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. 61/976,792, 62/078,334, 62/114,860, 14/680,566, 15/654,900, 16/434,958, 17/226,565, and 18/406,757, 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 aforementioned applications provide support for the shapes of the first and second connecting curves being different (claim 18), the first and second heights being the same (claim 28), the first and second heights being different (claims 29, 33, and 35), the main body being a metal (claims 32 and 34), and the first and second wall portions each extending along a plane parallel to the first axis and to the upper surface (claim 35). Accordingly, claims 18, 28-30, and 32-35 are not supported by the prior-filed applications.
Claim Objections
Claim 32 is objected to because of the following informalities: the word “in” should be deleted from “wherein in the main body” (line 1). Appropriate correction is required.
Claim 34 is objected to because of the following informalities: the word “in” should be deleted from “wherein in the main body” (line 1). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally-filed disclosure fails to provide support for the shapes of the first and second connecting curves being different as recited in claim 18. Accordingly, claim 18 contains new matter.
Claim 28 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally-filed disclosure fails to provide support for the first and second heights being the same as recited in claim 28, wherein the first height is measured at the first exterior lateral wall and the second height is measured at the second exterior lateral wall. Accordingly, claim 28 contains new matter.
Claims 29 and 30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally-filed disclosure fails to provide support for the first and second heights being different as recited in claim 29, wherein the first height is measured at the first exterior lateral wall and the second height is measured at the second exterior lateral wall. Claim 30 depends from claim 29. Accordingly, claims 29 and 30 contain new matter.
Claim 32 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally-filed disclosure fails to provide support for the main body comprising a metal as recited in claim 32 (note that the specification provides a list of specific materials but does not broadly include a metal – see para. 0103). Accordingly, claim 32 contains new matter.
Claims 33 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally-filed disclosure fails to provide support for the first and second heights being different as recited in claim 33, wherein the first height is measured at the first wall portion and the second height is measured at the second wall portion. Claim 34 depends from claim 33. Accordingly, claims 33 and 34 contain new matter.
Claim 34 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally-filed disclosure fails to provide support for the main body comprising a metal as recited in claim 34 (note that the specification provides a list of specific materials but does not broadly include a metal – see para. 0103). Accordingly, claim 34 contains new matter.
Claim 35 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally-filed disclosure fails to provide support for the first and second wall portions each extending along a plane parallel to the first axis and to the upper surface as recited in claim 35 (note that none of the figures appear to show any portion of either of the lateral walls extending either parallel or substantially parallel to the upper surface). Accordingly, claim 35 contains new matter.
Claim 35 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally-filed disclosure fails to provide support for the first and second heights being different as recited in claim 35, wherein the first height is measured at the first wall portion and the second height is measured at the second wall portion. Accordingly, claim 35 contains new matter.
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 16, 22-27, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ganem et al. (US 2011/0172769 A1).
Claim 16. Ganem discloses an intervertebral spacer (implant 1) for implantation within an opening in a spinal column, the intervertebral spacer comprising:
a main body having a first axis (extending through anterior transverse wall 2 and posterior transverse wall 3), the main body including an exterior proximal wall (outer wall of anterior transverse wall 2), an exterior distal wall (outer wall of posterior transverse wall 3), a first exterior lateral wall (outer wall of one of lateral walls 4) extending along a plane parallel to the first axis, a second exterior lateral wall (outer wall of the other of lateral walls 4) extending along a plane parallel to the first axis, an upper surface (see Fig. 1 inset) having rounded corners (see Fig. 1 inset), a lower surface (see Fig. 1 inset) having rounded corners (see Fig. 1 inset), an interior lateral wall (inner wall of the one of lateral walls 4) extending from the upper surface to the lower surface, and an interior cavity (internal space 5) partially defined by the interior lateral wall;
a first connecting portion (convex rounded surface 12 at the one of lateral walls 4) extending from the lower surface to the first exterior lateral wall, the first connecting portion defining a first connecting curve (because surface 12 is convex rounded, it has a curve);
a second connecting portion (convex rounded surface 12 at the other of lateral walls 4) extending from the lower surface to the second exterior lateral wall, the second connecting portion defining a second connecting curve (because surface 12 is convex rounded, it has a curve);
wherein each of the first connecting curve and the second connecting curve defines a shape that is based on one of the position at which the intervertebral spacer will be implanted within the spinal column (see para. 0035 and Fig. 4, which indicate that surfaces 12 bear against the uncovertebral surfaces) and the dimensions of the opening into which the intervertebral spacer will be implanted (Figs. 1-4; paras. 0030-0042).
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Claim 22. Ganem discloses wherein the first exterior lateral wall defines a first chamfered portion (inclined flank 10 of the one of lateral walls 4) (Figs. 1-4; paras. 0030-0042).
Claim 23. Ganem discloses wherein the first connecting curve extends to the first chamfered portion (Figs. 1-4; paras. 0030-0042).
Claim 24. Ganem discloses wherein the first chamfered portion is configured to accommodate implantation of the intervertebral spacer in contact with a first uncovertebral joint of the spinal column (see para. 0035 and Fig. 4, which indicate that flanks 10 bear against the uncovertebral surfaces) (Figs. 1-4; paras. 0030-0042).
Claim 25. Ganem discloses wherein the second exterior lateral wall defines a second chamfered portion (inclined flank 10 of the other of lateral walls 4) (Figs. 1-4; paras. 0030-0042).
Claim 26. Ganem discloses wherein the second connecting curve extends to the second chamfered portion (Figs. 1-4; paras. 0030-0042).
Claim 27. Ganem discloses wherein the second chamfered portion is configured to accommodate implantation of the intervertebral spacer in contact with a second uncovertebral joint of the spinal column (see para. 0035 and Fig. 4, which indicate that flanks 10 bear against the uncovertebral surfaces) (Figs. 1-4; paras. 0030-0042).
Claim 31. Ganem discloses wherein each of the first exterior lateral wall and the second exterior lateral wall defines a chamfered portion (inclined flank 10 of the one of lateral walls 4 and inclined flank 10 of the other of lateral walls 4) (Figs. 1-4; paras. 0030-0042).
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 17-21 and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ganem et al. (US 2011/0172769 A1).
Claim 21. Ganem discloses wherein at least one of the first connecting curve and the second connecting curve defines an angled portion (surfaces 12 are angled as shown in Fig. 3) (Figs. 1-4; paras. 0030-0042).
Claims 28 and 29. Ganem discloses wherein the first exterior lateral wall includes a first height (see Fig. 1 inset on pg. 9 above) and the second exterior lateral wall includes a second height (taken in the same location as the first height, but on the other of lateral walls 4) (Figs. 1-4; paras. 0030-0042).
Claim 30. Ganem discloses wherein at least one of the first exterior lateral wall and the second exterior lateral wall defines a chamfered portion (inclined flank 10 of the one of lateral walls 4 and inclined flank 10 of the other of lateral walls 4) (Figs. 1-4; paras. 0030-0042).
Ganem fails to disclose wherein the shape of the first connecting curve is a mirror image of the shape of the second connecting curve (claim 17), wherein the shape of the first connecting curve is different from the shape of the second connecting curve (claim 18), wherein at least one of the first connecting curve and the second connecting curve defines an S-curve (claim 19), wherein at least one of the first connecting curve and the second connecting curve defines a parabolic curve (claim 20), wherein the first height and the second height are the same (claim 28), and wherein the first height and the second height are different (claim 29).
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 spacer of Ganem such that the shape of the first connecting curve is a mirror image of the shape of the second connecting curve (claim 17), the shape of the first connecting curve is different from the shape of the second connecting curve (claim 18), at least one of the first connecting curve and the second connecting curve defines an S-curve (claim 19), and at least one of the first connecting curve and the second connecting curve defines a parabolic curve (claim 20), since Applicant has not disclosed that such solve 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 curved surfaces for contacting the uncovertebral surfaces. In re Dailey and Eilers, 149 USPQ 47 (1966). 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 spacer of Ganem such that the first height and the second height are the same (claim 28) and the first height and the second height are different (claim 29), since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 32 rejected under 35 U.S.C. 103 as being unpatentable over Ganem et al. (US 2011/0172769 A1) in view of Yu et al. (US 2013/0018466 A1).
Ganem fails to disclose wherein the main body comprises a metal (claim 32).
Yu teaches an intervertebral spacer (spacer 20) for implantation within the cervical region of the spinal column (see para. 0044), wherein the spacer comprises a main body comprising a biocompatible metal (see para. 0035) (Fig. 1; paras. 0035 and 0044).
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 spacer of Ganem such that the main body comprises a metal (claim 32), as suggested by Yu, 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 (CCPA 1960).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Ganem et al. (US 2011/0172769 A1) in view of Yu et al. (US 2013/0018466 A1).
Claim 33. Ganem discloses an intervertebral spacer (implant 1) for implantation within an opening in a spinal column, the intervertebral spacer comprising:
a main body having a first axis (extending through anterior transverse wall 2 and posterior transverse wall 3), the main body including an exterior proximal wall (outer wall of anterior transverse wall 2), an exterior distal wall (outer wall of posterior transverse wall 3), a first exterior lateral wall (outer wall of one of lateral walls 4) defining a first chamfered portion (inclined flank 10 of the one of lateral walls 4) and having a first wall portion (see Fig. 1 inset) extending along a plane parallel to the first axis, a second exterior lateral wall (outer wall of the other of lateral walls 4) defining a second chamfered portion (inclined flank 10 of the other of lateral walls 4) and having a second wall portion (located in the same location as the first wall portion, but on the other of lateral walls 4) extending along a plane parallel to the first axis, an upper surface (see Fig. 1 inset) having rounded corners (see Fig. 1 inset), a lower surface (see Fig. 1 inset) having rounded corners (see Fig. 1 inset), an interior lateral wall (inner wall of the one of lateral walls 4) extending from the upper surface to the lower surface, and an interior cavity (internal space 5) partially defined by the interior lateral wall;
a first connecting portion (convex rounded surface 12 at the one of lateral walls 4) extending from the lower surface to the first chamfered portion of the first exterior lateral wall, the first connecting portion defining a first connecting curve (because surface 12 is convex rounded, it has a curve);
a second connecting portion (convex rounded surface 12 at the other of lateral walls 4) extending from the lower surface to the second chamfered portion of the second exterior lateral wall, the second connecting portion defining a second connecting curve (because surface 12 is convex rounded, it has a curve);
wherein each of the first connecting curve and the second connecting curve defines a shape that is based on one of the position at which the intervertebral spacer will be implanted within the spinal column (see para. 0035 and Fig. 4, which indicate that surfaces 12 bear against the uncovertebral surfaces) and the dimensions of the opening into which the intervertebral spacer will be implanted; and
wherein the first wall portion has a first height (see Fig. 1 inset) and the second wall portion has a second height (taken in the same location as the first height, but on the other of lateral walls 4) (Figs. 1-4; paras. 0030-0042).
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Ganem fails to disclose that the second height is different from the first height (claim 33).
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 spacer of Ganem such that the second height is different from the first height (claim 33), since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Ganem et al. (US 2011/0172769 A1) as applied to claim 33 above, and further in view of Yu et al. (US 2013/0018466 A1).
Ganem fails to disclose wherein the main body comprises a metal (claim 34).
Yu teaches an intervertebral spacer (spacer 20) for implantation within the cervical region of the spinal column (see para. 0044), wherein the spacer comprises a main body comprising a biocompatible metal (see para. 0035) (Fig. 1; paras. 0035 and 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the spacer of Ganem such that the main body comprises a metal (claim 34), as suggested by Yu, 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 (CCPA 1960).
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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