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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “22” has been used to designate both the “femoral neck prosthesis” and the “barb structures” (see Figure 2).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference characters “401” and “402” are not in the description.
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. 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.
Specification
The disclosure is objected to because of the following informalities:
In the specification, reference number “22” has been used to identify the “femoral neck prothesis” and “the plurality of barb structures” (see paragraphs [0082] and [0083]).
In the specification, reference number “23” has been used to identify the “outer cup” and the “silica gel column” (see paragraph [0085]. Also, the reference numbers “201” and “23” have been used to identify the “silica gel column” (see paragraph [0085]).
Appropriate correction is required.
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 1-15 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).
In claim 1, lines 6-7, applicant positively recites part of a human, i.e. “the femoral head prosthesis partially protruding from the first end of the channel”. Thus, claims 1-15 include a human within their scope and are non-statutory.
Applicant is advised to recite the channel functionally, e.g. -- the femoral head prosthesis is adapted to partially protrude from a first end of the channel --. It would be considered as such for examination purposes and applicant is encouraged to amend the claim as such.
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 1-15 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.
In claim 1, line 6, “radially” is unclear without identifying the reference axis. Applicant is advised to amend the claim to recite with respect to what the nail hole penetrates radially, e.g. -- the prosthesis being provided with a nail hole penetrating radially a longitudinal axis of the prosthesis --, and will be considered as such for examination purposes. It is noted that the prosthesis has inherently a longitudinal axis, thus is not considered new matter.
In claim 1, line 6, “the first end” lacks antecedent basis. It should be amended to recite -- a first end --, and will be considered as such for examination purposes.
In claim 1, lines 9 and 10, “a guiding frame, a positioning sleeve and a guiding sleeve being arranged on the guiding frame” is indefinite because it is unclear what is arranged on the guiding frame, e.g. just the guiding sleeve or the positioning sleeve and guiding sleeve. Applicant is advised to amend the claim by changing the comma (,) after “a guiding frame” to a semi colon (;) , e.g. -- a guiding frame; a positioning sleeve and a guiding sleeve being arranged on the guiding frame --. It will be considered as such for examination purposes.
In claim 1, lines 10-12, “and positioning the extension rod” is indefinite because it is unclear what this statement means, e.g. it appears to be a method step in an apparatus claims. For examination purposes it will be interpreted as follow, -- the positioning sleeve being sleeved outside the extension rod such that a center line of the guiding sleeve and a center line of the nail hole are on a same line -- .
In claim 1, line 12, “the same straight line” lacks antecedent basis.
In claim 1, line 13, “to fix to” is unclear. Should be amended to -- to be fixed to --, and will be considered as such for examination purposes.
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 1-3, 11, 12 is/are rejected, as understood, under 35 U.S.C. 102(a)(1) as being anticipated by Cortes Cubero, et al. (Pub. No.: US 2020/0323575 A1).
With regard to claim 1, Cortes Cubero et al. disclose a prosthesis system comprising a prosthesis (see figure 8, combination of elements 1 and 2) configure to fill in a channel in a direction of a femoral head (see for example figure 12K), the prosthesis 2 having a first end and a second end opposite each other, a femoral head prosthesis 1 is provided at the first end of the prosthesis, the prosthesis is provided is a nail hole 21 penetrating radially. The femoral head prosthesis is capable of partially protrude a first end of the channel. The system further includes an extension rod (for example rod 402, see figures 12Ji, 12Jii and 30) detachably and fixedly connected with the second end of the prosthesis (see paragraph [0346]). The system further has a guiding frame (see figures 12Jii, 12K). The system also includes a positioning sleeve 401 and a guiding sleeve (see for example annotated figures 36c and 36B, below). The positioning sleeve 401 is positioned outside the extension rod 402. A center line of the guiding sleeve and a center line of the nail hole 21 are on a same straight line (see for example annotated figure 12Q, below). The system further has a locking nail 3 (see for example figures 10 and 11). The locking nail 3 is configured to be fixed in the nail hole 21 and both ends of the locking nail 3 protrude out of the prosthesis (see for example figures 10 and 11).
PNG
media_image1.png
883
673
media_image1.png
Greyscale
PNG
media_image2.png
908
1372
media_image2.png
Greyscale
With regard to claim 2, Cortes Cubero et al. disclose that the guiding frame has a U-shaped structure (see for example paragraph [0317], i.e. “multi-function handle guide 140 may have a generally U-shaped body 141”). The guiding frame (see for example annotated figure 12N, below) has a connecting end and a free end opposite each other. The positioning sleeve is arranged at the connecting end and the guiding sleeve is arranged at the free end (see annotated figure 12N, below).
PNG
media_image3.png
748
927
media_image3.png
Greyscale
With regard to claim 3, the locking nail 3 can be considered a hollow structure since part of the nail is hollow to receive bolt 107 (see for example figures 6A, 6E, 6F, 11).
With regard to claims 11 and 12, the prosthesis has a hollow structure (see for example figure 5C, e.g. the prosthesis has a longitudinal hole 23. The prosthesis can be considered a cage, e.g. has holes in the outer wall and the holes communicate with a longitudinal hole 23.
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Cortes Cubero et al. in view of Fixel (US Patent No. 5112333).
Cortes Cubero et al. disclose the claim invention except for external threads provided on an outer surface of the locking nail (it is noted that the locking nail of Cortes Cubero et al. is an intramedullary nail).
Fixel discloses an intramedullary nail (see figure 1) with the stem portion 11 having outer threads (see figure 1). Fixel discloses a number of reasons of why you would want to provide an intramedullary nail with an outer threaded portion (see column 2, lines 19-42), .e.g. to provide an intramedullary nail which will allow proper fixation of a closed, an open, or any other type of break or fracture of the femur or tibia.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the system of Cortes Cubero et al. with the locking nail, i.e. an intramedullary nail, having an outer threaded surface in view of Fixel, in order to ensure proper fixation of a closed, open, or any other type of break or fracture of the femur or tibia.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cortes Cubero et al.
Cortes Cubero et al. disclose the claim invention except for having two sets of the system.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the system of Cortes Cubero et al. with multiple sets of the parts of the system, e.g. multiple guide sleeve, locking nails, etc. since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Cortes Cubero et al. in view of Fagan (US Patent No. 8491584).
Cortes Cubero et al. disclose the claim invention except a plurality of barbs on an external surface of the prosthesis.
Fagan discloses a system similar to the one from Cortes Cubero et al. The system includes an intramedullary nail 40 and a prosthesis (i.e. body 201; It is noted that body 201 can reasonably be described as a temporary prosthesis since it occupies anatomical space normally filled by bone). The prosthesis 201, includes tangs 224 on the external surface (it is noted that tangs 224 are considered to be barbs, i.e. a sharp projection near the end of an arrow, fishhook, or similar item, angled away from the main portion so as to make extraction difficult) . The use of tangs or barbs 224 increases the mechanical connection between the bone and the prosthesis. The mechanical connection also fixes the prosthesis axially with respect to the bone, thus preventing unwanted rotation (see Fagan, column 6, lines 44-49).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the system of Cortes Cubero et al. with the prosthesis having a plurality of tangs/barbs on the outer surface in view of Fagan, in order to increase the mechanical connection between the bone and the prosthesis and fixing the prosthesis axially with respect to the bone thus preventing unwanted movements, e.g. rotation.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Cortes Cubero et al.
Cortes Cubero et al. disclose that femoral head prosthesis 1 can be unipolar, as described in the reference, or can be bipolar, i.e. a two-piece head assembly.
Cortes Cubero et al. disclose the claim invention except for the head prosthesis being integrally formed with the prosthesis.
It would have been obvious to one skill in the art at the time the invention was made to construct the system of Cortes Cubero et al. with the head prosthesis integral with the prosthesis, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Allowable Subject Matter
Claims 5, 7-10 and 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited art of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eduardo C Robert whose telephone number is (571)272-4719. The examiner can normally be reached M-F: 8 AM-4:30 PM.
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, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773