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 .
Response to Amendment
Applicant’s amendments of the specification are acknowledged by the Examiner. Applicant’s amendments of the specification has overcome the previous specification objections. Therefore, the previous specification objections are withdrawn.
Applicant’s amendments of claims 1, 7-11, 14, and 16 are acknowledged by the Examiner.
Applicant’s amendments of claim 1 has overcome the previous claim rejections for double patenting. Therefore, the double patenting rejections are withdrawn.
Applicant’s amendment of the limitations of claim 6 which are now included into claim 1, and the amendments of claims 9-10 have rendered the previous claim interpretations moot.
Applicant’s amendments of claim 1, 8, 14, and 16 has overcome the previous claim objections. Therefore, the previous claim objections are withdrawn.
Applicant’s amendment of claim 1, 7, 9, 11, and 14 has overcome the previous rejections under 35 U.S.C. 112(b). Therefore, the previous rejections under 35 U.S.C. 112(b) are withdrawn.
Claims 1, and 7-16 are pending in the current Application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 recites the limitation “an arm” in line 3. This limitation should be amended to recite “the arm”.
Appropriate correction is required.
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, 7-8, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auerbach et al. (US 2004/0103904 A1) (hereinafter Auerbach) in view of Reyes et al. (US 2007/0079834 A1) (hereinafter Reyes), Bainbridge (US 2011/0125112 A1), Namenye et al. (US 5,443,488 A) (hereinafter Namenye), and Goodman (US 4,119,093 A).
In regards to claim 1, Auerbach discloses a surgical drape (1; see [0027]; see figure 1) configured for sterile covering of a patient for a shoulder surgery (see [0007] and [0027]), comprising:
a main covering layer (2; see [0027]; see figure 1) having a front surface (4; see [0028]; see figure 2) and a back surface (5; see [0028]; see figure 3);
wherein a first cut (10; see [0028]; see figure 3; 10 is made via cutting 2 and therefore is considered a cut) is made through the main covering layer (see figure 4), the first cut being configured such that the surgical drape can move over an arm through the first cut (see figures 6a-d);
a limb sleeve (3; see [0027]; see figure 1) having a closed end (32; see [0028]; see figure 1) and an open end (31; see [0028]; see figure 4) wherein the limb sleeve is assembled to the main covering layer at the open end and the first cut aligned such that when the surgical drape is moved over the arm through the first cut, the arm is covered by the limb sleeve (see figures 6a-d); and
a tourniquet element (120; see [0048]; see figure 6d) having an opening (120 being a band or strap when formed has an opening) configured to move over the arm and assembled in the limb sleeve (3) at a first distance from the open end (see figure 6d; 120 being a strap or band is capable of moving over the arm and being positioned (i.e. assembled) in the limb sleeve at the distance seen in figure 6d);
an opening (60; see [0048]; see figure 6d) is provided in the limb sleeve (see figure 6d) for removing part of the limb sleeve at a second distance from the open end (see [0048]),
wherein first distance (distance of 120) is closer to the open end of the limb sleeve with respect to the second distance (distance of 60) such that the tourniquet element is connected to the limb sleeve at a position between the open end of the limb sleeve and the opening (see figure 6d),
wherein the surgical drape further comprises a reinforcement element (40; see [0033]; see figure 1), wherein the reinforcement element has a second cut (45; see [0045]; see figure 4; 45 being a fenestration through 40 is made via cutting 40 and therefore is considered a cut), the second cut being configured that the surgical drape can move over the arm through the second cut (see figures 6a-d) and wherein the reinforcement element is applied to the main covering layer with the second cut aligned to the first cut such that the surgical drape can move over the arm through the first cut and the second cut (10 and 45 are aligned as claimed; see figures 2-4),
wherein the limb sleeve has a larger width at the open end than at the closed end (the sleeve may have a tapered configuration to accommodate a user’s limb (see [0032]) and thus, would have a larger width at the open end than at the closed end to accommodate a user’s limb which tapers from the proximal end to the distal end).
Auerbach does not disclose an absorbing layer applied to the front surface wherein a first cut is made through the absorbing layer;
the tourniquet element having an elastic opening and a connection edge assembled in the limb sleeve;
wherein the opening is formed by perforations are provided in the limb sleeve for tearing off part of the limb sleeve;
wherein the reinforcement element is applied to the back surface of the main covering layer; and
wherein the absorbing layer adjacent to the first cut further comprises an attachment element selected from a double-sided tape and a hook-and-loop connection, which attachment element is configured for attaching a part of the limb sleeve between the open end of the limb sleeve and the perforations to the absorbing layer.
However, Reyes teaches an analogous surgical drape (10; see [0028]; see figure 1) for similar use in surgical procedures of a patient’s extremity (see [0006] and [0039]) comprising an analogous main covering layer (12; see [0028]; see figure 1) comprising a front surface (surface facing away from the patient; see figure 1) and back surface (surface facing the patient; see figure 1); further comprising an absorbing layer (14; see [0028]; see figure 2; 14 is treated to be absorbent (see [0037]) and thus, is an absorbing layer) applied to the front surface (see figure 1) wherein a first cut (30; see [0037]; see figure 2; 30 being a fenestration made through 14 is made via cutting 14 and therefore is considered a first cut) is made through the absorbing layer (see figure 2);
wherein the absorbing layer adjacent to the first cut further comprises an attachment element selected from a double-sided tape and a hook-and-loop connection (see [0038]) for the purpose of providing a material which absorbs blood and other body fluids to prevent said fluids from absorbing into the main covering layer and migrate through the material into contact with the patient's body (see [0031]) and for providing an attachment mechanism for attaching the absorbing layer to the drape (see [0038]).
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 drape as disclosed by Auerbach and to have included the absorbing layer attached to the main covering layer by double sided tape as taught by Reyes in order to have provided an improved surgical drape that would add the benefit of providing a material which absorbs blood and other body fluids to prevent said fluids from absorbing into the main covering layer and migrate through the material into contact with the patient's body (see [0031]) and for providing an attachment mechanism for attaching the absorbing layer to the drape (see [0038]).
Thus, as now combined Auerbach as now modified by Reyes discloses which attachment element (double sided tape of Reyes) is configured for attaching a part of the limb sleeve between the open end of the limb sleeve and the opening to the absorbing layer (the double-sided tape binds of Reyes binds 14 of Reyes to 2 of Auerbach on the front surface of 2, and is capable of attaching as claimed).
Auerbach as now modified by Reyes still does not disclose the tourniquet element having an elastic opening and a connection edge assembled in the limb sleeve;
wherein the opening is formed by perforations are provided in the limb sleeve for tearing off part of the limb sleeve;
wherein the reinforcement element is applied to the back surface of the main covering layer.
However, Bainbridge teaches an analogous limb sleeve (2; see [0074]; see figure 14a) for use during a medical procedure (see [0001]; decontamination prior to surgery is a medical procedure) further comprising an analogous torniquet element (41; see [0074]; see figure 14a; 42 of 41 is formed of Kraton™ (see [0077]) which is the same material as Applicant’s tourniquet element (see Applicant’s specification [0070]), and is structurally similar to Applicant’s torniquet element (see figure 15 and Applicant’s figure 6); thus, due to the inherent material properties of Kraton™ (see MPEP 2112.01) and structural similarities to Applicant’s torniquet element, 41 is capable of being used as a tourniquet element); the tourniquet element (41) having an elastic opening (48; see [0074]; see figure 15) and a connection edge (52; see [0075]; see figure 14a) assembled in the limb sleeve (2; see figure 14a) for the purpose of ensuring the tourniquet element is located and retained at a desired location within the limb sleeve (See [0075]) and for the purpose of forming the tourniquet element from an elastic material which retains elastic properties when stretched but does not rapidly return to its original shape (see [0077]).
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 tourniquet element as disclosed by Auerbach as now modified by Reyes and to have included the elastic opening and connection edge of the tourniquet element as taught by Bainbridge in order to have provided an improved tourniquet element that would add the benefit of ensuring the tourniquet element is located and retained at a desired location within the limb sleeve (See [0075]) and the benefit of forming the tourniquet element from an elastic material which retains elastic properties when stretched but does not rapidly return to its original shape (see [0077]).
Auerbach as now modified by Reyes and Bainbridge does not disclose wherein the opening is formed by perforations are provided in the limb sleeve for tearing off part of the limb sleeve;
wherein the reinforcement element is applied to the back surface of the main covering layer.
However, Namenye teaches an analogous drape (10; see [Col 4 ln 33-45]; see figure 1) comprising perforations (26, 28, 32, 34, and 38; see [Col 4 ln 60-Col 5 ln 20]; see figure 1) provided in the drape (10) for tearing off part of the drape (10; see figures 3, 5, 7, 9, 10 and 11) for the purpose of providing a variety of shapes and sizes of access openings to be selectively formed through the drape for access to the surgical site (see [abstract]).
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 opening of the limb sleeve intended to be placed over a surgical site as disclosed by Auerbach as now modified by Reyes and Bainbridge by including the perforations for providing access to the surgical site by tearing off part of the drape as taught by Namenye in order to have provided an improved limb sleeve that would add the benefit of providing a means for creating a variety of shapes and sizes of access openings to be selectively formed through the limb sleeve for access to the surgical site (see [abstract]).
Auerbach as now modified by Reyes, Bainbridge, and Namenye does not disclose wherein the reinforcement element is applied to the back surface of the main covering layer.
However, Goodman teaches an analogous surgical drape (30; see [col 3 ln 67-68]; see figure 1) for sterile covering of a patient for a shoulder surgery (see figure 10), comprising: a main covering layer (34; see [col 4 ln 5]; see figure 1) having a front surface (64; see [col 5 ln 44]; see figure 2) and a back surface (62; see [col 5 ln 45]; see figure 2); further comprising an analogous limb sleeve (38; [col 4 ln 9-10]; see figure 2) and reinforcement element (48; see [col 4 ln 15-20]; see figure 16); wherein the reinforcement element (48) is applied to the back surface (62) of the main covering layer (34) for the purpose of reinforcing the limb sleeve and covering the attachment of the limb sleeve to the main covering layer (see [col 4 ln 17-23]).
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 placement of the reinforcement element as disclosed by Auerbach as now modified by Reyes, Bainbridge, and Namenye and to have positioned the reinforcement element on the back surface of the main covering layer as taught by Goodman in order to have provided an improved surgical drape that would add the benefit of allowing the reinforcement element to reinforce the limb sleeve and cover the attachment of the limb sleeve to the main covering layer (see [col 4 ln 17-23]).
Furthermore, such a modification is held to be obvious since it has been held that "a mere rearrangement of parts was held to be an obvious matter of design choice" In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (See MPEP 2144.04 VI C). In the instant case Applicant's specification has not disclosed that the positioning of the reinforcement element on the back surface of the main covering layer provides an advantage, is used for a particular purpose, or solves a stated problem, and contrarily discloses “the reinforcement element 30, 130 which is in some embodiments of the invention glued on the back surface of the main covering layer” (See specification [0074]). Therefore, the specific configuration is considered not critical to the functionality of Applicant's device and is considered to be a design choice obvious to one of ordinary skill in the art.
In regards to claim 7, Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman discloses the invention as discussed above.
Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman does not explicitly disclose wherein the second distance is between 5cm and 9cm from the open end of the limb sleeve.
However, as can be seen in figure 6d of Auerbach, the removed portion of the limb sleeve (and therefore a location of the included perforations as taught by Namenye) is formed an undisclosed distance from the open edge of the limb sleeve.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the perforations of the limb sleeve of Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman to be formed at a distance between 5cm and 9cm from the open edge of the limb sleeve 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984) (see MPEP 2144.04 IV A). In the instant case, the limb sleeve of Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman would not operate differently with the claimed distance between the perforations and the open edge of the limb sleeve and the limb sleeve would function appropriately having the claimed distance. Further, applicant places no criticality on the range claimed, indicating simply that “In some embodiments of the invention, the perforations are at a distance between 5cm and 9cm from the open edge of the limb sleeve” (see [0013]) thereby implying that distances between the perforations and the open edge in other embodiments can be different from those claimed can be used in the limb sleeve.
In regards to claim 8, Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman discloses the invention as discussed above.
Auerbach as now modified by Namenye further discloses wherein the perforations (26, 28, 32, 34, and 38 of Namenye) are provided circumferentially around the limb sleeve (3 of Auerbach; see Namenye figure 1 that the perforations extend along a width and length of the drape; thus, when the perforations of Namenye are included into the limb sleeve of Auerbach, the perforations extending in the width direction of Namenye are provided circumferentially about the limb sleeve).
In regards to claim 14, Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman discloses the invention as discussed above.
Auerbach as now modified by Namenye further discloses A method of sterile covering of a patient for shoulder surgery (see Auerbach [0006] in reference to the device creating a sterile field for surgery; see Auerbach [0007] in reference to the device being used on shoulders) using the surgical drape according to claim 1 (see discussion above), comprising
moving the surgical drape (1 of Auerbach) over an arm of the patient such that the arm is covered by the limb sleeve (see figures 6a-d of Auerbach);
unfolding the main covering layer over the patient (see [0049] of Auerbach in reference to the panel portion being secured in place after applying the sleeve);
tearing off part of the limb sleeve at the perforations (See Namenye see [Col 6 ln 48-67] in reference to manually fracturing the perforations (i.e. tearing the drape); thus, 60 of Auerbach is torn off at the perforations of Namenye);
moving the part of the limb sleeve over the arm away from a shoulder to create an accessible area of desired size for the shoulder surgery (see figure 6d of Auerbach that the removed part 60 is moved away from the shoulder to create an accessible area as claimed) fixing a position of the part of the limb sleeve on the arm when the desired size for the accessible area is reached (see [col 7 ln 65-col 8 ln 21] of Namenye in reference to the use of tapes for fixing the flap portions created by tearing the perforations to form a surgical opening of a desired size and shape).
In regards to claim 15, Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman discloses the invention as discussed above.
Auerbach further discloses wherein the surgical drape is folded such that the limb sleeve can unfold without unfolding the main covering layer (see [0046]).
In regards to claim 16, Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman discloses the invention as discussed above.
Auerbach as now modified by Namenye further discloses wherein the fixing of the torn off part of the limb sleeve is executed by applying a tape on the torn off part of the limb sleeve (see Namenye [Col 7 ln 65-col 8 ln 21] in reference to the use of tapes for fixing the torn off parts of the drape, thus as now combined tape is used to fix the torn off parts of the limb sleeve of Auerbach).
Claim(s) 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auerbach in view of Reyes, Bainbridge, Namenye, and Goodman as applied to claim 7 above, and further in view of Haines et al. (US 2009/0178685 A) (hereinafter Haines).
In regards to claim 9, Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman discloses the invention as discussed above.
Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman does not disclose further comprising a label for indicating a location of the perforations, wherein the label for indicating the location of the perforations is provided on the limb sleeve.
However, Haines teaches an analogous drape (10; see [0021]; see figure 1) for use over an analogous surgical site (see [abstract]) comprising an analogous section to be torn away (24; see [0026]; see figure 1b) the section to be torn away (24) comprising analogous perforations (36; see [0030]; see figure 1b) configured to be torn to expose the surgical site (see [0030]) further comprising a label (30; see [0026]; see figure 1b) for indicating the location of the perforations (36), wherein the label (30) for indicating the location of the perforations (36) is provided on the section to be torn away (24) for the purpose of providing a predetermined verification procedure prior to the exposure of the surgical site (See [0026]).
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 area of the limb sleeve which comprises perforations as disclosed by Auerbach as now modified by Reyes, Bainbridge, Namenye, and Goodman by including the label for indicating the location of the perforations as taught by Haines in order to have provided an improved limb sleeve that would add the benefit of providing a predetermined verification procedure prior to the exposure of the surgical site (See [0026]) as well as providing a way of indicating the location of the perforations and accordingly, the surgical site.
In regards to claim 10, Auerbach as now modified by Reyes, Bainbridge, Namenye, Goodman, and Haines discloses the invention as discussed above.
Auerbach as now modified by Haines further discloses wherein the label for indicating the location of the perforations (30 of Haines) is glued on the limb sleeve (3 of Auerbach; see Haines [0028] in reference to 30 being attached via adhesive material; glued is defined by the Merriam-Webster Dictionary as “to cause to stick tightly with or as if with glue” (see https://www.merriam-webster.com/dictionary/glue); when 30 of Haines is included onto 38 of Goodman, the adhesive material of 30 of Haines causes 30 to stick tightly onto the limb sleeve and is by definition “glued” on the limb sleeve).
In regards to claim 11, Auerbach as now modified by Reyes, Bainbridge, Namenye, Goodman, and Haines discloses the invention as discussed above.
Auerbach further discloses wherein the limb sleeve (3) comprises a sleeve starting layer (flexible material; see [0043]) which is folded in a length direction (folded to form free ends; see [0043]), such that a fold is arranged between two folded parts of the limb sleeve starting layer, each of the two folded parts having a half of the length of the sleeve stating layer before folding (see [0043] in reference to the method of forming 3, 32 forms the fold as claimed, the upper and lower portions have the same width as can be seen in figure 1, and each have half of the length of the flexible material prior to folding to form 3), and which sleeve starting layer is glued on opposing sides of the folded parts (free ends; see [0043]; hot melt adhesives are considered to encompass hot gluing) to form the limb sleeve (3) with the closed end (32) and the open end (31), wherein the two folded parts (free ends) are glued up to a third distance (see figure 4 that the free ends of 3 are glued up to 31 as indicated by 36) from the open end (adjacent to 31; see figure 4), and wherein the perforations (perforations as taught by Namenye included onto 3 at a similar location to that of 60 of Auerbach; see Auerbach figure 6d) are at the second distance from the open end (31; see figure 6d) wherein the second distance is larger than or equal to the first distance (see figure 4 that the free ends of 3 are glued all the way to 31, and figure 6d that 60 being spaced from 31 is therefore a greater distance from 31 than the glued free ends).
In regards to claim 12, Auerbach as now modified by Reyes, Bainbridge, Namenye, Goodman, and Haines discloses the invention as discussed above.
Auerbach further discloses wherein the limb sleeve (3) is glued to the main covering layer (2; see [0044] in reference to adhesives or other supplemental securing techniques being used to secure 38 to 2; see [0045] in reference to glue being used to secure 40 to 2, therefore the adhesives used to secure 38 to 2 are considered to include glue).
In regards to claim 13, Auerbach as now modified by Reyes, Bainbridge, Namenye, Goodman, and Haines discloses the invention as discussed above.
Auerbach as now modified by Bainbridge further discloses wherein the tourniquet element (120 of Auerbach as now modified by Bainbridge) is glued in the limb sleeve (3 of Auerbach; see Bainbridge [0075] in reference to heat sealing or adhesive being utilized to adhere 42 of Bainbridge, thus 120 of Auerbach as now modified by Bainbridge is similarly attached within the sleeve).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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