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
Claims 9-16 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/6/25. Although Applicant states that claim 9, which is directed to a method of making, is amended to require the structure of claim 1, the reasons for restriction mailed on 8/8/25 still apply to the pending claims and thus are maintained. In particular, the product of invention I (e.g., claim 1) can be made by another and materially different process than invention II (e.g., claim 9), such as 3D printing, which is another and materially different process than the molding process of claim 9. Therefore, Applicant’s argument is not found persuasive. The requirement is still deemed proper and is therefore made FINAL. Accordingly, claims 9-16 and 23 are withdrawn, and claims 1, 4-8, and 24-30 are under examination.
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5 depends on cancelled claim 2. Appropriate correction is required. For the purposes of examination, claim 5 is interpreted as dependent on independent claim 1.
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 1 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2018/0005549 A1 to BLACK.
Regarding claim 1, BLACK teaches a simulated tissue structure (par. 0115: model 200… provides the one or more dissecting layer 226) comprising:
a first inner layer comprising a continuous length of fibers (par. 0115: fibers);
a second inner layer comprising an interlaced planar threaded material (par. 0115: mesh); and
an outer layer (par. 0115: silicone) surrounding the first inner layer and the second inner layer, the outer layer comprising of a material different from the first and second inner layers (par. 0115: fibers embedded in silicone; embedded mesh),
wherein the first inner layer and the second inner layer are configured to provide a longitudinal strength to the simulated tissue structure (par. 0115: fibers embedded in silicone that make the incisions and separation of the simulated uterus 216 realistic …embedded mesh that makes it possible for the silicone to hold sutures without easily tearing).
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 BLACK, as applied to claim 1, in view of US 2014/0248596 A1 to HART.
Regarding claim 4, BLACK teaches the elements above including an outer layer comprising silicone (par. 0115), but does not expressly disclose the silicone is a non- conductive silicone. However, HART discloses a related surgical simulation system comprising at least one simulated body organ (Abstract), and further discloses using materials including non-conductive silicone, as it is suitable for forming artificial organs (par. 0062). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of non-conductive silicone, as taught by HART, to the silicone outer layer of BLACK, in order to apply a known material that is recognized as suitable for forming artificial organs, thereby achieving predictable results.
Claim 8 is rejected under 35 U.S.C. 103 as being obvious over BLACK, as applied to claim 1, in view of US 2018/0240366 A1 to FELSINGER.
Regarding claim 8, BLACK teaches the elements above including an outer layer comprising silicone (par. 0115), but does not expressly disclose the silicone is a conductive material. However, FELSINGER discloses using conductive silicone to produce synthetic organs (par. 0032). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the use of conductive silicone, as taught by FELSINGER, to the silicone outer layer of BLACK, in order to apply a known material that is recognized as suitable for forming synthetic organs, thereby achieving predictable results.
Allowable Subject Matter
Claims 5-7 and 24-30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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