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 § 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.
Claim(s) 1, 2, 3, 10, 12, 13, 14, 17, 18, 19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller et al. (US Publication No. 2021/0085373 A1) in view of Konieczynski et al. (US Publication No. 2004/0267264 A1).
Regarding Claim 1, Mueller discloses an implantable receiver (514, Fig. 21) configured to couple to a head (507) of a bone fastener (503) (Fig. 21) [0047], the implantable receiver comprising:
a body (509) comprising a top, a bottom, and an opening extending from the top to the bottom;
a pressure cap (513) disposed within the opening of the body [0047-0048];
a retainer ring (511) disposed in a bottom portion of the body within the opening, wherein the retainer ring is expandable around a head of the bone fastener (507) [0047-0048] and wherein the retainer ring is configured to lock the head of the bone fastener into the body after the head of the bone fastener is inserted into the opening of the body [0048] and,
a compressible coil (550) disposed around the opening of the body above the retainer ring, wherein the compressible coil is configured to contact the head of the bone fastener and deform to provide a frictional engagement between the head of the bone fastener and the body (coil 550 is a split ring which would be able to expand/contract diameter) [0047-0048].
PNG
media_image1.png
577
469
media_image1.png
Greyscale
Mueller discloses that the coil (550) is biased downwards by the spring (552) force onto the head of the fastener to secure the fastener to the receiver [0048] which the Examiner considers to be an application of a frictional force by the coil to the head of the receiver. Mueller also shows in Fig. 22 that the coil (550) is a discontinuous ring member having a pair of free ends [0048]. However, Mueller is silent to the frictional force/engagement of the coil (550) being such that gravitational forces are resisted while permitting manual adjustment of the body relative to the head by a provider.
Konieczynski discloses a receiver in the same field of endeavor wherein a split ring (234) is biased against a head and deformed (spread/expanded) to overcome gravitational forces but allow manual positioning of the receiver relative to the head in order to pre-lock the receiver in place [0027-0028].
It would have been obvious to one having ordinary skill in the art before the effective filing date to configure the biasing of the coil of Mueller onto the head to be sufficient to spread the coil to pre-lock the receiver relative to the head but allow manual adjustment as taught by Konieczynski in order to assist the practitioner by holding the position of the receiver before tightening.
Regarding Claim 12, Mueller discloses a fastener assembly (Fig. 22) comprising: a receiver (514, Fig. 21) comprising: a body (509) comprising an opening (see figure above); a pressure cap (513) disposed within the opening of the body; a retainer ring (511) disposed within the opening proximate to a bottom of the opening; and, a compressible coil (550) disposed in the opening above the retainer ring and below the pressure cap [0047-0048]; and, a bone fastener (503) comprising a head (507) insertable through the bottom of the opening; wherein the retainer ring is expandable around the head and wherein the retainer ring is configured to lock the head of the bone fastener into the body after the head of the bone fastener is inserted into the bottom of the opening [0048]; and, wherein the compressible coil is fully capable of deforming to apply frictional force to the head (coil 550 is a split ring which would be able to expand/contract diameter) [0047-0048].
Mueller discloses that the coil (550) is biased downwards by the spring (552) force onto the head of the fastener to secure the fastener to the receiver [0048] which the Examiner considers to be an application of a frictional force by the coil to the head of the receiver. Mueller also shows in Fig. 22 that the coil (550) is a discontinuous ring member having a pair of free ends [0048]. However, Mueller is silent to the frictional force/engagement of the coil (550) being such that gravitational forces are resisted while permitting manual adjustment of the body relative to the head by a provider.
Konieczynski discloses a receiver in the same field of endeavor wherein a split ring (234) is biased against a head and deformed (spread/expanded) to overcome gravitational forces but allow manual positioning of the receiver relative to the head in order to pre-lock the receiver in place [0027-0028].
It would have been obvious to one having ordinary skill in the art before the effective filing date to configure the biasing of the coil of Mueller onto the head to be sufficient to spread the coil to pre-lock the receiver relative to the head but allow manual adjustment as taught by Konieczynski in order to assist the practitioner by holding the position of the receiver before tightening.
Regarding Claim 18, Mueller discloses a method of assembling an implantable device, the method comprising: providing a body (509) comprising a top, bottom, and an opening extending from the top to the bottom (see figure above with regards to claim 1); positioning a retainer ring (511) in a recess of the opening proximal to the bottom of the body [0048]; positioning a compressible coil (550) in a recess of the opening above the retainer ring [0048]; coupling a pressure cap (513) within the opening above the compressible coil [0048]; and, inserting a bone fastener (503) into the bottom of the opening; wherein the retainer ring expands around a head of the bone fastener; and, wherein the compressible coil applies a friction force to the head. The retainer ring locks the head of the fastener in the body [0048].
Mueller describes the coil (550) is a friction ring which pushes down upon the head to hold it, but does not explicitly disclose that the ring deforms when being forced against the head. Mueller is also silent to the frictional force/engagement of the coil (550) being such that gravitational forces are resisted while permitting manual adjustment of the body relative to the head by a provider.
Konieczynski discloses a receiver in the same field of endeavor wherein a split ring (234) is biased against a head and deformed (spread/expanded) to overcome gravitational forces but allow manual positioning of the receiver relative to the head in order to pre-lock the receiver in place [0027-0028].
It would have been obvious to one having ordinary skill in the art before the effective filing date to configure the biasing of the coil of Mueller onto the head to be sufficient to spread the coil to pre-lock the receiver relative to the head but allow manual adjustment as taught by Konieczynski in order to assist the practitioner by holding the position of the receiver before tightening.
Meuller in view of Konieczynski discloses the receiver as described in the rejection of claims 1, 12 and 18. Meuller discloses that modifications and variations are possible without departing from the scope of the invention, however is silent to the coil (550) being toroidally shaped (closed loop without free ends) (Claim 2 and 13 and 19), or the coil having a cross-sectional surface that is circularly shaped (Claims 3 and 14).
Konieczynski discloses a snap ring (234) for frictionally engaging the head of the bone screw within the receiver to apply frictional forces to overcome gravitational forces and allow manual movement of the fastener in order to provisionally maintain the receiver at a desired angular orientation [0024]. Konieczynski discloses that the ring can have a variety of configurations, shapes and sizes that are adapted to expand to fit around at least a portion of the spherical head [0025]. Konieczynski discloses an acceptable configuration is a toroidally shaped ring (234a, Fig. 2b) or a ring with a circular cross section (234d, Fig. 2b) [0025].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the configuration of the compressible coil of Meuller to be either toroidally shaped or have a circular cross section as taught by Konieczynski since these are shown to be suitable configurations for pressure rings within a receiver to predictably expand to frictionally-engage the head of a polyaxial bone screw.
Regarding Claim 21, Mueller shows that the coil (550) is closer to the pressure cap (513) than ring (511) when the fastener is in the body (fig. 22) [0048].
Regarding Claims 10 and 17, Mueller is silent to the coil (550) being in a coil recess. However, Konieczynski describes the snap ring (234) as adapted to fit within a corresponding groove 236 formed around an inner surface of the receiver member 218. The groove 236 maintains the snap ring 234 at a particular location with respect to the spherical head 216 of the bone screw such that the snap ring 234 is expanded around the head 216 [0026, Konieczynski]. It would have been obvious to one having ordinary skill in the art to provide a recess for the coil of Mueller as taught by Konieczynski to maintain the coil in a particular location with respect to the spherical head of the bone screw.
Claim(s) 11, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller et al. (US Publication No. 2021/0085373 A1) in view of in view of Konieczynski et al. (US Publication No. 2004/0267264 A1) in further view of Garamszegi (US Publication No. 2008/0269809 A1).
Regarding Claim 11 and 20, Meuller in view of Konieczynski discloses the receiver as described in the rejection of claims 1 and 18. Meuller discloses that modifications and variations are possible without departing from the scope of the invention [0049] and discloses that the receiver (514) may include additional components without departing from the scope of the disclosure [0048]. However Mueller in view of Konieczynski is silent to the body further comprises a pin that is receivable within a slot on the pressure cap.
Garamszegi teaches a receiver in the same field of endeavor wherein the pressure cap (705) and receiver body (110) are provisionally connected with a pin (905a,b) extending through slots (525, 720) in the two elements for the purpose of securing them relative to each other [0049].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection of the receiver body and pressure cap of Mueller in view of Konieczynski with a pin/slot connection as taught by Garamszegi in order to further secure the pressure cap and body relative to each other when in a fully assembled state.
Claim(s) 4-8, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller et al. (US Publication No. 2021/0085373 A1) in view of in view of Konieczynski et al. (US Publication No. 2004/0267264 A1) in further view of Arambula (US Publication No. 2012/0116462 A1).
Meuller) in view of in view of Konieczynski discloses the receiver as described in the rejection of claims 1 and 12. Meuller discloses that modifications and variations are possible without departing from the scope of the invention and further Konieczynski discloses the snap ring can have a variety of configurations [0026. However both Meuller and Konieczynski are silent to the compressible coil (550) having a cross-sectional surface that is elliptically shaped (Claims 4 and 15) , the cross-sectional surface of the compressible coil is angled outward (claim 5), the cross-sectional surface of the compressible coil being angled inward (claim 6), the compressible coil comprising a compressible polymer (claim 7), or the compressible coil being a coiled coil (claim 8).
Arambula teaches a compressible coil with a receiver in the same field of endeavor, wherein the compressible coil comprises a toroidal spring coil filled with an elastomer [0020] or elliptical toroidal ring with a surface angled inward/outward (Fig. 5- see below regarding orientation of surfaces being inward or outward when considered from a particular direction)[0020]. The toroidal member of Arambula functions to frictionally engage against the head of the bone screw in the receiver assembly.
PNG
media_image2.png
692
498
media_image2.png
Greyscale
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the configuration of the compressible coil of Meuller ) in view of in view of Konieczynski to be either an elliptical toroidal ring with a surface angled inward/outward or toroidal spring coil filled with an elastomer (polymer) as taught by Arambula since these are shown to be suitable configurations for pressure rings within a receiver to predictably frictionally-engage the head of a polyaxial bone screw.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller et al. (US Publication No. 2021/0085373 A1) in view of Konieczynski et al. (US Publication No. 2004/0267264 A1) in further view of Arambula (US Publication No. 2012/0116462 A1) in further view of Jackson et al. (US Publication No. 2017/0281241 A1).
Regarding Claim 9, Meuller in view of Konieczynski in view of Arambula discloses the receiver as described in the rejection of claim 8. Arambula teaches the compressible coil comprises a toroidal spring coil filled with an elastomer [0020]; however, Arambula (and Mueller, Konieczynski) is silent to the material of the coil comprising one or more of stainless steel, titanium, an alloy comprising cobalt and chromium, poly carbonate urethane (PCU), or polyether ether ketone (PEEK).
Jackson teaches a friction ring (80, Fig. 1) within a receiver in the same field of endeavor. Jackson teaches the friction ring (80) attaches the head of the screw to the inside of the receiver. The friction ring is made from a resilient material such as stainless steel, titanium alloy, cobalt chrome or the like [0093].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the coil or friction ring of Mueller in view of Konieczynski and Arambula from a resilient material such as stainless steel, titanium alloy, or cobalt chrome as taught by Jackson in order to use a suitable resilient material to connect between the head and receiver.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15, 17-21 have been considered but are moot due to the new grounds of rejection necessitated by amendment.
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 JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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, 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.
/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
Prosecution Insights