material is backed by a spring ([0060] – “The locking elements 422 a-b may be spring-loaded”, therefore when combined with the locking mechanism of Zhang the compressible material of Zhang would be backed by a spring).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the spring backed lock of Schafer to achieve the same results. One would have motivation to combine because “they move from the retracted position to the extended position when the pressure on the respective actuators 424 a-b is released” (Schafer [0060]).
Regarding claim 17, Seip, Zhang, Baumann, and Schafer discloses all the elements of the claimed invention as cited in claim 1.
Seip discloses further comprising a coupling component inserted between the probe and the head of a patient, wherein the coupling component comprises a […] gel (pg. 9 lines 14-15 – “ultrasound coupling gel can be re-applied, or an ultrasound coupling pad can be replaced”).
Seip does not explicitly disclose that the gel is semi-solid however one with ordinary art would find it obvious to use a semi-solid gel pad. A semi-solid gel pad would be solid enough to be considered a pad and because it is made of a coupling gel it is not completely solid and flexible enough to conform to the shape of the head.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1), Zhang (US 20110251489), Baumann (US 20230063412), and Schafer (US 20210361975) as applied to claim 1 above, and further in view of Andrews (US 20150265216).
Regarding claim 2, Seip, Zhang, Baumann, and Schafer disclose all the elements of the claimed invention as cited in claim 1.
As cited above Seip discloses a probe and a probe holder conversely Seip does not teach wherein the […holder] attaches to a fixed ring using a plurality of symmetrically located feet, and wherein the attachment comprises a lock and an unlock position.
However Andrews discloses wherein the […holder] attaches to a fixed ring using a plurality of symmetrically located feet, and wherein the attachment comprises a lock and an unlock position (Figs. 5A-5E, [0091] – “The removable guide stem 506, in some examples, may lock to the low profile skull anchoring device 504 using a screw mechanism, keyed locking mechanism, or other connector configured to firmly connect the removable guide stem 502 to the low profile skull anchoring device 504 with relative ease of removal”, [0092] – “The removable guide stem 506, for example, may include a series of guide stem connectors 514 (e.g., screws or locking pins) which mate with the connection points 512 of the low profile skull anchoring device 504”).
The disclosure of Andrews is an analogous art considering it is in the field of attaching a device to the skull.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the fixed ring of Andrews to achieve the same results. One would have motivation to combine because it provides a fixed position for the probe holder while allowing the probe holder to be removed.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1), Zhang (US 20110251489), Baumann (US 20230063412), and Schafer (US 20210361975) as applied to claim 1 above, and further in view of Yanping (CN 114699102A).
Regarding claim 5, Seip, Zhang, Baumann, and Schafer disclose all the elements of the claimed invention as cited in claims 1.
Conversely Seip does not teach wherein the brake assembly employs pads comprising a compressible material.
However Yanping discloses wherein the brake assembly employs pads comprising a compressible material (Figs. 6 and 7, [n0056] – “The anti-slip stripes 29 increase the coefficient of friction between the rubber pad 28 and the probe, thus preventing the probe from sliding relative to the rubber pad 28”).
The disclosure of Yanping is an analogous art considering it is in the field of an ultrasound probe holder.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the rubber pads of Yanping to achieve the same results. One would have motivation to combine because “the rubber pads protect the probe” (Yanping [n0015]).
Regarding claim 6, Seip, Zhang, Baumann, Schafer and Yanping disclose all the elements of the claimed invention as cited in claims 1 and 5.
Conversely Seip does not teach wherein the compressible material comprises silicone rubber.
However Yanping discloses wherein the compressible material comprises silicone rubber (Figs. 6 and 7, [n0056] – “The anti-slip stripes 29 increase the coefficient of friction between the rubber pad 28 and the probe, thus preventing the probe from sliding relative to the rubber pad 28”, one with ordinary skill in the art would find it obvious to use any rubber that is commonly used in medical applications such as silicone rubber because of its flexibility, resistance to fluids, and resistance to high temperatures).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the rubber pads of Yanping to achieve the same results. One would have motivation to combine because “the rubber pads protect the probe” (Yanping [n0015]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1), Zhang (US 20110251489), Baumann (US 20230063412), and Schafer (US 20210361975) as applied to claim 3 above, and further in view of Wurster (US 20170182339).
Regarding claim 7, Seip, Zhang, Baumann, and Schafer disclose all the elements of the claimed invention as cited in claims 1 and 3.
Conversely Seip does not teach wherein adjustment of x and y comprises a translation of up to 10 millimeters in at least one of the x and y directions.
However Wurster discloses wherein adjustment of x and y comprises a translation of up to 10 millimeters in at least one of the x and y directions (Fig. 2, [0069] – “TNS 100 is adjusted to nominal x and y positions by setting side adjustment knobs 122 each to 6 mm”, Although the allowable translation is less the 10mm it is close to 10mm therefore a prima facie case of obviousness exists, MPEP 2144.05 recites “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”, additionally one with ordinary skill in the art would recognize a larger diameter of the inner housing would provide a larger area for translation of the probe).
The disclosure of Wurster is an analogous art considering it is in the field of an ultrasound probe holder placed on the head.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the translation limit of Wurster to achieve the same results. One would have motivation to combine “so a focal point of ultrasonic energy is directed precisely over a target area inside of the brain of the patient” (Wurster [0029]).
Claims 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1), Zhang (US 20110251489), Baumann (US 20230063412), and Schafer (US 20210361975) as applied to claim 3 above, and further in view of Yuanyuan (CN113729780A).
Regarding claim 13, Seip, Zhang, Baumann, and Schafer disclose all the elements of the claimed invention as cited in claims 1 and 3.
Conversely Seip does not teach wherein adjustment with respect to the z- axis comprises rotation of a screw located at the z-axis.
However Yuanyuan discloses wherein adjustment with respect to the z- axis comprises rotation of a screw located at the z-axis ([n0040] – “an installation rod 7 is fixed on the upper part of the ultrasonic probe 1, and an installation hole 61 is provided on the mounting block 6 for insertion into the installation rod 7. The mounting block 6 is equipped with a positioning component for axial positioning of the mounting rod 7.” as seen in Figs. 3-5 the mounting rod is threaded, when combined with Seip the mounting rod would be located at the z-axis for adjustment with respect to the z- axis).
The disclosure of Yuanyuan is an analogous art considering it is in the field of positioning an ultrasound probe.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the screw of Yuanyuan to achieve the same results. One would have motivation to combine because it would allow for precise positioning in the z-axis with user control.
Regarding claim 14, Seip, Zhang, Baumann, Schafer and Yuanyuan disclose all the elements of the claimed invention as cited in claims 1, 3, and 13.
Conversely Seip does not teach wherein the screw is rotatable using an operator's fingers.
However Yuanyuan discloses wherein the screw is rotatable using an operator's fingers (Figs. 3-5, [n0040] – “an installation rod 7 is fixed on the upper part of the ultrasonic probe 1, and an installation hole 61 is provided on the mounting block 6 for insertion into the installation rod 7. The mounting block 6 is equipped with a positioning component for axial positioning of the mounting rod 7.”, [n0041] – “When performing the test on the patient, the staff holds the control lever with their hands, which allows for convenient and flexible adjustment of the height of the ultrasound probe 1 during the test”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the screw of Yuanyuan to achieve the same results. One would have motivation to combine because it would allow for precise positioning in the z-axis with user control.
Regarding claim 16, Seip, Zhang, Baumann, Schafer and Yuanyuan disclose all the elements of the claimed invention as cited in claims 1, 3, and 13.
Seip discloses adjustment in the z-axis is an adjustment of the separation distance between the probe and a patient's head (pg. 6 lines 9-10 – “which would hold the ultrasound probe 102 either further in (-Z) or further out (+Z)”).
Conversely Seip does not teach wherein the separation distance between the probe and a patient's head can be adjusted using the screw.
However the combination of Seip and Yuanyuan teaches wherein the separation distance between the probe and a patient's head can be adjusted using the screw (Figs. 3-5, [n0040] – “an installation rod 7 is fixed on the upper part of the ultrasonic probe 1, and an installation hole 61 is provided on the mounting block 6 for insertion into the installation rod 7. The mounting block 6 is equipped with a positioning component for axial positioning of the mounting rod 7.” as seen in Figs. 3-5 the mounting rod is threaded, when combined with Seip the mounting rod would be located at the z-axis for adjustment with respect to the z- axis and would provide adjustment of the separation distance between the probe and a patient's head).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the screw of Yuanyuan to achieve the same results. One would have motivation to combine because it would allow for precise positioning in the z-axis with user control.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1), Zhang (US 20110251489), Baumann (US 20230063412), Schafer (US 20210361975), and Yuanyuan (CN113729780A) as applied to claim 13 above, and further in view of Montanaro (US 20250065003).
Regarding claim 15, Seip, Zhang, Baumann, Schafer, and Yuanyuan discloses all the elements of the claimed invention as cited in claims 1, 3, and 13.
Conversely Seip does not teach wherein the screw comprises nylon.
However Montanaro discloses wherein the screw comprises nylon ([0077] – “The device may be formed from any suitable material(s)…Exemplary materials include nylon”, the device is a probe holder therefore it would be obvious for a component such as the screw to comprise nylon).
The disclosure of Montanaro is an analogous art considering it is in the field of a ultrasound probe holder.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the nylon material of Montanaro to achieve the same results. One would have motivation to combine because it is “resilient against a utilized disinfectant and/or those materials that can facilitate the delivery of the disinfectant to mated surfaces” (Montanaro [0020]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1), Zhang (US 20110251489), Baumann (US 20230063412), and Schafer (US 20210361975) as applied to claim 17 above, and further in view of Garrec (US 20230073081).
Regarding claim 18, Seip, Zhang, Baumann, and Schafer discloses all the elements of the claimed invention as cited in claims 1 and 17.
As cited above it would be obvious to use a semi-solid gel in view of the teachings of Seip. Conversely Seip does not teach wherein the coupling component comprises a […] gel layer and at least one adhesive tape layer.
However Garrec discloses wherein the coupling component comprises a […] gel layer and at least one adhesive tape layer ([0033] – “The means of coupling can include a film and/or gel pad, and optionally an adhesive for attaching the film and/or gel pad to the device.”).
The disclosure of Garrec is an analogous art considering it is in the field of using a gel pad as a coupling means for an ultrasound probe.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the adhesive layer of Garrec to achieve the same results. One would have motivation to combine “to reduce the sliding of the device and adaptable points of attachment” (Garrec [0119]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1), Zhang (US 20110251489), Baumann (US 20230063412), and Schafer (US 20210361975) as applied to claim 3 above, and further in view of Kim (US 20200000428).
Regarding claim 19, Seip, Zhang, Baumann, and Schafer discloses all the elements of the claimed invention as cited in claims 1 and 3.
Conversely Seip does not teach further comprising a fiducial assembly having a shaft that is inserted along the z axis of the probe.
However Kim discloses further comprising a fiducial assembly having a shaft that is inserted along the z axis of the probe ([0047] – “second marker 33 (see FIG. 2) fixed to the ultrasound transducer 30”, as seen in Figs. 2, 4A, 4B, 5A, and 5B the second marker is fixed along the z axis of the probe).
The disclosure of Kim is an analogous art considering it is in the field of transcranial ultrasound.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the fiducial assembly of Kim to achieve the same results. One would have motivation to combine because “an ultrasound transducer supported on the headgear may be moved to a specific position of a skull regardless of a position of the brain to which ultrasound needs to be transmitted, and thus the use convenience of a user may be improved” (Kim [0025]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1), Zhang (US 20110251489), Baumann (US 20230063412), Schafer (US 20210361975), and Kim (US 20200000428) as applied to claim 19 above, and further in view of Piferi (WO2015057807).
Regarding claim 20, Seip, Zhang, Baumann, Schafer, and Kim disclose all the elements of the claimed invention as cited in claims 1, 3, and 19.
Conversely Seip does not teach wherein the fiducial assembly further comprises an adapter that can be rotated 360° along each of two axes.
However Piferi discloses wherein the fiducial assembly further comprises an adapter that can be rotated 360° along each of two axes (Fig. 21A, adapter = reference frame bracket 1300, the reference frame bracket 1300 includes two starburst connectors 1302 which provide rotation along two different axes. Although the rotation appears to be less the 360 degrees it is close to 360 degrees there is a prima facie case of obviousness exists, MPEP 2144.05 recites “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”.
The disclosure of Piferi is an analogous art considering it is in the field of a device that can be fixed to the head.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe assembly of Seip to incorporate the adapter to provide rotation of the fiducial assembly along two axes of Piferi to achieve the same results. One would have motivation to combine because it “can allow for positional adjustment of the reference frame 1200 relative to the patient and/or base 110 of trajectory frame 100” (Piferi [00184]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.C.L./ Examiner, Art Unit 3797
/JOSEPH M SANTOS RODRIGUEZ/ Primary Examiner, Art Unit 3797
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