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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The Amendment filed 4/30/26 has been entered. Claim(s) 1-8 and 30-32 are pending in the application and are under examination.
In view of the claim amendment filed 4/30/26, the rejections under 35 USC 112, 35 USC 102, and 35 USC 103 are withdrawn. Therefore, Applicant’s arguments filed on 4/30/26 are moot. However, the amendment necessitates a new ground of rejection as set forth below.
Claim Rejections - 35 USC § 103 (AIA )
Claims 1-3, 5-8, and 30 are rejected under 35 U.S.C. 103 as being obvious over US 2018/0075777 A1 to IVERSON in view of US 8,491,309 B2 to PARRY.
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), but does not expressly disclose wherein the second simulated tissue extends around two or more surfaces of the at least one simulated muscle
Regarding claim 30, IVERSON teaches the elements above, but does not expressly disclose wherein the second simulated tissue fully surrounds the at least one simulated muscle.
To the extent IVERSON does not further disclose wherein the second simulated tissue extends around two or more surfaces of the at least one simulated muscle, as recited in claim 1, and wherein the second simulated tissue fully surrounds the at least one simulated muscle, as recited in claim 30, PARRY teaches a related realistic medical training tool comprising a skin replica that approximates human tissue (Abstract). PARRY discloses that it might be advantageous in some embodiments to include an internal layer 16 within a skin replica to replicate the properties of fat, muscle, bones, or internal organs, wherein the internal layer 16 is positioned within the skin replica 1 so that the uppermost layers, namely, highlight layers 2, 3, slough or exhibit an elastic deflection 18 much like skin does over muscle when a force 17 is applied thereto (FIG. 8A and 8B; col. 9, lines 19-31). PARRY further discloses that the internal layer should be enclosed within a base layer 4, as represented in FIG. 8b (FIG. 8A and 8B; col. 9, lines 31-34). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue phantom of IVERSON such that the muscle layer is positioned within the skin replica and enclosed within the skin replica by an outer tissue simulant layer, as taught by PARRY, in order to simulate the an elastic defection of actual skin over muscle when a force is applied, thereby simulating internal anatomical layers of a human anatomy, thus providing a more realistic training device.
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 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 4 is rejected under 35 U.S.C. 103 as being obvious over IVERSON in view of PARRY, as applied to claim 1, in further 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.
Claim 31 is rejected under 35 U.S.C. 103 as being obvious over IVERSON in view of PARRY, as applied to claim 1, in further view of US 10,580,327 B1 to SHRIVASTAVA.
Regarding claim 31, IVERSON teaches the elements above, but does not expressly disclose wherein the at least one simulated muscle includes a simulated tissue malformation. However, SHRIVASTAVA teaches a related anatomical model comprising simulated tissue comprising multiple layers of muscle, fat and connective tissue (Abstract), wherein the muscle layer includes a defect, e.g., an opening, which allows a user to practice the skill of correcting the fascial defect (col. 4, lines 6-9; col. 21, lines 22-44). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate defects in the muscle layer of a simulated tissue model, as taught by SHRIVASTAVA, into the modified invention of IVERSON, in order to allow users further practice in correcting defects in the simulated layers, thereby enhancing the usability of the synthetic tissue.
Claim 32 is rejected under 35 U.S.C. 103 as being obvious over IVERSON in view of PARRY and SHRIVASTAVA, as applied to claim 31, in further view of US 2016/0256061 A1 to FRYKMAN.
Regarding claim 32, IVERSON teaches the elements above, but does not expressly wherein the simulated tissue malformation is selected from the following: an imperforate anus, a rectal atresia, a rectal stenosis, a rectoperitoneal fistula, a cloacal fistula, a rectovestibular fistula, a rectobulbar urethral fistula, a rectoprostatic urethral fistula, or a rectobladder neck fistula. However, FRYKMAN further teaches anorectal malformations are a birth defect that may include openings in the wrong place or a connection, or fistula, joining the intestine and the urinary system, a connection joining the intestine and vagina, or (5) the intestine can join with the urinary system and vagina in a single opening (par. 0002) and that imperforate anus is a known type of anorectal malformation (par. 0022). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate anorectal malformations, such as an imperforate anus malformation, as taught by FRYKMAN, for the muscular defects in the modified invention of IVERSON, in order to simulate a particular type of birth defect in the muscle layer of a human, thereby providing focused surgical training for repairing anorectal malformations by providing a specific simulation of an anorectal malformation in a simulated human tissue model.
Conclusion
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form.
/JAMES B HULL/Primary Examiner, Art Unit 3715
Prosecution Insights