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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: drive mechanism in claims 1, 7 and 18; negative pressure device in claim 20; and locking device in claims 22, 23, 25 and 26.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3 and 22-28 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by King et al., WO 2022/170152 (previously cited in PTO-892 dated 5/22/2025).
Regarding claim 1, King et al. discloses a surgical bone drill, comprising: a housing (110, 112); a drill bit (204) comprising: a bit proximal portion (portion attached to drill 200) that is mounted within the housing, and a bit distal portion (portion extending beyond 106) that extends distally from the housing and including a cutting tip configured to drill into bone (92) of a patient; a depth limiter (102) having a limiter distal end (106) positioned adjacent the bit distal portion, the depth limiter being operatively coupled to the housing such that rotation of the depth limiter causes a change in an exposed length of the bit distal portion that extends beyond the limiter distal end, thereby limiting a depth that the drill bit is able to drill into the bone, the depth limiter being rotatable on the housing (via threading 103 and 112) over a plurality of rotations without locking; and a drive mechanism (portion of drill 200 that attaches to drill bit 204 within 110) disposed within the housing and operably connected with the bit proximal portion of the drill bit to rotate the drill bit to drill into the bone (Figs. 1-3 and paragraphs [0022]-[0023]).
Regarding claims 3 and 22-24, King et al. discloses wherein the housing (110, 112) includes a sleeve having sleeve threads (112), the sleeve being configured to receive the bit proximal portion; and the depth limiter (102) is threaded (via thread 103) to the sleeve threads to select the exposed length of the bit distal portion that extends beyond the limiter distal end, the depth limiter being rotatable on the sleeve threads over the plurality of rotations from a first position on the housing to a second position on the housing without locking or without unlocking a locking device and is configured to be rotatably removed from the housing without unlocking a locking device (Figs. 1-1a and paragraph [0022]).
Regarding claims 25-28, King et al. discloses wherein the depth limiter (102) further comprises a locking device configured to lock the depth limiter in a desired position on the housing/sleeve (110, 112); and the locking device is configured to be selectively disengaged to allow free rotation of the depth limiter; wherein the desired position on the sleeve is selected from a plurality of angular positions corresponding to one or more complete clockwise or counterclockwise revolutions of the depth limiter on the sleeve threads (112); and wherein the locking device comprises a locking nut threaded to the sleeve threads and configured to prevent the rotation of the depth limiter on the sleeve after the exposed length of the bit distal portion is selected (Fig. 1 and paragraph [0022]).
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over King et al., WO 2022/170152 in view of Knutson, U.S. PG-Pub 2011/0152866.
King et al. discloses the invention essentially as claimed except for wherein the cutting tip is a convex conical cutting tip with a spike extending distally from the cutting tip, the spike being sufficiently sharp to pierce a dura of the patient.
Knutson discloses a drill bit having a cutting tip (14) that is a convex conical cutting tip with a spike (12) extending distally from the cutting tip, the spike being sufficiently sharp to pierce bone (Figs. 4C-4D) as such carries, protects, and reinforces the spike during a portion of penetration into bone and reduces the risk of spike fracture during perforation (paragraph [0091]) and minimizes a total volume of bone removed and minimizes the work required to form both a bony conduit and a bony access seat (paragraph [0087]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cutting tip of the drill bit of King et al. such that the cutting tip is a convex conical cutting tip with a spike extending distally from the cutting tip, the spike being sufficiently sharp to pierce a dura of the patient in view of Knutson to permit carrying, protecting, and reinforcing the spike during a portion of penetration into bone and reduces the risk of spike fracture during perforation and minimizing a total volume of bone removed and minimizes the work required to form both a bony conduit and a bony access seat.
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over King et al., WO 2022/170152 in view of Asfora, U.S. PG-Pub 2009/0264811.
Regarding claims 19-21, King et al. et al. discloses a surgical kit comprising the surgical bone drill of claim 1 (see rejection of claim 1 above).
King et al. does not disclose one or more devices for evacuation of fluid from a subdural space of the patient; wherein the one or more devices for evacuation of fluid from the subdural space include a subdural evacuation port device and a negative pressure device; or a tapper for creating threads within a hole created by the drill.
Asfora discloses a surgical kit having a surgical bone drill (12); a subdural evacuation port device (10) with tapping threads (46; therefore, 10 is a tapper) and a negative pressure device (20) (Figs. 1-3) in order to remove a collection of fluid from a subdural space of a patient and imparting a uniform partial vacuum in the subdural space for promoting gradual re-expansion of the brain in the subdural space during the healing process (paragraph [0049]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical kit of King et al. to include one or more devices for evacuation of fluid from a subdural space of the patient; wherein the one or more devices for evacuation of fluid from the subdural space include a subdural evacuation port device and a negative pressure device; or a tapper for creating threads within a hole created by the drill in view of Asfora to permit removing a collection of fluid from a subdural space of a patient and imparting a uniform partial vacuum in the subdural space for promoting gradual re-expansion of the brain in the subdural space during the healing process.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knutson, U.S. PG-Pub 2011/0152866 in view of Jensen et al., U.S. PG-Pub 2007/0055249 (previously cited in PTO-892 dated 5/22/2025).
Knutson discloses a drill bit fully capable of being used on a cranium, comprising: an elongated body (14) having a bit distal portion including: a convex conical cutting tip (14) tapering distally to a first diameter and configured to drill into bone of a patient; and a spike (12) having a second diameter and extending distally form the cutting convex conical tip and terminating at a point, wherein the spike is configured to cut a dura of the patient, wherein the second diameter of the spike is smaller than the first diameter of the convex conical cutting tip (Figs. 4C-4D).
Knutson does not disclose a cutting portion that extends proximally from the convex conical cutting tip and defining a drill bit diameter large enough to drill a hole in the bone, the cutting portion configured to remove material as the convex conical cutting tip drills into the bone of the patient.
Jensen et al. discloses a bit having a cutting portion (74) that extends proximally (into shaft portion 32) from a convex conical cutting tip (66) (Fig. 2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bit distal portion of Knutson to include a cutting portion that extends proximally from the convex conical cutting tip and defining a drill bit diameter large enough to drill a hole in the bone, the cutting portion configured to remove material as the convex conical cutting tip drills into the bone of the patient in view of Jensen et al. to permit in aiding of cutting and tapping into bone.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knutson, U.S. PG-Pub 2011/0152866 in view of Jensen et al., U.S. PG-Pub 2007/0055249 as applied above, and further in view of King et al. WO 2022/170152.
Knutson in view of Jensen et al. discloses a surgical bone drill, comprising: a cranial drill bit according to claim 16 (see rejection of claim 16 above).
Knutson in view of Jensen et al. does not disclose wherein a proximal portion of the cranial drill bit extends into a housing; a depth limiter having a distal end portion positioned adjacent a bit distal portion, wherein a location of the depth limiter is adjustable with respect to the housing to select an exposed length of the bit distal portion that is exposed beyond the depth limiter, thereby limiting a depth that the drill bit is able to drill into the bone; and a drive mechanism disposed within the housing and operably connected with the proximal portion of the drill bit to rotate the drill bit to cause the drill to drill into bone.
King et al. discloses a surgical bone drill, comprising: a housing (110, 112); a drill bit (204) comprising: a bit proximal portion (portion attached to drill 200) that is mounted within the housing, and a bit distal portion (portion extending beyond 106) that extends distally from the housing and including a cutting tip configured to drill into bone (92) of a patient; a depth limiter (102) having a limiter distal end (106) positioned adjacent the bit distal portion, the depth limiter being operatively coupled to the housing such that rotation of the depth limiter causes a change in an exposed length of the bit distal portion that extends beyond the limiter distal end, thereby limiting a depth that the drill bit is able to drill into the bone, the depth limiter being rotatable on the housing (via threading 103 and 112) over a plurality of rotations without locking; and a drive mechanism (portion of drill 200 that attaches to drill bit 204 within 110) disposed within the housing and operably connected with the bit proximal portion of the drill bit to rotate the drill bit to drill into the bone (Figs. 1-3 and paragraphs [0022]-[0023]) in order to prevent the surgical drill form penetrating too far or plunging beyond a desirable depth (paragraph [0002]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the surgical bone drill of Knutson to include a depth limiter and drive mechanism further in view of King et al. to permit preventing the surgical drill from penetrating too far or plunging beyond a desirable depth.
Response to Arguments
Applicant’s arguments, see Remarks, filed 24 November 2025, with respect to the objection of claims 7 and 10 have been fully considered and are persuasive. The objection of claims 7 and 10 has been withdrawn.
Applicant's arguments filed 24 November 2025, regarding the claim interpretation under 35 U.S.C. 112(f) have been fully considered but they are not persuasive. Applicant contends “drive mechanism” and “negative pressure device” constitute structural elements. However, the claims limitations use a generic placeholder (i.e. “mechanism” and “device”) that is coupled with functional language (i.e. “drive” and “negative pressure”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Therefore, “drive mechanism” and “negative pressure device” are still being interpreted under 35 U.S.C. 112(f).
Applicant’s arguments, see Remarks, filed 24 November 2025, with respect to the rejection of claim 21 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claim 21 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments with respect to claim(s) 1 and 16 under 35 U.S.C. 102(a)(1) and 102(a)(2) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
Claims 7, 10-12, 14 and 29-33 are allowed.
Claim 4 is 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 Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775