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 .
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 feet of claim 2, a ring of elastomeric material that acts as a brake of claim 4, opposing fingers that are coupled to the probe of claim 4, and a pair of clamps of claim 8 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)(4) because reference character “52” has been used to designate both “a spherical surface 52 inside the probe holder 28” in paragraph [0022] and a ball joint in paragraphs [0022] and [0023]. 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.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0018] recites “prior art patent Ultrasound treatment system and ultrasonic diagnostic system, JP200639504A” however this should be read as “prior art patent Ultrasound treatment system and ultrasonic diagnostic system, JP2006305047A”.
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 7-12 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 7, claim 7 recites “a translation of up to approximately 10 millimeters”. The term “approximately” in claim 7 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore it is unclear how approximate the amount of translation should be to 10 millimeters.
Regarding claim 8, claim 8 recites “wherein a ball joint is provided between the probe holder and the probe case”. However the probe case has not been defined therefore there is insufficient antecedent basis for this limitation in the claim. In light of the specification the probe case appears to be part of the probe therefore for examination purposes the claim will be interpreted as “wherein a ball joint is provided between the probe holder and the probe”. Claims 9, 11, and 12 are also rejected due to their dependency.
Regarding claims 8 and 12, claims 8 and 12 both recite “the housing” however the housing has not been previously defined. There is insufficient antecedent basis for this limitation in the claim. In light of the specification this limitation in claim 8 will be interpreted as “a housing to the probe holder” and this limitation in claim 12 will be interpreted as “the housing to the probe holder”. Dependent claims are also rejected due to their dependency.
Regarding claim 10, claim 10 recites “an adjustment range of approximately 10 degrees”. The term “approximately” in claim 10 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore it is unclear how approximate the adjustment range should be to 10 degrees.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seip (WO 2015075603A1).
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”).
Regarding claim 3, 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”).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1) as applied to claim 1 above, and further in view of Andrews (US 20150265216).
Regarding claim 2, Seip discloses 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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1) as applied to claim 3 above, and further in view of Zhang (US 20110251489) and Baumann (US 20230063412).
Regarding claim 4, Seip discloses all the elements of the claimed invention as cited in claims 1 and 3.
Conversely Seip does not teach wherein adjustment with respect to cartesian coordinates x and y is accomplished using a pinch trigger to release an assembly comprising a ring of elastomeric material that acts as a brake when engaged with opposing fingers that are coupled to the probe.
However Zhang discloses wherein adjustment with respect to cartesian coordinates x and y is accomplished using a pinch trigger to release an assembly comprising a ring of […] material that acts as a brake when engaged […] the probe ([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”).
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 so not teach a ring of elastomeric material that acts as a brake when engaged with opposing fingers that are coupled to the probe.
However Baumann discloses a ring of elastomeric material that acts as a brake when engaged with opposing fingers that are coupled to the probe (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”).
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.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1), Zhang (US 20110251489), and Baumann (US 20230063412) as applied to claim 4 above, and further in view of Yanping (CN 114699102A).
Regarding claim 5, Seip, Zhang, and Baumann disclose all the elements of the claimed invention as cited in claims 1, 3, and 4.
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, and Yanping disclose all the elements of the claimed invention as cited in claims 1, 3, 4, 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) as applied to claim 3 above, and further in view of Wurster (US 20170182339).
Regarding claim 7, Seip discloses 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 approximately 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 approximately 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 8, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1) as applied to claim 3 above, and further in view of Zhang (US 20110251489).
Regarding claim 8, Seip discloses all the elements of the claimed invention as cited in claims 1 and 3.
Seip further discloses wherein a ball joint is provided between the probe holder and the probe case (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”), wherein […unlocking] while rotating the probe holder within the housing enables angular adjustment (pg. 5 lines 31-33 – “Initially, the hand-turnable rotation/angulation knob 118 is in its open/loose position, allowing smooth probe angulation and rotation by the user”).
Conversely Seip does not teach pinching a pair of clamps while rotating the probe […] enables angular adjustment.
However Zhang discloses pinching a pair of clamps while rotating the probe […] enables angular adjustment (Figs. 6C and 6D, [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)”, therefore by enlarging the interior dimensions of the probe mount it would enable room for angular adjustment).
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 9, Seip and Zhang disclose all the elements of the claimed invention as cited in claims 1, 3, and 8.
Seip further discloses adjustment of the angular orientation is performed in response to rotation of the probe (pg. 5 lines 30-33 – “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. Initially, the hand-turnable rotation/angulation knob 118 is in its open/loose position, allowing smooth probe angulation and rotation by the user”).
Regarding claim 11, Seip and Zhang disclose all the elements of the claimed invention as cited in claims 1, 3, and 8.
Conversely Seip does not teach wherein releasing a pinch trigger enables a braking action.
However Zhang discloses wherein releasing a pinch trigger enables a braking action (Figs. 6C and 6D, [0052] – “Releasing the adjustment mechanisms clamps and stably holds the probe interface component and probe housing within 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 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.
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1) as applied to claim 3 above, and further in view of Schafer (US 20210361975).
Regarding claim 10, Seip discloses 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 approximately 10 degrees.
However Schafer discloses wherein each of the two orientation angles has an adjustment range of approximately 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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1) and Zhang (US 20110251489) as applied to claim 11 above, and further in view of and Schafer (US 20210361975).
Regarding claim 12, Seip and Zhang disclose all the elements of the claimed invention as cited in claims 1, 3, 8, and 11.
Conversely Seip does not teach wherein the braking action comprises engagement of compressible material with a spherical surface of the housing, wherein the compressible material is backed by a spring.
However Zhang discloses wherein the braking action comprises engagement of compressible material with a spherical surface of the 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]).
Claims 13, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1) as applied to claim 3 above, and further in view of Yuanyuan (CN113729780A).
Regarding claim 13, Seip discloses 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 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 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) and Yuanyuan (CN113729780A) as applied to claim 13 above, and further in view of Montanaro (US 20250065003).
Regarding claim 15, Seip 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 17 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1).
Regarding claim 17, Seip 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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Seip (WO 2015075603A1) as applied to claim 17 above, and further in view of Garrec (US 20230073081).
Regarding claim 18, Seip 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) as applied to claim 3 above, and further in view of Kim (US 20200000428).
Regarding claim 19, Seip 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) and Kim (US 20200000428) as applied to claim 19 above, and further in view of Piferi (WO2015057807).
Regarding claim 20, Seip 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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, Christopher Koharski can be reached at 571-272-7230. 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.
/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797