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 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 1-9 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 1 recites “a plurality of bone anchors implanted onto a spinal column at multiple spine levels” (line 2). Such a recitation encompasses a human organism and is therefore unpatentable. In order to overcome this rejection, the Examiner suggests amending claim 1 to recite “a plurality of bone anchors configured to be implanted onto a spinal column at multiple spine levels” (line 2). Claims 2-9 are rejected because they depend from claim 1 and therefore also encompass a human organism.
Claims 10-15 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). Claim 10 recites “a plurality of bone anchors implanted onto a spinal column at multiple spine levels” (line 2). Such a recitation encompasses a human organism and is therefore unpatentable. In order to overcome this rejection, the Examiner suggests amending claim 10 to recite “a plurality of bone anchors configured to be implanted onto a spinal column at multiple spine levels” (line 2). Claims 11-15 are rejected because they depend from claim 10 and therefore also encompass a human organism.
Claims 16-20 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 16 recites “a plurality of bone anchors implanted onto a spinal column at multiple spine levels” (line 2). Such a recitation encompasses a human organism and is therefore unpatentable. In order to overcome this rejection, the Examiner suggests amending claim 16 to recite “a plurality of bone anchors configured to be implanted onto a spinal column at multiple spine levels” (line 2). Claims 17-20 are rejected because they depend from claim 16 and therefore also encompass a human organism.
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 1-9 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. It appears that Applicant has mixed up various components of the invention in the claims. Claim 1 recites that the first elongate member engages the second housing of the second bone anchor, that the first bearing component is connected to the first elongate member, and that the first pair of linkages is coupled to the first bearing component. Thus, because elongate member 68 engages the bone anchor housing (via housing-engaging feature 100), elongate member 68 must be the first elongate member, and therefore bearing component 54A must be the first bearing component and linkages 64A and 64B must be the first pair of linkages. Claim 1 recites that the second elongate member engages the rod, that the second bearing component is connected to the second elongate member, and that the second pair of linkages is coupled to the second bearing component. Thus, because elongate member 70 engages the rod (via rod-engaging feature 102), elongate member 70 must be the second elongate member, and therefore bearing component 54B must be the second bearing component and linkages 62A and 62B must be the second pair of linkages. Claim 1 then recites first and second lever arms extending from the second pair of linkages. However, as shown in Fig. 5, lever arms 66A and 66B extend from linkages 64A and 64B and therefore extend from the first pair of linkages. Furthermore, handles 72 and 74 cause the draw the bearing component 54B (the second bearing component, not the first bearing component) and elongate member 70 (the second elongate member, not the first elongate member) toward bearing component 54A (the first bearing component, not the second bearing component). In addition to claim 1, it appears that Applicant has incorrectly identified which bearing component the locking mechanism is connected to in claims 6 and 7 (button 82, which is the locking mechanism, is shown only on bearing component 54A) and which elongate member the detents are located on in claim 8 (detents 114A-114D are only shown on elongate member 68). Note that there may be additional components recited in the claims in a manner that does not correspond to the figures and the specification, and as such, the Examiner suggests Applicant read through the claims and compare the claims to the figures and specification to ensure that the components are properly recited in the claims. Claims 2-9 are rejected because they depend from claim 1.
Claims 10-15 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. Claim 10 recites the limitation "the first elongate mechanism" in line 2 of the paragraph beginning with “a handle mechanism.” There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner is interpreting “the first elongate mechanism” as “the first elongate member.” Claims 11-15 are rejected because they depend from claim 10.
Claim 12 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 12 recites the limitation "the first bearing" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner is interpreting “the first bearing” as “the first bushing.”
Claim 15 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 15 recites the limitations "the first bearing component" in line 2 and “the second bearing component” in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner is interpreting both “the first bearing component” and “the second bearing component” as “the bearing mechanism.”
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 the limitation "the first bearing" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner is interpreting “the first bearing” as “the first bushing.”
Claim 20 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 20 recites the limitations "the first bearing component" in line 4 and “the second bearing component” in line 5. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner is interpreting both “the first bearing component” and “the second bearing component” as “the bearing mechanism.”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 Oribe et al. (US 2005/0261702 A1).
Claim 1. Oribe discloses a system comprising:
a plurality of bone anchors (screws 3/103) implanted onto a spinal column at multiple spine levels;
a rod (rod 5/105) engaging first and second housings (head portions 53B) of first and second bone anchors of the plurality of bone anchors;
a rod reducer (instrument 11) configured to couple the rod to the second bone anchor, the rod reducer comprising:
a first elongate member (inner cylinder 13) engaging the second housing of the second bone anchor (via claw portions 15);
a second elongate member (outer cylinder 17) configured to slide along the first elongate member, the second elongate member engaging the rod positioned near the second housing;
a first bearing component (pivot 29) rotatably connected to the first elongate member;
a second bearing component (pins 25) rotatably connected to the second elongate member;
a hinge mechanism comprising:
a first pair of linkages (links 23) pivotably coupled to the first bearing component;
a second pair of linkages (links 21) pivotably coupled to the second bearing component;
first and second rotation elements (pins 27) connecting the first pair of linkages and the second pair of linkages; and
first and second lever arms (portions of links 23 extending upward above pivot 29 and engaged with pins 33) extending from the second pair of linkages; and
first and second handles (levers 31) connected to the first and second lever arms, respectively, configured to cause the second pair of linkages to draw the first bearing component and the first elongate member toward the second bearing component, causing the first elongate member to pull the second housing towards the first bearing component and the second elongate member to move the rod into the second housing;
wherein the first bearing component and the second bearing component permit the hinge mechanism to rotate about the first and second elongate members (Figs. 1-10C; paras. 0024-0058).
Claims 10, 11, 13, 16, 17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garamszegi (US 2007/0282337 A1).
Claim 10. Garamszegi discloses a system comprising:
a plurality of bone anchors (see “screws” in para. 0004) implanted onto a spinal column at multiple spine levels;
a rod (rod R) engaging first and second housings (coupling elements 220) of first and second bone anchors of the plurality of bone anchors;
a reducing mechanism (instrument 100) comprising:
a first elongate member (member 200) extending along an axis and configured to engage the second housing of the second bone anchor (via working end 210); and
a second elongate member (body 300) configured to slide along the first elongate member along the axis and configured to engage the rod when positioned near the second housing (via notch 305);
a hinge mechanism (portion of trigger element 400 extending from pivot point 430 toward ring 450; and portion of trigger element 500 extending from pivot point toward fork 520) slidably coupling the first elongate member and the second elongate member such that the first elongate member can translate relative to the second elongate member;
a handle mechanism (portion of trigger element 400 extending from pivot point 430 to connector 470; and portion of trigger element 500 extending from pivot point to ratchet mechanism 570) comprising a pair of handles (portion of trigger element 400 extending from pivot point 430 to connector 470; and portion of trigger element 500 extending from pivot point to ratchet mechanism 570) coupled to the hinge mechanism and configured to cause the hinge mechanism to translate the first elongate mechanism relative to the second elongate member, whereby the first elongate member pulls the second housing towards the rod to move the rod into the second housing; and
a bearing mechanism (ring 450, fork 520, and ring 550) configured to permit the handle mechanism to rotate about the axis independent of the first and second elongate members (Figs. 1-6; paras. 0017-0035).
Claim 11. Garamszegi discloses wherein the bearing mechanism comprises: a first bushing (ring 550) connected to the first elongate member; and a second bushing (ring 450) connected to the second elongate member (Figs. 1-6; paras. 0017-0035).
Claim 13. Garamszegi discloses wherein the reducing mechanism further comprises a locking mechanism (ratchet mechanism 570) configured to immobilize rotation of the handle mechanism relative to the reducing mechanism (Figs. 1-6; paras. 0017-0035).
Claim 16. Garamszegi discloses a system comprising:
a plurality of bone anchors (see “screws” in para. 0004) implanted onto a spinal column at multiple spine levels;
a rod (rod R) engaging a first but not a second housing (coupling element 220) of first and second bone anchors of the plurality of bone anchors;
a reducing mechanism (instrument 100) comprising:
a first elongate member (member 200) extending along an axis and configured to engage the second housing of the second bone anchor (via working end 210); and
a second elongate member (body 300) configured to slide along the first elongate member along the axis and configured to engage the rod when positioned near the second housing (via notch 305);
a hinge mechanism (portion of trigger element 400 extending from pivot point 430 toward ring 450; and portion of trigger element 500 extending from pivot point toward fork 520) slidably coupling the first elongate member and the second elongate member such that the first elongate member can translate relative to the second elongate member;
a handle mechanism (portion of trigger element 400 extending from pivot point 430 to connector 470; and portion of trigger element 500 extending from pivot point to ratchet mechanism 570) comprising a pair of handles (portion of trigger element 400 extending from pivot point 430 to connector 470; and portion of trigger element 500 extending from pivot point to ratchet mechanism 570) coupled to the hinge mechanism and configured to cause the first and second elongate members to translate relative to each other, whereby the first elongate member pulls the second housing towards the rod to move the rod into the second housing; and
a bearing mechanism (ring 450, fork 520, and ring 550) configured to permit the handle mechanism to rotate about the axis independent of the first and second elongate members (Figs. 1-6; paras. 0017-0035).
Claim 17. Garamszegi discloses wherein the bearing mechanism comprises: a first bushing (ring 550) connected to the first elongate member; and a second bushing (ring 450) connected to the second elongate member (Figs. 1-6; paras. 0017-0035).
Claim 19. Garamszegi discloses wherein the reducing mechanism further comprises a locking mechanism (ratchet mechanism 570) configured to immobilize rotation of the handle mechanism relative to the reducing mechanism (Figs. 1-6; paras. 0017-0035).
Double Patenting
Note that, upon amending the claims to overcome the various 35 U.S.C. 101 and 35 U.S.C. 112 rejections, one or more of claims 1-20 may be subject to a double patenting rejection in view of U.S. Patent No. 11,311,321 depending on the subject matter recited in the claims as amended.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm 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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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