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 Amendment
This is a Final Office action in response to communications filed on December
28, 2025. Applicant amended claims 1-2 and 13-15. Applicant’s amendments to the claims have overcome each objection set forth in the Non-Final Office Action dated September 30, 2025. Therefore, Examiner withdraws the claim objections. Claims 1-26 remain pending in this application.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 5-12, and 15-26 are rejected under 35 U.S.C. 102 as being unpatentable under WO 2012168287 A1 (“Mackenzie”).
In regards 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”):
a first inner portion comprising a harvested porcine uterus (page 3, lines 11-22, “Uterus … Model … Materials … Porcine uterus”), and a second outer portion comprising harvested porcine tissue, wherein the second outer portion surrounds the first inner portion (page 4, lines 26-28, “Porcine … filled with tissue” Examiner notes that the uterus is normally surrounded and supported by several layers of tissue.), 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”) and comprising harvested (page 3, lines 11-22, “Uterus … Model … Materials … Porcine uterus”) porcine tissue (page 11, lines 23-27, “affix the collagen sheet along all ‘ligament’ surfaces … This constitutes the … ‘anterior leaflet of the broad ligament’”).
In regards to claim 2, Mackenzie discloses
wherein the second outer portion comprises harvested porcine tissue other than a porcine uterus (page 4, lines 26-28, “Porcine … great vessels trimmed down to the base and heart … filled with tissue”).
In regards to claim 3, Mackenzie discloses
wherein the second outer portion comprises harvested porcine stomach (page 7, lines 17-21, “Materials … Porcine… stomach”).
In regards to claim 5, Mackenzie discloses
comprising a harvested porcine vagina coupled to the harvested porcine uterus to define a simulated human vagina (page 4, lines 10-14, “Construction of Biologic Tissue Models ... Porcine vagina” Examiner notes that the uterus and vagina are connected.).
In regards 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 regards 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 regards 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 regards 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 regards 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 regards 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 regards 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 regards 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);
a harvested porcine uterus portion within the recess to define a simulated human uterus (page 7, lines 12-15, “Model: ‘… peritoneum’” Examiner notes that a porcine uterus may be placed within a peritoneum for research purposes.);
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”).
In regards 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 regards 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 regards 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 regards 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 regards 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 regards 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.);
and positioning a harvested porcine uterus portion within the recess to define a simulated human uterus (page 7, lines 12-15, “Model: ‘… peritoneum’” Examiner notes that a porcine uterus may be placed within a peritoneum for research purposes.).
In regards to claim 22, Mackenzie discloses
comprising coupling a harvested porcine vagina 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 regards 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 regards 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 regards 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 regards 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 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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable under Mackenzie in view of KR 20250099424 A (“Black”).
In regards to claim 4, Mackenzie discloses the following limitations with the exception of the underlined limitations.
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.)
comprising synthetic material, the spacer being positioned between the first inner portion and the second outer portion.
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.).
Mackenzie and Black are considered analogous to the claimed invention because they are in the field of surgical training devices. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a surgical training model for simulating gynecological surgery comprising: a simulated human uterus comprising: 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 wherein the simulated human uterus is sized and shaped to replicate a human uterus; and a simulated human broad ligament comprising porcine tissue, as disclosed by Mackenzie, comprising synthetic material, the spacer being positioned between the first inner portion and the second outer portion, as disclosed by Black, to provide silicone sheets for surgical training tools and simulated tissue structures and models for teaching and practicing surgical techniques relating to laparoscopic, endoscopic and minimally invasive surgery.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable under Mackenzie in view of EP 3766060 B1 (“Alexander”).
In regards to claim 13, Mackenzie discloses the following limitations with the exception of the underlined limitations.
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.), wherein the tissue cassette is configured to be removably coupled to a mannequin.
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”).
Mackenzie and Alexander are considered analogous to the claimed invention because they are in the field of surgical training simulators. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a surgical training model for simulating gynecological surgery comprising: a simulated human uterus comprising: 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 wherein the simulated human uterus is sized and shaped to replicate a human uterus; and a simulated human broad ligament comprising porcine tissue, comprising a tissue cassette on which the simulated human uterus and human broad ligament are received, as disclosed by Mackenzie, wherein the tissue cassette is configured to be removably coupled to a mannequin, as disclosed by Alexander, to provide cassette, silicone framework, and mannequin for a hernia model surgical simulator.
In regards to claim 14, Mackenzie discloses the following limitations with the exception of the underlined limitations.
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.) 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.
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.).
Mackenzie and Alexander are considered analogous to the claimed invention because they are in the field of surgical training simulators. Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the applicant’s invention for a surgical training model for simulating gynecological surgery comprising: a simulated human uterus comprising: 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 wherein the simulated human uterus is sized and shaped to replicate a human uterus; and a simulated human broad ligament comprising porcine tissue, at least one colored dye to impart a dyed color to the simulated human uterus and broad ligament, wherein the simulated human uterus and broad ligament maintain their dyed color after freezing and thawing, as disclosed by Mackenzie, at least one colored dye to impart a dyed color to the simulated human uterus and broad ligament, wherein the simulated human uterus and broad ligament maintain their dyed color after freezing and thawing, as disclosed by Alexander, to provide a dyeing process for a hernia model surgical simulator.
Response to Arguments
Applicant's arguments filed December 28, 2025 have been fully considered but they are not persuasive. Claims 1-26 remain pending in this application. With respect 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, REMARKS, page 10, paragraph 1) and Applicant argues that “Mackenzie fails to disclose all of the features of independent Claim 1 … none of the other prior art properly supplies the deficiencies of Mackenzie.” (See AMENDMENT AND RESPONSE, REMARKS, page 11, paragraph 1). Examiner acknowledges Applicant’s remarks. However, Examiner notes in the 35 USC § 102 rejection of 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”): a first inner portion comprising a harvested porcine uterus (page 3, lines 11-22, “Uterus … Model … Materials … Porcine uterus”), and a second outer portion comprising harvested porcine tissue, wherein the second outer portion surrounds the first inner portion (page 4, lines 26-28, “Porcine … filled with tissue” Examiner notes that the uterus is normally surrounded and supported by several layers of tissue.), 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”) and comprising harvested (page 3, lines 11-22, “Uterus … Model … Materials … Porcine uterus”) porcine tissue (page 11, lines 23-27, “affix the collagen sheet along all ‘ligament’ surfaces … This constitutes the … ‘anterior leaflet of the broad ligament’”).
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during examination. Under BRI, the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Therefore, the rejection of claim 1, as anticipated by Mackenzie, is maintained. Consequently, the rejections of dependent claims 2-14 are maintained.
With respect to claim 15, Applicant argues 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, REMARKS, page 12, lines 4-6) and “Mackenzie fails to disclose all of the features of independent Claim 15 … none of the other prior art properly supplies the deficiencies of Mackenzie.” (See AMENDMENT AND RESPONSE, REMARKS, page 12, paragraph 1). Examiner acknowledges Applicant’s remarks. However, Examiner notes in the 35 USC § 102 rejection of 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); a harvested porcine uterus portion within the recess to define a simulated human uterus (page 7, lines 12-15, “Model: ‘… peritoneum’” Examiner notes that a porcine uterus may be placed within a peritoneum for research purposes.); 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”).
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during examination. Under BRI, the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Therefore, the rejection of claim 15, as anticipated by Mackenzie, is maintained. Consequently, the rejections of dependent claims 16-20 are maintained.
With respect to claim 21, Applicant argues that “independent Claim 21 is patentable for the same reasons as independent Claim 15” (See AMENDMENT AND RESPONSE, REMARKS, page 12, paragraph 1). Examiner acknowledges Applicant’s remarks. However, Examiner notes in the 35 USC § 102 rejection of 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.); and positioning a harvested porcine uterus portion within the recess to define a simulated human uterus (page 7, lines 12-15, “Model: ‘… peritoneum’” Examiner notes that a porcine uterus may be placed within a peritoneum for research purposes.).
MPEP § 2111 discusses proper claim interpretation, including giving claims their
broadest reasonable interpretation (“BRI”) in light of the specification during examination. Under BRI, the words of a claim must be given their plain meaning unless such meaning is inconsistent with the specification, and it is improper to import claim limitations from the specification into the claim. Applicant’s argument is not persuasive because the BRI is broader than what is argued. Therefore, the rejection of claim 21, as anticipated by Mackenzie, is maintained. Consequently, the rejections of dependent claims 22-26 are maintained.
Conclusion
Applicant's amendment necessitated the new grounds of rejections presented in
this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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
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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
/XUAN M THAI/Supervisory Patent Examiner, Art Unit 3715