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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-5, 8, 11-13, 15-16 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-5, 8, 11-13, 15-16 of U.S. Patent No. 12,042,182 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The table below shows the application claims and the patent claims side by side for direct comparison, with the differences between the claims are highlighted below by bolding all the limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Application Claims:
Patent Claims:
1. A coupling device for coupling a rod to a bone anchoring element, the coupling device comprising: a receiving part having a first end and a second end below the first end, a central axis extending through the first end and the second end, an accommodation space for accommodating a head of the bone anchoring element, an opening at the second end, and a recess at the first end for receiving the rod, the recess forming two legs; and a pressure member arranged at least partially in the accommodation space, the pressure member being adjustable from a first configuration where a topmost end of the pressure member is at a first axial position and an inserted head is pivotable in the accommodation space to a second configuration where the topmost end of the pressure member is at a second axial position below the first axial position and the pressure member exerts pressure onto the inserted head to provisionally lock the inserted head; wherein at the second configuration, a latching connection is formed between the pressure member and the receiving part to at least temporarily prevent the pressure member from being adjusted back towards the first configuration, and wherein the latching connection is releasable to adjust the pressure member from the second configuration back towards the first configuration.
1. A coupling device for coupling a rod to a bone anchoring element, the coupling device comprising: a receiving part having a first end and a second end below the first end, a central axis extending through the first end and the second end, an accommodation space for accommodating a head of the bone anchoring element, an opening at the second end sized to facilitate insertion of the head therethrough, and a recess at the first end for receiving the rod, the recess forming two legs; and a pressure member arranged at least partially in the accommodation space, the pressure member being adjustable from a first configuration where a topmost end of the pressure member is at a first axial position and an inserted head is pivotable in the accommodation space but prevented from removal from the accommodation space through the opening, to a second configuration where the topmost end of the pressure member is at a second axial position below the first axial position and the pressure member exerts pressure onto the inserted head to provisionally lock the inserted head; wherein at the second configuration, a latching connection is formed between the pressure member and the receiving part to at least temporarily prevent the pressure member from being adjusted back towards the first configuration, and wherein the latching connection is releasable by exerting a force in a direction transverse to the central axis from outside the receiving part on the pressure member to adjust the pressure member from the second configuration back towards the first configuration.
2. The coupling device of claim 1, wherein the pressure member comprises a head contacting portion configured to contact the head when the pressure member is in the accommodation space, and two arms extending away from the head contacting portion, wherein each of the legs defines a slot arranged between an outer wall and an inner wall of the legs, and wherein each of the arms extends into a respective one of the slots.
2. The coupling device of claim 1, wherein the pressure member comprises a head contacting portion configured to contact the head when the pressure member is in the accommodation space, and two arms extending away from the head contacting portion, wherein each of the legs defines a slot arranged between an outer wall and an inner wall of the legs, and wherein each of the arms extends axially into a respective one of the slots.
3. The coupling device of claim 2, wherein the pressure member comprises a first engagement portion and the receiving part comprises a second engagement portion, and wherein the latching connection is established when one of the first or second engagement portions snaps below the other one of the first or second engagement portions.
3. The coupling device of claim 2, wherein the pressure member comprises a first engagement portion and the receiving part comprises a second engagement portion, and wherein the latching connection is established when one of the first or second engagement portions snaps below the other one of the first or second engagement portions.
4. The coupling device of claim 3, wherein the first engagement portion is located at the arms of the pressure member, and the second engagement portion is located in the slot of the receiving part.
4. The coupling device of claim 3, wherein the first engagement portion is located at the arms of the pressure member, and the second engagement portion is located in the slot of the receiving part.
5. The coupling device of claim 2, wherein respective free ends of the arms of the pressure member are exposed to the outside at the first end of the receiving part.
5. The coupling device of claim 2, wherein respective free ends of the arms of the pressure member are exposed to the outside at the first end of the receiving part.
8. The coupling device of claim 1, wherein the pressure member is adjustable to the second configuration by exerting an axial force onto the topmost end of the pressure member.
8. The coupling device of claim 1, wherein the pressure member is adjustable to the second configuration by exerting an axial force onto the topmost end of the pressure member.
11. The coupling device of claim 1, wherein in the first configuration, the pressure member exerts a pressure on the inserted head to restrict pivoting of the head, while the recess of the receiving part remains substantially unobstructed such that a rod is insertable into and movable in the recess.
11. The coupling device of claim 1, wherein in the first configuration, the pressure member exerts a pressure on the inserted head to restrict pivoting of the head, while the recess of the receiving part remains substantially unobstructed such that a rod is insertable into and movable in the recess.
12. The coupling device of claim 11, wherein the coupling device is configured to maintain the first configuration without engaging a rod, fixation member, or instrument.
12. The coupling device of claim 11, wherein the coupling device is configured to maintain the first configuration without engaging a rod, fixation member, or instrument.
13. The coupling device of claim 1, wherein the receiving part comprises extensions that respectively extend above the legs, and wherein each of the extensions comprises an abutment for limiting upward movement of the pressure member in the first configuration.
13. The coupling device of claim 1, wherein the receiving part comprises extensions that respectively extend above the legs, and wherein each of the extensions comprises an abutment for limiting upward movement of the pressure member in the first configuration.
15. The coupling device of claim 1, wherein the receiving part and the pressure member are monolithically formed with one another.
15. The coupling device of claim 1, wherein the receiving part and the pressure member are monolithically formed with one another.
16. The coupling device of claim 1, wherein the receiving part and the pressure member are formed together by using an additive manufacturing method.
16. The coupling device of claim 1, wherein the receiving part and the pressure member are formed together by using an additive manufacturing method.
As is evident from the table above the Patent claims disclose all of the features of the application claims, with additional features not required by the application claims.
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(s) 11 is/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 11 recites the limitation “wherein in the first configuration, the pressure member exerts a pressure on the inserted head to restrict pivoting of the head” in lines 1-3 which renders the claim indefinite, since claim 1 recites the limitation “the pressure member being adjustable from a first configuration where a topmost end of the pressure member is at a first axial position and an inserted head is pivotable in the accommodation space” in lines 7-10. It is unclear how in the first configuration the pressure member can both enable the inserted head to pivot and to restrict pivoting of the head. It appears that the claim should recite “wherein in the second configuration”, and for the purpose of compact prosecution will be examined below under this assumption.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 8, 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson (U.S. Pub. No. 2006/0276789 A1, hereinafter “Jackson”).
Jackson discloses, regarding claim 1, a coupling device (1, see Fig. 1) for coupling a rod (21, see Fig. 22) to a bone anchoring element (6), the coupling device comprising: a receiving part (10) having a first end (e.g. end near 62, see Fig. 14) and a second end below the first end (e.g. end near 83, see Fig. 14), a central axis (C, see Fig. 1) extending through the first end and the second end (see Fig. 1), an accommodation space (78) for accommodating a head (8) of the bone anchoring element (see Fig. 22), an opening (84) at the second end (see Fig. 22), and a recess (56) at the first end for receiving the rod (21, see para. [0073]), the recess forming two legs (52, see Fig. 10); and a pressure member (14) arranged at least partially in the accommodation space (see Fig. 14), the pressure member being adjustable from a first configuration where a topmost end of the pressure member is at a first axial position and an inserted head is pivotable in the accommodation space (see Fig. 10, see paras. [0079] and [0104]) to a second configuration where the topmost end of the pressure member is at a second axial position below the first axial position and the pressure member exerts pressure onto the inserted head to provisionally lock the inserted head (see Fig. 11, see para. [0087]); wherein at the second configuration, a latching connection (124 and 89, see para. [0085]) is formed between the pressure member and the receiving part to at least temporarily prevent the pressure member from being adjusted back towards the first configuration (see Fig. 14, see para. [0085]), and wherein the latching connection is releasable to adjust the pressure member from the second configuration back towards the first configuration (see Fig. 23, see para. [0087]).
Regarding claim 2, wherein the pressure member comprises a head contacting portion (see annotated Fig. 14 below) configured to contact the head when the pressure member is in the accommodation space, and two arms extending away from the head contacting portion, wherein each of the legs defines a slot arranged between an outer wall and an inner wall of the legs (see annotated Fig. 14 below), and wherein each of the arms extends into a respective one of the slots (see Fig. 14, note that teeth 124 on each arm extend axially into the slot).
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Regarding claim 3, wherein the pressure member comprises a first engagement portion (124) and the receiving part comprises a second engagement portion (89), and wherein the latching connection is established when one of the first or second engagement portions snaps below the other one of the first or second engagement portions (see para. [0085]).
Regarding claim 4, wherein the first engagement portion is located at the arms of the pressure member (see Fig. 23), and the second engagement portion is located in the slot of the receiving part (see annotated Fig. 1 below).
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Regarding claim 5, wherein respective free ends of the arms of the pressure member are exposed to the outside at the first end of the receiving part (see Fig. 10).
Regarding claim 8, wherein the pressure member is adjustable to the second configuration by exerting an axial force onto the topmost end of the pressure member (via 154, see Fig. 14).
Regarding claim 11, wherein in the first configuration, the pressure member exerts a pressure on the inserted head to restrict pivoting of the head, while the recess of the receiving part remains substantially unobstructed such that a rod is insertable into and movable in the recess (see para. [0067], “the insert 14 allows for setting an angle of articulation between the shank body 6 and the head or receiver 10 prior to insertion of the rod 21”).
Regarding claim 12, wherein the coupling device is configured to maintain the first configuration without engaging a rod, fixation member, or instrument (see Fig. 11, see paras. [0085] and [0087]).
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.
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.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jackson, as applied to claim 1 above, and in view of Biedermann et al. (U.S. Pub. No. 2016/0331412 A1, hereinafter “Biedermann”).
Jackson discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 15, wherein the receiving part and the pressure member are monolithically formed with one another; and regarding claim 16, wherein the receiving part and the pressure member are formed together by using an additive manufacturing method.
Biedermann discloses a coupling device (see Fig. 1) for coupling a rod (100) to a bone anchoring element (1), with a receiving part (5) and a pressure member (6), wherein the receiving part and the pressure member are manufactured as a monolithic piece (see para. [0015]) using additive manufacturing method (see para. [0015]) and by exerting a force the connection breaks at the predetermined breaking point (see para. 0015]) in order to provide a suitable manufacturing method capable of manufacturing the sophisticated structures of the coupling device components (see para. [0015]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify receiving part and the pressure member in Jackson to be manufactured as a monolithic piece using additive manufacturing method and by exerting a force the connection breaks at the predetermined breaking point in view of Biedermann in order to provide a suitable manufacturing method capable of manufacturing the sophisticated structures of the coupling device components.
Allowable Subject Matter
Claim(s) 13 is/are would be allowable if a terminal disclaimer is filed to overcome the nonstatutory double patenting rejection, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, a coupling device comprising a receiving part and a pressure member, the pressure member being adjustable from a first configuration where a topmost end of the pressure member is at a first axial position and a second configuration where the topmost end of the pressure member is at a second axial position below the first axial position, wherein at the second configuration, a latching connection is formed between the pressure member and the receiving part to at least temporarily prevent the pressure member from being adjusted back towards the first configuration; and as per claim 13, wherein the receiving part comprises extensions that respectively extend above the legs, and wherein each of the extensions comprises an abutment for limiting upward movement of the pressure member in the first configuration.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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