DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 19 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 19 recites the limitation "the polygonal shape" in line 2. There is insufficient antecedent basis for this limitation in the claim, as a polygonal shape is not previously recited in the claim. Rather, the claim recites a polygonal shape or a circular shape.
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 1-13, 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,657,845. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter is recited or suggested in the claims of the ‘645 patent as follows:
Claim 1
Claims of ‘845 patent
A first entry model for practicing first entry surgical procedures,
Claim 1: A simulated tissue structure, comprising:
the first entry model comprising an anatomical portion configured to connect to a support to form a substantially planar or dome-shaped configuration;
Claim 1: an artificial anatomical portion configured to simulate a region of an abdominal wall
the anatomical portion having a plurality of anatomical layers
Claim 1: the anatomical portion including: a plurality of top layers with at least one layer having an opening
and a tubular structure connected to an uppermost layer of the anatomical portion and penetrating through at least one or more anatomical layers beneath the uppermost layer of the anatomical portion;
Claim 7: The simulated tissue structure of claim 1 further including a tubular structure having a proximal end and a distal end; the tubular structure being connected to a topmost layer of the plurality of top layers at the proximal end and extending through the at least one opening of the plurality of top layers and each of the openings of the plurality of middle layers.
the anatomical portion being captured between two frame elements adapted for attaching to a laparoscopic surgical training device.
Claim 1: the anatomical portion being connected to the support between the top frame and the bottom frame such that the anatomical portion is penetrable through the top opening and bottom opening;
While the claims of the ‘845 patent do not explicitly recite that the frame is adapted for attaching to a laparoscopic surgical training device, applicant is advised that it is proper under MPEP 804(II)(B)(2)(a) to use the specification as a guide to learn the meaning of a term in the claim. Further, the scope of the claims is to be determined not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction in light of the specification as it would be interpreted by one of ordinary skill in the art. The portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application. In this case, it is proper to consider the specification when considering the meaning and scope of “frame” as recited in the claims. The claims of the ‘845 patent as viewed in light of col. 7, lines 5-8 of its specification suggest the claim limitations reciting frame elements adapted for attaching to a laparoscopic surgical training device.
The limitations of claim 2 are suggested by the claims of the ‘845 patent as viewed in light of col. 6, lines 56-58 of the specification.
The limitations of claims 3, 6 and 8 are recited in claim 1 of the ‘845 patent.
The limitations of claims 4 and 5 are recited in claim 15 of the ‘845 patent.
The limitations of claim 7 are suggested by the claims of the ‘845 patent as viewed in light of col. 6, lines 58-63 of the specification.
The limitations of claims 9 and 10 are suggested by the claims of the ‘845 patent as viewed in light of col. 13, line 56 to col. 14, line 4 of the specification.
The limitations of claims 11-13 are suggested by the claims of the ‘845 patent as viewed in light of col. 14, lines 17-44 of the specification.
The limitations of claim 19 are suggested by the claims of the ‘845 patent as viewed in light of col. 6, line 67 to col. 7, line 3 of the specification.
With respect to claim 20, the device recited in claim 1 of the ‘645 patent is capable of being held in the hand of a user. The claim language “for sales demonstration purposes” is functional language, describing an intended use or purpose of the device. Under MPEP 2114, such claim language will not overcome the prior art.
Claims 16-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,657,845. in view of claims 1-20 of U.S. Patent No. 11,854,425. The claims of the ‘845 patent disclose or suggest the limitations of claim 16 with the exception of the base and top cover connected to and spaced apart from the base and having an opening as recited. These features are recited in claim 1 of the ‘425 patent. The combined teachings of the references suggest the claimed invention. With respect to claims 17 and 18, the recited limitations are disclosed by the combined teachings of the ‘845 and ‘429 patents as viewed in light of col. 7, lines 38-56 of the ‘429 patent.
Allowable Subject Matter
Claims 14 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KURT FERNSTROM whose telephone number is (571)272-4422. The examiner can normally be reached M-F 10-6.
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/KURT FERNSTROM/Primary Examiner, Art Unit 3715
November 26, 2025