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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 3/20/2026 has been entered.
Claim Rejections - 35 USC § 103
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.
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.
Claims 58 and 74-76 are rejected under 35 U.S.C. 103 as being unpatentable over Sauter-Starace (2013/0204317A1) in view of Ngheim (2010/0100157A1).
Regarding claim 58, Sauter-Starace discloses a cranial device (Figs. 1-7), comprising:
a cranial implant (2, 3) shaped and dimensioned for placement within an intercranial space as defined by a resected portion of a patient's anatomy (Fig. 10 depicts the implant is held in cavity CA; [0089]);
and a cavity formed in the cranial implant (See Fig. 5 below; [0095]), the cavity being shaped and dimensioned to receive and interdigitate with a functional neurosurgical implant (Fig. 1 depicts the cavity receives a functional neurosurgical implant 4.
The cavity held to the functional neurosurgical implant 4 by apertures 11 (Fig. 5) to interconnect the cranial implant and the functional neurosurgical implant during performance of a cranioplasty (Fig. 10 depicts the two pieces are connected. During performance of a cranioplasty is a statement of intended use. The two pieces are capable of being connected sometime during or before the procedure.)
Such that the cranial implant (2-3) and the functional neurosurgical implant 4 mesh together providing brain protection (implanted in figure 10, is therefore capable to provide protection to the brain by providing material between the cranium and the brain [0088, fig 10]).
Wherein the relationship between the cranial implant 2,3 and the functional neurosurgical implant 4 is optimized during a manufacturing process by superimposing a digitally rendered functional neurosurgical implant on a digitally rendered base static cranial implant and ultimately shaping the cavity to allow the connecting relationship with functional neurosurgical implant. This is a product-by-process limitation, patentable only based on the resulting structure, which appears to be the cranial implant and neurosurgical implant having an interdigitating (interlocking shape), as shown in figures 1-2. If the applicant is trying to claim a different end structure, the claim should be amended to include those limitations.
However, Sauter-Starace remains silent to the interdigitating relationship (interpreted as interlocking) connecting the cavity and neurosurgical implant in a key in lock type arrangement (interpreted as a closely conforming or high tolerance fit).
Ngheim teaches an interdigitating relationship between two portions of an implantable device (720, 721) in a key in lock type fit (defined in the instant disclosure as a closely conforming or high tolerance fit) [0079: interference fit] that optimizes a spatial arrangement between the cranial implant and the functional neurosurgical implant in a manner providing protection to the body (the case as a whole will provide protection to the body by acting as a barrier).
It would have been obvious to one of ordinary skill in the art of medical implants at the time the invention was filed to use the interference fit of Ngheim between the neurosurgical implant and cavity of Sauter-Starace through functional equivalence as this is an alternative connection and it appears either connection would work equally well MPEP 2144.06II.
PNG
media_image1.png
313
455
media_image1.png
Greyscale
Regarding claim 74, Sauter-Starace discloses the cranial device according to claim 58, and further discloses the cranial implant includes a two-piece construction (Fig. 1 depicts the implant is made of two pieces 2 and 3).
Regarding claim 75, Sauter-Starace discloses the cranial device according to claim 74, and further discloses the cranial implant includes a base cranial implant member (3) and a cover cranial implant member (2), and the base cranial implant member 3 includes a recess formed along an outer surface so as to define the cavity (See Fig. 5 below).
PNG
media_image2.png
313
471
media_image2.png
Greyscale
Regarding claim 76, Sauter-Starace discloses the cranial device according to claim 58, and further discloses the cranial implant 2,3 is a customized cranial implant [0054] – device is manufactured from measurements made on the cranium).
The claim phrase “the cavity is formed within the cranial implant by augmenting, reducing, and/or modifying the cranial implant to include the cavity for optimal anatomical placement of the functional neurosurgical implant” is being treated as a product by process limitation; that is the cavity is formed by augmenting, reducing, and/or modifying the cranial implant. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even through the product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Thus, even though Sauter-Starace is silent as to the process used to make the cavity, it appears that the cavity would be the same as that claimed; especially since both applicant’s cavity and the prior art cavity are shaped and dimensioned to receive and interdigitate with a functional neurosurgical implant.
Claims 59-63 are rejected under 35 U.S.C. 103 as being unpatentable over Sauter-Starace (2013/0204317A1) in view of Ngheim (2010/0100157A1) and in further view of Hirata (WO2012/063377 A1).
Regarding claim 59, Sauter-Starace teaches the cranial device according to claim 58, wherein the cranial implant is a customized implant ([0054] – device is manufactured from measurements made on the cranium) that includes an outer convex surface (2a ; [0089]) and a peripheral edge (3b) shaped and dimensioned for engagement with a skull of a patient upon implantation (Fig. 10 depicts the side of the device 1 contact the cranium C. One of ordinary skill in the art would understand that in order for the peripheral edges to contact the skull, the peripheral edges would be shaped and dimensioned for the cavity),
However, Sauter-Starace does not disclose an inner concave surface.
Hirata teaches a cranial implant and teaches an inner concave surface (Fig. 14 – inner surface 603).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bottom surface of the implant of Sauter-Starace to be concave as taught by Hirata for the purpose of matching the inner shape of the resected skull (Hirata: Lines 295-296).
Regarding claim 60, Sauter-Starace discloses the cranial device according to claim 59, and further teaches the outer convex surface and the inner concave surface of the customized cranial implant are curved in a superior to inferior direction, a posterior to anterior direction, and a medial to lateral direction (Figs. 1 and 3 of Sauter-Starace depicts the outer convex surface 2 having a rounded shape in all directions. Therefore, the outer convex surface would be curved in the superior to interior direction, posterior to anterior direction, and medial to lateral direction.)
However, Sauter-Starace does not teach the inner concave surface.
Hirata further teaches wherein the inner surface would be curved in the superior to inferior, the posterior to anterior direction, and the medial to lateral direction (Hirata: Lines 625-626 – the body of the artificial bone 28 is curved in a spherical shell shape meaning it is curved in a superior to inferior direction, a posterior to anterior direction, and a medial to lateral direction).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bottom surface of the implant of Sauter-Starace to be concave as taught by Hirata for the purpose of matching the inner shape of the resected skull (Hirata: Lines 295-296).
Regarding claim 61, Sauter-Starace meets the claim limitations as discussed in the rejection of claim 60. Sauter-Starace further discloses the functional neurosurgical implant (4).
Regarding claim 62, Sauter-Starace in view of Hirata discloses the cranial device according to claim 61. Sauter-Starace further discloses wherein the cranial implant includes structural elements (11) shaped and designed to accommodate the functional neurosurgical implant 4 (Figs. 1, 2, 5, 6).
Regarding claim 63, Sauter-Starace meets the claim limitations as discussed in the rejection of claim 61. Sauter-Starace further teaches wherein the cranial implant is dimensioned to fill the resected portion of the skull (Fig. 10 depicts the implant 1 fills the cavity CA).
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Sauter-Starace (2013/0204317A1) in view of Ngheim (2010/0100157A1) and further in view of Hirata (WO2012/063377 A1) and in further view of Brogan (9,993,337 B1).
Regarding claim 65, Sauter-Starace meets the claim limitations as discussed in the rejection of claim 63, but does not teach wherein the cranial implant is clear and fully lucent.
Brogan teaches a method of making a cranial implant and teaches wherein the cranial implant is clear and fully lucent (Column 2 lines 36-42 – device can be made of PMMA which results in a clear or transparent material. The pieces would be lucent as clear PMMA is fully lucent according to the instant specification Page 17).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the implant of Sauter-Starace to be made of a material which is clear and fully lucent as taught by Brogan for optimal viewing of the surgical field (Column 2 lines 42-52).
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Sauter-Starace in view of Ngheim (2010/0100157A1) and in further view of Brogan (9,993,337 B1).
Regarding claims 65, Sauter-Starace meets the claim limitations as discussed in the rejection of claim 58, but does not teach wherein the cranial implant is clear and fully lucent.
Brogan teaches wherein the cranial implant is clear and fully lucent (Column 2 lines 36-42 – device can be made of PMMA which results in a clear or transparent material. The pieces would be lucent as clear PMMA is fully lucent according to the instant specification Page 17).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the implant and case of Sauter-Starace in view of Hirata, including both the case and portions of the circuit board, to be made of a material which is clear and fully lucent as taught by Brogan for allowing optimal viewing of the surgical field (Column 2 lines 42-52).
Claim 66 is rejected under 35 U.S.C. 103 as being unpatentable over Sauter-Starace (2013/0204317A1) in view of Ngheim (2010/0100157A1) and in further view of Prada (2016/0193048 A1).
Regarding claim 66, Sauter-Starace discloses the cranial device according to claim 58, but does not disclose wherein the cranial implant allows for ultrasound transmission through the cranial implant.
Prada discloses a cranial implant and teaches wherein the cranial implant allows for ultrasound transmission through the cranial implant (Paragraph 0020 – implant is made of a material which is compatible with ultrasound).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the cranial implant of Sauter-Starace to allow for ultrasound transmission as taught by Prada for the purpose of making it possible to view of the brain during follow-up checkups of the patient (Prada: Paragraph 0030).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Sauter-Starace (2013/0204317A1) in view of Ngheim (2010/0100157A1) and in further view of Morgan (5,814,048).
Regarding claim 67, Sauter-Starace discloses the cranial device according to claim 58, but does not disclose wherein the cranial implant is radiolucent.
Morgan discloses a cranioplasty plate and teaches wherein the cranial implant is radiolucent (Column 3 lines 49-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the cranial implant of Sauter-Starace to be radiolucent as taught by Morgan in order to ensure no imaging artifacts are created during X-ray, CT, and MRI examination (Morgan: Column 3 lines 49-53).
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Sauter-Starace (2013/0204317A1) in view of Ngheim (2010/0100157A1) and in further view of McClure (2011/0196450 A1).
Regarding claim 68, Sauter-Starace discloses the cranial device according to claim 58, but does not disclose wherein the cranial implant includes an embedded serial number viewable via CT or MRI scan.
McClure teaches a device used to deliver electrical stimulation to the brain and teaches wherein the cranial implant includes an embedded serial number viewable via CT or MRI scan (Paragraph 0056 – the device is checked to see if it has a serial number which is MRI labeled. One of ordinary skill in the art would understand that the serial number would be embedded in the implant in order to be MRI labeled).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cranial implant of Sauter-Starace to include an embedded serial number as taught McClure for the purpose of determining if the implant is suitable for operation in a disruptive energy field (McClure: [0056]).
Claims 69-72 are rejected under 35 U.S.C. 103 as being unpatentable over Sauter-Starace (2013/0204317A1) in view of Ngheim (2010/0100157A1) and in further view of Antoine (EP 0834295 A1).
Regarding claim 69, Sauter-Starace meets the claim limitations as discussed in the rejection of claim 58, but does not teach wherein the cranial implant includes alignment markings.
Antoine teaches an implant and teaches wherein the implant includes alignment markings (Fig. 1 – marking 33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cranial implant of Sauter-Starace to include alignment markings as taught by Antoine for the purpose of identifying portions of the implant (Antoine: Lines 283-284).
Regarding claim 70, Sauter-Starace teaches the cranial device according to claim 69, but does not teach the alignment markings as claimed.
Antoine further teaches the alignment markings are in a shape of a cross (the modification of the surface of the implant of Sauter-Starace with the markings of Antoine would teach the markings having a cross shape (Antoine: Fig. 1)).
Regarding claim 71, Sauter-Starace meets the claim limitations as discussed in the rejection of claim 69 but does not teach alignment markings as claimed.
Antoine teaches alignment markings 33 as discussed in the rejection of claim 69.
Although the combination of Sauter-Starace and Antoine does not explicitly disclose the alignment markings identify a superior to inferior direction and a posterior to anterior direction, one of ordinary skill in the art would understand that because the indicia are used to help identify portions of the implant, they can be arranged in many ways as desired and this constitutes no more than design choice or a rearrangement of parts. In this case, when the indicia are placed on the cranial implant of Sauter-Starace, they can be arranged to identify a superior to inferior direction and a posterior to anterior direction when properly implanted. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04I; VIC
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cranial implant of Sauter-Starace in view of Antoine to indicate a superior to inferior direction and a posterior to anterior direction in order to make sure the implant is placed correctly for a specific user.
Regarding claim 72, Sauter-Starace teaches the cranial device according to claim 58, but does not teach wherein the cranial implant includes laser cut lines identifying potential cuts for the cranial device.
Antoine teaches wherein the prosthesis includes laser cut lines identifying potential cuts for the prosthesis (Fig. 1 – laser markings 33).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cranial implant of Sauter-Starace to include laser cut lines to identify potential cuts for the cranial device as taught by Antoine for the purpose of identifying specific areas on the implant.
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Sauter-Starace (2013/0204317A1) in view of Ngheim (2010/0100157A1) and in further view of Auxepaules (2005/0060040A1).
Regarding claim 73, Sauter-Starace discloses the cranial device according to claim 58, but does not disclose wherein the cranial implant includes laser markings to provide an indication of critical anatomy relating to installation of the cranial device.
Auxepaules discloses an implant configured to be installed on a bone and teaches wherein the implant includes laser markings to provide an indication of critical anatomy relating to installation of the device ([0046] – marks 33 can be created by a laser in order to assist in aligning the cup in the acetabulum meaning it indicates critical anatomy for installation of the implant).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cranial implant of Sauter-Starace to include laser markings to indicate critical anatomy as taught by Auxepaules for the purpose of correctly aligning the device (Auxepaules: [0046]).
Response to Arguments
In regard to the 103(a) rejection of claims 58 and 74-76 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1), the applicant’s arguments have been fully considered but are directed towards new claim limitations which have been addressed above.
In regard to the 103(a) rejection of claims 59-63 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) and further in view of Hirata (WO2012/063377A1), no further arguments have been presented.
In regard to the 103(a) rejection of claim 64 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) and further in view of Hirata (WO2012/063377A1) and further in view of Brogan (9993337B1), the applicant’s arguments have been fully considered. The applicant argues that there is no motivation for the combination because the circuit board of Sauter-Strauss impedes the view. The examiner respectfully disagrees as a clear outer shell still improves visibility compared to an opaque outer shell around the edges and at certain angles.
In regard to the 103(a) rejection of claim 65 as unpatentable over Singhal (2005/0245984A1) in view of Brogan, no further arguments have been submitted.
In regard to the 103(a) rejection of claim 66 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) and further in view of Prada (2016/0193048A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claim 67 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) and further in view of Morgan (5814048) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 68 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) and further in view of McClure (2011/0196450A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claims 69-72 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) and further in view of Antoine (WP0834295A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 73 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) and further in view of Auxepaules (2005/0060040A1) no further arguments have been submitted.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
Prosecution Insights