DETAILED ACTION
Remarks
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 Invention I (claims 1-8) in the reply filed on 10/28/25 is acknowledged. Accordingly, claims 9-29 are withdrawn from examination.
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.
Claim 7 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 7 recites “the flexible reinforcing material” which lacks sufficient antecedent basis in the claims.
Claim Rejections – 35 USC 102 (AIA )
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 and 5-8 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2018/0075777 A1 to IVERSON.
Regarding claim 1, IVERSON teaches a surgical model (Abstract: synthetic tissue phantoms, which mimic the properties of real human or animal tissue; par. 0028: multilayered construct will provide different sensory feedback to, for example, an operator performing a simulated surgical procedure) comprising:
at least one simulated muscle including a reinforcing material disposed therein (par. 0029: the muscle layers 30 and 300; par. 0025: any or all of layers … 30 can include a reinforcing material; par. 0048: individual layers … 30 … and 300 may include … reinforcement layers; par. 0064: it may be desirable to include a reinforcing layer 50 or 500 in layer 30 or 300); and
a second simulated tissue at least partially encapsulating the at least one simulated muscle (par. 0029: simulated fat layers 20 and 200… overlaying the muscle layers 30 and 300).
Regarding claim 2, IVERSON further teaches wherein the reinforcing material comprises a porous non-woven material impregnated with a flexible matrix material (par. 0038: a muscle layer 300 having a Shore hardness of from about A0 to about A30, and in another embodiment, from about A5 to about A15; par. 0057: the reinforcing layer composed of a … non-woven fabric; par. 0066: layer 30 or 300 consists essentially of a single silicone rubber … and reinforcing layer; par. 0079 disclosing the manner of incorporating a reinforcement into a layer as: contents of the container were spread into a … mold[,] … TX609 TechniCloth Nonwoven Wipe … placed over the spread contents so as to completely cover the layer … in the mold. The weave of the fabric was positioned such that it was at a 45 degree angle to the major axes of the mold. A thin layer of the remaining contents was spread over the fibrous reinforcement sheet).
Regarding claim 3, IVERSON further teaches wherein the flexible matrix material is silicone (par. 0066: layer 30 or 300 consists essentially of a single silicone rubber … and reinforcing layer).
Regarding claim 5, IVERSON further teaches wherein the second simulated tissue is a simulated fat layer (par. 0029: simulated fat layers 20 and 200).
Regarding claim 6, IVERSON further teaches wherein the reinforcing material comprises at least one selected from a woven fabric, a non-woven fabric, a mesh, and a web (par. 0057: the reinforcing layer composed of a woven or non-woven fabric).
Regarding claim 7, IVERSON further teaches wherein the flexible reinforcing material is elastic (par. 0057: the reinforcing layer composed of … nylon, acrylic, [or] wool … reinforcing layer 50 and/or 500 can be produced from TYVEK® or SORONA® materials, which are available from DuPont, Inc. TYVEK® is a spun bounded olefin sheet material).
Regarding claim 8, IVERSON further teaches wherein the at least one flexible reinforcing material is substantially inextensible (par. 0057: the reinforcing layer composed of … polyester, rayon, …[or] cotton).
Claim Rejections - 35 USC § 103 (AIA )
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being obvious over IVERSON, as applied to claim 1, in view of US 2012/0034587 A1 to TOLY.
Regarding claim 4, IVERSON further teaches wherein the reinforcing material is a polymer (par. 0057: the reinforcing layer composed of a … non-woven fabric; par. 0075: reinforcing layer composed of polyester and rayon which are types of polymer), but does not expressly define the polyester as polymer felt. TOLY, which teaches related simulated physiological structures for use as medical training aids (par. 0002), discloses the use of felt material in a silicone coated fibrous layer, such as in the abdomen area, to impart a realistic resistance to cutting (par. 0066). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the felt material, as taught by TOLY, for the reinforcing material of IVERSON, in order to incorporate a known material that imparts a realistic resistance to cutting, thereby using a known technique to improve similar device in the same way.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715