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 .
Election/Restrictions
Applicant's election with traverse of Group I, Species 1, and Species i in the reply filed on 06/29/2026 is acknowledged. The traversal is on the ground(s) that “because Groups I, II, and III would “all be equally as useful for securing wires to a wall,” none has separate utility.” This is not found persuasive because this combines two different inquiries. MPEP § 806.05(c)(B) asks whether the subcombination has utility other than as used in the claimed combination. It does not require that the asserted utility be unavailable to, or different from, the utility of the combination. That the combination may also be capable of a given use is irrelevant to whether the subcombination is limited to use in that combination.
The fastener assembly of Group I has utility apart from the fastener kit of Group III. The assembly of claim 1 requires none of the additional components recited in claim 23 and may be used as a standalone bone anchor or in materially different combinations, including with a laminar or pedicle hook, a rod-to-rod or lateral offset connector, a bone plate, a cable or tether construct, or an external fixation frame. It further has utility in non-spinal osteosynthesis, including sacroiliac, pelvic, long bone, sternal, and craniomaxillofacial fixation.
The receiver of Group II has utility apart from the fastener assembly of Group I. The receiver of claim 9 is recited in structural terms and is not limited to the particular bone shank of claim 1. It may be assembled to a hook, a bolt, a cable anchor, a rod-to-rod connector, or a bone anchor of structure materially different from that claimed in Group I.
An example of separate utility is provided. The utility need not be the preferred, commercially desirable, or patentable use of the subcombination. Applicant’s assertion that a person of ordinary skill would find a particular use “extremely unreasonable” is unsupported by evidence and does not establish that the subcombinations are incapable of use outside their respective combinations.
The search burden is reiterated: the inventions are classified in divergent areas (A61B17/7032, A61B17/7037, and A61B17/70), require different fields of search, and require different search queries directed to non-coextensive structural features, such that a search for one group would not necessarily encompass a search for the others.
The requirement is still deemed proper and is therefore made FINAL.
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 1-8 and 27-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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, in the final "wherein" clause, "when the pressure insert is in a second longitudinal position distal, the ridge is disengaged from the depression." The term "distal" is a relative term recited without a reference point, and it is unclear whether the second longitudinal position is distal to the first longitudinal position, distal to the ridge, or distal to some other structure. The metes and bounds of the claim cannot be determined. For purposes of examination, the limitation is interpreted as "a second longitudinal position distal to the first longitudinal position."
Claim 1 further recites that, in the second longitudinal position, the ridge is "urged” against the rounded corner of the pressure insert. No structure is recited that performs the urging, and it is unclear whether the claim requires an additional element (e.g., a compression screw or rod) to establish the recited relationship. Clarification is required.
Claim 3 recites "the receiver comprises an interior conical surface defining the chamber." Claim 1, from which claim 3 ultimately depends, already requires "the chamber comprising a conical interior surface." It is unclear whether the "interior conical surface" of claim 3 is the same surface as the "conical interior surface" of claim 1 or an additional, distinct surface. Consistent terminology is required.
Claim 5 recites that the compression screw is “configured to compress the fixation rod against the pressure insert." The fixation rod is not positively recited as an element of the claimed assembly (claim 1 recites only "a channel for receiving a fixation rod therein"), and it is therefore unclear whether the claim requires the presence of the rod. See MPEP § 2115.
Claim 9 is rejected on two grounds:
(a) The claim recites "a head of a bone shank" in the axial bore limitation and later recites "a head portion of a bone shank" in the split retainer ring limitation. It is unclear whether these are the same element. Consistent terminology is required.
(b) The claim recites maintaining the pressure insert "in a first state associated with a first longitudinal position within the receiver." The term "state" is not defined in the specification in structural terms, and it is unclear what structural condition of the pressure insert, if any, distinguishes the "first state" from the recited first longitudinal position itself.
Claim 27 recites "a depression in the surface of the axial bore." There is insufficient antecedent basis for "the surface" in the claim.
Claim 27 further recites "a ridge protruding from the exterior surface of the pressure insert." There is insufficient antecedent basis for "the exterior surface" in the claim.
Claims 2, 4-8, 28 and 29 are rejected as depending from, or as reciting the same deficiencies as, the rejected claims above.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 7 recites that the groove "comprises a non-symmetrical cross-sectional profile." The specification describes the circumferential depression 305 of the pressure cap as semi-circular (see par. 0102) and describes the cooperating detent 220 as having a symmetrical cross-section rounded on both its top and bottom sides (see par. 0097). The specification does not appear to describe a depression or groove having a non-symmetrical cross-sectional profile. Applicant is requested to identify support for this limitation.
Claim Rejections - 35 USC § 103
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 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 1-2, 6-8, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson (US 9,883,892 B2) in view of Biedermann et al. (US 9,486,246 B2).
Regarding claim 1, Jackson discloses a fastener assembly for a spinal fixation system comprising: a bone shank (shank 4) comprising a head portion (integral upper portion) and a distal threaded portion configured to be implanted into bone; a receiver (receiver 10) comprising: a channel for receiving a fixation rod therein (upper channel for receiving a longitudinal connecting member); and an axial bore extending longitudinally through the receiver from a proximal opening of the receiver to a distal opening, the distal opening being sized and shaped to receive the head portion of the bone shank therethrough (lower cavity 61 communicating with a lower opening, the shank upper portion being up-loadable through the lower opening); a chamber (see Fig. 24, element 61) disposed adjacent the distal opening, the chamber comprising a conical interior surface, the conical interior surface comprising a distal portion having a first diameter (see Fig. 24, near element 101), and a proximal portion (see Fig. 24, near element 97) having a second diameter larger than the first diameter; and a split retainer ring (friction-fit split retaining ring 12; see col. 14, lines 7-8) disposed in the chamber, the split retainer ring being configured to expand within the chamber to allow the head portion of the bone shank to pass therethrough and thereafter support the head portion in a pivotable relationship (pop-on/snap-on assembly of the shank with the receiver, the retainer thereafter capturing the shank upper portion); and a pressure insert (compression insert 14) disposed at least partly above the split retainer ring, the pressure insert comprising: a saddle (see Fig. 17, near element 175) configured to seat the fixation rod; a distally-facing concave surface (see Fig. 19, near element 173) configured to contact the head portion of the bone shank. Jackson further discloses that the pressure insert is movable longitudinally within the receiver between an upper position and a lower position, that the pressure insert outer surface is releasably frictionally locked against the receiver, and that the pressure insert frictionally engages the shank upper portion so as to provide an unlocked but non-floppy positioning of the shank relative to the receiver prior to final locking.
Jackson does not explicitly disclose a ridge protruding from a surface of the axial bore, a depression formed in an exterior surface of the pressure insert, or the recited engagement of the depression with the ridge to maintain the insert at a first longitudinal position with disengagement at a second, distal longitudinal position.
Biedermann teaches a bone anchoring device having a receiving part and a pressure element, wherein a projection (83) on the pressure element engages a recessed portion (9d) formed in the receiving part such that the pressure element is retained against escaping from the receiving part, and wherein the pressure element is thereafter movable within the receiving part until the projection abuts an edge of the recess, which acts as a stop (Biedermann, FIGS. 10a-10d and accompanying text). Biedermann thus teaches an interengaging projection-and-recess detent between a pressure element and a receiving part that indexes the pressure element at defined longitudinal positions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the receiver and compression insert of Jackson with the interengaging projection-and-recess detent taught by Biedermann in order to retain the compression insert at a predetermined longitudinal position within the receiver during assembly, thereby preventing inadvertent migration or escape of the insert prior to rod placement, as expressly taught by Biedermann.
With respect to the particular arrangement in which the ridge is carried by the receiver bore and the depression is carried by the insert exterior, the reverse of Biedermann's arrangement, it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. No unexpected result is attributed to the reversal in the present record.
Regarding claim 2, Jackson discloses a spherical shank upper portion and a retainer having an inner concave radiused (partially spherical) surface 132 contacting that portion to provide the pivotable relationship.
Regarding claims 6-8, Biedermann teaches the detent recess and cooperating projection; providing the depression as a groove extending circumferentially across the exterior of the insert, and selecting symmetrical versus non-symmetrical cross-sectional profiles for the cooperating groove and ridge, would have been obvious matters of design choice absent a showing of criticality, since a circumferential groove permits engagement irrespective of the rotational orientation of the insert and rounded/asymmetric profiles are conventional means of tuning the insertion and withdrawal forces of a detent.
Regarding claims 27-29, claim 27 recites the same structure as claim 1 except that the ridge is formed in the pressure insert and the depression is formed in the receiver bore. Biederman expressly discloses a ridge formed in the pressure insert and a depression formed in the receiver bore (projection 83 on the pressure element; recess 9d in the receiving part), and the combination is therefore rejected for the reasons given with respect to claim 1, without need for reliance on reversal of parts.
Claim 28's rounded corner adjacent the depression is taught by Biedermann's recess edge acting as a stop and by Jackson's frictional insert-to-receiver interface. Claim 29 is rejected for the reasons given with respect to claim 2.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 9,782,204 B2 (Spratt et al.) disclose a receiver member having an annular groove in its inner wall carrying a split drag ring that frictionally engages the head of the bone anchor.
US 11,439,437 B2 (Roberts et al.) and US 12,201,327 B2 (Roberts et al.) disclose bottom-loading bone anchor assemblies having a retaining ring seated in a groove formed in the receiver member and a saddle advanced through the distal opening to bias the shank head.
US 9,414,863 B2 (Jackson) discloses a compression insert having shallow grooves in its outer surface that receive receiver tabs in frictional engagement.
US 7,682,377 B2 (Konieczynski et al.) disclose a polyaxial bone screw having a compression cap with a concave distal surface seating the head, and a ring member disposed in a groove of the receiver.
US 8,974,501 B2 (Dikeman) discloses a distal-loading receiver with cooperating ribs and transverse recesses joining a retaining ring to the receiver body.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773
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