DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 § 102
2. 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.
3. Claims 1-6, 8, 9, 11, 12 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakezles et al. (US 2022/0392375 A1).
Regarding claims 1-6, 8, 9, 11, 12 and 14-20, Sakezles discloses a surgical training device (Par. 87) comprising:
a body shaped to correspond to an animal (see Fig. 1); and
an insert (e.g. module) configured to be removably inserted into an opening in the body (Par. 88), wherein: the insert is configured to be covered by a cover (e.g. abdomen cover 91) configured to be removably attached to the insert (Par. 122), and
an entirety or majority of the body, the insert, and the cover comprises materials sourced from sources other than the animal (artificial material such as hydrogel – Par. 88) (as per claim 1),
no portion of the body, the cover, and the insert comprises materials sourced from the animal (Par. 06) (as per claim 2),
a bodily structure within the insert, and an entirety or majority of the bodily structure comprises materials sourced from sources other than the animal (see e.g. Par. 133 – diaphragm component 151 that includes a replaceable diaphragm hernia section 152 including a slit and other components) (as per claim 3),
the bodily structure is an anatomically accurate reproduction of an organ of the animal, and no portion of the bodily structure comprises materials sourced from the animal (Par. 06) (as per claim 4),
the bodily structure comprises an anatomically accurate reproduction of one or more of a liver, a pancreas, skin, an ovary, a heart, a testicle, a thymus, muscles, a trachea, or a bone of the animal (Par. 102) (as per claim 5),
the animal is a mammal (dog) (as per claim 6),
the animal comprises one of a rat, a mouse, a guinea pig, a hamster, a rabbit, a cat, a dog, a bobcat, a javelina, a possum, a raccoon (dog) (as per claim 8),
the opening is defined in a belly of the body (Fig. 11 – Par. 122) (as per claim 9),
the insert is a first insert and the surgical training device further comprises a second insert (see Par. 108 – e.g. independently replaceable muscles) (as per claim 11),
the first insert and the second insert are configured to be interchangeably inserted into the opening in the body (Par. 108) (as per claim 12),
the cover comprises a first layer and a second layer (Par. 110) (as per claim 14),
the first layer is an inner layer configured to correspond to internal tissue of the animal and the second layer is an outer layer configured to correspond to skin of the animal (Par. 110) (as per claim 15),
the insert comprises an inner frame (e.g. bone), an outer frame (e.g. tissues), and intermediate frame (e.g. muscle), the inner frame is configured to nest within the intermediate frame and to hold the inner layer in a friction fit between the inner frame and the intermediate frame to tension the inner layer across an opening of the inner frame, and the intermediate frame is configured to nest within the outer frame and to hold the outer layer in a friction fit between the intermediate frame and the outer frame to tension the outer layer across an opening of the intermediate frame (see Par. 59) (as per claim 16),
a training method using a surgical training device, the training method comprising: covering a first frame with a first layer; forming an insert of the surgical training device by nesting the first frame within a second frame to hold the first layer in a friction fit between the first frame and the second frame to tension the first layer across an opening of the first frame; inserting the insert into an opening of a body of the surgical training device (Par. 59), wherein the body is shaped to correspond to an animal (see Fig. 1), wherein an entirety or majority of the body and the insert comprise materials sourced from sources other than the animal (Par. 06); and performing a surgical training procedure on the first layer (e.g. airway access procedure, gastropexy procedure, etc. – Par. 121-122) (as per claim 17),
trimming, before inserting the insert into the opening, the first layer (forming collared portion and flanged portion – Par. 106) (as per claim 18),
forming the insert comprises: covering, after nesting the first frame within the second frame, the second frame with a second layer; and nesting the second frame within a third frame to hold the second layer in a friction fit between the second frame and the third frame to tension the second layer across an opening of the second frame (Par. 59) (as per claim 19), and
trimming, before inserting the insert into the opening, the first layer and the second layer (Par. 106) (as per claim 20).
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. Claims 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sakezles et al. (US 2022/0392375 A1) in view of Rios et al. (US 2014/0120505 A1).
Regarding claims 7 and 10, to the extent that Sakezles does not explicitly disclose the animal is a rodent (as per claim 7), and the opening is defined in a back of the body (as per claim 10), Rios discloses a surgical training system with an embodiment corresponding to a rat (see Fig. 28), and simulating any human or animal part including the back (Par. 9, 61). It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the teachings of Sakezles by utilizing a rat embodiment, and defining the opening in a back of the body, as suggested by Rios, to obtain predictable results of training the user on a wider array of animals and body parts.
7. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sakezles et al. (US 2022/0392375 A1) in view of King (US Patent No. 9,342,996 B1).
Regarding claim 13, to the extent that Sakezles does not explicitly disclose the opening in the body is a first opening and the body further comprises a second opening, and the second insert is configured to be removably inserted into the second opening in the body, King clearly discloses providing multiple openings for multiple separate inserts in a similar system (see Fig. 6A). It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the teachings of Sakezles by providing multiple openings as taught by King. Such a modification would be an obvious duplication of parts to provide predictable results of enhancing the realism of the training device.
Conclusion
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER EGLOFF whose telephone number is (571)270-3548. The examiner can normally be reached on Monday - Friday 9:00 am - 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai can be reached at (571) 272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Peter R Egloff/
Primary Examiner, Art Unit 3715