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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 distal region plate and the proximal region plate moving within each other (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 Objections
Applicant is advised that should claim 1 be found allowable, claim 4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 1 recites …at least one plate central body…. Claim 4 recites …plate central body between the distal plate region plate and the proximal region plates…. Claim 4 appears to duplicate the limitation of claim 1. The claims appear to be a direct translation. The examiner recommends the applicant review the claims for any additional issues.
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 therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 2, 3, 6, 8, and 9 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 2 line 1 recites …the distal region plate, which is fixed to the distal of the femur bone… positively reciting a part of a human. Thus claim 2 includes a human within its scope and is non-statutory.
Claim 3 lines 2-3 recite …the proximal region plate, which is fixed with proximal region lock screws, in the proximal of the femur bone… positively reciting a part of a human. Thus claim 3 includes a human within its scope and is non-statutory.
Claim 6 line 2 recites …the plate central body, which is fixed to the bone… positively reciting a part of a human. Thus claim 6 includes a human within its scope and is non-statutory.
Claim 8 lines 3-5 recite …fixed with locking and non-locking screws in the distal, proximal and cortical regions on the femur bone… positively reciting a part of a human. Thus claim 8 includes a human within its scope and is non-statutory.
Claim 9 lines 2-4 recite …the distal region plate, the proximal region plate, and the plate central body in which stability is achieved with locked and unlocked screws in distal, proximal and cortical regions…of the long bone… positively reciting a part of a human. Thus claim 9 includes a human within its scope and is 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). The claims appear to be a direct translation. The examiner recommends the applicant review the claims for any additional issues under 35 U.S.C. 101.
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 1-10 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.
Claim 1 recites the limitation "the distal region plate" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim1 recites the limitation “the proximal region plate” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “in the proximal and distal direction” in line 4. There is insufficient antecedent basis for this limitation in the claim.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. The examiner has provided a few examples of the numerous 35 U.S.C. 112(b) issues in the claims. The examiner recommends the applicant review the claims for additional issues under 35 U.S.C. 112(b). For examination purposes, the examiner will interpret and reject the claims as best understood.
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.
Claims 1-10 are rejected as best understood under 35 U.S.C. 102(a)(1) as being anticipated by Reitzig (U.S. Patent 8,821,552).
Reitzig discloses a device (for example see Figures 7-12) comprising:
(claim 1) a distal region plate (a first element 28 near element 3)
(claim 2) wherein the distal region plate is capable of being fixed to a femur bone with distal region lock screws capable of not coming to a child growth line
(claim 5) a groove
(claim 10) a D-shaped tip (5)
(claim 1) a proximal region plate (2)
(claim 1) wherein the distal region plate and the proximal region plate are capable of moving within and being locked relative to each other (for example see Figure 4)
(claim 3) wherein the proximal region plate is capable of being fixed to a proximal region of a femur bone with proximal region lock screws
(claim 5) a groove
(claim 10) a D-shaped tip (5)
(claim 1) at least one plate central body (a second element 28 between the first element 28 and element 2; for example see Figure 12)
(claim 4) wherein the at last one plate central body is positioned between the distal region plate and the proximal region plate
(claim 4) wherein the at least one plate central body is configured to allow the proximal region plate and the distal region plate to slide relative to the at least one plate central body
(claim 6) wherein the at least one plate central body is capable of being fixed to a bone with diaphysis lock screws
(claim 7) wherein the distal region plate and the proximal region plate are capable of preventing rotation between each other while sliding axially relative to the at least one plate central body
(claim 8) wherein the at least one plate central body is configured to be a thin profile (bone plates are known to be designed with a think profile to limit inflammation)
(claim 8) wherein the at least one plate central body is capable of being placed on the distal and proximal anatomy of a femur bone
(claim 8) wherein the at least one central plate body is capable of being fixed to a femur bone with locking and non-locking screws in the distal, proximal, and cortical regions of the femur bone
(claim 8) wherein the distal region plate and the proximal region plate are capable of moving telescopically relative to the at least one central plate body
(claim 9) wherein the proximal region plate, the distal region plate, and the at least one central plate body are capable of being fixed on the proximal and distal anatomy of a long bone with locked and unlocked screw in the distal, proximal, and cortical regions
(claim 10) wherein the D-shaped tips of the proximal region plate and the distal region plate are received within the at least one central plate body and are capable of allowing axial movement in a distal direction and a proximal direction
(claim 5) fixing screws (18)
(claim 5) wherein the fixing screws and the grooves in the proximal regional plate and the distal region plate are capable of preventing sliding motion between the plates after tightening the fixing screws in the plate central body (the plate portions can be positioned such that the bone segments are touching and prevented from sliding more into each other)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited reference 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775