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 § 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 Singhal (2005/0245984A1).
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 during performance of a cranioplasty (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 mesh together to ultimately define a single product (see figure 4, the components 2-3 and implant 4 are put together to form a single product) 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.
Singal teaches an interdigitating relationship between two portions of a cranial implant [0082: restraining mechanisms known in the arts including snap rings].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the snap ring connection of Singal between the cavity and neurosurgical implant of Sauter-Starace through functional equivalents since both connections attach portions of a cranial implant together. 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 2144.06II
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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).
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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 Singhal (2005/0245984A1) 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 Singhal (2005/0245984A1) 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 Singhal (2005/0245984A1) 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 of Sauter-Starace in view of Hirata 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 Singhal (2005/0245984A1) 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 Singhal (2005/0245984A1) 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 Singhal (2005/0245984A1) 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 Singhal (2005/0245984A1) 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 Singhal (2005/0245984A1) 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 112b rejection of claim 58, the amendment overcomes the rejection.
In regard to the 101 rejection of claim 63, the amendment overcomes the rejection.
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. The applicant states that the examiner has interpreted interdigitating to mean interlocking and states that while some interlocking relationships are interdigitating not all of them are. However, the applicant has not pointed out what definition they wish to be used for interdigitating. The instant specification states that “interdigitating is meant to refer to the interlocking of two distinct elements” (page 12, paragraph 1 of the instant disclosure) and accordingly, this definition has been used in examination. The applicant is reminded this case is inherited and conversations with the former examiner are unknown unless they are disclosed in the written record.
The applicant states that Sauter-Starace does not disclose an interdigitating relationship because the snap rings are intended for use when the component differs in shape from the non-elastomeric components. The disclosure of Singhal does not state the components must differ in shape to use a snap ring. As shown in figure 5A, the components appear to be similar in shape to one another before combined.
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 (WO201206337A1), no further arguments have been presented.
In regard to the 103(a) rejection of claims 64 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) and further in view of Hirata (WO201206337A1) and further in view of Brogan (9993337B1) no further arguments have been presented.
In regard to the 103(a) rejection of claims 65 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) further in view of Brogan (9993337B1) no further arguments have been presented.
In regard to the 103(a) rejection of claims 66 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) further in view of Prada (2016/0193048A1) no further arguments have been presented.
In regard to the 103(a) rejection of claim 67 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) further in view of Morgan (5814048) no further arguments have been presented.
In regard to the 103(a) rejection of claim 68 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) further in view of McClure (2011/0196450A1) no further arguments have been presented.
In regard to the 103(a) rejection of claims 69-72 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) further in view of Antoine (EP0834295A1) no further arguments have been presented.
In regard to the 103(a) rejection of claim 73 as unpatentable over Sauter-Starace (2013/0204317A1) in view of Singhal (2005/0245984A1) further in view of Auxepaules (2005/0060040A1) no further arguments have been presented.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774