DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements filed 03/14/2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5, line 3 recites “wen” and should be amended to recite “when”.
Appropriate correction is required.
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 3-10, 12, 17 and 21 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 3 recites the limitation "to receive a head of a bone anchor" in line 15. It is unclear whether “a bone anchor” is referring to the bone anchor disclosed in line 1 of claim 3, or if it is referring to a different bone anchor. For the purpose of examining the claims, “to receive a head of a bone anchor” will be interpreted as “to receive a head of the bone anchor”.
Claim 7 recites the limitation "wherein the force causes the expandable portion to compress onto the head of the bone anchor so as to prevent locking the head with respect to polyaxial rotation”. However, lines 15-17 of claim 3 recites “wherein the body is configured to receive a head of the bone anchor, such that a force applied to the rotatable member in the downward direction locks the head with respect to polyaxial rotation”. It is unclear how the force prevents locking the head with respect to polyaxial rotation as recited in claim 7, but also locks the head with respect to polyaxial rotation as recited in claim 3. The limitations seem to contradict each other.
Claim 12 recites the limitation "from the lower end" in line 2. It is unclear whether “the lower end” is referring to the lower end of the body, as disclosed in line 3 of claim 11, or if it is referring to the lower expandable portion of the insert member, as disclosed in line 10 of claim 11. For the purpose of examining the claim, “from the lower end” in line 2 of claim 12 will be interpreted as “from the lower expandable portion”.
Claim 17 recites the limitation "the lower end of the insert member" in lines 2-3. It is unclear whether “the lower end” is referring to the lower end of the body, as disclosed in line 3 of claim 11, or if it is referring to the lower expandable portion of the insert member, as disclosed in line 10 of claim 11. For the purpose of examining the claim, “the lower end of the insert member” in lines 2-3 of claim 17 will be interpreted as “the lower expandable portion of the insert member”.
Claim 21 recites the limitation "the position of the bone anchor" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the position of the bone anchor” will be interpreted as “a position of the bone anchor”.
Appropriate corrections are required.
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.
Claims 11, 12, 14 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 10 and 15 of U.S. Patent No. 11,134,992 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Independent claim 11 recites all of the elements of independent claim 1 of the patent. The difference between independent claim 11 of the application and independent claim 1 of the patent lies in the fact that the patent claim further recites “the insert member defining a plurality of slots extending from the lowermost end towards the upper end portion”. Thus, the invention of claim 1 of the patent is in effect a “species” of the “generic” invention of claim 11 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Circ. 1993). Since claim 11 of the application is anticipated by respective claim 1 of the patent, it is not patently distinct from claim 1.
Furthermore, dependent claims 12, 14 and 22 of the application recite all of the elements of independent claim 1 and dependent claims 3 and 10 of the patent.
Claim 1 (col.35, ll.65-col.36, ll.3) of the patent recites “the insert member defining a plurality of slots extending from the lowermost end towards the upper end portion so that the lower end portion is radially expandable so that the head of the bone anchor can be inserted into the interior cavity of the insert member”, thus reciting all of the elements of claim 12 of the application.
Claim 10 of the patent recites “whereby the body has an enlarged chamber portion whereby the insert member is expandable to permit the head of the bone anchor to be received within the interior cavity of the insert member”, thus reciting all of the elements of claim 14 of the application.
Claim 3 of the patent recites “wherein the upper sleeve end has a first arm and a second arm that are spaced from one another so as to define the second rod-receiving channel therebetween”, thus reciting all of the elements of claim 22 of the application.
Independent claim 11 recites all of the elements of independent claim 15 of the patent. The difference between independent claim 11 of the application and independent claim 15 of the patent lies in the fact that the patent claim further recites “the sleeve having an upper sleeve end and a lower sleeve end” and “the insert member defining 1) a recess at the upper end portion, the lower sleeve end being configured to be received in the recess, 2) an interior cavity that extends into the lower end portion towards the upper end portion and that is configured to receive at least a portion of a head of a bone anchor, and 3) a plurality of slots extending from the lower end portion towards the upper end portion so that the lower end portion is radially expandable so that the head of the bone anchor can be inserted into the interior cavity of the insert member”. Thus, the invention of claim 15 of the patent is in effect a “species” of the “generic” invention of claim 11 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Circ. 1993). Since claim 11 of the application is anticipated by respective claim 15 of the patent, it is not patently distinct from claim 15.
Furthermore, claim 15 (col.37, ll.13-17) of the patent recites “a plurality of slots extending from the lower end portion towards the upper end portion so that the lower end portion is radially expandable so that the head of the bone anchor can be inserted into the interior cavity of the insert member”, thus reciting all of the elements of claim 12 of the application.
Claims 11-14, 21 and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 6 and 14 of U.S. Patent No. 11,812,998 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Independent claim 11 recites all of the elements of independent claim 1 of the patent. The difference between independent claim 11 of the application and independent claim 1 of the patent lies in the fact that the patent claim further recites “at least one movable element, the at least one movable element being configured to be received within the bore of the body, wherein the at least one movable element is engageable with the body and movable along the longitudinal axis from a first position to a second position”, and “wherein at least one arm includes an end that is configured to engage the movable element such that movement of the movable element from the first position to the second position urges the sleeve along the longitudinal axis”. Thus, the invention of claim 1 of the patent is in effect a “species” of the “generic” invention of claim 11 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Circ. 1993). Since claim 11 of the application is anticipated by respective claim 1 of the patent, it is not patently distinct from claim 1.
Furthermore, dependent claims 12, 13 and 21 of the application recite all of the elements of independent claim 1 and dependent claim 2 of the patent.
Claim 1 (col.35, ll.65-col.36, ll.3) of the patent recites “the insert member defining at least one slot extending from the lower end portion towards the upper end portion so that the lower end portion is expandable and collapsible so that the head of the bone anchor can be inserted into the interior cavity of the insert member and locked in the interior cavity”, thus reciting all of the elements of claim 12 of the application.
Claim 1 (col.35, ll.10-15) of the patent recites “wherein the at least one arm includes an end that is configured to engage the movable element such that movement of the movable element from the first position to the second position urges the sleeve along the longitudinal axis, thus reciting all of the elements of claim 13 of the application.
Claim 2 of the patent recites “further comprising the bone anchor, wherein the head of the bone anchor is a partially spherical head, and wherein the unlocked position, the bone anchor is poly-axially rotatable with respect to the body and the insert member, and in the locked position, the insert member secures the position of the bone anchor with respect to the body and the insert member”, thus reciting all of the elements of claim 21 of the application.
Independent claim 11 recites all of the elements of independent claim 4 of the patent. The difference between independent claim 11 of the application and independent claim 4 of the patent lies in the fact that the patent claim further recites “the insert member defining an interior cavity that extends into the lower end portion towards the upper end portion and that is configured to receive at least a portion of the partially spherical head of the bone anchor, the insert member defining a plurality of slots extending from the lower end portion towards the upper end portion”. Thus, the invention of claim 4 of the patent is in effect a “species” of the “generic” invention of claim 11 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Circ. 1993). Since claim 11 of the application is anticipated by respective claim 4 of the patent, it is not patently distinct from claim 4.
Furthermore, dependent claims 12, 14, 21 and 22 of the application recite all of the elements of independent claim 4 and dependent claims 6 and 14 of the patent.
Claim 4 (col.36, ll.55-60) of the patent recites “the insert member defining a plurality of slots extending from the lower end portion towards the upper end portion so that the lower end portion is radially expandable so that the partially spherical head of the bone anchor can be inserted into the interior cavity of the insert member”, thus reciting all of the elements of claim 12 of the application.
Claim 14 of the patent recites “wherein the body has an enlarged chamber portion whereby the insert member is expandable to permit the head of the bone anchor toe be received within the interior cavity of the insert member”, thus reciting all of the elements of claim 14 of the application.
Claim 4 of the patent recites “further comprising the bone anchor” (col.36, ll.39) and “wherein the insert member is configured to engage the partially spherical head of the bone anchor when the partially spherical head is disposed in the interior cavity, and the sleeve is configured to urge the partially spherical head and the insert member so as to move the insert member within the bore from an unlocked position to a locked position, and wherein in the unlocked position, the bone anchor is poly-axially rotatable with respect to the body, and in the locked position, the insert member secures a position of the bone anchor with respect to the body by engaging the partially spherical head of the bone anchor” (col.36, ll.61-col.37, ll.6), thus reciting all of the elements of claim 21 of the application.
Claim 6 of the patent recites “wherein the upper sleeve end has a first arm and a second arm that are spaced from one another so as to define the second rod-receiving channel”, thus reciting all of the elements of claim 22 of the application.
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 –
(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 3-6, 8-17 and 21-22, as best understood, are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Peterson et al. (U.S. Publication No.2008/0294202 A1; hereinafter “Peterson”).
Regarding claim 3, Peterson discloses an anchor assembly configured to couple a bone anchor to a spinal rod to stabilize bones or bone fragments (Figure 1), the anchor assembly comprising: a body (104) having an upper end (114) that defines an upper opening (414), and a lower end (118) that defines a lower opening (415) and that is spaced from the upper end in a downward direction (Figure 7), the body defining a rod-receiving channel (101) configured to receive the spinal rod (108)(see Figure 1), and the body comprising at least one stop (see the first horizontal wall wherein slots 715a, 715b begin as shown in annotated Figure 7); and a rotatable member (sleeve 612 and collet 814) having at least one outwardly projecting wing (retention tabs 613a, 613b), wherein the rotatable member is sized and configured to be 1) inserted into the body in the downward direction in a first rotational position (see annotated Figure 7 below) whereby no part of the at least one outwardly projecting wing is aligned with the at least one stop along a longitudinal direction that includes the downward direction and an upward direction that is opposite the downward direction (see annotated Figure 7 below), and 2) after the at least one outwardly projecting wing has passed the at least one stop, rotated to a second rotational position (when retention tabs 613a,b reside within slots 715a,b) so that the at least one outwardly projecting wing is aligned with the at least one stop with respect to the longitudinal direction (see annotated Figure 7 below). It is noted that although sleeve 612 is inserted downward through housing 710 so that retention tabs 613a,b snap into respective slots 715a and 715b, sleeve 612 is capable of being rotated and is capable of performing the functional limitations above (the slots can extend or be formed across the width or circumference of the interior housing wall so that the sleeve can rotate in the housing, para.0038). Peterson further discloses wherein the body is configured to receive a head of a bone anchor (Figure 7), such that a force applied to the rotatable member in the downward direction locks the head with respect to polyaxial rotation (as the set screw is driven still further downward, the saddle presses the rod further downward which causes sleeve 612 to move downward, compressing collet 814 against the head of anchor member 106, locking the anchor member in place, see para.0060).
Regarding claim 4, Peterson further discloses wherein the at least one wing (613a,b) is disposed adjacent the at least one stop in the downward direction when the rotatable member is in the second rotational position (see annotated Figure 7 below).
Regarding claim 5, Peterson further discloses wherein the at least one stop cooperates with another surface of the body (see the second horizontal wall that defines slot 715a,b in annotated Figure 7 below) to capture the rotatable member with respect to movement along the longitudinal direction when the rotatable member is in the second rotational position (see annotated Figure 7 below).
Regarding claim 6, Peterson further discloses an expandable portion (collet 814) that receives the head of the bone anchor so as to capture the head therein (see annotated Figure 7 below).
Regarding claim 8, Peterson further discloses wherein the rotatable member (612, 814) has a plurality of arms (fingers 810 on collet 814) separated by slots (806) so as to define the expandable portion (Figure 8).
Regarding claim 9, Peterson further discloses wherein the body has an enlarged chamber portion (assembly groove 712), whereby the expandable portion is expandable to permit the head of the bone anchor to be received within an interior cavity of the expandable portion (see end of para.0046).
Regarding claim 10, Peterson further discloses wherein body is configured to receive the head of the bone anchor in the lower end (see end of para.0046, see also Figure 7).
PNG
media_image1.png
651
828
media_image1.png
Greyscale
Regarding claim 11, Peterson discloses an anchor assembly configured to couple a bone anchor to a spinal rod to stabilize bones or bone fragments (Figure 1), the anchor assembly comprising: a body (104) having an upper end (114) that defines an upper opening (414), and a lower end (118) that defines a lower opening (415) and that is spaced from the upper end (Figure 7), the body defining a bore (116) that extends between the upper opening and the lower opening (Figure 2), and the body defining a first rod-receiving channel (101) configured to receive the spinal rod (108)(see Figure 1); a sleeve (612) disposed in the bore of the body (Figure 7), the sleeve defining a second rod-receiving channel (610) configured to receive a portion of the spinal rod (Figure 7B1); and an insert member (814) received in the bore of the body (Figure 7), the insert member including an upper end portion (820) and a lower expandable portion (812) that is expandable so as to receive a head of a bone anchor while the insert member is in an unlocked configuration (Figure 25)(para.0046 and 0055), wherein the lower expandable portion is compressible against the head in a locked configuration (Figure 37) so as to lock the head in the insert member (para.0046), wherein the sleeve is configured to receive a force, which causes the sleeve to bear against the insert member, thereby transitioning the insert member from the unlocked configuration to the locked configuration while the head of the bone anchor is received in the insert member, and wherein in the unlocked configuration, the bone anchor is poly-axially rotatable in the insert member with respect to the body, and in the locked configuration, the insert member prevents the bone anchor from rotating polyaxially with respect to the body (para.0055, 0060-0061).
Regarding claim 12, Peterson further discloses wherein the insert member (814) defines at least one slot (806) extending from the lower expandable portion towards the upper end portion (Figure 8) so that the lower expandable portion is expandable and collapsible so that the head of the bone anchor can be inserted into an interior cavity of the insert member and locked in the interior cavity (para.0043).
Regarding claim 13, Peterson further discloses wherein the sleeve (612) includes at least one arm (615a, 615b) that defines a portion of the second rod-receiving channel (610), wherein the at least one arm includes an end (top inner surface 622) that that is configured to engage a movable element (saddle 1100) such that movement of the movable element from a first position to a second position urges the sleeve along a longitudinal axis that the bore extends along (end of para.0055).
Regarding claim 14, Peterson further discloses wherein the body (104) has an enlarged chamber portion (assembly groove 712), whereby the insert member (814) is expandable to permit the head of the bone anchor to be received within an interior cavity of the insert member (para.0048).
Regarding claim 15, Peterson further discloses wherein when the insert member (814) is in the unlocked configuration, the lower expandable portion is configured to expand within the enlarged chamber portion such that the head of the bone anchor is permitted to be received within the interior cavity of the insert member (para.0055).
Regarding claim 16, Peterson further discloses wherein the body comprises at least one stop (see annotated Figure 7 below) that is configured to limit axial movement of the insert member (814) when the insert member is in the unlocked configuration such that the lower expandable portion is configured to expand to receive the head of the bone anchor (when head 717 is inserted into the bottom opening 812 of the collet 814, the sleeve is positioned to allow the collet to expand so that the head may pass through bottom opening 812 and thereafter the collet would contract to hold the head 717 of the anchor member 106, see end of para.0046).
Regarding claim 17, Peterson further discloses wherein the insert member (814) is configured to move axially along a longitudinal axis, that the bore extends along, such that the lower end of the insert member moves into a lower chamber surface of the body so that the lower expandable portion of the insert member is compressed inward (fingers 810 of the collet can be compressed to allow the collet to be inserted through bottom opening 415, and once within anchor head 104, the fingers can expand, see para.0046).
Regarding claim 21, Peterson further discloses the bone anchor (106), wherein the head (717) of the bone anchor is a partially spherical head (Figure 7), and wherein the unlocked configuration, the bone anchor is poly-axially rotatable with respect to the body and the insert member (Figure 25)(para.0046 and 0055), and in the locked configuration, the insert member secures the position of the bone anchor with respect to the body and the insert member (Figure 37)(para.0046).
Regarding claim 22, Peterson further discloses wherein the sleeve (612) includes a first arm and a second arm (615a,b) that define opposing sides of the second rod-receiving channel (610)(see Figure 7B1).
PNG
media_image2.png
302
316
media_image2.png
Greyscale
PNG
media_image3.png
651
740
media_image3.png
Greyscale
PNG
media_image4.png
429
235
media_image4.png
Greyscale
PNG
media_image5.png
506
323
media_image5.png
Greyscale
Allowable Subject Matter
Claims 18-20 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.
The following is a statement of reasons for the indication of allowable subject matter: Claims 18-20 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, the claimed combination of limitations recited in independent claim 11. In particular, none of the cited references teach or suggest wherein the insert member comprises a first wing and a second wing, and the bore comprises an interference zone that comprises first and second channels, wherein the first wing is configured to be received in the second channel while the second wing is received in the first channel, as required by claim 18.
Peterson discloses the claimed invention except for wherein the insert member comprises a first wing and a second wing, and the bore comprises an interference zone that comprises first and second channels, wherein the first wing is configured to be received in the second channel while the second wing is received in the first channel, as required by claim 18. Peterson’s collet fails to disclose any features that can be interpreted as the claimed first wing and second wing. Furthermore, Peterson’s bore 116 fails to disclose any channel like features within an interference zone that is configured to receive said first and second wings.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ensign U.S. Publication No.2007/0225711 A1
Baker et al. U.S. Patent No.7,811,310 B2
Strausbaugh et al. U.S. Publication No.2007/0118123 A1
Biedermann et al. U.S. Patent No.6,835,196 B2
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773