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 .
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 1-2, 4-11 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (US 2018/0008429 A1).
Regarding claim 1, Li discloses a system configured to maintain spacing between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina, of an adjacent superior vertebra and an adjacent inferior vertebra, the system comprising:
a dynamic implant (device shown in Figs. 6-8; para. 0063-0065) having an implanted position in which the dynamic implant resides in a space between the superior spinous process and the superior lamina, and the inferior spinous process and the inferior lamina (interspinous dynamic stabilization device illustrated in Figs. 6-12 is designed for implantation between adjacent upper and lower spinous processes and laminae; para. 0064), the dynamic implant comprising:
an interconnecting member (elastic structure 3, comprising two U-shaped structures 301; Figs. 6-8; see para. 0067, 0078 and claim 13);
a superior member (defined by base plate 104 of first fixing part 1; Figs. 6-8; para. 0068) that faces the superior lamina in the implanted position (as described in para. 0065-0067, 0078); and
an inferior member (defined by base plate 204 of second fixing part 2; Figs. 6-8; para. 0065) that faces the inferior lamina in the implanted position (as described in para. 0065-0067, 0078);
wherein:
the dynamic implant defines a cavity between the superior member and the inferior member (as shown, cavity defined between respective base plates 104 and 204 of superior and inferior members; Figs. 6-8);
the cavity comprises an opening at a first distal end (see Figs. 6 and 8; cavity has opening at left/distal end between the two U-shaped structures 301; para. 0067); and
the cavity allows independent movement of the superior member and the inferior member in a generally superior-inferior direction in response to movement of the adjacent superior vertebra and/or the adjacent inferior vertebra (cavity between base plates 104 and 204 of the superior and inferior members enables independent movement of each in a generally vertical direction, i.e. superior-inferior direction, in response to movement of adjacent vertebrae to which the interspinous dynamic implant shown in Figs. 6-8 is attached).
Regarding claim 2, Li discloses the system of claim 1, wherein, with the dynamic implant in the implanted position, the superior member contacts the superior lamina and the inferior member contacts the inferior lamina (when implanted, the distal ends of superior member 104 and inferior member 204, i.e. adjacent respective barbs 6 which engage the root of respective spinous process as noted in para. 0026, is configured to contact the respective superior/inferior lamina; para. 0065).
Regarding claim 4, Li discloses the system of claim 1, wherein:
the superior member comprises a superior ridge and the inferior member comprises an inferior ridge each extending along a lateral direction transverse to a proximal-distal direction (barbs 6 formed on superior member 104 and inferior member 204 define superior/inferior ridges, shown to extend in a lateral direction across respective members; Figs. 6-8; para. 0065, 0069); and
the superior ridge and the inferior ridge are positioned to contact the superior spinous process and/or the superior lamina, and the inferior spinous process and/or the inferior lamina (para. 0026 describes barbs/ridges 6 for engaging the root of respective superior/inferior spinous processes, so that ridges 6 in Figs. 6-8 are contact respective superior/inferior spinous processes and/or laminae in the implanted position).
Regarding claim 5, Li discloses the system of claim 1, wherein: the superior member comprises a superior living hinge portion proximate the interconnecting member; the inferior member comprises an inferior living hinge portion proximate the interconnecting member (see Examiner’s Annotated Fig. 7 below); and the superior living hinge portion and the inferior living hinge portion enable a first distal portion of the superior member and a second distal portion of the inferior member to flex in response to movement of the adjacent superior vertebra and/or the adjacent inferior vertebra (see Examiner’s Annotated Fig. 7 below).
PNG
media_image1.png
578
838
media_image1.png
Greyscale
Examiner’s Annotated Fig. 7 of Li
Regarding claim 6, Li teaches the system of claim 5, wherein a first thickness of the superior living hinge portion and a second thickness of the inferior living hinge portion are each selected to provide a desired level of dynamic force urging the superior member and the inferior member apart (where the dynamic implant device is designed to achieve the interspinous resilient distraction and spine movement such as extension and flexion by the U-shaped structures 301 to “maximize the matching of the mobility in each direction to the human body” as described in at least para. 0023, as well as para. 0082, the superior and inferior living hinge portions identified in Examiner’s Annotated Fig. 7 above each have a thickness understood to provide this resilient distraction, i.e. desired level of dynamic force, for urging superior member 104 and inferior member 204 apart as claimed; Figs. 6-8).
Regarding claim 7, Li teaches the system of claim 5, wherein a second distal end of the superior member and a third distal end of the inferior member are configured to engage at least one of the superior lamina and the inferior lamina such that the superior living hinge portion and the inferior living hinge portion urge the superior lamina and the inferior lamina apart (see Figs 6-8 and Examiner’s Annotated Fig. 7 above, where the distal end portions of superior member 104 and inferior member 204 include barbs 6 for engaging the root of respective superior/inferior spinous processes, so that the respective distal ends are configured to engage superior and inferior laminae and superior and living hinge portions urge the laminae apart; para. 0026, 0065-0067, 0078).
Regarding claim 8, Li teaches the system of claim 1, wherein, with the dynamic implant in the implanted position, the opening is oriented towards a vertebral body (with implant of Figs. 6-8 implanted, wings 103 and 203 engage superior and inferior spinous processes and barbs 6 engage the root of respective spinous processes, so that the opening defined between U-shaped structures 301 is oriented towards a vertebral body; para. 0026, 0065-0067).
Regarding claim 9, Li discloses a system configured to maintain spacing between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina, of an adjacent superior vertebra and an adjacent inferior vertebra, the system comprising:
a dynamic implant (device shown in Figs. 6-8; para. 0063-0065) having an implanted position in which the dynamic implant resides in a space between the superior spinous process and the superior lamina, and the inferior spinous process and the inferior lamina (interspinous dynamic stabilization device illustrated in Figs. 6-12 is designed for implantation between adjacent upper and lower spinous processes and laminae; para. 0064), the dynamic implant comprising:
an interconnecting member (elastic structure 3, comprising two U-shaped structures 301; Figs. 6-8; see para. 0067, 0078 and claim 13);
a superior member (defined by base plate 104 of first fixing part 1; Figs. 6-8; para. 0068) that faces the superior lamina in the implanted position (as described in para. 0065-0067, 0078), the superior member comprising a superior living hinge portion proximate the interconnecting member (see Examiner’s Annotated Fig. 7 above); and
an inferior member (defined by base plate 204 of second fixing part 2; Figs. 6-8; para. 0065) that faces the inferior lamina in the implanted position (as described in para. 0065-0067, 0078), the inferior member comprising an inferior living hinge portion proximate the interconnecting member (see Examiner’s Annotated Fig. 7 above);
wherein:
the superior living hinge portion and the inferior living hinge portion enable a first distal portion of the superior member and a second distal portion of the inferior member to flex in response to movement of the adjacent superior vertebra and/or the adjacent inferior vertebra (see Examiner’s Annotated Fig. 7 above); and
a first thickness of the superior living hinge portion and a second thickness of the inferior living hinge portion are each selected to provide a desired level of dynamic force urging the superior member and the inferior member apart (where the dynamic implant device is designed to achieve the interspinous resilient distraction and spine movement such as extension and flexion by the U-shaped structures 301 to “maximize the matching of the mobility in each direction to the human body” as described in at least para. 0023, as well as para. 0082, the superior and inferior living hinge portions identified in Examiner’s Annotated Fig. 7 above each have a thickness understood to provide this resilient distraction, i.e. desired level of dynamic force, for urging superior member 104 and inferior member 204 apart as claimed; Figs. 6-8).
Regarding claim 10, Li teaches the system of claim 9, wherein: the dynamic implant defines a cavity between the superior member and the inferior member (as shown, cavity defined between respective base plates 104 and 204 of superior and inferior members; Figs. 6-8); and the cavity allows independent movement of the superior member and the inferior member in a generally superior-inferior direction in response to movement of the adjacent superior vertebra and/or the adjacent inferior vertebra (cavity between base plates 104 and 204 of the superior and inferior members enables independent movement of each in a generally vertical direction, i.e. superior-inferior direction, in response to movement of adjacent vertebrae to which the interspinous dynamic implant shown in Figs. 6-8 is attached).
Regarding claim 11, Li teaches the system of claim 10, wherein the cavity comprises an opening at a distal end (see Figs. 6 and 8; cavity has opening at left/distal end between the two U-shaped structures 301; para. 0067) and, with the dynamic implant in the implanted position, the opening is oriented towards a vertebral body (with implant of Figs. 6-8 implanted, wings 103 and 203 engage superior and inferior spinous processes and barbs 6 engage the root of respective spinous processes, so that the opening defined between U-shaped structures 301 is oriented towards a vertebral body; para. 0026, 0065-0067).
Regarding claim 13, Li teaches the system of claim 9, wherein, with the dynamic implant in the implanted position, the superior member directly contacts the superior lamina and the inferior member directly contacts the inferior lamina (when implanted, the distal ends of superior member 104 and inferior member 204, i.e. adjacent respective barbs 6 which engage the root of respective spinous process as noted in para. 0026, is configured to directly contact the respective superior/inferior lamina; para. 0065-0069).
Regarding claim 14, Li discloses the system of claim 9, wherein:
the superior member comprises a superior ridge and the inferior member comprises an inferior ridge each extending along a lateral direction transverse to a proximal-distal direction (barbs 6 formed on superior member 104 and inferior member 204 define superior/inferior ridges, shown to extend in a lateral direction across respective members; Figs. 6-8; para. 0065, 0069); and
the superior ridge and the inferior ridge are positioned to contact the superior spinous process and/or the superior lamina, and the inferior spinous process and/or the inferior lamina (para. 0026 describes barbs/ridges 6 for engaging the root of respective superior/inferior spinous processes, so that ridges 6 in Figs. 6-8 are contact respective superior/inferior spinous processes and/or laminae in the implanted position).
Regarding claim 15, Li discloses a system configured to maintain spacing between a superior spinous process and a superior lamina, and an inferior spinous process and an inferior lamina, of an adjacent superior vertebra and an adjacent inferior vertebra, the system comprising:
a dynamic implant (device shown in Figs. 6-8; para. 0063-0065) having an implanted position in which the dynamic implant resides in a space between the superior spinous process and the superior lamina, and the inferior spinous process and the inferior lamina (interspinous dynamic stabilization device illustrated in Figs. 6-12 is designed for implantation between adjacent upper and lower spinous processes and laminae; para. 0064), the dynamic implant comprising:
an interconnecting member (elastic structure 3, comprising two U-shaped structures 301; Figs. 6-8; see para. 0067, 0078 and claim 13);
a superior member (defined by base plate 104 of first fixing part 1; Figs. 6-8; para. 0068) that faces the superior lamina in the implanted position (as described in para. 0065-0067, 0078), the superior member comprising a superior living hinge portion proximate the interconnecting member (see Examiner’s Annotated Fig. 7 above); and
an inferior member (defined by base plate 204 of second fixing part 2; Figs. 6-8; para. 0065) that faces the inferior lamina in the implanted position (as described in para. 0065-0067, 0078), the inferior member comprising an inferior living hinge portion proximate the interconnecting member (see Examiner’s Annotated Fig. 7 above);
wherein:
the superior member is spaced apart from the inferior member thereby allowing independent movement of the superior member and the inferior member in a generally superior-inferior direction in response to movement of the adjacent superior vertebra and/or the adjacent inferior vertebra (superior member 104 and inferior member 204 are spaced apart, as shown in Figs. 6-8, thereby enabling independent movement of each in a generally vertical direction, i.e. superior-inferior direction, in response to movement of adjacent vertebrae to which the interspinous dynamic implant shown in Figs. 6-8 is attached); and
a first distal end of the superior member and a second distal end of the inferior member are configured to engage at least one of the superior lamina and the inferior lamina such that the superior living hinge portion and the inferior living hinge portion urge the superior lamina and the inferior lamina apart (see Figs 6-8 and Examiner’s Annotated Fig. 7 above, where the distal end portions of superior member 104 and inferior member 204 include barbs 6 for engaging the root of respective superior/inferior spinous processes, so that the respective distal ends are configured to engage superior and inferior laminae and superior and living hinge portions urge the laminae apart; para. 0026, 0065-0067, 0078).
Regarding claim 16, Li teaches the system of claim 15, wherein: the superior member comprises a superior ridge and the inferior member comprises an inferior ridge each extending along a lateral direction transverse to a proximal-distal direction (barbs 6 formed on superior member 104 and inferior member 204 define superior/inferior ridges, shown to extend in a lateral direction across respective members; Figs. 6-8; para. 0065, 0069); and
the superior ridge and the inferior ridge are positioned to contact the superior spinous process and/or the superior lamina, and the inferior spinous process and/or the inferior lamina (para. 0026 describes barbs/ridges 6 for engaging the root of respective superior/inferior spinous processes, so that ridges 6 in Figs. 6-8 are contact respective superior/inferior spinous processes and/or laminae in the implanted position).
Regarding claim 17, Li teaches the system of claim 15, wherein: the superior member comprises a superior living hinge portion proximate the interconnecting member; the inferior member comprises an inferior living hinge portion proximate the interconnecting member (see Examiner’s Annotated Fig. 7 of Li above); and the superior living hinge portion and the inferior living hinge portion enable a first distal portion of the superior member and a second distal portion of the inferior member to flex in response to movement of the adjacent superior vertebra and/or the adjacent inferior vertebra (see Examiner’s Annotated Fig. 7 of Li above).
Regarding claim 18, Li teaches the system of claim 15, wherein: the dynamic implant defines a cavity between the superior member and the inferior member (as shown, cavity defined between respective base plates 104 and 204 of superior and inferior members; Figs. 6-8); and the cavity allows independent movement of the superior member and the inferior member in a generally superior-inferior direction (cavity between base plates 104 and 204 of the superior and inferior members enables independent movement of each in a generally vertical direction, i.e. superior-inferior direction, in response to movement of adjacent vertebrae to which the interspinous dynamic implant shown in Figs. 6-8 is attached).
Regarding claim 19, Li teaches the system of claim 18, wherein the cavity comprises an opening at a third distal end and, with the dynamic implant in the implanted position, the opening is oriented towards a vertebral body (see Figs. 6 and 8; cavity has opening at left/distal end between the two U-shaped structures 301 and, with implant of Figs. 6-8 implanted, wings 103 and 203 engage superior and inferior spinous processes and barbs 6 engage the root of respective spinous processes, so that the opening defined between U-shaped structures 301 is oriented towards a vertebral body; para. 0026, 0065-0067).
Regarding claim 20, Li teaches the system of claim 15, wherein, with the dynamic implant in the implanted position, the superior member directly contacts the superior lamina and the inferior member directly contacts the inferior lamina (when implanted, the distal ends of superior member 104 and inferior member 204, i.e. adjacent respective barbs 6 which engage the root of respective spinous process as noted in para. 0026, is configured to directly contact the respective superior/inferior lamina; para. 0065-0069).
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 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2018/0008429 A1) in view of Soo (US 2021/0052307 A1)
Regarding claims 3 and 12, Sheffer discloses the system of claims 1 and 9, respectively.
While Li teaches that the inferior and superior members may be “connected and integrated” to the elastic interconnecting member (see para. 0069, Figs. 6-8), Li does not explicitly teach wherein the dynamic implant is formed as a single piece.
Soo, in analogous art, is directed towards an interspinous implant (100; Figs. 1A-1D, 2A-2D; para. 0044-0048) comprising a superior member (120; Figs. 1A, 2A; para. 0046), an inferior member (122; Figs. 1A, 2A), an interconnecting member (124; Fig. 1A), and superior and inferior living hinge portions (200, 202; Fig. 2A; para. 0064), and Soo discloses wherein the superior member, inferior member and interconnecting member “may optionally be formed as a single piece with each other” or, in alternative embodiments, “may be formed separately and coupled together” (see para. 0046).
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 Sheffer’s dynamic interspinous implant as a single piece, as claimed and as taught by Soo, because Soo recognizes that such implants may be formed in such a manner (see Soo, Fig. 1A, para. 0046, 0051).
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 CN 106901820 A teaching a dynamic implant with a cavity opening towards a vertebral body (shown in Figs. 16-17).
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.
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, Eduardo Robert can be reached at (571)272-4719. 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.
/ANNA V. LITTLE/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773