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
Applicant’s election without traverse of Group I, claims 1-13, in the reply filed on 11/19/2025 is acknowledged. Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/19/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/31/2023 was filed before the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Pieringer (US20180085185A1 published 03/29/2018) in view of Lober (US20070055290A1 published 03/08/2007).
Regarding claim 1, Pieringer teaches a tissue marking system (a surgical marker – Fig. 2 and abstract) for marking a tissue specimen, the tissue marking system comprising:
an applicator removable from a container (a marker 200 removable from a container – Fig. 2 and paragraph 40), the applicator comprising:
a body having a reservoir containing tissue marking dye (a body 202 having a chamber 236 containing an ink cartridge 242 – paragraph 36 and Fig. 2);
an applicator head (an ink cartridge 242 – Fig. 2);
a porous pad of the applicator head (a tip 204 – Fig. 2) (the tip 204 is formed from a porous assembly of fibers or fibrous flow-inducing channels, such as felt, nylon, polyester, plastic, and is deemed to read on a porous pad – paragraph 22);
a base of the applicator head supporting the porous pad (a base of the ink cartridge 242 at an elongate sleeve 246 supporting the tip 204 – Fig. 2);
a through opening of the base (a channel formed by the sleeve 246 of the ink cartridge 242 – Fig. 2) configured to facilitate passage of tissue marking dye between the reservoir and the porous pad (the channel holds the tip 204 and a buffer 244 to enable a free flow of ink – Fig. 2 and paragraph 36); and
the porous pad configured to transfer tissue marking dye from the porous pad to the tissue specimen in response to the porous pad contacting the tissue sample (the tip 204 transfers ink to a tissue sample – paragraph 22 and claim 1).
However, Pieringer does not teach a container and an applicator in the container.
Lober teaches a surgical site marking kit 50 comprising a container (sealable packaging enclosure 52 adapted to receive one or more component parts of the kit – paragraphs 56, 61 and Fig. 11) and an applicator in the container (a plastic surgical site marking pens 60 – paragraph 56 and Fig. 11). Lober teaches to use a surgical site marking kit 50 to include multiple marking pens 60 and instructions for use and/or additional marketing materials.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the marker, taught by Pieringer, by packing multiple pens in the marking kit, taught by Lober, to provide multiple marking tools and instructions for use and/or additional marketing materials. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Pieringer and Lober teach surgical site marking tools.
Regarding claim 2, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the porous pad comprises a foam pad (the tip 204 is formed from a porous assembly of fibers or fibrous flow-inducing channels, such as felt, nylon, polyester, plastic, and is deemed to read on a foam pad – Pieringer paragraph 22).
Regarding claim 3, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the base comprises a planar upper surface below the porous pad (the base of the ink cartridge 242 comprising a planar section below the extension 240 of the tip 204 – Pieringer Fig. 2), the planar upper surface extending about the through opening of the base (the planar section extending about the channel of the ink cartridge 242 – Pieringer Fig. 3).
Regarding claim 4, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the applicator has a central, longitudinal axis (the marker 200 having a central, longitudinal axis – Pieringer Fig. 2);
a protruding member having a curved distal end surface (a plunger 206 having a curved distal end – Pieringer Fig. 2) and a side surface extending proximally away from the curved distal end surface (an arm 224 of the plunger 206 extending proximally away from the distal end – Pieringer Fig. 2); and
wherein the protruding member is aligned with the through opening of the base along the central longitudinal axis of the applicator (the distal end of the plunger 206 is aligned with the channel along the central longitudinal axis – Pieringer Fig. 2).
Regarding claim 5, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the applicator has a central longitudinal axis (the marker 200 having a central, longitudinal axis – Pieringer Fig. 2);
wherein the body has a socket portion with an opening that opens to the reservoir (the body 202 having an upper end 208 with an opening 232 that opens to the chamber 236 – Pieringer Fig. 2); and
a plug member engaged in the socket portion (a plunger 206 engaged in the upper end 208 – Pieringer Fig. 2), the plug member having an opening aligned with the through opening of the base along the central longitudinal axis of the applicator (the plunger 206 having an annular groove at a sealing element 254, and the center of the annular groove aligns with the channel along the central, longitudinal axis – Pieringer Fig. 2).
Regarding claim 6, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the body includes a plastic material (a plastic tube – Lober paragraph 61) and has a unitary, one-piece construction (the body 202 is unitary – Pieringer Fig. 2);
wherein the body has an open end portion (lower end 210 – Pieringer Fig. 2), a closed end portion (upper end 208 – Pieringer Fig. 2), and a thin sidewall extending therebetween (a thin sidewall extending between lower end 210 and the upper end 208 – Pieringer Fig. 2).
Regarding claim 7, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the applicator includes a resilient member configured to resiliently deform (a sealing element 254 for example, a gasket – Pieringer paragraph 38 and Fig. 2) and facilitate the flow of tissue marking dye to the pad (sealing element 254 provides a substantially airtight seal and allows the chamber 236 to pressurize, thereby facilitate the flow of ink from the ink cartridge 242 to the tip 204 – Pieringer Fig. 2 and paragraph 38).
Regarding claim 8, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the body includes a handle portion (an upper end 208 with flanges – Pieringer Fig. 2), the handle portion having at least a portion of the reservoir therein (the upper end 208 having at least a portion of the chamber 236 – Pieringer Fig. 2).
Regarding claim 9, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the body includes a closed end portion (upper end 208 – Pieringer Fig. 2) and an open end portion (lower end 210 – Pieringer Fig. 2) opposite the closed end portion, the open end portion having a body opening (an opening 238 in the lower end 210 – Pieringer Fig. 2); and
a support member below the pad and extending into the body opening (a tapered base of the ink cartridge 242 below the extension 240 of the tip 204 and extending into the opening 238 – Pieringer Fig. 2).
Regarding claim 10, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 further comprising a cap in the container (the sealable packaging enclosure 52 comprising a lid – Lober Fig. 11).
Regarding claim 11, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the tissue marking dye in the reservoir of the body is a first color (the mark 200 comprising ink cartridge 242 of a first color – Pieringer Fig. 2), the tissue marking system further comprising a second body (multiple surgical site marking pens 60 – Lober paragraph 56 and Fig. 11) having a reservoir containing a tissue marking dye of a second color (suitable marking agents such as methylene blue, brilliant green and/or gentian violet – Lober paragraph 42).
Regarding claim 12, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the container has a sterile interior, the porous pad is sterile, and the tissue marking dye in the reservoir is sterile (Pieringer and Lober teach devices used during surgical procedures; therefore, it would have been obvious to one of ordinary skill that the devices are sterile – Pieringer paragraph 2 and Lober paragraph 6).
Regarding claim 13, Pieringer, modified by Lober, teaches the tissue marking system of claim 1 wherein the container comprises a tray having a sterile interior (Pieringer and Lober teach devices used during surgical procedures; therefore, it would have been obvious to one of ordinary skill that the devices are sterile – Pieringer paragraph 2 and Lober paragraph 6) and an opening that opens to the sterile interior (an opened top of the sealable packaging enclosure 52 – Lober Fig. 11), the container further comprising a lid covering the opening of the tray (the sealable packaging enclosure 52 comprising a lid – Lober Fig. 11).
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796