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
Applicant’s arguments with respect to claim(s) below 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. The examiner reinterpreted the prior art in view of applicant’s amendments.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “arrowhead shape” in claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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.
Claim 18 is 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.
Claim 18 recites that “the body member has no cavities”, where it is unclear if this means that the body member does not have one or more cavities or that the body members does not have more than 1 cavity. Claim 1 recites the protrusion “embedded in the body member” (seen in Fig 5a-5c), where the protrusion is in held in a cavity of the body member (Fig 5a-5c). As such, the examiner is treating this limitation as the body member can have a single cavity (for the protrusion) but does not have any more than that. Clarification is requested.
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.
Claims 1-8, 11-13, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Dinkler US 2008/0251086 in view of Lehmann US 2007/0233061, Bremer US 5,122,132 (cited by applicant) and Arn US 2007/0270801.
Regarding Claim 1, 2, 4, 6, 8, Dinkler discloses a skull pin (#10) capable of fixing the head of an animal (abstract), the skull pin comprising:
a body member (see Fig below, Fig 2); and a
tip member (#20) having a conical shape (#310, see Fig below), the tip member configured to be fixed to a tip of the body member (Fig 2-3, paragraph 22), to contact the head (Fig 2-3, paragraph 19), and to include at least one of metal (paragraph 24-26 can be made out of metal or ceramic), ceramics (paragraph 24-26 can be made out of metal or ceramic), cermet and
a second reinforced plastic;
(Claim 2) wherein the second reinforced plastic includes a reinforced plastic containing 30 wt % to 70 wt % of a second reinforcing fiber and 30 wt % to 70 wt % of a second resin:
(claim 4) wherein the second reinforced plastic is at least one of carbon fiber reinforced plastic, glass fiber reinforced plastic, carbon fiber reinforced plastic, boron fiber reinforced plastic, aramid fiber reinforced plastic, Kevlar fiber reinforced plastic, Dyneema fiber reinforced plastic, and Zylon fiber reinforced plastic; or
(claim 6) the resin includes at least one of a thermosetting resin and a thermoplastic resin; or
(claim 8) wherein the second reinforcing fiber is a carbon fiber with a length of 0.5 mm to 5 mm
(Claim 11) wherein the tip member includes at least one of carbon fiber reinforced plastic, glass fiber reinforced plastic, carbon fiber reinforced plastic, boron fiber reinforced plastic, aramid fiber reinforced plastic, Kevlar fiber reinforced plastic, Dyneema fiber reinforced plastic, and Zylon fiber reinforced plastic as the second reinforced plastic.
The examiner notes that “the second reinforced plastic” in claim 1 is one of four material choices for the tip member and Claims 2, 4, 6, 8, and 11 further limit the “second reinforced plastic”. Claims 2, 4, 6, 8, and 11 does not positively recite that the tip member include the second reinforced plastic, only that if the second reinforced fiber is chosen in claim 1, then the second reinforced fiber would additionally require the limitations recited in Claim 2 (as well as Claims 4, 6, 8) or Claim 11. The current rejection relies upon one of the other material choices for the tip member, metal or ceramic (as discussed in the rejection above).
Regarding Claim 1, Dinkler further discloses wherein the tip member (#20) includes at least one of stainless steel (paragraph 25 in Dinkler), titanium, iron, nickel, cobalt, and cemented carbide as the metal, and includes at least one shape of conical (see Fig below), truncated cone and rotational body,
the body member has a shaft member (see Fig below) and a tapered member (see Fig below), the tapered member having a shape of a truncated cone (see Fig below), and the tapered member contacts the tip member (see Fig below, Fig 2), and
a minimum diameter of the tapered member where the tapered member contacts the tip member is equal to the maximum diameter of the tip member (see Fig below, between the two dotted line represents the minimum diameter of the tapered member and the maximum diameter of the tip member).
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Dinkler discloses the skull pin is held by a clamp (Fig 1) and the body member (#30) can be made out of plastic/resin (PEEK paragraph 31) and filled with carbon (paragraph 31) but does not disclose the body member is of a first reinforced plastic including 30 wt % to 70 wt % of a first reinforcing fiber and 30 wt % to 70 wt % of a first resin. Dinkler discloses that the dimensions of the skull pin is exemplary (“can have” paragraph 23), where the tip member defines a terminal end for the skull pin (Fig 2, see fig above) and does not disclose the maximum length being 1.5 to 3.0 mm.
Lehmann discloses a bone pin with a body member (#103, Fig 1) of a first reinforced plastic including 30% to 70% by volume of a first reinforcing fiber and 30% to 70% by volume of a first resin (paragraph 26, 28, PEEK as the resin and “carbon fibers, or aramid fibers”), where the reinforcing fiber reinforces the body to help maintain the position of the pin and improves gripping of the bone pin by a clamp (paragraph 5, 9, 26). The examiner notes that percent weight and percent volume are related by knowing the densities of the material. Since the densities of the reinforcing fiber and resin are relatively close to each other, the percent by volume and percent by weight would also close to each other. Given the relatively large range for percent by weight, when converting the percent by volume to percent by weight, one would arrive at the claimed range. See Interview Summary mailed 8/11/2025 and Response to Arguments in the office action mailed 10/21/2025.
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the body member of Dinkler to be of first reinforced plastic including 30% to 70% by volume of a first reinforcing fiber and 30% to 70% by volume of a first resin in view of Lehmann above because the reinforcing fiber reinforces the body to help maintain the position of the pin and improves gripping of the bone pin by a clamp, where since the densities of the first reinforcing fiber and resin are similar, it would also be obvious that the first reinforced plastic would be 30 wt % to 70 wt % of the first reinforcing fiber and 30 wt % to 70 wt % of the first resin.
Bremer discloses a skull pin (#10, Fig 1) with a tip member (#22, see fig below), where the tip member defines a terminal end for the skull pin (see Fig below) and a conical shape (as seen in Fig 2-3), a maximum diameter of the tip member being 1.5 mm to 3.0 mm (see Fig below, Col 3 lines 58-61, between the two dotted lines defines the maximum diameter, where the maximum diameter also corresponds to the diameter of section #20, which is 0.07 inch or 1.778 mm, Col 3 lines 58-61).
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It would have been obvious to one having ordinary skill to one having ordinary skill in the art at a time before effective filing date of the claimed invention to modify the bottom surface of Dinkler to have a maximum length of 1.5-3.0 mm (1.778 mm) in view of Bremer above because this provides a known alternate dimension for the bottom surface of a tip member of a skull pin having a conical shape. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). MPEP 2144.04 (IV)(A).
Dinkler further discloses the tip member includes a protrusion (#330) extending towards the body member (Fig 2-3), the protrusion, by being embedded in the body member, enables fixation of the tip member to the body member (Fig 2, paragraph 29) where the protrusion includes a taper that ends with a flat end (#350, Fig 3), but does not disclose the protrusion has an arrowhead shape.
It would have been an obvious matter of design choice to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to have the protrusion have an arrowhead shape, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a forming a protrusion for engagement with the body member. In re Dailey and Eilers, 149 USPQ 47 (1966). See MPEP 2144.04 (IV)(B).
Furthermore, Arn discloses a cylindrical protrusion (#4) that is pressed fit into a bore (#8, paragraph 33), where the cylindrical protrusion can come in a variety of shapes (Fig 3, 5-6), including an arrowhead shape (as seen in Fig 3).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to have the protrusion of Dinkler have an arrowhead shape in view of Arn, since this provides a known alternative shape to obtain predictable results press fitting and coupling a protrusion into a corresponding opening.
Regarding Claim 3, Dinkler as modified discloses the first reinforced plastic is at least one of carbon fiber reinforced plastic (paragraph 28 in Lehmann), glass fiber reinforced plastic, carbon fiber reinforced plastic, boron fiber reinforced plastic, aramid fiber reinforced plastic, Kevlar fiber reinforced plastic, Dyneema fiber reinforced plastic, and Zylon fiber reinforced plastic.
Regarding Claim 5, Dinkler as modified discloses the first resin includes at least one of a thermosetting resin and a thermoplastic resin (paragraph 31 in Dinkler, PEEK).
Regarding Claim 12-13, Dinkler as modified discloses the tip member (Fig 3 in Dinkler) includes a protrusion (#330 in Dinker) extending towards the body member (#30 in Dinkler), and the protrusion, by being embedded in the body member, enables fixation of the tip member to the body member (Fig 2-3, paragraph 22-23),
wherein the protrusion includes at least one of a cylindrical shape (as seen in Fig 3), tapered shape, screw shape, flange shape, and arrowhead shape.
Regarding Claim 14, Dinkler as modified discloses the conical shape (#310 in Dinkler, see fig above in claim 1) has an axial length of 2.5 mm to 3.8 mm (end of paragraph 23 in Dinkler where the max length can be 0.225-0.215 inch or 5.715 mm - 5.461 mm, where the conical shape defines an axial length of 2.5-3.8 mm)(examiner notes that applicant claiming that the conical shape has a max length of 2.5-3.8 mm).
Regarding Claim 15-16, Dinkler as modified discloses the tip member includes a protrusion (#330) having a bottom surface length of 1 mm (end of paragraph 23 in Dinkler, where a bottom surface length or diameter is 1.651-2.159 mm or 0.085-0.065 inch, where the bottom surface defines a length of 1 mm)(examiner notes that applicant is not claiming that the bottom surface length has a max length of 1mm) and an axial length of 2 mm (end of paragraph 23 in Dinkler where the axial length can be 3.302-3.048 mm or 0.130-0.120 inch and thus the axial length defines a length of 2 mm)(examiner notes that applicant is not claiming the max axial length is 2 mm).
Regarding Claim 18, Dinkler as modified discloses the body member has no cavities (see rejection for claim 1 where the body member has a single cavity for the protrusion but does not have any additional cavities, see 112 rejection above).
Regarding Claim 7, Dinkler as modified discloses the first reinforcing fiber is a carbon fiber (paragraph 28 in Lehmann) but does not disclose a length of 0.5 mm to 5 mm.
However, Lehmann further discloses that the carbon fiber can have a length of 0.1-2mm (paragraph 28).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Dinkler as modified to have the carbon fiber have a length of 0.5-2mm, such that it falls in the range of 0.5-2 mm in view of Lehmann above because this provides known values for the length of carbon fibers. The examiner also notes that the disclosed range in Lehmann significantly overlaps with 0.5-2 mm.
Regarding Claim 17, Dinkler discloses the tip member has a radius of curvature at an apex (conical point #300, Fig 3 in Dinkler where there is a radius of curvature at an apex) but does not disclose the radius of curvature at an apex of 0.2 mm.
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to have a radius of curvature at an apex of 0.2 mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art and since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous values a person ordinary skill in the art would find obvious for the purpose of providing a conical tip of a tip member. [In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980), se MPEP 2144.05 (II)]
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Dinkler US 2008/0251086, Lehmann US 2007/0233061, Bremer US 5,122,132 and Arn US 2007/0270801, as applied to claim 1 above, and in further view of Edlauer US 2009/0014011.
Dinkler as modified discloses the claimed invention as discussed above where ethe tip member is made out of ceramic (paragraph 26 in Dinkler) but does not disclose wherein the tip member includes at least one of zirconia, alumina, silicon carbide, silicon nitride, sialon, cordierite, ferrite, barium titanate, lead zirconate titanate, forsterite, zircon, mullite, steatite, and aluminum nitride as the ceramics.
Edlauer discloses a bone pin with a tip (Fig 7) made from silicon nitride (paragraph 64, 100, see also claim 9) a known type of ceramic that largely retains their symmetrical shape after having used compared to other materials in the art (paragraph 100).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Dinkler as modified to have the ceramic be silicon nitride in view of Edlauer above because this is a known type of ceramic in the art that largely retains their symmetrical shape after having used compared to other materials in the art.
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 JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773
