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 .
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 disclosures of the prior-filed applications, Application Nos. 15/820,125, 16/995,192, and 18/491,186, fail 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. None of the prior-filed applications provide support for the plurality of enlarged contact members being located in a peripheral area of a superior or inferior surface of the implant as recited in claim 13. In the specification, the only reference to “peripheral” is with respect to peripheral strut 2650 shown in Fig. 21 (see, for example, para. 00117 of Application No. 18/491,186). These struts are located at a side surface of the implant and do not appear to include enlarged contact members (see para. 00117 and Fig. 21). Figs. 3-5 show enlarged contact areas 540 (not labeled in Figs. 3 and 4) located on a superior or inferior surface of the implant. However, these enlarged contact areas do not appear to be located in a peripheral area of the superior or inferior surface. Accordingly, claims 13-20 are not supported by the prior-filed applications.
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: the plurality of enlarged contact members being located in a peripheral area of a superior or inferior surface of the implant as recited in claim 13 (see above for explanation).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the plurality of enlarged contact members being located in a peripheral area of a superior or inferior surface of the implant (claim 13) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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 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 7-12 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 7 recites the limitation "the outer portion of the body" in line 3 on pg. 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner is interpreting “the outer portion of the body” as “an outer portion of the body.” Claims 8-12 are rejected because they depend from claim 7.
Claims 13-20 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 13 recites that the plurality of enlarged contact members being located in a peripheral area of a superior or inferior surface of the implant as recited in claim 13. In the specification, the only reference to “peripheral” is with respect to peripheral strut 2650 shown in Fig. 21 (see para. 00117). Such use of “peripheral” with respect to peripheral strut 2650 is consistent with the common meaning of “peripheral,” which the Examiner understands to be in reference to a perimeter of a structure. Peripheral strut 2650 is located at a side surface of the implant and does not appear to include enlarged contact members (see para. 00117 and Fig. 21). Figs. 3-5 show enlarged contact areas 540 (not labeled in Figs. 3 and 4) located on a superior or inferior surface of the implant. However, these enlarged contact areas do not appear to be located in a peripheral area of the superior or inferior surface, which would be located adjacent outer struts 512. Instead, enlarged contact areas 540 appear to be located a substantial distance from outer struts 512.
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.
Claims 1 and 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Afzal (US 2017/0258606 A1) in view of Forterre et al. (US 2014/0228960 A1).
Claim 1. Afzal discloses an intervertebral implant comprising:
a body (scaffold 10 with bone graft material – see para. 0031) having an open lattice structure (cage 12 is an open lattice structure) formed by a plurality of elongate struts, including a first strut (see Fig. 1 inset) and a second strut (see Fig. 1 inset);
the first strut having a first longitudinal length (measurement extending from the node arcing downward) and a first lateral width (measurement extending substantially parallel to the length of surface strut 24, wherein the length of surface strut 24 extends from centerpoint 26 to frame 30), the first longitudinal length being longer than the first lateral width;
the second strut having a second longitudinal length (measurement extending from the node arcing downward) and a second lateral width (measurement extending substantially parallel to the length of surface strut 24, wherein the length of surface strut 24 extends from centerpoint 26 to frame 30), the second longitudinal length being longer than the second lateral width;
the body including a contact surface (superior support surface 14 or inferior support surface 16) configured to confront a bone plate (see paras. 0022-0023);
the contact surface including a node (see Fig. 1 inset; note that the node is at the intersection of the first strut, the second strut, and surface strut 24) defined by an intersection of the first strut and the second strut (Figs. 1-5).
Claim 3. Afzal discloses wherein at least a portion of the first strut and at least a portion of the second strut extend inward from the enlarged contact member toward a central core (bone graft material – see para. 0031) of the body (note that the first and second struts arc away from surface strut 24) (Figs. 1-5).
Claim 5. Afzal discloses wherein at least one of the first strut and the second strut includes a curved arch portion (note that the first and second struts arc away from surface strut 24) (Figs. 1-5).
[AltContent: textbox (Node)][AltContent: textbox (First Strut)][AltContent: textbox (Second Strut)]
Afzal fails to disclose wherein the implant includes an enlarged contact member disposed at the node defined by the intersection of the first strut and the second strut (claim 1), wherein the enlarged contact member has a substantially flattened outer-facing surface forming part of the contact surface (claim 1), wherein the enlarged contact member has a shape that is oblong along a first axis that extends at an angle with respect to at least one of the first strut and the second strut (claim 1), wherein the enlarged contact member is asymmetrically disposed with respect to the intersection of the first strut and the second strut (claim 4), and wherein at least one of the first strut and the second strut has a flattened cross-sectional shape (claim 6).
Forterre et al. teach an intervertebral implant comprising: a body (intervertebral section 20) including a contact surface (surface contacting vertebral body 10); the contact surface including a node (enlarged portion at central axis 52 upon which spike 62 is located), the node being at an intersection of a first strut (see Fig. 3 inset) and a second strut (see Fig. 3 inset); wherein the implant includes an enlarged contact member (note that the identified node – see above – is enlarged relative to the width of webs 54) disposed at the node defined by the intersection of the first strut and the second strut; wherein the enlarged contact member has a substantially flattened outer-facing surface (surface upon which spike 62 is located) forming part of an outer portion of the body; wherein the enlarged contact member is asymmetrically disposed with respect to the intersection of the first strut and the second strut; wherein at least one of the first strut and the second strut has a flattened cross-sectional shape (note that the surface that would contact vertebral body 10 is flattened such that it is complementary to the bone plate); and wherein the enlarged contact member includes an anchoring element (spike 62) to penetrate into the bone plate to prevent sliding of the intervertebral implant (see para. 0024) (Figs. 1-3).
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[AltContent: connector][AltContent: textbox (First Strut)][AltContent: connector][AltContent: textbox (Second Strut)]
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 implant of Afzal such that the implant includes an enlarged contact member disposed at the node defined by the intersection of the first strut and the second strut (claim 1), the enlarged contact member has a substantially flattened outer-facing surface forming part of the contact surface (claim 1), the enlarged contact member is asymmetrically disposed with respect to the intersection of the first strut and the second strut (claim 4), at least one of the first strut and the second strut has a flattened cross-sectional shape (claim 6), and the enlarged contact member includes an anchoring element, as suggested by Forterre et al., as such an enlarged contact member provides a location for an anchoring element, which can penetrate into the bone plate to prevent sliding of the intervertebral implant, and the flattened cross-sectional shape complements the shape of the bone plate it contacts. 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 implant of Afzal such that the enlarged contact member has a shape that is oblong along a first axis that extends at an angle with respect to at least one of the first strut and the second strut (claim 1), since Applicant has not disclosed that such an oblong shape solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing an enlarged contact member at the intersection of the first strut and the second strut. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claims 7-9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Afzal (US 2017/0258606 A1) in view of Forterre et al. (US 2014/0228960 A1).
Claim 7. Afzal discloses an intervertebral implant comprising:
a body (scaffold 10 with bone graft material – see para. 0031) having a lattice structure (cage 12 is an open lattice structure) formed by a plurality of elongate struts, including a first strut (see Fig. 1 inset), a second strut (see Fig. 1 inset), a third strut (see Fig. 1 inset), and a fourth strut (see Fig. 1 inset);
the first strut having a first longitudinal length (measurement extending from the node arcing downward) and a first lateral width (measurement extending substantially parallel to the length of surface strut 24, wherein the length of surface strut 24 extends from centerpoint 26 to frame 30), the first longitudinal length being longer than the first lateral width;
the second strut having a second longitudinal length (measurement extending from the node arcing downward) and a second lateral width (measurement extending substantially parallel to the length of surface strut 24, wherein the length of surface strut 24 extends from centerpoint 26 to frame 30), the second longitudinal length being longer than the second lateral width;
the third strut having a third longitudinal length (measurement extending from the node arcing downward) and a third lateral width (measurement extending substantially parallel to the length of surface strut 24, wherein the length of surface strut 24 extends from centerpoint 26 to frame 30), the third longitudinal length being longer than the third lateral width;
the fourth strut having a fourth longitudinal length (measurement extending from the node arcing downward) and a fourth lateral width (measurement extending substantially parallel to the length of surface strut 24, wherein the length of surface strut 24 extends from centerpoint 26 to frame 30), the fourth longitudinal length being longer than the fourth lateral width;
the body including a superior surface (superior support surface 14), an inferior surface (inferior support surface 16);
the superior surface configured to confront an upper bone plate (see paras. 0022-0023);
the inferior surface configured to confront a lower bone plate (see paras. 0022-0023);
at least one of the superior surface and the inferior surface including a first node (see Fig. 1 inset; note that the node is at the intersection of the first strut, the second strut, and surface strut 24) defined by an intersection of the first strut and the second strut and a second node (see Fig. 1 inset; note that the node is at the intersection of the third strut, the fourth strut, and surface strut 24) defined by an intersection of the third strut and the fourth strut (Figs. 1-5).
Claim 8. Afzal discloses wherein at least one of the first strut and the second strut includes a curved arch portion (note that the first and second struts arc away from surface strut 24) (Figs. 1-5).
[AltContent: textbox (First Node)][AltContent: textbox (First Strut)][AltContent: textbox (Second Strut)][AltContent: textbox (Second Node)][AltContent: textbox (Third Strut)][AltContent: textbox (Fourth Strut)]Claim 11. Afzal discloses wherein at least a portion of the first strut and at least a portion of the second strut extend inward from the first enlarged contact member toward a central core (bone graft material – see para. 0031) of the body (note that the first and second struts arc away from surface strut 24) (Figs. 1-5).
Afzal fails to disclose wherein the implant includes a first enlarged contact member disposed at the node and a second enlarged contact member disposed at the second node (claim 7), wherein the first enlarged contact member and the second enlarged contact member each include a substantially flattened outer-facing surface forming part of the outer portion of the body (claim 7), wherein the first enlarged contact member has a shape that is oblong along a first axis that extends at an angle with respect to at least one of the first strut and the second strut (claim 7), wherein the second enlarged contact member has a shape that is oblong along a second axis that extends at an angle with respect to at least one of the third strut and the fourth strut (claim 7), wherein the substantially flattened surface is oriented along one of the superior surface and the inferior surface of the intervertebral implant (claim 9), and wherein at least one of the first strut and the second strut has a flattened cross-sectional shape (claim 12).
Forterre et al. teach an intervertebral implant comprising: a body (intervertebral section 20) including a superior surface (surface contacting vertebral body 10) and an inferior surface (surface contacting vertebral body 12); the superior surface including a node (enlarged portion at central axis 52 upon which spike 62 is located), the node being at an intersection of a first strut (see Fig. 3 inset) and a second strut (see Fig. 3 inset); wherein the node includes an enlarged contact member (note that the identified node – see above – is enlarged relative to the width of webs 54); wherein the enlarged contact member has a substantially flattened outer-facing surface (surface upon which spike 62 is located) forming part of an outer portion of the body; wherein the enlarged contact member includes a substantially flattened surface (surface upon which spike 62 is located) that is oriented along the superior surface of the intervertebral implant, wherein the substantially flattened surface is textured via an anchoring element (spike 62) to penetrate into the bone plate to prevent sliding of the intervertebral implant (see para. 0024); wherein at least one of the first strut and the second strut has a flattened cross-sectional shape (note that the surface that would contact vertebral body 10 is flattened such that it is complementary to the bone plate); and wherein the flattened cross-sectional shape of the at least one of the first strut and the second strut is oriented along one of the superior surface and the inferior surface of the intervertebral implant (Figs. 1-3).
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[AltContent: connector][AltContent: textbox (First Strut)][AltContent: connector][AltContent: textbox (Second Strut)]
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 implant of Afzal such that the implant includes a first enlarged contact member disposed at the node and a second enlarged contact member disposed at the second node (claim 7), the first enlarged contact member and the second enlarged contact member each include a substantially flattened outer-facing surface forming part of the outer portion of the body (claim 7), the substantially flattened surface is oriented along one of the superior surface and the inferior surface of the intervertebral implant (claim 9), and at least one of the first strut and the second strut has a flattened cross-sectional shape (claim 12), as suggested by Forterre et al., as such an enlarged contact member provides a location for an anchoring element, which can penetrate into the bone plate to prevent sliding of the intervertebral implant, and the flattened cross-sectional shape complements the shape of the bone plate it contacts. 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 implant of Afzal such that the first enlarged contact member has a shape that is oblong along a first axis that extends at an angle with respect to at least one of the first strut and the second strut (claim 7) and the second enlarged contact member has a shape that is oblong along a second axis that extends at an angle with respect to at least one of the third strut and the fourth strut (claim 7), since Applicant has not disclosed that such an oblong shape solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing an enlarged contact member at the intersection of the first/third strut and the second/fourth strut. In re Dailey and Eilers, 149 USPQ 47 (1966).
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 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12,186,200 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The difference between claim 2 and claim 7 of the patent is that claim 7 of the patent includes superior and inferior surfaces as opposed to a contact surface as recited in claim 2 (thus, claim 7 of the patent includes an additional contact surface). As such, the invention of claim 7 of the patent is in effect a species of the generic invention of claim 2. 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 2 is anticipated by claim 7 of the patent, it is not patentably distinct from claim 7.
Allowable Subject Matter
Claim 2 is objected to as being dependent upon a rejected base claim, but would be allowable (a) if rewritten in independent form including all of the limitations of the base claim and any intervening claims and (b) upon the filing of a terminal disclaimer to overcome the double patenting rejection set forth above.
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable (a) if rewritten in independent form including all of the limitations of the base claim and any intervening claims and (b) upon amending claim 7 to overcome the 35 U.S.C. 112 rejection set forth above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hunt (US 2013/0123935 A1 – see Fig. 6C), Morris (US 2016/0324656 A1 – see Fig. 14A), McShane (US 2017/0042697 A1 – see Fig. 10), Nyahay (US 2018/0256352 A1 – see Fig. 3), and Bishop (US 2018/0256361 A1 – see Fig. 1) each disclose an intervertebral implant having a plurality of intersecting struts.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
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