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
Claims 1, 9, and 14 are objected to because of the following informalities:
Claim 1 recites the limitation “the ultrasonic image” in line 22 should read “the image”.
Claim 9 recites the limitation “a base plane” should read “the base plane”.
Claim 14 recites the limitation “the medical device” should read “the medical imaging device”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 13-14, 20, and 23 of copending Application No. 17/269,439 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variation of each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Current application
Copending Application No. 17/269,439
Claim 1: An apparatus for facilitating medical imaging of a subject comprising:
- a medical imaging device receiver configured to receive an ultrasound medical imaging device adapted to transmit sound waves in a first direction of transmission,
- a sound wave manipulation module comprising a soundwave deflection surface arranged to alter the transmission of at least part of the sound waves from the ultrasound medical imaging device to the subject from the first direction of transmission to a second direction of transmission, and
- at least one auxiliary equipment receiver configured to receive an auxiliary equipment and to provide a channel for insertion of the auxiliary equipment, wherein the channel extends through the sound wave manipulation module from the soundwave deflection surface to a base plane of the apparatus when rested on the subject, and an image of the subject is formed by the ultrasound medical imaging device for guiding insertion of the auxiliary equipment towards an insertion point in a target portion of the subject, and wherein the position of the channel is calibrated by being aligned with the second direction of transmission such that the insertion point of the auxiliary equipment will correspond to the target region of the subject shown in the ultrasonic image that has been captured by the ultrasonic medical imaging device being used.
Claim 1: An apparatus for facilitating medical imaging of a subject comprising:
- a medical imaging device receiver configured to receive an ultrasound medical imaging device for transmitting sound waves, - a sound wave manipulation module comprising a soundwave deflection surface arranged to alter a direction of transmission of at least part of the sound waves between the ultrasound medical imaging device and the subject
- the sound wave manipulation module further comprising at least one auxiliary equipment receiver configured as an aperture or channel through the soundwave transmission portion to receive an auxiliary equipment and to provide a pathway for insertion of the auxiliary equipment, wherein the pathway extends from the soundwave deflection surface to a base plane of the apparatus that rests on a body surface of the subject when the apparatus is being used, an image of the subject being formed by the ultrasound medical imaging device for guiding insertion of the auxiliary equipment received by the auxiliary equipment receiver towards a target portion of the subject.
Claim 2: The apparatus according to claim 1, wherein the soundwave deflection surface is configured to facilitate at least one of the following: - reflection, refraction, diffraction of sound waves.
Claim 3: The apparatus according to claim 2, wherein the soundwave deflection surface is configured to facilitate at least one of the following: reflection, refraction, diffraction of sound waves.
Claim 3: The apparatus according to claim 1, wherein the soundwave deflecting surface is formed from a material having a sound transmission velocity at a ratio ranging from 1.0 to 11.0 relative to water.
Claim 4: The apparatus according to claim 2, wherein the soundwave deflecting surface is formed from a material having a sound transmission velocity at a ratio ranging from 3.0 to 11.0 relative to water, and wherein different said material can alternatively be selected for the soundwave deflecting surface.
Claim 4: The apparatus according to claim 1,wherein the soundwave manipulation module comprises a soundwave transmission portion arranged to facilitate transmission of the sound waves between at least the ultrasound medical imaging device and the soundwave deflection surface.
Claim 1: a sound wave manipulation module comprising a soundwave deflection surface arranged to alter a direction of transmission of at least part of the sound waves between the ultrasound medical imaging device and the subject, and a soundwave transmission portion arranged to facilitate transmission of the sound waves between at least the ultrasound medical imaging device and the soundwave deflection surface
Claim 5: The apparatus according to claim 4, wherein the soundwave transmission portion is formed from a material having a sound transmission velocity at a ratio ranging from 0.8 to 5.0 relative to water.
Claim 1: the soundwave transmission material has a sound transmission velocity with a value falling within a ratio range of from 0.8 to 5.0 relative to water
Claim 6: The apparatus according to claim 4, wherein the soundwave transmission portion comprises a gel-based material.
Claim 23: The apparatus according to claim 1, wherein the sound transmission material comprises water, gelatine, polyvinyl alcohol, agarose, or polyacrylamide.
Claim 7: The apparatus according to claim 6, wherein the gel-based material is disposed at a hollow portion of the sound wave manipulation module.
Claim 1 +23: wherein the sound wave manipulation module comprises a hollow portion arranged between the ultrasound medical imaging device receiver and the soundwave deflection surface, the hollow portion containing a soundwave transmission material arranged as a medium for the sound waves to travel to the soundwave deflection surface, and between the soundwave deflection surface and the target portion of the subject, and the soundwave transmission material has a sound transmission velocity with a value falling within a ratio range of from 0.8 to 5.0 relative to water. The apparatus according to claim 1, wherein the sound transmission material comprises water, gelatine, polyvinyl alcohol, agarose, or polyacrylamide.
Claim 13: The apparatus according to claim1, comprising a handle for controlling movement of the apparatus on a body surface of the subject.
Claim 13: The apparatus according to claim 1, comprising a handle for controlling movement of the apparatus on a body surface of the subject.
Claim 14: The apparatus according to claim1, comprising a locking mechanism for maintaining the medical device at a desired position relative to a part of the apparatus.
Claim 14: The apparatus according to claim 1, comprising a locking mechanism for maintaining the ultrasound medical imaging device at a desired position relative to a part of the apparatus.
Claim 15: A method for deploying the apparatus of claim 1 comprising the steps of:- - attaching an ultrasound medical imaging device to the medical imaging device receiver of the apparatus;- placing the apparatus on a body surface of a subject; - moving the apparatus on the body surface for obtaining an image of a target portion of the subject; - attaching an auxiliary equipment to the at least one auxiliary equipment receiver of the apparatus; - adjusting position of the auxiliary equipment along the pathway provided by the at least one auxiliary equipment receiver based on the image of the target portion, and inserting the auxiliary equipment towards the target portion.
A method for deploying the apparatus of claim 1 comprising the steps of:- - attaching the ultrasound medical imaging device to the medical imaging device receiver of the apparatus;- placing the apparatus on a body surface of the subject;- moving the apparatus on the body surface for obtaining an image of the target portion of the subject; - attaching the auxiliary equipment to the at least one auxiliary equipment receiver of the apparatus; - adjusting position of the auxiliary equipment based on the image of the target portion, and inserting the auxiliary equipment along the pathway provided by the at least one auxiliary equipment receiver towards the target portion.
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 9-10 and 15-16 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.
Claim 9 recites the limitation “wherein the gel-based material is accommodated within a gel pad that protrudes through a calibration window provided at a base plane of the apparatus” it is unclear what is meant by a calibration window and how the calibration further limits the window. The examiner questions if the calibration window is just an opening at the base for the gel pad to protrudes from? For examination purposes the examiner is interpreting the calibration window as an opening in the base for the gel pad to extend from and contact the skin of the subject.
Claim 10 recites the limitation “wherein the tubular channel extends to or through calibration window” it is unclear what is meant by a calibration window and how the calibration further limits the window. The examiner questions if the calibration window is just an opening at the base for the gel pad and the tubular channel to extend from? For examination purposes the examiner is interpreting the calibration window as an opening in the base.
Claim 15 recites the limitation "the pathway" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “inserting the gel pad into the hollow section of the sound transmission module such that a portion of the gel pad protrudes through the calibration window.” it is unclear what is meant by a calibration window and how the calibration further limits the window. The examiner questions if the calibration window is just an opening at the base for the gel pad to extend from? For examination purposes the examiner is interpreting the calibration window as an opening in the base.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-2, 4-5, 11-12, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watson et al. (US 2008/0015442).
Regarding claim 1, Watson teaches an apparatus for facilitating medical imaging of a subject comprising (figure 1, element 3, para. 0108; the ultrasound waveguide):-
a medical imaging device receiver configured to receive an ultrasound medical imaging device adapted to transmit sound waves in a first direction of transmission (figure 1, element 13, paras. 0111-0112; the face of the cuboidal prism section 5 located opposite to the right angled isosceles prism section 4 comprise an arcuate recess 13. The function of the arcuate recess is to receive and secure the ultrasound transducer 2. Fastening means (not shown) in the form of clips, nuts and bolts, a frame, tape and/or a hollow within the surface of arcuate recess 13 can also be employed to further secure the ultrasound transducer 2 to the ultrasound waveguide 3. The ultrasound transducer 2 comprises a curved transducer array employed to generate and subsequently detect ultrasound. ),
- a sound wave manipulation module comprising a soundwave deflection surface arranged to alter the transmission of at least part of the sound waves from the ultrasound medical imaging device to the subject from the first direction of transmission to a second direction of transmission (figure 1, elements 4 and 10, paras. 0108-0112; Ultrasound waves 14 generated by the transducer 2 are coupled into the waveguide 3 at the arcuate recess. These waves 14 then travel through the waveguide 3 before being reflected at the internal surface of hypotenuse face 10 so as to exit the waveguide 3 via the planar anterior face 6. The examiner notes that the waveguide comprise a section 4 that has the deflecting surface 10 that reflects the ultrasound waves received from the transducer in the first direction to the base), and
- at least one auxiliary equipment receiver configured to receive an auxiliary equipment and to provide a channel for insertion of the auxiliary equipment, wherein the channel extends through the sound wave manipulation module from the soundwave deflection surface to a base plane of the apparatus when rested on the subject (figure 1, element 9, paras. 0109 and 0130; The ultrasound waveguide 3 can be further seen to comprise a channel 9 extending from a hypotenuse face 10 of the right angled isosceles prism section 4 through to the planar anterior face 6. the channel 9 allows the operator 19 to use the channel 9 as a guide for the subsequent insertion of a needle. In use, the operator 19 positions a touchy needle centrally within the channel 9, and inserts the needle into the patient 15. The examiner notes that the auxiliary equipment receiver is the channel 9 that extends from the hypotenuse face (the deflecting surface) to the planar anterior face (base plane) that receives a needle for insertion into a target region) and an image of the subject is formed by the ultrasound medical imaging device for guiding insertion of the auxiliary equipment towards an insertion point in a target portion of the subject (paras. 0128-0130; The probe 1 is shown, pressed against contact with the skin 20 of the patient 15 via gel 21. The ultrasound, waves 14, split into two components 14a and 14b produces an image of region 22. The image shows spinous processes 23 differentiated from soft tissue 24. The image allows the operator 19 to identify the target area, which in this case is a lumbar interspace 25. The spatial separation of the ultrasound wave components 14a and 14b causes a discontinuity in the image, shown as a shadow 26. In use, the shadow 26, and hence the channel 9, is aligned with the lumbar interspace 25. The correspondence of the shadow 26 in the image with the channel 9 allows the operator 19 to use the channel 9 as a guide for the subsequent insertion of a needle. The examiner notes that the image created by the ultrasound probe provides a guide for inserting the needle into a target region identified in the image), and wherein the position of the channel is calibrated by being aligned with the second direction of transmission such that the insertion point of the auxiliary equipment will correspond to the target region of the subject shown in the ultrasonic image that has been captured by the ultrasonic medical imaging device being used (paras. 0128-0130; The probe 1 is shown, pressed against contact with the skin 20 of the patient 15 via gel 21. The ultrasound, waves 14, split into two components 14a and 14b produces an image of region 22. The image shows spinous processes 23 differentiated from soft tissue 24. The image allows the operator 19 to identify the target area, which in this case is a lumbar interspace 25. The spatial separation of the ultrasound wave components 14a and 14b causes a discontinuity in the image, shown as a shadow 26. In use, the shadow 26, and hence the channel 9, is aligned with the lumbar interspace 25. The correspondence of the shadow 26 in the image with the channel 9 allows the operator 19 to use the channel 9 as a guide for the subsequent insertion of a needle. In use, the operator 19 positions a touchy needle centrally within the channel 9, and inserts the needle into the patient 15. The needle is aligned with a lumbar interspace 25, and passes safely through this gap into the epidural space. The examiner notes that based on the image created by the ultrasound probe, the operator can identify a target region and align the channel, by moving the waveguide, with the target region to align the needle entry point with the identified target region. Therefore, the position of the channel is calibrated or adjusted based on the ultrasound image used to guide the needle insertion.).
Regarding claim 2, Watson teaches the apparatus according to claim 1, wherein the soundwave deflection surface is configured to facilitate at least one of the following: - reflection, refraction, diffraction of sound waves (para. 0112; These waves 14 then travel through the waveguide 3 before being reflected at the internal surface of hypotenuse face 10 so as to exit the waveguide 3 via the planar anterior face 6. The examiner notes that the hypotenuse face reflects ultrasound waves).
Regarding claim 4, Watson teaches the apparatus according to claim 1, wherein the soundwave manipulation module comprises a soundwave transmission portion arranged to facilitate transmission of the sound waves between at least the ultrasound medical imaging device and the soundwave deflection surface (figure 1, element 5, paras. 0108 and 0111-0112; the ultrasound waveguide 3 can be seen to comprise two distinct sections, namely a right angled isosceles prism section 4 and a substantially cuboidal prism section 5. Both the right angled. isosceles prism section 4 and the cuboidal prism section 5 are made from a material with an acoustic impedance chosen to match that of the target object, in this case the material being Rexolite. The sections 4 and 5 may be made from a single piece of material. it can also be seen that the face of the cuboidal prism section 5 located opposite to the right angled isosceles prism section 4 comprise an arcuate recess 13. The function of the arcuate recess is to receive and secure the ultrasound transducer 2. Ultrasound waves 14 generated by the transducer 2 are coupled into the waveguide 3 at the arcuate recess. These waves 14 then travel through the waveguide 3 before being reflected at the internal surface of hypotenuse face 10 so as to exit the waveguide 3 via the planar anterior face 6. The examiner notes that the cuboidal prism section 5 that receives the ultrasound probe is the transmission section transmitting ultrasound wave from the ultrasound transducer to the deflection surface 10).
Regarding claim 5, Watson teaches the apparatus according to claim 4, wherein the soundwave transmission portion is formed from a material having a sound transmission velocity at a ratio ranging from 0.8 to 5.0 relative to water (para. 0108; the ultrasound waveguide 3 can be seen to comprise two distinct sections, namely a right angled isosceles prism section 4 and a substantially cuboidal prism section 5. Both the right angled. isosceles prism section 4 and the cuboidal prism section 5 are made from a material with an acoustic impedance chosen to match that of the target object, in this case the material being Rexolite. The examiner notes that Rexolite is a brand name of cross-linked polystyrene material. A review of the specification of instant application discloses in paras. 0061-0063 that polystyrene material has a sound transmission velocity at a ratio ranging from 0.08 to 5.0 relative to water. Therefore, the soundwave transmission potion 5 is made of Rexolite material which has a sound transmission velocity at a ratio ranging from 0.08 to 5.0 relative to water).
Regarding claim 11, Watson teaches the apparatus according to claim 1, wherein the soundwave manipulation module is formed from a homogenous material having a sound transmission velocity at a ratio ranging from 1.0 to 3.0 relative to water (paras. 0108 and 0112; the ultrasound waveguide 3 can be seen to comprise two distinct sections, namely a right angled isosceles prism section 4 and a substantially cuboidal prism section 5. Both the right angled. isosceles prism section 4 and the cuboidal prism section 5 are made from a material with an acoustic impedance chosen to match that of the target object, in this case the material being Rexolite. The sections 4 and 5 may be made from a single piece of material. The two sections are integrated as a single acoustic prism so as to provide a substantially planar anterior face 6. The examiner notes that the section that comprise the deflecting surface is prism section 4 and is made of Rexolite material which is brand name of cross-linked polystyrene material. A review of the specification of instant application discloses in paras. 0082-0084 that polystyrene material has a sound transmission velocity at a ratio ranging from 1.0 to 3.0 relative to water. Therefore, the soundwave manipulation module 4 is made of Rexolite material which has a sound transmission velocity at a ratio ranging from 1.0 to 3.0 relative to water.).
Regarding claim 12, Watson teaches the apparatus according to claim 11, wherein the sound wave manipulation module, the medical imaging device receiver and the auxiliary equipment receiver are integrally formed as a one-piece element (figure 1, para. 0108; the ultrasound waveguide 3 can be seen to comprise two distinct sections, namely a right angled isosceles prism section 4 and a substantially cuboidal prism section 5. Both the right angled. isosceles prism section 4 and the cuboidal prism section 5 are made from a material with an acoustic impedance chosen to match that of the target object, in this case the material being Rexolite. The sections 4 and 5 may be made from a single piece of material. The two sections are integrated as a single acoustic prism so as to provide a substantially planar anterior face 6. The examiner notes that the section that receives the ultrasound probe (Section 5) and the section that comprise the needle channel 9 and the deflecting surface 10 (Section 4) are integrated as a single acoustic prism).
Regarding claim 14, Watson teaches the apparatus according to claim 1, comprising a locking mechanism for maintaining the medical device at a desired position relative to a part of the apparatus (para. 0111; The function of the arcuate recess is to receive and secure the ultrasound transducer 2. Fastening means (not shown) in the form of clips, nuts and bolts, a frame, tape and/or a hollow within the surface of arcuate recess 13 can also be employed to further secure the ultrasound transducer 2 to the ultrasound waveguide 3.).
Regarding claim 15, Watson teaches a method for deploying the apparatus of claim 1 comprising the steps of:
- attaching an ultrasound medical imaging device to the medical imaging device receiver of the apparatus (para. 0111; it can also be seen that the face of the cuboidal prism section 5 located opposite to the right angled isosceles prism section 4 comprise an arcuate recess 13. The function of the arcuate recess is to receive and secure the ultrasound transducer 2. Fastening means (not shown) in the form of clips, nuts and bolts, a frame, tape and/or a hollow within the surface of arcuate recess 13 can also be employed to further secure the ultrasound transducer 2 to the ultrasound waveguide 3.);
- placing the apparatus on a body surface of a subject (para. 0113; the ultrasound probe 1 comprising the transducer 2 and the waveguide 3 may be held against the body of the patient 15 during use.);
- moving the apparatus on the body surface for obtaining an image of a target portion of the subject (paras. 0123-0130; In use an operator 19 views the image on the display 18, and controls the position of the probe 1 with respect to the patient 15.);
- attaching an auxiliary equipment to the at least one auxiliary equipment receiver of the apparatus (paras. 0123-0130; the operator 19 positions a touchy needle centrally within the channel 9, and inserts the needle into the patient 15. );
- adjusting position of the auxiliary equipment along the pathway provided by the at least one auxiliary equipment receiver based on the image of the target portion, and inserting the auxiliary equipment towards the target portion (paras. 0128-0130; The probe 1 is shown, pressed against contact with the skin 20 of the patient 15 via gel 21. The ultrasound, waves 14, split into two components 14a and 14b produces an image of region 22. The image shows spinous processes 23 differentiated from soft tissue 24. The image allows the operator 19 to identify the target area, which in this case is a lumbar interspace 25. The spatial separation of the ultrasound wave components 14a and 14b causes a discontinuity in the image, shown as a shadow 26. In use, the shadow 26, and hence the channel 9, is aligned with the lumbar interspace 25. The correspondence of the shadow 26 in the image with the channel 9 allows the operator 19 to use the channel 9 as a guide for the subsequent insertion of a needle. In use, the operator 19 positions a touchy needle centrally within the channel 9, and inserts the needle into the patient 15. The needle is aligned with a lumbar interspace 25, and passes safely through this gap into the epidural space.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 3 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (US 2008/0015442) in the view of Dardel et al. (US 5,261,409).
Regarding claim 3, Watson teaches the apparatus according to claim 1, however, fails to explicitly teach wherein the soundwave deflecting surface is formed from a material having a sound transmission velocity at a ratio ranging from 1.0 to 11.0 relative to water.
Dardel, in the same field of endeavor, teaches wherein the soundwave deflecting surface is formed from a material having a sound transmission velocity at a ratio ranging from 1.0 to 11.0 relative to water (col 2, lines 28-37; the ultrasound reflector 12 (reflector for the ultrasound beam), which consists of a flat metal plate. The examiner notes that a review of the specification of the instant application discloses in paras. 0054-0057 that metal material has a wave transmission velocity at a ratio ranging from 1 to 11 relative to water. Thus, Dardel metal reflecting surface has a transmission velocity at a ratio ranging from 1 to 11 relative to water).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Watson deflecting surface to include Dardel metal deflecting surface to provide a soundwave deflecting surface is formed from a material having a sound transmission velocity at a ratio ranging from 1.0 to 11.0 relative to water. This modification would ensure proper ultrasound reflection at the soundwave deflecting surface.
Regarding claim 6, Watson teaches the apparatus according to claim 4, however fails to explicitly teach wherein the soundwave transmission portion comprises a gel-based material.
Dardel, in the same field of endeavor, teaches soundwave transmission portion comprises a gel-based material (figures 2-3, elements 15 and 16, col 2, line 38 to col 3, line 11; The ultrasound probe 20 emits an ultrasound beam (symbolized by two arrows U) into a cavity 15 filled with a coupling gel (not shown), the beam being reflected off the reflector 12 to the outlet aperture 15a. In FIG. 2 the coupling gel 16 is indicated, with which the cavity 15 (FIG. 3) is filled. The examiner notes that the soundwave transmission portion 15 comprise a cavity that is filled with a gel material).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Watson soundwave transmission portion to include Dardel gel filled soundwave transmission portion to provide a soundwave transmission portion that comprises a gel-based material. This modification would improve soundwave transmission and increase image clarity and resolution.
Regarding claim 7, Watson teaches the apparatus according to claim 6, however fails to explicitly teach wherein the gel-based material is disposed at a hollow portion of the sound wave manipulation module.
Dardel, in the same field of endeavor, teaches wherein the gel-based material is disposed at a hollow portion of the sound wave manipulation module (figures 2-3, elements 15 and 16, col 2, line 38 to col 3, line 11; The ultrasound probe 20 emits an ultrasound beam (symbolized by two arrows U) into a cavity 15 filled with a coupling gel (not shown), the beam being reflected off the reflector 12 to the outlet aperture 15a. In FIG. 2 the coupling gel 16 is indicated, with which the cavity 15 (FIG. 3) is filled. The examiner notes that the soundwave transmission portion 15 comprise a cavity that is filled with a gel material).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Watson soundwave transmission portion to include Dardel soundwave transmission portion cavity to provide a gel-based material is disposed at a hollow portion of the sound wave manipulation module. This modification would allow the acoustic coupling medium to be removable or replaceable. Additionally, it would allow the use of different acoustic coupling medium with different soundwave transmission velocity suitable for the imaging target.
Regarding claim 8, Watson teaches the apparatus according to claim 8, however fails to explicitly teach wherein the channel of the auxiliary equipment receiver is provided by a tubular channel extending through the hollow section.
Dardel, in the same field of endeavor, teaches wherein the channel of the auxiliary equipment receiver is provided by a tubular channel extending through the hollow section (figure 1 and 2, col 2, line 38 to col 3 line 11; The ultrasound probe 20 emits an ultrasound beam (symbolized by two arrows U) into a cavity 15 filled with a coupling gel (not shown), the beam being reflected off the reflector 12 to the outlet aperture 15a. The outlet aperture 15a in this first embodiment is circular, and the ultrasound beam comes out perpendicular to this aperture. The needle guide duct 13, accordingly, is also perpendicular to the outlet aperture 15a. When the puncturing device is in use the aperture 15a is held at an angle to the surface of the body. The needle 30, which is attached to a syringe 31, is driven along the convergent ultrasound beam (focus F)--after location of the blood vessel 50 by means of the Doppler effect-into this vessel 50. In FIG. 2 the coupling gel 16 is indicated, with which the cavity 15. The examiner notes that the needle channel extends from the receiving point through the cavity to exit the apparatus at the exit point in the base contacting the skin of the subject).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Watson auxiliary equipment receiver to include Dardel needle duct to provide a tubular channel extending through the hollow section. This modification would ensure that the needle stays visible on the ultrasound image and the ultrasound beam and the needle path remains precisely aligned. Thus, improves the needle guidance and ensures proper puncturing of the target region.
Claim(s) 9-10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (US 2008/0015442) in the view of Dardel et al. (US 5,261,409) and in further view of Wendelken et al. (US 2005/0096547).
Regarding claim 9, Watson in the view of Dardel teach the apparatus according to claim 8, however fails to explicitly teach wherein the gel-based material is accommodated within a gel pad that protrudes through a calibration window provided at a base plane of the apparatus.
Wendelken, in the same field of endeavor, teaches gel-based material is accommodated within a gel pad that protrudes through a calibration window provided at a base plane of the apparatus (figure 9, paras. 0061 and 0066; multi-ribbed standoff holder 10 mounted over the external surface of ultrasound transducer 20 with gel insert 26 placed within opening 18 of expansion collar 14. Gel insert 26 touches and covers acoustic window 22 located on the distal end of ultrasound transducer 20. Pad 24 may be comprised of gel or any other material that freely allows the passage of ultrasound waves and subsequent echoes from and transducer 20. The examiner notes that the base of the holder comprises an opening (calibration window) which a gel pad extends outwardly from.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Watson in the view of Dardel base to include Wendelken base with opening to provide a gel pad that protrudes through a calibration window provided at a base plane of the apparatus. This modification would ensure appropriate coupling of an ultrasound probe to a body which will be receiving either therapeutic or diagnostic ultrasound waves; shift or move the images being observed during an ultrasound exam, deeper into the field on the ultrasound monitor; conform to a hard noncompliant surface; and reduces discomfort produced by pressure on an area as disclosed within Wendelken in paras. 0003-0005.
Regarding claim 10, Watson teaches the apparatus according to claim 8, wherein the tubular channel extends to or through the base plane (Figure 1, element 9, para. 0109; the ultrasound waveguide 3 can be further seen to comprise a channel 9 extending from a hypotenuse face 10 of the right angled isosceles prism section 4 through to the planar anterior face 6.).
However, Watson in the view of Dardel fail to explicitly teach a calibration window.
Wendelken, in the same field of endeavor, teaches g a calibration window provided at a base plane of the apparatus (figure 9, paras. 0061 and 0066; multi-ribbed standoff holder 10 mounted over the external surface of ultrasound transducer 20 with gel insert 26 placed within opening 18 of expansion collar 14. Gel insert 26 touches and covers acoustic window 22 located on the distal end of ultrasound transducer 20. Pad 24 may be comprised of gel or any other material that freely allows the passage of ultrasound waves and subsequent echoes from and transducer 20. The examiner notes that the base of the holder comprises an opening (calibration window) which a gel pad extends outwardly from.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Watson in the view of Dardel base to include Wendelken base with opening to provide a gel pad and tubular channel to protrude through a calibration window provided at a base plane of the apparatus. This modification would ensure that parts of the apparatus directly contact the imaging target such as the needle and the gel pad. Additionally, providing an opening in the base of the apparatus allows gel pads to extend outwardly from the base to provide appropriate coupling of an ultrasound probe to a body which will be receiving either therapeutic or diagnostic ultrasound waves; shift or move the images being observed during an ultrasound exam, deeper into the field on the ultrasound monitor; conform to a hard noncompliant surface; and reduces discomfort produced by pressure on an area as disclosed within Wendelken in paras. 0003-0005.
Regarding claim 16, Watson teaches a process of manufacturing an apparatus according to claim 9, however, fails to explicitly teach comprising a process step of inserting the gel pad into the hollow section of the sound transmission module such that a portion of the gel pad protrudes through the calibration window.
Dardel, in the same field of endeavor, teaches of inserting the gel based material into the hollow section of the sound transmission module (figures 2-3, elements 15 and 16, col 2, line 38 to col 3, line 11; The ultrasound probe 20 emits an ultrasound beam (symbolized by two arrows U) into a cavity 15 filled with a coupling gel (not shown), the beam being reflected off the reflector 12 to the outlet aperture 15a. In FIG. 2 the coupling gel 16 is indicated, with which the cavity 15 (FIG. 3) is filled. The examiner notes that the soundwave transmission portion 15 comprise a cavity that is filled with a gel material).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Watson soundwave transmission portion to include Dardel soundwave transmission portion cavity to provide a gel-based material that is disposed at a hollow portion of the sound wave manipulation module. This modification would allow the acoustic coupling medium to be removable or replaceable. Additionally, it would allow the use of different acoustic coupling medium with different soundwave transmission velocity suitable for the imaging target.
However, Watson in the view of Dardle fail to explicitly teach gel-based material is accommodated within a gel pad that protrudes through a calibration window provided at a base plane of the apparatus.
Wendelken, in the same field of endeavor, teaches gel-based material is accommodated within a gel pad that protrudes through a calibration window provided at a base plane of the apparatus (figure 9, paras. 0061 and 0066; multi-ribbed standoff holder 10 mounted over the external surface of ultrasound transducer 20 with gel insert 26 placed within opening 18 of expansion collar 14. Gel insert 26 touches and covers acoustic window 22 located on the distal end of ultrasound transducer 20. Pad 24 may be comprised of gel or any other material that freely allows the passage of ultrasound waves and subsequent echoes from and transducer 20. The examiner notes that the base of the holder comprises an opening (calibration window) which a gel pad extends outwardly from.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Watson in the view of Dardel base to include Wendelken base with opening to provide a gel pad that protrudes through a calibration window provided at a base plane of the apparatus. This modification would ensure appropriate coupling of an ultrasound probe to a body which will be receiving either therapeutic or diagnostic ultrasound waves; shift or move the images being observed during an ultrasound exam, deeper into the field on the ultrasound monitor; conform to a hard noncompliant surface; and reduces discomfort produced by pressure on an area as disclosed within Wendelken in paras. 0003-0005.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. (US 2008/0015442) in the view of Ridley et al. (US 2011/0087105).
Regarding claim 13, Watson teaches the apparatus according to claim 1, however, fails to explicitly teach comprising a handle for controlling movement of the apparatus on a body surface of the subject.
Ridley, in the same field of endeavor, teaches a handle for controlling movement of the apparatus on a body surface of the subject (figure 1, elements 102 or 104, para. 0049; a handle for controlling movement of the apparatus on a body surface of the subject.).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Watson device to include Ridley handle to provide a handle for controlling movement of the apparatus on a body surface of the subject. This modification would allow the device to be comfortably held in the hand while the device is being utilized as disclosed within Ridley in para. 0049.
Conclusion
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797