DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 19-29) in the reply filed on January 22, 2026 is acknowledged.
Claims 30-38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 22, 2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 60/950,995, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application fails to disclose the claimed first, second, and third diameters (see claim 19). Accordingly, none of claims 19-27 have been awarded priority to this application.
The disclosure of the prior-filed application, Application No. 60/988,584, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed application fails to disclose the claimed first, second, and third diameters (see claim 19). Accordingly, none of claims 19-27 have been awarded priority to this application.
The claims have been awarded priority to PCT/US2008/070670, which was filed on July 21, 2008.
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 29 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 29 recites “when the expandable portion is in a locked position” (line 3). However, claim 19 already recites a locked position (see line 5 of the last paragraph). Thus, it is unclear whether “a locked position” in claim 29 is intended to be the same locked position recited in claim 19 or an additional locked position. For examination purposes, the Examiner is interpreting “a locked position” in claim 29 as being the same locked position as recited in claim 19.
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
(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 19, 20, and 28 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Jackson (US 2005/0049588 A1).
Claim 19. Jackson discloses an assembly configured to be connected to an elongated spinal rod, the assembly comprising:
a body (head 4) that extends along a longitudinal axis (see Fig. 3 inset) that extends between an upper end (see Fig. 3 inset) of the body and a lower end (see Fig. 3 inset) of the body that is spaced from the upper end of the body in a downward direction along the longitudinal axis, the body including an upper opening (see Fig. 3 inset), a lower opening (see Fig. 3 inset), and a bore (see Fig. 3 inset) extending between the upper and lower openings, the bore having a first diameter (see Fig. 3 inset) at a first portion (portion with guide structures 34) of the body that is spaced from the lower end along an upward direction that is opposite the downward direction and the bore further defining a rod-receiving channel (cradle 30) extending from the upper end toward the lower end, the rod-receiving channel disposed along a channel axis (extends into the page in Fig. 4) that is oriented perpendicular to the longitudinal axis, the bore at least partially defined by a lower edge portion (neck 26) of the body, the lower edge portion of the body defining a first curved inner surface (surface of seat 40) that is spaced from the first portion of the body in the downward direction, the bore further at least partially defined by a second curved inner surface (surface of cavity 38), wherein the second curved inner surface is disposed between the first curved inner surface and the first portion with respect to the longitudinal axis, the bore has a second diameter (see Fig. 3 inset) at the first curved inner surface, and the bore has a third diameter (see Fig. 3 inset) at the second curved inner surface, the third diameter is larger than the first diameter, and the first diameter is larger than the second diameter; and
an expandable portion (ring 7) configured to be disposed within the bore of the body, to expand to receive a head of a bone anchor, to secure the head of the bone anchor relative to the expandable portion, and to move within the bore from the upper opening along the downward direction toward the first curved inner surface such that the expandable portion is movable from a loading position (see Figs. 5 and 6) to a locked position (see Figs. 7 and 8), in which the expandable portion contacts the first curved inner surface and a curvate surface of the expandable portion contacts the head of the bone anchor such that the head is unable to move relative to the curvate surface (Figs. 1-8; paras. 0025-0035).
Claim 20. Jackson discloses wherein the expandable portion is configured to expand within an enlarged diameter portion (cavity 38) of the bore defined by the second curved inner surface (Figs. 1-8; paras. 0025-0035).
Claim 28. Jackson discloses wherein the first portion of the body extends between the second curved inner surface and the upper end, and wherein the bore defines the first diameter proximate the upper opening (Figs. 1-8; paras. 0025-0035).
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Claims 19-21, 23, 24, and 27-29 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Lab et al. (US 8,197,517 B1).
Claim 19. Lab discloses an assembly configured to be connected to an elongated spinal rod, the assembly comprising:
a body (receiver 100) that extends along a longitudinal axis (see Fig. 5 inset) that extends between an upper end (see Fig. 5 inset) of the body and a lower end (see Fig. 5 inset) of the body that is spaced from the upper end of the body in a downward direction along the longitudinal axis, the body including an upper opening (see Fig. 5 inset), a lower opening (see Fig. 5 inset), and a bore (see Fig. 5 inset) extending between the upper and lower openings, the bore having a first diameter (see Fig. 5 inset) at a first portion (portion with thread 130) of the body that is spaced from the lower end along an upward direction that is opposite the downward direction and the bore further defining a rod-receiving channel (channel 120) extending from the upper end toward the lower end, the rod-receiving channel disposed along a channel axis (extending into the page in Fig. 5) that is oriented perpendicular to the longitudinal axis, the bore at least partially defined by a lower edge portion (see Fig. 5 inset) of the body, the lower edge portion of the body defining a first curved inner surface (see Fig. 5 inset) that is spaced from the first portion of the body in the downward direction, the bore further at least partially defined by a second curved inner surface (see Fig. 5 inset), wherein the second curved inner surface is disposed between the first curved inner surface and the first portion with respect to the longitudinal axis, the bore has a second diameter (see Fig. 5 inset) at the first curved inner surface, and the bore has a third diameter (see Fig. 5 inset) at the second curved inner surface, the third diameter is larger than the first diameter, and the first diameter is larger than the second diameter; and
an expandable portion (see Fig. 3b inset) configured to be disposed within the bore of the body, to expand to receive a head of a bone anchor, to secure the head of the bone anchor relative to the expandable portion, and to move within the bore from the upper opening along the downward direction toward the first curved inner surface such that the expandable portion is movable from a loading position (see Fig. 8) to a locked position (see Fig. 10), in which the expandable portion contacts the first curved inner surface and a curvate surface of the expandable portion contacts the head of the bone anchor such that the head is unable to move relative to the curvate surface (Figs. 1-10; col. 3, l. 11 through col. 7, l. 9).
Claim 20. Lab discloses wherein the expandable portion is configured to expand within an enlarged diameter portion (see Fig. 5 inset) of the bore defined by the second curved inner surface (Figs. 1-10; col. 3, l. 11 through col. 7, l. 9).
Claim 21. Lab discloses a seat (end surface 430) configured to contact the rod when the rod is disposed within the rod-receiving channel of the body (Figs. 1-10; col. 3, l. 11 through col. 7, l. 9).
Claim 23. Lab discloses wherein the body is a first body and the assembly further comprises:
a second body (collet 400) that forms both the expandable portion and the seat (Figs. 1-10; col. 3, l. 11 through col. 7, l. 9).
Claim 24. Lab discloses wherein the second body is configured to receive a tool therethrough (see Fig. 3b, which shows that collet 400 is hollow and therefore is capable of receiving a tool therethrough) (Figs. 1-10; col. 3, l. 11 through col. 7, l. 9).
Claim 27. Lab discloses the bone anchor (screw 200), which includes the head (head 250) and an externally-threaded shaft (shaft 260 with threads 270) that defines a shaft axis (axis 210) and is axially fixed relative to the head, the bone anchor being configured to extend through the lower opening of the body such that at least a head portion of the head is disposed within the bore of the body, wherein the bone anchor is rotatable through a range of angles with respect to the expandable portion and the body (see col. 6, ll. 15-29) (Figs. 1-10; col. 3, l. 11 through col. 7, l. 9).
Claim 28. Lab discloses wherein the first portion of the body extends between the second curved inner surface and the upper end, and wherein the bore defines the first diameter proximate the upper opening (Figs. 1-10; col. 3, l. 11 through col. 7, l. 9).
Claim 29. Lab discloses wherein the expandable portion comprises a flexible portion (see Fig. 3b inset) that includes flexible fingers (see Fig. 3b inset) that are configured to engage the head of the bone anchor such that when the expandable portion is in a locked position the flexible fingers engage the head such that the head is fixed relative to the flexible fingers (Figs. 1-10; col. 3, l. 11 through col. 7, l. 9).
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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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 22 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lab et al. (US 8,197,517 B1) in view of Konieczynski et al. (US 2008/0140135 A1).
Claim 22. Lab discloses wherein the seat includes a surface (flat surface 430) that is configured to contact the rod (Figs. 1-10; col. 3, l. 11 through col. 7, l. 9).
Lab fails to disclose wherein the surface is concave and wherein the concave surface opens in the upward direction away from the expandable portion (claim 22).
Konieczynski teaches an assembly comprising: a body (receiver member 318); an expandable portion (collet 333) configured to be disposed within the body, to expand to receive a head of a bone anchor, and to secure the head of the bone anchor relative to the expandable portion; and a seat (recess 326) configured to contact a rod when the rod is disposed within the body, wherein the seat includes a concave surface (see Fig. 3A, which shows that recess 326 is concave) that is configured to contact the rod (see Fig. 3C), wherein the concave surface opens in an upward direction away from the expandable portion, and wherein the concave surface of the seat is complementary in shape to rod (see Fig. 3C) (Figs. 3A-3C).
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 assembly of Lab such that the surface of the seat is concave, wherein the concave surface opens in the upward direction away from the expandable portion (claim 22), and wherein the concave surface of the seat is complementary in shape to rod, as suggested by Konieczynski, as such a configuration provides a more secure connection between the rod and the seat and provides for better force distribution between the rod and the seat due to the multiple contact points between the rod and the seat.
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,663,298 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The difference between claim 1 of the application and claim 1 of the patent is that claim 1 of the patent includes more elements and is therefore more specific (claim 1 of the patent includes spherical undercuts in the body and recites that the expandable portion is a collet). Thus, the invention of claim 1 of the patent is in effect a species of the generic invention of claim 1 of the application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Because claim 1 of the application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,819,247 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The difference between claim 1 of the application and claim 1 of the patent is that claim 1 of the patent includes more elements and is therefore more specific (claim 1 of the patent includes an enlarged diameter portion in the body and recites that the expandable portion is a collet). Thus, the invention of claim 1 of the patent is in effect a species of the generic invention of claim 1 of the application. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Because claim 1 of the application is anticipated by claim 1 of the patent, it is not patentably distinct from claim 1 of the patent.
Claims 25 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,998,246 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The difference between claims 25 and 26 of the application and claim 20 of the patent is that claim 20 of the patent includes more elements and is therefore more specific (regarding claim 25, claim 20 includes all subject matter of claim 25 and also includes additional structural features of the body/first body, additional structural features of the expandable portion/second body, a bone anchor, and a set screw; regarding claim 26, claim 20 includes all subject matter of claim 26 and also includes additional structural features of the body/first body, additional structural features of the expandable portion/second body, and a bone anchor). Thus, the invention of claim 20 of the patent is in effect a species of the generic invention of claims 25 and 26. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Because claims 25 and 26 are anticipated by claim 20 of the patent, they are not patentably distinct from claim 20.
Allowable Subject Matter
Claims 25 and 26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and upon the filing of a terminal disclaimer to overcome the double patenting rejections set forth above.
Saint Martin (US 2004/0249378 A1) teaches a body (head 6) wherein each arm (branch 8) includes an elongated horizontal slot (face 60) and vertically-extending grooves (cavities 136) having concave lower surfaces (see Fig. 8), wherein the vertically-extending grooves are open to a rod-receiving channel (see U-shaped channel in Fig. 8) and open away from the lower end toward the upper end (at tips 16) of the body (see Fig. 8 and para. 0066) (Fig. 8). However, the vertically-extending grooves do not have first and second planar surfaces as recited in claim 25.
Dec (US 2008/0051794 A1) teaches a body (body portion 20) wherein each arm (arms 28 and 30) includes an elongated horizontal slot (horizontal portion of recess shown adjacent reference character 28 in Fig. 1), a cut-out (upwardly-extending curved portion of recess shown adjacent reference character 28 in Fig. 1) extending vertically from the slot, and vertically-extending grooves (grooves such as groove adjacent reference character 26 as shown in Fig. 1) having first and second planar surfaces (see Fig. 4) (Figs. 1-4). However, the vertically-extending grooves are not open toward the upper end of the body and do not include a concave surface disposed below the second planar surface as recited in claim 25.
Shluzas (US 2008/0077143 A1) teaches a slot and cut-out configuration similar to that of Dec (see Fig. 5 of Shluzas) and a vertically-extending groove configuration similar to that of Saint Martin (see Fig. 5 of Shluzas) (Fig. 5).
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.
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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