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 Objections
Claims 7, 8 and 16 are objected to because of the following informalities: In claims 7 and 8, “various pattern of openings” should be “various patterns of openings”. In claim 16, it appears that “Tolldt’s fascia” should be “Toldt’s fascia”.. Appropriate correction is required.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,131,664. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed subject matter is recited or disclosed in the claims of the ‘664 patent, as follows:
Claim 1
Claim 6 of ‘664 patent
A simulated tissue structure comprising:
A simulated tissue structure comprising:
a planar first base layer having a first side and a second side defining a substantially uniform thickness therebetween;
a planar first base layer having a first side and a second side defining a substantially uniform thickness therebetween;
a planar second base layer having a first side and a second side defining a substantially uniform thickness therebetween; the second side of the second base layer facing the first side of the first base layer; the second base layer being in contact with the first base layer;
a planar second base layer having a first side and a second side defining a substantially uniform thickness therebetween; the second side of the second base layer facing the first side of the first base layer; the second base layer being adhered to the first base layer;
and at least one functional layer comprising a functional material located at an interface between the first base layer and the second base layer;
and at least one functional layer comprising a functional material located between the first base layer and the second base layer,
the at least one functional layer imparting desired interface properties by tailoring a custom arrangement of the functional material in select regions of the interface between the first base layer and the second base layer.
wherein the functional layer is formed via a stencil having at least one hole for applying the functional material.
One of ordinary skill in the art would understand that the stencil as recited in claim 6 of the ‘664 patent is operable to tailor a custom arrangement of the functional material as recited in claim 1.
The limitations of claim 2 are recited in claim 9 of the ‘664 patent.
The limitations of claim 3 are recited in claim 7 of the ‘664 patent.
With respect to claim 4, while the claims of the ‘664 patent do not explicitly recite multiple functional layers as recited, the provision of such layers is considered to be an obvious duplication of elements having no new or unexpected results under MPEP 2144.04(VI)(B). Further, 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 “functional layer” as recited in the claims. In particular, claim 6 of the ‘664 patent as viewed in light of col. 22, lines 56-67 suggests the limitations of claim 4.
The limitations of claim 5 are suggested by claim 6 of the ‘664 patent as viewed in light of col. 18, lines 8-12 of the specification.
The limitations of claim 6 are recited in claim 6 of the ‘664 patent.
The limitations of claims 7 and 8 are suggested by claim 6 of the ‘664 patent as viewed in light of col. 14, line 66 to col. 15, line 5 of the specification.
The limitations of claim 9 are suggested by claim 6 of the ‘664 patent as viewed in light of col. 15, lines 25-34 of the specification.
The limitations of claim 10 are suggested by claim 6 of the ‘664 patent as viewed in light of col. 14, lines 49-59 of the specification.
The limitations of claim 11 are recited in claims 7 & 11 of the ‘664 patent.
The limitations of claim 12 are suggested by claim 11 of the ‘664 patent as viewed in light of col. 17, lines 45-48 of the specification.
The limitations of claim 13 are recited in claim 4 of the ‘664 patent.
The limitations of claim 14 are suggested by claim 6 of the ‘664 patent as viewed in light of col. 15, lines 41-49 of the specification. Additionally, claim 14 recites an intended purpose of the device rather than a discrete structural limitation, which under MPEP 2113 is not sufficient to impart patentability.
The limitations of claim 15 are recited in claim 5 of the ‘664 patent.
The limitations of claim 16 are suggested by claim 6 of the ‘664 patent as viewed in light of col. 23, lines 47-51 of the specification.
The limitations of claim 17 are recited in claim 7 of the ‘664 patent.
The limitations of claim 18 are suggested by claim 7 of the ‘664 patent as viewed in light of col. 17, lines 12-15 of the specification.
The limitations of claim 19 are suggested by claim 7 of the ‘664 patent as viewed in light of col. 23, lines 32-40 of the specification.
The limitations of claim 20 are suggested by claim 6 of the ‘664 patent as viewed in light of col. 14, lines 52-55 of the specification.
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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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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/KURT FERNSTROM/Primary Examiner, Art Unit 3715
July 16, 2026
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