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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/19/2026 has been entered.
Response to Amendment
Applicant’s amendments of claims 1, 2, and 6 are acknowledged by the Examiner.
Applicant’s cancelation of claim 17 is acknowledged by the Examiner.
Currently claims 1-3, 5-7, 9-15, 18-20, 25, 28, and 30 are pending in the current Application.
Response to Arguments
Applicant’s arguments, see remarks, filed 03/19/2026, with respect to the rejection(s) of claim(s) 1 and 2 under 35 U.S.C. 103 in view of Lofgren et al. (US 3,989,040 A) as a primary reference have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection under 35 U.S.C. 103 is made in view of Comstock et al. (US 5,985,395 A) in view of Lofgren et al. as will be discussed below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5-6, 11-14, 18-20, 25, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Comstock et al. (US 5,985,395 A) (hereinafter Comstock) in view of Lofgren et al. (US 3,989,040 A) (hereinafter Lofgren).
In regards to claim 1, Comstock discloses A surgical incise drape (10; see [col 3 ln 60]; see figure 11) comprising:
a flexible substrate (21; see [col 3 ln 64]; see figure 11) having a rectangular configuration (see figure 11) characterized by four vertices A, B, C, and D,
the flexible substrate comprising:
a first base (AB) defined by a first base length (ABL) measured between vertices A and B (see annotated figure 11 below),
a second base (CD) defined by a second base length (CDL) measured between vertices C and D (see annotated figure 11 below),
a first side (AC) defined by a first side length (ACL) measured between vertices A and C (see annotated figure 11 below), and
a second side (BD) defined by a second side length (BDL) measured between vertices B and D (see annotated figure 11 below); and
an antimicrobial adhesive composition (9; see [col 3 ln 65]; see figure 2) comprising:
an antimicrobial agent selected from an iodophor, chlorhexidine gluconate (see [col 10 ln 27]), octenidine hydrochloride, polyhexamethylene biguanide, a silver salt (see [col 10 ln 31]), a copper salt, or a combination thereof, and
a pressure-sensitive adhesive (see [col 10 ln 11-12]).
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Comstock further discloses the flexible substrate may be applied to a user’s arm or leg (see [col 4 ln 54-55]) and may be generally rectangular (see [col 3 ln 61]) of which trapezoid configurations can be considered “generally rectangular”, but does not disclose the flexible substrate having a trapezoidal configuration, and wherein ABL > CDL.
However, Lofgren discloses an analogous surgical drape (drape; see [col 2 ln 34-67]; see figure 1) which is similarly intended to cover a patient’s arm or leg during surgery (see [abstract]) comprising:
a flexible substrate (14; see [col 2 ln 34-67]; see figure 1) having a trapezoidal configuration (see [Col 3 ln 1-10] in reference to the drape being tapered, therefore as seen in figure 1, 14 has a trapezoidal configuration), wherein ABL > CDL (see [Col 3 ln 1-10] in reference to the drape being tapered, therefore ABL > CDL; see annotated figure 1 below).
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Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the surgical incise drape as disclosed by Comstock and to have formed the drape in a trapezoidal configuration where the first base (AB) length is larger than the second base (CD) length as taught by Lofgren in order to have provided an improved surgical incise drape that would add the benefit of being tapered to better conform to and cover the patient’s arm or leg (which have tapering diameters from a proximal to a distal portion of the limb) over which the surgical incise drape is applied.
In regards to claim 2, Comstock discloses A surgical incise drape (10; see [col 3 ln 60]; see figure 11) for use on a subject in preparation for surgery (10 is utilized for surgical procedures (see [abstract]) and thus, is for use on a subject in preparation for surgery (i.e. being applied to the patient prior to surgery), the surgical incise drape comprising:
a flexible substrate (21; see [col 3 ln 64]; see figure 11) having a rectangular configuration (see figure 11) characterized by four vertices A, B, C, and D,
the flexible substrate comprising:
a first base (AB) defined by a first base length (ABL) measured between vertices A and B (see annotated figure 11 above),
a second base (CD) defined by a second base length (CDL) measured between vertices C and D (see annotated figure 11 above),
a first side (AC) defined by a first side length (ACL) measured between vertices A and C (see annotated figure 11 above), and
a second side (BD) defined by a second side length (BDL) measured between vertices B and D (see annotated figure 11 above); and
an antimicrobial adhesive composition (9; see [col 3 ln 65]; see figure 2) comprising:
an antimicrobial agent (see [col 10 ln 27-31]), and
a pressure-sensitive adhesive (see [col 10 ln 11-12]).
wherein the surgical incise drape is configured in three separate subsections (first and second 16 and 25; see [col 7 ln 10-20]; see figure 11) which form the rectangular configuration (see figure 11), the three separate subsections comprise:
a drape seal (first 16 adjacent indicated A and B; see figure 11);
an incise seal (25; see figure 11); and
a stockinette seal (second 16 adjacent indicated C and D; see figure 11);
wherein the three separate subsections of the surgical incise drape are separated by perforations (32; see [col 7 ln 53-54]; see figure 11).
Comstock further discloses the flexible substrate (and therefore, the drape seal, incise seal, and stockinette seal) may be applied to a user’s arm (see [col 4 ln 54-55]). Comstock does not explicitly disclose that the drape seal configured to overlay one or more of a proximal end of a humerus, a distal end of a clavicle, and at least a portion of a neck of the subject, the incise seal configured to overlay one or more of a shoulder, a bicep, a tricep, and an under-armpit area of the subject, and the stockinette seal configured to overlay a forearm of the subject. Though intended use and positioning does not inhibit the structure, design or disclosure of Comstock, for full clarity it is obvious that the drape seal, incise seal, and stockinette seal of Comstock may be used and positioned as claimed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known that the intended use and positioning of the drape seal, incise seal, and stockinette seal as claimed does not inhibit the structure, design or disclosure of Comstock and the drape seal, incise seal, and stockinette seal of Comstock are fully capable of being used and positioned as claimed.
Comstock further discloses the flexible substrate may be applied to a user’s arm or leg (see [col 4 ln 54-55]) and may be generally rectangular (see [col 3 ln 61]) of which trapezoid configurations can be considered “generally rectangular”, but does not disclose the flexible substrate having a trapezoidal configuration, and wherein ABL > CDL.
However, Lofgren discloses an analogous surgical drape (drape; see [col 2 ln 34-67]; see figure 1) which is similarly intended to cover a patient’s arm or leg during surgery (see [abstract]) comprising:
a flexible substrate (14; see [col 2 ln 34-67]; see figure 1) having a trapezoidal configuration (see [Col 3 ln 1-10] in reference to the drape being tapered, therefore as seen in figure 1, 14 has a trapezoidal configuration), wherein ABL > CDL (see [Col 3 ln 1-10] in reference to the drape being tapered, therefore ABL > CDL; see annotated figure 1 above).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the surgical incise drape as disclosed by Comstock and to have formed the drape in a trapezoidal configuration where the first base (AB) length is larger than the second base (CD) length as taught by Lofgren in order to have provided an improved surgical incise drape that would add the benefit of being tapered to better conform to and cover the patient’s arm or leg (which have tapering diameters from a proximal to a distal portion of the limb) over which the surgical incise drape is applied.
In regards to claim 3, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses wherein the flexible substrate (21) comprises a polyurethane film (see [col 9 ln 43-44]), a polyester film (see [col 9 ln 47-48]), a polyether block amide film (see [col 9 ln 49-50]), a thermoplastic polyester elastomer film (see [col 9 ln 47-48]), or a combination thereof.
In regards to claim 5, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses wherein the flexible substrate (21) has a thickness of less than 200 µm (see [col 9 ln 53-59]).
Comstock as now modified by Lofgren does not explicitly disclose the specific range of 25-200 µm as claimed. However, the thickness of the flexible substrate being less than 200 µm fully encompasses Applicant’s claimed range of 25-200 µm.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thickness of the flexible substrate as disclosed by Comstock as now modified by Lofgren from less than 200 µm to 25-200 µm as applicant appears to have placed no criticality on the claimed range (see Specification [0046] which discloses the thickness may be the range as claimed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 6, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses wherein the flexible substrate (21) has a length of 0.15-1.2 m (see [col 3 ln 59-65]).
Comstock as now modified by Lofgren does not explicitly disclose the specific range of 0.5-0.7 m as claimed. However, the length of the flexible substrate being 0.15-1.2 m disclosed by Comstock fully encompasses Applicant’s claimed range of 0.5-.07 m.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the flexible substrate as disclosed by Comstock as now modified by Lofgren from 0.15-1.2 m to 0.5-0.7 m as applicant appears to have placed no criticality on the claimed range (see Specification [0045] which discloses the length may be the range as claimed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 11, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock as now modified by Lofgren further discloses wherein a ratio ACL and BDL is 1:1 (see Lofgren figure 1 that the trapezoidal configuration is an isosceles trapezoid; therefore, the lengths of sides AC and BD as indicated in figure 1 above are the same length having a 1:1 ratio).
In regards to claim 12, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock as now modified by Lofgren further discloses wherein ACL and BDL are independently selected from about 0.158-1.2 m (see Lofgren [col 4 ln 27-30] the larger base is 31 inches (.7874 m) and the smaller base is 27 inches (.6858 m); See Comstock [col 3 ln 60-65] that the length of the drape may be 0.15-1.2 m; thus, using these dimensions of the height, the large base, and the small base, the calculated range of lengths of ACL and BDL is from 0.158-1.2 m).
Comstock as now modified by Lofgren does not explicitly disclose the specific range of 0.35-0.75 m as claimed. However, the length of ACL and BDL being 0.158-1.2 m as disclosed by Comstock as now modified by Lofgren fully encompasses Applicant’s claimed range of 0.35-0.75 m.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimensions of ACL and BDL as disclosed by Comstock as now modified by Lofgren from 0.158-1.2 m to 0.35-0.75 m as applicant appears to have placed no criticality on the claimed range (see Specification [0078] which discloses the length may be the range as claimed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 13, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock as now modified by Lofgren further discloses wherein AB and AC form an angle AƟ, and AB and BD form an angle BƟ, wherein angle AƟ and angle BƟ, are independently selected from about 75° to about 89° (see Lofgren [col 4 ln 27-30] the larger base is 31 inches (.7874 m) and the smaller base is 27 inches (.6858 m); See Comstock [col 3 ln 60-65] that the length of the drape may be 0.15-1.2 m; thus, using these dimensions of the height, the large base, and the small base, the calculated range of angles of AƟ and BƟ is 71.29° at 0.15 m height to 87.58° at 1.2 m height).
Comstock as now modified by Lofgren does not explicitly disclose the specific range of about 75° to about 89° as claimed. However, the angles of AƟ and BƟ are 71.29° at 0.15 m height to 87.58° at 1.2 m height disclosed by Comstock as now modified by Lofgren which fully encompasses Applicant’s claimed range of about 75° to about 89°.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimensions of AB and AC which form angles of AƟ and BƟ as disclosed by Comstock as now modified by Lofgren to result in an angle of about 75° to about 89° as applicant appears to have placed no criticality on the claimed range (see Specification [0090] which discloses the angles may be the range as claimed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 14, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock as now modified by Lofgren further discloses wherein AC and CD form an angle CƟ and CD and BD form an angle DƟ, wherein angle CƟ and angle DƟ are selected from about 100° to about 105° (see Lofgren [col 4 ln 27-30] the larger base is 31 inches (.7874 m) and the smaller base is 27 inches (.6858 m); See Comstock [col 3 ln 60-65] that the length of the drape may be 0.15-1.2 m; thus, using these dimensions of the height, the large base, and the small base, the calculated range of angles of CƟ and DƟ is 108.7° at 0.15 m height to 92.42° at 1.2 m height).
Comstock as now modified by Lofgren does not explicitly disclose the specific range of about 100° to about 105° as claimed. However, the angles of CƟ and DƟ are 108.7° at 0.15 m height to 92.42° at 1.2 m height disclosed by Comstock as now modified by Lofgren which fully encompasses Applicant’s claimed range of about 100° to about 105°.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the dimensions of CD and BD which form angles of CƟ and DƟ as disclosed by Comstock as now modified by Lofgren to result in an angle of about 100° to about 105° as applicant appears to have placed no criticality on the claimed range (see Specification [0091] which discloses the angles may be the range as claimed) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In regards to claim 18, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses wherein the pressure-sensitive adhesive is selected from acrylates, polyurethanes, silicones, rubber-based adhesives, and a combination thereof (see [col 10 ln 20-25]).
In regards to claim 19, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses further comprising a delivery system (14 and 15; see [col 3 ln 65-67]; see figure 2) in contact with at least a portion of the flexible substrate (21; see figures 1-3).
In regards to claim 20, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses wherein the delivery system comprises handling tabs (14 and 15 are strips of material attached to 21 and are used to manipulate 21 into position (see [col 7 ln 1-11]) and thus, 14 and 15 are considered to be handling tabs); see .
In regards to claim 25, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses A method of preparing the surgical incise drape of claim 1 (see discussion above), the method comprising:
providing the flexible substrate (21) and the antimicrobial adhesive composition (9; see figure 2); and
disposing the antimicrobial adhesive composition onto the flexible substrate (see figure 2 that 9 is disposed on 21).
In regards to claim 28, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses A method for preparing a shoulder for surgery, the method comprising:
providing the surgical incise drape of claim 1 (see discussion above); and
contacting the surgical incise drape to a skin surface of a subject (see [col 4 ln 50-55], see [col 10 ln 11-19]).
Claim(s) 7, and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Comstock in view of Lofgren as applied to claim 1 above, and further in view of Zhao (US 2017/0355170 A1).
In regards to claim 7, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses the width of the drape can be from 10-100 cm (see [col 3 ln 59-62]) and Lofgren teaches the length of ABL is 31 inches, and the length of CDL is 27 inches (see [Col 4 ln 28-35]) thereby teaching the ratio ABL:CDL is 31:27.
Comstock as now modified by Lofgren does not disclose wherein a ratio ABL:CDL is at least about 2:1.
However, Zhao teaches an analogous article (1; see [0045]; see figure 1) to be used as a surgical drape (see [0006]) comprising an analogous flexible substrate (21; see [0045]; see figure 1) which is formed from an analogous trapezoidal configuration (see [0091] and figure 4a) and rolled into a sleeve (see figure 1); wherein a ratio ABL:CDL is at least about 2:1 (see [0091] in reference to the longer base being 25 inches, and the shorter base being 12 inches; thereby having a ratio of 2.083:1).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ratio of ABL:CDL of the flexible substrate as disclosed by Comstock as now modified by Lofgren and to have formed the ratio of ABL:CDL of the flexible substrate as 2.083:1 as taught by Zhao in order to have provided a more tapered drape that would conform better to the portions the user’s extremity.
Further, such a modification would have been obvious to one of ordinary skill in the art since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (see MPEP 2144.04 IV A). In the instant case, the device of Comstock as now modified by Lofgren and Zhao would not perform differently having the ratio of the larger and smaller base of the flexible substrate as taught by Zhao.
In regards to claim 9, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses the width of the drape (and thus, ABL in the combination of Comstock as now modified by Lofgren) can be from 10-100 cm (see [col 3 ln 59-62]).
However, Comstock as now modified by Lofgren does not explicitly disclose wherein ABL is selected from about 0.15 m to about 0.65 m.
However, Zhao teaches an analogous article (1; see [0045]; see figure 1) to be used as a surgical drape (see [0006]) comprising an analogous flexible substrate (21; see [0045]; see figure 1) which is formed from an analogous trapezoidal configuration (see [0091] and figure 4a) and rolled into a sleeve (see figure 1); wherein ABL (larger base) is selected from about .15 m to about 0.65 m. (see [0091] in reference to the larger base being 25 inches (.635 m)).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the larger base of the flexible substrate as disclosed by Comstock as now modified by Lofgren and to have formed the larger base with a length of .636 m as taught by Zhao in order to have provided a larger base of the drape that would conform better to the upper portions the user’s extremity.
Further, such a modification would have been obvious to one of ordinary skill in the art since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (see MPEP 2144.04 IV A). In the instant case, the device of Comstock as now modified by Lofgren and Zhao would not perform differently having the length of the larger base of the flexible substrate as taught by Zhao.
In regards to claim 10, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses the width of the drape (and thus, CDL in the combination of Comstock as now modified by Lofgren) can be from 10-100 cm (see [col 3 ln 59-62]).
However, Comstock as now modified by Lofgren does not explicitly disclose wherein CDL is selected from about 0.07 m to about 0.3 m.
However, Zhao teaches an analogous article (1; see [0045]; see figure 1) to be used as a surgical drape (see [0006]) comprising an analogous flexible substrate (21; see [0045]; see figure 1) which is formed from an analogous trapezoidal configuration (see [0091] and figure 4a) and rolled into a sleeve (see figure 1) similar to the device of Lofgren; wherein CDL (shorter base) is selected from about .07 m to about .3m (see [0091] in reference to the shorter base being 12 inches (.305 m which is about .3m)).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the shorter base of the flexible substrate as disclosed by Comstock as now modified by Lofgren and to have formed the shorter base with a length of .305 m as taught by Zhao in order to have provided a more tapered drape that would conform better to the lower portions the user’s extremity.
Further, such a modification would have been obvious to one of ordinary skill in the art since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” (see MPEP 2144.04 IV A). In the instant case, the device of Comstock as now modified by Lofgren and Zhao would not perform differently having the length of the smaller base of the flexible substrate as taught by Zhao.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Comstock in view of Lofgren as applied to claim 1 above, and further in view of Teunissen (US 2019/0083194 A1).
In regards to claim 15, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock as now modified by Lofgren does not disclose wherein one or more of the first base AB, the second base CD, the first side AC, and the second side BD comprise concave contouring.
However, Teunissen teaches an analogous drape (1; see [0078]; see figure 1a) for use during surgery (see [0080]) comprising analogous first, second, bases and first and second sides (see figure 1a that 1 comprises two bases and two sides); wherein one or more of the first base and the second base, the first side, and the second side comprise concave contouring (2; see [0078]) for the purpose of accommodating a portion of the patient (see [0078]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first base as disclosed by Comstock as now modified by Lofgren and to have included the concave contouring of the base as taught by Teunissen in order to have provided an improved first base that would add the benefit of accommodating a portion of the patient (see [0078]), thereby allowing the flexible substrate to better conform to the user.
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Comstock in view of Lofgren as applied to claim 1 above, and further in view of Villari (US 3,835,851 A).
In regards to claim 30, Comstock as now modified by Lofgren discloses the invention as discussed above.
Comstock further discloses A kit (10 and application tabs 14 and 15; see figure 1) comprising:
the surgical incise drape of claim 1 (see discussion above).
Comstock as now modified by Lofgren does not disclose a set of instructions directing a user to contact the surgical incise drape to a skin surface of a subject.
However, given the instructions as claimed are merely instructions for use of a known product, the instructions are not related to the invention as claimed. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864, and thus are considered to have no functional relationship between the printed matter of the instructions and associated substrate. Therefore, the printed matter is owed no patentable weight Id. at 850, 117 USPQ2d at 1268 (see MPEP 2111.05 I B).
Nonetheless, Villari teaches an analogous kit (20 and associated instructions; see [Col 3 ln 28-35]; see figure 7; and [Col 5 ln 20-30]) comprising a surgical incise drape (20); and a set of instructions (instructions) directing a user to contact the surgical incise drape (20) to a skin surface of the subject (see [col 5 ln 20-30]) for the purpose of ensuring the drape was properly secured to the patient (see [Col 5 ln 20-30]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the kit as disclosed by Comstock as now modified by Lofgren by including the set of instructions as taught by Villari in order to have provided an improved kit that would provide clear instructions for the application of the drape for the purpose of ensuring the drape was properly secured to the patient (see [Col 5 ln 20-30]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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