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 .
Claim Objections
Claims 25, 28, and 30 are objected to because of the following informalities:
Claim 25 recites the limitation “A method of preparing a surgical incise drape of claim 1”. This limitation should be amended to recite “a method of preparing the surgical incise drape of claim 1”.
Claim 28 recites the limitation “providing a surgical incise drape of claim 1”. This limitation should be amended to recite “providing the surgical incise drape of claim 1”.
Claim 30 recites the limitation “a kit comprising: a surgical incise drape of claim 1”. This limitation should be amended to recite “a kit comprising the surgical incise drape of claim 1”.
Appropriate correction is required.
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.
Claim 7, 11, and 25 and 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.
Claim 7 recites the limitation “the ratio ABL:CDL” in line 2. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, Examiner will interpret this limitation as “a ratio”.
Claim 1 recites the limitation “the ratio ACL:BDL” in line 2. There is insufficient antecedent basis for this limitation in the claims. For the purpose of examination, Examiner will interpret this limitation as “a ratio”.
Claim 25 recites the limitations “providing a flexible substrate; and an antimicrobial adhesive composition”. These limitations are held to be unclear given claim 1 from which claim 25 depends recites both structures of “a flexible substrate” and “an antimicrobial adhesive composition”. Therefore, it is unclear as to if the structures of claim 25 are the same as presented in claim 1, or new structures to be used in addition to those of claim 1. For the purpose of examination, Examiner will interpret these as being the same.
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, 5, 11-13, 17-18, 25, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lofgren et al. (US 3,989,040) (hereinafter Lofgren) in view of Rosso et al. (US 4,323,557) (hereinafter Rosso).
In regards to claim 1, Lofgren discloses A surgical incise drape (drape; see [col 2 ln 34-67]; see figure 1) 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) characterized by four vertices A, B, C, and D (see annotated figure 1 below),
the flexible substrate (14) comprising:
a first base (AB) defined by a first base length (ABL) measured between vertices A and B (see figure 1 below),
a second base (CD) defined by a second base length (CDL) measured between vertices C and D (see figure 1 below),
wherein ABL > CDL (see [Col 3 ln 1-10] in reference to the drape being tapered, therefore ABL > CDL),
a first side (AC) defined by a first side length (ACL) measured between vertices A and C (see figure 1 below), and
a second side (BD) defined by a second side length (BDL) measured between vertices B and D (see figure 1 below); and
an adhesive composition (22; see [Col 3 ln 1-10]; see figure 1) comprising: a pressure-sensitive adhesive (see [Col 4 ln 63-67]).
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Lofgren does not disclose the adhesive composition is an antimicrobial adhesive composition comprising: an antimicrobial agent.
However, Rosso teaches an analogous adhesive composition (pressure sensitive adhesive containing iodine; see [Col 1 ln 5-10]) comprising an analogous pressure sensitive adhesive (pressure sensitive adhesive; see [col 1 ln 5-10]) for use on analogous drapes (see [col 4 ln 50-55]) the adhesive composition (pressure sensitive adhesive containing iodine) is an antimicrobial adhesive composition (see [col 1 ln 5-10]) comprising: an antimicrobial agent (iodine; see [col 1 ln 5-10]) for the purpose of exhibiting anti-septic broad spectrum antimicrobial activity in a controlled and sustained manner (see [col 1 ln 5-10]).
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 pressure sensitive adhesive of the surgical drape as disclosed by Lofgren and to have used a pressure sensitive adhesive composition formulated with iodine, therefore forming an antimicrobial adhesive composition as taught by Rosso in order to have provided an improved surgical drape that would add the benefit of exhibiting anti-septic broad spectrum antimicrobial activity in a controlled and sustained manner (see [col 1 ln 5-10]).
In regards to claim 5, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses wherein the flexible substrate (14) has a thickness of about 25 µm to about 200 µm (see [Col 4 ln 20-25] in reference to the polyethylene film being 2mil (thousandths of an inch) which is 50.8 µm).
In regards to claim 11, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses wherein the ratio ACL and BDL is 1:1 (see 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, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses wherein ACL and BDL are independently selected from about .35 m to about .75 m (see figure 1 that the trapezoidal configuration is an isosceles trapezoid; see [col 4 ln 27-30] that the larger base is 31 inches (.7874 m) and the smaller base is 27 inches (.6858 m) and [Col 4 ln 53-60] that the folded tube length (and therefore the length or height of the trapezoid) is 15 inches (.381 m) using these dimensions the calculated ACL and BDL of the trapezoidal configuration is 15.133 inches or .384 m).
In regards to claim 13, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses wherein AB and AC form an angle AƟ (see figure 1), and AB and BD form an angle BƟ (see figure 1), wherein angle AƟ and angle BƟ, are independently selected from about 75° to about 89° (see figure 1 that the trapezoidal configuration is an isosceles trapezoid; see [col 4 ln 27-30] that the larger base is 31 inches (.7874 m) and the smaller base is 27 inches (.6858 m) and [Col 4 ln 53-60] that the folded tube length (and therefore the length or height of the trapezoid) is 15 inches (.381 m) using these dimensions the calculated angle AƟ and angle BƟ of the trapezoidal configuration is 82.4°).
In regards to claim 17, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren as now modified by Rosso further discloses wherein the antimicrobial agent is selected from iodine (see Rosso [Col 1 ln 5-10] that the antimicrobial agent is iodine), an iodophor, chlorhexidine gluconate, octenidine hydrochloride, polyhexamethylene biguanide, a silver salt, a copper salt, and a combination thereof.
In regards to claim 18, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses wherein the pressure-sensitive adhesive (22) is selected from acrylates (see [Col 4 ln 40-50] in reference to the adhesive used in the device being acrylic latex; an acrylate PSA), polyurethanes, silicones, rubber-based adhesives and a combination thereof.
In regards to claim 25, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren as now modified by Rosso further discloses A method of preparing a surgical incise drape of claim 1 (see discussion above), the method comprising: providing a flexible substrate (14 of Lofgren) and an antimicrobial adhesive composition (22 of Lofgren as now modified by Rosso to include iodine); and disposing the antimicrobial adhesive composition (22 of Lofgren as now modified by Rosso to include iodine) onto the flexible substrate (14 of Lofgren; see figure 4 that 22 is disposed onto 14).
In regards to claim 28, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses a method for preparing for surgery (see [Col 2 ln 10-15]) the method comprising:
providing a surgical incise drape (drape) of claim 1 (see discussion above); and
contacting the surgical incise drape (drape) to a skin surface of a subject (see [Col 3 ln 30-31]; see figure 8).
Lofgren as now modified by Rosso does not explicitly disclose the surgery is a shoulder surgery.
However, Lofgren teaches in [Col 2 ln 10-15] the drape is intended used for patient extremities and in [Col 1 ln 20-25] in reference to draping a user’s arm. Thus, to the extent that the prior art apparatus meets the structural limitations of the apparatus, as claimed, it is obvious that it will also perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); MPEP 2112.01(I). In the present case, the drape recited in method claims 28 is identical to the device recited in claims 1 which is unpatentable over Lofgren in view of Rosso (see rejection above). Since the prior art drape of Lofgren in view of Rosso is the same as the device for carrying out the claimed method, it is obvious that the device will perform the claimed process and, therefore, the method claimed is considered to be obvious in view of the prior art device.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lofgren in view of Rosso and Rothrum (US 5,611,356).
In regards to claim 1, Lofgren discloses A surgical incise drape (drape; see [col 2 ln 34-67]; see figure 1) 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) characterized by four vertices A, B, C, and D (see annotated figure 1 below),
the flexible substrate (14) comprising:
a first base (AB) defined by a first base length (ABL) measured between vertices A and B (see figure 1 below),
a second base (CD) defined by a second base length (CDL) measured between vertices C and D (see figure 1 below),
wherein ABL > CDL (see [Col 3 ln 1-10] in reference to the drape being tapered, therefore ABL > CDL),
a first side (AC) defined by a first side length (ACL) measured between vertices A and C (see figure 1 below), and
a second side (BD) defined by a second side length (BDL) measured between vertices B and D (see figure 1 below); and
an adhesive composition (22; see [Col 3 ln 1-10]; see figure 1) comprising: a pressure-sensitive adhesive (see [Col 4 ln 63-67]).
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Lofgren does not disclose the adhesive composition is an antimicrobial adhesive composition comprising: an antimicrobial agent,
wherein the flexible substrate is divided into three separate subsections, and
wherein the three separate subsections together form the trapezoidal configuration.
However, Rosso teaches an analogous adhesive composition (pressure sensitive adhesive containing iodine; see [Col 1 ln 5-10]) comprising an analogous pressure sensitive adhesive (pressure sensitive adhesive; see [col 1 ln 5-10]) for use on analogous drapes (see [col 4 ln 50-55]) the adhesive composition (pressure sensitive adhesive containing iodine) is an antimicrobial adhesive composition (see [col 1 ln 5-10]) comprising: an antimicrobial agent (iodine; see [col 1 ln 5-10]) for the purpose of exhibiting anti-septic broad spectrum antimicrobial activity in a controlled and sustained manner (see [col 1 ln 5-10]).
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 pressure sensitive adhesive of the surgical drape as disclosed by Lofgren and to have used a pressure sensitive adhesive composition formulated with iodine, therefore forming an antimicrobial adhesive composition as taught by Rosso in order to have provided an improved surgical drape that would add the benefit of exhibiting anti-septic broad spectrum antimicrobial activity in a controlled and sustained manner (see [col 1 ln 5-10]).
Lofgren as now modified by Rosso still does not disclose wherein the flexible substrate is divided into three separate subsections, and
wherein the three separate subsections together form the trapezoidal configuration.
However, Rothrum teaches an analogous drape to be used during surgery (universal drape system; see [Col 3 ln 20-30]; see figure 1) comprising an analogous flexible substrate (combination of nonwoven and film materials; see [Col 7 ln 18-34]) wherein the flexible substrate (combination of nonwoven and film materials) is divided into three separate subsections (see [Col 8 ln 50-60] that the one of the four subsections may be omitted thereby forming three separate subsections) for the purpose of providing a universal drape capable of being customized to individual users (see [Col 3 ln 40-50]).
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 flexible substrate having a trapezoidal configuration as disclosed by Lofgren as now modified by Rosso and to have formed the flexible substrate having a trapezoidal configuration from three separate subsections connected to one another via pressure sensitive adhesives as taught by Rothrum in order to have provided an improved flexible substrate that would add the benefit of providing a universal drape capable of being customized to individual users (see [Col 3 ln 40-50]).
Thus, as now combined Lofgren as now modified by Rosso and Rothrum discloses the claimed limitation of wherein the three separate subsections (three separate subsections of the trapezoidal drape of Lofgren as now modified by Rothrum) together form the trapezoidal configuration (the flexible substrate of Lofgren is in a trapezoidal configuration, thus making the flexible substrate from three separate subsections would still form a trapezoidal configuration).
Claim(s) 3, 6-7, 9-10, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lofgren in view of Rosso as applied to claim 1 above, and further in view of Zhao (US 2017/0355170 A1).
In regards to claim 3, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses the flexible substrate (14) may be formed from one of multiple polymeric materials (see [Col 4 ln 24-26], and [Col 5 ln 21-30]). Lofgren as now modified by Rosso does not disclose wherein the flexible substrate comprises a polyurethane film, a polyester film, a polyether block amide film, a thermoplastic polyester elastomer film, or a combination thereof.
However, Zhao teaches an analogous article (1; see [0045]; see figure 1) to be used as a surgical drape (see [0006]) which is formed from an analogous trapezoidal configuration (see [0091] and figure 4a) and rolled into a sleeve (see figure 1) as well as formed from a similar laminate nonwoven and film material (see [0005]) comprising an analogous flexible substrate (21; see [0045]; see figure 1); wherein the flexible substrate (21) comprises a polyurethane film, a polyester film, a polyether block amide film, a thermoplastic polyester elastomer film (see [0039] in reference to a thermoplastic polyester elastomer being contemplated for use), or a combination thereof for the purpose of providing a polymer film that is selectively permeable to water vapor but substantially impermeable to liquid water (see [0039]).
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 material of the flexible substrate as disclosed by Lofgren as now modified by Rosso and to have utilized the thermoplastic polyester elastomer film as taught by Zhao in order to have provided an improved flexible substrate that would add the benefit of providing a polymer film that is selectively permeable to water vapor but substantially impermeable to liquid water (see [0039]).
In regards to claim 6, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses the flexible substrate (14) has a length formed as 15 inches (see [Col 4 ln 53-60] that the folded tube length (and therefore the length or height of the trapezoid) is 15 inches (.381 m)). Lofgren as now modified by Rosso does not disclose the flexible substrate characterized having a length from about 0.5 m to about 0.7 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; the flexible substrate (21) characterized having a length from about 0.5 m to about 0.7 m (see [0091] in reference to the height or length of the flexible substrate being 25 inches or .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 height of the flexible substrate as disclosed by Lofgren as now modified by Rosso and to have formed the height of the flexible substrate as 25 inches or .635 m as taught by Zhao in order to have provided a longer drape that would cover a larger portion of 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 Lofgren as now modified by Rosso and Zhao would not perform differently having the length of the flexible substrate as taught by Zhao.
In regards to claim 7, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses the length of ABL is 31 inches, and the length of CDL is 27 inches (see [Col 4 ln 28-35]) thereby disclosing the ratio ABL:CDL is 31:27. Lofgren as now modified by Rosso does not disclose wherein the 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) similar to the device of Lofgren; wherein the 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 Lofgren as now modified by Rosso 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 Lofgren as now modified by Rosso 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, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses the length of ABL is 31 inches (.7874 m; see [Col 4 ln 28-35]). Lofgren as now modified by Rosso does not disclose wherein ABL is selected from about .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) similar to the device of Lofgren; 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 Lofgren as now modified by Rosso 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 Lofgren as now modified by Rosso 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, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses the length of CDL is 27 inches (.6858 m; see [Col 4 ln 28-35]). Lofgren as now modified by Rosso does not 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 Lofgren as now modified by Rosso 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 Lofgren as now modified by Rosso and Zhao would not perform differently having the length of the smaller base of the flexible substrate as taught by Zhao.
In regards to claim 14, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses wherein AC and CD form an angle CƟ (see figure 1), and CD and BD form an angle DƟ (see figure 1), wherein angle CƟ and angle DƟ, are independently selected from about 100° to about 105° (see figure 1 that the trapezoidal configuration is an isosceles trapezoid; see [col 4 ln 27-30] that the larger base is 31 inches (.7874 m) and the smaller base is 27 inches (.6858 m) and [Col 4 ln 53-60] that the folded tube length (and therefore the length or height of the trapezoid) is 15 inches (.381 m) using these dimensions the calculated angle CƟ and angle DƟ of the trapezoidal configuration is 97.6° which is about 100°).
Nonetheless, Zhao teaches 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 AC and CD form an angle CƟ (see figure 4), and CD and BD form an angle DƟ (see figure 4), wherein angle CƟ and angle DƟ, are independently selected from about 100° to about 105° (see [0091] in reference to the flexible substrate being formed as an isosceles trapezoid, with ABL (larger base) being 25 inches (see [0091]), CDL (shorter base) being 12 inches (see [0091]), and the height of the trapezoidal device being 25 inches (see [0091]); using these dimensions the calculated angles of CƟ and DƟ are 104.57°).
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 dimensions of the flexible substrate as disclosed by Lofgren as now modified by Rosso and to have formed the flexible substrate with the dimensions and angles as taught by Zhao in order to have provided an improved flexible that would add the benefit of conforming to the extremity in which the flexible substrate is applied over. 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 Lofgren as now modified by Rosso and Zhao would not perform differently having the dimensions of the flexible substrate as taught by Zhao.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lofgren in view of Rosso as applied to claim 1 above, and further in view of Teunissen (US 2019/0083194 A1).
In regards to claim 15, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren as now modified by Rosso does not disclose wherein one or more of the first base AB, and 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 Lofgren as now modified by Rosso 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) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lofgren in view of Rosso as applied to claim 1 above, and further in view of Gavriely (US 2005/0080450 A1).
In regards to claim 19, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren as now modified by Rosso does not disclose further comprising a delivery system in contact with at least a portion of the flexible substrate.
However, Gavriely teaches an analogous flexible substrate (20; see [0012]; see figure 1) which is intended to be applied over a user’s limb during surgery (see [0011]; see figure 3); further comprising a delivery system (24 and 26; see [0012]; see figure 1) in contact with at least a portion of the flexible substrate (20; see figure 1) for the purpose of streamlining the application of the flexible substrate to the user’s limb (See [0013]).
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 flexible substrate as disclosed by Lofgren as now modified by Rosso and to have included the delivery system as taught by Gavriely in order to have provided an improved means for applying the flexible substrate to the user’s limb that would add the benefit of streamlining the application of the flexible substrate to the user’s limb (See [0013]).
In regards to claim 20, Lofgren as now modified by Rosso and Gavriely discloses the invention as discussed above.
Lofgren as now modified by Gavriely further discloses wherein the delivery system (24 and 26 of Gavriely) comprises handling tabs (26 of Gavriely).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lofgren in view of Rosso as applied to claim 1 above, and further in view of Villari (US 3,835,851).
In regards to claim 30, Lofgren as now modified by Rosso discloses the invention as discussed above.
Lofgren further discloses a kit (total draping system package; see [col 4 ln 1-2]) comprising:
a surgical incise drape (drape) of claim 1 (see discussion above).
Lofgren as now modified by Rosso does not disclose a set of instructions directing a user to contact the surgical incise drape to a skin surface of the subject. However, given the instructions are merely instructions for use of a known product, the instructions are not related to that particular set of chemicals. 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 and 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 Lofgren as now modified by Rosso 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
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/DANIEL A MILLER/Examiner, Art Unit 3786