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 Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claims 1-5 are rejected under 35 U.S.C. 101 because they are drawn to non-statutory subject matter. In claim 1, line 2, the applicant positively recites part of a human, i.e. "…a guide portion disposed on a front side of the tibia…”. In claim 1, line 5, the applicant positively recites part of a human, i.e. “…a retractor portion disposed on a back side of the tibia…”. In claim 1, lines 10-11, the applicant positively recites part of a human, i.e. “…a fixing portion that fixes the guide portion with respect to the tibia…”. Thus claims 1-5 include a human within their scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970).
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 1 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 1 recites the limitation "the tibia" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ammann (U.S. Publication 2007/0244487).
Ammann discloses a device (for example see Figure 20) comprising:
(claim 1) a guide portion (600)
(claim 1) wherein the guide portion is capable of being disposed on a front side a tibia
(claim 1) wherein the guide portion guides a bone cutting tool (625) for cutting the tibia
(claim 1) wherein the guide portion includes a guide hole (615)
(claim 1) wherein the guide hole receives the bone cutting tool
(claim 1) wherein the guide hole penetrates the guide portion in the first direction, i.e. the direction of the thickness of the bone between the guide portion and the retractor portion) and extends in a second direction, i.e. perpendicular to the first direction, intersecting the first direction
(claim 1) a retractor portion (500)
(claim 1) wherein the retractor portion is capable of being disposed on a back side of the tibia
(claim 1) wherein the retractor portion is arranged to be spaced apart from the guide portion in a first direction, i.e. the depth of the bone between the retractor portion and the guide portion
(claim 1) wherein the retractor portion is disposed in a region overlapping at least the guide hole in a plan view in the first direction (for example see paragraph 106)
(claim 1) a connection portion (620)
(claim 1) wherein the connection portion connects the guide portion and the retractor portion
(claim 1) a fixing portion (300)
(claim 20) wherein the fixing portion fixes the guide portion with respect to the tibia
(claim 5) a first unit including the guide portion and a portion of the connection portion (the flange of element 600 that connects with element 620; see Figure 20)
(claim 5) a second unit including the retractor portion and another portion of the connection portion (the flange of element 500 that attaches to 620 and the flange of element 600; see Figure 20) for attaching to the other portion of the first unit
(claim 5) wherein the second unit is capable of being used with either the left leg or the right leg
Allowable Subject Matter
Claims 2-5 are 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. However, claims 2-5 are rejected under 35 U.S.C. 101 and 35 U.S.C. 112(b) as discussed above.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, Robichaud (U.S. Patent 11,589,876) teaches a device (for example see Figure 1) comprising a guide portion (117) that guides a bone cutting tool, i.e. a saw blade, and another guide portion (115) that includes a plurality of pin holes (122) that guide a pin through the guide portion and into a bone in order to weaken the bone in the same plane as the cutting guide to ease cutting the bone with the bone cutting tool (see column 11 line 57 to column 12 line 16).
Regarding claim 2, the examiner was unable to find a reference or a combination of references that disclose and/or teach the connection portion having a holding portion that alternately holds the guide portion and the other guide portion such that the guide hole and the plurality of pin holes are arranged at a same position.
Regarding claim 3, the examiner was unable to find a reference or a combination of references that disclose and/or teach the invention of claim 1 wherein the fixing portion including a first clamping portion and a second clamping portion to sandwich a tibia and an adjustment portion that adjusts a distance between the clamping portions.
Regarding claim 5, the examiner was unable to find a reference or a combination of references that disclose and/or teach the invention of claim 1 further comprising a second unit for a left leg and a second unit for a right leg, wherein the second unit for the left leg and the second unit for the right leg are symmetrical to each other to a plane in the first direction.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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