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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/15/2026 has been entered.
Drawings
Applicant’s arguments, see pages 7-9, filed 06/15/2026, with respect to the drawing objection have been fully considered and are persuasive. Therefore, the drawing objection has been withdrawn.
Response to Amendment
The amendment to the claims filed on 6/15/2026 is acknowledged. In the amendment, claims 1, 7, 9, and 19 are amended. Claims 1-5 and 7-21 are currently pending.
Response to Arguments
Applicant’s arguments, see page 12, first paragraph filed 6/15/2026, with respect to the rejection(s) of claim(s) 1, 9 and 17 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 Therefore, the rejection has been withdrawn.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 newly cited Buchalter (US 2008/0200810) in view of previously cited Dye US 2013/0247921).
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, 3-5, 7-9 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buchalter (US 2008/0200810) in view of Dye (US 2013/0247921).
Regarding claim 1, Buchalter discloses a covering (1) ([0016]; [0038]; capable of intended use as it has a textile/support that is brought in contact with the human body and is thus a covering), comprising: an acoustic window (11) ([0037], [0044], the aperture receives a gel pad 2 that is for ultrasound and thus it is an acoustic window) formed in the surgical covering ([0037], aperture formed in the support/surgical covering); a coupling material (2) positioned in the acoustic window ([0037]), the coupling material comprising a gel composition ([0037], gel pad) fixed within the acoustic window ([0037], the gel pad is received in the aperture) and fixed to the covering ([0037], the gel pad is received within the aperture 11 and is thus fixed to the support 3/covering as the aperture is formed in the support 3), the coupling material being configured to be in direct contact with skin of a subject ([0038], gel pad 2 and frame come into close contact with the human body); wherein the acoustic window and the coupling material are configured to allow a coupling of an ultrasound wave with a subject ([0015], the gel pad acts as a couplant i.e. as a material that facilitates the transmission of ultrasonic energy from the transducer into the test specimen/human; [0015], gel pad brought in contact with the skin; [0037], gel pad is received in the aperture/window).
Buchalter further discloses at [0016] that the support [covering] may be any element that provides a stable connection between the skin of the human and the gel pad when the ultrasound coupling device is adhered to the body but Buchalter does not explicitly disclose the covering is a surgical covering.
Dye teaches an analogous covering (10) that is a surgical covering ([0050], drape 10 is a surgical drape used during a surgical operation), comprising an analogous 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 analogous 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).
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 covering of Buchalter is a surgical covering as taught by Dye, in order to provide an improved covering that can be used during surgical procedures (Dye, [0050]).
Regarding claim 3, Buchalter in view of Dye discloses the invention as described above with regard to claim 1.
Buchalter further discloses wherein the acoustic window is configured to be located at specific anatomical locations ([0044], human body; capable of intended use); and wherein the acoustic window is configured to couple the ultrasound wave with the subject for visualizing a portion within the subject ([0004],[0045], Ultrasound is used for imaging the internal organs and systems of the body and for diagnosing abnormalities; capable of intended use).
Regarding claim 4, Buchalter in view of Dye discloses the invention as described above with regard to claim 3.
Buchalter further discloses wherein the portion within the subject is anatomy ([0004], [0044], human body is anatomy).
Regarding claim 5 Buchalter in view of Dye discloses the invention as described above with regard to claim 3.
The combination further discloses further comprising a procedure portal (30, 32; annotated Dye 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 Dye Fig. 8; NOTE: in the combination the acoustic window is a window per Buchalter), and wherein the acoustic window allows visualization (ultrasound visualization is allowed, Buchalter [0044]) while providing surgical access to an anatomy (Dye, [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, Buchalter in view of Dye discloses the invention as described above with regard to claim 1.
Buchalter further discloses wherein the acoustic window includes a passage formed in a sheet (3) of the surgical covering ([0037], aperture is a passage in the support/surgical covering); wherein the gel composition is fixed to a portion of the sheet to at least partially cover the passage ([0037], gel is received within the aperture of support 3/sheet and as seen in Fig. 1 is fixed to a portion of the sheet and as it is received it at least partially covers the passage).
Regarding claim 8, Buchalter in view of Dye discloses the invention as described above with regard to claim 7.
Buchalter further discloses wherein the coupling material includes a first side and a second side ([0038]; gel pad is flush with frame 8, gel pad with flush frame and has a first side and a second side), wherein at least one of the first side or the second side includes an adhesive ([0042], frame 8 acts as a fixing area A for a transducer and has an adhesive that fixes the transducer head to the support; as gel pad is flush with and is connected with the frame it is connected to the coupling material and therefore the coupling material includes the frame on a first side which includes an adhesive), and wherein the adhesive is configured to adhere to at least one of the sheet or the subject ([0042], adhesive adheres to the sheet as it is on the frame which is on the sheet).
Regarding claim 9, Buchalter discloses a method of providing a covering (1) for a procedure ([0016]; [0038]; capable of intended use as the covering has a textile/support that is brought in contact with the human body and is thus a covering and the procedure is ultrasound), comprising: providing a sheet (3) (Fig. 3 shows support 3 is a sheet in that it is a broad stretch of something) providing an acoustic window (11) formed in the sheet ([0037], [0044]; aperture of support is an acoustic window formed in the sheet as ultrasound occurs at the window); providing a coupling material (2) comprising a gel composition ([0037], gel pad) within the acoustic window ([0037], the gel pad is received within the aperture) and fixed to the sheet ([0037], the gel pad is received within the aperture 11 which is within the support 3 and is thus fixed to the support 3/sheet), the coupling material being configured to be in direct contact with skin of a subject[0038], gel pad 2 and frame come into close contact with the human body); and configuring the acoustic window and the coupling material to allow a coupling of an ultrasound wave with the subject ([0015], the gel pad acts as a couplant i.e. as a material that facilitates the transmission of ultrasonic energy from the transducer into the test specimen/human; [0015], gel pad brought in contact with the skin; [0037], gel pad is received in the aperture/window).
Buchalter further discloses at [0016] that the support [covering] may be any element that provides a stable connection between the skin of the human and the gel pad when the ultrasound coupling device is adhered to the body but Buchalter does not explicitly disclose the covering is a surgical covering.
Dye teaches an analogous covering (10) that is a surgical covering ([0050], drape 10 is a surgical drape used during a surgical operation), comprising an analogous 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 analogous 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).
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 covering of the method of providing a covering for a procedure of Buchalter is a surgical covering as taught by Dye, in order to provide an improved covering that can be used during surgical procedures (Dye, [0050]).
Regarding claim 17, Buchalter discloses a covering (1) ([0016]; [0038]; capable of intended use as it has a textile/support that is brought in contact with the human body and is thus a covering), comprising: an acoustic window (11) formed in a sheet (3) (Fig. 3 shows support 3 is a sheet in that it is a broad stretch of something; [0037], [0044]; aperture of support is an acoustic window formed in the sheet as ultrasound occurs at the window); a coupling material (2) comprising a gel composition ([0037], gel pad) fixed within the acoustic window ([0037], the gel pad is received within the aperture and is thus fixed within the acoustic window) and fixed to the sheet ([0037], the gel pad is received within the aperture 11 and is thus fixed to the support 3/surgical covering as the aperture is formed in the support 3), the coupling material being configured to be in direct contact with skin of a subject ([0038], gel pad 2 and frame come into close contact with the human body) and to provide direct acoustic coupling of ultrasound signals between an ultrasound transducer and the subject during a medical procedure; wherein the acoustic window and the coupling material are configured to allow coupling of an ultrasound wave with the subject while covering the subject ([0015], the gel pad acts as a couplant i.e. as a material that facilitates the transmission of ultrasonic energy from the transducer into the test specimen/human; [0015], gel pad brought in contact with the skin).
Buchalter further discloses at [0016] that the support [covering] may be any element that provides a stable connection between the skin of the human and the gel pad when the ultrasound coupling device is adhered to the body.
Buchalter does not explicitly disclose the covering is a surgical covering and a procedure portal formed through the sheet.
Dye teaches an analogous covering (10) that is a surgical covering ([0050], drape 10 is a surgical drape used during a surgical operation), comprising an analogous 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 a sheet (Fig. 8, opening in the drape/sheet); 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); and a procedure portal a procedure portal (30, 32; annotated Dye Fig. 8 above with regard to the claim 5 rejection; [0068]; NOTE: providing an instrument is a procedure thus the portal 32 which is associated with the instrument is a procedural portal) formed through the sheet (annotated Fig. 8 above with regard to claim 5).
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 covering of Buchalter is a surgical covering, as taught by Dye, and to provide to the covering a procedure portal formed through the sheet, as taught by Dye, in order to provide an improved covering that can be used during surgical procedures (Dye, [0050]) and that permits non-sterile medical instruments to be introduced to the sterile surgical field (Dye, [0003]).
Regarding claim 18, Buchalter in view of Dye discloses the invention as described above with regard to claim 17.
Buchalter further discloses wherein the acoustic window is configured to be placed at specific anatomical locations of the subject ([0044], human body; capable of intended use); and wherein the acoustic window and the coupling material are configured to couple the ultrasound wave with the subject for visualizing a portion within the subject ([0004], [0045], Ultrasound is used for imaging the internal organs and systems of the body and for diagnosing abnormalities; capable of intended use).
Claim(s) 2 and 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buchalter (US 2008/0200810) in view of Dye (US 2013/0247921), as applied to claim 1 and to claim 9, respectively above, and in further view of Sumanaweera (US 2008/0021317).
Regarding claim 2, Buchalter in view of Dye discloses the invention as described above with regard to claim 1.
Buchalter in view of Dye does not disclose wherein the surgical covering includes a plurality of acoustic windows, including the acoustic window formed in the surgical covering.
Sumanaweera teaches an analogous covering (82) for a body ([0076], Fig. 8, shows a covering on a body) comprising an analogous acoustic window (84) ([0046], acoustic windows; [0077], one of the windows 84) formed in the covering (Fig. 8), wherein the analogous covering includes a plurality of acoustic windows (84) ([0082], greater or fewer windows may be used) including the acoustic window formed in the analogous surgical covering (Fig. 8; [0081]; [0082]).
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 surgical covering of Buchalter in view of Dye includes as plurality of acoustic windows, including the acoustic window formed in the surgical covering, as taught by Sumanaweera, in order to provide an improved surgical covering that facilitates generating an image and a multiplanar reconstruction (Sumanaweera, [0083]; [0084]).
Regarding claim 10, Buchalter in view of Dye discloses the invention as described above with regard to claim 9.
Buchalter does not disclose wherein providing the acoustic window in the sheet includes providing a plurality of acoustic windows.
Sumanaweera teaches an analogous method of providing an analogous covering (82) for a body ([0076], Fig. 8, shows a covering on a body) comprising providing a plurality of acoustic windows (84) ([0046], acoustic windows; [0082], greater or fewer windows may be used).
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 method of providing a surgical covering of Buchalter in view of Dye includes providing a plurality of acoustic windows, as taught by Sumanaweera, in order to provide an improved surgical covering that facilitates generating an image and a multiplanar reconstruction (Sumanaweera, [0083]; [0084]).
Regarding claim 11, Buchalter in view of Dye and in further view of Sumanaweera discloses the invention as described above with regard to claim 10.
The combination further discloses providing the plurality of acoustic windows in the sheet at specific anatomical locations (in the combination, Buchalter discloses providing an acoustic window in the sheet at a specific anatomic location ([0044], human body) and Sumanweera teaches providing a plurality of acoustic windows also at specific anatomic locations [Fig. 8], thus in the combination a plurality of acoustic windows are provided in the sheet at specific anatomical locations); 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 (Buchalter, [0045]).
Regarding claim 12, Buchalter in view of Dye and in further view of Sumanweera discloses the invention as described above with regard to claim 11.
Buchalter further discloses wherein configuring the acoustic window to couple the ultrasound wave with the subject enables visualization of anatomy within the subject ([0044] to [0045]; [0004] envisioning internal organs and systems).
Regarding claim 13, Buchalter in view of Dye and in further view of Sumanweera discloses the invention as described above with regard to claim 11.
The combination further comprising: providing a procedure portal (30, 32; annotated Dye Fig. 8 above with regard to the rejection to claim 5; 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 Dye Fig. 8; NOTE: in the combination the acoustic window is a window per Buchalter), wherein the acoustic window allows visualization (ultrasound visualization is allowed, (Buchalter, [0044]) while providing surgical access to an anatomy (Dye, [0068]; NOTE: as there is a sterile surgical field it is implied that surgical access to an anatomy is provided; 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 surgical covering of Buchalter in view of Dye includes as plurality of acoustic windows, including the acoustic window formed in the surgical covering, as taught by Sumanaweera, in order to provide an improved surgical covering that facilitates generating an image and a multiplanar reconstruction (Sumanaweera, [0083]; [0084]).
Claim(s) 14-15 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buchalter (US 2008/0200810) in view of Dye (US 2013/0247921), as applied to claim 9 above with regard to claims 14-15 and as applied to claim 17 above with regard to claim 19, and in further view of Matsumoto (US 2015/0245811).
Regarding claim 14, Buchalter in view of Dye discloses the invention as described above with regard to claim 9.
Buchalter further discloses wherein providing the coupling material includes providing the gel composition at the acoustic window (Buchalter [0037], gel pad is received within the aperture) to provide direct coupling of an ultrasound signal to and from the subject (Buchalter, [0044], [0045]; [0004], ultrasound is used for imaging the internal organs and systems of the body).
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 Buchalter in view of Dye is a wide-band ultrasound signal, as taught by Matsumoto , in order to provide an improved method of providing a surgical covering that has ten kinds of resonance frequences (Matsumoto, [0107]) and that improves the ultrasound transmission/reception sensitivity (Matsumoto, [0068]).
Regarding claim 15, Buchalter in view of Dye and in further view of Matsumoto discloses the invention as described above with regard to claim 14.
Buchalter further discloses providing the acoustic window as a passage formed in the sheet ([0037], aperture is a passage formed in the support/surgical covering); and providing the gel composition fixed to a portion of the sheet to at least partially cover the passage ([0037], gel is received within the aperture of support 3 and as seen in Fig. 1 is fixed to a portion of the sheet and as it is received it at least partially covers the passage).
Regarding claim 19, Buchalter in view of Dye discloses the invention as described above with regard to claim 17.
Buchalter further discloses wherein the gel composition is configured to provide direct acoustic coupling of an ultrasound signal to and from the subject (Buchalter, [0044], [0045]; [0004], ultrasound is used for imaging the internal organs and systems of the body).
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 for direct coupling to and from the subject of the surgical covering for a procedure of Buchalter in view of Dye 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 Buchalter (US 2008/0200810) in view of Dye (US 2013/0247921), as applied to claim 9 and to claim 1 respectively, above and in further view of Macia Barber (US 2023/0122713).
Regarding claim 16, Buchalter in view of Dye 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]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to provide that providing the gel composition of the method of providing a surgical covering of Buchalter in view of Dye includes providing a silicone material as taught by Macia-Barber, in order to provide an improved method that has a gel composition that is capable of transmitting ultrasound pulses without introducing significant interference or attenuation, such that an acceptable acoustic response can be obtained from the target site (Macia-Barber, [0037]).
Regarding claim 21, Buchalter in view of Dye discloses the invention as described above with regard to claim 1.
Buchalter in view of Dye does not disclose where 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]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buchalter (US 2008/0200810) in view of Dye (US 2013/0247921), as applied to claim 17 above and in further view of Csavoy (US 2008/0269600).
Regarding claim 20, Buchalter in view of Dye discloses the invention as described above with regard to claim 17.
Buchalter in view of Dye does not disclose an optical tracking device, an electromagnetic tracking device, or a fiducial fixed to the sheet.
Csavoy teaches an analogous surgical covering (surgical drape, [0080]) comprising an optical tracking device ([0082], [0083]) , an electromagnetic tracking device, or a fiducial fixed to the sheet ([0083]).
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 surgical covering of Buchalter in view of Dye is further comprising an optical tracking device, an electromagnetic tracking device, or a fiducial fixed to the sheet as taught by Csavoy, in order to provide an improved surgical covering that facilitates providing position information of the patient (Csavoy, [0083]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Brien (US 2019/0175144) teaches an analogous covering (400) for a body ([0070], workspace can be overlaid across a surface of a portion of the patient) comprising a plurality of acoustic windows (401-416) ([0071]).
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/G.M./ Examiner, Art Unit 3786
/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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