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 .
Detailed Action
This is in response to the amendment filed 08/19/2024.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/20/2025 has been entered.
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.
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.
Claim(s) 10-14, 16-19, 21-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,961,519 (Bruce et al.) in view of U.S. Patent Number 6,348,052 (Sammarco)
Regarding claims 10-12, 16, 21-23 Bruce et al. discloses as shown in Figures 1, 3 a burr hole cover (burr hole cover 80, see col. 3, lines 44-52) capable of affixation within a recessed region formed in a skull bone to thereby cover a burr hole formed in the skull bone, the burr hole cover comprising: a contact surface (bottom surface of cover generally indicated as A) capable of contacting the skull bone; a top surface (top surface of cover generally indicated as B) opposite the contact surface wherein the top surface is curved; and one or more apertures (one or more of screw-receiving openings 74 see col. 4, lines 10-16) extending from the top surface to the contact surface, each of the one or more apertures configured to receive a surgical fixation device such that when the surgical fixation device is fully inserted into a respective aperture, to thereby affix the burr hole cover to the skull bone, the surgical fixation device is at or below the top surface, wherein when the burr hole cover is affixed within the recessed region, the top surface is capable of being substantially flush with a surface of the skull bone, wherein each of the one or more apertures includes a sidewall that is inwardly beveled (described as tapered, see col. 4, lines 10-16), wherein the burr hole cover has a non-uniform thickness, the thickness being measured from the top surface to the contact surface, wherein the at least one perforation includes a uniform side wall, a plurality of perforations (vent slots 76 and hole 64, see col. 4, lines 10-16) separate from the apertures, the first perforation is sized differently from the second, wherein the plurality of perforations are uniformly dispersed around the center of the burr hole cover.
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To be clear, the Office is interpreting the top surface as curved or convexly curved in a direction opposite the skull bone because Figure 4 shows the top surface is bent around the curved surface of the skull which would necessarily require the top surface be curved. This interpretation is further supported by col. 3, lines 24-35 which state that the surgeon can shape the cover to match the contours of the cranium.
Alternatively, 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 burr hole cover disclosed by Bruce so that it was curved or convexly curved in a direction opposite the skull bone as a matter of engineering design choice. Applicant has not disclosed that the shape of the top surface provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0020] of the specification. One of ordinary skill in the art, furthermore, would have expected Bruce et al.’s top surface, and applicant’s invention, to perform equally well with either shape because both spacing dimensions would perform the same function of conforming to the skull equally well considering the relative dimensions disclosed.
Bruce et al. fails to disclose each of the perforations sized the same as the others. It would have been an obvious to one of ordinary skill in the art, before the effective filing date of the claims invention to modify each of the perforations sized the same as the others as a matter of design choice. Applicant has not disclosed that each of the perforations sized the same provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0022]. One of ordinary skill in the art, furthermore, would have expected Bruce’s perforations, and applicant’s invention, to perform equally well with either the sizing taught by Bruce or the claimed same sizing because both sizing and dimensions would perform the same function of providing an opening well considering the relative dimensions disclosed.
Sammarco, from the same field of endeavor teaches a similar burr hole cover as shown in Figure 3, where each of the perforations (holes 13, 15, see col. 3, lines 1-15) sized the same as the others.
Alternatively, it would have been obvious to one ordinary skill in the art, before the effective filing date of the claimed invention to modify the burr hole cover disclosed by Bruce et al. substituting the size of each perforation such that they were the same size as taught by Sammarco because it would only require the simple substitution of one known alternative configuration for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Regarding claims 13, 14, since Bruce et al. discloses each of the arms of the cover 80 can be contoured to skull, and each arm includes the contact and top surface; see col. 3, lines 52-56; it follows that Bruce discloses the wherein the contact surface has a contour that matches a contour of the skull bone, wherein the top surface has a contour that matches a contour of the skull bone.
Regarding claims 17-19, Bruce et al. discloses wherein the burr hole cover includes one or more perforations (vent slots 98-103, see col. 3, lines 52-56) separate from the one or more apertures, wherein at least one perforation is sized such that a medical instrument is capable of positioned through the at least one perforation, wherein at least one perforation is sized such that air and/or moisture is capable of flowing through the at least one perforation when the burr hole cover is affixed within the recessed region.
Regarding claim 24, Bruce et al. fails to disclose the burr hole cove comprises a continuously arcuate perimeter.
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 burr hole cover disclosed by Bruce et al. that it was arcuate as matter of engineering design choice.
Applicant has not disclosed the shape of the perimeter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Bruce et al.’s perimeter, and applicant’s invention, to perform equally well with either the shape by Bruce et al. or the arcuate shape because both spacing dimensions would perform the same function of conforming to the skull equally well considering the relative dimensions disclosed.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,961,519 (Bruce et al.) in view of U.S. Patent Publication Number 2019/0046248 (Kuhn)
Regarding claim 15, Bruce et al. fails to disclose wherein the burr hole cover is constructed of titanium.
Kuhn, from the same field of endeavor teaches a similar burr hole cover as shown in Figure 1A wherein the burr hole cover is constructed of titanium. See paragraph [0007].
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 burr hole cover disclosed by Bruce et al. by substituting the material of the burr hole cover disclosed by Bruce for the material of the burr hole cover taught by Kuhn such that the burr hole cover is constructed of titanium because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 5,961,519 (Bruce et al.) in view of U.S. Patent Publication Number 2016/0242863 (Kirschman)
Regarding claim 20, the Office interprets “wherein the burr hole cover is constructed from additive manufacturing or freeform fabrication” as a product by process.
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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 though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding "interbonded by interfusion" to limit structure of the claimed composite and noting that terms such as "welded," "intermixed," "ground in place," "press fitted," and "etched" are capable of construction as structural limitations). See also In re Nordt Dev. Co., 881 F.3d 1371,1375-76, 125 USPQ2d 1817, 1820 (Fed. Cir. 2018)(holding "the specification demonstrates that ‘injected molded’ connotes an integral structure," and discussing several cases since Garnero that held "limitations to convey structure even when they also describe a process of manufacture").
"[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Office personnel should note that reliance on the alternative grounds of 35 U.S.C. 102 or 35 U.S.C. 103 does not eliminate the need to explain both the anticipation and obviousness aspects of the rejections.
In this case, there appears to be structure implied by the process additive manufacturing or freeform fabrication; see paragraph [0026] and thus the Office considers Bruce et al. to disclose what reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim.
Kirschman, from the same field of endeavor teaches a similar burr hole cover as shown in Figure 1, where the burr hole cover is constructed from additive manufacturing. See paragraph [0011].
Alternatively, 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 burr hole cover disclosed by Bruce et al. by substituting the method of manufacture disclosed by Bruce et al. for the additive manufacturing taught by Kirschman such that the burr hole cover is constructed from additive manufacturing or freeform fabrication because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Response to Arguments
Applicant's arguments filed 07/25/2025, see pages 5-8, have been fully considered but are moot in view of the new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is (571)270-1965. The examiner can normally be reached on Monday – Friday, 9:30 am – 6 pm.
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/RICHARD G LOUIS/Primary Examiner, Art Unit 3771