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 .
Applicant’s submission of a Response
Applicant’s submission of a response was received on 03/02/2026. Presently, claims 1-4 and 6-17 are now pending.
Response to Arguments
Applicant's arguments filed on 03/02/2026 have been fully considered but they are not persuasive. Applicant’s representative asserts that the amended claims limitations are not met. However, the rejection of claim 1-4 and 6-17 is maintained as presented below. Moreover, some objections have not been addressed, as discussed in detail below.
Applicant’s representative alleges the following:
In regards to amended claim 1, a thin flexible polymer bag forming base of edema device not found in in Applied Art (Page 3 of Remarks).
In regards to amended claim 1, a skin-simulating outer layer coupled to an outer surface of the thin flexible polymer bag not found in Applied Art (Page 5 of Remarks).
In regards to amended claim 1, a permeable foam inner layer within the thin flexible polymer bag not found in Prior Art (Page 5 of Remarks).
In regards to amended claim 2, Katayama is non analogous as it is directed to “a device for collecting a trace amount of liquid sample” such as a tear (Page 7 of Remarks).
In regards to amended claim 3, Haiyan clearly fails to teach or suggest the claimed three layer arrangement (Page 7 of Remarks).
In regards to amended claims 12, 13, and 16, these claims are believed to further structurally distinguish the present claimed invention from the applied prior art (Page 7 of Remarks).
In regards to amended claims 14, and 17, it seems clear that the Haiyan simulator could be for either for pitting or non-pitting edema simulation, but not both (Page 8 of Remarks).
In regards to amended claim 4, Everette is directed to ballistic testing rather than edema simulation (Page 8 of Remarks).
In regards to amended claims 6-8 and 11, the examiner has not clarified why one of ordinary skill in the art would sift through the complex fluid transfer system of Lopez and strip out the single syringe 222b. (Page 9 of Remarks).
In regards to amended claims 10, further PEPM expressly teaches four simulators representing four stages of edema. This is analogous to the second embodiment in which the examiner has already identified is patentably distinct from the present claimed invention (Page 10 of Remarks).
Regarding point (1), the examiner respectfully disagrees.
Applicant’s representative argues that Haiyan fails to reasonable teach or suggest the claimed thin flexible polymer bag and Katayama is non-analogous and is simply not directed to a similar edema simulation issue as it relates to “a device for collecting a trace amount of liquid sample” such as a tear noting that “it has been difficult to safely and sufficiently collect a trace sample such as tear fluid with the liquid collection instruments known so far.”
In response to the arguments above, Katayama is directed to collect and manage fluid in the medical area, which follows the same principle of an Edema simulation device because it needs to collect and manage fluid in order to simulate the edema device. Thus, one of ordinary skill in the art would understand that a structure with the shape of a bag and a permeable foam layer within that bag will mimic the structure for an edema simulator (See 103 rejection below).
Regarding point (2), the examiner respectfully disagrees.
Applicant’s representative argues that there is no skin-simulating outer layer coupled to an outer surface of a thin flexible polymer bag in the bag-shaped main body structure of the tear collecting device of Katayama.
In response to the arguments above, Haiyan is the reference used to disclose the skin-simulating outer layer and the thin flexible bag, but does not explicitly disclose the polymer material used for the thin flexible bag. However, Katayama is used to teach that a bag used for absorption and fluid management is made of flexible polymer (See 103 rejection below).
Regarding point (3), the examiner respectfully disagrees.
Applicant’s representative argues that Katayama is non analogous as it is directed to “a device for collecting a trace amount of liquid sample” such as a tear. The Katayama “trace amount liquid sample collector” structure does disclose an inner “polyurethane sponge, processed into a diameter of 5 mm” for absorbing and distributing a tear or other fluid sample.
In response to the arguments above, Katayama is directed to collect and manage fluid in the medical area, which follows the same principle of an Edema simulation device because it needs to collect and manage fluid in order to simulate the edema device. Thus, one of ordinary skill in the art would understand that a structure with the shape of a bag and a permeable foam layer within that bag will mimic the structure for an edema simulator (See 103 rejection below).
Regarding point (4), the examiner respectfully disagrees.
Applicant’s representative argues that Katayama is non-analogous as noted above and simply does not teach or suggest an edema simulator of ANY shape. Further, the examiners suggested modification destroys the operation of the principal reference as a hand simulator, including hand bone and finger simulating elements.
In response to the arguments above, Katayama is directed to collect and manage fluid in the medical area, which follows the same principle of an Edema simulation device because it needs to collect and manage fluid in order to simulate the edema device. Thus, one of ordinary skill in the art would understand that a structure with the shape of a bag and a permeable foam layer within that bag will mimic the structure for an edema simulator. Furthermore, Katayama is specifically focused on teaching the material used a bag like structure with the capabilities of collecting and managing fluid, which does not destroy the operation of Haiyan (See 103 rejection below).
Regarding point (5), the examiner respectfully disagrees.
Applicant’s representative argues that Haiyan states the “skin can be made of elastic latex or silica gel, and can be set in the shape of a glove according to needs. It can be detached and cleaned, simple and convenient, and the skin thickness is less than 0.2cm; the blood vessels are made of latex material; the hand bones and joints are made of PVC material.” Haiyan clearly fails to teach or suggest the claimed three layer arrangement.
In response to the arguments above, claim 3 does not mention a three layer arrangement, it merely states that the skin simulating outer artificial skin layer is covered with a thin flexible polymer sheet (See 103 rejection below).
Regarding point (6), the examiner respectfully disagrees.
Applicant’s representative argues that Haiyan teaches a hand edema simulation quite clearly and this also helps show the structural differences between such a simulator and the claimed macular edema simulation (Claim 12), for use for pulmonary edema simulation (Claim 13) and configured for cerebral edema simulation (Claim 16). These claims are believed to further structurally distinguish the present claimed invention from the applied prior art.
In response to the arguments above, simulating edema in multiple places of the body follows the same principle, such as the bag whose volume can be manipulated by injecting or withdrawing liquid can be used to simulate edema in multiple regions. Furthermore, there are no specific descriptions on the specification as to how the present invention is used to simulate each type of edema differently, therefore the same principle would apply to all of them. (See 103 rejection below).
Regarding point (7), the examiner respectfully disagrees.
Applicant’s representative argues that it seems clear that the Haiyan simulator could be for either for pitting or non-pitting edema simulation, but not both. The examiner’s glossing over these two opposing simulators evidences he is not addressing the limitations found in the claims.
In response to the arguments above, simulating edema in multiple places of the body follows the same principle, such as the bag whose volume can be manipulated by injecting or withdrawing liquid can be used to simulate different types of edema, such as pitting edema, which leaves an indentation when pressing on the skin or non-pitting edema, which doesn’t leave an indentation when pressing on the skin. (See 103 rejection below).
Regarding point (8), the examiner respectfully disagrees.
Applicant’s representative argues that Everette is directed to ballistic testing rather than edema simulation.
In response to the arguments above, claim 4 is not specifically directed to the edema simulation itself, but to simulating realistic artificial skin. Although Everette is directed to ballistic testing, it’s trying to simulate realistic skin that mimics key characteristics of real skin tissue in the same way that the present invention does. (See 103 rejection below).
Regarding point (9), the examiner respectfully disagrees.
Applicant’s representative argues that the examiner has not clarified why one of ordinary skill in the art would sift through the complex fluid transfer system of Lopez and strip out the single syringe 222b. The examiner’s suggestion seems to be against the teachings of Lopez considered as a whole.
In response to the arguments above, examiner has already stated that a system, such as the one disclosed in Lopez, teaches that transfers of fluids to a bag are done using a valve and syringe in the medical field. We are not implementing the full complex system found in Lopez, but a feature of transferring fluid or liquid, which is one of the many methods to transfer fluid or liquid (See 103 rejection below).
Regarding point (10), the examiner respectfully disagrees.
Applicant’s representative argues that this is analogous to the second embodiment in which the examiner has already identified is patentably distinct from the present claimed invention.
In response to the arguments above, the examiner stated that the second embodiment is not an obvious variant because the first embodiment focused on a syringe to add or remove liquid to simulate different stages of edema and in the second embodiment there is not a syringe to add or remove liquid because there are already 4 different bags that simulate each stage of edema. However, PEPM is used to teach an adhesive strap, not the syringe to add or remove liquid (See 103 rejection below).
Applicant’s representative argues that since the prior art does not disclose or suggest the suggested features of claim 1, all dependent claims are patentable. However, in light of the remarks and standing rejection below, the examiner asserts the prior art of record teaches all the elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
Claim Objections
Claim 12-17 objected to because of the following informalities:
Claims 12-17, have multiple instances of “An edema simulation device” and it should read “The edema simulation device”.
Claim 4, in line 2, “the artificial skin-simulating outer layer” should read “the skin-simulating outer layer”.
Claim Rejections - 35 USC § 103
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.
Claims 1-3, 9, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Haiyan et al. (CN209133052U see-translation; hereinafter Haiyan) in view of Katayama et al. (US 20210007720 A1; hereinafter Katayama).
Regarding claim 1, Haiyan discloses an edema simulation device (¶8) comprising of: a) A thin flexible polymer bag (thin water bag is disclosed in ¶25 but not specifically made of polymer, which will be addressed below); b) A skin-simulating outer layer coupled to an outer surface of the thin flexible polymer bag (skin made of elastic latex or silica gel; ¶17); c) A permeable foam inner layer within the thin flexible polymer bag (water absorbing material is disclosed in ¶18 but not specifically made of foam, which will be addressed below); and d) A fluid or gel selectively positioned within the thin flexible polymer bag (water bag that holds liquid; ¶10), wherein the edema simulation device is configured to simulate at least one of four stages of edema (simulates edema; ¶8) through selective transfer of the fluid or gel into and out of the thin flexible polymer bag (adjusting the water capacity to simulate different stages of edema; ¶8).
Haiyan does not explicitly disclose the thin flexible bag to be made of polymer, a permeable foam inner layer within the thin flexible bag, and wherein the permeable foam inner layer allows the fluid or gel to perfuse through the permeable foam inner layer. However, Katayama focuses on liquid sample collector and this type of structure is used to collect and manage fluid in the medical area, such as using the structure of a bag with a water absorbing foam to collect liquids, which is what the water bag in Haiyan is doing with their water absorbing material. Katayama teaches the thin flexible bag to be made of polymer (bag-like structure by having 2 silicone sheets on top of each other; Fig 1 and ¶56), a permeable foam inner layer within the thin flexible bag (foam water absorbing sponge inside the bag in Fig 1), and wherein the permeable foam inner layer allows the fluid or gel to perfuse through the permeable foam inner layer (an inherent property of permeable foam).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Haiyan to implement the teachings of Katayama because a bag that is used to collect and manage fluid has to be permeable to allow liquid, gas, air, or vapor to pass and has the benefit of realistically replicating physical and mechanical properties of swollen biological tissue.
Regarding claim 2, Haiyan does not explicitly disclose wherein the thin flexible polymer bag and the permeable foam inner layer is one of circular, rectangular, triangular, square hexagonal or octagonal in shape.
However, Katayama focuses on this type of structure to collect fluid in the medical area, which relates to Haiyan because it shows how the structure of a bag with a water absorbing foam can be used to collect liquids, which is what the water bag in Haiyan is doing with their water absorbing material. Katayama teaches wherein the bag and foam can be one of circular, rectangular, triangular, square hexagonal or octagonal in shape (circular shape in Fig 1).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Haiyan to implement the teachings of Katayama because certain shapes can be better to simulate certain human tissue.
Regarding claim 3, Haiyan discloses further including a thin flexible polymer sheet layer wherein the skin-simulating outer layer is covered with the thin flexible polymer sheet layer (elastic latex is a thin flexible polymer used for skin; ¶17).
Regarding claim 9, Haiyan discloses wherein the fluid or gel is comparable in characteristics, reaction and pigmentation to bodily fluids (there is also another bag for blood in Haiyan which holds blood as mentioned in ¶21, blood or simulated blood would have the characteristics and pigmentation of blood as a bodily fluid).
Regarding claim 12, Haiyan discloses wherein the edema simulation device is configured for macular edema simulation (the principle behind edema is the same, so the bag whose volume can be manipulated by injecting or withdrawing liquid can be used to simulate edema in multiple regions such as the eye region).
Regarding claim 13, Haiyan discloses wherein the edema simulation device is configured for use for pulmonary edema simulation (the principle behind edema is the same, so the bag whose volume can be manipulated by injecting or withdrawing liquid can be used to simulate edema in multiple regions such as the lungs).
Regarding claim 14, Haiyan discloses wherein the edema simulation device is configured for non-pitting edema simulation (the principle behind edema is the same, so the bag whose volume can be manipulated by injecting or withdrawing liquid can be used to simulate different types of edema, such as non-pitting edema, which doesn’t leave an indentation when pressing on the skin).
Regarding claim 15, Haiyan discloses wherein the edema simulation device is configured for peripheral edema simulation (the principle behind edema is the same, so the bag whose volume can be manipulated by injecting or withdrawing liquid can be used to simulate edema in multiple regions, such as the legs/ankles/hands/feet/arms).
Regarding claim 16, Haiyan discloses wherein the edema simulation device is configured for cerebral edema simulation (the principle behind edema is the same, so the bag whose volume can be manipulated by injecting or withdrawing liquid can be used to simulate edema in multiple regions, such as the brain).
Regarding claim 17, Haiyan discloses wherein the edema simulation device is configured for pitting edema simulation (the principle behind edema is the same, so the bag whose volume can be manipulated by injecting or withdrawing liquid can be used to simulate different types of edema, such as pitting edema, which leaves an indentation when pressing on the skin).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Haiyan in view of Katayama in view of Richard K. Everett (US 20100311025 A1; hereinafter Everett).
Regarding claim 4, Haiyan discloses the artificial skin-simulating outer layer comprising pigment (inherent because this is necessary to simulate color of human skin). Haiyan does not explicitly disclose where the artificial skin-simulating outer layer is comprised of gelatin and glycerin.
However, Everett focuses on an artificial skin that can include gelatin and glycerin and it relates to Haiyan because Haiyan also tries to simulate human skin. Everett teaches where the artificial skin-simulating outer layer is comprised of gelatin, glycerin (human tissue can include gelatin and glycols such as glycerol; See abstract and ¶35).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Haiyan to implement the teachings of Everett because their chemical composition allows to mimic key characteristics of real skin tissue, such as the collagen from glycerin and flexibility from gelatin.
Claims 6-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Haiyan in view of Katayama in view of Lopez et al. (US 20180161244 A1; hereinafter Lopez).
Regarding claim 6, Haiyan does not explicitly disclose wherein the fluid or gel transfer will be done via a valve and syringe but examiner notes that Haiyan implies this feature by adjusting the water capacity and tubing but does not disclose the specific mechanism of a syringe being used.
However, Lopez focuses on a system that transfers fluids and can use a valve and syringe to do it, which relates to Haiyan because Haiyan also transfers fluid to a bag. Lopez teaches wherein the fluid or gel transfer will be done via a valve (connectors connecting to the container can have valves; ¶107) and syringe (fluid transfer done with a syringe; ¶106).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Haiyan to implement the teachings of Lopez for the benefit of providing a syringe and valve for precision and essential control when adding or removing fluid from a bag. Furthermore, in a training environment there will be no leaks because the fluid will only go from syringe to bag or from bag to syringe.
Regarding claim 7, Haiyan discloses wherein further including flexible tubing extending from the syringe to the thin flexible polymer bag (tubing going to the bag but not disclosing the syringe; ¶10 – read below for syringe), wherein the flexible tubing connects to the thin flexible polymer bag via a small molded port (port is inherent because if the tube is connecting, there needs to be a port to receive the tube). Haiyan does not explicitly disclose the tubing extending from the syringe to the thin flexible polymer bag.
However, Lopez focuses on a system that transfers fluids and can use a valve and syringe to do it, which relates to Haiyan because Haiyan also transfers fluid to a bag. Lopez teaches tubing extending from the syringe to the thin flexible polymer bag (fluid transfer done with a syringe in ¶106 and there is tubing in ¶114).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Haiyan to implement the teachings of Lopez for the benefit of providing a syringe for precision and essential control when adding or removing fluid from a bag. Furthermore, in a training environment there will be no leaks because the fluid will only go from syringe to bag or from bag to syringe.
Regarding claim 8, Haiyan discloses wherein the fluid or gel is transferred via the flexible tubing (can be filled with water and removed; ¶16). Haiyan does not explicitly disclose the fluid or gel transferred via flexible tubing to and from the syringe.
However, Lopez focuses on a system that transfers fluids and can use a valve and syringe to do it, which relates to Haiyan because Haiyan also transfers fluid to a bag. Lopez teaches the fluid or gel is transferred via flexible tubing to and from the syringe (fluid transfer done with a syringe in ¶106 and tubing using in ¶114).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Haiyan to implement the teachings of Lopez for the benefit of providing a syringe for precision and essential control when adding or removing fluid from a bag. Furthermore, in a training environment there will be no leaks because the fluid will only go from syringe to bag or from bag to syringe.
Regarding claim 11, Haiyan discloses wherein the four stages of edema can be varied by removal or addition of fluid or gel (adjusting the water to simulate different stages of edema; ¶8). Haiyan does not explicitly disclose removal or addition of fluid or gel via a syringe.
However, Lopez focuses on a system that transfers fluids and can use a valve and syringe to do it, which relates to Haiyan because Haiyan also transfers fluid to a bag. Lopez teaches removal or addition of fluid or gel via a syringe (fluid transfer done with a syringe; ¶106).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Haiyan to implement the teachings of Lopez for the benefit of providing a syringe for precision and essential control when adding or removing fluid from a bag. Furthermore, in a training environment there will be no leaks because the fluid will only go from syringe to bag or from bag to syringe.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Haiyan in view of Katayama in view of Kyoto Kagaku (Pitting Edema Palpation Model; hereinafter Kyoto).
Regarding claim 10, Haiyan does not disclose further including an adhesive back that allows attachment of the edema simulation device in a desired position.
However, Kyoto focuses on an edema palpitation model, which relates to Haiyan because they both simulate edema with a bag. Kyoto teaches further including an adhesive back that allows attachment of the edema simulation device in a desired position (Edema simulation bag has an adhesive strap to place in desired position; Page 3).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Haiyan to implement the teachings of Kyoto for the benefit of placing the edema model in multiple parts of the body to simulate the condition in different areas of the body.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSE ANGELES whose telephone number is (703)756-5338. The examiner can normally be reached Mon-Fri 8am-5pm.
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) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dmitry Suhol can be reached at (571) 272-4430. 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.
/JOSE ANGELES/Examiner, Art Unit 3715
/Jay Trent Liddle/Primary Examiner, Art Unit 3715