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 .
Election/Restrictions
Claims 10-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of making and method of using, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 10th, 2026.
Applicant’s election without traverse of Group I (claims 1-9) in the reply filed on January 10th, 2026, is acknowledged.
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 6 is 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 6 recites the indefinite phrase “closely attached.” It is unclear, at what threshold, the first and second layers may be considered “closely attached” around the at least one first instrument through hole. It is possible that “closely attached” means “attached.” However, “closely attached” could, instead, imply direct contact. The present specification does not provide any particular guidance as to how the phrase “closely attached” should be interpreted (i.e., there is no reference point for providing a definition). In the interest of compact prosecution, the claim will be interpreted as reciting a first layer and second layer which are “attached”.
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).
Conclusion
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.
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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.
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/E.W./
Examiner, Art Unit 1783
/MARIA V EWALD/ Supervisory Patent Examiner, Art Unit 1783