DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s amendments dated 5/30/25 are hereby entered.
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.
Claim 35 is 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 35 is directed to an apparatus (“surgical training device”) and a method step of using that apparatus (“are achieved by forward, backward, and side-to-side tilting of the top cover relative to the base”) and is thereby indefinite. See MPEP 2173,05(p)(II).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 21, 25, 29-31, 33, 35, and 40 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by PGPUB US 20050064378 A1 by Toly (“Toly”).
In regard to Claim 21, Toly teaches a surgical training device for practicing minimally invasive surgical procedures, comprising:
a base; and
(see, e.g., F3, 32, lower portion);
a top cover having a top surface and a bottom surface; the top cover being connected to and spaced apart from the base via a height adjusting mechanism to define an internal cavity having an adjustable height;
wherein the height adjusting mechanism is configured to interconnect the top cover and the base around their peripheries to accommodate a variety of simulated patient positions in a Trendelenburg position or a reverse Trendelenburg position
(see, e.g., F3, 32, upper portion (“top cover”); e.g., F3, front and back supports that make up the housing; see, e.g., p51 regarding the unit being collapsible (“having an adjustable height”; and, e.g., see F3 in regard to it teaches the same angled device as Applicant’s PGPUB at, e.g., F21 (“a variety of patient positions…position”)).
In regard to Claim 25, Toly teaches these limitations. See, e.g., F2, 34 and 36.
In regard to Claims 29-31, Toly teaches these limitations. See, e.g., F2, 32, bottom portion, F3, 14, and p52.
In regard to Claim 33, Toly teaches these limitations. See, e.g., F3, front and back supports that make up the housing being locked in place.
In regard to Claim 35, Toly teaches these limitations. See, e.g., F3 in regard to it teaches the same angled device as Applicant’s PGPUB at, e.g., F21 (“variety of simulated patient positions”).
In regard to Claim 40, Toly teaches these limitations. See, e.g., p39.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 22-24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Toly, in view of PGPUB US 20090176196 A1 by Niblock et al (“Niblock”).
In regard to Claim 22, Niblock teaches these limitations (see, e.g., F1, 14);
Furthermore, the combination of the cited prior art would have been obvious to one of ordinary skill in the art at the time of filing because the prior art contains a device/method/etc. which differed from the claimed device by the substitution of some components/steps/elements with other components; the substituted components and their functions were known in the art; one of ordinary skill in the art could have substituted one known element for another; and the results of the substitution would have been predictable.
Specifically, it would have been obvious to have substituted the lid of Niblock for the upper portion of the housing otherwise taught by Toly, in order to provide more stable, fixed insertion points for the trainee to employ during the simulation.
In regard to Claim 23, Niblock teaches the top cover having a central opening (see, e.g., F4, 34, center-most apertures; and, e.g., F7B, 48) with apertures located around the opening. To the extent that Niblock may fail to teach the opening necessarily being larger than any of the other apertures there is no criticality disclosed in Applicant’s specification in regard to this feature and it is merely, then, a matter of design choice and does not distinguish over the cited prior art. MPEP 2144.04(VI)(C).
In regard to Claim 24, Niblock teaches these limitations (see, e.g., F7A, 50 and p67).
Claims 26-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Toly, in view of Niblock.
In regard to Claim 26, Niblock teaches these limitations (see, e.g., F1, 14);
Furthermore, the combination of the cited prior art would have been obvious to one of ordinary skill in the art at the time of filing because the prior art contains a device/method/etc. which differed from the claimed device by the substitution of some components/steps/elements with other components; the substituted components and their functions were known in the art; one of ordinary skill in the art could have substituted one known element for another; and the results of the substitution would have been predictable.
Specifically, it would have been obvious to have substituted the lid of Niblock for the cover otherwise taught by Toly, in order to provide more stable, fixed insertion points for the trainee to employ during the simulation.
In regard to Claim 27, Niblock teaches these limitations (see, e.g., F7A, 50 and p67).
In regard to Claim 28, Niblock teaches these limitations (see, e.g., F1, 14).
Claim 32 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Toly, in view of PATENT US 5403191 A to Tuason (“Tuason”), in view of official notice.
In regard to Claim 32, Tuason teaches employing pins in order to secure the simulated anatomical structures to the lower portion of the housing (see, e.g., Figures 6 and 7),
Furthermore, the combination of the cited prior art would have been obvious to one of ordinary skill in the art at the time of filing because the cited prior art includes each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the cited prior art being the lack of actual combination of the elements in a single prior art reference; one of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately; and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Specifically, it would have been obvious to have added the pins taught by Tuason to the system otherwise taught by Toly, in order to hold the simulated anatomical structure temporarily in place.
Furthermore, while Tuason may not also specifically teach employing clips attached to wires for the same purpose, however,
the Examiner takes OFFICIAL NOTICE that employing such clips was old and well-known at the time of Applicant’s invention. Such functionality allows for items to be temporarily fixed into place. As such it would have been obvious to one of ordinary skill in the art at the time of invention to implement the claimed clips within the invention of the cited prior art so as to allow the simulated anatomical structures to be temporarily clipped into place.
Claim 39 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Toly, in view of official notice.
In regard to Claim 39, Toly teaches a display monitor separate from the surgical training device (see, e.g., F2, 38)
however, the Examiner takes OFFICIAL NOTICE that attaching such a display to a simulation device with a hinge was old and well-known at the time of Applicant’s invention. Such functionality allows for the display and the device to be integrated. As such it would have been obvious to one of ordinary skill in the art at the time of invention to implement the claimed clips within the invention of the cited prior art so as to allow the display and device to be integrated so as to make it easier to set up.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-40 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,854,112. Although the claims at issue are not identical, they are not patentably distinct from each other because Claims 21-40 claims a broader version of the same subject matter claimed by claims 1-20 of the ‘112 patent.
Conclusion
The prior art made of record and not relied upon is listed in the attached PTO-Form 892 and is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Mike Grant whose telephone number is 571-270-1545. The Examiner can normally be reached on Monday through Friday between 8:00 a.m. and 5:00 p.m., except on the first Friday of each bi-week.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's Supervisory Primary Examiner, 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL C GRANT/Primary Examiner, Art Unit 3715
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