DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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. 17/892,663, 16/148,120, 15/098,897, 14/470,992, and 12/757,443, 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. The aforementioned prior-filed applications fail to provide support for an implant having a combination of spikes and keels as recited in claims 1 and 12. As such, none of the pending claims are 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: an implant having a combination of spikes and keels as recited in claims 1 and 12.
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 keel as recited in claims 1, 3-5, 8, 12, 13, 15, and 16 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.
Specification
The disclosure is objected to because of the following informalities: the specification fails to describe the keel as recited in claims 1, 3-5, 8, 12, 13, 15, and 16.
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 4 and 5 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. It is unclear how the keel extends along a central longitudinal axis of the second component (claim 4) when the keel extends from the outer surface of the first component (claim 1). For examination purposes, the Examiner is interpreting claim 4 as reciting that the keel extends along a central longitudinal axis of the first component, not the second component. Claim 5 is rejected because it depends from claim 4.
Claim 11 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. It is unclear whether “the outer surface” (line 3) refers to the outer surface of the first component or the outer surface of the spike. For examination purposes, the Examiner is interpreting the outer surface as referring to the outer surface of the first component.
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. It is unclear how the keel extends along a central longitudinal axis of the second component (claim 13) when the keel extends from the outer surface of the first component (claim 12). For examination purposes, the Examiner is interpreting claim 13 as reciting that the keel extends along a central longitudinal axis of the first component, not the second component.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 is not further limiting because it cannot depend from itself. For examination purposes, the Examiner is interpreting claim 10 as depending from claim 9. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(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 1-4, 6-10, 12-15, and 17-20 are rejected under pre-AIA 35 U.S.C. 102(a) and 102(e) as being anticipated by Arramon et al. (US 2009/0276051 A1).
Claim 1. Arramon discloses an implant for insertion into an intervertebral space between two adjacent vertebrae, the implant comprising:
a first component (plate 110) having an outer surface (surface from which serrations 118 and fin member 116 extend) for engaging one of the adjacent vertebrae and an inner surface (see Fig. 5 inset) opposite the outer surface, the first component including first and second fixation elements (fin member 116 and serrations 118) extending from the outer surface, wherein the first fixation element comprises a keel (fin member 116) and the second fixation element comprises a spike (one of serrations 118); and
[AltContent: textbox (Inner Surface)][AltContent: textbox (Inner Surface)]a second component (plate 112) having an outer surface (surface from which serrations 118 and fin member 116 extend) for engaging the other of the adjacent vertebrae and an inner surface (see Fig. 5 inset) opposite the outer surface (Figs. 3-6; paras. 0067-0069).
Claim 2. Arramon discloses wherein the second component comprises a fixation element (fin member 116 and/or serrations 118) extending from the outer surface (Figs. 3-6; paras. 0067-0069).
Claim 3. Arramon discloses wherein the fixation element of the second component comprises one of a keel (fin member 116) or a spike (Figs. 3-6; paras. 0067-0069).
[AltContent: textbox (Central Longitudinal Axis (extends into page))][AltContent: textbox (X)][AltContent: textbox (X)][AltContent: textbox (Central Longitudinal Axis (extends into page))]Claim 4. Arramon discloses wherein the keel substantially extends along a central longitudinal axis (see Fig. 5 inset) of the second component (Figs. 3-6; paras. 0067-0069).
Claim 6. Arramon discloses wherein the first component is an upper endplate (the implant can be oriented in such a manner that plate 110 is located at the upper side and is therefore an upper endplate) and the second component is a lower endplate (the implant can be oriented in such a manner that plate 112 is located at the lower side and is therefore a lower endplate) (Figs. 3-6; paras. 0067-0069).
Claim 7. Arramon discloses wherein the second component is an upper endplate (the implant can be oriented in such a manner that plate 112 is located at the upper side and is therefore an upper endplate) and the first component is a lower endplate (the implant can be oriented in such a manner that plate 110 is located at the lower side and is therefore a lower endplate) (Figs. 3-6; paras. 0067-0069).
Claim 8. Arramon discloses wherein the fixation element of the second component comprises a plurality of spikes (serrations 118) and a keel (fin member 116) that substantially extends along a central longitudinal axis (see Fig. 5 inset on pg. 8 above) of the second component (Figs. 3-6; paras. 0067-0069).
Claim 9. Arramon discloses wherein the implant has a longitudinal axis (see Fig. 3 inset) and the second fixation element of the first component comprises a first set of least two spikes (see Fig. 3 inset) laterally offset (see Fig. 3 inset) from the longitudinal axis and a second set of at least two spikes (see Fig. 3 inset) laterally offset (see Fig. 3 inset) from the longitudinal axis on an opposite side of the longitudinal axis (Figs. 3-6; paras. 0067-0069).
[AltContent: arrow][AltContent: arrow]
Claim 10. Arramon discloses wherein the first set of spikes comprises at least two spikes (see Fig. 3 inset on pg. 9 above) offset from each other in a longitudinal direction, wherein the at least two spikes are laterally offset (see Fig. 3 inset on pg. 9 above) from each other (Figs. 3-6; paras. 0067-0069).
Claim 12. Arramon discloses an implant for insertion into an intervertebral disc space between two adjacent vertebrae, the implant comprising:
a first component (plate 112) having an outer surface (surface from which serrations 118 and fin member 116 extend) for engaging one of the adjacent vertebrae and a concave surface (see Fig. 5 inset) opposite the outer surface, the first component comprising a keel (fin member 116) extending from the outer surface;
a second component (plate 110) having an outer surface (surface from which serrations 118 and fin member 116 extend) for engaging the other of the adjacent vertebrae and an inner surface (see Fig. 5 inset) opposite the outer surface, the second component comprising a spike (one of serrations 118) extending from the outer surface; and
an articulating core member (core 114) residing between the first and second components, the articulating core member comprising a convex surface (see Fig. 5 inset) in contact with the concave surface of the first component (Figs. 3-6; paras. 0067-0069).
[AltContent: textbox (Inner Surface)][AltContent: textbox (Concave Surface of Plate 112 and Convex Surface of Core 114)]
[AltContent: textbox (Central Longitudinal Axis (extends into page))][AltContent: textbox (X)][AltContent: textbox (X)][AltContent: textbox (Central Longitudinal Axis (extends into page))]Claim 13. Arramon discloses wherein the keel substantially extends along a central longitudinal axis (see Fig. 5 inset) of the second component (Figs. 3-6; paras. 0067-0069).
Claim 14. Arramon discloses wherein the first component further comprises a plurality of spikes (serrations 118) extending from the outer surface (Figs. 3-6; paras. 0067-0069).
Claim 15. Arramon discloses wherein the second component further comprises a keel (fin member 116) that substantially extends along a central longitudinal axis (see Fig. 5 inset on pg. 11 above) of the second component (Figs. 3-6; paras. 0067-0069).
Claim 17. Arramon discloses wherein the implant has a longitudinal axis (see Fig. 3 inset) and the second component comprises a first set of least two spikes (see Fig. 3 inset) laterally offset (see Fig. 3 inset) from the longitudinal axis and a second set of at least two spikes (see Fig. 3 inset) laterally offset (see Fig. 3 inset) from the longitudinal axis on an opposite side of the longitudinal axis (Figs. 3-6; paras. 0067-0069).
[AltContent: arrow][AltContent: arrow]
Claim 18. Arramon discloses wherein the first set of spikes comprises at least two spikes (see Fig. 3 inset above) offset from each other in a longitudinal direction, wherein the at least two spikes are laterally offset (see Fig. 3 inset above) from each other (Figs. 3-6; paras. 0067-0069).
Claim 19. Arramon discloses wherein the implant has a longitudinal axis (see Fig. 3 inset on pg. 12 above) and the first component comprises a first set of least two spikes (see Fig. 3 inset on pg. 12 above) laterally offset (see Fig. 3 inset on pg. 12 above) from the longitudinal axis and a second set of at least two spikes (see Fig. 3 inset on pg. 12 above) laterally offset (see Fig. 3 inset on pg. 12 above) from the longitudinal axis on an opposite side of the longitudinal axis (Figs. 3-6; paras. 0067-0069). Note that plates 110 and 112 are mirror images with respect to their outer surfaces as shown in Fig. 5, and thus the labeling of plate 110 applies to plate 112.
Claim 20. Arramon discloses wherein the first set of spikes comprises at least two spikes (see Fig. 3 inset on pg. 12 above) offset from each other in a longitudinal direction, wherein the at least two spikes are laterally offset (see Fig. 3 inset on pg. 12 above) from each other (Figs. 3-6; paras. 0067-0069). Note that plates 110 and 112 are mirror images with respect to their outer surfaces as shown in Fig. 5, and thus the labeling of plate 110 applies to plate 112.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 11 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Arramon et al. (US 2009/0276051 A1) in view of Heinz (US 2007/0270956 A1).
Arramon fails to disclose wherein the spike comprises at least one outer surface extending between a base and a tip outwardly spaced from the outer surface of the first component, the spike further comprising a recess extending into the outer surface at a location between the tip and the base, and wherein the recess extends from a first end having a first portion that extends into the spike, and a second portion that extends through the outer surface of the first component and into, but not through, the first component (claim 11).
However, Arramon teaches an alternative embodiment wherein a first component (plate 110) comprises a spike (tooth 122) extending from an outer surface (see Fig. 2 inset) of the first component, wherein the spike comprises at least one outer surface (see Fig. 2 inset) extending between a base (see Fig. 2 inset) and a tip (see Fig. 2 inset) outwardly spaced from the outer surface of the first component, the spike further comprising a recess (see Fig. 2 inset) having a second portion (see Fig. 2 inset) extending into the outer surface at a location between the tip and the base, wherein the second portion extends through the outer surface of the first component and into, but not through, the first component (Fig. 2; paras. 0050-0051).
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[AltContent: textbox (Outer Surface)][AltContent: connector][AltContent: connector][AltContent: textbox (Second Portion of Recess)][AltContent: connector][AltContent: textbox (Base)][AltContent: connector][AltContent: connector][AltContent: textbox (Outer Surface)][AltContent: textbox (Tip)]
Heinz teaches a first component comprising an outer surface (surface 16) and a spike (cutting feature 20) extending from the outer surface, wherein the spike comprises at least one outer surface (trailing surface 32) extending between a base (see Fig. 2 inset) and a tip (see Fig. 2 inset) outwardly spaced from the outer surface of the first component, the spike further comprising a recess (see Fig. 2 inset) that extends from a first end having a first portion (see Fig. 2 inset) that extends into the spike and a second portion (see Fig. 2 inset) that extends through the outer surface of the first component, wherein such a spike allows for removal of bone during insertion of the implant (see para. 0033) (Figs. 1-5; paras. 0027-0037).
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[AltContent: connector][AltContent: textbox (Base)][AltContent: connector][AltContent: textbox (Tip)][AltContent: connector][AltContent: connector][AltContent: textbox (First Portion of Recess)][AltContent: textbox (Second Portion of Recess)]
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the implant of Arramon such that the spike comprises at least one outer surface extending between a base and a tip outwardly spaced from the outer surface of the first component, the spike further comprising a recess extending into the outer surface at a location between the tip and the base, and wherein the recess extends from a first end having a first portion that extends into the spike, and a second portion that extends through the outer surface of the first component and into, but not through, the first component (claim 11), as suggested by an alternative embodiment of Arramon and Heinz, as such a spike would allow for removal of bone during insertion of the implant to better promote fixation of the outer surface to the vertebra without the removed bone interfering with the articulating core (core 114 of Arramon) of the implant.
Claims 1, 4, 5, 12, 15, and 16 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marnay et al. (US 2004/0117022 A1) in view of Arramon et al. (US 2009/0276051 A1).
Claim 1. Marnay discloses an implant for insertion into an intervertebral space between two adjacent vertebrae, the implant comprising:
a first component (part 11) having an outer surface (surface 12) for engaging one of the adjacent vertebrae and an inner surface (surface 24) opposite the outer surface, the first component including a first fixation element (keel 16) extending from the outer surface, wherein the first fixation element comprises a keel (keel 16); and
a second component (part 30) having an outer surface (surface 31) for engaging the other of the adjacent vertebrae and an inner surface (surface 32) opposite the outer surface (Figs. 1-17; paras. 0041-0051).
[AltContent: connector][AltContent: textbox (First End)][AltContent: connector][AltContent: textbox (Second End)]Claim 4. Marnay discloses wherein the keel substantially extends along a central longitudinal axis (see Fig. 4 inset) of the second component (Figs. 1-17; paras. 0041-0051).
Claim 5. Marnay discloses wherein the keel comprises first and second ends (see Fig. 4 inset on pg. 17 above), and further wherein the first end comprises a recess (recess 17) extending from the first end to a location between the first and second ends (Figs. 1-17; paras. 0041-0051).
Marnay fails to disclose wherein the first component comprises a second fixation element extending from the outer surface, wherein the second fixation element comprises a spike (claim 1).
Arramon teaches a first component (plate 110) comprising first and second fixation elements (fin member 116 and serrations 118) extending from an outer surface (surface from which serrations 118 and fin member 116 extend) of the first component, wherein the first fixation element comprises a keel (fin member 116) and the second fixation element comprises a spike (one of serrations 118), wherein the combination of first and second fixation elements ensures retention and bone integration (see para. 0067) (Figs. 3-6; paras. 0067-0069).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the implant of Marnay such that the first component comprises a second fixation element extending from the outer surface, wherein the second fixation element comprises a spike (claim 1), as suggested by Arramon, as such a combination of first and second fixation elements ensures retention and bone integration.
Claim 12. Marnay discloses an implant for insertion into an intervertebral disc space between two adjacent vertebrae, the implant comprising:
a first component (part 11) having an outer surface (surface 12) for engaging one of the adjacent vertebrae and a concave surface (concave portion 25) opposite the outer surface, the first component comprising a keel (keel 16) extending from the outer surface;
a second component (part 30) having an outer surface (surface 31) for engaging the other of the adjacent vertebrae and an inner surface (surface 32) opposite the outer surface; and
an articulating core member (inlay 50) residing between the first and second components, the articulating core member comprising a convex surface (convex portion 52) in contact with the concave surface of the first component (Figs. 1-17; paras. 0041-0051).
Claim 15. Marnay discloses wherein the second component further comprises a keel (keel 16) that substantially extends along a central longitudinal axis (see Fig. 4 inset) of the second component (Figs. 1-17; paras. 0041-0051).
[AltContent: connector][AltContent: textbox (First End)][AltContent: connector][AltContent: textbox (Second End)]
Claim 16. Marnay discloses wherein the keel comprises first and second ends (see Fig. 4 inset above), wherein the first end comprises a recess (recess 41) extending from the first end to a location between the first and second ends (Figs. 1-17; paras. 0041-0051).
Marnay fails to disclose wherein the second component comprises a spike extending from the outer surface (claim 12).
Arramon teaches a first component (plate 110) and a second component (plate 112) each comprising a keel (fin member 116) and a spike (one of serrations 118) extending from their respective outer surfaces (surfaces from which serrations 118 and fin member 116 extend), wherein the combination of keels and spikes ensures retention and bone integration (see para. 0067) (Figs. 3-6; paras. 0067-0069).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the implant of Marnay such that each of the first and second components each comprise a keel and a spike extending from their respective outer surfaces such that the second component comprises a spike extending from the outer surface (claim 12), as suggested by Arramon, as such a combination of keels and spikes ensures retention and bone integration.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 8,858,636 B2 in view of Arramon et al. (US 2009/0276051 A1). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 17 of the patent claims an implant (col. 24, l. 56) for insertion into an intervertebral space between two adjacent vertebrae, the implant comprising: a first component having an outer surface for engaging one of the adjacent vertebrae and an inner surface opposite the outer surface (col. 24, ll. 57-60), the first component including a second fixation element extending from the outer surface, wherein the second fixation element comprises a spike (col. 25, ll. 32-34); and a second component having an outer surface for engaging the other of the adjacent vertebrae (col. 25, ll. 8-10). Claim 17 of the patent also includes additional limitations not present in claim 1. In this aspect, claim 17 of the patent is in effect a species of the generic invention of claim 1. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claim 17 of the patent fails to include a first fixation element extending from the outer surface, wherein the first fixation element comprises a keel, and that the second component has an inner surface opposite the outer surface. Arramon teaches an implant comprising: a first component (plate 110), the first component comprising first and second fixation elements (fin member 116 and serrations 118) extending from an outer surface (surface from which serrations 118 and fin member 116 extend) of the first component, wherein the first fixation element comprises a keel (fin member 116) and the second fixation element comprises a spike (one of serrations 118), wherein the combination of first and second fixation elements ensures retention and bone integration (see para. 0067); and a second component (plate 112) having an outer surface (surface from which serrations 118 and fin member 116 extend) for engaging one of the adjacent vertebrae and an inner surface (surface in contact with core 114) opposite the outer surface for engagement with an articulating core (core 114) (Figs. 3-6; paras. 0067-0069). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the implant of claim 17 such that the first component comprises a second fixation element extending from the outer surface, wherein the second fixation element comprises a spike, as suggested by Arramon, as such a combination of first and second fixation elements ensures retention and bone integration. It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the implant of claim 17 such that the second component has an inner surface opposite the outer surface, as suggested by Arramon, in order to provide a surface for engagement with an articulating core.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,333,088 B2 in view of Arramon et al. (US 2009/0276051 A1). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the patent claims an implant (col. 22, l. 47) for insertion into an intervertebral space between two adjacent vertebrae, the implant comprising: a first component having an outer surface for engaging one of the adjacent vertebrae and an inner surface opposite the outer surface (col. 22, ll. 48-54), the first component including a second fixation element extending from the outer surface, wherein the second fixation element comprises a spike (col. 23, ll. 5-8); and a second component having an outer surface for engaging the other of the adjacent vertebrae and an inner surface opposite the outer surface (col. 22, ll. 58-64). Claim 1 of the patent also includes additional limitations not present in claim 1. In this aspect, claim 1 of the patent is in effect a species of the generic invention of claim 1. It has been held that the generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claim 1 of the patent fails to include a first fixation element extending from the outer surface, wherein the first fixation element comprises a keel. Arramon teaches an implant comprising: a first component (plate 110), the first component comprising first and second fixation elements (fin member 116 and serrations 118) extending from an outer surface (surface from which serrations 118 and fin member 116 extend) of the first component, wherein the first fixation element comprises a keel (fin member 116) and the second fixation element comprises a spike (one of serrations 118), wherein the combination of first and second fixation elements ensures retention and bone integration (see para. 0067) (Figs. 3-6; paras. 0067-0069). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the implant of claim 1 such that the first component comprises a second fixation element extending from the outer surface, wherein the second fixation element comprises a spike, as suggested by Arramon, as such a combination of first and second fixation elements ensures retention and bone integration.
Conclusion
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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