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 Amendment
This Office action is in response to the applicant’s communication filed 07/22/2026.
Status of the claims:
Claims 1 – 3, 5, 7, 9, 13, 15, 17 – 18, 20 – 22, and 25 – 33 are pending in the application.
Claims 1 – 3, 5, 7, 9, 13, 15,17 – 18, and 25 are withdrawn.
Claims 20 – 22 and 28 – 32 are amended.
Claim 33 is new.
Response to Arguments
Applicant's arguments filed 07/22/2026 have been fully considered but they are not persuasive. More specifically:
Applicant’s arguments rely on language solely recited in preamble recitations in claim 20. When reading the preamble in the context of the entire claim, the recitation “for a cranial perforator for cutting a hole through bone tissue” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
In response to Applicant’s argument that “the skilled person would understand that the list of materials recited on page 8 paragraph [0004] of Hatzlhoffer is not a list of materials in which each material is suitable for each component of the tool 1…. and Hatzlhoffer does not disclose a cutting head made up of austenitic steel” and “in dental implant drilling, a rotational speed of a drill is typically below 500 rpm --- as such, torque is relatively higher than for a perforator where rotational speed of a cutting head is typically about 1,000 to 2,000 rpm”, Hatzlhoffer states on page 8 paragraph [0004] “One, several or all parts of the tool shank, the machining part and the guide element or the cutting can be made of steel, industrial steel no. 1.4301, 1.4303,…”, and the Examiner has designated the machining part as the cutting head. The recitation above discloses that all of the parts of the machining head can be made up of the claimed steel. Further, Hatzlhoffer does not require the machining part 4 (i.e., the cutting head) to be driven at any specific rpm nor does Hatzlhoffer require the machining part 4 (i.e., the cutting head) to be used with a specific driver that can only operate within specific rpm range, there is nothing that would prevent the machining part 4 (i.e., the cutting head) from cutting at an rpm of 500. Lastly, the claims as currently written do not require the cutting head to be operated at any given rpm range. Therefore, Applicant’s arguments are not persuasive.
In response to Applicant's argument that Hatzlhoffer does not disclose “a cutting head for a cranial perforator”, firstly “for a cranial perforator” is a recitation of intended use, and a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The cutting head (machining part 4) of Hatzlhoffer is structurally the same as the claimed cutting head which only requires the cutting head to have cutting edges and be made up of a steel disclosed by Hatzlhoffer; therefore, the Examiner contends that the cutting head (machining part 4) of Hatzlhoffer is capable of performing the intended use. Therefore, Applicant’s arguments are not persuasive.
In response to Applicant's argument that “Regarding claim 29, the Examiner suggests that the machining part 4 having an inner channel 3 makes it capable of receiving an inner cutting head. However, the machining part 4 receives a guiding element 5 only - the inner channel 3 is neither large enough, nor suitable for, receiving an inner cutting head”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. There is nothing that prohibits the inner channel from receiving an inner cutter that is sized and dimensioned smaller than the receiving channel of the machining part (i.e., the cutting head); therefore, the machining part 4 (i.e., the cutting head) of Hatzlhoffer is capable of being used in the manner claimed. Therefore, Applicant’s arguments are not persuasive.
In response to Applicant’s argument that “then there is no reason why the skilled person would have selected the particular material, or type of material, of claim 30 (i.e. austenitic steel as recited in claim 20) from the list, and combined it with the teaching of Gordon. The rejection of claim 30 is based on the Examiner's knowledge of the disclosure of the application, employing impermissible hindsight.” and “the skilled person would have to select a specific material and combine it with Gordon, specifically the cutting head(s) of Gordon, requiring many choices without specific guidance.”, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). With that said, Hatzlhoffer teaches the claimed materials are known materials used to make cutting heads for medical devices used in cutting bone tissue; it is well within the purview of one of ordinary skill in the art to choose any of the materials from any list of known materials used to make cutting heads for medical devices used to cut bone tissue, and the results of which would be predictable and result in a cutting head that is capable of cutting bone tissue. Therefore, Applicant’s arguments are not persuasive.
Applicant’s argument directed to claim 33 is directed to a newly added claim, which has been addressed in the rejection of claim 33 below.
Drawings
The drawings were received on 07/22/2026. These drawings are accepted and overcome the previous drawing objections in the Non-Final office action mailed on 04/23/2026.
Claim Objections
The objections to claims 20 and 32 in the previous action dated 04/23/2026 have been withdrawn in light of the Applicant’s amendments filed 07/22/2026. Specifically, the objection to claim 20, regarding the phrase “characterised”, and the objection to claim 32, regarding the phrases “the perforator”, “an inner cutting head”, and “an outer cutting head”, have been withdrawn as the appropriate corrections have been made.
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.
The rejection of claims 21 and 28 – 32 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 04/23/2026 have been withdrawn in light of the Applicant’s amendments filed 07/22/2026. Specifically, the rejection of claim 21, regarding the lack of clarity in the phrase following the term "optionally", the rejection of claims 28 – 29, regarding the lack of clarity in the phrase(s) "a perforator" and “the perforator”, the rejection of claim 30, regarding the lack of clarity in the phrase "the drive shaft of a drill", and the rejection of claims 31 – 32 for being dependent on an indefinite claim have been withdrawn as the appropriate corrections have been made.
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][2] (PDF version attached).
Regarding claims 20, 21, 22, and 26, Hatzlhoffer discloses a cutting head (machining part 4) (abstract, page 10 paragraphs [0008 – 0009], and Figs. 2 – 13) capable of being for a cranial perforator for cutting a hole through bone tissue (Examiner’s note: it should be understood that a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67,190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d150,152,88. 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 equated by the Examiner as a perforator), which is used to drill into the jaw bone which makes it a bone a perforator, furthermore, because it is used to drill through the jaw bone and is structurally similar to that of the structure of the ‘cranial perforator’ below, the Examiner contends that the machining part 4 is capable of being used to drill through cranial bone; and the tool 1 is capable of being a cranial perforator),
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 or 1.4301; 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. Additionally, stainless steel 1.4301 is austenitic which is unhardened and has an HB of 70[2] and an HRC of <=19. Therefore, Hatzlhoffer discloses the cutting head as claimed).
Regarding claim 27, Hatzlhoffer discloses wherein the cutting head has a surface finish (coated - page 8 paragraph [0004]).
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 20 – 22, 28, 29, 30, 32, and 33 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 20 – 22, Gordon discloses a cutting head (outer drill 46) for a cranial perforator (cranial perforator 40) for cutting a hole through bone tissue (abstract, paragraphs [0036], [0051], [0067], [0070], Figs. 1 – 19), the cutting head comprising a plurality of cutting edges (cutting faces 210 with edges) (paragraph [0070] and Fig. 10).
However, Gordon is silent regarding (i) the cutting head being made of an austenitic 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) for cutting a hole in bone tissue (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.
Regarding claim 29, as discussed above, the combination of Gordon and Hatzlhoffer makes obvious the cutting head of claim 20. Additionally, Gordon discloses wherein the cutting head is an outer cutting head (outer drill 46) for the cranial perforator (cranial perforator 40) comprising an axial aperture for receiving an inner cutting head (inner drill 44) (paragraphs [0047 – 0048], [0051 – 0055] and Figs. 2, 8 – 11).
Regarding claims 20 – 22, (alternate interpretation – changes italicized) Gordon discloses a cutting head (inner drill 44) for a cranial perforator (cranial perforator 40) for cutting a hole through bone tissue (abstract, paragraph [0036], and Figs. 1 – 19), the cutting head comprising a plurality of cutting edges (cutting flutes 146 – 152) (paragraphs [0047 – 0048], [0051 – 0055] and Figs. 2, 8 – 11).
However, Gordon is silent regarding (i) the cutting head being made of an austenitic 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) for cutting a hole in bone tissue (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 result in the cutting head of Gordon being able to perforate the cranial bone as intended.
Regarding claim 33, (alternate interpretation) as discussed above, the combination of Gordon and Hatzlhoffer makes obvious the cutting head of claim 20. Additionally, Gordon discloses wherein the cutting head is an inner cutting head (inner drill 44) for the cranial perforator, configured to be received within an axial aperture of an outer cutting head (outer drill 46) for the cranial perforator (perforator 40) (paragraphs [0047 – 0048], [0051 – 0055] and Figs. 2, 8 – 11).
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) for cutting a hole in bone tissue (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
[2] Stainless Steel - Grade 304 / 1.4301 - 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
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached 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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/Andrew Restaino/Primary Examiner, Art Unit 3771
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