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 .
Response to Arguments
This Office action is in response to the applicant’s communication filed on 8/12/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 10, with respect to Applicant’s amendments to the drawings made in view of the previous objections to the drawings have been fully considered and are persuasive. The previous objections to the drawings have been withdrawn.
Applicant’s arguments, see page 11, with respect to Applicant’s amendments to the Abstract made in view of the previous objections to the Abstract have been fully considered and are persuasive. The previous objections to the Abstract have been withdrawn.
Applicant's arguments regarding independent claims 1 and 8, see pages 11-13, alleging that Chavez fails to disclose wherein the first alignment mark is aligned with the second alignment mark in the direction substantially orthogonal to the cranium when the cover is aligned with and in a final, locked position connected to the base (emphasis added) have been fully considered but they are not persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the vertical alignment occurring in a final, locked position) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is the Examiner’s position, as set forth in the previous office action, that Chavez expressly discloses the first and second alignment marks aligned in the vertical direction when the cover is coaxially inserted into and thereby connected to the base (as expressly shown in Figs. 1A, 3, 7 and 13A; [0058]; [0072]). For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see pages 13-15, alleging that Chavez fails to disclose the newly amended subject matter in independent claim 14 have been fully considered but they are not persuasive. It is the Examiner‘s position that Chavez expressly discloses the newly amended subject matter of claim 14. Chavez discloses the first lead retaining member comprising a protrusion (i.e., sidewall shoulders/protrusions forming channels 130) extending from the upper surface of the base (i.e., sidewall shoulders/protrusions extend generally inward from upper surface of the ring-shaped base 110) and adapted to engage the lead (203) of the medical device (see annotated Fig. 13A below, and see also Figs. 1A, 2B-3 and 13A-13B). Furthermore, Chavez discloses the second lead retaining member (192) comprising a protrusion (i.e., sidewall shoulders/protrusions forming channels 192) extending from the inner surface of the cover (160) (i.e., sidewall shoulders/protrusions extend generally outward from the inner surface of the cover 160) (as shown in annotated Fig. 13B below) and laterally spaced apart from the protrusion of the first lead retaining member (130) when the cover (160) is connected to the base (110) (as shown in Figs. 13A-13B; the protrusions of the second lead retaining member are laterally and radially spaced inward relative to the protrusions of the first lead retaining member thereby forming aperture 310), wherein the protrusion of the second lead retaining member (192) is adapted to engage the lead (203) of the medical device (as shown in annotated Figs. 13A-13B below). For at least these reasons, Applicant’s arguments are not persuasive.
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Claim Rejections - 35 USC § 102
Claim(s) 1, 7-8, 13-14, 22-23 and 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chavez et al. (US 2014/0257325).
Chavez discloses (see Figs. 1A-3 and 11-14B) a cranial burr hole cover and method comprising the following claim limitations:
(claim 1) An apparatus (100) adapted to be fastened to a cranium (202) around a burr hole (200) formed therethrough (as shown in Figs. 2A-2B), the apparatus (100) comprising: a base (110, Fig. 1A) comprising an orifice (128), an upper surface, and a lower surface (as shown in Fig. 1A), wherein the orifice (128) is adapted to be aligned with the burr hole (200) in a direction substantially orthogonal to the cranium (202) (as shown in Figs. 2A-2B); and a cover (160) adapted to connect to the base (110) and extend over the orifice (128) of the base (110) (as shown in Figs. 2B-3); wherein the base (110) further comprises a first alignment mark (134, Fig. 1A) and the cover (160) comprises a second alignment mark (186, Fig. 1A), wherein the first alignment mark (134) is aligned with the second alignment mark (186) in the direction substantially orthogonal to the cranium (202) when the cover (160) is aligned with and connected to the base (110) (as shown in Figs. 1A, 3, 7 and 13A; [0058]; [0072]; first and second alignment marks aligned in the vertical direction when the cover 160 is coaxially inserted into and thereby connected to the base 110);
(claim 7) wherein the first alignment mark (134) comprises a recess disposed in the upper surface of the base (110) (as expressly shown in Fig. 1A) and the second alignment mark (186) comprises a protrusion disposed on an inner surface of the cover (160) (as expressly shown in Fig. 1A), wherein the first alignment mark (134) is adapted to engage the second alignment mark (186) when the cover (160) is connected to the base (110) (as shown in Figs. 1A, 3, 7 and 13A; [0058]; [0072]);
(claim 8) A method comprising: disposing a base (110) on a cranium (202) such that an orifice (128) of the base (110) is substantially aligned in a direction substantially orthogonal to the cranium (202) with a burr hole (200) disposed through the cranium (202) (as shown in Figs. 2A-3), wherein the base (110) further comprises an upper surface and a lower surface (as shown in Figs. 1A); and connecting a cover (160) to the base (110) such that a first alignment mark (134, Fig. 1A) disposed on the base (110) is aligned with a second alignment mark (186, Fig. 1A) disposed on the cover (160) in the direction substantially orthogonal to the cranium (202), wherein the cover (160) occludes the orifice (128) of the base (110) (as shown in Figs. 1A, 3, 7 and 13A; [0058]; [0072]; first and second alignment marks aligned in the vertical direction when the cover 160 is coaxially inserted into and thereby connected to the base 110);
(claim 13) wherein the first alignment mark (134) comprises a recess disposed in the upper surface of the base (110) (as expressly shown in Fig. 1A) and the second alignment mark (186) comprises a protrusion disposed on an inner surface of the cover (160) (as expressly shown in Fig. 1A), wherein the first alignment mark (134) is adapted to engage the second alignment mark (186) when the cover (160) is connected to the base (110) (as shown in Figs. 1A, 3, 7 and 13A; [0058]; [0072]);
(claim 14) An apparatus (100) adapted to be fastened to a cranium (202) around a burr hole (200) formed therethrough, the apparatus (100) comprising: a base (110) comprising an orifice (128), an upper surface, and a lower surface (as shown in Fig. 1A), wherein the orifice (128) is adapted to be aligned with the burr hole (200) in a direction substantially orthogonal to the cranium (202) (as shown in Figs. 2A-2B); and a cover (160) adapted to be connected to the base (110), wherein the cover (160) comprises an inner surface (i.e., bottom surface, as shown in Fig. 12) and a slot (162) adapted to receive a lead (203) of a medical device (as shown in Fig. 1A and 3); wherein the upper surface of the base (110) comprises a first lead retaining member (130) and the inner surface of the cover (160) comprises a second lead retaining member (192, Fig. 14B), wherein the first lead retaining member comprises a protrusion (i.e., sidewall shoulders/protrusions forming channels 130) extending from the upper surface of the base (110) (i.e., sidewall shoulders/protrusions extend generally inward from upper surface of the ring-shaped base 110) and adapted to engage the lead (203) of the medical device (as shown in annotated Fig. 13A, provided in the Response to Argument section above) (see also Figs. 1A, 2B-3 and 13A-13B), wherein the second lead retaining member (192) comprises a protrusion (i.e., sidewall shoulders/protrusions forming channels 192) extending from the inner surface of the cover (160) (i.e., sidewall shoulders/protrusions extend generally outward from the inner surface of the cover 160) (as shown in annotated Fig. 13B, provided in the Response to Argument section above) and laterally spaced apart from the protrusion of the first lead retaining member (130) when the cover (160) is connected to the base (110) (as shown in Figs. 13A-13B; the protrusions of the second lead retaining member are laterally and radially spaced inward relative to the protrusions of the first lead retaining member thereby forming aperture 310), wherein the protrusion of the second lead retaining member (192) is adapted to engage the lead (203) of the medical device (as shown in annotated Figs. 13A-13B above; provided in the Response to Argument section above), and wherein the first and second lead retaining members are adapted to retain the lead (203) when the cover (160) is connected to the base (110) and the lead (203) extends between the first and second lead retaining members (as shown in Figs. 13A-13B);
(claim 22) wherein the second lead retaining member (192) of the cover (160) comprises a second protrusion (i.e., “other” radius/shoulder protrusion defining channel 192/1210) laterally spaced from the protrusion of the second lead retaining member such that the protrusion (i.e., respective sidewall shoulders/protrusions forming channels 130) of the first lead retaining member of the base (110) is laterally disposed between the protrusion and the second protrusion of the second lead retaining member when the cover (160) is connected to the base (110) (as shown in annotated Fig. 14B below);
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(claim 23) wherein the upper surface of the base (110) comprises a third lead retaining member (i.e., “other” 130) disposed such that the orifice (128) is disposed between the first (130) and third (other 130) lead retaining members (as shown in annotated Fig. 13A provided in the Response to Argument section above), and further wherein the inner surface of the cover (160) comprises a fourth lead retaining member (i.e., “other” 192), wherein the third and fourth lead retaining members are adapted to retain the lead (203) of the medical device when the cover (160) is connected to the base (110) and the lead (203) extends between the third and fourth lead retaining members (as shown in annotated Fig. 13A provided in the Response to Argument section above);
(claim 25) wherein the first and second lead retaining members are adapted to retain at least two leads (203) when the cover (160) is connected to the base (110) and each of the at least two leads (230) extend between the first and second lead retaining members (as shown in Figs. 1A, 3, 7, 13A-13B; [0044]; four sets of first and second lead retaining members depicted for holding up to four leads simultaneously (i.e., holding greater than two leads is expressly disclosed));
(claim 26) wherein the first alignment mark (134) is disposed on the upper surface of the base (110) (as expressly shown in Fig. 1A, slot 134 is expressly depicted as being disposed both on and through the upper surface of the base 110); and
(claim 27) wherein the second alignment mark (186) is disposed on an inner surface of the cover (160) (as expressly shown in Fig. 12, protrusion 186 is expressly depicted as being disposed on the lower surface of the cover 160).
Claim Rejections - 35 USC § 103
Claim(s) 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Chavez as applied to claims 1 and 8 above, and further in view of Solar (US 2004/0122446).
Chavez, as applied above, discloses a cranial burr hole cover and method comprising all the limitations of the claim except for the cover being substantially transparent such that the first alignment mark is visible through the cover when the cover is connected to the base.
However, Solar teaches a similar burr hole access system and method comprising a cover being substantially transparent ([0046]; [0086]; transparent components expressly taught) such that the first alignment mark is visible through the cover when the cover is connected to the base in order to beneficially increase the visibility of an opening in a subject and thereby a surgeon's ability to see the opening and to see inside the opening is increased ([0046]; [0086]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Chavez to have the cover being substantially transparent such that the first alignment mark is visible through the cover when the cover is connected to the base in order to beneficially increase the visibility of an opening in a subject and thereby a surgeon's ability to see the opening and to see inside the opening is increased, as taught by Solar.
Claim(s) 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Chavez as applied to claims 1 and 8 above.
Chavez, as applied above, discloses a cranial burr hole cover and method comprising all the limitations of the claim except for the first alignment mark comprising a protrusion disposed on the upper surface of the base and the second alignment mark comprising a recess disposed in an inner surface of the cover, wherein connecting the cover to the base further comprises inserting the first alignment mark into the second alignment mark.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to switch the male protrusions and the female recesses of Chavez, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167.
Claim(s) 9 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chavez as applied to claims 8 and 16 above, and further in view of Stratton et al. (US 2010/0312193).
Chavez, as applied above, discloses a cranial burr hole cover and method comprising all the limitations of the claim except for a core fastened to the cranium around the burr hole prior to disposing the base on the cranium, wherein the core comprises a ring portion that surrounds the burr hole, and further wherein the base encapsulates a ring portion of the core when the base is disposed on the cranium.
However, Stratton teaches (see Figs. 1-4) a similar burr hole access system and method comprising a core (18) fastened to the cranium around the burr hole prior to disposing the base (12) on the cranium ([0032]; [0036]), wherein the core (18) comprises a ring portion (20) that surrounds the burr hole, and further wherein the base (12) encapsulates the ring portion (20) of the core (18) when the base (12) is disposed on the cranium (as shown in Figs. 2 and 4) in order to beneficially provide a fluid seal between the base of the access system and the patient’s skull/head ([0032]; [0036]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Chavez to have a core fastened to the cranium around the burr hole prior to disposing the base on the cranium, wherein the core comprises a ring portion that surrounds the burr hole, and further wherein the base encapsulates a ring portion of the core when the base is disposed on the cranium in order to beneficially provide a fluid seal between the base of the access system and the patient’s skull/head, as taught by Stratton.
Allowable Subject Matter
Claims 3-5, 11 and 17-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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