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 .
Information Disclosure Statement
The information disclosure statement filed July 26, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein pertaining to the foreign patent documents and non patent literature has not been considered.
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 coupling port of claims 1, 9 and 17; the passage of claims 7, 15 and 17; and the gel-like material fixed to a portion of the sheet to at least partially cover the passage of claim 15 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 Objections
Claim 8 is objected to because of the following informalities: Claim 8 recites “whedrein” in line 3. It appears it should recite –wherein--. Appropriate correction is required.
Claims 6, 14 and 19 are objected to because of the following informalities. They recite “a wide-band ultrasound signals” which appears grammatically incorrect. For example, these claims could be amended to recite --a wide-band ultrasound signal--.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: coupling material in claim 1.
Claim limitation “coupling material” has been interpreted under 35 USC 112(f) or pre-AIA 35 USC 112, sixth paragraph, because it uses a generic placeholder “material” as a substitute for means coupled with functional language “coupling” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
A review of the specification shows that the corresponding structure of the 35 U.S.C. 112(f) or pre-AIA U.S.C. 112, sixth paragraph limitation “coupling material” described in the specification includes a gel-like material (Applicant’s specification, [0070]) and tape or a thin flexible member (Applicant’s specification, [0072] and claim 6; NOTE: claim 6 indicates a coupling material includes a low impedance material and [0072] indicates that a low impedance material is a tape, or a thin flexible member).
Claim limitation “tracking device” has been interpreted under 35 USC 112(f) or pre-AIA 35 USC 112, sixth paragraph, because it uses a generic placeholder “device” as a substitute for means coupled with functional language “tracking” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
A review of the specification shows that the corresponding structure of the 35 U.S.C. 112(f) or pre-AIA U.S.C. 112, sixth paragraph limitation “tracking device” described in the specification includes an optical localizer; electromagnetic localizer; controller, interface and processor; acoustic radiation; or radar (Applicant’s specification, [0055]-[0056]; [0059]).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 3-8 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 3 recites “wherein the coupling port is located at specific anatomical locations” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite “ wherein the coupling port is configured to be located at specific anatomical locations”.
As claims 4-5 depend from claim 3 they rejected for at least the same reasons as claim 3.
Claim 6 recites “a low acoustic impedance material at the coupling ports that provide direct coupling of a wide-band ultrasound signals to and from the subject” which positively claims the human body. Language such as “configured to “ or “adapted for” is recommend to positively avoid claiming human body parts. For example, the claim could be amended to recite --a low acoustic impedance material at the coupling ports that is configured to provide direct coupling of a wide-band ultrasound signals to and from the subject--.
As claims 7-8 depend from claim 6 they are rejected for at least the same reasons as claim 6.
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 5-8, 11-13 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “near” in claim 5 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination the term near will be interpreted as being on any part of the surgical covering.
Claim 6 recite the limitation "the coupling ports" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as –the coupling port--.
The term “low” in claim 6 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination the term near will be interpreted as a thin flexible member (per Applicant’s specification at [0072], a thin flexible member is a low acoustic impedance material).
As claims 7-8 depend from claim 6, they are rejected for at least the same reasons as claim 6.
Claim 11 recites the limitation "the coupling window" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as --a coupling window--.
As claim 12 depends from claim 11, it is rejected for at least the same reasons as claim 11.
The term “near” in claim 13 is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination the term near will be interpreted as being on any part of the surgical covering.
Claim 19 recite the limitation "the coupling ports" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination it will be interpreted as –the coupling port-
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 7-13, 15 and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dye (US 2013/0247921).
Regarding claim 1, Dye discloses a surgical covering (10), comprising: a coupling port (opening in the drape 10 in which the transmissive window 26 is disposed; Fig. 1B; [0041]; [0050]; [0054]; [0071]; annotated Fig. 7B below; NOTE: Applicant’s specification at [0070] indicates an opening is also referred to as a coupling port or portal and note that window 26 in Dye is formed in an opening of the drape [Fig. 1B] as per [0041] at it is secured to the sheet with a seal and surrounded by opaque portions of the 28 as seen in Fig. 1B thus evidencing it is secured within an opening and the opening is the coupling port)
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formed in the surgical covering ([0041]; Fig. 1B); a coupling material (26)(34) (NOTE: per 112f analysis above a coupling material is a thin flexible member, tape or gel; [0041]; [0042]; NOTE: in Dye the window 26 is a transmissive window that can be constructed of an impervious polymer and can be rectangular or square and as seen in Fig. 1B is relatively thin and long and is thus equivalent to tape under the 112f analysis above and it is a polymer that is thin and implied to have some flexibility and is thus a thin flexible member; ALSO NOTE: [0056]; gel is provided to the sheath 34 and the sheath is inserted through the coupling port [window opening] and thus a gel [coupling material] is formed in the surgical covering; ALSO NOTE: the distal tip of the sheath can include an ultrasound coupling interface and the sheath is a polymeric material and is thus equivalent to tape or a thin flexible member as per the 112f analysis above and is positioned in the coupling port [window opening]) positioned in the coupling port (Fig. 1B shows the transmissive window 26 in the coupling port; [0055]; [0056]; also see description above of gel on the sheath which is within the opening of the transmissive window 26 [coupling port] and also of the sheath being in the opening 16 which is in the coupling port [opening in which the transmissive window is disposed]); wherein the coupling port and the coupling material are configured to allow a coupling of an ultrasound wave with a subject ([0049]; [0056]; [0070];[0053]; claims 14 and 8; Fig. 8; capable of intended use).
Regarding claim 2, Dye discloses the invention as described above.
Dye further discloses wherein the coupling port includes a plurality of coupling ports ([0042]; [0070] NOTE: one or more portals can be attached to the transmissive window 26 and each portal has an opening 16 thus there are a plurality of coupling ports; Also the port in which the transmissive window 26 is disposed and the opening 16 are a plurality of coupling ports; [0050]; NOTE: also more than one transmissive window may be included thus more than one coupling port in which the window is disposed).
Regarding claim 3, Dye discloses the invention as described above.
Dye further discloses wherein the coupling port is located at specific anatomical locations (Fig. 8; [0053]; [0056]; [0070]; NOTE: the opening at which is the transmissive window 26 [the coupling port] is at specific anatomical locations as seen in Fig. 8 and the opening 16 which is a part of the coupling port is at a specific anatomical location); wherein the coupling port is configured to couple the ultrasound wave with the subject for visualizing a portion within the subject ([0056]; [0070];[0053]; claims 14 and 8; Fig. 8; capable of intended use).
Regarding claim 4, Dye discloses the invention as described above with regard to claim 3.
Dye further discloses wherein 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 discloses the invention as described above with regard to claim 3.
Dye further discloses further comprising: a procedure portal (30) ([0042]; [0053]; NOTE: one or more portals may be attached and each portal has a sheath used for a procedure such as for example radiation monitoring); wherein the procedure portal is near the coupling port ([0042]; NOTE: as the portals are attached to the transmissive window and the portals include the procedural portal and the coupling portal the procedural portal is near the coupling port) and the coupling port allows visualization (see claim 3 for description of the coupling port allowing 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).
Regarding claim 7, Dye discloses the invention as described above with regard to claim 3.
Dye further discloses wherein the coupling port includes a passage (16) formed in a sheet ([0053]; [0054]; [0071]; Fig. 2B; Fig. 1B; NOTE: opening 16 is within the coupling port and it includes a passage for the working end of the non-sterile device 50 of the sheath 34 and the opening is formed in a transmissive window of the drape; wherein the low acoustic impedance material is fixed to a portion of the sheet ([0041]; NOTE: transmissive window is fixed to the sheet).
Regarding claim 8, Dye discloses the invention as described above with regard to claim 3.
Dye further discloses wherein the low acoustic impedance material includes a first side and a second side ([0041]; NOTE: it is implied that transmissive window 26 has a first side and a second side), wherein at least one of the first side or the second side includes an adhesive ([0041]; chemical adhesives), 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 ([0035]), comprising: providing a sheet (10) (Fig. 8; Fig. 1B; NOTE: surgical drape is a sheet); providing a coupling port (opening in the drape 10 in which the transmissive window 26 is disposed; Fig. 1B; [0041]; [0050]; [0054]; [0071]; annotated Fig. 7B above with regard to claim 1 rejection; NOTE: Applicant’s specification at [0070] indicates an opening is also referred to as a coupling port or portal and note that window 26 in Dye is formed in an opening of the drape [Fig. 1B] as per [0041] at it is secured to the sheet with a seal and surrounded by opaque portions of the 28 as seen in Fig. 1B thus evidencing it is secured within an opening and the opening is the coupling port) formed in the sheet (Fig. 7A; [0041]); providing a coupling material (26)(34) (NOTE: per 112f analysis above a coupling material is a thin flexible member, tape or gel; [0041]; [0042]; NOTE: in Dye the window 26 is a transmissive window that can be constructed of an impervious polymer and can be rectangular or square and as seen in Fig. 1B is relatively thin and long and is thus equivalent to tape under the 112f analysis above and it is a polymer that is thin and implied to have some flexibility and is thus a thin flexible member; ALSO NOTE: [0056]; gel is provided to the sheath 34 and the sheath is inserted through the coupling port [window opening] and thus a gel [coupling material] is formed in the surgical covering; ALSO NOTE: the distal tip of the sheath can include an ultrasound coupling interface and the sheath is a polymeric material and is thus equivalent to tape or a thin flexible member as per the 112f analysis above and is positioned in the coupling port [window opening])) positioned in the coupling port (Fig. 1B shows the transmissive window 26 in the coupling port; [0055]; [0056]; also see description above of gel on the sheath which is within the opening of the transmissive window 26 [coupling port] and also of the sheath being in the opening 16 which is in the coupling port [opening in which the transmissive window is disposed]); configuring the coupling port and the coupling material to allow a coupling of an ultrasound wave with a subject ([0049]; [0056]; [0070];[0053]; claims 14 and 8; Fig. 8; capable of intended use).
Regarding claim 10, Dye discloses the invention as described above with regard to claim 9.
Dye further discloses wherein providing the coupling port in the sheet includes providing a plurality of coupling ports ([0042]; [0070] NOTE: one or more portals can be attached to the transmissive window 26 and each portal has an opening 16 thus there are a plurality of coupling ports; Also the port in which the transmissive window 26 is disposed and the opening 16 are a plurality of coupling ports [0042]; [0070]; [0050]; NOTE: also more than one transmissive window may be included thus more than one coupling port within which the window is disposed).
Regarding claim 11, Dye discloses the invention as described above with regard to claim 10.
Dye further discloses providing the coupling port in the sheet at specific anatomical locations (Fig. 8; [0053]; [0056]; [0070]; NOTE: the opening at which is the transmissive window 26 [the coupling port] is at specific anatomical locations as seen in Fig. 8 and the opening 16 which is a part of the coupling port is at a specific anatomical location); wherein configuring the coupling port and the coupling window (26) ([0041]) to allow the coupling of the ultrasound wave with the subject includes configuring the coupling port to couple the ultrasound wave with the subject for visualizing a portion within the subject ([0056]; [0070];[0053]; claims 14 and 8; Fig. 8; capable of intended use).
Regarding claim 12, Dye discloses the invention as described above with regard to claim 11.
Dye further discloses wherein configuring the coupling port to couple the ultrasound wave with the subject for visualizing the portion within the subject (see claim 11 description above) includes visualization of anatomy within the subject ([0056]; [0070];[0053]; claims 14 and 8; Fig. 8; capable of intended use).
Regarding claim 13, Dye discloses the invention as described above with regard to claim 9.
Dye further discloses providing a procedure portal (30) ([0042]; [0053]; NOTE: one or more portals may be attached and each portal has a sheath used for a procedure such as for example radiation monitoring) near the coupling port ([0042]; NOTE: as the portals are attached to the transmissive window and the portals include the procedural portal the procedural portal is near the coupling port and per the 112f analysis above as they are both on the surgical covering the limitation of near is met) and the coupling port allows visualization (([0056]; [0070];[0053]; claims 14 and 8; Fig. 8; capable of intended use) 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).
Regarding claim 15, Dye discloses the invention as described above with regard to claim 14.
Dye further discloses providing the coupling port as a passage (16) formed in the sheet ([0053]; [0054]; NOTE: opening 16 is a part of the coupling port as it is within the transmissive window which is in the coupling port and it includes a passage for the working end of the non-sterile device 50 of the sheath 34); providing the gel-like material fixed to a portion (34) of the sheet ([0039]; NOTE: sheath 34 is a portion of the sheet insofar as it is connected to it via the portal [poral can be attached to the drape] to at least partially cover the passage ([0055]; [0056]; capable of intended use in that the sheath is inserted in the passage and the sheath has the gel at a tip).
Regarding claim 17, Dye discloses a surgical covering (10), comprising: a coupling port (opening in the drape 10 in which the transmissive window 26 is disposed; Fig. 1B; [0041]; [0050]; [0054]; [0071]; annotated Fig. 7B above with regard to the claim 1 rejection; NOTE: Applicant’s specification at [0070] indicates an opening is also referred to as a coupling port or portal and note that window 26 in Dye is formed in an opening of the drape [Fig. 1B] as per [0041] at it is secured to the sheet with a seal and surrounded by opaque portions of the 28 as seen in Fig. 1B thus evidencing it is secured within an opening and the opening is the coupling port) formed as a passage (16) in a sheet ([0053]; [0054]; NOTE: opening 16 is a within the coupling port and it includes a passage for the working end of the non-sterile device 50 of the sheath 34); a coupling material (26)(34) (NOTE: per 112f analysis above a coupling material is a thin flexible member, tape or gel; [0041]; [0042]; NOTE: in Dye the window 26 is a transmissive window that can be constructed of an impervious polymer and can be rectangular or square and as seen in Fig. 1B is relatively thin and long and is thus equivalent to tape under the 112f analysis above and it is a polymer that is thin and implied to have some flexibility and is thus a thin flexible member; ALSO NOTE: [0056]; gel is provided to the sheath 34 and the sheath is inserted through the coupling port [window opening] and thus a gel [coupling material] is formed in the surgical covering; ALSO NOTE: the distal tip of the sheath can include an ultrasound coupling interface and the sheath is a polymeric material and is thus equivalent to tape or a thin flexible member as per the 112f analysis above and is positioned in the coupling port [window opening]) positioned in the coupling port (NOTE: transmissive window 26 is positioned in the port as seen in Fig. 1B; [0050]; [0056]; NOTE: sheath which has a distal tip with gel is in the coupling port and is is part of the portal 30 which is in the port and attached to the transmissible window) and fixed to the sheet (Fig. 1B; [0041]; [0050]; [0055]; [0056]; NOTE: the transmissive window is fixed to the sheet [drape] and also note the gel on the sheath is a part of the portal which is within the opening of the transmissive window 26 and attached to the transmissive window which is part of the drape [sheet]); and a procedure portal (30, 34) ([0042]; [0053]; NOTE: one or more portals may be attached and each portal has a sheath used for a procedure such as for example radiation monitoring) formed through the sheet ([0054]; Fig. 7A shows opening 16 [portal] through the sheet and the sheath of the portal is inserted into an opening which is formed in the drape [sheet]); wherein the coupling port and the coupling material are configured to allow a coupling of an ultrasound wave with a subject while covering the subject ([0049]; [0056]; capable of intended use).
Regarding claim 18, Dye discloses the invention as described above with regard to claim 17.
Dye further discloses wherein the coupling port is located to be placed at specific anatomical locations of the subject ((Fig. 8; [0053]; [0056]; [0070]; NOTE: the opening at which is the transmissive window 26 [the coupling port] is at specific anatomical locations as seen in Fig. 8 and the opening 16 which is a part of the coupling port is at a specific anatomical location); wherein the coupling port and the coupling material are configured to couple the ultrasound wave with the subject for visualizing a portion within the subject (([0056]; [0070];[0053]; claims 14 and 8; Fig. 8; capable of intended use).
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) 6, 14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dye (US 2013/0247921) as applied to claims 1, 9, and 17 above, respectively, and in view of Matsumoto (US 2015/0245811).
Regarding claim 6, Dye discloses the invention as described above with regard to claim 3.
Dye further discloses wherein the coupling material positioned in the coupling port includes a low acoustic impedance material at the coupling ports ([0041]; NOTE: transmissive window 26 is in the port of drape and it is a low acoustic impedance material in that it is a thin flexible member [[0041]; Fig. 1B; NOTE: it is a polymer and thus it has some level of flexibility and it is thin as seen in Fig. 1B; NOTE: see 112b analysis above for interpretation of low acoustic impedance material) that provide direct coupling of a ultrasound signals to and from the subject ([0056]; [0039]; [0049]; [0050]; NOTE: as applicator frame 32 is attached to the transmissive window [0050] and the applicator frame is including the sheath and the distal tip of the sheath that can include an ultrasound coupling interface [0056] which is capable of ultrasound imaging and the intended use it follows that the low acoustic impedance material [transmissive window] at the coupling port that provides direct coupling of a ultrasound signals to and from the subject as the coupling interface is within the transmissive window).
Dye does not disclose coupling of a wide-band ultrasound signals 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 coupling ports of Dye that provide direct coupling of a ultrasound signals to and from the subject provide direct coupling of a wide-band ultrasound signals to and from the subject , as taught by Matsumoto , in order to provide an improved surgical covering that has ten kinds of resonance frequencies (Matsumoto, [0107]) and that improves the ultrasound transmission/reception sensitivity (Matsumoto, [0068]). Regarding claim 14, Dye discloses the invention as described above with regard to claim 9.
Dye further discloses wherein providing a coupling material positioned in the coupling port includes providing a gel-like material at the coupling ports ([0056]; see description with regard to claim 9 above and a coupling material; NOTE: gel is provided to the sheath and the sheath is inserted through the portal and opening of the surgical covering and thus a coupling material positioned in the coupling port includes a gel-like material) that provide direct coupling of a wide-band ultrasound signals to and from the subject (([0056]; [0039]; [0049]; [0050]; NOTE: as applicator frame 32 is attached to the transmissive window [0050] [coupling port] and the applicator frame is including the sheath and the distal tip of the sheath that can include an ultrasound coupling interface [0056] which is capable of ultrasound imaging and the intended use it follows that the coupling port provides direct coupling of a ultrasound signals to and from the subject through its attachment to the applicator frame).
Dye does not disclose coupling of a wide-band ultrasound signals 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 coupling ports of Dye that provide direct coupling of a ultrasound signals to and from the subject provide direct coupling of a wide-band ultrasound signals to and from the subject, 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 19, Dye discloses the invention as described above with regard to claim 17.
Dye further discloses wherein the coupling material is a gel-like material at the coupling ports (Fig. 1B; [0054]; [0055]; [0056]; NOTE: a distal tip of the sheath has gel and is a part of the portal and is in the coupling port) that provide direct coupling of a wide-band ultrasound signals to and from the subject ([0056]; [0039]; [0049]; [0050]; NOTE: as applicator frame 32 is attached to the transmissive window [0050] and the applicator frame is including the sheath and the distal tip of the sheath that can include an ultrasound coupling interface [0056] which is capable of ultrasound imaging and the intended use it follows that the coupling port provides direct coupling of a ultrasound signals to and from the subject through its attachment to the applicator frame).
Dye does not disclose coupling of a wide-band ultrasound signals 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 coupling ports of Dye that provide direct coupling of a ultrasound signals to and from the subject provide direct coupling of a wide-band ultrasound signals to and from the subject, as taught by Matsumoto , in order to provide an improved surgical covering that has ten kinds of resonance frequencies (Matsumoto, [0107]) and that improves the ultrasound transmission/reception sensitivity (Matsumoto, [0068]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dye (US 2013/0247921) as applied to claim 9 above, in view of Macia Barber (US 2023/0122713).
Regarding claim 16, Dye discloses the invention as described above with regard to claim 9.
Dye does not disclose wherein providing the gel-like material includes providing a silicone material.
Macia Barber teaches providing an analogous gel-like material ([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-like material 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-like material in the method of providing a surgical covering for a procedure of Dye includes providing a silicone material as taught by Macia Barber, in order to provide an improved method of providing a surgical covering for a procedure 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 Dye (US 2013/0247921) as applied to claim 17 above, in view of Pollak (2020/0397525).
Regarding claim 20, Dye discloses the invention as described above with regard to claim 17.
Dye does not disclose a tracking device or a fiducial fixed to the sheet.
Pollak teaches an analogous surgical covering (200, 210) further comprising a tracking device or a fiducial fixed to the sheet ([0031]).
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 Dye is further comprising a tracking device or a fiducial fixed to the sheet, as taught by Pollak, in order to provide an improved surgical covering that facilitates alignment of the drape with the patient (Pollak, [0031]).
Conclusion
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/G.M./Examiner, Art Unit 3786
/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786