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 .
Claim Objections
Claims 2 and 3 are objected to because of the following informalities:
Claim 2, line 2, “the” should be inserted immediately before “longitudinal”.
Claim 3, after “within”, “the” (repeated instance) should be deleted.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“attachment feature” (i.e., a feature or means for attachment) in claim 7;
“driver engagement feature” (i.e., a feature or means for driver engagement) in claim 10;
“locking element engagement feature” (i.e., a feature or means for locking element engagement) in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 2, 15, 17, 19 and 20 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 2, line 2, the claimed angular relationship is unclear. As best understood, “a central longitudinal axis of the” (or the like) should precede “capture ring” to clarify the angles being compared. For purposes of examination, the claim will be interpreted in this manner.
Claim 15, line 2, “the oblique angle of the internal groove” lacks antecedent basis.
Claim 15, line 2, “the internal groove” itself further lacks antecedent basis.
Claim 15, line 2, the claimed angular relationship is unclear. As best understood, “a central longitudinal axis of” (or the like) should precede “the internal groove” (once proper antecedent basis for this terminology is established; cf. supra) to clarify the angles being compared. For purposes of examination, the claim will be interpreted in this manner.
Claim 17, line 2, “on one of the pair of arms” is unclear. The claim should read “on one arm of the pair of arms”. As best understood, and for purposes of examination, the claim will be interpreted in this manner.
Claim 17, line 3, “on the other of the pair of arms” is unclear. The claim should read “on the other arm of the pair of arms”. As best understood, and for purposes of examination, the claim will be interpreted in this manner.
Claim 19, the claimed angular relationship is unclear. As best understood, “a central longitudinal axis of the” (or the like) should precede “second capture ring” to clarify the angles being compared. For purposes of examination, the claim will be interpreted in this manner.
Claim 20, the claimed angular relationship is unclear. As best understood, “a central longitudinal axis of” (or the like) should precede “the internal groove” to clarify the angles being compared. For purposes of examination, the claim will be interpreted in this manner.
Appropriate correction is required.
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.
Claims 1-7, 9-13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McKinley et al. (2008/0177260).
Regarding claim 1, McKinley et al. disclose a spinal fixation system (Figs. 1 and 4) comprising:
a spinal rod 102; and
a bone anchor 100 configured to secure the spinal rod to the spine, wherein the bone anchor comprises:
a rod housing 106 configured to receive the spinal rod, wherein the rod housing comprises:
a base (Fig. 4; e.g., bottom of 132),
a pair of arms (Fig. 4) extending proximally from the base and separated by a rod channel 144 dimensioned to receive the spinal rod therein,
a longitudinal axis 136 extending through a distal opening 140 in the base, and a capture ring 108 disposed within the rod housing 106 (Figs. 4 and 7), the capture ring 108 including a frustospherical capture surface 160 (Fig. 4; para. 0058; note that the exterior surface is also frustospherical, i.e., convex); and
a bone fastener 104 comprising a fastener head 122 (Fig. 4) disposed within the base (Fig. 7), and a shank 126 (Fig. 4) integrally coupled to the fastener head 122 and configured to engage bone (para. 0056).
Regarding claim 2, a central longitudinal axis of the capture ring 108 is oriented at an oblique angle a relative to longitudinal axis that is more acute than a maximum deflection angle A of the bone fastener relative to the longitudinal axis (see annotated Fig. 8, below).
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Regarding claim 3, the capture ring 108 is configured to rotate within the rod housing 106 (Figs. 7 and 8).
Regarding claim 4, the capture ring 108 comprises a slit 162 (Fig. 4) capable of enabling the capture ring to be transiently compressed if desired.
Regarding claim 5, the bone anchor 100 further comprises a load ring 114 (Fig. 4) disposed within the base proximal to the capture ring 108 (Fig. 7), wherein the load ring 114 is configured to exert a compressive force on the fastener head 122 (id.).
Regarding claim 6, the distal opening 140 in the rod housing 106 includes a minimum diameter that is greater than a maximum diameter of the fastener head 122 (Fig. 7).
Regarding claim 7, each arm of the pair of arms of the rod housing 106 (Fig. 4) comprises an attachment feature (circumferential exterior slot; Figs. 1, 2 and 4) capable of engaging one or more tools if desired.
Regarding claim 9, a driving tool is configured drive the bone anchor 104 into bone (see para. 0060, discussing a driver engaging portion for a driver engagement feature; cf. 184 and driver engagement feature in head 122 of bone anchor 104 in Fig. 4).
Regarding claim 10, the fastener head 122 comprises a driver engagement feature configured to receive a driving tool therein (Fig. 4).
Regarding claim 11, a locking element 116 is configured to lock the spinal rod 102 to the bone anchor 100 (Figs. 1 and 4).
Regarding claim 12, the pair of arms (Fig. 4) comprise a locking element engagement feature configured 146 (threads) to engage the locking element 116 to lock the spinal rod 102 within the rod channel 144 (Figs. 1 and 4).
Regarding claim 13, the locking element engagement feature 144 comprises a threaded portion disposed on each arm of the pair of arms (Fig. 4), and wherein the locking element 116 comprises a locking cap having a threaded portion 182 configured to threadably engage the threaded portion 146 of the pair of arms (Figs. 1 and 4).
Regarding claim 16, the bone anchor 100 comprises a biocompatible material as it is fastened to bone (para. 0001).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over McKinley et al. (2008/0177260) in view of Harvey et al. (2010/0145394).
McKinley et al. disclose the claimed invention except for explicitly reciting an indentation on a distal side of each circumferential slot.
Harvey et al. show a bone anchor 22 having an indentation on a distal facing side of a slot in the exterior of the arms (Fig. 1B) configured to receive one or more tools therein. The indentation facilitates retaining a corresponding tool in the slot.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the circumferential slot of McKinley et al. with an indentation on a distal facing side of each circumferential slot, in view of Harvey et al. to facilitate retaining a corresponding tool in the slot. It would have also been obvious to have positioned the indentation on the distal side, as this would amount to an obvious design choice and would provide an alternate equivalent configuration to facilitate retaining a corresponding tool in the slot.
Claims 14, 15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over McKinley et al. (2008/0177260) in view of Biedermann et al. (2019/0038321).
Regarding claim 14, McKinley et al. disclose the claimed invention, except wherein the base of the rod housing comprises a recess dimensioned to complement the bone fastener, wherein the recess is configured to increase a maximum deflection angle of the bone fastener relative to the longitudinal axis.
Biedermann et al. disclose a rod housing comprising an angled recess defined by and beneath an angled 51b (Fig. 15) capture area (e.g., the base 5b, groove 54, and other capture components; Fig. 14). The recess complements a bone fastener 2 by increasing a maximum deflection angle Β1 of the bone fastener 2 relative to the longitudinal axis (id.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the rod housing 106 of McKinley et al. with an angled recess defined by and beneath an angled capture area (e.g., the comparable base of the rod housing, frustospherical groove 142, and other capture components; Fig. 5), in view of Biedermann et al., to complement the bone fastener and increase a maximum deflection angle of the bone fastener relative to the longitudinal axis.
Regarding claim 15, the angled recess of the combination forms an oblique angle with the longitudinal axis (i.e., angle B1; supra) that is greater than the oblique angle θ of a central longitudinal axis of the internal frustospherical groove 142 of the combination (supra; cf. Biedermann et al. annotated Fig. 15, below).
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Regarding claim 17, the rod housing 106 of the combination (cf. supra) includes an internal frustospherical groove 142 (McKinley; Fig. 5) wherein a first side (e.g., left; cf. annotated Fig. 15, supra) of the internal frustospherical groove 142 of the combination is on one of the pair of arms and a second side (e.g., right; id.) of the internal groove is on the other of the pair of arms, wherein the first side is positioned vertically above the second side of the internal groove relative to the distal opening (e.g., at portion adjacent to label 5b; id.) in the base of the combination (see second annotated Fig. 15, below, showing the relevant portions with horizontal bars).
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Regarding claim 18, McKinley et al. disclose a second bone anchor (Fig. 1). Therefore, the system of the combination (cf. supra) would include a second bone anchor 100 configured to secure the spinal rod 102 to the spine, wherein the second bone anchor would comprise:
a second rod housing 106 configured to receive the spinal rod 102,
wherein the second rod housing would comprise a base (Fig. 4), a pair of arms extending proximally from the base and separated by a rod channel 144 dimensioned to receive the spinal rod 102 therein (Figs. 1 and 4), a second longitudinal axis 136 extending through a distal opening 140 in the base, and an internal frustospherical groove disposed within the base between the pair of arms and the distal opening,
wherein the internal frustospherical groove 142 of the combination (supra) is oriented at an oblique angle relative to the second longitudinal axis 136 (supra; cf. first annotated Fig. 15, supra);
a second capture ring 108 disposed within the internal frustospherical groove 142 (McKinley, Fig. 7); and
a second bone fastener 104 comprising a fastener head 122 (Fig. 4) disposed within the base, and a shank 126 integrally coupled to the fastener head 122 and configured to engage bone (McKinley et al., para. 0056).
Regarding claim 19, a central longitudinal axis of the second capture ring 108 of the second bone anchor 100 of the combination (cf. supra) is oriented at an oblique angle a that is more acute than a maximum deflection angle A of the second bone fastener relative to the second longitudinal axis (see annotated Fig. 8, supra).
Regarding claim 20, the base of the second rod housing 106 of the combination (cf. supra) comprises an angled recess (supra) dimensioned to complement the second bone fastener 104 of the combination, wherein the angled recess is configured to increase a maximum deflection angle of the second bone fastener 104 relative to the second longitudinal axis 136, and wherein the recess forms an oblique angle θ with the second longitudinal axis 136 that is greater than the oblique angle of the internal frustospherical groove 142 in the second rod housing 106 of the combination (supra).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,364,517. Although the claims at issue are not identical, they are not patentably distinct from each other because the differences amount to minor changes in the arrangement and phraseology of the claim limitations. The only substantive difference between the application claims and the patent claims resides in the fact that the patent claims include more elements and are more specific (e.g., the proximal opening, the internal groove and its orientation, the frustoconical external contour, the bone fastener extending through the distal opening and comprising a mating surface). Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Regarding independent application claim 1, patent claim 1 sets forth a spinal fixation system comprising:
a spinal rod; and
a bone anchor configured to secure the spinal rod to the spine, wherein the bone anchor comprises:
a rod housing configured to receive the spinal rod, wherein the rod housing comprises:
a base, a pair of arms extending proximally (to an upper proximal end) from the base and separated by a rod channel dimensioned to receive the spinal rod therein, a longitudinal axis extending through a distal opening in the base, and a capture ring disposed within the rod housing, the capture ring including a frustospherical capture surface; and
a bone fastener comprising a fastener head disposed within the base, and a shank coupled to the fastener head and configured to engage bone.
The dependent application claims are also directly mapped to the patent claims as set forth in the table below:
Appl. 19/274,852
Pat. 12,364,517
1
1
2
2
3
3
4
4
5
5
6
6
7
7
8
8
9
9
10
10
11
11
12
12
13
13
14
14
15
15
16
16
17
17
18
18
19
19
20
20
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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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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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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