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 .
Application Data Sheet
The Application Data Sheets of May 1, 2024, and June 20, 2025, are inconsistent with Applicant’s specification regarding parent application 17/654,872 being a (straight) continuation rather than a continuation-in-part (as incorrectly stated in the ADS of May 1, 2024) of grandparent application 16/291,624.
Specification
The disclosure is objected to because of the following informalities: The status of parent applications 17/654,872 and 17/654,879 needs to be updated with regard to the corresponding patent numbers. 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 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14 and 21 of U.S. Patent No. 11,311,384 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim 21 sets forth “a sonolucent custom craniofacial implant for cranial, craniofacial, and/or facial defects requiring large-size cranioplasty of >25 square centimeters” (column 24, lines 40-43), with an outer flat surface and an inner curved surface enhancing “ultrasound images obtained through the craniofacial implant” (column 24, lines 54-57). Patent claim 14 adds “a neurological device incorporated within the craniofacial implant” (column 24, lines 7-8).
Claims 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,004,954 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant features are plainly evident from the claims of the patent.
Claims 21-22 and 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 8, 10, 12, 14, 16, and 18-20 of U.S. Patent No. 12,213,884 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed “cranial or craniofacial implant” (column 20, line 12) being sonolucent and permitting a surgeon to ultrasonically image brain anatomy through the implant would have been obvious from the “functional component providing for ultrasound functionalities” (column 20, lines 27-28), being “encased within a void-space defined by [an implant cavity]” (column 20, lines 29-34), and performing imaging and duplex ultrasound (patent claims 19-20) in order to provide ultrasonic diagnostic tools. The implant matching a required cranioplasty of greater than 25 cm2 would have been obvious in order to accommodate a diversity of patients and indications. Regarding claim 22, a neurological device incorporated within the implant would have been obvious from patent claim 18 in order to monitor a physiological condition of the brain. Regarding claims 24-25, customized inside and outside curved surfaces would have been obvious in order to better fit a particular patient’s skull curvature (column 20, lines 16 and 36).
Claim Rejections - 35 USC § 102
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.
Claims 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manwaring et al., US 9,044,195 B2. Figures 8A-8B illustrate a sonolucent craniofacial implant for cranial defects [abstract; column 2, lines 1-6; column 3, line 34 (“craniotomy defect”); column 4, lines 8-10], the implant permitting a surgeon to ultrasonically image brain anatomy through the craniofacial implant (column 2, lines 12-14; column 4, lines 33-38 and 53-56; column 5, lines 28-37 and 45-51). Manwaring et al. specify “length and width dimensions of approximately 2 to 3 cm” but are open to other dimensions corresponding “to the size of the opening that has been formed through the cranium” (column 2, lines 33-39). Moreover, cranial “defects requiring cranioplasty of >25 square centimeters” (Applicant’s claim 21 at lines 2-3) do not necessitate the implant itself to be greater than 25 cm2, since a Manwaring et al. implant of 2 or 3 cm in length and width is structurally capable of being implanted into an elongate defect in conjunction with other such implants and/or a ubiquitous bone plate for covering the remainder of the defect (via adhesive and/or press fitting and/or friction and/or fusing: column 3, lines 18-35), even though such was not the intent (MPEP § 2114).
Regarding claim 22, metal mesh 152 is viewed as a neurological device [column 2, lines 1-3 (“prevents deformation of the brain due to pressure changes”); column 4, lines 4-6 (“metal mesh that provides strength to and facilitates shaping of the sonic window”)]. Regarding claims 23-24, the implant includes outer flat surfaces along body 154 of sonolucent material and inside curved surfaces defined by circular elements 156 (Figures 8A-8B; column 5, lines 4-17). Regarding claim 25, the implant may be customized for a particular patient (column 2, lines 24-32; column 5, lines 26-27).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Melanie Tyson can be reached at telephone number 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774
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