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 without traverse of Group I (claims 14-19) in the reply filed on March 6, 2026, is acknowledged. Claims 1-13 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I or III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 6, 2026.
Claim Objections
Claim 14 is objected to because of the following informalities:
In line 1 of claim 14, “which is a column” should read ---the implant comprising a column---.
Appropriate correction is required.
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 14-15, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over McKay (US 2008/0114458 A1) in view of O’Neil (US 2008/0065218 A1).
Regarding claim 14, McKay teaches an intervertebral disc annulus fibrosus implant (disc repair device 21 in Fig. 3, used as an annulus fibrosus implant as shown in Fig. 10 for sealing a rupture in the annulus fibrosus; para. 0025, 0036),
which is a column (as shown, the column having a generally conical shape; Fig. 3; para. 0036),
wherein the column has a top surface (24; Fig. 3), an opposite bottom surface (22; Fig. 3), and a peripheral surface (23; Fig. 3) connecting the top surface and the bottom surface (as shown; Fig. 3),
wherein an area of the top surface is smaller than that of the bottom surface (as shown in Fig. 3, described in para. 0036).
McKay also discloses that the implant, i.e. disc treatment device, may be formed from a natural polymer such as collagen (see para. 0039).
However, McKay does not explicitly disclose (I) the column having a plurality of ring-shaped collagen fiber layers and (II) wherein the intervertebral disc annulus fibrosus implant is substantially free of cells, water and microorganisms.
O’Neil, in analogous art, teaches an intervertebral disc annulus fibrosus implant (regeneration matrix 12 of device 10; Figs. 1-5; para. 0021-0022), which is a column having a plurality of ring-shaped collagen fiber layers (as depicted in at least Fig. 5, implant/matrix 12 is formed as a column having a plurality of layers 1-5, the layers being ring-shaped to correspond to a ring-shaped void 40 of the annulus fibrosus, and the matrix layers may be formed of natural collagen; para. 0026, 0031, 0047), and wherein the implant is substantially free of cells, water and microorganisms (para. 0034 teaches that the naturally-derived collagen used to form the plurality of layers may be collagen type I that is about 90% of dry weight, i.e. substantially free of water, and has been cleaned, disinfected and sterilized, i.e. to be substantially free of cells and microorganisms; Fig. 5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed McKay’s annulus fibrosus implant column of a plurality of collagen fiber layers and substantially free of cells, water and microorganisms as claimed, because where McKay discloses collagen as a suitable material for the implant column, O’Neil recognizes that forming such a column from ring-shaped collagen layers provide an appropriate biologically compatible structure for filling a void in a patient’s annulus fibrosus (see O’Neil, Fig. 5 and para. 0047-0048) and acknowledges that providing a sterilized and substantially dry collagen-based implant reduces risk of infection transmission (see O’Neil, para. 0034).
Regarding claim 15, McKay and O’Neil teach the intervertebral disc annulus fibrosus implant of claim 14, and McKay teaches wherein the top surface and the bottom surface are each independently circular or polygonal (McKay’s implant 21 is described as having a “generally conical shape with a larger end 22 and an outer surface 23 that tapers towards a smaller opposing end” in para. 0036, shown in Fig. 3 having a truncated conical shape, so that each of the top surface 24 and bottom surface 22 have a circular shape).
Regarding claim 18, McKay and O’Neil teach the intervertebral disc annulus fibrosus implant of claim 14, wherein the intervertebral disc annulus fibrosus implant is derived from an intervertebral disc of a vertebrate (where McKay’s implant is formed from naturally-derived collagen from a host animal as taught by O’Neil, the modified implant is understood to be derived from an intervertebral disc of a vertebrate; see O’Neil, para. 0031-0034) or an artificially cultured intervertebral disc annulus fibrosus mimic.
Regarding claim 19, McKay and O’Neil teach the intervertebral disc annulus fibrosus implant of claim 14.
However, the above-cited references do not explicitly teach wherein the column has a length of 6-10 mm and a maximum width of 3-5 mm.
Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the annulus fibrosus implant to have a length between 6-10mm and a maximum width of 3-5m, since such a modification would have involved a mere change in the size of a component, and further because one of ordinary skill in the art would reasonably select a length and width depending on the size of the void in the annulus fibrosus to be repaired. 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 17 is rejected under 35 U.S.C. 103 as being unpatentable over McKay (US 2008/0114458 A1) and O’Neil (US 2008/0065218 A1), as applied to claim 14 above, further in view of Lotz (US 2009/0234457 A1).
Regarding claim 17, McKay and O’Neil teach the intervertebral disc annulus fibrosus implant of claim 14, wherein the plurality of ring-shaped collagen fiber layers have a type I collagen content (as described above, McKay’s implant 21 in Fig. 3 is formed of O’Neil’s ring-shaped collagen layers of type I collagen; see O’Neil para. 0034).
However, the combination of references does not disclose wherein the type I collagen content increased along a direction from the top surface to the bottom surface.
Lotz, related to treatment of intervertebral disc disorders, teaches that the “collagen content of the disc steadily increases from the center of the nucleus to the outer layers of the annulus” (see para. 0011).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the modified implant having a plurality of layers of collagen fiber so that the collagen content increases from the top surface to the bottom surface, because in a scenario where the top surface is oriented toward the nucleus of the intervertebral disc when implanted, providing the implant with type I collagen content increasing in a direction towards the bottom surface as claimed would more accurately correspond to the natural collagen content of the patient’s intervertebral disc, in view of the teachings of Lotz.
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claim 16 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations. In particular, none of the cited references teach or suggest “wherein the plurality of ring-shaped collagen fiber layers have an interlayer density increased along a direction from the top surface to the bottom surface” as required by claim 16. The most relevant prior art of record includes O’Neil (US 2008/0065218 A1) teaching an annulus fibrosus implant having a plurality of ring-shaped collagen fiber layers (see Fig. 5, para. 0047), as well as Lotz (US 2009/0234457 A1) and Francis (US 2020/0113705 A1), each related to treatment of intervertebral disc disorders, respectively teaching that the “collagen content of the disc steadily increases from the center of the nucleus to the outer layers of the annulus” (see Lotz, para. 0011) and that the “overall collagen content of the intervertebral disc steadily increases from the center of the nucleus propulsus to the outer layers of the annulus fibrosus” (see Francis, para. 0004). Thus, while it is understood that collagen content of a natural intervertebral disc, and annulus fibrosus thereof, in a direction outwards from the center, the prior art of record does not provide clear motivation for forming collagen layers of an annulus fibrosus implant such as O’Neil’s so that the interlayer density increases along a direction from the top surface to the bottom surface as claimed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant references can be found in the attached PTO-892, including Semler (US 2011/0004311 A1) and Trieu (US 2004/0039392 A1), each of which teach an annulus fibrosus implant (see Figs. 6A-7B of Semler, Figs. 1-2 and 4A-F of Trieu).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
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/ANNA V. LITTLE/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773