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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 02/17/2026 is acknowledged.
Claims 1 – 5, 7 – 9, 11 – 15, 17, 18, and 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of manufacturing, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference numbers “32”, “34”, “36” (See Figs. 3A,B) , “31” (See Fig. 4) , “62”, “64” (See Figs. 6A,B), and “317A”, “404” (See Figs. 9,10A). Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 20 and 32 objected to because of the following informalities:
Claim 20 recites “characterised” in line 2, however this appears to be a typographical error, and the Examiner suggests the line be amended to read “characterized”;
Claim 32 recites the phrases “the perforator”, “an inner cutting head”, and “an outer cutting head” in lines 2, 3, and 3, respectively, although the lines are understood by the Examiner to mean “the cranial perforator”, “the inner cutting head”, and “the outer cutting head” as previously defined, the Examiner suggests the lines be amended to read “the cranial perforator”, “the inner cutting head”, and “the outer cutting head” for the purpose of maintaining consistent language throughout the claims;
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21 and 28 – 32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 21, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of examination the Examiner will read the claims as not requiring the proceeding limitations.
Regarding claims 28 and 29, the phrase(s) "a perforator" and “the perforator” renders the claim indefinite because it is unclear whether Applicant is intending for the “perforator” to be the same “cranial perforator” defined in claim 20, or an entirely different perforator. For the purpose of examination the Examiner will read the claim to mean the former.
Regarding claim 30, the phrase "the drive shaft of a drill" renders the claim indefinite because it is unclear whether Applicant is intending for “the drive shaft” to be the same drive shaft as the drive shaft previously defined, such that the “drill” is actually “the perforator” or if Applicant is intending for “the drive shaft” to be a different drive shaft than the drive shaft of the perforator that was previously defined. Based on a brief discussion with Applicant’s representative, wherein Applicant’s representative indicated that the limitation “the drive shaft of a drill” should read simply “the drive shaft” and the limitation should be examined without the “drill” limitation, the Examiner will read the limitation to mean the “drive shaft” is the of the perforator and the claim does NOT require a drill.
Claims 31 and 32 are rejected as being indefinite for being dependent on an indefinite claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 20 – 22 and 26 – 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hatzlhoffer (WO 2011/131357 A2) (cited machined translated pdf version attached) and evidenced by Venus[1] (PDF version attached).
Regarding claims 20, 21, and 22, Hatzlhoffer discloses a cutting head (machining part 4) capable of being used as a cranial perforator for cutting a hole in bone tissue (Examiner’s note: as stated in the abstract, on page 10 paragraph [0008], and on page 11 paragraph [0006], the machining part 4 is used on tool 1, which is used to drill into the jaw bone; and because the tool 1 is used to drill through bone it is a perforator, furthermore, because it is used to drill through the jaw bone, it is capable of being used to drill through cranial bone) (abstract, page 10 paragraphs [0008 – 0009], and Figs. 2 – 13),
the cutting head (machining part 4) comprising a plurality of cutting edges (cutting edges 10, 15) (page 10 paragraphs [0008 – 0011], page 11 paragraph [0004], and Figs. 2 – 13), characterized in that the cutting head (machining part 4) is made of stainless austenitic steel having a Rockwell C hardness HRC of less than 25 HRC, or less than 20 HRC (Examiner’s note: as stated on page 8 paragraph [0004] the machining part and the cutting part can be made up of steel no. 1.4303; and as stated by Venus, steel no. 1.4303 is an austenitic stainless steel with an HB of <= 215[1], which equates to an HRC of <= 19. Therefore, Hatzlhoffer discloses the cutting head as claimed).
Regarding claim 28, Hatzlhoffer discloses further comprising a connector (tip of shank 2) for reversibly coupling the cutting head (machining part 4) to a drive shaft (shank 2) of a perforator (tool 1) (page 10 paragraphs [0008], [0010], and Figs. 1-6).
Regarding claim 29, Hatzlhoffer discloses wherein the cutting head (machining part 4) is an outer cutting head (machining part 4) for a perforator (rotatable tool) (page 10 paragraph [0008] – page 11 paragraph [0006]), comprising an axial aperture for receiving an inner cutting head (Examiner’s note: it should be understood that the preceding limitation is an intended use limitation, which requires only that the structure of the prior art be capable of functioning in the manner claimed; with that said because the machining part 4 comprises an inner channel 3, it is capable of receiving an inner cutting head of a perforator).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable Gordon et al (US 2009/0024129 A1) and in view of Hatzlhoffer (WO 2011/131357 A2) (cited machined translated pdf version attached) and evidenced by Venus[1] (PDF version attached).
Regarding claims 30 and 32, Gordon discloses a cranial perforator (cranial perforator 40) for cutting a hole in bone tissue (abstract, paragraph [0036], and Figs. 1 – 19), comprising:
a drive shaft (head 42) with a rotation axis A (longitudinal axis) (paragraph [0040]);
a cutting head (inner drill 44), comprising a plurality of cutting edges (cutting flutes 146 – 152) with the same rotational axis A (paragraphs [0047 – 0048], [0051 – 0055] and Figs. 2, 8 – 11) ; and
a coupling mechanism (plunger 54 and drive cap 58) for connecting the cutting head (inner drill 44) to the drive shaft (head 42) (paragraph [0078]) (Examiner’s note: as stated in paragraph [0078] the cap notches 96 seat against the inner drill legs 128; and the cap is coupled to the head 42 via the plunger 54),
wherein the coupling mechanism (plunger 54 and drive cap 58) is configured to decouple the drive shaft (head 42) and the cutting head (inner drill 44) upon the cutting head perforating the bone tissue (paragraphs [0078], [0091], and [0098]).
[claim 32] wherein the cutting head is an inner cutting head (inner drill 44), and wherein the perforator further comprises an outer cutting head (outer drill 46) (paragraphs [0036], [0051], [0067]), wherein the outer cutting head (outer drill 46) is arranged coaxially around the inner cutting head (inner drill 44) (paragraph [0036]), and in which the inner cutting head is configured to be displaceable relative to the drive shaft along the rotational axis A between a distal position in which the cutting heads are not drivable by the drive shaft (paragraphs [0075], [0091], [0092], and [0098]), and a proximal position in which the cutting heads are drivable by the drive shaft (paragraphs [0077 – 0083], and [0086]).
However, Gordon is silent regarding (i) the cutting head being made of stainless steel having a Rockwell C hardness HRC of less than 30 HRC.
As to the above, Hatzlhoffer teaches a cutting head (machining part 4) capable of being used as a cranial perforator for cutting a hole in bone tissue (Examiner’s note: as stated in the abstract, on page 10 paragraph [0008], and on page 11 paragraph [0006], the machining part 4 is used on tool 1, which is used to drill into the jaw bone; and because the tool 1 is used to drill through bone it is a perforator, furthermore, because it is used to drill through the jaw bone, it is capable of being used to drill through cranial bone) (abstract, page 10 paragraphs [0008 – 0009], and Figs. 2 – 13), wherein the cutting head (machining part 4) comprising a plurality of cutting edges (cutting edges 10, 15) (page 10 paragraphs [0008 – 0011], page 11 paragraph [0004], and Figs. 2 – 13), characterized in that the cutting head (machining part 4) is made of stainless austenitic steel having a Rockwell C hardness HRC of less than 25 HRC, or less than 20 HRC (Examiner’s note: as stated on page 8 paragraph [0004] the machining part and the cutting part can be made up of steel no. 1.4303; and as stated by Venus, steel no. 1.4303 is an austenitic stainless steel with an HB of <= 215[1], which equates to an HRC of <= 19. Therefore, Hatzlhoffer discloses the cutting head as claimed).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the cutting head of Gordon to be made up of the claimed stainless steel, based on the teachings of Hatzlhoffer, as using a known material to make up known devices used in perforating bone tissue is well within the purview of one of ordinary skill in the art, and one of ordinary skill in the art would have a reasonable expectation of success in such a modification such that the results would be predicable and resulted in the cutting head of Gordon being able to perforate the cranial bone as intended.
Citations
[1] Stainless Steel - Grade 305 / 1.4303 - Venus Wires
Allowable Subject Matter
Claim 31 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.
The closest prior art, Gordon, listed above, teaches the device of claim 30, as detailed above. However, Gordon does not disclose or make obvious having the coupling mechanism comprise two different materials with two different hardness levels. Additionally, it would not be obvious to one of ordinary skill in the art to make the coupling mechanism or at least a part of the coupling mechanism of Gordon out of multiple different materials.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bake (US 4,600,006), Baker (US 4,803,982), Reimels et al (US 4,362,161), and Baker (US 5,007,911) teach cranial / bone perforators comprising a shaft and cutting head.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771
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