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 .
Response to Remarks
This is a Non-Final Office action in response to communications filed on April
20, 2026. Claims 1-26 remain pending in this application.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claims 1-3, 5-12, and 15-26 are rejected under 35 U.S.C. 103 as being unpatentable under WO 2012168287 A1 (“Mackenzie”) and in view of Grzesiak, Malgorzata, et al. “Expression of vitamin D receptor in the porcine uterus and effect of 1,25(OH)2d3 on progesterone and estradiol-17β secretion by uterine tissues in vitro.” Theriogenology, vol. 125, Feb. 2019, pp. 102–108, https://doi.org/10.1016/j.theriogenology.2018.10.026. (“Grzesiak”).
In regard to claim 1, Mackenzie discloses
A surgical training model for simulating gynecological surgery comprising (page 1, lines 6-8, “The present invention relates to surgical training …, in particular to … real tissue artificial organs for use in surgical training simulations”): a simulated human uterus comprising (page 3, lines 25-26, “Figures 1-14 illustrate the steps for preparing a basic … Uterus … prep model”): wherein the simulated human uterus is sized and shaped to replicate a human uterus (page 2, lines 20-26, “‘real tissue models’ (RTMs) … can be … constructed/modified to accurately mimic normal … human anatomy.”);
and a simulated human broad ligament associated with the simulated human uterus (page 3, lines 25-26, “Figures 1-14 illustrate the steps for preparing a basic … Uterus … prep model”)
Mackenzie does not disclose
a first inner portion comprising a harvested porcine uterus, and a second outer portion comprising harvested porcine tissue, wherein the second outer portion surrounds the first inner portion, and comprising harvested porcine tissue
However, in the analogous art of porcine uterus research,
Grzesiak discloses
a first inner portion comprising a harvested porcine uterus, and a second outer portion comprising harvested porcine tissue, wherein the second outer portion surrounds the first inner portion, and comprising harvested porcine tissue (page 103, paragraph 3, “Porcine uteri were obtained from sexually mature crossbred gilts (Large White x Polish Landrace; 100-110 kg body weight) at a local abattoir under veterinarian control”).
Therefore, it would have been obvious to one of ordinary skill in the art
(PHOSITA) before the effective filing date to have added the missing claimed
limitations, the claim limitations, a first inner portion comprising a harvested porcine uterus, and a second outer portion comprising harvested porcine tissue, wherein the second outer portion surrounds the first inner portion, and comprising harvested porcine tissue, of Grzesiak into the modified surgical simulation training and the modified method of producing artificial organs of Mackenzie, and it would not change the basic principle operation of Mackenzie, nor would it render Mackenzie unsuitable for its intended purpose of surgical simulation training and a method of producing artificial organs; rather it would enhance Mackenzie by adding a porcine uteri.
In regard to claim 2, Mackenzie discloses
wherein the second outer portion comprises harvested porcine tissue other than a porcine uterus wherein the second outer portion comprises harvested porcine tissue other than a porcine uterus (page 103, paragraph 5, “Tissue collection and the preparation of endometrial or myometrial explants, medium components and incubation parameters were chosen”).
In regard to claim 3, Mackenzie discloses
wherein the second outer portion comprises harvested porcine stomach (page 7, lines 17-21, “Materials … Porcine… stomach”).
In regard to claim 5, Mackenzie discloses
comprising a harvested porcine vagina coupled to define a simulated human vagina (page 4, lines 10-14, “Construction of Biologic Tissue Models ... Porcine vagina”).
Mackenzie does not disclose
the harvested porcine uterus
However, in the analogous art of porcine uterus research,
Grzesiak discloses
the harvested porcine uterus (page 103, paragraph 3, “Porcine uteri were obtained from sexually mature crossbred gilts (Large White x Polish Landrace; 100-110 kg body weight) at a local abattoir under veterinarian control”).
Therefore, it would have been obvious to one of ordinary skill in the art
(PHOSITA) before the effective filing date to have added the missing claimed
limitations, the claim limitation, the harvested porcine uterus, of Grzesiak into the modified surgical simulation training and the modified method of producing artificial organs of Mackenzie, and it would not change the basic principle operation of Mackenzie, nor would it render Mackenzie unsuitable for its intended purpose of surgical simulation training and a method of producing artificial organs; rather it would enhance Mackenzie by adding a porcine uteri.
In regard to claim 6, Mackenzie discloses
wherein said simulated human broad ligament comprises harvested porcine leaf fat membrane (page 11, lines 23-27, “affix the collagen sheet along all ‘ligament’ surfaces … This constitutes the … ‘anterior leaflet of the broad ligament’”).
In regard to claim 7, Mackenzie discloses
comprising a harvested porcine ureter (page 4, lines 20-21, “Porcine … with attached maximal full length ureters - can be cleared”) coupled to the second outer portion to define a simulated round ligament (page 7, lines 12-13, “Pelvic Model… round ligament”).
In regard to claim 8, Mackenzie discloses
comprising a harvested porcine ureter (page 4, lines 20-21, “Porcine … with attached maximal full length ureters - can be cleared”) coupled to the second outer portion to define a simulated human ovarian ligament (page 7, lines 12-14, “Pelvic Model… ovarian suspensory ligaments”).
In regard to claim 9, Mackenzie discloses
comprising a harvested porcine ureter (page 4, lines 20-21, “Porcine … with attached maximal full length ureters - can be cleared”) coupled to the second outer portion to define a simulated human uterine artery (page 7, lines 12-15, “Pelvic Model… uterine and ovarian arteries”).
In regard to claim 10, Mackenzie discloses
comprising a pump (page 12, lines 11-15, “Basic Hysteroscopy … Model Materials : … porcine … heart” Examiner notes that the heart pumps blood.) coupled to the harvested porcine ureter (page 4, lines 20-21, “Porcine … with attached maximal full length ureters - can be cleared”) to simulate human blood flow through the simulated human uterine artery (page 7, lines 12-15, “Pelvic Model… uterine and ovarian arteries”).
In regard to claim 11, Mackenzie discloses
comprising a harvested porcine bladder and (page 4, lines 16-20, “Model Materials : Porcine … bladder with attached maximal full length ureters”) associated urethra adjacent the second outer portion to define a simulated human bladder and associated urethra (page 5, lines 18-20, “Model Assembly: … Bladder … having … urethra”).
In regard to claim 12, Mackenzie discloses
comprising a harvested porcine colon adjacent the second outer portion to define a simulated human colon (page 16, lines 15-16 and page 17, line 1, “embodiments that are within the scope of the invention include: … Porcine … Colon”).
In regard to claim 15, Mackenzie discloses
A surgical training model comprising: a compressible spacer having a recess therein (page 7, lines 12-15, “Model: … peritoneum” Examiner notes that the peritoneum is a thin, soft tissue membrane that is compressible, that the peritoneum contains numerous recesses, and that the peritoneum can be used as a spacer between the uterus and other tissues.);
a harvested porcine stomach (page 7, lines 17-21, “Materials … Porcine… stomach” Examiner notes that a peritoneum can be placed around a porcine stomach for research purposes.) around the compressible spacer (page 7, lines 12-15, “Model: ‘… peritoneum’” Examiner notes that the peritoneum is a thin, soft tissue membrane that is compressible);
and harvested porcine ligament-simulating tissue (page 11, lines 23-27, “affix the collagen sheet along all ‘ligament’ surfaces … This constitutes the … ‘anterior leaflet of the broad ligament’”) coupled to the harvested porcine stomach to define a simulated at least one human ligament (page 7, lines 17-21, “Materials … Porcine… stomach”).
Mackenzie does not disclose
a harvested porcine uterus portion within the recess to define a simulated human uterus;
However, in the analogous art of porcine uterus research,
Grzesiak discloses
a harvested porcine uterus portion within the recess to define a simulated human uterus (page 103, paragraph 3, “Porcine uteri were obtained from sexually mature crossbred gilts (Large White x Polish Landrace; 100-110 kg body weight) at a local abattoir under veterinarian control”)
Therefore, it would have been obvious to one of ordinary skill in the art
(PHOSITA) before the effective filing date to have added the missing claimed
limitations, the claim limitations, a harvested porcine uterus portion within the recess to define a simulated human uterus, of Grzesiak into the modified surgical simulation training and the modified method of producing artificial organs of Mackenzie, and it would not change the basic principle operation of Mackenzie, nor would it render Mackenzie unsuitable for its intended purpose of surgical simulation training and a method of producing artificial organs; rather it would enhance Mackenzie by adding a porcine uteri.
In regard to claim 16, Mackenzie discloses
comprising a harvested porcine vagina coupled to the harvested porcine uterus portion to define a simulated human cervix and vagina (page 12, lines 11-20, “Basic Hysteroscopy ‘Uterus and Cervix’ Model … Materials: … porcine vagina”).
In regard to claim 17, Mackenzie discloses
wherein the compressible spacer comprises a compressible tubular body (page 7, lines 12-15, “Model: ‘… peritoneum’” Examiner notes that the peritoneum can be used as a spacer and that the peritoneum is a thin, soft tissue membrane that is compressible. Examiner also notes that a tubular peritoneum can be created for research purposes.).
In regard to claim 18, Mackenzie discloses
wherein the harvested porcine ligament-simulating tissue comprises harvested porcine leaf fat membrane to define a simulated at least one human broad ligament (page 11, lines 23-27, “affix the collagen sheet along all ‘ligament’ surfaces … This constitutes the … ‘anterior leaflet of the broad ligament’”).
In regard to claim 19, Mackenzie discloses
wherein the harvested porcine ligament-simulating tissue comprises a harvested porcine ureter (page 4, lines 20-21, “Porcine … with attached maximal full length ureters - can be cleared”) to define a simulated at least one round ligament (page 7, lines 12-13, “Pelvic Model… round ligament”).
In regard to claim 20, Mackenzie discloses
wherein the harvested porcine ligament-simulating tissue comprises a harvested porcine ureter (page 4, lines 20-21, “Porcine … with attached maximal full length ureters - can be cleared”) to define a simulated at least one human ovarian ligament (page 7, lines 12-14, “Pelvic Model… ovarian suspensory ligaments”).
In regard to claim 21, Mackenzie discloses
A method for making a surgical training model comprising: positioning a harvested porcine stomach around a spacer having a recess therein (page 7, lines 17-21, “Materials … Porcine… stomach” Examiner notes that a peritoneum can be placed around a porcine stomach for research purposes.);
Mackenzie does not disclose
and positioning a harvested porcine uterus portion within the recess to define a simulated human uterus.
However, in the analogous art of porcine uterus research,
Grzesiak discloses
and positioning a harvested porcine uterus portion within the recess to define a simulated human uterus (page 103, paragraph 3, “Porcine uteri were obtained from sexually mature crossbred gilts (Large White x Polish Landrace; 100-110 kg body weight) at a local abattoir under veterinarian control”)
Therefore, it would have been obvious to one of ordinary skill in the art
(PHOSITA) before the effective filing date to have added the missing claimed
limitations, the claim limitations, and positioning a harvested porcine uterus portion within the recess to define a simulated human uterus, of Grzesiak into the modified surgical simulation training and the modified method of producing artificial organs of Mackenzie, and it would not change the basic principle operation of Mackenzie, nor would it render Mackenzie unsuitable for its intended purpose of surgical simulation training and a method of producing artificial organs; rather it would enhance Mackenzie by adding a porcine uteri.
In regard to claim 22, Mackenzie discloses
comprising coupling a harvested porcine vagina to define a simulated human vagina (page 4, lines 10-14, “Construction of Biologic Tissue Models ... Porcine vagina”).
Mackenzie does not disclose
the harvested porcine uterus
However, in the analogous art of porcine uterus research,
Grzesiak discloses
the harvested porcine uterus (page 103, paragraph 3, “Porcine uteri were obtained from sexually mature crossbred gilts (Large White x Polish Landrace; 100-110 kg body weight) at a local abattoir under veterinarian control”).
Therefore, it would have been obvious to one of ordinary skill in the art
(PHOSITA) before the effective filing date to have added the missing claimed
limitations, the claim limitation, the harvested porcine uterus, of Grzesiak into the modified surgical simulation training and the modified method of producing artificial organs of Mackenzie, and it would not change the basic principle operation of Mackenzie, nor would it render Mackenzie unsuitable for its intended purpose of surgical simulation training and a method of producing artificial organs; rather it would enhance Mackenzie by adding a porcine uteri.
In regard to claim 23, Mackenzie discloses
wherein the spacer comprises a compressible tubular body (page 7, lines 12-15, “Model: ‘… peritoneum’” Examiner notes that the peritoneum can be used as a spacer and that the peritoneum is a thin, soft tissue membrane that is compressible. Examiner also notes that a tubular peritoneum can be created for research purposes.).
In regard to claim 24, Mackenzie discloses
comprising coupling harvested porcine leaf fat membrane to the harvested porcine stomach to define a simulated human broad ligament (page 11, lines 23-27, “affix the collagen sheet along all ‘ligament’ surfaces … This constitutes the … ‘anterior leaflet of the broad ligament’”).
In regard to claim 25, Mackenzie discloses
comprising coupling a harvested porcine ureter (page 4, lines 20-21, “Porcine … with attached maximal full length ureters - can be cleared”) to the harvested porcine stomach to (page 7, lines 17-21, “Materials … Porcine… stomach”) define a simulated round ligament (page 7, lines 12-13, “Pelvic Model… round ligament”).
In regard to claim 26, Mackenzie discloses
comprising coupling a harvested porcine ureter to the (page 4, lines 20-21, “Porcine … with attached maximal full length ureters - can be cleared”) harvested porcine stomach to (page 7, lines 17-21, “Materials … Porcine… stomach”) define a simulated human ovarian ligament (page 7, lines 12-14, “Pelvic Model… ovarian suspensory ligaments”).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable under Mackenzie in view of Grzesiak and in further view of KR 20250099424 A (“Black”).
In regard to claim 4, Mackenzie discloses
wherein the simulated human uterus comprises a third intermediate portion comprising a spacer (page 7, lines 12-15, “Model: ‘… peritoneum’” Examiner notes that the peritoneum can be used as a spacer between the uterus and other tissues.)
Mackenzie does not disclose
comprising synthetic material, the spacer being positioned between the first inner portion and the second outer portion.
However, in an analogous art of surgical training,
Black discloses
comprising synthetic material, the spacer being positioned between the first inner portion and the second outer portion (page 23, paragraph 1, “Each of the first sheet …, the second sheet …, and the third sheet … comprises … silicone” Examiner notes that silicone is synthetic material.).
Therefore, it would have been obvious to one of ordinary skill in the art
(PHOSITA) before the effective filing date to have added the missing claimed
limitations, the claim limitations, comprising synthetic material, the spacer being positioned between the first inner portion and the second outer portion, of Black into the modified surgical simulation training and the modified method of producing artificial organs of Mackenzie, and it would not change the basic principle operation of Mackenzie, nor would it render Mackenzie unsuitable for its intended purpose of surgical simulation training and a method of producing artificial organs; rather it would enhance Mackenzie by adding silicone sheets.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable under Mackenzie in view of Grzesiak and in further view of EP 3766060 B1 (“Alexander”).
In regard to claim 13, Mackenzie discloses
comprising a tissue cassette (page 3, lines 2-3, “tissue ‘cassettes’ are constructed to closely mimic … normal and abnormal human anatomy.”) on which the simulated human uterus (page 3, lines 11-22, “Uterus … Model … Materials … Porcine uterus”) and the simulated human broad ligament are received (page 11, lines 23-27, “affix the collagen sheet along all ‘ligament’ surfaces … This constitutes the … ‘anterior leaflet of the broad ligament’” Examiner notes that a uterus prep model can be a simulated.)
Mackenzie does not disclose
wherein the tissue cassette is configured to be removably coupled to a mannequin.
However, in the analogous art of surgical simulators,
Alexander discloses
wherein the tissue cassette is configured to be removably coupled to a mannequin (column 6, lines 7-9, “The cassette can be affixed into an anatomically correct silicon framework in the abdominal cavity of a mannequin”).
Therefore, it would have been obvious to one of ordinary skill in the art
(PHOSITA) before the effective filing date to have added the missing claimed
limitations, the claim limitations, wherein the tissue cassette is configured to be removably coupled to a mannequin, of Alexander into the modified surgical simulation training and the modified method of producing artificial organs of Mackenzie, and it would not change the basic principle operation of Mackenzie, nor would it render Mackenzie unsuitable for its intended purpose of surgical simulation training and a method of producing artificial organs; rather it would enhance Mackenzie by adding a cassette, a silicon framework, an abdominal cavity, and a mannequin.
In regard to claim 14, Mackenzie discloses
wherein the simulated human uterus (page 3, lines 25-26, “Figures 1-14 illustrate the steps for preparing a basic … Uterus … prep model”) and the simulated human broad ligament include (page 11, lines 23-27, “affix the collagen sheet along all ‘ligament’ surfaces … This constitutes the … ‘anterior leaflet of the broad ligament’” Examiner notes that a uterus prep model can be a simulated.)
Mackenzie does not disclose
at least one colored dye to impart a dyed color to the simulated human uterus and the simulated human broad ligament, wherein the simulated human uterus and the simulated human broad ligament maintain their dyed color after freezing and thawing.
However, in the analogous art of surgical simulators,
Alexander discloses
at least one colored dye to impart a dyed color to the simulated human uterus and the simulated human broad ligament, wherein the simulated human uterus and the simulated human broad ligament maintain their dyed color after freezing and thawing (paragraph 12, lines 42-44, “silicone … can be prepared using silicone casting, and dyed to appear more natural using a dyeing process.” Examiner notes that silicone maintains its color after freezing and thawing.).
Therefore, it would have been obvious to one of ordinary skill in the art
(PHOSITA) before the effective filing date to have added the missing claimed
limitations, the claim limitations, at least one colored dye to impart a dyed color to the simulated human uterus and the simulated human broad ligament, wherein the simulated human uterus and the simulated human broad ligament maintain their dyed color after freezing and thawing, of Alexander into the modified surgical simulation training and the modified method of producing artificial organs of Mackenzie, and it would not change the basic principle operation of Mackenzie, nor would it render Mackenzie unsuitable for its intended purpose of surgical simulation training and a method of producing artificial organs; rather it would enhance Mackenzie by adding silicone and a dyeing process.
Response to Arguments
Applicant's arguments filed April 20, 2026 have been fully considered. Claims 1-26 remain pending in this application. Pertaining to claim 1, “Applicant notes that Mackenzie fails to disclose a first inner portion comprising a harvested porcine uterus as in the claimed invention of Claim 1.” (See AMENDMENT AND RESPONSE AFTER FINAL, REMARKS, page 11, paragraph 1) and Applicant submits that “Independent Claim 15 recites a surgical training model comprising a compressible spacer having a recess therein; a harvested porcine stomach around the compressible spacer; and a harvested porcine uterus portion within the recess to define a simulated human uterus. MacKenzie fails to disclose this claimed structure.” (See AMENDMENT AND RESPONSE AFTER FINAL, REMARKS, page 11, paragraph 3). Examiner acknowledges Applicant’s remarks. However, Applicant’s arguments are moot in view of the new grounds of rejection which rely on a new combination of prior art.
Pertaining to claim 15, Applicant submits that “Mackenzie fails to disclose the harvested porcine uterus portion within the recess to define a simulated human uterus as in Claim 15.” (See AMENDMENT AND RESPONSE AFTER FINAL, REMARKS, page 12, paragraph 2) and “Mackenzie fails to disclose all of the features of independent Claim 15.” (See AMENDMENT AND RESPONSE AFTER FINAL, REMARKS, page 12, paragraph 1). Examiner acknowledges Applicant’s remarks. However, Applicant’s arguments are moot in view of the new grounds of rejection which rely on a new combination of prior art.
Contact Information
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Lisa Antoine whose telephone number is
(571) 272-4252 and whose email address is lantoine@uspto.gov. The examiner can be
reached Monday-Thursday, 7:30 am-5:30 pm CT. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based
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supervisor, Xuan Thai, can be reached on (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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/LISA H ANTOINE/
Examiner, Art Unit 3715
/JAMES B HULL/Primary Examiner, Art Unit 3715
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