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 .
Election/Restrictions
Applicant’s election of Species C, Fig. 21 in the reply filed on June 15, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10, 11, 15, 18, and 21-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 15, 2026.
Claim 3 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (front section 31 and rear section 32 are not secured to each other as claimed – see paras. 0144-0145 and Fig. 21), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 15, 2026.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (rear fastening fiber 42 does not form a loop and receive front fastening fiber 41 – see paras. 0144-0145 and Fig. 21), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 15, 2026.
Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (interspinous vertebropexy does not include a vector component in the dorsal direction – see para. 0063), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 15, 2026.
Claims 1, 2, 4-6, 8, 9, 12-14, 17, 19, and 20 have been examined.
Drawings
The drawings are objected to because it is difficult to see the structure due to the shading and the text is difficult to read due to the size and/or blurriness. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 5 is objected to because of the following informalities: “components” should be “component” (line 2). Appropriate correction is required.
Claims 6, 13, and 14 are objected to because of the following informalities: the rear section has been identified with reference character 31 instead of 32 (lines 3-4 of claim 6; line 2 of claim 13; and line 2 of claim 14). Appropriate correction is required.
Claims 8 and 9 are objected to because of the following informalities: the rear fastening fiber has been identified with reference character 41 instead of 42 (line 2 of claim 8; and lines 2-3 of claim 9). Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the second fastening edge has been identified with reference character 11 instead of 21 (lines 4-5). 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.
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. Regarding claim 4, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 8 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. Regarding claim 8, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 12 and 13 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 12 recites the limitations "the fastening edge of the cranial vertebra" (lines 2-3) and "the fastening edge of the caudal vertebra" (lines 3-4). There is insufficient antecedent basis for these limitations in the claim. Claim 1 recites “a first fastening edge” and “a second fastening edge.” Claim 13 is rejected because it depends from claim 12. For examination purposes, the Examiner is interpreting “the fastening edge of the cranial vertebra" as “the first fastening edge” and "the fastening edge of the caudal vertebra" as “the second fastening edge.”
Claim 13 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. Regarding claim 13, the phrases "preferably" and “more preferably” render the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
Claim 17 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. Regarding claim 17, the phrases "preferably" and “more preferably” render the claim indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
Claim 20 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 20 recites the limitations "a/the front fastening fiber" and " a/the rear fastening fiber" (line 2). There is insufficient antecedent basis for these limitations in the claim. Claim 1 recites “a front section” and “a rear section.” For examination purposes, the Examiner is interpreting “a/the front fastening fiber" as “the front section” and " a/the rear fastening fiber" as “the rear section.”
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 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, 4, 12, 14, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malandain et al. (US 2013/0325065 A1).
Claim 1. Malandain discloses a method of stabilizing the spine of a patient in need thereof, comprising:
a. providing a first vertebra (vertebra V having superior spinous process SSP) having a first fastening edge (upper surface of superior spinous process SSP) and a second vertebra (vertebra V having inferior spinous process ISP) having a second fastening edge (lower surface of inferior spinous process ISP), wherein the first fastening edge and the second fastening edge are arranged opposite each other and facing away from each other (see Fig. 8M);
b. providing a strap (tether structure 820) extending in a longitudinal direction from a front section (section at free end 821) to a rear section (section attached to buckle 810);
c. passing the front section of the strap around the first fastening edge, then from the first fastening edge to the second fastening edge and then around the second fastening edge (see Figs. 8F, 8G, 8J, and 8K);
d. optionally passing the front section of the strap from the second fastening edge to the first fastening edge and repeating step c;
e. tensioning the strap and fastening the front section to the rear section such that the first vertebra and the second vertebra are fixated relative to each other (see para. 0075) (Figs. 8A-8N; paras. 0068-0076).
Claim 4. Malandain discloses wherein the strap comprises a non-metallic cerclage (see para. 0068, which states that tether structure 820 is a textile), a ligament or a tendon, preferably a tendon (Figs. 8A-8N; paras. 0068-0076).
Claim 12. Malandain discloses wherein one of the two vertebrae is a cranial vertebra (vertebra V having superior spinous process SSP) and the other of the two vertebrae is a caudal vertebra (vertebra V having inferior spinous process ISP), wherein the fastening edge of the cranial vertebra is arranged on the spinous process of the cranial vertebra and/or the fastening edge of the caudal vertebra is arranged on the spinous process of the caudal vertebra (see Fig. 8M) (Figs. 8A-8N; paras. 0068-0076).
Claim 14. Malandain discloses wherein after fastening the front section to the rear section, the strap exerts a tensile force on the first vertebra and on the second vertebra in a tensile force direction that is essentially in parallel to the direction of extension of the spine between the first vertebra and the second vertebra (due to the positioning of tether structure 820 as shown in Fig. 8M, the tensile force applied by tether structure 820 would be essentially in a direction parallel to the direction of extension of the spine) (Figs. 8A-8N; paras. 0068-0076).
Claim 19. Malandain discloses wherein after tensioning the strap, the front section and the rear section of the strap are interspaced from each other by a gap (gap occupied by portion of buckle 810 between first slot 811 and section of tether structure 820 attached to buckle 810; see Figs. 8K and 8L) (Figs. 8A-8N; paras. 0068-0076).
Claim 20. Malandain discloses wherein the step of fastening the front section to the rear section comprises interconnecting a/the front fastening fiber to a/the rear fastening fiber (via buckle 810), thereby bridging the gap (Figs. 8A-8N; paras. 0068-0076).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bevan et al. (US 5,725,582 A).
Claim 1. Bevan discloses a method of stabilizing the spine of a patient in need thereof, comprising:
a. providing a first vertebra (upper vertebra 24) having a first fastening edge (defined by the upper surface of spinous process 23) and a second vertebra (lower vertebra 24) having a second fastening edge (defined by the lower surface of spinous process 23), wherein the first fastening edge and the second fastening edge are arranged opposite each other and facing away from each other (see Figs. 1-2);
b. providing a strap (implant 20) extending in a longitudinal direction from a front section (one of tails 25) to a rear section (the other of tails 25);
c. passing the front section of the strap around the first fastening edge, then from the first fastening edge to the second fastening edge and then around the second fastening edge (see Figs. 1-2);
d. optionally passing the front section of the strap from the second fastening edge to the first fastening edge and repeating step c (see Fig. 2, which shows that implant 20 is wrapped around spinous processes 23 twice);
e. tensioning the strap and fastening the front section to the rear section such that the first vertebra and the second vertebra are fixated relative to each other (see col. 5, ll. 38-47) (Figs. 1-2; col. 5, ll. 38-47).
Claims 1, 6, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barker et al. (US 5,540,703 A).
Claim 1. Barker discloses a method of stabilizing the spine of a patient in need thereof, comprising:
a. providing a first vertebra (vertebra C2) having a first fastening edge (defined by the hole through the spinous process; see col. 12, ll. 44-55) and a second vertebra (unlabeled vertebra below vertebra C2) having a second fastening edge (defined by the lower surface of the spinous process), wherein the first fastening edge and the second fastening edge are arranged opposite each other and facing away from each other (see Figs. 38 and 39);
b. providing a strap (cable 70) extending in a longitudinal direction from a front section (end of cable 70 adjacent needle 81; see col. 12, ll. 44-55; see Fig. 37) to a rear section (opposite end of cable 70);
c. passing the front section of the strap around the first fastening edge, then from the first fastening edge to the second fastening edge and then around the second fastening edge (see Figs. 37 and 38);
d. optionally passing the front section of the strap from the second fastening edge to the first fastening edge and repeating step c;
e. tensioning the strap and fastening the front section to the rear section such that the first vertebra and the second vertebra are fixated relative to each other (see col. 12, ll. 11-25; see col. 12, ll. 44-55) (Figs. 23-32 and 37-39; col. 11, l. 49 through col. 12, l. 25 and col. 12, ll. 44-55).
Claim 6. Barker discloses wherein the strap comprises a front fastening fiber (cable 70 is a braid and thus has front fastening fibers adjacent needle 81) connected to a main body of the strap in or near the front section and a rear fastening fiber (cable 70 is a braid and thus has rear fastening fibers at end 73) connected to the main body of the strap in or near the rear section (Figs. 23-32 and 37-39; col. 11, l. 49 through col. 12, l. 25 and col. 12, ll. 44-55).
Claim 9. Barker discloses wherein the step of tensioning the strap comprises creating a tension knot between the front fastening fiber and the rear fastening fiber (see col. 12, ll. 11-25), tensioning at least the front fastening fiber (applying tension to cable 70 would also apply tension to front fastening fibers) and tightening the tension knot (see col. 12, ll. 11-25) (Figs. 23-32 and 37-39; col. 11, l. 49 through col. 12, l. 25 and col. 12, ll. 44-55).
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Malandain et al. (US 2013/0325065 A1).
Malandain fails to disclose wherein the distance in the longitudinal direction between a front end of the front section and a front end of the rear section of the strap in a relaxed state ranges from 300% to 500%, preferably from 350% to 450%, more preferably from 380% to 420%, of the distance between the first fastening edge and the second fastening edge (claim 13) and wherein during the step of tensioning the strap, a tension force from 40 N to 200 N, preferably from 50 N to 100 N, more preferably from 50 N to 70 N, is applied (claim 17).
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 method of Malandain such that the distance in the longitudinal direction between a front end of the front section and a front end of the rear section of the strap in a relaxed state ranges from 300% to 500%, preferably from 350% to 450%, more preferably from 380% to 420%, of the distance between the first fastening edge and the second fastening edge (claim 13) and during the step of tensioning the strap, a tension force from 40 N to 200 N, preferably from 50 N to 100 N, more preferably from 50 N to 70 N, is applied (claim 17), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bevan et al. (US 5,725,582 A) in view of Carls et al. (US 2010/0274289 A1).
Bevan fails to disclose wherein the strap is hyperelastic (claim 2).
Carls teaches a strap (tie 10) used in stabilizing the spine of a patient (see Figs. 1 and 9), wherein the strap can be made from a variety of materials (see paras. 0023-0027), wherein the material can be a hyperelastic material (see para. 0026, which refers to superelastic materials).
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 method of Bevan such that the strap is hyperelastic (claim 2), as suggested by Carls, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bevan et al. (US 5,725,582 A) in view of Tipirneni et al. (US 2009/0306718 A1).
Bevan fails to disclose wherein the strap comprises a hybrid material comprising a ligament component and a synthetic components (claim 5).
Tipirneni teaches a strap (see “filament” in para. 0092) used in stabilizing a patient’s bones (see para. 0092), wherein the strap can be made from a hybrid material comprising a ligament and a synthetic material (see para. 0092) such that the strap permits the desired amount of movement and flexibility for the intended use (see para. 0092).
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 method of Bevan such that the strap comprises a hybrid material comprising a ligament component and a synthetic components (claim 5), as suggested by Tipirneni, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Barker et al. (US 5,540,703 A) in view of Azuero et al. (US 2013/0079778 A1).
Barker fails to disclose wherein the front fastening fiber and/or the rear fastening fiber are each connected to the main body of the strap by a stitch, preferably a Krackow stitch, a Baseball stitch, a Prusik or a SpeedWhip (claim 8).
Azuero teaches a strap (strap 64) having a front fastening fiber (at first braided end 68; braids are comprised of fibers) and a rear fastening end (at second braided end 70; braids are comprised of fibers), wherein the front and rear fastening fibers can be connected to the strap by a stitch (see para. 0038, which states that first and second braided ends 68 and 70 can be sewn to the strap) (Figs. 6A-6E; para. 0038).
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 method of Barker such that the front fastening fiber and/or the rear fastening fiber are each connected to the main body of the strap by a stitch, preferably a Krackow stitch, a Baseball stitch, a Prusik or a SpeedWhip (claim 8), as suggested by Azuero, as such is a well-known way to secure braided fibers to a strap.
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, 4, 6, 8, 9, 14, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7, and 12 of copending Application No. 18/224,679 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. The difference between the claims of this application and those of the copending application is that the claims of the copending application include more elements (the fastening edges being located on spinous processes and the strap comprising synthetic material as recited in claim 1 of the copending application) and are therefore more specific. Thus, the invention of the claims of the copending application is in effect a species of the generic invention of the claims of this 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 claims 1, 4, 6, 8, 9, 14, and 17 are anticipated by claims 1, 4-7, and 12 of the copending application, they are not patentably distinct from the claims of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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