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 .
Drawings
The drawings are objected to because they include the following reference character(s) not mentioned in the description: 4005, 4010, 4015, 4020, 4105, 4110, 4115, 4205, 4210, 4215, 4660, and 4665. Reference characters 4005, 4010, 4015, 4020, 4105, 4110, 4115, 4205, 4210, and 4215 appear in FIGS. 40, 41, 42A, and 42B, which are described at [0071] without the use of any reference characters. Reference characters 4660 and 4665 appear in FIGS. 46 and 47. Correction may be made by amendment of either the drawings or the specification.
The drawings are objected to because they do not include the following reference sign(s) mentioned in the description: 2742, 2917, 4625, and 4650. Bifurcation 2742 is described at [0044] as being in simulated vascular vessel 2710 of FIG. 27. Simulated skin cover 2917 is described at [0055] as being on top of modular insert 2915 of FIGS. 29A and 29B. Insert receiving chamber 4625 and fluidic tubing 4650 are described at [0077] with respect to FIG. 46.
The drawings are objected to because reference character 2230 is used to designate different parts. In FIGS. 22A and 22B, reference character 2230 designates a branch of simulated vascular vessel 2205, as described at [0035]. In FIG. 23, the same reference character designates a branch of simulated vascular vessel 2305. [0039] recites that simulated vessel 2305 includes branches 2312, 2315, 2325, and 2330. It appears that reference character 2230 in FIG. 23 should be 2330.
The drawings are objected to because reference character 3420 is used in FIG. 34B to designate different parts. [0064] recites that FIG. 34B shows conduit 3435 connecting fluid flow connector 3415 to conduit connector 3420. FIG. 34B applies reference character 3420 both to the conduit connector extending from the lower portion of wall 3410 and to the conduit extending along the outside surface of wall 3410. It appears that the latter occurrence of reference character 3420 in FIG. 34B should be 3435.
The drawings are objected to because FIGS. 46 and 47 include reference character 4644, which is not mentioned in the description, designating an indent in top surface 4610. [0077] recites that top surface 4610 includes indents 4622, 4624. It appears that reference character 4644 should be 4624 in both figures.
The drawings are objected to because FIG. 7 includes the reference character x20, which is not a proper reference character. [0024] recites that FIG. 7 illustrates the one or more layers of material 620 with the anatomical mold 510 removed. It appears that the reference character should be 620.
The drawings are objected to because FIG. 31 includes the reference character 29nn, which is not a proper reference character. FIG. 31 is described at [0060]. Applicant should supply the appropriate reference character and add a corresponding recitation to the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Page 5 (Brief Description of the Drawings): The entry for FIG. 22D recites “another view of the simulated vascular vessel of FIG. 22B”. FIG. 22D illustrates simulated vascular vessel 2255 and aneurysm 2257, which are the vessel and aneurysm of FIG. 22C. It appears that the entry should recite FIG. 22C.
[0027]: The term anatomical anomaly is recited four times, twice with respect to element 1325 and twice with respect to element 1425. The remainder of the disclosure and all of claims 1-23 recite anatomical abnormality.
[0028]: The recitation “anatomical mold 15 removed” should recite anatomical mold 1510.
[0028]: The disclosure recites that “[a] portion of the material of one or more layers 1620 remains adjacent the inner surface… as a simulated anatomical abnormality 1745”. One or more layers 1620 form the wall of the simulated vascular vessel. The simulated anatomical abnormality is formed from a remaining portion of the material of the anatomical mold, as described at [0017] and [0027] and as required by claims 1, 22, and 23. It appears that the recitation should recite anatomical mold 1510.
[0031]: The recitation housing 1920 appears three times. FIG. 19 designates the housing as 1910 and the simulated vascular vessel as 1920. It appears that each instance should recite housing 1910.
[0041]: The recitation simulated anatomical component 2405 should recite 2505. FIG. 25 designates the simulated vascular vessel as 2505, element 2405 is the simulated vascular vessel of FIG. 24, and [0043] recites simulated vessels 2305, 2405, 2505, and 2605.
[0042]: The recitation simulated anatomical component 2505 should recite 2605. FIG. 26 designates the simulated vascular vessel as 2605.
[0055]: The recitation modular insert 2910 appears twice. Element 2910 is the insert receiving chamber. It appears that each instance should recite modular insert 2915.
[0055] and [0066]: Element 2920 is recited as a slit opening at [0055] and as a slot at [0066].
[0066]: The recitation wings 3630 should recite wings 3625. FIGS. 36A and 36B designate the wings as 3625, and [0068] recites wings 3625.
[0070]: The recitation wings 3635 should recite wings 3625.
[0070]: The recitation “another exemplary top view of the 3800” should recite “another exemplary top view of the system 3800”.
[0072]: The recitation fluid flow connector 4645 should recite fluid flow connector 4345. Element 4645 appears in the embodiment of FIGS. 46 and 47.
[0075]: The recitation “connects through liftable portion 4535” should recite liftable portion 4320. Element 4535 is a fluid flow connector.
[0078]: The recitation “mate with fluid flow connector 4625” should recite fluid flow connector 4645. Element 4625 is the insert receiving chamber, and [0078] further recites that the fluid flow connectors of modular insert 4705 are connected to 4640 and 4645.
Appropriate correction is required.
The use of the terms Trinket and Arduino, which are trade names or marks used in commerce, has been noted in this application at [0049]. The terms should be accompanied by the generic terminology and should be capitalized wherever they appear or accompanied by the appropriate symbol for a trade name or mark.
Claim Objections
Claims 1, 22, and 23 are objected to because of the following informalities:
Claims 1, 22, and 23 each recite “a wall around a passage of the anatomical component”. Each claim previously introduces “a simulated anatomical component”. It is suggested that the recitation be amended to “a passage of the simulated anatomical component”. Applicant’s attention is directed to claim 19, which recites that “the simulated anatomical component represents an anatomical component selected from the group consisting of a vascular vessel, a mucous membrane, [etc.]”. In other words, claim 19 uses “anatomical component” to refer to the actual anatomy that the simulated anatomical component represents. Usage of these terms should be consistent throughout the claims.
In claim 23, the limitation “wherein the housing includes one or more holes configured to connect to the surgical simulation device and allow fluid to flow from the fluid flow components to the passage” appears within the element reciting “a simulated skin cover attached to the housing and covering the simulated anatomical component”. The recited holes are formed in the housing and are unrelated to the simulated skin cover. It is suggested that this limitation instead be recited at the end of the element beginning “a simulated anatomical component inside the housing”, following the recitation “the passage configured for liquid to pass therethrough”, which introduces the passage to which the limitation refers.
Appropriate correction is required.
Claim 19 recites “ocular tissues” in the plural among otherwise singular alternatives in the Markush group. As drafted, this alternative is being read to require more than one ocular tissue, unlike the remaining alternatives. No objection is made and no correction is required. Applicant may wish to review this recitation.
Claim Rejections - 35 USC § 112
Claims 1-23 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 22, and 23 each recite “a simulated anatomical abnormality within the passage, the simulated anatomical abnormality formed as a material of an anatomical mold used to form the simulated anatomical component that has been partially removed to form the passage”. It is unclear what structure the limitation “that has been partially removed to form the passage” modifies. The limitation may modify “the simulated anatomical component”, which is the nearest antecedent, may modify “an anatomical mold”, or may modify “a material”. Each reading results in a different claim scope.
The disclosure indicates that it is the anatomical mold that is partially removed. [0017] recites that at least a portion of the anatomical mold is removed from the one or more layers of material leaving at least a portion of the material of the mold adjacent the one or more layers of material to form a simulated anatomical abnormality, and [0027] describes the same process with respect to FIGS. 11-14. The claims, however, do not identify which structure is partially removed.
For purposes of examination, the limitation is interpreted as requiring that the anatomical mold has been partially removed to form the passage.
It is suggested that the limitation be amended to recite “a simulated anatomical abnormality within the passage, the simulated anatomical abnormality formed as a material of an anatomical mold, the anatomical mold used to form the simulated anatomical component and partially removed to form the passage”.
Claims 2-21 are rejected based on their dependency from claim 1.
The term “closely associated with” in claims 8, 10-13, 17, 22, and 23 is a relative term which renders the claims indefinite. The term “closely associated with” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure uses the term a single time, at [0031], in a parenthetical example reciting that a simulated skin may include layers simulating other tissues and organs “as part of the simulated skin or closely associated or attached thereto”. No definition is provided and no standard is given for determining what degree of association is required.
For purposes of examination, the term is interpreted as encompassing any positional relationship in which the recited simulated component is adjacent to, in contact with, or joined to the simulated skin cover.
Claim 4 recites “wherein the simulated skin cover is part of a structural material as one or more walls of the housing”. It is unclear whether this limitation requires that the simulated skin cover be formed of the same material as the one or more walls of the housing, that the simulated skin cover be integral with the one or more walls of the housing, or that the simulated skin cover constitute one or more of the walls of the housing. [0047] recites that a simulated skin cover may “be part of the same structural material as one or more of the side walls of modular insert”. It appears that the claim has omitted “the same” and “of the side walls of”, and the omission renders the metes and bounds of the claim unascertainable.
Claim 17 recites “further comprising as part of the simulated skin cover a simulated muscle, a simulated nerve tissue, and a simulated adipose tissue closely associated with or attached to the simulated skin cover”. The recitation “as part of the simulated skin cover” requires the recited components to be constituents of the simulated skin cover, such that the components and the simulated skin cover together form a single structure. The alternative recitation “attached to the simulated skin cover” requires the recited components to be joined to the simulated skin cover, which presupposes that the components and the simulated skin cover are separate structures. A component cannot simultaneously be a constituent of the simulated skin cover and a separate structure joined to the simulated skin cover. It is therefore unclear whether claim 17 requires an integral configuration, requires a separate but joined configuration, or excludes the “attached to” alternative. [0031] describes these as alternatives, reciting that a simulated skin may include layers simulating other tissues and organs “as part of the simulated skin or closely associated or attached thereto”.
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.
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, 6-8, 11, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0126449 A1 (“Horst”) in view of US 2015/0282963 A1 (“Gounis”).
Horst describes the anatomical training model in two implementations having the same construction, a venipuncture implementation using reference characters 110-160 and a radial arterial implementation using reference characters 1110-1160. See [0074] and [0093]. Horst describes the second implementation by reference to the first. See [0101]. The citations below are to whichever implementation describes the feature at issue in greater detail.
Regarding claim 1, Horst discloses a surgical simulation system (the vascular access training simulator system and its anatomical training model 110, which comprises a puncture insert 115, a support base 130, and an anatomical model limb 140, see [0074]), comprising:
a housing (the transparent housing 120, whose first opposing pair of walls 120a and second opposing pair of walls 120b form a hollow rectangular encasement configured to contain the transparent simulated body tissue 122, see [0086]);
a simulated anatomical component inside the housing (the simulated blood vessel 124, which is suspended in the transparent simulated body tissue 122 disposed within the transparent housing 120, see [0074] and [0090]) and having one or more layers of material forming a wall around a passage of the anatomical component (the wall of the synthetic vein tube forming the simulated vessel 124, which is a transparent silicon tubing molded within the simulated body tissue, see [0090] and [0102]), the passage configured for liquid to pass therethrough (the pulsatile pump draws simulated blood from the fluid reservoir 1131 and pumps the simulated blood through the simulated blood vessel 1124 via the flow inlet 1134, see [0095] and [0097]).
Horst does not disclose a simulated anatomical abnormality within the passage.
The recitation “the simulated anatomical abnormality formed as a material of an anatomical mold used to form the simulated anatomical component that has been partially removed to form the passage” is a product-by-process limitation appearing in a claim drawn to a system. Under MPEP 2113, a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. The structure implied by the recited steps is a mass of material located within the passage and adjacent the wall formed by the one or more layers of material. The recitation requires no particular composition for that mass, no particular geometry, and no particular manner of union between the mass and the wall. The claimed system is therefore not structurally distinguishable from a system in which a mass of material is separately formed and thereafter secured within the passage adjacent the wall. Where the claimed product reasonably appears to be the same as or only slightly different from a product disclosed in the prior art, the burden is on applicant to establish that the product of the prior art does not necessarily or inherently possess the characteristics of the claimed product. See MPEP 2112(V). The Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims. See MPEP 2113(II).
Gounis is directed to methods of manufacturing anatomically accurate vascular replicas incorporating simulated atherosclerotic plaque, for use in evaluating imaging sequences and in testing medical devices. See [0060] and [0073]. Gounis discloses a plaque model having a stenosed vessel lumen 401, a fibrous cap plaque component 402, and a lipid plaque component 403. See Figure 4 and [0071]. A core-shell mold is built for each plaque component, the mold is filled with silicone and dissolved to yield a silicone container, a gelatin-based plaque component is infused into the silicone container and set, and the container is cut open to release the shaped plaque component. The shaped plaque component is then attached to the polyvinyl alcohol vascular replica of a stenosed vessel wall by coating a layer of adhesive, such as a liquid polyvinyl alcohol solution, on one or both of the shaped plaque and the vascular replica and performing a curing process. See [0072]. Gounis further discloses that each plaque component can be attached or glued to the vascular replica using an adhesive such as polyvinyl alcohol, and that the resulting replica can be attached to a flow loop filled with a blood mimicking fluid driven by a cardiac duplicator. See [0060].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the simulated blood vessel of Horst with a simulated plaque component disposed within its lumen, as taught by Gounis, in order to permit the clinician to practice and to evaluate vascular access in a diseased vessel rather than only in a healthy one. Gounis identifies the purpose served by such a replica, namely that it can be used as a gold standard phantom on which imaging sequences developed to visualize plaque can be evaluated by quantifiable metrics, and that the technique has larger implications for medical device testing in realistic models of the human vasculature. See [0060] and [0073] of Gounis. That purpose applies directly to Horst, whose transparent housing, transparent simulated tissue, and imaging devices exist so that the simulated vessel can be visualized during and after an insertion procedure. See [0086] and [0102] of Horst. The modification is the use of a known technique (the attachment of a separately formed plaque component to a vascular replica by adhesive coating and curing) to improve a similar device in the same way, and the results would have been predictable. See MPEP 2143(I)(C). The modification further requires no change to the manner in which Horst constructs the puncture insert, because Gounis attaches the plaque component to a completed vessel wall by adhesive rather than during the molding of the vessel itself. See [0060] and [0072] of Gounis.
Regarding claim 22, Horst discloses a surgical simulation system comprising:
a modular insert housing, the modular insert housing configured to be connected to a surgical simulation device (the anatomical puncture insert 1115, which comprises the transparent housing 1120 and is removably attachable to the support base 1130 so that it can be replaced with a new insert as needed, see [0093], the transparent housing being removably secured in place on the support base via fasteners 132 such as screws or bolts, see [0085]);
a simulated anatomical component inside the housing and having one or more layers of material forming a wall around a passage of the anatomical component, the passage configured for liquid to pass therethrough (see the mapping of these limitations in the rejection of claim 1 above);
a simulated skin cover attached to the housing and covering the simulated anatomical component (the layer of synthetic skin 126, which covers a top of the housing 120 and the simulated body tissue 122 and which may be removably secured thereto by a plurality of clip fasteners 136 attached to the housing, see [0085] and [0086]); and
one or more simulated components selected from the group consisting of a simulated muscle, a simulated nerve tissue, a simulated adipose tissue, and any combinations thereof (the transparent simulated body tissue 1122, which comprises a tissue-mimicking gelatin that simulates human subcutaneous fat and connective tissue, see [0087] and [0101], and which per the table at [0089] includes connective tissue present in subcutaneous fat between the epidermis-dermis and the target vessel as well as contrasting subcutaneous fat layers), the one or more simulated components being closely associated with or attached to the simulated skin cover (the subcutaneous fat is located between the epidermis-dermis and the target vessel, and the layer of synthetic skin 126 covers the simulated body tissue 122 directly, see [0086] and [0089]).
Horst does not disclose a simulated anatomical abnormality within the passage. The treatment of that limitation in the rejection of claim 1 above, including the interpretation of the limitation under MPEP 2113, the teaching of Gounis, and the motivation to combine, applies equally to claim 22.
Regarding claim 23, Horst discloses a surgical simulation system comprising:
a surgical simulation device having fluid flow components (the support base 1130, which comprises a fluid reservoir 1131 configured to hold a supply of fluid such as synthetic blood, a flow outlet 1133 in fluid communication with the fluid reservoir and a pulsatile arterial simulation pump, and a flow inlet 1134 in fluid communication with the pulsatile pump and the simulated blood vessel 1124, see [0095]);
a modular insert housing, the modular insert housing configured to be removably connected to the surgical simulation device (the anatomical puncture insert 1115 and its transparent housing 1120, which is removably attachable to the support base 1130 so that it can be replaced with a new insert as needed and which is removably secured in place on the support base via fasteners 132 such as screws or bolts, see [0085] and [0093]);
a simulated anatomical component inside the housing and having one or more layers of material forming a wall around a passage of the anatomical component, the passage configured for liquid to pass therethrough (see the mapping of these limitations in the rejection of claim 1 above);
a simulated skin cover attached to the housing and covering the simulated anatomical component (the layer of synthetic skin 126, see [0085] and [0086]), wherein the housing includes one or more holes configured to connect to the surgical simulation device and allow fluid to flow from the fluid flow components to the passage (the simulated blood vessel 124 extends through the transparent housing 120, see [0074], and the blood vessel inlet tubing 1135 and the blood vessel outlet tubing 1136 are connected to the blood vessel inlet end and the blood vessel outlet end of the simulated blood vessel 1124 within the puncture insert 1115, see [0098]); and
one or more simulated components selected from the group consisting of a simulated muscle, a simulated nerve tissue, a simulated adipose tissue, and any combinations thereof, the one or more simulated components being closely associated with or attached to the simulated skin cover (the transparent simulated body tissue 1122 and the subcutaneous fat located between the epidermis-dermis and the target vessel, see [0087], [0089], and [0101]).
Horst does not disclose a simulated anatomical abnormality within the passage. The treatment of that limitation in the rejection of claim 1 above, including the interpretation of the limitation under MPEP 2113, the teaching of Gounis, and the motivation to combine, applies equally to claim 23.
Regarding claim 2, modified Horst discloses a simulated skin cover attached to the housing and covering the simulated anatomical component (the layer of synthetic skin 126 of Horst, which covers a top of the transparent housing 120 and the transparent simulated body tissue 122, see [0074] and [0086]).
Regarding claim 3, modified Horst discloses wherein the simulated skin cover is removably attached to the housing (the layer of synthetic skin 126 covering the top of the housing 120 in Horst may be removably secured thereto by a plurality of clip fasteners 136 attached to the housing, and is clipped onto the top of the housing 120 by those fastening clips during assembly, see [0085] and [0090]).
Regarding claim 6, modified Horst discloses one or more simulated tissues or organs (the transparent simulated body tissue and organs 122 contained within the transparent housing 120 in Horst, see [0074] and [0086]).
Regarding claim 7, modified Horst discloses wherein the one or more simulated tissues or organs includes a simulated tissue or organ selected from the group consisting of a muscle, an adipose tissue, a nerve tissue, and any combinations thereof (the tissue-mimicking gelatin forming the simulated body tissue 122 of Horst, which maintains the desired transparency while also simulating human subcutaneous fat and connective tissue, see [0087] and [0101]). Horst further discloses that the anatomical training model may include other anatomical features such as nerves, muscles, and bones. See [0105].
Regarding claim 8, modified Horst discloses wherein the one or more simulated tissues or organs are closely associated with or attached to the simulated skin cover (the table at [0089] of Horst specifies connective tissue present in subcutaneous fat between the epidermis-dermis and the target vessel, and the layer of synthetic skin 126 covers the simulated body tissue 122 directly, see [0086] and [0089]).
Regarding claim 11, modified Horst discloses a simulated adipose tissue closely associated with or attached to the simulated skin cover (the tissue-mimicking gelatin simulating human subcutaneous fat, together with the connective tissue present in subcutaneous fat between the epidermis-dermis and the target vessel and the contrasting subcutaneous fat layers of the table at [0089] of Horst, the layer of synthetic skin 126 covering the simulated body tissue 122 directly, see [0086], [0087], [0089], and [0101]).
Regarding claim 18, modified Horst discloses wherein the simulated anatomical abnormality includes an abnormality selected from the group consisting of a plaque, an embolism, a stenosis, a thrombosis, a calcification, and any combinations thereof (the fibrous cap plaque component 402 and the lipid plaque component 403 of Gounis, disposed within the stenosed vessel lumen 401, see Figure 4 and [0071] of Gounis).
Regarding claim 19, modified Horst discloses wherein the simulated anatomical component represents an anatomical component selected from the group consisting of a vascular vessel, a mucous membrane, a tissue of an organ, an anatomical duct, a skin tissue, a fascia, ocular tissues, any sub-portion thereof, and any combinations thereof (the simulated blood vessel 124 of Horst, which in the radial arterial implementation is a simulated artery within a simulated forearm, see [0074] and [0096]).
Regarding claim 20, modified Horst discloses wherein the housing is a modular insert to a surgical simulation device (the anatomical puncture insert 1115 of Horst, which comprises the transparent housing 1120 and is removably attachable to the support base 1130 so that it can be replaced with a new insert as needed after several insertions of the needle into the simulated artery and tissue have been performed, see [0093], the transparent housing being removably secured in place on the support base via fasteners 132 such as screws or bolts, see [0085]).
Regarding claim 21, modified Horst discloses wherein the housing includes one or more holes configured to connect the passage of the simulated anatomical component to a fluid flow component of the surgical simulation device to allow for a fluid to flow through the passage (in Horst, the simulated blood vessel 124 extends through the transparent housing 120, see [0074], and the blood vessel inlet tubing 1135 and the blood vessel outlet tubing 1136 are connected to the blood vessel inlet end and the blood vessel outlet end of the simulated blood vessel 1124 within the puncture insert 1115, placing the vessel in fluid communication with the fluid reservoir 1131 and the pulsatile pump of the support base 1130, see [0095] and [0098]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Horst in view of Gounis, as applied to claim 2 above, and further in view of US 2014/0186809 A1 (“Hendrickson”).
Claim 4 is also rejected under 35 U.S.C. 112(b) above. For purposes of applying prior art, the limitation “wherein the simulated skin cover is part of a structural material as one or more walls of the housing” is treated as requiring that the simulated skin cover constitute, or be formed of the same structural material as, one or more walls of the housing.
Modified Horst does not expressly disclose wherein the simulated skin cover is part of a structural material as one or more walls of the housing.
Hendrickson is directed to a surgical simulator comprising an artificial organ and an enclosure substantially enclosing the artificial organ. See [0009]. Hendrickson discloses a simulator 300 that includes an enclosure 305 having an exterior wall 320 defining an interior volume 325, an organ support assembly 310, an artificial organ 210, and a fluid supply system 315. See [0144]. In one embodiment the enclosure 305 is configured to replicate the appearance and construction of a human or animal torso, the exterior wall 320 is configured to replicate the appearance and construction of a body wall, and the instrument openings 330 must be surgically created in the exterior wall by a trocar, scalpel, or other surgical instrument. See [0146]. The exterior wall 320 in the form of a body wall may have a multi-layer arrangement wherein an epidermis-dermis layer extends over a muscle belly layer having a fascia capsule enclosing a muscle layer, together with other body wall layers such as a subcutaneous layer and a peritoneum or pleura layer. See [0146]. Hendrickson further discloses that a portion of the exterior wall can have an artificial body wall formed of platinum cured room temperature vulcanization silicone rubber, that surgical openings can be created in the artificial body wall via a trocar or scalpel in the process of performing a simulated surgery, and that the artificial body wall is then replaced with a new artificial body wall when the rest of the simulator is reused. See [0161].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the simulated skin cover of modified Horst as a portion of a wall of the housing, as taught by Hendrickson, in order to require the clinician to create the access opening through the simulated skin as would be done in an actual procedure rather than to work through a pre-existing opening in the housing. See [0146] and [0161] of Hendrickson. Modified Horst is already arranged for the modification, because a top of the housing 120 is open to expose the simulated body tissue and the layer of synthetic skin 126 closes that opening. See [0086] of Horst. The use of a one-piece construction instead of the structure disclosed in the prior art is further a matter of obvious engineering choice. See MPEP 2144.04(V)(B) and In re Larson.
In the resulting combination, modified Horst discloses wherein the simulated skin cover is part of a structural material as one or more walls of the housing (the artificial body wall constituting the exterior wall 320 of the enclosure 305 of Hendrickson, see [0146] and [0161] of Hendrickson).
Claims 5, 9, 10, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Horst in view of Gounis, as applied to claim 2 or 6 above, and further in view of US 2012/0034587 A1 (“Toly”).
Modified Horst does not disclose the material of which the simulated skin cover is formed, does not disclose simulated tissues or organs that are part of the simulated skin cover or that form layers of the simulated skin cover, and does not disclose the structure of a simulated nerve tissue beyond stating that the anatomical training model may include other anatomical features such as nerves, muscles, and bones. See [0105] of Horst.
Toly is directed to medical procedure trainers having simulated human tissue structures formed of layered elastomeric compositions. Toly discloses a simulated human tissue structure 200 that is the visible exterior at the surgical practice areas of the trainer and that includes a number of strata of an elastomeric composition selected so as to replicate the actual layered membranes and sub-membranes of a human body, a stratum or layer being defined as a substantially uniform area extending over a portion of the structure, the layers being optionally bonded to one another, placed atop one another without being bonded, or even separated by members that are not a part of the human tissue structure. See [0065]. The uppermost and outermost layer is a composite layer 222 simulating human skin and including a silicone blend 202 and a reinforcing silicone-coated fibrous layer 204 made of a nylon mesh material or a felt material, the fibrous layer imparting a realistic resistance to cutting. See [0066]. Under skin layer 222 is a subcutaneous fat layer 206 formed of a silicone blend, which simulates the subcutaneous fat found in actual human tissue and is about 10 to about 60 millimeters thick. See [0067]. Underlying the anterior rectus sheath layer 224 is a muscle layer 212 whose formulation is adjusted to realistically simulate the texture and consistency of actual muscle. See [0068] and [0069]. The simulated human tissue is secured to the trainer by hook and loop fasteners or snap fasteners, thereby making the exterior tissues replaceable at the end of their useful life. See [0064]. In a further embodiment, a trainer configured as a simulated human upper torso includes an exterior body cover 110, a chest tissue structure 114, and a neck tissue structure 116, the neck tissue structure including three simulated brachial plexus nerve bundles disposed at the interscalene site, each nerve bundle being formed of an electrically conductive elastomer and each being surrounded by a conductive sheath also formed of an electrically conductive elastomer. See Figure 26 and [0189].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have constructed the layer of synthetic skin of modified Horst as a multi-stratum cover having the composite skin layer, the subcutaneous fat layer, and the muscle layer taught by Toly, and to have provided simulated nerve tissue within that cover as taught by Toly, in order to replicate the actual layered membranes and sub-membranes of the human body at the insertion site and to render the cover incisable and suturable. See [0064] through [0066] of Toly. Horst itself contemplates the modification, since Horst states that the simulated tissue material may comprise a mixture of layers with various geometries having different concentrations or formulations of the tissue materials, and that the anatomical training model may include other anatomical features such as nerves, muscles, and bones. See [0087] and [0105] of Horst. The modification combines prior art elements according to known methods to yield predictable results, and applies a known technique to a known device that is ready for the improvement. See MPEP 2143(I)(A) and MPEP 2143(I)(D).
The proposed modification does not render Horst unsatisfactory for its intended purpose. The transparency on which Horst depends is the transparency of the housing 120, of the simulated body tissue 122, and of the simulated blood vessel 124, which are the structures viewed by the second imaging device 160 and by the angled mirror 1125. See [0074] and [0102] of Horst. Horst does not describe the layer of synthetic skin 126 as transparent, and describes the benefit of the transparent construction as the ability to view underneath the surface of the synthetic skin 126, which presupposes that the synthetic skin is not part of the viewing path. See [0086] of Horst. The layered tissue of Toly is likewise intended for use with ultrasound imaging, since Toly discloses that an ultrasound probe can be used to image the tissue and the underlying body vasculature and nerves at the site, and that the electrically conductive elastomer forming the nerve bundles appears just like an actual nerve when observed in an image of the site produced using an ultrasound probe. See [0187] and [0189] of Toly.
Regarding claim 5, modified Horst discloses wherein the simulated skin cover includes a material selected from the group consisting of an elastomer, a fabric, a hydrogel, a leather, and any combinations thereof (the composite layer 222 of Toly, which includes a silicone blend 202 and a reinforcing silicone-coated fibrous layer 204 made of a nylon mesh material or a felt material, see [0066] of Toly).
Regarding claim 9, modified Horst discloses wherein the one or more simulated tissues or organs are part of the simulated skin cover (the subcutaneous fat layer 206 and the muscle layer 212, which are strata of the simulated human tissue structure 200 of Toly whose uppermost and outermost layer is the composite skin layer 222, see [0065], [0067], and [0069] of Toly).
Regarding claim 10, modified Horst discloses a simulated nerve tissue closely associated with or attached to the simulated skin cover (the three simulated brachial plexus nerve bundles disposed at the interscalene site within the neck tissue structure 116 of Toly, each formed of an electrically conductive elastomer and each surrounded by a conductive sheath, the trainer further including an exterior body cover 110 through which the trainee pierces the neck tissue structure, see Figure 26 and [0189] of Toly).
Regarding claim 12, modified Horst discloses a simulated muscle closely associated with or attached to the simulated skin cover (the muscle layer 212 of Toly, which underlies the anterior rectus sheath layer 224, the subcutaneous fat layer 206, and the composite skin layer 222 of the simulated human tissue structure 200, see [0066] through [0069] of Toly).
Regarding claim 13, modified Horst discloses a simulated muscle, a simulated nerve tissue, and a simulated adipose tissue closely associated with or attached to the simulated skin cover (the muscle layer 212 and the subcutaneous fat layer 206 of the simulated human tissue structure 200 of Toly, see [0067] and [0069] of Toly, together with the simulated brachial plexus nerve bundles within the neck tissue structure 116 of Toly, see [0189] of Toly).
Regarding claim 14, the recitation “a simulated nerve tissue as a layer of the simulated skin cover” does not require the simulated nerve tissue to be in the form of a continuous sheet. Applicant’s disclosure uses the term “layer” loosely with respect to nerve tissue. [0031] recites that a simulated skin may include associated simulated layers representing tissues and organs such as a muscle, adipose tissue, nerve tissue, other tissues, and any combinations thereof. [0044] and FIG. 27, however, apply the term “layer” only to skin layer 2730, adipose tissue layer 2735, and thin muscle layer 2740, and identify simulated nerves 2755 and 2760, which may simulate a vagus nerve and a hypoglossal nerve, as discrete elongate structures rather than as sheets. No sheet of simulated nerve tissue is depicted in any figure. For purposes of examination, the limitation is interpreted as requiring simulated nerve tissue disposed at a stratum of the simulated skin cover.
Under that interpretation, modified Horst discloses a simulated nerve tissue as a layer of the simulated skin cover (the three simulated brachial plexus nerve bundles disposed at the interscalene site within the neck tissue structure 116 of Toly, each formed of an electrically conductive elastomer and each surrounded by a conductive sheath, see [0189] of Toly, a stratum or layer being defined by Toly as a substantially uniform area extending over a portion of the structure, with layers optionally unbonded or separated by members that are not a part of the human tissue structure, see [0065] of Toly).
In the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the simulated nerve tissue of modified Horst as a sheet-form layer of the simulated skin cover. Toly discloses that a conductive fabric can be cut into the shape and pattern desired, placed onto a lower elastomeric layer, and covered by an upper elastomeric layer such that the conductive fabric is embedded within an elastomeric matrix. See [0157], [0159], and [0160] of Toly. Toly further discloses such a conductive elastomer 398 disposed between the fibrous layer 210 and the muscle layer 212 of the simulated human tissue structure 200a. See Figure 15 and [0161] of Toly. Toly does not state that the simulated nerve is itself a fabric, the conductive elastomer 398 of Figure 15 is a lavage depth circuit rather than a nerve, and [0158] of Toly identifies a conductive yarn rather than a conductive fabric as more realistically simulating nerves. Nevertheless, one of ordinary skill in the art would have recognized from these teachings that a conductive textile representing nerve tissue can be laid up as a stratum within a layered elastomeric tissue structure, and would have had a reasonable expectation of success in doing so. See MPEP 2143(I)(A).
Regarding claim 15, modified Horst discloses a simulated adipose tissue as a layer of the simulated skin cover (the subcutaneous fat layer 206 of Toly, which is disposed under skin layer 222, simulates the subcutaneous fat found in actual human tissue, and is about 10 to about 60 millimeters thick, see [0067] of Toly).
Regarding claim 16, modified Horst discloses a simulated muscle as a layer of the simulated skin cover (the muscle layer 212 of Toly, which underlies the anterior rectus sheath layer 224 of the simulated human tissue structure 200, see [0069] of Toly).
Regarding claim 17, claim 17 is also rejected under 35 U.S.C. 112(b) above. For purposes of applying prior art, the recitation “as part of the simulated skin cover” and the recitation “closely associated with or attached to the simulated skin cover” are each given effect. Modified Horst discloses as part of the simulated skin cover a simulated muscle and a simulated adipose tissue (the muscle layer 212 and the subcutaneous fat layer 206, which are strata of the simulated human tissue structure 200 of Toly whose uppermost and outermost layer is the composite skin layer 222, see [0065], [0067], and [0069] of Toly), and a simulated nerve tissue closely associated with or attached to the simulated skin cover (the three simulated brachial plexus nerve bundles disposed at the interscalene site within the neck tissue structure 116 of Toly, see [0189] of Toly).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1 and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 20, 22, and 23 of US 11,904,508 B2 in view of US 2020/0126449 A1 (“Horst”).
Claim 1 of US 11,904,508 recites a method of producing a simulated vascular vessel, comprising forming a vascular vessel mold from a first material that includes a soluble polymer and/or meltable material, the vascular vessel mold defining an interior void of a vascular vessel for a surgical simulation system, applying one or more layers of elastomer around the vascular vessel mold to form a simulated vascular vessel, allowing the one or more layers of elastomer to cure to form a wall of the simulated vascular vessel, and removing a first portion of the vascular vessel mold via dissolving and/or melting to create a passage for liquid in the simulated vascular vessel, wherein when said removing is completed to form the passage, a second portion of the vascular vessel mold remains in the passage as a simulated vascular abnormality, wherein the passage includes an opening for receiving a fluid flow, and wherein the simulated vascular abnormality is positioned adjacent the wall of the simulated vascular vessel such that the simulated vascular abnormality and the simulated vascular vessel are configured to allow the fluid flow to pass through the passage by the simulated vascular abnormality.
The simulated vascular vessel produced by the method of reference claim 1 is the simulated anatomical component of instant claim 1. The one or more layers of elastomer allowed to cure to form a wall of the simulated vascular vessel are the one or more layers of material forming a wall around a passage of the anatomical component. The passage created in the simulated vascular vessel by removing the first portion of the vascular vessel mold is the passage configured for liquid to pass therethrough, and reference claim 1 further requires that the passage include an opening for receiving a fluid flow and that the vessel be configured to allow the fluid flow to pass through the passage. The second portion of the vascular vessel mold that remains in the passage adjacent the wall of the simulated vascular vessel is the simulated anatomical abnormality within the passage of instant claim 1.
The product-by-process limitation of instant claim 1, namely that the simulated anatomical abnormality is formed as a material of an anatomical mold used to form the simulated anatomical component that has been partially removed to form the passage, recites the same operation that reference claim 1 recites as a method step. Reference claim 1 forms the vascular vessel mold, applies and cures the layers of elastomer around it to form the component, removes a first portion of that mold to create the passage, and leaves a second portion of that same mold in the passage as the abnormality. Instant claim 1 accordingly recites no structure that the practice of reference claim 1 does not necessarily produce, with the exception of the housing addressed below. A claim drawn to a product is not patentably distinct from a claim drawn to a method that necessarily produces that product.
Reference claim 1 does not recite a housing, and does not recite that the simulated vascular vessel is inside a housing. Reference claim 1 does recite that the vascular vessel mold defines an interior void of a vascular vessel for a surgical simulation system, and reference claims 22 and 23 recite that the simulated vascular vessel includes at least one terminal end, that one or more of the at least one terminal end is configured to connect with a corresponding fluid flow connector of a surgical simulation system, and that the terminal end includes an opening configured to connect with the corresponding fluid flow connector of a surgical simulation system or includes a mating fluid flow connector configured to connect with the corresponding fluid flow connector of a surgical simulation system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have disposed the simulated vascular vessel of the reference claims inside a housing of the surgical simulation system for which the reference claims recite it is intended, to have provided that housing as a modular insert to the surgical simulation device, and to have provided the housing with one or more holes connecting the passage to a fluid flow component of that device, as taught by Horst. Horst discloses a transparent housing 120 whose walls form a hollow rectangular encasement configured to contain the simulated body tissue in which the simulated blood vessel 124 is suspended, the simulated blood vessel extending through the transparent housing. See [0074] and [0086] of Horst. Horst further discloses an anatomical puncture insert 1115 that comprises the transparent housing 1120 and is removably attachable to a support base 1130 so that it can be replaced with a new insert as needed, blood vessel inlet tubing 1135 and outlet tubing 1136 connecting the simulated blood vessel 1124 within the insert to the fluid reservoir 1131 and the pulsatile pump of the support base. See [0093], [0095], and [0098] of Horst. Reference claims 22 and 23 already require the terminal end of the simulated vascular vessel to mate with a fluid flow connector of a surgical simulation system, so the housing and the holes through it are the conventional means by which that recited connection is made and by which the vessel and its fluid are supported and contained. See also the rejections of instant claims 1, 20, and 21 under 35 U.S.C. 103 above, which set forth this reasoning in full.
Instant claim 18 is not patentably distinct from reference claim 3, which recites that the simulated vascular abnormality includes an abnormality selected from the group consisting of a plaque, an embolism, a stenosis, a thrombosis, a calcification, and any combinations thereof. The Markush group of reference claim 3 and the Markush group of instant claim 18 are identical.
Instant claim 19 is not patentably distinct from reference claim 20, which recites that the simulated vascular vessel includes a vessel selected from the group consisting of an artery, a vein, a capillary, a heart chamber, an arteriole, a venule, and any combinations thereof. Each member of that group is a vascular vessel within the meaning of instant claim 19.
Instant claims 20 and 21 are not patentably distinct from the reference claims for the reasons given above with respect to the housing of instant claim 1.
Claims 2-17, 22, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 20, 22, and 23 of US 11,904,508 B2 in view of Horst, and further in view of US 2014/0186809 A1 (“Hendrickson”) and US 2012/0034587 A1 (“Toly”).
The analysis of instant claim 1 set forth above applies to instant claims 2 through 17, each of which depends from instant claim 1, and to the corresponding recitations of instant claims 22 and 23. Instant claims 22 and 23 recite a modular insert housing configured to be connected to or removably connected to a surgical simulation device, a simulated anatomical component inside the housing having one or more layers of material forming a wall around a passage configured for liquid to pass therethrough, and a simulated anatomical abnormality within the passage formed as a material of an anatomical mold used to form the simulated anatomical component that has been partially removed to form the passage. Each of these recitations corresponds to the reference claims as set forth above, and instant claim 23 further recites a surgical simulation device having fluid flow components and one or more holes in the housing, which correspond to the fluid flow connector of a surgical simulation system recited in reference claims 22 and 23 as modified by Horst.
The reference claims do not recite a simulated skin cover, do not recite simulated tissues or organs, and do not recite a simulated muscle, a simulated nerve tissue, or a simulated adipose tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the surgical simulation system of the reference claims as modified above with a simulated skin cover attached to the housing and covering the simulated anatomical component, with the skin cover being removably attached to the housing, with the skin cover being part of a structural material as one or more walls of the housing, with the skin cover including an elastomer and a fabric, and with simulated muscle, simulated nerve tissue, and simulated adipose tissue closely associated with, attached to, part of, or forming layers of that skin cover, as taught by Horst, Hendrickson, and Toly. The teachings relied upon and the reasons for the combination are set forth in full in the rejections of instant claims 2-17, 22, and 23 under 35 U.S.C. 103 above, and are incorporated here.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of US 12,128,587 B2 in view of Horst, and further in view of Hendrickson and Toly.
Claim 1 of US 12,128,587 recites a method of producing a simulated vascular vessel, comprising forming a vascular vessel mold from a soluble polymer, the vascular vessel mold defining an interior void of a vascular vessel for a surgical simulation system, applying one or more layers of elastomer around the vascular vessel mold to form the simulated vascular vessel, allowing the one or more layers of elastomer to cure to form a wall of the simulated vascular vessel, and at least partially dissolving the vascular vessel mold to create a passage for liquid in the simulated vascular vessel, wherein at least a portion of the soluble polymer remains in the passage as a simulated vascular abnormality. Reference claim 4 recites that the simulated vascular abnormality includes an abnormality selected from the group consisting of a plaque, an embolism, a stenosis, a thrombosis, a calcification, and any combinations thereof.
The correspondence between the simulated vascular vessel produced by reference claim 1 and the simulated anatomical component, wall, passage, and simulated anatomical abnormality of instant claims 1, 22, and 23, and the treatment of the product-by-process limitation, are the same as set forth with respect to US 11,904,508 above. Reference claim 4 corresponds to instant claim 18 and its Markush group is identical to that of instant claim 18.
The claims of US 12,128,587 do not recite a housing, do not recite the vessel species of instant claim 19, do not recite a connection to a fluid flow connector of a surgical simulation system, and do not recite a simulated skin cover or any simulated muscle, nerve tissue, or adipose tissue. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have supplied each of these features to the simulated vascular vessel of the reference claims, as taught by Horst, Hendrickson, and Toly, for the reasons set forth in the rejections of instant claims 1 through 23 under 35 U.S.C. 103 above and in the double patenting rejections over US 11,904,508 above.
Applicant is advised that a terminal disclaimer filed to overcome the rejections over US 11,904,508 B2 does not overcome the rejection over US 12,128,587 B2. A terminal disclaimer directed to each reference patent is required.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2008/0076101 A1 (“Hyde”) is directed to forming vascular diseases within anatomical models. See [0007] and [0008], which describe a known lost wax process in which portions of the wax or other core material are modified to form the lesions directly, the wax core thereafter being dissolved and the wire removed, leaving the model with the blemish formed within the void created. See also [0048] through [0050] and claim 3, which describe creating a void in a portion of a core of a mold by removing a portion of the wax at the appropriate locations on the wax core, placing a separately formed simulated vascular disease in the void, and filling the mold with polyvinyl alcohol so that curing bonds the simulated vascular disease within the specific anatomical structure.
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/John J DeRusso/Primary Examiner, Art Unit 1744
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