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 .
Response to Arguments
Applicant's arguments filed September 8, 2026 have been fully considered but they are not persuasive. Regarding independent claim 56, Applicant as amended to include “wherein the outer layer of the first elongated member forms an uppermost surface of the tissue distraction device and the outer layer of the second elongated member forms a lowermost surface of the tissue distraction device.”
Regarding independent claim 64, Applicant as amended to include “wherein the second layer of the first elongated member and the second layer of the second elongated member are diametrically opposed.”
Regarding independent claim 70, Applicant as amended to include “wherein the tissue-contacting layer of the first elongated member is configured to abut a superior vertebra and the tissue-contacting layer of the second elongated member is configured to abut an inferior vertebra.”
Examiner directs attention to rejection below, specifically [0153] of Schaller, which describes:
Elongated members may also be manufactured using molding techniques. Molding techniques include co-molding various materials together to form an elongated member, as well as molding a second material over a first material. Elongated members may also be manufactured by injection molding or extrusion processes.
Applicant argues that:
Schaller discloses "[f]lexibility of the elongated member may also be achieved or varied by fabricating the device from a combination of materials with different degrees of flexibility." Schaller, paragraph [0144]. Schaller discloses "for instance, by located more rigid material on one side of a member, the member may be easier to bend or deflect toward that side." Id. (emphasis added). Schaller discloses "[p]articularly if the member is preformed into a desired curved in situ configuration and temporarily straightened for insertion, the more rigid material may tend to retain the desired configuration to a greater degree than the other material and form the desired configuration which introduced into the disc or vertebra." Id. Figure 26 of Schaller is reproduced below illustrating "a semicircular distraction device having a first elongated member, a second elongated member and an augmenting elongated member forming a structure as it would appear in situ in a disc or vertebra." Id., paragraph [0050].
Examiner contends that this argued feature of Schaller (ability to include more rigid material on one side of a member to promote deflection towards that side) is found in one embodiment of the device and is not inclusive within all potential embodiments of the device, including that described in [0153].
Examiner contends that primary reference Lee further supports the claimed orientation of materials. [0061] of Lee reads:
The distraction device 10 shown in FIGS. 1 and 2 is comprised of a first or lower elongated member 12, a second or upper elongated member 14, an augmenting elongated member 16, and a locking member 18. The augmenting elongated member 16 cooperatively interacts with the first and second elongated members 12 and 14 to increase a dimensional aspect of the distraction device or support structure 10. The distraction device 10 is preferably comprised of elongated members made of biocompatible materials (including metals and polymers) that are suitable for long term implantation into human tissue where treatment is needed.
[0067] of Lee reads: In this manner, selected regions of the elongated member will be easier or more difficult to bend or deflect to assist the shaping of the distraction device 10 in a desired configuration, such as a circular, rectangular, or oval shape. Alternatively, the flexibility features can be located uniformly along a segment or the whole of the elongated member to provide regions of uniform flexibility.
[0068] of Lee reads: Flexibility of the elongated members may also be achieved or varied by fabricating the device from a combination of materials with different degrees of flexibility.
[0062] of Lee reads: Elongated members may also be manufactured using molding techniques. Molding techniques include co-molding various materials together to form an elongated member, as well as molding a second material over a first material.
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.
Claims 56-75 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.
Examiner contends that there is not support within the specification for “wherein the outer layer of the first elongated member forms an uppermost surface of the tissue distraction device and the outer layer of the second elongated member forms a lowermost surface of the tissue distraction device, wherein the inner layer and the outer layer comprise different materials, wherein the inner layer comprises a polymer, and wherein the outer layer comprises a metal” of independent claim 56, for “wherein the second layer of the first elongated member and the second layer of the second elongated member are diametrically opposed, wherein the first material and the second material comprise different materials, wherein the first material comprises a polymer, and wherein the second material comprises a metal” of independent claim 64, and “wherein the tissue-contacting layer of the first elongated member is configured to abut a superior vertebra and the tissue-contacting layer of the second elongated member is configured to abut an inferior vertebra, wherein the first material and the second material comprise different materials, wherein the core comprises a polymer, and wherein the tissue-contacting layer comprises a metal” of independent claim 70.
Regarding layers of different materials in the orientations as claimed, Examiner refers to [0063] of the specification:
The distraction device is preferably comprised of elongated members made of biocompatible materials (including metals and polymers) that are suitable for long-term implantation into human tissue where treatment is needed. The biocompatible materials may, for example, be calcium phosphate, tricalcium phosphate, hydroxyapatite, polyetheretherketone (PEEK), nylon, titanium, Nitinol (NiTi) or any other suitable biocompatible material. Suitable biocompatible material may also include PEEK with carbon fibers, polyethylenes of low, medium, and/or high densities, as well as nylons and blends of materials that contain nylons. It is also within the scope of the present disclosure for the elongated members to be at least partially comprised of one or more bioabsorbable materials, such as polyglycolic acid (PGA) or poly-L lactic acid (PLLA), for example.
[0069 and 0070] further describe:
The various portions of the veneer member 5 may be sequentially formed using any suitable approach, including three-dimensional (“3D”) printing. A 3D-printed object is formed by sequentially forming a plurality of thin layers of material, with each successive layer being positioned at least partially above and onto the immediately preceding layer. Thus, if the veneer member 5 of FIGS. 5A-5D is formed via 3D printing, a first lower layer is applied to a platform or printing bed. A second lower layer is applied onto the first lower layer, followed by subsequent lower layers being applied onto each other until the lower portion “L” of FIG. 5A has been formed. Next, a first intermediate layer is applied onto the uppermost lower layer (i.e., onto the lower portion “L”), followed by subsequent intermediate layers being applied onto each other until the intermediate portion “I” of FIG. 5B has been formed. Then, after the internal core member 4 has been inserted into the cavity “C” defined by the intermediate portion “I”, a first upper layer is applied onto the uppermost intermediate layer (i.e., onto the intermediate portion “I”), followed by subsequent upper layers being applied onto each other until the upper portion “U” (and, hence, the veneer member 5) has been completely formed.
The individual layers may be formed by any suitable approach. For example, if the veneer member 5 is to be formed of a metallic material, a thin layer of metal powder may be applied to a printing bed and sintered using a laser system. Another layer of metal powder is then applied onto the first layer, with the second layer being sintered using the laser system. This process is repeated until enough layers of metal powder have been applied and sintered to form the various portions of the veneer member 5, with the process being suspended between formation of the intermediate portion “I” and the upper portion “U” to allow for insertion of the internal core member 4.
Examiner contends that the specification mentions that the device can be made from different materials, and that the inner and outer members can be manufactured using a 3D printing technique forming a plurality of layers. However, there is no disclosure of these layers being different material (For example, if the veneer member 5 is to be formed of a metallic material), or an indication of an outer layer being a metal, and an inner layer being a polymer.
Claim Rejections - 35 USC § 103
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 56-75 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2014/0277481 to Lee et al. in view of U.S. Patent Pub. No. 2008/0234687 to Schaller et al.
As to Claim 56, Lee discloses a tissue distraction device (10, Fig. 1) comprising a first elongated member (12, Figs. 1, 4, 11, [0061]) and a second elongated member (14, Figs. 1, 4, 11, [0061]), an augmenting elongated member (16, Figs. 1, 11, [0061, 0064]) configured to be at least partially inserted between the first elongated member and the second elongated member to increase a dimensional aspect of at least a portion of the tissue distraction device [0061, 0064]. The first elongated member (12) and the second elongated member (14) comprise a layered structure comprising an inner layer and an outer layer (molding of second material over a first material described in [0062]), wherein the outer layer of the first elongated member forms an uppermost surface of the tissue distraction device and the outer layer of the second elongated member forms a lowermost surface of the tissue distraction device ([0062] molding a second material over a first material), wherein the inner layer and the outer layer comprise different materials (metals and polymers described in [0061]).
As to Claim 57, Lee discloses a tissue distraction device wherein the polymer comprises polyetheretherketone (PEEK materials described in [0061]).
As to Claim 58, Lee discloses a tissue distraction device wherein the metal comprises titanium (biocompatible metal materials described in [0061]).
As to Claim 60, Lee discloses a tissue distraction device wherein the outer layer comprises a plurality of sections spaced along the length of the inner layer (e.g. sections 38, [0074]).
As to Claim 61, Lee discloses a tissue distraction device wherein the first elongated member (12) and the second elongated member (14) are configured to be inserted in a generally linear configuration [0063].
As to Claim 62, Lee discloses a tissue distraction device wherein the first elongated member and the second elongated member are configured to change to a less linear configuration (described in [0065]).
As to Claim 63, Lee discloses a tissue distraction device wherein the outer layer comprises a porous surface (materials having porous surfaces described in [0061]).
As to Claim 64, Lee discloses a tissue distraction device (10, Fig. 1) comprising a first elongated member (12, Figs. 1, 4, 11, [0061]) and a second elongated member (14, Figs. 1, 4, 11, [0061]), an augmenting elongated member (16, Figs. 1, 11, [0061, 0064]) configured to be at least partially inserted between the first elongated member and the second elongated member to increase a dimensional aspect of at least a portion of the tissue distraction device [0061, 0064]. The first elongated member (12) and the second elongated member (14) comprise a composite structure (e.g. PEEK with carbon fibers described in [0061]) comprising an inner layer and an outer layer (molding of second material over a first material described in [0062]), wherein the second layer of the first elongated member and the second layer of the second elongated member are diametrically opposed ([0062] molding a second material over a first material), wherein the inner layer and the outer layer comprise different materials (metals and polymers described in [0061]).
As to Claim 65, Lee discloses a tissue distraction device wherein the polymer comprises polyetheretherketone (PEEK materials described in [0061]).
As to Claim 66, Lee discloses a tissue distraction device wherein the metal comprises titanium (biocompatible metal materials described in [0061]).
As to Claim 67, Lee discloses a tissue distraction device wherein the first elongated member and the second elongated member are configured to change from a generally linear configuration [0063] to a less linear configuration (described in [0065]).
As to Claim 69, Lee discloses a tissue distraction device wherein the second layer comprises a porous surface (materials having porous surfaces described in [0061]).
As to Claim 70, Lee discloses a tissue distraction device (10, Fig. 1) comprising a first elongated member (12, Figs. 1, 4, 11, [0061]) and a second elongated member (14, Figs. 1, 4, 11, [0061]), an augmenting elongated member (16, Figs. 1, 11, [0061, 0064]) configured to be at least partially inserted between the first elongated member and the second elongated member to increase a dimensional aspect of at least a portion of the tissue distraction device [0061, 0064]. The first elongated member (12) and the second elongated member (14) comprise a first material and a tissue-contacting layer comprising a second material, wherein the first material and the second material comprise different materials (metals and polymers described in [0061]), wherein the core comprises a polymer (PEEK materials described in [0061]), wherein the tissue-contacting layer of the first elongated member is configured to abut a superior vertebra and the tissue-contacting layer of the second elongated member is configured to abut an inferior vertebra ([0062] molding a second material over a first material engagement with endpates described in [0064]), and wherein the tissue-contacting layer comprises a metal (biocompatible metal materials described in [0061]).
As to Claim 71, Lee discloses a tissue distraction device wherein the polymer comprises polyetheretherketone (PEEK materials described in [0061]).
As to Claim 72, Lee discloses a tissue distraction device wherein the metal comprises titanium (biocompatible metal materials described in [0061]).
As to Claim 74, Lee discloses a tissue distraction device wherein the first elongated member and the second elongated member are configured to change from a generally linear configuration [0063] to a less linear configuration (described in [0065]).
As to Claim 75, Lee discloses a tissue distraction device wherein the second layer comprises a porous surface (materials having porous surfaces described in [0061]).
As to Claims 56-75, Lee discloses the claimed invention except for wherein the inner layer comprises a polymer, wherein the outer layer comprises a metal, wherein the outer layer at least partially surrounds the inner layer, wherein the first and second elongated members comprise a composite structure that combines a first layer comprising a first material and a second layer comprising a second material, and wherein the first and second elongated members comprise a core comprising a first material and a tissue-contacting layer comprising a second material, wherein the tissue-contacting layer at least partially surrounds the core.
Schaller discloses a tissue distraction device (239, Fig. 22, [0138]) wherein the inner layer comprises a polymer, and wherein the outer layer comprises a metal (combinations of material, different materials on opposing sides described in [0144]). The outer layer at least partially surrounds the inner layer (at interface of materials described in [0144]). The first and second elongated members comprise a composite structure that combines a first layer comprising a first material and a second layer comprising a second material (distinct materials described in [0144], composite materials described in [0139]). The first and second elongated members comprise a core comprising a first material and a tissue-contacting layer comprising a second material (combinations of material, different materials on opposing sides described in [0144]). The tissue-contacting layer at least partially surrounds the core (at interface of materials described in [0144]) in order to allow for varying degrees of flexibility of the members [0144].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the tissue distraction device of Lee with the layer material modification of Schaller in order to allow for varying degrees of flexibility of the members.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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