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 .
Priority
This application claims priority from provisional application 62/696,788, filed 07/11/2018.
Status of Claims
Claims 1-9, 11-13, 15, 16, 18 and 20-25 are pending.
Claims 15-16 and 18 have been withdrawn from consideration.
Claims 10, 14, 17, and 19 have been cancelled.
Election/Restrictions
Applicant elected Invention I (System) and Species 2 (Figures 35-52) without traverse on 06/25/2024.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-9, 11-12, and 21-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 is rendered indefinite because it lacks antecedent basis for “the through hole of the coupling member”. The applicant is advised to amend this limitation to say a through hole of the coupling member.
Claim 7 is rendered indefinite because it comprises a broad range further limited by a narrower range. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “wherein the bottom surface is shaped to be at least one of curved, arcuate or arced”, and the claim also recites “wherein the curved, arcuate or arced shape is a concave shaped bottom surface” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The applicant is advised to amend claim 7 to just define the bottom surface as having a concave shape.
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.
Claim(s) 1, 13, 20, and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeng et al (Jeng) US 2014/0107798 A1 in view of Slater US 2011/0184413 A1.
1. Jeng discloses the invention substantially as claimed being a fusion system, comprising:
an alignment guide system (Figures 8-12), comprising: an alignment guide (Figures 8-12); and
an implant (Figures 1-5), comprising:
a body portion (starting near 28 and extending upward in Figure 2) comprising: at least one first through hole 41 extending through the body portion from a top surface to a bone contacting surface of the implant (Figures 1-2); and at least one opening 61 extending through the body portion from the top surface to the bone contacting surface (Figures 1-2);
an extension member (near 69 Figure 2) extending away (upward in Figure 2) from a first end of the body portion (above 28 in Figure 1) to a first end of the implant (top of Figures 1-2), wherein the extension member comprises: at least one second through hole (small elongated hole between holes 69 and 61) and a compression slot positioned 62 near the first end of the implant (top of Figures 1-2), wherein the at least one second through hole is positioned between the compression slot and the body portion (Figures 1-2);
a curved portion (near 16 Figure 2) extending away from a second end of the body portion (downward away from 28 in Figure 2), wherein the curved portion comprises: a third through hole 29 and a fourth through hole 32, each extending through the curved portion from the top surface to the bone contacting surface of the implant (Figures 1-2);
a foot member (near 18 and bottom of Figures 1-2) extending away from the curved portion at the second end of the implant in a direction opposite a bone contacting surface of the body portion (the foot member includes the portion surrounding 18 that is thicker than the rest of the implant making it extend away from and opposite the inner bone contacting surface on the right side of Figure 2), wherein the foot member comprises: a fifth through hole 18 extending through the foot member from the top surface to the bone contacting surface of the implant;
wherein a greatest width of the extension member is lesser than a greatest width of the foot member (as seen in Figures 1 and 2 the portion of 12 adjacent 18 widens around the opening through the foot making it narrower than the elongated extension member, furthermore in view of the 103 modification below the foot member of Jeng will be even wider);
wherein a thickness of the curved portion is greater than a thickness of the foot member and a thickness of the body portion (the applicant did not limit the thickness to being the greatest or in a specific location so this limitation allows for identifying any thickness of the portions/members the greatest thickness of the curved portion is the thickness shown in Figure 2, which is greater than the reduced thicknesses located within the tapered sections around holes in both the foot and body portion shown in Figure 2); and
a fastener ( Jeng discloses a plurality of components that read upon fastener including the pins and screws of Figure 12), wherein the fastener engages the alignment guide system to position the fastener relative to the body portion of the implant (Figure 12 clearly shows the pins and screw fasteners all engage the alignment guide system and can be used to position the fastener relative to the implant),
wherein the alignment guide system couples to the implant (Figures 8, 9, and 12).
However, Jeng discloses the foot member only comprises a single through hole.
Slater teaches the use of bone fusion system comprising an implant comprising an extension portion attached to a foot comprising two through holes 84/85 extending along the widest portion (Figure 1) in the same field of endeavor for the purpose of providing increased stabilizing and attachment to the implant site through more surface contact and a second fastener.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the foot of Jeng to include a wider section with two through holes as taught by Slater in order to providing increased stabilizing and attachment to the implant site through more surface contact and a second fastener.
13. Jeng discloses the extension member has a width (narrowed rounded portion at the very top of Figure 1) that is lesser than that of the body portion (widened portion near 42) and the cured portion (widened portion near 29).
20. Jeng discloses a top surface of the foot member comprises a substantially curved geometry and a bottom surface of the foot member comprises a substantially curved geometry (Figure 2), and wherein the foot member is angled relative to the body portion at a substantially oblique angle (Figure 2).
However Jeng does not disclose that these top and bottom are concave/convex as they extend laterally. The natural bone surface this portion of the implant is designed to engage is convex.
Therefore it would have been obvious to one or ordinary skill in the art to modify these curved surfaces to be concave and convex in all directions (M/L and P/D) in order to better fit the shape of the bone they are designed to mate with.
23. Jeng discloses the fixation member (84) comprises a knob (enlarged upper portion of 84 Figure 11) integrally coupled to a first end of a shaft (skinny portion of 84 Figure 11), wherein a second end of the shaft comprises an engagement member (lower threaded portion 84 Figure 11), wherein the engagement member threadingly attaches to a corresponding threaded opening of the opening of the body on the top surface of the implant (Figures 12 and 16).
24. Jeng as modified by Slater discloses the fifth through hole and the sixth through hole of the foot member (see modification in view of Slater above) extend through the foot member and are positioned along the greatest width of the foot member (shown clearly in Figures 5-8 of Slater).
25. Jeng discloses the fastener is positioned fully below the bone contacting surface of the implant (the claim fails to disclose any context for this recitation, for example when must it be positioned below the bone contacting surface? When packaged? Additionally Jeng clearly discloses a plurality of fasteners including the lower screw shown in Figure 22 which is clearly positioned fully below the entire implant).
Claim(s) 2-9, 11, 12, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeng and Slater (Combination 1) as applied to claims 1, 13, 20, and 23-25 above, and further in view of Collazo US 2010/0087824 A1.
Combination 1 discloses the invention substantially as claimed being described above. Jeng does not disclose the specifics of the coupling member other than depicting the larger head portion (lower right cylindrical portion on the base of 82 shown in Figures 10-11) Additionally, Jeng does not disclose the coupling member as a bushing shaft.
Collazo teaches the use of bone fusion system comprising a coupling member utilizing a bushing shaft 22 that extends through the body of the alignment guide (Figure 1) in the same field of endeavor for the purpose of stabilizing and guiding the fixation members while reinforcing the through hole.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the coupling member of Jeng to include a bearing shaft extending up through the through hold of the attachment portion as taught by Collazo in order to reinforce the through hole and guide the fixation member therethrough.
2. Jeng discloses the alignment guide comprises a body (Figures 11-12), with the body comprising:
an arm (near 80 Figures 10-11) extending from a first end of the body (left side Figures 10-11) to a second end of the body (right side Figures 10-11);
an attachment portion (near 82 Figures 10-11) coupled to the arm at the first end of the body;
a fixation member (84) engaging a first end of the body;
a tissue protector (78) engaging a second end of the body; and
a coupling member received within a through hole of the attachment portion (see modification in view of Collazo above adding bushing 28 to the through hole of the attachment portion), and
wherein the fixation member extends through the through hole of the coupling member (as explained above the bushing 28 of Collazo lines the through hole and allows for the fixation member to extend there through) and
wherein an end of the fixation member couples to the implant at the at least one opening of the body portion of the implant (projection at the base of 84 extends through to opening 42 of the body Figure 12).
3. Jeng as further modified by Collazo disclose the coupling member comprises a shaft (elongated cylindrical portion of 22 of Collazo) and a head (enlarged cylindrical portion at the right bottom side of 82 in Figures 11-12 of Jeng) positioned at a first end of the coupling member (Figure 1 of Collazo).
4. Jeng discloses the attachment portion comprises: a through hole (hole for receiving fixation member 84); and an alignment pin (protrusion on bottom left side of 82 Figure 11) extending away from a bottom surface of the attachment portion (Figures 11-12), wherein the alignment pin is positioned within an opening of the at least one opening of the body portion of the implant (61 shown best in Figures 12 and 16).
5. Jeng as further modified by Collazo disclose the head of the coupling member comprises: an outer diameter that is larger than an outer diameter of the shaft (the head shown in Jeng is larger than the hole where the bearing shaft would extend).
6. Jeng discloses the through hole of the attachment portion extends from a top surface of the attachment portion through to the bottom surface of the attachment portion (through hole of Jeng allows for attachment of fixation member 84 to extend through top surface and bottom surface to couple to the implant Figures 11-12).
7. Jeng discloses the head of the coupling member further comprises a bottom surface comprising a concave shape (see modification explained with respect to claim 20 above, the implant surfaces have been modified to better match the natural bone, a person of ordinary skill in the art would further modify the round bottom surface of the coupling member to also have the concave shape so that it would sit flush on the implant).
8. Jeng as further modified by Collazo the through hole of the coupling member extends through a length of the shaft of the coupling member (the through hole inherently extends the entire length otherwise the fixation member could not pass through), wherein the through hole is sized to receive a shaft of the fixation member (Figures 10 and 11).
9. Jeng discloses the at least one first through hole 42 of the body portion of the implant comprises:
an engagement opening (42 opening at top surface of the implant Figures 1-2) for receiving a portion of the fixation member (Figure 12); and
an alignment opening (42 opening at the bottom surface of the implant Figures 1-2) spaced diagonally from the engagement opening relative to a longitudinal axis of the implant (the spacing is dependent upon the orientation of the longitudinal axis implant, which would vary because of the curved shape of the implant, with the longitudinal axis rotated at an angle to the curved portion the openings will appear diagonally spaced), wherein the alignment opening receives an alignment pin of the attachment portion (the openings are fully capable of receiving any of the alignment pins used in Figure 18, it is noted that the pins are not positively claimed and this recitation given limited weight because it is considered intended use).
11. Jeng discloses third through hole and the fourth through hole of the curved portion extend through the implant at an angle relative to a top surface of the implant (every hole is inherently at an angle since the surface is curved as seen in Figures 1-2), wherein the third through hole and the fourth through hole are positioned below the bone contacting surface of the extension member (the position would depend upon the position and orientation of the implant, they are fully capable of being below the bone contacting surface of the extension if it is position at an angle upward).
12. Jeng discloses the fifth and sixth through holes of the foot member extend through the implant at an angle relative to the top surface of the implant, (hole 18 and the additional hole added by Slater are angled relative to the top surface of the implant Figure 2), wherein the angle of the third hole is larger than the angle of the fourth hole (the angles wholly depend on what portion of the top surface is being identified, it is also noted that the angle can be measured at a variety of configurations including the smaller or larger angle depending on which direction it is measured from the top surface since the top surface curves around substantially there is inherently a portion that can be identified which would give the fifth and sixth holes a larger angles,).
21. Jeng as further modified by Collazo disclose the head further comprises a recessed region extending therein (see explanation with respect to claim 7 above which defines the bottom surface of the head as concave shaped, which provides the central recessed region).
22. Jeng as further modified by Collazo disclose the outer diameter of the shaft corresponds to an internal diameter of the through hole of the attachment portion (it is old and well known in that bushing shafts have external diameters corresponding to the holes they are inserted within in order to function properly).
Response to Arguments
Applicant's arguments filed 02/09/2025 have been fully considered but they are not persuasive.
The applicant argues that the curved section of Jeng fails to disclose the 2 through holes. This is not persuasive because as clearly shown in Figure 1 the curved portion comprises third through hole 29 and fourth through hole 32.
The applicant further argues that the foot member of Jeng fails to disclose the 2 through holes. This is not persuasive because Jeng as modified by Slater fifth and sixth through holes are clearly shown in Figures 5-8 of Slater.
The applicant further argues that Jeng fails to disclose the thickness of the curved portion is greater than the thickness of the foot member and body portion. As explained above these portions and members have a variety of thicknesses including a largest thickness and smaller thicknesses in the tapered sections around through holes. Therefore Jeng discloses thicknesses in the portions/members that read upon the claimed configuration.
The applicant further argues that Jeng fails to disclose the alignment guide system is coupled to the implant at the at least one opening of the body portion of the implant. This is not persuasive because this configuration is clearly shown in Figures 11, 12, and 16-21.
With respect to the previous 103 rejections the applicant presents the same arguments as addressed in the prior art rejection and response above.
With respect to new claim 25, the applicant’s arguments have been addressed in the 103 rejection above.
Finally, it is noted that the applicant is positively claiming through holes and openings throughout the claims. These holes and openings are both positively claimed as extending through structures from a top surface to a bottom surface. However, it is uncertain what actually makes these structures different. It is common place in the art to use the term opening as the window through a surface and a hole being the portion connecting or extending from the opening into an object. Since the applicant has specifically named these features differently, rather than identifying the openings with numbers like the list of through holes, there must be something differentiating them. Clarification of the record is requested to understand if the applicant intends for through holes and openings to require different features.
Conclusion
THIS ACTION IS MADE FINAL. 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 D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christopher D. Prone/Primary Examiner, Art Unit 3774
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