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 .
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.
Claims 56-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,583,327. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and granted patent disclose a tissue distraction device. The device comprises a first elongated member and a second elongated member, an augmenting elongated member configured to cooperatively interact with the first elongated member and the second elongated member to increase a dimensional aspect of the tissue distraction device, wherein the first elongated member and the second elongated member comprises an inner member and an outer member at least partially surrounding the inner member, wherein the inner member and the outer member comprise different materials, wherein the inner member comprises a polymer material, and the outer member comprises a metallic material.
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 inner layer and the outer layer comprise different materials (metals and polymers described in [0061]), (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 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]), 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
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
Prosecution Insights