DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 4 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. It is unclear how the male member is integrally formed with the second coupler as the male member is the second coupler. For examination purposes, the Examiner is interpreting claim 4 as reciting that the male member is integrally formed with the second body.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1, 5, 7, 9-12, and 15-17 are rejected under pre-AIA 35 U.S.C. 102(a) and 35 U.S.C. 102(e) as being anticipated by Moore et al. (US 2008/0306538 A1).
Claim 1. Moore discloses a coupling assembly comprising:
a first body (rod connection member 12) comprising:
a first coupler (ball joint receptacle 34); and
a first receptacle (upper portion 46 of receptacle 40) configured to receive a first anchor (screw 42); and
a second body (rod connection member 14 and cross member connecting assembly 20, in combination) comprising:
a second coupler (cross connecting member 96) configured to couple with the first coupler; and
a second receptacle (upper portion 46 of receptacle 40) configured to receive a second anchor (screw 42),
wherein at least one of the first coupler and the second coupler comprises a female member (ball joint receptacle 34), and another of the at least one of the first coupler and the second coupler comprises a male member (cross connecting member 96) comprising a rounded portion (ball 64) configured to be inserted at a selectively adjustable and polyaxial angle into the female member to couple the first body and the second body together in a rigid relationship (Figs. 5A-7C and 11A-12; paras. 0030-0043).
Claim 5. Moore discloses wherein the rounded portion is integrally formed with the male member (Figs. 5A-7C and 11A-12; paras. 0030-0043).
Claim 7. Moore discloses a coupling assembly comprising:
a first anchor (screw 42) comprising:
a first anchor shaft (portion extending from flange 52 and including threaded portion 50); and
a first anchor head (head 54 and flange 52) coupled to the first anchor shaft;
a second anchor (screw 42) comprising:
a second anchor shaft (portion extending from flange 52 and including threaded portion 50); and
a second anchor head (head 54 and flange 52) coupled to the second anchor shaft;
a rod (cross member connecting assembly 20) comprising a first end (end with ball 64) and a second end (end with ball 82);
a first body (rod connection member 12) comprising:
a first anchor receptacle (upper portion 46 of receptacle 40) having an opening (opening where upper portion 46 begins to narrow to form restricting ledge 48) configured to receive the first anchor head therethrough and retain the first anchor head within the first anchor receptacle such that the first anchor shaft extends through the opening and away from the first anchor receptacle (see, for example, Fig. 3); and
a first rod receptacle (ball joint receptacle 34) configured to receive the first end of the rod;
a second body (rod connection member 14) comprising:
a second anchor receptacle (upper portion 46 of receptacle 40) configured to receive the second anchor head; and
a second rod receptacle (ball joint receptacle 36) configured to receive the second end of the rod (Figs. 5A-7C and 11A-12; paras. 0030-0043).
Claim 9. Moore discloses wherein the first rod receptacle is configured to receive the first end of the rod polyaxially (Figs. 5A-7C and 11A-12; paras. 0030-0043).
Claim 10. Moore discloses wherein the first anchor receptacle is substantially perpendicular to the first rod receptacle (Figs. 5A-7C and 11A-12; paras. 0030-0043).
Claim 11. Moore discloses wherein the first end of the rod comprises a rounded portion (ball 64) configured to facilitate a polyaxial coupling with the first rod receptacle (Figs. 5A-7C and 11A-12; paras. 0030-0043).
Claim 12. Moore discloses wherein the rounded portion is integrally formed with the first end of the rod (Figs. 5A-7C and 11A-12; paras. 0030-0043).
Claim 15. Moore discloses wherein the first body further comprises an additional rod receptacle (rod connection passage 22) disposed opposite the rod receptacle, the additional rod receptacle being configured to receive a first end of an additional rod (Figs. 5A-7C and 11A-12; paras. 0030-0043).
Claim 16. Moore discloses wherein the first body is substantially cylindrical (Figs. 5A-7C and 11A-12; paras. 0030-0043).
Claim 7. Moore discloses a coupling assembly comprising:
a first anchor (screw 42) comprising:
a first anchor shaft (portion extending from flange 52 and including threaded portion 50); and
a first anchor head (head 54 and flange 52) coupled to the first anchor shaft;
a second anchor (screw 42) comprising:
a second anchor shaft (portion extending from flange 52 and including threaded portion 50); and
a second anchor head (head 54 and flange 52) coupled to the second anchor shaft;
a rod (cross member connecting assembly 20) comprising a first end (end with ball 64) and a second end (end with ball 82);
a first body (rod connection member 12) comprising:
a first anchor receptacle (upper portion 46 of receptacle 40) having an opening (opening where upper portion 46 begins to narrow to form restricting ledge 48) configured to receive the first anchor head therethrough and retain the first anchor head within the first anchor receptacle such that the first anchor shaft extends through the opening and away from the first anchor receptacle; and
a first rod receptacle (ball joint receptacle 34) configured to receive the first end of the rod;
a second body (rod connection member 14) comprising:
a second anchor receptacle (upper portion 46 of receptacle 40) configured to receive the second anchor head; and
a second rod receptacle (ball joint receptacle 36) configured to receive the second end of the rod (Figs. 1-10B; paras. 0030-0043).
Claim 17. Moore discloses wherein a distance between the first body and the second body is selectively adjustable while the first body is coupled to the second body via the rod (due to the adjustable length of cross member connecting assembly 20 via insertion arm 86 and receiving passage 68) (Figs. 1-10B; paras. 0030-0043).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-4, 6, and 18-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dant et al. (US 2006/0052784 A1) in view of Sweeney et al. (US 2005/0107789 A1).
Claim 1. Dant discloses a coupling assembly comprising:
a first body (left receiver portion 34 and washer 60 as shown in Fig. 1) comprising:
a first receptacle (defined by interior surface 64) configured to receive a first anchor (anchor 20); and
a second body (right receiver portion 34 and washer 60 as shown in Fig. 1) comprising:
a second receptacle (defined by interior surface 64) configured to receive a second anchor (anchor 20) (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
Claim 2. Dant discloses wherein the first body comprises a top (see Fig. 1 inset) defining an upper bore (see Fig. 1 inset), a first side (see Fig. 1 inset), and a bottom (see Fig. 1 inset) opposite the top, the bottom defining the first receptacle (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
Claim 3. Dant discloses wherein the first receptacle comprises an opening (see Fig. 1 inset; see also Fig. 2) having a width (defined by a diameter of head 24) that is larger than a width (see Fig. 1 inset) of the upper bore (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
Claim 6. Dant discloses wherein the first receptacle is configured to receive the first anchor polyaxially (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
[AltContent: textbox (Upper Bore)][AltContent: textbox (First Side)][AltContent: textbox (Top)][AltContent: textbox (Bottom)][AltContent: textbox (Width)][AltContent: textbox (Opening)]
Dant fails to disclose wherein the first body comprises a first coupler, wherein the second body comprises a second coupler, wherein at least one of the first coupler and the second coupler comprises a female member, and another of the at least one of the first coupler and the second coupler comprises a male member comprising a rounded portion configured to be inserted at a selectively adjustable and polyaxial angle into the female member to couple the first body and the second body together in a rigid relationship (claim 1), wherein the first side comprises the coupler (claim 2), and wherein the male member is integrally formed with the second body (claim 4).
However, Dant discloses a connecting component (bridge portion 32) connecting the first body to the second body (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
Sweeney teaches a coupling assembly comprising: a first body (connecting end 30) comprising a first receptacle (recess 32) and a first side (side with opening 40 and socket 46); a second body (rod 42 and connecting end 44 in combination) comprising a second receptacle (recess 76); and a connecting component (rod 42, ball 48, and socket 46) connecting the first body to the second body, wherein the connecting component comprises a first coupler (socket 46) on the first side of the first body, a second coupler (rod 42 and ball 48) on the second body, the second coupler configured to couple with the first coupler; wherein at least one of the first coupler and the second coupler comprises a female member (socket 46), and another of the at least one of the first coupler and the second coupler comprises a male member (rod 42) comprising a rounded portion (ball 48) configured to be inserted at a selectively adjustable and polyaxial angle into the female member to couple the first body and the second body together in a rigid relationship, wherein the male member is integrally formed with the second body, and wherein the connecting component enables adjustment of the distance and the angular relationship between the first and second receptacles (see para. 0021) (Figs. 2-3; paras. 0016-0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second body of Dant and substitute the connecting component of Sweeney for that of Dant such that the first body comprises a first coupler, such that the second body comprises a second coupler, such that at least one of the first coupler and the second coupler comprises a female member, and another of the at least one of the first coupler and the second coupler comprises a male member comprising a rounded portion configured to be inserted at a selectively adjustable and polyaxial angle into the female member to couple the first body and the second body together in a rigid relationship (claim 1), such that the first side comprises the coupler (claim 2), and such that the male member is integrally formed with the second body (claim 4), as suggested by Sweeney, as such a configuration would enable adjustment of the distance and the angular relationship between the first and second receptacles, thereby allowing the assembly to accommodate a variety of anatomical issues.
Claim 18. Dant discloses a coupling assembly comprising:
a first anchor (anchor 20) comprising:
an anchor shaft (bone-engaging end 22 with threads 28); and
an anchor head (head 24);
a second anchor (anchor 20);
a first body (left receiver portion 34 and washer 60 as shown in Fig. 1) comprising:
a top (see Fig. 1 inset); and
a bottom (see Fig. 1 inset) disposed opposite the top, the bottom defining a first receptacle (defined by interior surface 64) having an opening (see Fig. 1 inset) configured to receive the anchor head therethrough such that the anchor head is disposed within the first receptacle and the anchor shaft extends out of the opening; and
a second body (right receiver portion 34 and washer 60 as shown in Fig. 1) comprising:
a second receptacle (defined by interior surface 64) configured to receive the second anchor (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
[AltContent: textbox (Top)][AltContent: textbox (Bottom)][AltContent: textbox (Opening)]
Dant fails to disclose wherein the first body comprises a first coupler comprising a female member, wherein the second body comprises a second coupler configured to couple with the first coupler, the second coupler comprising a male member configured to form a polyaxial connection with the female member (claim 18), wherein the male member comprises a substantially spherical portion configured to be disposed within the female member (claim 19), and wherein the substantially spherical portion is fixedly coupled to the male member (claim 20).
However, Dant discloses a connecting component (bridge portion 32) connecting the first body to the second body (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
Sweeney teaches a coupling assembly comprising: a first body (connecting end 30) comprising a first receptacle (recess 32); a second body (rod 42 and connecting end 44 in combination) comprising a second receptacle (recess 76); and a connecting component (rod 42, ball 48, and socket 46) connecting the first body to the second body, wherein the connecting component comprises a first coupler (socket 46) in the form of a female member (socket 46) on the first body, a second coupler (rod 42 and ball 48) in the form of a male member (rod 42) on the second body, the male member configured to couple with the female member to form a polyaxial connection; wherein the male member comprises a substantially spherical portion (ball 48) configured to be disposed within the female member, wherein the substantially spherical portion is fixedly coupled to the male member (via set screw 68), and wherein the connecting component enables adjustment of the distance and the angular relationship between the first and second receptacles (see para. 0021) (Figs. 2-3; paras. 0016-0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second body of Dant and substitute the connecting component of Sweeney for that of Dant such that the first body comprises a first coupler comprising a female member, wherein the second body comprises a second coupler configured to couple with the first coupler, the second coupler comprising a male member configured to form a polyaxial connection with the female member (claim 18), such that the male member comprises a substantially spherical portion configured to be disposed within the female member (claim 19), and such that the substantially spherical portion is fixedly coupled to the male member (claim 20), as suggested by Sweeney, as such a configuration would enable adjustment of the distance and the angular relationship between the first and second receptacles, thereby allowing the assembly to accommodate a variety of anatomical issues.
Claims 7, 8, 13, and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dant et al. (US 2006/0052784 A1) in view of Moore et al. (US 2008/0306538 A1).
Claim 7. Dant discloses a coupling assembly comprising:
a first anchor (anchor 20) comprising:
a first anchor shaft (bone-engaging end 22 with threads 28); and
a first anchor head (head 24) coupled to the first anchor shaft;
a second anchor (anchor 20) comprising:
a second anchor shaft (bone-engaging end 22 with threads 28); and
a second anchor head (head 24) coupled to the second anchor shaft;
a rod (bridge portion 32) comprising a first end (end connected to left receiver portion 34 as shown in Fig. 1) and a second end (end connected to right receiver portion 34 as shown in Fig. 1);
a first body (left receiver portion 34 and washer 60 as shown in Fig. 1) comprising:
a first anchor receptacle (defined by interior surface 64) having an opening (see Fig. 1 inset; see also Fig. 2) configured to receive the first anchor head therethrough and retain the first anchor head within the first anchor receptacle such that the first anchor shaft extends through the opening and away from the first anchor receptacle; and
a second body (right receiver portion 34 and washer 60 as shown in Fig. 1) comprising:
a second anchor receptacle (defined by interior surface 64) configured to receive the second anchor head (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
Claim 8. Dant discloses wherein the first anchor receptacle is configured to receive the first anchor polyaxially (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
Claim 13. Dant discloses wherein the first body further comprises a top (see Fig. 1 inset) and a bottom (see Fig. 1 inset) disposed opposite the top, wherein the bottom comprises the first anchor receptacle, and wherein the top comprises an upper bore (see Fig. 1 inset) having a width (see Fig. 1 inset) that is smaller than a width (defined by a diameter of head 24) of the opening of the first anchor receptacle (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
Claim 14. Dant discloses wherein the first anchor further comprises a first anchor cannula (see opening in head 24 as shown in Fig. 2), and wherein the first anchor cannula is fluidically connected with the upper bore (Figs. 1-7, 10, 11, and 14; paras. 0032-0061).
[AltContent: textbox (Upper Bore)][AltContent: textbox (Top)][AltContent: textbox (Bottom)][AltContent: textbox (Width)][AltContent: textbox (Opening)]
Dant fails to disclose wherein the first body comprises a first rod receptacle configured to receive the first end of the rod, wherein the second body comprises a second rod receptacle configured to receive the second end of the rod (claim 7).
Moore teaches a coupling assembly comprising: a rod (cross member connecting assembly 20) comprising a first end (end with ball 64) and a second end (end with ball 82); a first body (rod connection member 12) comprising a first anchor receptacle (passage 22) and a first rod receptacle (ball joint receptacle 34) configured to receive the first end of the rod; and a second body (rod connection member 14) comprising a second anchor receptacle (passage 24) and a second rod receptacle (ball joint receptacle 36) configured to receive the second end of the rod; wherein the configuration of the rod and the interaction between the rod and the first and second bodies enables adjustment of the angular relationship between the first and second bodies (see para. 0035) (Figs. 5A-7C and 11A-12; paras. 0030-0043).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second body of Dant and substitute the rod of Moore for that of Dant such that the first body comprises a first rod receptacle configured to receive the first end of the rod and such that the second body comprises a second rod receptacle configured to receive the second end of the rod (claim 7), as suggested by Moore, as such a configuration would enable adjustment of the angular relationship between the first and second bodies, thereby allowing the assembly to accommodate a variety of anatomical issues.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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