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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 6, and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "therein" in line 2. It is vague which renders the claim indefinite because it is unclear what the limitation refers to.
Claim 6 recites the limitation "the plurality of fluid conduits" in lines 1-2. It is ambiguous which renders the claim indefinite because it is unclear whether the limitation refers to “a plurality of first fluid conduits” in claim 1 or “a plurality of second fluid conduits” in claim 1.
Claim 14 recites the limitation “extend diagonally.” It is unclear extend diagonally from which reference point(s). A careful review of the specification, inter alia ¶¶31, 32 and FIG. 5, reveals that FIG. 5 provides any clue for the meaning of diagonal extension but FIG. does not provide any reference point defining the diagonal extension.
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.
Claim(s) 1-17 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lowe (U.S. Patent Application Publication 2014/0011172).
Regarding claims 1 and 20, Lowe discloses an emergency C-Section task trainer (Abstract; ¶47) comprising:
a rigid frame (patient simulator 110);
a simulated torso having an abdomen area mounted within the frame (torso 142 in FIG. 2; ¶38);
a simulated uterus in the torso below the abdomen area (uterus 210);
a simulated fetus in the uterus (¶47: “the multi-layer abdominal wall insert further includes a uterus with a fetus disposed therein that can be surgically removed by a user”);
a plurality of first fluid conduits extending across the abdomen area (ovarian vessels 223 (arteries and veins) in FIG. 5); and
a plurality of second fluid conduits extending across the uterus (uterine vessels 220 (arteries and veins) in FIG. 5, 6).
Regarding claim 2, Lowe further discloses that the frame has a cavity formed therein (See FIG. 2).
Regarding claim 3, Lowe further discloses that the torso is inserted into the cavity (FIG. 2 shows the torso is fitted into the patient simulator 110).
Regarding claim 4, Lowe further discloses that the abdomen area is constructed from a plurality of differing layers (FIG. 3d; ¶43: “the abdominal wall insert 120 includes a simulated skin layer 170”; ¶45: “As shown in FIG. 3d, the abdominal wall insert 120 includes a subcutaneous layer 176, a fascial layer 177, a muscle layer 178, and a peritoneal layer 179.”).
Regarding claim 5, Lowe further discloses that the plurality of differing layers represent a layer of skin (¶43: “a simulated skin layer 170”), an underlayer of fat (¶45: “a fascial layer 177”), and a further under layer of muscle (¶45: “a muscle layer 178”).
Regarding claim 6, Lowe further discloses that the plurality of fluid conduits extend through the further under layer (see FIG. 4, 5; uterine assembly 200 having uterine vessels 220 and ovarian vessels 223 lies under the abdominal wall insert 120).
Regarding claim 7, Lowe further discloses that the plurality of first fluid conduits extend laterally across the abdomen area (FIG. 5 illustrates the ovarian vessels 223 across the abdomen area).
Regarding claim 8, Lowe further discloses that each of the plurality of first fluid conduits has a first end connected to a first manifold and a second end also connected to the first manifold (see FIG. 155; ¶536: “ovarian artery and vein connections”).
Regarding claim 9, Lowe further discloses a first fluid supply in fluid communication with the first manifold (FIG. 156 illustrates all the artery and veins are connected with the manifold).
Regarding claim 10, Lowe further discloses a first pump in fluid communication with the first fluid supply (FIG. 156 shows the conduits are controlled by air pump; see also ¶¶155, 156).
Regarding claim 11, Lowe further discloses that each of the plurality of second fluid conduits has a first end connected to a second manifold and a second end also connected to the second manifold (¶536: “uterine artery and vein connections”).
Regarding claim 12, Lowe further discloses that a second fluid supply in fluid communication with the second manifold (FIG. 156 illustrates all the artery and veins are connected with the manifold).
Regarding claim 13, Lowe further discloses a second pump in fluid communication with the second fluid supply (FIG. 156 shows the conduits are controlled by air pump; see also ¶¶155, 156).
Regarding claim 14, Lowe further discloses that the plurality of second fluid conduits extend diagonally across the uterus (it is noted that the term “diagonally” is indefinite; see FIG. 5).
Regarding claim 15, Lowe further discloses that the abdomen area is releasably connected to the torso (see FOG. 2).
Regarding claim 16, Lowe further discloses that the torso is constructed from a rigid polymer (¶130: “each organ is molded with a specific pigmentation and silicone blend to maintain fidelity”).
Regarding claim 17, Lowe further discloses a basin located at least partially in the frame (FIG. 2 shows a space for receiving the abdominal wall insert 120).
Regarding claim 19, Lowe further discloses comprising a fluid filled bag located below the fetus (FIG. 6 shows bladder 214 is located under the uterus).
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.
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.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lowe in view of Lowe et al (U.S. Patent Application Publication 2014/0212863), hereinafter Lowe2.
Regarding claim 18, Lowe does not explicitly disclose a simulated umbilical sac, wherein the simulated fetus is inside the simulated umbilical sac.
Lowe2 teaches a simulated pregnant abdominal system and associated devices (Abstract) comprising a simulated umbilical sac, wherein the simulated fetus is inside the simulated umbilical sac (FIG. 15; ¶86: “FIG. 15 shows a perspective view of the fully assembled amniotic sac 108 with the fetus 110 therein.”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention was made to modify the invention in Lowe by adding the simulated pregnant abdominal features as taught in Lowe2 in order to provide “realistic and/or includes additional simulated features” (¶4 of Lowe2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lounsbury (U.S. Patent 5104328) teaching C section training model.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J HONG whose telephone number is (571)272-0993. The examiner can normally be reached 9AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Vasat can be reached at (571) 270-7625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THOMAS J. HONG
Primary Examiner
Art Unit 3715
/THOMAS J HONG/Primary Examiner, Art Unit 3715