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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/1/26 has been entered.
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 12-14 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 12 recites “the blade post includes a blade post holder configured to receive the blade post”. It is unclear how the blade post can have a feature to receive itself. This limitation appears to have a typographical error, and for examination purposes will be interpreted as “the carriage includes a blade post holder configured to receive the blade post” (as found in [0056] of the specification). Dependent claims 13-14 are rejected under 112(b) as they contain all the deficiencies of claim 12 from which they depend.
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) 1-6, 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nowak et al. (US Patent No. 9089299 B2) in view of O’Connell et al. (US Publication No. 2018/0206833 A1).
Regarding Claim 1, Nowak discloses a retraction system (600, Fig. 9), comprising:
a first retraction assembly (all elements shown in Fig. 9 except for auxiliary retractor assembly 900 and clamp 610), the first retraction assembly including:
a first arm (see below) coupled to a rack (620) at a proximal portion (630) and a first retractor blade (800) at a distal portion,
a second arm (see below) coupled to the rack (620) at a proximal portion (760) and a second retractor blade (850) at a distal portion, and
a translator (642, 742) coupled to each of the proximal portion of the first arm (630) and the proximal portion of the second arm (730), the translators (642,742) configured to affect translation of each respective arm relative to the rack (620), and each translator comprises a pawl (gear or pinion described in col. 9; ln. 50) configured to engage teeth (622) of the rack (col. 9; ln. 47-57, col. 10; ln. 36-51);
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a second retraction assembly (900, Fig. 9), the second retraction assembly (900) including: a carriage (clamp 910) configured to engage a blade post (902) having a blade (col. 12; ln. 15-20, retractor shown in Farely et al. US 2010/0217089 A1 incorporated by reference in Nowak has blade 108 in Fig. 1) coupled to a distal end (904) and a handle coupled to a proximal end (proximal end of post is a handle because it is a graspable section), the blade post (902) adjustable relative to the carriage (910) (clamp can be loosened to allow adjustment of the blade post); and a third retractor blade (col. 12; ln. 15-20, retractor shown in Farely et al. US 2010/0217089 A1 incorporated by reference in Nowak has blade 108 in Fig. 1) coupled to the blade post and configured to move with five degrees of freedom relative to the carriage and including a translation in two dimensions as well as yaw, pitch, and roll rotational motion (Nowak’s blade post can translate along longitudinal axis as shown below due to mechanical connection between blade post, and carriage. The translation of the post in the up/down direction can occur in the same manner described in Applicant’s specification [0053] which states “up and down movement of the blade 130 may be accomplished via simultaneous pitch of the carriage 122 and “toeing” (e.g., pivoting) the blade holder 132”. In this same way, the carriage can be rotated or pitched around rod 612 and while blade holder 904 is toed thereby translating the blade up/down as shown below. Other freedoms of movement include: the post can also rotate about its longitudinal axis relative to the carriage if the carriage is loosened. Further, Farely teaches the connection between the blade and the post allows pivoting in two more directions. This renders the blade having 5 degrees of freedom relative to the carriage.)
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Nowak does not describe a pivotable linkage on the first and second arms which allow the first and second retractor blades to pivot about an axis parallel to a longitudinal axis of the rack (running along direction of the length of the rack).
O’Connell discloses a retraction system in the same field of endeavor which comprises first and second arms (120, 122) coupled to a rack (24, 26) at a proximal portion and coupled to a retractor blade (14, 16) at a distal end (fig. 1-9). The arms (120, 122) each have a pivotable linkage (132, 126, Fig. 9) thereon which is configured to pivot the blade about an axis parallel to a longitudinal axis of the rack (see below). O’Connell describes this configuration in [0219] and [0017] and explains that the addition of the pivoting capability of the middle section allows the arms to be more flexible to eliminate caudal-cranial blade skew issues encountered when facing difficult patient anatomy.
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It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the arms of Nowak to include a pivotable linkage as taught by O’Connell which enables the blade about an axis parallel to the longitudinal axis of the rack in order for the arms to be more flexible to eliminate caudal-cranial blade skew issues encountered when facing difficult patient anatomy.
Regarding Claim 2, Nowak disclose the retraction system of claim 1, comprising an adaptor (610) having a first region (614) configured to engage the rack (620) and a second region (612) configured to engage the carriage (910) (fig. 9).
Regarding Claim 3, the adaptor (610) is configured to translate relative to the rack (620) (jaws 614 can be loosened and the adapter slid along the rack to a new location) (col. 8; ln. 18-39).
Regarding Claim 4, the adaptor (610) is fixed to the rack (620) (when jaws 614 are fully tightened, adapter is fixed to the rack, see col. 8; ln. 18-39).
Regarding Claim 5, the adaptor (610) includes a clamping mechanism (jaws 614) configured to releasably secure the adaptor to the rack (col. 8; ln. 18-39).
Regarding Claim 6, the adaptor (610) includes an aperture (gap between jaws 614); and wherein the rack (620) extends through the aperture (fig. 9) (col. 8; ln. 18-39).
Regarding Claim 10, the third retractor blade is fully capable of retracting away from the first retractor blade and the second retractor blade to establish an operative corridor anterior to the psoas (the retractor can be placed in the patient so that the blades create this passageway).
Regarding Claim 11, the first retractor blade and the second retractor blade are configured to translate along a first plane (see below); wherein the third retractor blade is configured to retract along a second plane relative to the first plane (see below); and wherein retraction of the third retractor blade is fully capable of establishing an operative corridor anterior to the psoas(the retractor can be placed in the patient so that the blades create this passageway).
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Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nowak et al. (US Patent No. 9089299 B2) in view of O’Connell et al. (US Publication No. 2018/0206833 A1) in further view of O’Connell et al. (US Publication No. 2018/0168566 A1, “O’Connell2”).
Regarding Claim 7, Nowak in view of O’Connell discloses the retraction system of claim 2 as described in the rejection above. Nowak disclose that the carriage (910) clamps onto a horizontal bar (612) of the carriage (610) as a convenient location for securing the clamp (carriage) (col. 8; ln. 18-26). However, Nowak in view of O’Connell is silent to the carriage (910) including a projection, and wherein the adaptor (610) includes a groove configured to engage the projection.
O’Connell2 discloses a connection mechanism of a retractor carriage in the same field of endeavor. O’Connell2 disclose that a carriage (clamp) 30 which clamps onto a retractor blade post 36 can be secured to a frame component 4 through a slot/projection configuration. The carriage comprises a projection (28) which slidably engages a groove (24) in the framework. This connection is clamped in place when desired placement is achieved in order to lock the position of the carriage relative to the frame. [0034-0035]
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the connection between the carriage and adapter taught by Nowak in view of O’Connell with a projection/groove connection as taught by O’Connell2 in order to use a mechanism known in the art to achieve predictable clamping and attachment of the retractor carriage to the adapter.
Regarding Claim 8, the projection is configured to translate within the groove of the adaptor (this is taught by O’Connell2, [0034]); and wherein translation of the projection within the groove of the adaptor is fully capable of moving the third retractor blade in a cranial-caudal direction relative to a patient (This functionality is based on orientation of the assembly. This movement is fully capable of occurring if the retractor is oriented so that the groove runs in the cranial-caudal direction.)
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nowak et al. (US Patent No. 9089299 B2) ) in view of O’Connell et al. (US Publication No. 2018/0206833 A1) in further view of Spann et al. (US Publication No. 2018/0303473 A1).
Regarding Claim 9, Nowak in view of O’Connell discloses the retraction system of claim 1 as described in the rejection above. However Nowak is silent to the coupling between the first retractor blade and the first arm is such that a height of the first retractor blade is adjustable relative to the first arm; wherein the coupling between the second retractor blade and the second arm is such that a height of the second retractor blade is adjustable relative to the second arm; wherein the retraction system further includes a first wag mechanism configured to cause a first distal end of the first retractor blade to wag side to side; wherein the [retraction system] further includes a second wag mechanism configured to cause a second distal end of the second retractor blade to wag side to side; wherein the retraction system further includes a first telescoping section configured to permit the first retractor blade to be moved closer to or further from the rack; and wherein the retraction system further includes a second telescoping section configured to permit the second retractor blade to be moved closer to or further from the rack.
Spann discloses a retraction assembly (Fig. 5) in the same field of endeavor wherein the two blades (130, 126) attached to opposing arms (139, 137) are height adjustable relative to the arms (vertical adjustment capability, [0068]) and each blade is attached with a wag mechanism (blade holder assembly 128, 132) which allows a distal end of the blade to pivot side to side (rotate about the arm) [0068]. The retractor arms further have telescoping sections (distal sections sliding through holder assemblies) to allow the opposing blades to move closer/further from the frame section (translate longitudinally along the arms, [0068]). Spann discloses these mechanical connections allow for positioning the third retractor blades in any suitable manner to create a customizable operative corridor [0068].
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 first and second arms and respective blades of Nowak in view of O’Connell to include height adjustable blades with wag mechanisms and telescoping sections as taught by Spann in order to provide more degrees of flexibility when placing the blades in the patient and retracting tissue.
Claim(s) 12-14 (as best understood) is/are rejected under 35 U.S.C. 103 as being unpatentable over Nowak et al. (US Patent No. 9089299 B2) in view of O’Connell et al. (US Publication No. 2018/0206833 A1) in further view of Liu et al. (US Patent No. 6083154).
Regarding Claim 12, Nowak discloses in col. 12; ln. 15-20, the third retractor assembly shown in Farely et al. US 2010/0217089 A1 is used and the disclosure thereof is incorporated by reference. This retractor assembly provides a blade post holder, element 106 shown below, which receives the blade post (132 shown below) and provides the roll, pitch and yaw motions to the blade. Element 106 is the only element contact the blade and therefore the rotation and pivoting about the x, y and z axes all come from the direct rotation/pivoting of the blade post holder. Nowak in view of O’Connell is silent to these motions being provided by the blade post holder (see element below) on the carriage which is configured to receive the blade post. However, Nowak does show in Fig. 1 that the carriage (910, Nowak) is a rod-to-rod clamp.
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Liu discloses in the same field of endeavor a clamp (7, Fig. 2) for holding a retractor blade having a clamp component (blade post holder 12) for attaching to an elongate blade post (20) and also to a frame (8) of a retractor (fig. 1). The connection between the blade post holder 12 and the remainder of the clamp is a ball joint (17) which allows for side-to-side pivoting, front-to-back pivoting and the clamp itself allows for the blade shaft to rotate therein thereby providing roll, pitch and yaw rotations while still being able to clamp down onto the blade post (col. 4; ln. 34-col. 5; ln. 6).
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 blade post holder and carriage clamp with a ball joint as taught by Liu in order to provide more range of motion and opportunity for retractor adjustment.
Regarding Claim 13, the resultant device would comprise the blade post holder with a ball joint with a slot for receiving the blade post (slot receiving blade post 908 shown in Fig. 9 of Nowak would remain).
Regarding Claim 14, the carriage has a manual lever arm:
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Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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