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 .
Any References cited but not appearing in any current Form 892 may be found in previous Form 892’s or IDS’s.
Response to Amendment
The amendment to the claims filed on 12/09/2025 has been entered. In the amendment, claims 1-5 and 7-20 are amended. Claim 6 is cancelled. Claims 21 is added. Claims 1-5 and 7-21 are currently pending.
The amendment to claim 8 overcomes the objection to claim 8.
The cancellation of claim 6 renders moot the objection and 101 and 112b rejections to claim 6.
The amendment to claims 14 and 19 overcomes the objections to those claims.
The amendment to claim 3 overcomes the 101 rejection to claim 3.
The amendment to claim 5 overcomes the 112b rejection to claim 5.
The amendment to claim 11 overcomes the 112b rejection to claim 11.
The amendment to claim 13 overcomes the 112b rejection to claim 13.
The amendment to claim 19 overcomes the 112b rejection to claim 19.
The amendments to claims 7, 9 and 17 overcomes the objection to the drawings pertaining to the coupling port.
The amendment to claim 17 overcomes the objection to the drawings pertaining to the passage.
The drawing objection is maintained with regard to the objection to the drawings pertaining to the passage in claims 7 and 15 as outlined below in the Objection to the Drawings.
Response to Arguments
Applicant’s arguments, see page 12, filed 12/09/2025, with respect to the rejection(s) of claim(s) 1 under 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of previously cited Dye (US 2013/0247921) in view of newly cited Nguyen (US 2019/0365351).
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 passage of claims 7 and 15; and the coupling material comprising a gel composition positioned, within, and fixed within the acoustic window of claims 1, 9 and 17 respectively, 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.
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.
Claim(s) 1-5, 7-13, 17-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable Dye (US 2013/0247921) in view of Nguyen (US 2019/0365351).
Regarding claim 1, Dye discloses a surgical covering (10), comprising an acoustic window (Fig. 8, [0053], an opening in the drape 10 where element 26 is disposed is a window and it is an acoustic window in that the window is for use for ultrasound e.g. echocardiogram, and is thus an acoustic window) formed in the surgical covering (Fig. 8, opening in the drape/surgical covering); a coupling material (26) ([0053], Fig. 8, transmissive window 26 is a coupling material in the acoustic window [opening] and it is coupling as ultrasound occurs through it and couples the probe 52 to the subject); wherein the acoustic window and the coupling material are configured to allow a coupling of an ultrasound wave with a subject ([0056]; [0070];[0053]; claims 14 and 8; Fig. 8; capable of intended use).
Dye does not disclose the coupling material comprising a gel composition fixed within the acoustic window; wherein the acoustic window and the coupling material are configured to allow a coupling of an ultrasound wave with a subject.
Nguyen teaches an array (200) comprising patches (210) having components of ultrasound arrays ([0026]) comprising an analogous coupling material (224-a, 228; sheet that allows for ultrasound transition plus gel) ([0027]; [0031], The membrane 224-a may be a continuous sheet of flexible material disposed across substantially the entire transmission surface of the array. The acoustic coupling fluid 228 and flexible membrane provided on the transmission side aids in acoustically coupling the transmission side of the array to the subject by allowing the lower surface of the array to conform to the surface of the subject to be imaged. NOTE: the membrane 224-a is analogous to coupling material of Dye which is a visually transmissive window 26 that is disposed across a surface underneath which a subject is to undergo ultrasound thus the coupling material couples the a subject for ultrasound) comprising a gel composition (228) ([0031], Fig. 4A, acoustic coupling fluid is positioned in the cavities 226 with membrane 224a); wherein coupling material is configured to allow a coupling of an ultrasound wave with a subject ([0026], the patches which include the membrane and gel at a transmissive side are coupled to the ultrasound scanner; capable of intended use).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the coupling material of the surgical covering of Dye positioned in the acoustic window, is comprising a gel composition, wherein the coupling material is configured to allow a coupling of an ultrasound wave with a subject, as taught by Nguyen, by providing to the transmissive window of Dye the cavities and the gel composition of Nguyen (as well as other ultrasound elements of the patch), in order to provide an improved surgical covering that facilitates obtaining a large field of view for ultrasound imaging (Nguyen, [0024]).
Dye in view of Nguyen discloses the invention as described above.
The combination further discloses the coupling material comprising a gel composition fixed within the acoustic window; wherein the acoustic window and the coupling material are configured to allow a coupling of an ultrasound wave with a subject (In the combination the coupling material is the transmissive window 26 of Dye and the gel of Nguyen is also the coupling material and in the combination the coupling material 26 is disposed in acoustic window of Dye and the gel is disposed with the coupling material thus the gel is fixed within the acoustic window and in the combination the transmissive window and gel are both configured to allow a coupling of an ultrasound wave with a subject).
Regarding claim 2, Dye in view of Nguyen discloses the invention as described above with regard to claim 1.
Nguyen further teaches wherein the surgical covering includes a plurality of acoustic windows (226), ([0031]; cavities are window-like in that they have an opening and aid in acoustically coupling the transmission side to the subject and are thus acoustic windows) including the acoustic window formed in the surgical covering (in the combination the acoustic window [opening] is positioned within the drape and is thus formed in the surgical covering).
Regarding claim 3, Dye in view of Nguyen discloses the invention as described above with regard to claim 1.
The combination further discloses wherein the acoustic window is configured to be located at specific anatomical locations (Fig. 8; [0053]; [0056]; [0070]; NOTE: the opening at which is the transmissive window 26 [the acoustic window] is at/near specific anatomical locations as seen in Fig. 8 ); and wherein the acoustic window is configured to couple the ultrasound wave with the subject for visualizing a portion within the subject (Nguyen, [0026], coupled to ultrasound scanner).
Regarding claim 4, Dye in view of Nguyen discloses the invention as described above with regard to claim 1.
Dye further discloses wherein the portion within the subject is anatomy ([0068], it is implied that since an instrument whether sterile or not is to be used in a sterile surgical field that the portion within the subject is anatomy; [0056]; [0070]; Fig. 8; claims 14 and 8; NOTE: it is implied that as the surgical instrument is an ultrasound imaging probe that the subject is anatomy).
Regarding claim 5, Dye in view of Nguyen discloses the invention as described above with regard to claim 3.
Dye further discloses further comprising: a procedure portal (30, 32) (annotated Fig. 8 below; [0068]; NOTE: providing an instrument is a procedure thus the portal 32 which is associated with the instrument is a procedural portal);
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wherein the procedure portal is positioned adjacent to the acoustic window (annotated Fig. 8), and wherein the acoustic window allows visualization (ultrasound visualization is allowed, see in Dye, [0052] for example, doppler imaging occurs in the acoustic window and also per the teaching of Nguyen, [0024], [0026] ultrasound/sonography occurs thus ultrasound visualization) while providing surgical access to an anatomy ([0068]; NOTE: as there is a sterile surgical field it is implied that surgical access to an anatomy is provided; capable of intended use).
Regarding claim 7, Dye in view of Nguyen discloses the invention as described above with regard to claim 1.
The combination further discloses wherein the acoustic window includes a passage (226) (Nguyen, [0031], cavity includes a passage) formed in a sheet (in the combination the acoustic window [cavity 226] is in the drape 10 of Dye and is thus formed in a sheet); wherein the gel composition is fixed to a portion of the sheet to at least partially cover the passage (Nguyen, [0031], the portion of the cavity not occupied by the patch may be filled with an acoustic coupling fluid e.g. ultrasound gel thus the gel is fixed to a portion of the sheet to at least partially cover the passage [cavity] as the passage which the gel covers is fixed to the sheet/drape of Dye).
Regarding claim 8, Dye in view of Nguyen discloses the invention as described above with regard to claim 7.
The combination further discloses wherein the coupling material includes a first side and a second side (transmissive window 26 of Dye [part of the coupling material] has a first side and a second side, Fig. 8 shows a side that is a left side and a second side that is a right side), wherein at least one of the first side or the second side includes an adhesive (Dye, [0041]; chemical adhesives), and wherein the adhesive is configured to adhere to at least one of the sheet ([0041]) or the subject.
Regarding claim 9, Dye discloses a method of providing a surgical covering (10) for a procedure (Fig. 8 shows a surgical covering; Dye, [0068], [0049], surgical drape 10 has a sterile side 12 and as it is a surgical drape it is a surgical covering for a procedure), comprising: providing a sheet (10) ([0049], drape is a sheet); providing an acoustic window (Fig. 8, [0053], [0050], an opening in the drape 10 where element 26 is disposed is a window and it is an acoustic window in that the window is for use for ultrasound, e.g. echocardiogram and thus an acoustic window is provided) formed in the sheet (Fig. 8, formed in the surgical drape 10); providing a coupling material (26) ([0053], Fig. 8, transmissive window 26 is a coupling material as ultrasound occurs through it and couples the probe 52 to the subject positioned in the acoustic window) within the acoustic window (Fig. 8 shows coupling material 26 provided to the acoustic window [opening]), the coupling material being configured to contact skin of a subject (Fig. 8, [0052]; [0053], for ultrasound the transmissive window would contact the subject); and configuring the acoustic window and the coupling material to allow a coupling of an ultrasound wave with the subject (([0056]; [0070];[0053]; claims 14 and 8; Fig. 8).
Dye does not disclose providing a coupling material comprising a gel composition within the acoustic window.
Nguyen teaches providing an array (200) comprising patches (210) having components of ultrasound arrays ([0026]) comprising providing an analogous coupling material (224-a, 228; sheet that allows for ultrasound transition plus gel) ([0027]; [0031], The membrane 224-a may be a continuous sheet of flexible material disposed across substantially the entire transmission surface of the array. The acoustic coupling fluid 228 and flexible membrane provided on the transmission side aids in acoustically coupling the transmission side of the array to the subject by allowing the lower surface of the array to conform to the surface of the subject to be imaged. NOTE: the membrane 224-a is analogous to coupling material of Dye which is a visually transmissive window 26 that is disposed across a surface underneath which a subject is to undergo ultrasound thus the coupling material couples the subject for ultrasound) comprising a gel composition (228), the coupling material being configured to contact skin of a subject ([0031], the flexible membrane 224-a is coupled to the subject thus configured to contact the skin of a subject).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide a coupling material comprising a gel composition, as taught by Nguyen, by providing to the transmissive window of Dye the cavities and the gel composition of Nguyen (as well as other elements of the array for ultrasound), in order to provide an improved method of providing a surgical covering that facilitates obtaining a large field of view for ultrasound imaging (Nguyen, [0024]).
Dye in view of Nguyen discloses the invention as described above.
The combination further discloses providing a coupling material comprising a gel composition within the acoustic window (Nguyen [0031] teaches a gel within cavities, thus the gel [coupling material] would be within the acoustic window of Dye in the combination as transmissive window 26 of Dye is provided with the cavities and gel of Nguyen) and configuring the acoustic window and the coupling material to allow a coupling of an ultrasound wave with the subject (in the combination, Nguyen [0031] teaches configuring the coupling material [gel] is configured to allow coupling of an ultrasound wave with the subject and Dye [0053] teaches the transmissive window is configured to allow coupling of an ultrasound wave with the subject and the transmissive window is in the acoustic window thus in the combination configuring the acoustic window and the coupling material to allow a coupling of an ultrasound wave with the subject occurs).
Regarding claim 10, Dye in view of Nguyen discloses the invention as described above with regard to claim 9.
The combination further discloses wherein providing the acoustic window in the sheet (Dye discloses providing the acoustic window in the sheet, see claim 1 explanation) includes providing a plurality of acoustic windows (In the combination Nguyen [0031] teaches providing a plurality of acoustic windows 226 [cavities] which are positioned in the acoustic window of Dye).
Regarding claim 11, Dye in view of Nguyen discloses the invention as described above with regard to claim 10.
The combination further discloses providing plurality of acoustic windows in the sheet at specific anatomical locations (In the combination Nguyen teaches a plurality of acoustic windows 226 that are provided in the sheet of Dye); wherein configuring the acoustic window to allow the coupling of the ultrasound wave with the subject includes configuring the acoustic window to couple the ultrasound wave with the subject for visualizing a portion within the subject ([0056]; [0070];[0053]; claims 14 and 8; the recitations disclose and Fig. 8 shows ultrasound of a subject occurring thus visualizing a portion within the subject occurs; Nguyen, [0026] teaches ultrasound scanning and it would occur in the location of ultrasound of Dye).
Regarding claim 12, Dye in view of Nguyen discloses the invention as described above with regard to claim 11.
The combination further discloses wherein configuring the acoustic window to couple the ultrasound wave with the subject enables visualization of anatomy within the subject ([0056]; [0070];[0053]; claims 14 and 8; the recitations disclose and Fig. 8 shows ultrasound of a subject occurring thus visualizing a portion within the subject occurs and Nguyen teaches ultrasound that would occur in the visualizing portion of Dye).
Regarding claim 13, Dye in view of Nguyen discloses the invention as described above with regard to claim 11.
Dye further discloses providing a procedure portal (30, 32) (annotated Fig. 8 above with regard to claim 5; [0068]; NOTE: providing an instrument is a procedure thus the portal 32 which is associated with the instrument is a procedural portal) positioned adjacent to the acoustic window (annotated Fig. 8 above with regard to the claim 5 rejection shows the portal adjacent to the acoustic window), wherein the acoustic window allows visualization (ultrasound visualization is allowed, see in Dye, [0052] for example, doppler imaging occurs in the acoustic window) while providing surgical access to an anatomy ([0068]; NOTE: as there is a sterile surgical field and a surgical drape is provided surgical access to an anatomy is provided).
Regarding claim 17, Dye discloses a surgical covering (10) (Fig. 8), comprising: an acoustic window (opening in the drape 10 within which element 26 is disposed) formed in a sheet (10) (([0050], [0053], Fig. 8, drape 10 is a sheet it is implied there is an opening within the sheet in which the transmissive window is disposed and that opening is the acoustic window as ultrasound occurs therethrough); a coupling material (26) ([0053], Fig. 8, transmissive window 26 is a coupling material as ultrasound occurs through it) and fixed to the sheet (Fig. 8 shows transmissive window 26 [coupling material] is fixed to the sheet), the coupling material being configured to be in direct contact with skin of a subject (Fig. 8) and to provide direct acoustic coupling of ultrasound signals between an ultrasound transducer and the subject during a medical procedure ([0068]; NOTE: providing an instrument is a procedure; [0052]; [0053]; Fig. 8, the working end of the device may be a probe or wand for Doppler/flow [ultrasound]); and a procedure portal (30, 32) formed through the sheet ([0068]; NOTE: providing an instrument is a procedure thus the portal 32 which is associated with the instrument is a procedural portal; see annotated Fig. 8 with regard to claim 5 above, the portal is formed through a portion of the drape 10 having second window 26); wherein the acoustic window and the coupling material are is configured to allow coupling of an ultrasound wave with the subject ([0056]; [0070];[0053]; claims 14 and 8; Fig. 8; capable of intended use) while covering the subject (window 26 [near probe 52] is shown covering the subject in Fig. 8).
Dye does not disclose a coupling material is comprising a gel composition fixed within the acoustic window.
Nguyen teaches an array (200) comprising patches (210) having components of ultrasound arrays ([0026]) comprising an analogous coupling material (224a, 228; sheet that allows for ultrasound transition plus gel) ([0027]; [0031], The membrane 224-a may be a continuous sheet of flexible material disposed across substantially the entire transmission surface of the array. The acoustic coupling fluid 228 and flexible membrane provided on the transmission side aids in acoustically coupling the transmission side of the array to the subject by allowing the lower surface of the array to conform to the surface of the subject to be imaged. NOTE: the membrane 224-a is analogous to coupling material of Dye which is a visually transmissive window 26 that is disposed across a surface underneath which a subject is to undergo ultrasound thus the coupling material couples the subject for ultrasound.) comprising a gel composition (228) ([0031], Fig. 4A, acoustic coupling fluid is positioned in the cavities 226); wherein the coupling material is configured to allow a coupling of an ultrasound wave with a subject ([0026], the patches which include the membrane and gel at a transmissive side are coupled to the ultrasound scanner; capable of intended use).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the coupling material of Dye that is fixed within the acoustic window and fixed to the sheet is comprising a gel composition, as taught by Nguyen, by providing to the transmissive window of Dye the cavities and gel composition of Nguyen (as well as other components of the array for ultrasound), in order to provide an improved surgical covering that facilitates obtaining a large field of view for ultrasound imaging (Nguyen, [0024]).
Dye in view of Nguyen discloses the invention as described above.
The combination further discloses a coupling material comprising a gel composition fixed within the acoustic window (In the combination the coupling material is the transmissive window 26 of Dye and the gel of Nguyen is also the coupling material and in the combination the coupling material 26 is disposed in acoustic window of Dye and the gel is disposed with the coupling material thus the gel is fixed within the acoustic window) wherein the acoustic window and the coupling material are configured to allow a coupling of an ultrasound wave with the subject (in the combination, Nguyen [0031] teaches the coupling material [gel] is configured to allow coupling of an ultrasound wave with the subject and Dye [0053] teaches the transmissive window is configured to allow coupling of an ultrasound wave with the subject and the transmissive window is in the acoustic window thus in the combination the acoustic window and the coupling material are configured to allow a coupling of an ultrasound wave).
Regarding claim 18, Dye in view of Nguyen discloses the invention as described above with regard to claim 17.
The combination further discloses wherein the acoustic window is configured to be placed at specific anatomical locations of the subject (Dye, Fig. 8 shows the acoustic window [opening where transmissive window 26 currently is] is placed at [near] anatomical location of the subject); and wherein acoustic window ([opening]) and the coupling material (In the combination the coupling material includes a transmissive membrane [per Dye] and gel [per teaching of Nguyen]) are configured to couple the ultrasound wave with the subject for visualizing a portion within the subject (Nguyen, [0018]; capable of intended use).
Regarding claim 20, Dye in view of Nguyen discloses the invention as described above with regard to claim 17.
Nguyen further teaches further comprising an optical tracking device, an electromagnetic device ([0045], electromagnetic tracking system), of a fiducial fixed to the sheet.
Claim(s) 14-15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dye (US 2013/0247921) in view of Nguyen (US 2019/0365351) as applied to claim 9 with regard to claims 14-15 and as applied to claim 17 with regard to claim 19, above, and in further view of Matsumoto (US 2015/0245811).
Regarding claim 14, Dye in view of Nguyen discloses the invention as described above with regard to claim 9.
The combination further discloses wherein providing the coupling material includes providing the gel composition at the acoustic window (Nguyen [0031] teaches providing the gel composition and in the combination the gel is provided to the transmissive window of Dye which is disposed in the acoustic window of Dye thus the gel composition is provided at the acoustic window) to provide direct coupling of an ultrasound signal to and from the subject (Dye, [0056]; [0039]; [0049]; [0050]; Fig. 8 and the cited recitations of Dye disclose ultrasound of the subject occurs thus there is direct coupling of an ultrasound signal to and from the subject as occurs with ultrasound; Nguyen, [0031], acoustic coupling fluid/ultrasound gel for ultrasound).
The combination does not disclose coupling of a wide-band ultrasound signal to and from the subject.
Matsumoto teaches ultrasound methods and apparatuses ([0005]) that provide coupling of a wide-band ultrasound signals to and from the subject ([0005]; [0087]; [0068]; NOTE: as element 20 provides transmission and reception of a wide-band ultrasound signals, it is implied that it is transmission and reception to and from a subject as the apparatus is a diagnostic ultrasound apparatus).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the ultrasound signal to and from the subject of the method of providing a surgical covering for a procedure in Dye in view of Nguyen is a wide-band ultrasound signal, as taught by Matsumoto , in order to provide an improved surgical covering that has ten kinds of resonance frequences (Matsumoto, [0107]) and that improves the ultrasound transmission/reception sensitivity (Matsumoto, [0068]).
Regarding claim 15, Dye in view of Nguyen and in further view of Matsumoto discloses the invention as described above with regard to claim 14.
The combination further discloses further comprising: providing the acoustic window as a passage (226) (Nguyen, [0031], cavities include a passage and cavities are in the acoustic window in the combination) formed in the sheet (In the combination cavities 226 are provided in the sheet/drape of Dye); and providing the gel composition fixed to a portion of the sheet (Nguyen, [0031], the gel is fixed to the cavities which are fixed to a sheet of Dye in the combination thus the gel composition is fixed to a portion of the sheet) to at least partially cover the passage (in the combination, Nguyen teaches [see Fig. 4A, [0031]] gel 228 is provided to cavities 226 which are provided to the transmissive window 26 of Dye which is fixed to the sheet and thus the gel is fixed to a portion of the sheet to cover the passage of each of the cavities).
Regarding claim 19, Dye in view of Nguyen discloses the invention as described above with regard to claim 17.
The combination further discloses wherein the coupling material comprises a gel composition positioned in the acoustic window (In the combination Nguyen teaches a gel composition 228 and this composition is positioned in the acoustic window [opening] of Dye as it is provided to the transmissive window 26 of Dye in the combination which is in the acoustic window) and configured to provide direct acoustic coupling of an ultrasound signal to and from the subject (Dye, [0056]; [0039]; [0049]; [0050]; Fig. 8 and the cited recitations of Dye disclose ultrasound of the subject occurs thus there is direct coupling of an ultrasound signal to and from the subject as occurs with ultrasound).
The combination does not disclose coupling of a wide-band ultrasound signal to and from the subject.
Matsumoto teaches ultrasound methods and apparatuses ([0005]) that provide coupling of a wide-band ultrasound signals to and from the subject ([0005]; [0087]; [0068]; NOTE: as element 20 provides transmission and reception of a wide-band ultrasound signals, it is implied that it is transmission and reception to and from a subject as the apparatus is a diagnostic ultrasound apparatus).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the ultrasound signal to and from the subject of the surgical covering of Dye in view of Nguyen is a wide-band ultrasound signal, as taught by Matsumoto , in order to provide an improved surgical covering that has ten kinds of resonance frequences (Matsumoto, [0107]) and that improves the ultrasound transmission/reception sensitivity (Matsumoto, [0068]).
Claim(s) 16 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dye (US 2013/0247921) in view of Nguyen (US 2019/0365351) as applied to claim 9 and claim 1, respectively, above, and in further view of Macia Barber (US 2023/0122713).
Regarding claim 16, Dye in view of Nguyen discloses the invention as described above with regard to claim 9.
The combination does not disclose wherein providing the gel composition includes providing a silicone material.
Macia Barber teaches providing an analogous gel composition ([0037]; silicone gel or other adhesive material) that provides coupling of ultrasound signals to and from the subject ([0035]; [0037], capable of intended use) wherein providing the gel composition includes providing a silicone material (silicone gel, [0037]).
Regarding claim 21, Dye in view of Nguyen discloses the invention as described above with regard to claim 1.
The combination does not disclose wherein providing the gel composition comprises a silicone gel.
Macia Barber teaches providing an analogous gel composition ([0037]; silicone gel or other adhesive material) that provides coupling of ultrasound signals to and from the subject ([0035]; [0037], capable of intended use) wherein providing the gel composition includes providing a silicone gel (silicone gel, [0037]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that the gel composition in the surgical covering of Dye in view of Nguyen comprises a silicone gel as taught by Macia Barber, in order to provide an surgical covering that is capable of transmitting ultrasound pulses without introducing significant interference or attenuation (Macia Barber, [0037]).
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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/G.M./Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786
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