DETAILED ACTION
In the preliminary amendment filed 4/10/23, Applicant amended claims 1, 3-4 and 17-27; and amended the specification. Currently, claims 1-27 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p) because they include written descriptions of the figures when only reference characters, sheet numbers and/or view numbers are permitted. Appropriate revision is required.
The drawings are objected to because some figures are not of sufficient quality to permit examination (i.e. figure 1). Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
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.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it includes phrases which can be implied (i.e. “Devices…are disclosed herein”) and includes legal phraseology (i.e. “comprise”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 3-27 are objected to as failing to comply with 37 CFR 1.121 because each of these claims fails to include markings to identify changes which have been made to the claim. For example, in line 1 of each claim, the claim previously recited “The device of any one of the preceding Clauses” or “The device of Clause…” but has now been amended to recite “The device of claim…” without any markings to indicate that such changes have been made. Specifically, terms have not been included with strikethrough to properly remove the terms from the claim and/or provided with underlining to show addition of new terms in the claim. This is not a complete listing of all instances where there is missing strikethrough and/or underlining but merely examples of the types of issues present with the pending claims. Under MPEP §714(II)(C)(B), “claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. The changes in any amended claim must be shown by strike-through (for deleted matter) or underlining (for added matter) with 2 exceptions: (1) for deletion of five or fewer consecutive characters, double brackets may be used (e.g., [[eroor]]); (2) if strike-through cannot be easily perceived (e.g., deletion of number “4” or certain punctuation marks), double brackets must be used (e.g., [[4]])”. Therefore, currently amended claims 3-27 do not comply with 37 CFR 1.121. It has been assumed for examination purposes that Applicant intended for the claims to include the language which is currently present in the claims, but revision is nevertheless required (i.e. proper strikethrough and/or underlining of deleted/added terms).
Claims 1-2, 5, and 24-26 are objected to because of the following informalities which require appropriate correction:
In claim 1 line 1: “the dissemination” should be “a dissemination”.
In claim 1 line 2: “the surrounding environment” should be “a surrounding environment”.
In claim 1 line 4: “the patient’s head” should be the head of the patient”.
In claim 1 line 5: “the procedure” should be “a procedure”.
In claim 2 line 1: “the dissemination” should be “a dissemination”.
In claim 2 line 2: “the surrounding environment” should be “a surrounding environment”.
In claim 2 line 4: “the patient’s head” should be the head of the patient”.
In claim 2 line 5: “the procedure” should be “a procedure”.
In claim 5 line 2: “its patient-facing surface” should be “a patient-facing surface”.
In claim 5 line 2: “the patient’s body” should be “the body of the patient”.
In claim 24 line 3: “the patient’s skin” should be “the skin of the patient”.
In claim 25 line 2: “wherein, wherein the barrier” should be amended to recite “wherein the barrier”.
In claim 25 line 3: “the patient’s head” should be “the head of the patient”.
In claim 25 line 3: “the procedure” should be “a procedure”.
In claim 25 line 4: “the patient’s nose” should be “the nose of the patient”.
In claim 25 line 5: “the patient’s cheeks” should be “the cheeks of the patient”.
In claim 25 line 4: “the patient’s head” should be “the head of the patient”
In claim 26 line 3: “the surrounding portions” should be “surrounding portions”.
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 25 is 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).
Specifically, Claim 25 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim 25 positively recites part of the human body in combination with the device, as for example: in claim 25, the limitation reciting “…the barrier is positioned on the patient’s head…” of the claim encompasses a human being. It has been held that a claim directed to or including within its scope, a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the constitution. Accordingly, proper procedure where a claim is directed to an apparatus “attached to” the human body or any part thereof is to reject such claim under 35 U.S.C 101 with an explanation that, because the claim positively recites a part of the human body, it is directed to nonstatutory subject matter. See Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987). Therefore, for at least this reason, claim 25 has been rejected under 35 USC 101. It is suggested that the claim be amended to recite “…the barrier is configured to be positioned on the head of the patient…” in order to overcome this rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 20, 26 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gobel (US 2008/0236598).
With respect to claim 1, Gobel discloses a device for preventing or substantially inhibiting the dissemination of pathogens from a patient to the surrounding environment during endotracheal intubation of the patient (para [0006;0009;0039-0042]; fig 1 shows the drape covering a patient having an inserted endotracheal tube), the device comprising: a flexible barrier (drape shown in figs 1-3) configured to be positioned over all or a portion of the patient's head during the procedure (as shown in fig 1; see para [0028]), the barrier comprising a first side configured to face towards the patient during the procedure (lower surface 210 that faces towards the patient; fig 1, para [0028]) and a second side configured to face towards a healthcare worker during the procedure (upper surface 200 that faces away from the patient; fig 1, para [0028]), wherein the barrier includes an access region configured to be positioned at or near a mouth of the patient when the barrier is positioned on the patient during the procedure (opening 120 in the central region 60 of the drape; shown in figs 1-2), and wherein the access region is configured to provide passage of a medical device through the barrier and into an oral cavity of the patient while maintaining a physical barrier around the medical device (as shown in figure 1, endotracheal tube 30 passes through the drape at the opening 120 in the central region 60 of the drape and is inserted into the oral cavity of the patient while the base sheet 80 of the drape maintains a barrier around the device).
With respect to claim 3, Gobel discloses the device as claimed (see rejection of claim 1) and Gobel also discloses that the barrier is sized to cover all or a portion of an upper torso of the patient and a head of the patient (shown in fig 1; see para [0028]).
With respect to claim 4, Gobel discloses the device as claimed (see rejection of claim 1) and Gobel also discloses an extension extending from an edge of the barrier wherein the extension is sized to cover all or a portion of an upper torso of the patient and a head of the patient (as shown in fig 1, the base sheet 80 extends from an edge of the central region 60 and covers at least a portion of the upper torso at the chest and the head of the patient).
With respect to claim 20, Gobel discloses the device as claimed (see rejection of claim 1) and Gobel also discloses that at least a portion of the barrier is transparent (para [0008]).
With respect to claim 26, Gobel discloses the device as claimed (see rejection of claim 1) and Gobel also discloses that the barrier comprises a reinforced portion at the access region (central region 60 may be formed of multiple layers and be configured to provide reinforcement to the areas around the opening – para [0037]), wherein the reinforced portion has a thickness greater than a thickness of the surrounding portions of the barrier (the central region 60 formed of multiple layers incorporates the material of the base sheet with an additional, different material and thus is thicker than the surrounding portions of the drape which only include the material of the base sheet; see para [0037]).
With respect to claim 27, Gobel discloses the device as claimed (see rejection of claim 1) and Gobel also discloses that the barrier comprises a reinforced portion at the access region (central region 60 may be formed of multiple layers and be configured to provide reinforcement to the areas around the opening – para [0037]), wherein the reinforced portion is less flexible than the rest of the barrier (less flexible materials may be used for the central region – para [0039]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 6, 8, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2008/0236598) in view of Hart et al (US 5848992).
With respect to claim 2, Gobel discloses a device for preventing or substantially inhibiting the dissemination of pathogens from a patient to the surrounding environment during endotracheal intubation of the patient (para [0006;0009;0039-0042]; fig 1 shows the drape covering a patient having an inserted endotracheal tube), the device comprising: a flexible barrier (drape shown in figs 1-3) configured to be positioned over all or a portion of the patient's head during the procedure (as shown in fig 1; see para [0028]), the barrier comprising a first side configured to face towards the patient during the procedure (lower surface 210 that faces towards the patient; fig 1, para [0028]) and a second side configured to face towards a healthcare worker during the procedure (upper surface 200 that faces away from the patient; fig 1, para [0028]), wherein the barrier includes a first access region configured to be positioned at or near a mouth of the patient when the barrier is positioned on the patient during the procedure (opening 120 in the central region 60 of the drape; shown in figs 1-2), and wherein the access region is configured to provide passage of a medical device through the barrier and into an oral cavity of the patient while maintaining a physical barrier around the medical device (as shown in figure 1, endotracheal tube 30 passes through the drape at the opening 120 in the central region 60 of the drape and is inserted into the oral cavity of the patient while the base sheet 80 of the drape maintains a barrier around the device).
Gobel does not, however, disclose a second access region configured to be positioned at or near a mouth of the patient when the barrier is positioned on the patient during the procedure and configured to provide passage of a medical device through the barrier and into an oral cavity of the patient while maintaining a physical barrier around the medical device.
Hart, however, teaches a device (10; fig 4) comprising a flexible barrier (flexible base 14; fig 4) configured for removable attachment to a portion of skin 16 (col 6 lines 5-6) which includes first and second access regions (plurality of hollow stems 18 attached to the base 14 – col 7 lines 49-50; fig 4) each configured to be positioned at or near a mouth of the patient when the barrier is positioned on the patient during the procedure and configured to provide passage of a medical device through the barrier and into an oral cavity of the patient while maintaining a physical barrier around the medical device (provides access into an operative region “through almost any number of differing locations” and also allows the use of multiple surgical or other operable instruments 24 each of which may be passed through an individual operative passageway 26 within each hollow stem 18 – col 7 lines 50-57; the device is interpreted as being capable of being positioned at/near the mouth to provide passage of an instrument into the oral cavity since it provides access “through almost any number of differing locations”; as shown in fig 4, the material around the stems 18 will maintain a physical barrier around medical devices that are passed through the stems). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Gobel to include a second access region configured to be positioned at or near a mouth of the patient when the barrier is positioned on the patient during the procedure and configured to provide passage of a medical device through the barrier and into an oral cavity of the patient while maintaining a physical barrier around the medical device, as taught by Hart, in order to permit use of multiple surgical instruments during a procedure while maintaining a sterile barrier around the instruments.
With respect to claim 6, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) and Gobel also discloses that the first access region is configured to receive an endotracheal tube (para [0041]; fig 1 shows the drape covering a patient having an inserted endotracheal tube).
With respect to claim 8, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) and Gobel also discloses that the first access region comprises a single slit in the barrier (as best shown in fig 2, there is a single opening 120 in the device).
With respect to claim 15, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) and Hart further teaches a third access region configured to receive at least one of an endotracheal tube therethrough (fig 4 shows three stems 18 provided in the base 14 – each provides access into an operative region “through almost any number of differing locations” and also allows the use of multiple surgical or other operable instruments 24 each of which may be passed through an individual operative passageway 26 within each hollow stem 18 – col 7 lines 50-57; the device is interpreted as being capable of being used to pass an endotracheal tube therethrough since it provides access “through almost any number of differing locations”). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Gobel in view of Hart to include a third access region configured to receive at least one of an endotracheal tube therethrough, as taught by Hart, in order to permit use of three separate surgical instruments during a procedure while maintaining a sterile barrier around the instruments.
With respect to claim 16, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) but does not explicitly disclose that the barrier further comprises a fourth access region configured to receive a medical instrument therethrough. It would have been obvious, however, to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Gobel in view of Hart to have four access regions (instead of only three as shown in fig 4 of Hart) because mere duplication of the essential working parts of a device involves only routine skill in the art and, furthermore, because such a modification would permit use of four separate surgical instruments during a procedure while maintaining a sterile barrier around the instruments.
Claim(s) 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2008/0236598) in view of Hart et al (US 5848992) and further in view of Dash et al (US 4976254).
With respect to claim 7, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) but does not explicitly disclose that the first and/or second access regions comprise slits in the barrier.
Dash teaches an endoscopy shield comprising an access region (opening 12 through which the tubular portion of endoscope 16 extends – col 3 lines 57-60; fig 4) wherein the access region includes slits in the barrier (slits 27 shown in fig 4). Dash teaches that the slits 27 define a plurality of flexible sections 22 which are configured to fold towards the user side of sheet 18 and resiliently press back towards endoscope 16 during insertion of the endoscope to form a seal around the endoscope (see fig 6; col 3 line 55- col 4 line 40). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the access regions on the device of Gobel in view of Hart to comprise slits in the barrier like the access region on the device of Dash in order to permit a seal to be formed around an instrument that is inserted into the access region.
With respect to claim 10, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) but does not explicitly disclose that the first and/or second access regions comprise a plurality of linear and/or curved slits radiating outwardly from a central point.
Dash teaches an endoscopy shield comprising an access region (opening 12 through which the tubular portion of endoscope 16 extends – col 3 lines 57-60; fig 4) wherein the access region includes a plurality of linear and/or curved slits (slits 27 shown in fig 4) radiating outwardly from a central point (slits 27 radiate outwardly from hole 24 as shown in fig 4). Dash teaches that the slits 27 define a plurality of flexible sections 22 which are configured to fold towards the user side of sheet 18 and resiliently press back towards endoscope 16 during insertion of the endoscope to form a seal around the endoscope (see fig 6; col 3 line 55- col 4 line 40). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the access regions on the device of Gobel in view of Hart to comprise a plurality of linear and/or curved slits radiating outwardly from a central point, like the access region on the device of Dash. in order to permit a seal to be formed around an instrument that is inserted into the access region.
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2008/0236598) in view of Hart et al (US 5848992) and further in view of Kaldany (US 5082005).
With respect to claim 9, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) but does not explicitly disclose that the first and/or second access regions comprise a plurality of slits arranged in an "x", star, or pinwheel shape.
Kaldany, however, teaches a surgical access device which includes a one way valve (35) comprised of slits arranged in a pinwheel shape (as shown in figs 1-2) which permit passage therethrough in one direction but prevent passage back through the valve in the reverse direction (col 3 lines 25-28). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the access regions on the device of Gobel in view of Hart to comprise a plurality of slits in a pinwheel shape like the valve in Kaldany in order to provide a structure which allows passage therethrough in one direction but prevents passage back through in the reverse direction.
With respect to claim 12, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) but does not disclose that the first and/or second access regions include a bicuspid valve.
Kaldany, however, teaches a surgical access device which includes a one way valve (35) comprised of slits defining a plurality of flaps (as shown in figs 1-2) which permit passage therethrough in one direction but prevent passage back through the valve in the reverse direction (col 3 lines 25-28). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the access regions on the device of Gobel in view of Hart to comprise a valve that is configured as in Kaldany in order to provide a structure which allows passage therethrough in one direction but prevents passage back through in the reverse direction.
Kaldany does not explicitly teach that the valve is a bicuspid valve and, furthermore, shows that the valve 35 comprises more than two flaps (as shown in figs 1-2). However, Kaldany also teaches that “many types of valves suitable for this purpose are known in the art” (col 3 lines 28-29). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the valve of the device of Gobel in view of Hart and further in view of Kaldany to have only two flaps and thus be a bicuspid valve since double flap airlock valves are routinely used for maintaining an air seal between different pressure zones.
Claim(s) 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2008/0236598) in view of Hart et al (US 5848992) and further in view of Ghosh (US 2014/0138270).
With respect to claim 11, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) but does not explicitly disclose that the first and/or second access regions include a valve.
Ghosh, however, teaches a drape 40 which includes a valve 50 which is configured for sealing a vacuum source provided through the drape by permitting air flow through the valve when the vacuum is applied but prohibiting airflow back through the valve when the vacuum is not being applied (see para [0048]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the access regions on the device of Gobel in view of Hart to include a valve like the valve 50 on the drape of Ghosh in order to permit one-way passage through the opening during use and formation of a seal that prevents passage back through the opening when not in use.
With respect to claim 13, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) but does not explicitly disclose that the first and/or second access regions include a valve configured to open in response to insertion of an endotracheal tube or suction device, and close once the endotracheal tube or suction device is withdrawn.
Ghosh, however, teaches a drape 40 which includes a valve 50 which is configured for use with a suction device (configured for sealing a vacuum source provided through the drape) wherein the valve is configured to open in response to insertion of suction (permits air flow through the valve when the vacuum is applied) but closes when suction is withdrawn (prohibits airflow back through the valve when the vacuum is not being applied) (see para [0048]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the access regions on the device of Gobel in view of Hart to include a valve configured to open in response to insertion of an endotracheal tube or suction device, and close once the endotracheal tube or suction device is withdrawn. like the valve 50 on the drape of Ghosh, in order to permit one-way passage through the opening during use and formation of a seal that prevents passage back through the opening when not in use.
Claim(s) 5, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2008/0236598) in view of Bodenham et al (US 2008/0006279).
With respect to claim 5, Gobel discloses the device as claimed (see rejection of claim 4) but does not disclose that the extension comprises an adhesive at its patient-facing surface configured to adhere to the patient's body.
Bodenham teaches an analogous drape which includes an adhesive material on the patient side of the drape to enable the drape to be adhered to the patient's skin (para [0006]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape of Gobel so that the extension includes an adhesive at its patient-facing surface configured to adhere to the patient's body, like the drape of Bodenham, in order to assist with attachment of the drape to a patient’s body to maintain the drape in position during use.
With respect to claim 24, Gobel discloses the device as claimed (see rejection of claim 1) but does not disclose that the barrier comprises an adhesive along all or a portion of a surface of the first side, the adhesive configured to (a) detachably adhere to the patient's skin and/or (b) detachably adhere to a surface in the vicinity of the patient.
Bodenham teaches an analogous drape which includes an adhesive material on the patient side of the drape to enable the drape to be adhered to the patient's skin (para [0006]). Specifically, the adhesive is along a portion of the first side (patient side) because it may be a strip extending as a border around an incise window in the drape (para [0007]) to enable the drape to be adhered to the patient's skin in the region of the incise window (para [0006]). Additionally, the adhesive is interpreted as being configured to detachably adhere to the skin since it is not permanently attached to the skin and the drape is described as being capable of being readily removed (para [0014]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape of Gobel so that the barrier comprises an adhesive along a portion of a surface of the first side wherein the adhesive is configured to detachably adhere to the patient's skin, like the drape of Bodenham, in order to assist with attachment of the drape to a patient’s body to maintain the drape in position during use.
With respect to claim 25, Gobel discloses the device as claimed (see rejection of claim 1) but does not disclose that the barrier comprises an adhesive along selected portions of a surface of the first side, wherein, wherein the barrier is positioned on the patient's head during the procedure, the selected portions correspond to one or more of the patient's nose, the patient's cheeks, and/or a portion of the patient's head inferior to a chin of the patient.
Bodenham teaches an analogous drape which includes an adhesive material on the patient side of the drape to enable the drape to be adhered to the patient's skin (para [0006]). Specifically, the adhesive is along selected portions of the first side (patient side) because it may be a strip extending as a border around an incise window in the drape (para [0007]) to enable the drape to be adhered to the patient's skin in the region of the incise window (para [0006]). Additionally, Bodenham teaches that the barrier is positioned on the patient's head during the procedure (para [0006]) wherein the selected portions correspond to a portion of the patient's head inferior to a chin of the patient (the incise window is located to be positioned over the neck of the patient, and has the adhesive material on the patient side of the drape in the region of the incise window to enable the drape to be adhered to the patient's skin in the region of the incise window – para [0006]; thus, the adhesive around the incise window is configured to be attached to the skin in the neck region, which is inferior to the chin). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape of Gobel so that the barrier comprises an adhesive along selected portions of a surface of the first side, wherein the barrier is positioned on the patient's head during the procedure, and the selected portions correspond to a portion of the patient's head inferior to a chin of the patient, like the drape of Bodenham, in order to assist with attachment of the drape to a patient’s body to maintain the drape in position during use.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2008/0236598) in view of Hart et al (US 5848992) and further in view of Ghosh (US 2014/0138270) and Heipp (US 2016/0297599).
With respect to claim 14, Gobel in view of Hart discloses the invention substantially as claimed (see rejection of claim 2) but does not explicitly disclose that the first and/or second access regions include a spring-activated hinge valve.
Ghosh, however, teaches a drape 40 which includes a valve 50 which is configured for sealing a vacuum source provided through the drape by permitting air flow through the valve when the vacuum is applied but prohibiting airflow back through the valve when the vacuum is not being applied (see para [0048]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the access regions on the device of Gobel in view of Hart to include a valve like the valve 50 on the drape of Ghosh in order to permit one-way passage through the opening during use and formation of a seal that prevents passage back through the opening when not in use.
Ghosh does not specifically teach that the valve is a spring-activated hinge valve, but Heipp, however, teaches use of a valve that has a spring-loaded hinge so that upon removal of a force, the valve spontaneously returns to a closed position. Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have used a spring-activated hinge valve as taught by Heipp as the valve on the device of Gobel in view of Hart and further in view of Ghosh in order to permit the valve to spontaneously return to a closed position when not in use.
Claim(s) 17-19, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2008/0236598) in view of Singh et al (US 2014/0007886).
With respect to claim 17, Gobel discloses the device as claimed (see rejection of claim 1) but does not explicitly disclose that the barrier is disposable.
Singh, however, teaches a surgical drape 1 with a fenestration 2 wherein the drape is formed from a disposable material (para [0033]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the barrier of Gobel from a disposable material like the drape of Singh in order to assist in maintaining a sterile surgical field by requiring use of a new, unused drape for each procedure while also allowing for time savings and easy clean up by simply disposing of the drape rather than requiring additional cleaning and sterilizing steps.
With respect to claim 18, Gobel discloses the device as claimed (see rejection of claim 1) but does not explicitly disclose that the barrier is configured for single use.
Singh, however, teaches a surgical drape 1 with a fenestration 2 wherein the drape is formed from a disposable material (para [0033]) and is packaged together with other surgical implements as a “single-use” surgical drape system (para [0045]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the barrier of Gobel from a disposable material and packaged the drape as a single-use surgical drape system like the drape of Singh in order to assist in maintaining a sterile surgical field by requiring use of a new, unused drape for each procedure while also allowing for time savings and easy clean up by simply disposing of the drape rather than requiring additional cleaning and sterilizing steps.
With respect to claim 19, Gobel discloses the device as claimed (see rejection of claim 1) but does not explicitly disclose that at least a portion of the barrier is translucent.
Singh, however, teaches a surgical drape 1 with a fenestration 2 wherein the entire drape 1 is preferably translucent (para [0033]; figure 3 shows that sheet 1 comprises the entire drape – thus, if sheet 1 is translucent, the entire drape is translucent). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the entire drape of Gobel from a translucent material, like the drape in fig 3 of Singh, in order to permit partial viewing through the material for a physician while also providing some level of privacy for the patient.
With respect to claim 21, Gobel discloses the device as claimed (see rejection of claim 1) but does not explicitly disclose that all of the barrier is translucent.
Singh, however, teaches a surgical drape 1 with a fenestration 2 wherein the entire drape 1 is preferably translucent (para [0033]; figure 3 shows that sheet 1 comprises the entire drape – thus, if sheet 1 is translucent, the entire drape is translucent). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the entire drape of Gobel from a translucent material, like the drape in fig 3 of Singh, in order to permit partial viewing through the material for a physician while also providing some level of privacy for the patient.
With respect to claim 22, Gobel discloses the device as claimed (see rejection of claim 1) and also discloses that part of the barrier is transparent (the central region is desirably transparent – para [0039]; the portion of the drape that surrounds the medical device comprises a transparent plastic film – claim 22) but does not explicitly disclose that all of the barrier is transparent.
Singh, however, teaches a surgical drape 1 with a fenestration 2 wherein the entire drape 1 can be transparent (para [0033]; figure 3 shows that sheet 1 comprises the entire drape – thus, if sheet 1 is transparent, the entire drape is transparent). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the entire drape of Gobel from a transparent material, like the drape in fig 3 of Singh, in order to permit viewing through the drape to assist with placement and in order to observe skin condition and a surgical site during a procedure.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Gobel (US 2008/0236598) in view of Gilhuly et al (US 2010/0292580).
With respect to claim 23, Gobel discloses the device as claimed (see rejection of claim 1) but does not disclose that the barrier comprises an antifog coating.
Gilhuly, however, teaches barriers configured to be disposed between a patient and a medical device which can include a transparent, thin plastic film window (para [0007]) that can further comprise an anti-fog coating (para [0008]) to prevent the patient's breath or other humidity from fogging the window and interfering with measurement or observation (para [0032]). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added an antifog coating, as taught by Gilhuly, to the barrier of Gobel, in order to prevent a patient’s breath or other humidity from fogging the barrier and thereby interfering with viewing through the material.
Conclusion
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786