DETAILED ACTION
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
In response to the remarks filed 2/19/2026; claims 1-20 are pending; claim 21 has been cancelled.
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, 10 – 16, 18 – 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hall et al. (WIPO publication WO 2020/0185385 A1).
Re claims 1, 19, 20:
Hall teaches 1. A test model (Hall, pg. 1, [0004]) comprising:
a chamber comprising a base, a lid, and an interior volume defined between the base and the lid (Hall, fig. 3; [0039]- [0043]);
a tissue simulation material disposed in the interior volume of the chamber, wherein the tissue simulation material includes a first surface and a second surface, and wherein the tissue simulation material is configured to deform when the second surface is exposed to a lower pressure than the first surface in the interior volume of the chamber (Hall, [0039], “first… second … surface”; [0040] states “The panel 120 is coupled to the body 108 and seals against the body 108 to prevent air from entering the wound 110 through the first surface 116. As shown in FIGS. 2-3, the panel 120 is a generally optically transparent window through which an observer may view the deformation of the body 108 and the wound 110. The panel 120 is generally rectangular and substantially covers the first surface of the body 108” and Applicant’s fig. 3; [0045], “the size of the aperture 114 decreases with increasing negative pressure. An observer may visually inspect the deformation of the simulated wound 110 through the panel 120 while the NPWT device 20 is operational”; [0047], “the lip 142 prevents overflow of any adhesive product that may be used to further secure the panel 120 and/or simulated tissue 102 in position with respect to the outer frame 104”; [0050], “The panel 120 is optically transparent in order to provide an observer with unimpeded visual access to the wound 110. The panel 120 may be made from a variety of different materials. According to an exemplary embodiment, the panel 120 includes a clear acrylic panel or another transparent plastic. In yet other embodiments, the panel 120 may include glass.” Hall explains that the panel 120 is made of glass and sealed to the outer frame of the model by adhesive (Hall, [0043]; [0047]). It is the office’s position that when negative pressure applies to the first surface 116 of the wound to cause the deformation of the body 108, the inner surface of the panel 120 experience lower pressure than the exterior surface of the panel because it is air-tight sealed); and
a visual indicator configured to provide a visual state change in response to deformation of the tissue simulation material (Hall, [0039], “the wound 110”; [0053], “the aperture 114”).
19. A method of demonstrating tissue distension (Hall, pg. 1, [0004]), the method comprising:
providing a chamber comprising a base, a lid, and an interior volume defined between the base and the lid (Hall, fig. 3; [0039]- [0043]);
disposing a tissue simulation material within the interior volume of the chamber, the tissue simulation material comprising a first surface and a second surface, and wherein the tissue simulation material is configured to deform when the second surface is exposed to a lower pressure than the first surface in the interior volume of the chamber (Hall, [0039], “first… second … surface”; [0040] states “The panel 120 is coupled to the body 108 and seals against the body 108 to prevent air from entering the wound 110 through the first surface 116. As shown in FIGS. 2-3, the panel 120 is a generally optically transparent window through which an observer may view the deformation of the body 108 and the wound 110. The panel 120 is generally rectangular and substantially covers the first surface of the body 108” and Applicant’s fig. 3; [0045], “the size of the aperture 114 decreases with increasing negative pressure. An observer may visually inspect the deformation of the simulated wound 110 through the panel 120 while the NPWT device 20 is operational”; [0047], “the lip 142 prevents overflow of any adhesive product that may be used to further secure the panel 120 and/or simulated tissue 102 in position with respect to the outer frame 104”; [0050], “The panel 120 is optically transparent in order to provide an observer with unimpeded visual access to the wound 110. The panel 120 may be made from a variety of different materials. According to an exemplary embodiment, the panel 120 includes a clear acrylic panel or another transparent plastic. In yet other embodiments, the panel 120 may include glass.” Hall explains that the panel 120 is made of glass and sealed to the outer frame of the model by adhesive (Hall, [0043]; [0047]). It is the office’s position that when negative pressure applies to the first surface 116 of the wound to cause the deformation of the body 108, the inner surface of the panel 120 experience lower pressure than the exterior surface of the panel because it is air-tight sealed);
coupling a reduced-pressure port of the chamber to a reduced-pressure source (Hall, [0062], “a negative pressure is applied across the wound by the NPWT device 20”; [0040]);
activating the reduced-pressure source to expose the second surface of the tissue simulation material to a lower pressure than the first surface within the interior volume of the chamber (Hall, [0005], “The walls may be configured to deform in response to the negative pressure applied across the simulated wound”); and
visually perceiving a visual indicator configured to provide a visual state change in response to deformation of the tissue simulation material (Hall, [0039], “the wound 110”; [0053], “the aperture 114”).
20. A method of demonstrating tissue distension, the method comprising:
providing a chamber including an interior volume and a tissue simulation material disposed within the interior volume (Hall, fig. 3; [0039]- [0043]);
exposing a first surface of the tissue simulation material to atmospheric pressure and a second surface of the tissue simulation material to a reduced-pressure (Hall, [0039], “first… second … surface”; [0040], “a negative pressure”); and
visually perceiving a visual state change when the second surface is exposed to the reduced-pressure (Hall, [0039], “the wound 110”; [0053], “the aperture 114”).
Re claim 2:
2. The test model of claim 1, wherein the chamber is formed from a transparent material, and wherein the visual indicator can be visually perceived from an exterior of the chamber through the transparent material (Hall, [0039]).
Re claim 3:
3. The test model of claim 1, wherein the tissue simulation material is gas impermeable and elastic (Hall, [0051]).
Re claim 10
10. The test model of claim 1, wherein the visual indicator is configured to provide the visual state change in response to the second surface of the tissue simulation material being exposed to the lower pressure (Hall, [0045], “The simulated wound 110 is configured to deform in response to the negative pressure applied by the NPWT device”).
Re claim 11:
11. The test model of claim 1, wherein the visual state change includes one or more of a change in size, a change in shape, a change in position, or a change in color (Hall, [0039]).
Re claim 12:
12. The test model of claim 1, wherein the tissue simulation material comprises a silicone disk (Hall, [0046], “the opening 106 may be circular”; [0056]).
Re claim 13:
13. The test model of claim 1, wherein the tissue simulation material comprises a flexible membrane (Hall, [0051]).
Re claim 14:
14. The test model of claim 1, wherein the visual indicator comprises at least one circle cast into the tissue simulation material (Hall, [0046]).
Re claim 15:
15. The test model of claim 1, wherein the visual indicator comprises at least one circle etched into the lid of the chamber (Hall, [0046]).
Re claim 16:
16. The test model of claim 1, wherein the visual indicator comprises at least one slit or at least one hole or both the at least one slit and the at least one hole in the tissue simulation material (Hall, fig. 3).
Re claim 18:
18. The test model of claim 1, wherein the visual indicator comprises at least one colored area of the tissue simulation material (Hall, [0069]).
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:
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.
Claims 4 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (WIPO publication WO 2020/0185385 A1) in view of Kuo et al. (US 2009/0098521 A1).
Re claim 4:
Hall teaches 4. The test model of claim 1, wherein the tissue simulation material is positioned between a first portion of the interior volume of the chamber and a second portion of the interior volume of the chamber, wherein the first surface of the tissue simulation material is exposed to the first portion and the second surface of the tissue simulation material is exposed to the second portion (Hall, figs. 3 - 6).
Hall does not explicitly disclose a first portion is fluidly isolated from the second portion. Kuo teaches a
Kuo teaches a tissue mimicking phantom (Kuo, Abstract). Kuo teaches wherein the first portion is fluidly isolated from the second portion (Kuo, [0020]; [0025]). Therefore, in view of Kuo, 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 model described in Hall, by providing the pressure fluid as taught by Kuo, since it known in the art to use liquid as medium to transfer pressure (hydraulic).
Re claim 5:
5. The test model of claim 4, wherein the second portion of the interior volume of the chamber extends from the base to the lid and surrounds the first portion of the interior volume of the chamber (Hall, fig. 3).
Re claim 6:
6. The test model of claim 4, further comprising a chamber seal configured to extend from the first surface of the tissue simulation material to the lid of the chamber and to fluidly seal the first portion of the interior volume from the second portion of the interior volume within the chamber, wherein the first portion of the interior volume is defined between the first surface of the tissue simulation material and the lid of the chamber (Hall, fig. 3; [0040]; [0043]).
Re claim 7:
7. The test model of claim 4, wherein the second portion of the interior volume of the chamber is configured to be fluidly coupled to a reduced-pressure source through a reduced-pressure port in the chamber (Hall, [0040]).
Re claim 8:
8. The test model of claim 4, wherein the first portion of the interior volume of the chamber is configured to be in fluid communication with ambient atmospheric pressure through an atmospheric port in the chamber (Hall, [0009]).
Re claim 9:
9. The test model of claim 4, further comprising foam disposed in the second portion of the interior volume of the chamber (Hall, fig. 3; [0040]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (WIPO publication WO 2020/0185385 A1) in view of Normand (US 2017/0345339 A1).
Re claim 17:
Hall does not explicitly disclose fiber embedded into the tissue simulation material. Normand teaches a wound debridement model for practicing debridement during classroom training (Normand, Abstract). Normand teaches 17. The test model of claim 1, wherein the visual indicator comprises at least one fiber embedded into the tissue simulation material (Normand, [0031]). Therefore, in view of Normand, 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 model described in Hall, by providing the fiber as taught by Normand, since it was known in the art to apply different materials to simulate different tissues in a human model.
Response to Arguments
Applicant's arguments filed 2/19/2026 have been fully considered but they are not persuasive.
Applicant argues: Regarding Claim 1, among other features, Claim 1 recites: "wherein the tissue simulation material is configured to deform when the second surface is exposed to a lower pressure than the first surface in the interior volume of the chamber .... " In the rejection of Claim 1, the Office Action suggests that Hall discloses this feature. The only description and citation to Hall provided by the examiner to support the rejection is the following: "(Hall, [0039], "first... second ... surface"; [0040], "a negative pressure")." Office Action at pg. 3. After careful review of Hall, the Applicant respectfully asserts that nothing in these cited passages in Hall, or anywhere else, discloses a configuration including a second surface of a tissue simulation material exposed to a lower pressure than a first surface as recited above in Claim 1.
According to the following paragraphs in Hall:
para. [0040] states “The panel 120 is coupled to the body 108 and seals against the body 108 to prevent air from entering the wound 110 through the first surface 116. As shown in FIGS. 2-3, the panel 120 is a generally optically transparent window through which an observer may view the deformation of the body 108 and the wound 110. The panel 120 is generally rectangular and substantially covers the first surface of the body 108” and Applicant’s fig. 3. Para. [0045], “the size of the aperture 114 decreases with increasing negative pressure. An observer may visually inspect the deformation of the simulated wound 110 through the panel 120 while the NPWT device 20 is operational.”
Para. [0047], “the lip 142 prevents overflow of any adhesive product that may be used to further secure the panel 120 and/or simulated tissue 102 in position with respect to the outer frame 104.”
Para. [0050], “The panel 120 is optically transparent in order to provide an observer with unimpeded visual access to the wound 110. The panel 120 may be made from a variety of different materials. According to an exemplary embodiment, the panel 120 includes a clear acrylic panel or another transparent plastic. In yet other embodiments, the panel 120 may include glass.”
Hall explains that the panel 120 is made of glass and sealed to the outer frame of the model by adhesive (Hall, [0043]; [0047]). It is the office’s position that when negative pressure applies to the first surface 116 of the wound to cause the deformation of the body 108, the inner surface of the panel 120 experience lower pressure than the exterior surface of the panel because it is air-tight sealed.
Applicant argues: Regarding dependent Claim 14, the examiner cites Hall, [0046], for disclosing "wherein the visual indicator comprises at least one circle cast into the tissue simulation material;" however, Hall does not support the examiner's allegation and no further description or explanation is provided … Claim 15, the examiner cites Hall, [0046], for disclosing "wherein the visual indicator comprises at least one circle etched into the lid of the chamber;" however, Hall does not support the examiner's allegation and no further description or explanation is provided.
Para. [0046] in Hall teaches an opening that is circular.
Applicant argues: This cited passage in Hall does not disclose or suggest at least the step of "activating the reduced-pressure source to expose the second surface of the tissue simulation material to a lower pressure than the first surface within the interior volume of the chamber ... " as recited in Claim 19.
In Para. [0062], Hall states “In operation 306, a negative pressure is applied across the wound by the NPWT device 20. This may include activating a pump within the device to remove air from the dressing (e.g., the aperture in the simulated tissue).” Hall teaches the structure to reduce the pressure exert on the panel 120.
Applicant argues: None of the above structure disclosed in Hall is capable of "expos[ing] the second surface of the tissue simulation material to a lower pressure than the first surface within the interior volume of the chamber ... " as recited in Claim 19. Turning to Claim 20, among other features, Claim 20 recites: "exposing a first surface of the tissue simulation material to atmospheric pressure and a second surface of the tissue simulation material to a reduced-pressure .... " In the rejection of Claim 20, the Office Action suggests that Hall discloses this feature. The only description and citation to Hall provided by the examiner to support the rejection is the following: "(Hall, [0039], "first... second ... surface"; [0040], "a negative pressure")." Office Action at pg. 4. After careful review of Hall, the Applicant respectfully asserts that Hall does not include any disclosure in these passages, or anywhere else, that any surf ace of its simulated tissue 102 is exposed to atmospheric pressure. For at least this reason.
It is the office’s position that when negative pressure applies to the first surface 116 of the wound to cause the deformation of the body 108, the inner surface of the panel 120 experience lower pressure than the exterior surface of the panel because it is air-tight sealed.
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 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.
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/JACK YIP/ Primary Examiner, Art Unit 3715
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