DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 27 October 2025.
Notice of 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 .
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 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.
Response to Arguments
The 112 rejections are withdrawn in light of Applicant’s amendment.
In the response filed 27 October 2025, Applicant argues the rejection under Bloom’737 in view of Young’768 is improper because the invention has additional advantages over Bloom’737, which requires rotating and flipping the template to provide four flap options, compared to the present invention which clearly outlines the four flap options without rotation and flipping. Specifically, Applicant argues the steps of rotating and flipping can lead to more confusion and the surgeon may resort to freehand drawing rather than use the Bloom’737 template.
This argument is not persuasive. MPEP 716.01(c) Section I states “Objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984) “ Further, MPEP 716.01(c)II states “Arguments presented by the applicant cannot take the place of evidence in the record.” In this case, Applicant’s arguments regarding the superiority of the present invention over the prior art is not supported by evidence.
Applicant further argues that Bloom’737 does not provide a motivation or suggestion to combine with Young’768 and that Bloom’737 does not suggest providing a opening in the shape of a rhomboid, instead of a plurality of apertures in the shape of a rhomboid would be useful. This is not persuasive. Bloom’737 is the primary reference in a rejection under 35 USC 103. If Bloom’737 provided a motivation to modify itself, it would be a matter of anticipation under 35 USC 102 not obviousness under 35 USC 103. 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).
For these reasons, the rejections are maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 5-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bloom (US Patent 4,944,737) in view of Young (US Patent 7,752,768).
Claim 1: Bloom’737 teaches a surgical template (Figure 5) for marking a pattern on skin prior to performing surgery to create a skin flap for closing an opening or wound in the skin (column 2, lines 20-29), the template comprising:
a substantially planar sheet (30) having a series of perforations (40) in the shape of a rhomboid (32), the sheet having:
a first hole (42 – see labeled copy of Figure 5 below) linearly spaced along an axis passing through opposed obtuse corners of the rhomboid such that the distance between the corner of the rhomboid and the adjacent hole of the first pair of holes is equal to the length of the sides of the rhomboid (Figure 5), and
a second hole (42 – see labeled copy of Figure 5 below) the second hole is spaced from the first hole such that a line from the first hole to the second hole is parallel to and equal in length to the adjacent side of the rhomboid (Figure 3), wherein the perforations of the sheet defining the shape of the rhomboid are for guiding a marker for making incision points to be connected by an incision line on the skin surrounding the portion of skin intended to be removed (column 5, lines 24-30 and column 2, lines 20-40).
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The first and second holes define an axis (82) therebetween for marking incision lines on the skin forming a pattern for the skin flap.
Bloom’737 teaches the rhomboid shape in the sheet comprises perforations rather than an opening.
Like Bloom’737, Young’768 teaches a planar sheet (13) for marking an area of skin to be excised. Instead of perforations to delineate the tissue being removed, as in Bloom’737, Young’768 teaches an opening (33). This opening (33) is advantageous over perforations because it allows the skin cancer, which is often raised, to pass through the opening in the template so the template is positioned closer to the skin for more precise marking of the tissue.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the template taught by Bloom’737 with a rhomboid-shaped opening, rather than a rhomboid-shaped set of perforations, as taught by Young’768, in order to position the template directly on the skin while accommodating the raised tissue being removed to allow for more precise marking of tissue.
Bloom’737 does not teach the first hole is a pair of holes, the second hole is a pair of holes or a third pair of holes. Instead, Bloom’737 teaches rotating the sheet and/or flipping the sheet to allow the surgeon to create the flap in the most advantageous location and orientation (column 5, lines 15-23). By rotating and flipping the sheet, the surgeon has the same options for creating a rhomboid flap as if there were a first pair of openings, a second pair openings and a third pair of openings. It’s been held that the mere duplication of essential working parts (in this case, the pairs of holes) involves only routine skill in the art and duplication of parts has no patentable significance unless a new and unexpected result is produced. In this case, Bloom’737 teaches a template for creating a rhomboid flap. The rhomboid flap is old and well known (see Bloom’737’s citation of Local Flaps in Head and Neck Reconstruction by I.T. Jackson in column 1) and can be created in any orientation about the excised tissue. Modifying Bloom’737 to have pairs of holes, as recited in the claims, would not change the template since the same holes can be created by flipping and rotating the template, as taught by Bloom’737 at column 5, lines 15-23 and Figure 6.
Claim 3: In the resulting device of Bloom’737 in view of Young’768, the rhombus is an opening. These edges are configured for receiving a cutting edge and guiding an incising instrument.
Claim 5: Bloom’737 teaches a method for marking a pattern on skin prior to performing surgery to create a skin flap for closing an opening or wound in the skin (column 2, lines 20-29), the skin pattern marking method comprising the steps of:
providing a substantially planar sheet, as recited in claim 1 (see the rejection of claim 1 above under Bloom’737 in view of Young’768);
positioning the sheet on the skin (column 5, lines 10-11);
marking the skin along the perforations of the sheet defining the rhomboid pattern to the skin for use as excision lines for skin removal forming a hole in the skin (Figure 7 shows dots 50 for forming the rhomboid shaped skin removal section);
marking dots (52, 52) on the skin through the holes for indicating an area from which to obtain the skin flap by drawing an incision line extending from the adjacent corner of the rhomboid opening and between the dots representing the incision to be made in the skin to produce the flap (Figure 7 and column 5, lines 24-27);
excising following the lines of the closed geometric figure marking for removing skin making a hole to be closed (column 5, lines 27-30 and Figures 2); and
making an incision in the skin along the lines between the dots to produce a local flap to cover the hole in the skin (column 5, lines 27-30 and Figures 2-4).
Bloom’737 does not teach marking the skin along the opening of the sheet because the rhomboid shape in the sheet comprises perforations rather than an opening.
Like Bloom’737, Young’768 teaches a planar sheet (13) for marking an area of skin to be excised. Instead of perforations to delineate the tissue being removed, as in Bloom’737, Young’768 teaches an opening (33). This opening (33) is advantageous over perforations because it allows the skin cancer, which is often raised, to pass through the opening in the template so the template is positioned closer to the skin for more precise marking of the tissue.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the template taught by Bloom’737 with a rhomboid-shaped opening, rather than a rhomboid-shaped set of perforations, as taught by Young’768, in order to position the template directly on the skin while accommodating the raised tissue being removed to allow for more precise marking of tissue.
Claim 6: Bloom’737 teaches selecting a predetermined opening size from among a plurality of templates having different sizes of rhomboid-shaped perforations (column 5, lines 11-14).
Claim 7: Bloom’737 teaches selecting the orientation of the flap by rotating the template on the skin (column 5, lines 15-23).
Claim 10: Bloom’737 teaches cutting through the skin along the excision lines (column 5, lines 27-30 and Figures 2) and removing the patch of skin of rhomboid shape (Figure 2).
Claims 2, 4 are rejected under 35 U.S.C. 103 as being unpatentable over Bloom’737 in view of Young’768, as applied to claim 1, further in view of Wilson (US Patent 4,192,312).
Claim 2: Bloom’737 teaches the sheet comprises a transparent (abstract), but does not specifically teach the sheet is flexible.
Like Bloom’737, Young’768 teaches a planar sheet (13) for marking an area of skin to be excised. Wilson’312 teaches the sheet is flexible. This flexibility allows the template to be readily applied to different contoured areas of the body (column 3, lines 12-16).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the sheet taught by Bloom’737 such that the sheet is flexible, as taught by Wilson’312, so the sheet can be applied to curved areas of the body.
Claim 4: Bloom’737 does not teach the inner surface of the sheet is adhesive.
Like Bloom’737, Young’768 teaches a planar sheet (13) for marking an area of skin to be excised. Wilson’312 teaches the inner surface of the sheet (13) is adhesive (23) to enable the sheet to be removably attached to the patient’s skin (column 4, lines 11-25).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Bloom’737 with adhesive, as taught by Wilson’312, in order to allow the sheet to be adhered to skin so it is held in place during the marking of the incision lines.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bloom’737 in view of Young’768, as applied to claim 7, further in view of Hon et al. (Hon et al. “Rhomboid Flap” Atlas Oral Maxilofacial Surg Clin N Am 28 (2020) pages 17-22).
Claim 8: Bloom’737 teaches does not teach identifying the line of maximum extensibility (LME), aligning the template so that two sides of the rhomboid pattern are parallel to the LME and aligning a short diagonal of the flap to be parallel to the LME.
Hon teaches identifying the LME and incising tissue such that two sides of the rhombus are parallel to the LME (pages 18-19 under “Flap Design” and “Surgical Technique”).
The short diagonal is parallel with two sides of the rhombus so the “short diagonal” will also be parallel with the LME.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify Bloom’737 such that two sides of the rhombus are parallel with the LME, as taught by Hon, in order to minimize distortion of adjacent tissue structures (page 18).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bloom’737 in view of Young’768, as applied to claim 7, further in view of Fee et al. (Rhomboid Flap Principles and Common Variations, The Laryngoscope, November 1976, pages 1706-1711)
Claim 9: Bloom’737 teaches does not teach selecting the orientation of the flap by considering the relaxed skin tension line (RSTL) and the vector of tension (VOT) for anticipating distortion of adjacent tissues.
Fee teaches a method of planning a rhomboid flap which considers the RSTL and VOT to reduce distortion of adjacent tissues (page 1706, paragraph 2 under introduction through page 1708).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method taught by Bloom’737 by considering the RSTL and VOT when planning a rhomboid flap orientation, as taught by Fee, in order to reduce scarring (page 1706).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Friday 9am-5pm and alternating Fridays.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 10 November 2025
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771