DETAILED ACTION
In Applicant’s Response filed 12/29/25, Applicant has amended claims 21, 26, 31, 34 and 40; and added new claims 41-42. Claims 1-20 have been cancelled. Currently, claims 21-42 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/29/25 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 31 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Madan et al (US 2016/0329614) in view of Dye et al (US 2013/0247921).
With respect to claim 31, Madan discloses a method of using a drape during a surgical procedure (figs 18-19 depict a method of using a drape 940 on a mayo stand 930 which is used during surgical procedures - para [0075;0081]), comprising:
unfolding the drape (drape 940 inherently is unfolded in order to arrive at the configuration shown in fig 18) comprising a top surface and a bottom surface (top and bottom surfaces of drape 940 are shown in fig 19 – top surface faces handpiece 950 and bottom surface faces mayo stand 930), the top surface of the drape comprising a sleeve (sleeve of drape 940 is shown in figs 18-19 conforming to upright peg portion 908), the sleeve comprising a cavity extending from the bottom surface of the drape through a length of the sleeve (as shown in fig 19; the cavity accommodates the upright peg portion 908);
inserting the sleeve onto a post of a surgical table (the sleeve of drape 940 is inserted onto the upright peg portion 908 which is located on the mayo stand 930; the mayo stand is used during surgical procedures and thus is interpreted as being a surgical table);
positioning a bracket on top of the post (the handpiece 950 includes a recess 956 that is configured to receive upright peg portion 908 as shown in fig 19 and is interpreted as being a “bracket” since it functions to attach the coils 910,952 of the charging device 900 in place on the upright peg portion 908 – see fig 19; para [0075-0076]) such that the sleeve is securely positioned between the bracket and the post (as shown in fig 19; the drape 940 conforms to the interface between handpiece 950 and device 900 – para [0076]), the bracket being coupled via the post to the surgical table (the handpiece 950 is held in place on the mayo stand when provided on upright peg portion 908 and thus is interpreted as being “coupled” to the mayo stand via the upright peg portion).
Madan does not, however, disclose in the embodiment of figures 18-19 unfolding the drape such that the bottom surface contacts a patient undergoing the surgical procedure.
Madan does, however, teach another embodiment in figure 20 wherein a charging pad (1020) is draped directly over the torso of a patient (1030) and may have a sterile drape placed over it (and under it) to avoid contaminating medical device (1000) and patient (1030) (para [0079]). Thus, the embodiment of figure 20 teaches unfolding a drape such that the bottom surface contacts a patient undergoing the surgical procedure. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the method shown in figures 18-19 of Madan so that the drape is unfolded such that the bottom surface contacts a patient undergoing the surgical procedure, as taught in the embodiment of figure 20, in order to avoid contaminating a medical device and patient during a procedure.
Madan also does not disclose that the drape comprises a flap.
Dye, however, teaches a drape (10; figure 8) for use in a surgical procedure (device is a “surgical drape” used to provide a channel into a sterile operating field — abstract; thus the drape is interpreted as being used in surgical procedures), comprising at least one sleeve (extended sheath 34) extending perpendicularly away from a first surface of the drape (as shown in figure 8 the sheath 34 extends in a perpendicular direction away from side 12 of drape 10); the at least one sleeve including an opening extending from the opposite second surface of the drape to an interior of the at least sleeve (opening 16 extends through the drape 10 from side 14 to side 12 as shown in fig 7A and provides access to the interior of sheath 34); at least one flap (70; shown in figure 5B). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added a flap as taught by Dye to the top surface of the drape of Madan in order to provide added support and a sterile barrier surface over the bracket during a procedure.
With respect to claim 36, Madan in view of Dye discloses the invention substantially as claimed (see rejection of claim 31) and Madan also discloses that the bottom surface of the drape comprises a sterile portion of the drape, and the unfolding of the drape comprises deploying the drape with the bottom surface of the drape contacting the patient (the sterile drape is disclosed as being capable of use such that it is placed under a charging pad that is directly on the torso of a patient – thus the drape is configured to contact a patient undergoing a procedure if such a use is desired and the bottom surface which contacts the patient is interpreted as being the sterile portion in order to maintain a sterile barrier for the procedure).
Claims 32-34 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Madan et al (US 2016/0329614) in view of Dye et al (US 2013/0247921) and further in view of Morris (US 4569341).
With respect to claim 32, Madan in view of Dye discloses the invention substantially as claimed (see rejection of claim 31) but does not disclose positioning the drape on the patient such that a u-shaped opening of the drape is positioned on or around an incision site of the surgical procedure as the bottom surface of the drape covers the patient.
Morris, however, teaches a surgical drape comprising an opening/fenestration 15
that is u-shaped as shown in figure 1 to permit the drape to be placed around an incision site (the u-shape allows placement about a limb to thereby isolate the limb on which the surgical procedure will be performed – thus the isolated limb includes the incision site; see col 1 lines 51-62) as the bottom surface of the drape covers the patient (as shown in fig 4a-4b). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape of Madan in view of Dye to include a u-shaped opening and to position the drape on the patient such that a u-shaped opening of the drape is positioned on or around an incision site of the surgical procedure as the bottom surface of the drape covers the patient, as taught by Morris, in order to allow for placement of the drape such that a surgical site is isolated from the rest of the patient’s body.
With respect to claim 33, Madan in view of Dye and further in view of Morris discloses the invention substantially as claimed (see rejection of claim 32) and Morris further teaches a protective outer covering of an adhesive tape (release cover 20 over adhesive 19; col 2 lines 47-56) on the bottom surface of the drape (fig 2) that runs substantially along at least one edge of the u-shaped opening (shown in fig 2), the method further comprising: peeling-off the protective outer covering of an adhesive tape from the bottom surface of the drape (shown in fig 2; col 2 lines 54-56), wherein the peeling-off the protective outer covering allows the u-shaped opening to be firmly engaged to the patient via the adhesive tape (the cover 20 is removed for application to a patient – col 2 lines 54-56). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the drape and method of Madan in view of Dye and further in view of Morris so that the drape further comprises a protective outer covering of an adhesive tape on the bottom surface of the drape that runs substantially along at least one edge of the u-shaped opening, and the method further comprises: peeling-off the protective outer covering of an adhesive tape from the bottom surface of the drape, wherein the peeling-off the protective outer covering allows the u-shaped opening to be firmly engaged to the patient via the adhesive tape, as taught by Morris, in order to permit secure attachment of the drape to a patient’s body and maintain the drape in position during a procedure.
With respect to claim 34, Madan in view of Dye and further in view of Morris discloses the invention substantially as claimed (see rejection of claim 32) but Madan does not disclose that the sleeve and a flap are a first sleeve and a first flap, the drape comprising a second sleeve and a second flap, and further wherein the u-shaped opening of the drape comprises a first side and an opposite second side, wherein the first side of the u-shaped opening is adjacent to the first sleeve and first flap, and the second side of the u-shaped opening is adjacent to the second and second flap.
Dye further teaches that the at least one sleeve includes a first sleeve and a different second sleeve (the drape can be configured to include multiple portals 30 — para [0069]; surgical drape 10 can be configured with more than one portal 30 pre-attached — para [0069]; each separate portion will be configured as shown in figure 5A having its own individual sheath 34), and the at least one flap includes a first flap and a different second flap (each portal 30 is interpreted as having its own individual flap 70 as shown in figure 5B). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Madan in view of Dye and further in view of Morris to provide first and second sleeves with respective first and second flaps, as taught by Dye, in order to provide a means to hold multiple articles at the same time, with the same drape.
Morris further teaches that the u-shaped opening of the drape comprises a first side and an opposite second side (inherent structural features of a u-shaped opening; shown in fig 1-2). Morris does not, however, teach that the first side of the u-shaped opening is adjacent to a first sleeve and first flap, and that the second side of the u-shaped opening is adjacent to a second sleeve and second flap. It would have been obvious, however, to one having ordinary skill in the art, before the effective filing date of the invention, to have further modified the device of Madan in view of Dye and further in view of Morris to have modified the drape by repositioning the sleeves and flaps so that the first side of the u-shaped opening is adjacent to the first sleeve and first flap, and the second side of the u-shaped opening is adjacent to the second and second flap since rearranging parts of an invention involves only routine skill in the art.
With respect to claim 37, Madan in view of Dye discloses the invention substantially as claimed (see rejection of claim 31) but Madan does not disclose the drape comprising one or more markings on the bottom surface of the drape, the one or more markings configured to inform a user how to orient the drape with respect to the patient wherein the unfolding of the drape comprises identifying the one or more markings on a bottom surface of the drape.
Dye, however, teaches at least one marking on a bottom surface of the drape, the at least one marking configured to identify a position of the user relative to the drape (markings 15 which can be directions stamped on the sterile side of the drape — para [0049]). Additionally, it is inherent that when the drape is unfolded to cover a patient, the unfolding of the drape comprises identifying the one or more markings on a bottom surface of the drape because the markings 15 providing directions on the bottom, sterile side of the drape would be visible and thus identified by the user unfolding the drape.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added at least one marking configured to identify a position of the first user relative to the drape to inform a user how to orient the drape with respect to the patient wherein the unfolding of the drape comprises identifying the one or more markings on a bottom surface of the drape, as taught by Dye, to the bottom surface of the drape of Madan in view of Dye, in order to provide directions to assist with use and/or placement/ positioning of the drape (see Dye para [0049]).
Madan in view of Dye does not, however, disclose positioning the drape on the patient such that a u-shaped opening of the drape is positioned on or around an incision site of the surgical procedure as the bottom surface of the drape covers the patient.
Morris, however, teaches a surgical drape comprising an opening/fenestration 15
that is u-shaped as shown in figure 1 to permit the drape to be placed around an incision site (the u-shape allows placement about a limb to thereby isolate the limb on which the surgical procedure will be performed – thus the isolated limb includes the incision site; see col 1 lines 51-62) as the bottom surface of the drape covers the patient (as shown in fig 4a-4b). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the drape of Madan in view of Dye to include a u-shaped opening and to position the drape on the patient such that a u-shaped opening of the drape is positioned on or around an incision site of the surgical procedure as the bottom surface of the drape covers the patient, as taught by Morris, in order to allow for placement of the drape such that a surgical site is isolated from the rest of the patient’s body.
Allowable Subject Matter
Claims 21-30 and 41 are allowed.
The following is an examiner’s statement of reasons for allowance:
With respect to independent claim 21: Applicant's arguments, see Applicant's Response filed 12/29/25, with respect to the rejection of claim 21 under 35 USC 103, have been fully considered and are persuasive. Applicant argued that the prior art of record fails to disclose or suggest the step of “folding the flap over the bracket such that the flap is configured to act as a protective covering layer over the bracket” as recited in independent claim 21 (see Remarks pages 12-15). More specifically, Applicant argued that the Dye reference fails to teach this step because when Dye’s sheath 34 is in use, the cover panel 70 (which the Office interprets as being equivalent to the claimed flap) is not in use but, instead, is pivoted away from the sheath 34. Applicant further argued that this configuration is unlike the claimed method which requires the flap to be folded over the bracket during a surgical procedure and even if the cover panel 70 (flap) in Dye would be capable of performing the claimed method step, there is no disclosure of the method step itself because Dye does not disclose wrapping the panel 70 around the sheath 34 when in use. The Office is persuaded by these arguments and therefore agrees that the following subject matter of independent claim 21 could either not be found or was not suggested in the prior art of record: A method of using a drape which comprises a sleeve and a flap during a surgical procedure, comprising: inserting the sleeve onto a post of a surgical table; positioning a bracket on top of the post such that the sleeve is securely positioned between the bracket and the post; and folding the flap over the bracket such that the flap is configured to act as a protective covering layer over the bracket, in combination with the other elements in the claims.
Therefore, the rejection of claim 21 has been withdrawn and claim 21 is allowed.
Claims 22-30 and 41 are allowed insofar as they depend on claim 21 and thus contain the same allowable limitations
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 35, 38-40 and 42 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With respect to claim 35, the claim includes the same allowable subject matter as claim 21 (as described above). Therefore, for at least the same reasons as provided above with respect to claim 21, the prior art of record fails to disclose the subject matter of claim 35.
With respect to claim 38, the following is a statement of reasons for the indication of allowable subject matter: The subject matter of claims 38 could either not be found or was not suggested in the prior art of record. The subject matter not found was a method of using a drape wherein positioning of the bracket comprises rotating the bracket relative to a surgical table jack such that the bracket is configured to be positioned relative to a femur of the patient, in combination with the other elements in the claims.
As discussed above, Madan in view of Dye (with respect to claim 31) and further in view of Matta (see rejection of claim 21) discloses the method substantially as claimed, but Madan is silent as to whether the bracket (handpiece 950) is capable of rotating. Furthermore, Madan does not disclose a surgical table jack and, thus fails to disclose or suggest that the handpiece 950 can be rotated relative to a surgical table jack to position the handpiece relative to a femur of the patient. Termanini teaches a mechanical elevating femoral jack and attachment device suitable for elevating a femur to allow a surgeon to prepare the femur for implanting a prosthesis (para [0015]). However, Termanini also fails to disclose brackets (C clamps 22, 24) that rotate relative to the femoral jack because, instead, Termanini teaches that the C clamps are applied over the side rails and squeezed onto the rails when knobs 18 and 23 are turned to solidly attach to the surgical table (para [0016]). Clamps that provide a solid attachment to the surgical table are interpreted as being incapable of rotating relative to a surgical table jack to be positioned relative to a femur of the patient. Therefore, for at least these reasons, the prior art of record fails to disclose the subject matter of claim 38.
Claim 39 depends from claim 38 and, therefore, contains the same allowable subject matter.
With respect to claim 40, the following is a statement of reasons for the indication of allowable subject matter: The subject matter of claim 40 could either not be found or was not suggested in the prior art of record. The subject matter not found was a method of using a drape wherein the bracket comprises a plurality of openings in order to position the receiving end of the femoral support hook at an appropriate distance from a femur of the patient to be supported for the surgical procedure, in combination with the other elements in the claims.
Madan in view of Dye discloses the method substantially as claimed (see rejection of claim 31). Specifically, Madan has been interpreted as disclosing the step of positioning a bracket on top of a post of a surgical table (the handpiece 950 includes a recess 956 that is configured to receive upright peg portion 908 as shown in fig 19 and is interpreted as being a “bracket” since it functions to attach the coils 910,952 of the charging device 900 in place on the upright peg portion 908 – see fig 19; para [0075-0076]). However, the bracket in Madan is a handpiece 950 of a medical device that receives the upright peg portion 908 so that a coil 910 within upright peg portion 908 is positioned within sufficient proximity to a secondary coil 952 that is in handpiece 950 for the coils 910,952 to inductively couple, forming a transformer and charging power source 954 (para [0076]). The handpiece 950 does not include an opening configured for positioning a receiving end of a femoral support hook therein, nor does it comprise a plurality of openings in order to position the receiving end of the femoral support hook at an appropriate distance from a femur of the patient to be supported for the surgical procedure. Furthermore, modification of the handpiece 950 of Madan to have such a configuration would render the device inoperable for its intended purpose of providing an inductive charging device.
Termanini (US 2017/0231612) teaches a method of using a drape wherein a drape is provided over posts on a surgical table (the drape covers side rails of the table – see para [0016]) and brackets (C clamps 22, 24) are positioned on top of the posts such that the drape is securely positioned between the bracket and the post (the C clamps fit over the drape and conformably hug the top and bottom edges of the side rails of the surgical table – para [0016]). Termanini further teaches that a gear box 1 is attached to the table via the C clamps and includes an opening configured for positioning a receiving end of a femoral support hook therein (the vertical shaft 3 of the femoral hook 6 is positioned in an opening within the gear box 1 as shown in fig 1). Termanini does not, however, teach a plurality of openings for positioning the receiving end of the femoral support hook at an appropriate distance from a femur of the patient to be supported for the surgical procedure. Thus, Termanini fails to overcome the deficiencies of Madan in view of Dye.
Therefore, for at least these reasons, the prior art of record fails to disclose the subject matter of claim 40.
With respect to claim 42, the following is a statement of reasons for the indication of allowable subject matter: The subject matter of claim 42 could either not be found or was not suggested in the prior art of record. The subject matter not found was a method of using a drape wherein the sleeve is configured to be on the post as the post is vertically moved, the post configured to vertically move relative to the surgical table, in combination with the other elements in the claims.
Madan in view of Dye discloses the method substantially as claimed (see rejection of claim 31). Specifically, Madan has been interpreted as disclosing the step of positioning a bracket on top of a post of a surgical table (the handpiece 950 includes a recess 956 that is configured to receive upright peg portion 908 as shown in fig 19 and is interpreted as being a “bracket” since it functions to attach the coils 910,952 of the charging device 900 in place on the upright peg portion 908 – see fig 19; para [0075-0076]). However, there is no disclosure in Madan of the post (peg portion 908) being configured to vertically move relative to the surgical table.
Termanini (US 2017/0231612) teaches a method of using a drape wherein a drape is provided over posts on a surgical table (the drape covers side rails of the table – see para [0016]) but is silent with respect to vertically moving the posts relative to a surgical table.
Therefore, for at least these reasons, the prior art of record fails to disclose the subject matter of claim 42.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 12/29/25 have been fully considered as follows:
Regarding the objections to the claims, Applicant’s amendments have been fully considered and are sufficient to overcome most of the objections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 112, Applicant’s amendments and arguments have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the rejection of claim 31 under 35 USC 103, Applicant’s arguments on pages 7-18 of the Response have been fully considered but are not persuasive. Applicant argued on page 18 that the prior art of record fails to disclose or suggest the subject matter of claim 31 for at least the same reasons as provided with respect to claim 21. However, claim 31 does not include the same allowable limitations as claim 21 and the Office is not persuaded by Applicant’s arguments with respect to the remaining limitations in claim 21.
Specifically, the Office has noted Applicant’s arguments on pages 8-10 of the Remarks wherein Applicant argues that the Office fails to show that Madan discloses the step of unfolding the drape such that the bottom surface is configured to contact a patient because the Office relies on two separate embodiments of Madan to allege that the prior art discloses these claimed features. These arguments are rendered moot, however, in view of the revised/modified grounds of rejection presented above which clarify how it would have been obvious to modify the method shown in figures 18-19 of Madan so that the drape is unfolded such that the bottom surface contacts a patient undergoing the surgical procedure, as taught in the embodiment of figure 20, in order to avoid contaminating a medical device and patient during a procedure.
The Office has also noted Applicant’s arguments on pages 10-11 that one of ordinary skill in the art would not have combined the two embodiments in Madan because a need does not exist in the second embodiment for the peg portion structure of the first embodiment. The Office is not persuaded by this argument, however, because the Office has not suggested that the peg in the embodiment of figs 18-19 should be added to the charging pad in the embodiment of figure 20 but, instead, has suggested that the drape should be repositioned such that the bottom contacts the patient as taught in the embodiment of figure 20. Thus, for at least this reason, the Office is not persuaded by this argument.
The Office has also noted Applicant’s argument on page 11 that the prior art of record fails to disclose the subject matter of claim 21 because a mayo stand (such as element 930 in Madan) is not a table configured to support a patient (as is required by the claimed method). The Office is not persuaded by this argument, however, because the Matta reference has been cited for teaching a patient on a table that is specifically configured to support a patient. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Thus, for at least this reason, the Office is not persuaded by this argument.
The Office has also noted Applicant’s argument on page 11 that the Dye reference fails to remedy the alleged deficiencies in Madan because the drape 10 in Dye is vertically deployed adjacent to a patient and does not contact the patient undergoing the surgical procedure. The Office is not persuaded by this argument, however, because the Madan reference has been cited for teaching this limitation (see revised claim rejections above) and in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Thus, for at least this reason, the Office is not persuaded by this argument.
The Office has also noted Applicant’s arguments on pages 12-15 of the remarks, but these arguments are not relevant to claim 31 since the claim limitations at issue are not included in the claim.
The Office has also noted Applicant’s arguments on pages 15-18 but for at least the same reasons as provided above, the Office is not persuaded by these arguments and/or the arguments are not relevant to claim 31 since they are directed to limitations that are not in the claim.
Therefore, for at least the reasons outlined above, the Office is not persuaded by Applicant’s arguments and, therefore, maintains that the prior art of record reads on claim 31 substantially as recited in the present application.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786