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 Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muller (US4,899,762A).
With regards to claim 1, Muller discloses a surgical drape, dressing, and closure structure including an incision guide line, the structure having a body member 64 and an adhesive material 66 disposed underneath the body member 64 (i.e., a bi-layer surgical guideline marking layer comprising a first layer and a second layer relatively disposed under, or disposed under relative to, the first layer), the entire structure being made of transparent material (i.e., the first layer being a transparent material and the second layer being a transparent material) (Muller: co. 1, lines 21-37; col. 7, lines 4-19; Fig. 8). The structure of Muller is disposed such that it has a first edge of a peripheral drape portion 16 which is raised around a first edge of a periphery of the overall structure (i.e., forming a first receiving tank disposed on a first same side of the first layer and the second layer, as the peripheral drape portion 16 is made of the drape structure, which is capable of absorbing fluids, and is therefore considered a “first receiving tank” in view of the present specification) (Muller: col. 4, line 58 through to col. 5, line 11; Figs 1-8).
With regards to claim 2, Muller further discloses the peripheral drape portion 16 as having a second edge disposed on a second same side of the first layer and the second layer, and disposed at an opposite side of the first edge (i.e., a second receiving tank disposed opposite the first receiving tank) (Muller: Figs. 1-8).
With regards to claim 3, as best understood, since the body layer 64 is formed of a permeable membrane, then technically, a first permeable membrane exists between the first same side and the first receiving tank (see attached). In addition, Muller discloses forming an incision into the entire structure (i.e., includes an access hole disposed on the first layer) (Muller: Figs. 1-8).
With regards to claim 4, the structure of Muller includes a first permeable membrane (i.e., a part of the first layer disposed in a central portion as opposed to the peripheral portion 16) disposed between the first same side and the first receiving tank, and a second permeable membrane disposed between the second receiving tank, the first layer, and the second layer (i.e., constituting an edge of the peripheral portion 16 between the first and second edges, or between the first and second receiving tanks), and an incision disposed in the first layer (i.e., an access hole disposed on the first layer) (Muller: Figs. 1-8). It is noted that the first and second permeable membranes are a part of the overall first layer.
With regards to claim 7, the structure of Miller includes a folded portion disposed on the first layer, under the first layer, on the second layer, and under the second layer (i.e., the fold constituting both a tactile structure and a body positioning mark) (Muller: Figs. 1-8).
Claims 5-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Muller as applied to claim 1 above.
With regards to claim 5, Muller discloses a bi-layer surgical guideline marking layer as applied to claim 1 above (see above discussion). Although Muller is not explicit as to its first layer as displaying a first color, the second layer displaying a second color, the first color different from the second color, such that when the first layer overlaps the second layer, the first layer displays a third color, Muller more broadly teaches that portions of its structure maybe color coded to designate various specific medications, dressing sizes, shapes, standards, or other specific structures or functions (Muller: col. 9, lines 5-16). Muller also notes that its structure may be translucent (i.e., as best understood, both “transparent” according to the present specification, while also showing a color, such that when any two different-colored portions of the structure of Muller are overlapped, a third color appears due to color mixing) (Muller: col. 5, lines 32-41). Therefore, a person of ordinary skill in the art would have found it obvious to have selected a first color and second color, the first color being different from the second color, as claimed, in order to designate the sizes, shapes, and locations of the individual layers of the structure of Muller (i.e., to denote the location of its first layer and second layer) (see above discussion). Furthermore, since the layers of Muller are transparent and colored (i.e., translucent), a third color would result when the layers of Muller are overlapped.
With regards to claim 6, Muller discloses the use of forceps or a clamp with respect to its structure, and Muller depicts the inclusion of an incision (i.e., a first instrument through hole penetrating the first layer and the second layer) (Muller: col. 5, lines 3-11; Figs. 1-8). As Muller discloses using forceps or a clamp, it would have been obvious to have used the forceps or clamp, such that the forceps or clamp are closely attached around the at lest one first instrument through hole, as Muller expressly suggests use of clamps or forceps with its structure (i.e., it would have been obvious to have placed the forceps or clamp as-needed during surgery, and selection of the incision would have been obvious) (Muller: col. 5, lines 3-11; Figs. 1-8).
With regards to claim 8, a person of ordinary skill in the art would have found obvious to have included index lines (i.e., wires) across the entirety of the first and second layers (i.e., all around the first and second layers) in order to facilitate alignment of the structure during surgery (Muller: col. 6, lines 18-36). It is noted that since the entire structure is foldable, the index lines are also foldable.
With regards to claim 9, a person of ordinary skill in the art would have found it obvious to have applied grid lines made of radio-opaque material to the grid lines of Muller (i.e., to have disposed at least one signal element disposed on the foldable wire) in order to facilitate alignment of the structure during surgery (Muller: col. 6, lines 18-36). As best understood, the radio-opaque material is capable of sensing an attached state of the bi-layer surgical guideline marking layer (i.e., at least, in the sense that radio-sensing may be used to determine the location of the structure, and therefore, would be capable of sensing an attached state).
Response to Arguments
Applicant’s arguments/amendments with respect to the grounds of rejection under 35 U.S.C. 112(b) have been fully considered and they are found persuasive. Applicant has deleted the indefinite term “closely”, and therefore, the present grounds of rejection under 35 U.S.C. 112(b) have been withdrawn.
The remainder of Applicant’s arguments have been fully considered, but they are not found persuasive.
On pages 5-8, Applicant argues that the drape portion is a relatively slick non-absorbent drape, and therefore, it is not a structure configured to receive or contain liquid (i.e., and therefore, not a first receiving tank disposed on a first same side of the first layer and the second layer). Based on the cited portion of Muller (column 8, lines 7 to 10), Applicant believes the argued limitation is neither disclosed nor taught by Muller. The relevant portion of Applicant’s citation is copied for quick re-reference:
“Further, in accordance with the method of the invention, during the surgical procedure, the relatively slick non-absorbent drape portion 16 of the combination surgical dressing and drape 10 permits easy wiping of body fluids and debris in and around the surgical field.”
The cited portion of Muller is noted. The Examiner finds the underlined portion quite relevant, and in observing the underlined portion, it is believed Applicant’s position is made rather clear (i.e., that the drape portion cannot be considered a tank per the present claims, as it is being described as non-absorbent). However, the Examiner notes col. 4, line 66 through to col. 5, line 3 of Muller as stating the following:
“As shown in FIG. 3, both the dressing portion 14 and drape portion 16 of the combination drape and dressing 10 include a central, substantially flat, body part or base 20 constructed of an open cell polymer such as polyurethane or silicone compound which is absorbent to body fluids and is inert with respect thereto.”
PNG
media_image1.png
162
656
media_image1.png
Greyscale
Figure 3 of Muller also depicts the following:
In response, the Examiner considers base 20 to be an open cell polymer which is absorbent to body fluids, the base 20 being a part of drape portion 16, the base 20 capable of acting as a tank per the present claims (i.e., as it is an absorbent layer). Figure 3 of Muller depicts base 20 as porous, as best understood, and as extending to form part of drape portion 16. As best understood from Figure 3 of Muller in view of its description of a base 20 as being porous and absorbent to body fluids, the drape portion 16 (which includes the porous base 20) would therefore also be absorbent to body fluids (and therefore, would meet the tank of the claims). It is the Examiner’s position that, at least per Figure 3 of Muller, a “tank” per the present claims is present.
To further address the cited portion of Muller by Applicant, the Examiner notes col. 5, lines 18-23 of Muller as reciting the following:
“Top cover 24 is made of conventional slick material such as paper or plastic film to allow it to be wiped off during surgery and is removed after surgery, during closure, to allow the straddling member 12 to be applied over and become adherent to the exposed body member 20 according to the invention.”
As best understood from Muller, the structure providing the “relatively slick, non-absorbent drape portion 16” is top cover 24, which is applied later during the operation. Therefore, the portion of Muller cited by Applicant is not directed to the base structure of Muller, but rather, a structure of Muller which results after several steps of use (i.e., after application of the structure of Muller, and at some time during surgery). In further support, Figures 6-8 of Muller are provided on the following page. In the embodiment of Figures 6-8 of Muller, Applicant’s indicated “relatively slick, non-absorbent drape portion 16” has been formed later in Muller’s disclosed surgical procedure.
PNG
media_image2.png
628
696
media_image2.png
Greyscale
Therefore, in one embodiment, Muller discloses an absorbent drape portion 16 which meets the present claims (i.e., including the claimed receiving tank), and therefore, the claimed invention is anticipated by Muller (despite the existence of a later embodiment which does not meet the present claims in the proposed manner).
Alternatively, the Examiner notes that, technically, the drape portion 16 still forms sidewalls of a “tank” (i.e., sidewalls surrounding a central portion). Therefore, the drape portion 16, even in embodiments where it is non-absorbent, still functions as a tank, as it has non-absorbent walls which are capable of containing a fluid (i.e., as in, surrounding a periphery of a central portion, the central portion potentially containing fluid, as it is absorbent).
Conclusion
THIS ACTION IS MADE FINAL. 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 ETHAN WEYDEMEYER whose telephone number is (571)270-1907. The examiner can normally be reached Monday - Friday 8:30 - 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria V. Ewald can be reached at (571) 272-8519. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.W./
Examiner, Art Unit 1783
/MARIA V EWALD/ Supervisory Patent Examiner, Art Unit 1783
Prosecution Insights