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 to clearly define what is considered the tip member. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The applicant argues that Bremer does not have a tapered member and shaft member as claimed and that the tip member of Bremer should also include section #21 and thus would not have a maximum diameter between 1.5-3mm. However, as discussed below, Dinkler already discloses the shaft member and tapered member as claimed. The conical tip member of Dinkler defines a terminal end for the skull pin. Bremer also has a conical tip member (#22) defining a terminal end of the bone pin, where the tip member has a maximum diameter between 1.5-3mm. The examiner interpreted the claims in view of applicant’s specification and drawings where a terminal end of the skull pin is the conical tip member. Dinkler and Bremer each have terminal ends defining conical tip members (see Fig below). Looking at the current invention, the conical tip member of Bremer was interpreted consistent with applicant’s specification (see annotated figs below). If one applies applicant’s arguments to their own invention, then their own invention would not read on the claims as one would have to include section #2 of applicant’s invention as the tip member. In short, Dinkler already discloses the tapered member and shaft where the rejection is not relying upon the Bremer for the shaft and tapered member but only for the maximum dimension of the tip member at the terminal end of the skull pin. At present, the examiner does not have a suggestion to overcome the rejection in view of Bremer as it relates to the maximum diameter of the tip member. Applicant is welcome to contact the examiner if they have questions.
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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 are rejected under 35 U.S.C. 103 as being unpatentable over Dinkler US 2008/0251086 in view of Lehmann US 2007/0233061 and Bremer US 5,122,132 (cited by applicant).
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).
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 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 and Bremer US 5,122,132, 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.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Dinkler US 2008/0251086 Lehmann US 2007/0233061 and Bremer US 5,122,132, as applied to claim 1 above, and in further view of Arn US 2007/0270801.
Regarding Claim 18, Dinkler as modified discloses the claimed invention as discussed above where the body member has a cavity (#410, Fig 4 in Dinkler) for receipt of a protrusion (#330 in Dinkler) of the tip member (paragraph 22, 29 in Dinkler) but does not disclose the body member has no cavities.
Arn discloses a skull pin (Fig 2) having a body member (#4) and a tip member (#5), where the body member has a cavity for placement of the tip member (Fig 7). Alternatively, there is a reverse configuration where the tip member has a cavity (#8), the body member has no cavities as it is fitted into the cavity of the tip member (Fig 2, see also Fig 3-6 where different shapes for the cavity of the tip member are contemplated, paragraph 29, 30, 33).
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 as modified to have no cavities, the tip member having a cavity that receives the body member in view of Arn above because this provides a known alternate configuration to couple the tip member to the body member. Furthermore, such a modification is merely a reversal of parts where 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. See MPEP 2144.04 (VI)(A). The examiner notes that Applicant has not claimed what defines “cavities” and the specification lacks any special definition for the term “cavities.”
Conclusion
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.
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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