Detailed Action
This is the first office action on the merits for US application number 19/268,578.
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
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18/515,470, 15/889,587, and 13/790416, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 18/515,470, 15/889,587, and 13/790416 fail to provide adequate support for at least a combined implant tamp and joint locator of claims 1-26.
The disclosure of the prior-filed application, Application No. 18/739,209, 18/208,963, 15/899,577, 15/195,191, 14/537,327, 13/625, 180, and 63/471,788, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 18/739,209, 18/208,963, 15/899,577, 15/195,191, 14/537,327, 13/625, 180, and 63/471,788 fail to provide adequate support for at least a combined implant tamp and joint locator of claims 1-26.
The disclosure of the prior-filed application, Application No. 63/713,933, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 63,713,933 fails to provide adequate support for at least a combined implant tamp and joint locator of claims 1-26.
The disclosure of the prior-filed application, Application No. 63/670,550, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 63/670,550 fails to provide adequate support for a distalmost end of each of the two cannula prongs of the directional cannula are aligned with a distalmost end of each of the two tamp prongs of the combined implant tamp and joint locator of claim 3.
Thus, claims 1, 2, and 4-26 are considered as of July 12, 2024, i.e. the filing date of 63/670,550, and claim 3 is considered as of July 14, 2025, i.e. the filing date of the instant application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 3, the specification appears to lack proper antecedent basis for “a distalmost end of each of the two cannula prongs of the directional cannula are aligned with a distalmost end of each of the two tamp prongs of the combined implant tamp and joint locator” of claim 3. That is, the specification is silent to such a disclosure regarding aligned structures. Thus, the specification fails to provide proper antecedent basis for “a distalmost end of each of the two cannula prongs of the directional cannula are aligned with a distalmost end of each of the two tamp prongs of the combined implant tamp and joint locator” of claim 3.
As to claim 9, the specification appears to lack proper antecedent basis for “the distal cut-out of the main body of the directional cannula comprises a distal end surface comprising a generally planar surface defined by a plane transverse to the longitudinal axis of the lumen, the generally planar surface being configured to seat securely against the sacrum; an intermediate surface extending at an angle to the to the longitudinal axis of the lumen, wherein the intermediate surface has a length that is less than half of a diameter of the main body of the directional cannula, the intermediate surface being configured to seat securely against the ilium; and a pair of side surfaces extending parallel to the longitudinal axis of the lumen from the distal end surface to the intermediate surface” for the directional cannula and combined implant tamp and joint locator of claim 1. That is, the specification is silent to such a disclosure and Figs 13-18 do not appear to provide views of the apparatus of claim 1 that support these limitations. Thus, the specification fails to provide proper antecedent basis for “the distal cut-out of the main body of the directional cannula comprises a distal end surface comprising a generally planar surface defined by a plane transverse to the longitudinal axis of the lumen, the generally planar surface being configured to seat securely against the sacrum; an intermediate surface extending at an angle to the to the longitudinal axis of the lumen, wherein the intermediate surface has a length that is less than half of a diameter of the main body of the directional cannula, the intermediate surface being configured to seat securely against the ilium; and a pair of side surfaces extending parallel to the longitudinal axis of the lumen from the distal end surface to the intermediate surface”.
As to claim 17, the specification appears to lack proper antecedent basis for “a distalmost end of each of the two cannula prongs of the directional cannula are aligned with a distalmost end of each of the two tamp prongs of the combined implant tamp and joint locator” of claim 17. That is, the specification is silent to such a disclosure regarding aligned structures. Thus, the specification fails to provide proper antecedent basis for “a distalmost end of each of the two cannula prongs of the directional cannula are aligned with a distalmost end of each of the two tamp prongs of the combined implant tamp and joint locator” of claim 17.
As to claim 23, the specification appears to lack proper antecedent basis for “a distal end of the implant body comprises a cutting edge” of claim 23. That is, the specification is silent to such a disclosure and such does not appear to be shown. Thus, the specification fails to provide proper antecedent basis for “a distal end of the implant body comprises a cutting edge” of claim 23.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because currently provided Figs. 19-32 do not constitute black and white line drawings as required by CFR 1.84 and the provided figures do not provide a clear indication of where one element begins and another ends as well as light coloring that is unclear whether a void space is indicated or an element is present. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “the intermediate surface has a length that is less than half of a diameter of the main body of the directional cannula” of claim 9, “the two cannula prongs and the two tamp prongs engage the sacroiliac joint, with a first portion of the cut- out of the main body of the directional cannula seated against the sacrum and a second portion of the cut-out of the main body of the directional cannula seated against the ilium” of claim 22, “a distal end of the implant body comprises a cutting edge” of claim 23 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1 and 9 is/are objected to because of the following informalities:
Claim 1 line 1 should read “An apparatus for positioning”.
Claim 9 should read “an intermediate surface extending at an angle to the
Claim 19 should read “applying a force to the combined implant tamp and joint locator so as to advance the combined implant tamp and joint locator through the lumen of the directional cannula.
Appropriate correction is required.
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.
Claim(s) 9 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 9 recites/recite the limitation "the longitudinal axis of the lumen". There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “a generally planar surface defined by a plane transverse to [[the]]a longitudinal axis of the lumen”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4-6, 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Castro (US 2002/0143343).
The claimed phrases “cut-out” and “formed” are being treated as a product by process limitations; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 1, Castro discloses an apparatus (10, 50, Figs. 1-13) capable of use for positioning a fusion implant (400) into a sacroiliac joint (Figs. 9-13 show such in a spinal joint, ¶s 37 and 40 disclose use in joint repair, spinal stabilization, etc.), the apparatus comprising: a directional cannula (10) comprising: a main body (Fig. 1) having a distal end (right end as shown in Fig. 1, Figs. 1), a proximal end (left end as shown in Fig. 1, Figs. 1) and a lumen (18) extending between the distal end and the proximal end (Figs. 1 and 9, ¶42); two cannula prongs (30s) extending distally from the distal end of the main body (Fig. 1); a distal cut-out (24) formed in the distal end of the main body (as defined, Fig. 1); and a proximal notch (22) formed in the proximal end of the main body (as defined, Fig. 1) so as to define a first proximal end surface (right-most surface of 22 as shown in Fig. 1, Fig. 1, i.e. portion shown abutting 58 in Fig. 9) and a second proximal end surface (left-most surface of 14 as shown in Fig. 1, Fig. 1), wherein the first proximal end surface is disposed distal to the second proximal end surface (as defined, Fig. 1); and a combined implant tamp and joint locator (50, Fig. 1; where the structure shown in Fig. 1 is capable of use both as an implant tamp and a joint locator) capable of being disposed in the lumen of the directional cannula (Fig. 9), the combined implant tamp and joint locator comprising: a tamp body (Fig. 1) having a distal end (right end as shown in Fig. 1, Figs. 1) and a proximal end (left end as shown in Fig. 1, Figs. 1); two tamp prongs (upper and lower portions of 64 as shown in Fig. 1, Fig. 1) extending distally from the distal end of the tamp body (shown extending from 62 in Fig. 1, Fig. 1); and a proximal stop (58, 56) formed at the proximal end of the tamp body (as defined, Fig. 1) so as to define a first stop surface (surface of 58) and a second stop surface (right-facing surface of 56 as shown in Fig. 1, Fig. 1), wherein the first stop surface is disposed distal to the second stop surface (as defined, Fig. 1).
As to claim 2, Castro discloses that the first stop surface of the combined implant tamp and joint locator is capable of engaging with the first proximal end surface of the directional cannula when the combined implant tamp and joint locator is disposed in the lumen of the main body in a first radial position (Fig. 9), and the second stop surface of the combined implant tamp and joint locator is capable of engaging with the second proximal end surface of the directional cannula when the combined implant tamp and joint locator is disposed in the lumen of the main body in a second radial position (Fig. 9).
As to claim 4, Castro discloses that the second radial position is disposed 180 degrees relative to the first radial position (Figs. 1, 2, 7, and 9).
As to claim 5, Castro discloses that the proximal end of the tamp body comprises an enlarged proximal head portion (54, Fig. 1).
As to claim 6, Castro discloses that the lumen of the main body of the directional cannula comprises a transverse profile (Figs. 4 and 5) that matches a transverse profile of the fusion implant (Figs. 8 and 12).
As to claim 10, Castro discloses that the apparatus is capable of use with a fusion implant that comprises an implant body, a first stabilizer extending outwardly from a top surface of the implant body and a second stabilizer extending outwardly from a bottom surface of the implant body (if one so chooses to insert such an appropriately sized implant therein, Figs. 1, 4, and 5).
As to claim 11, Castro discloses that the apparatus is capable of use with the first stabilizer and the second stabilizer are diametrically opposed from one another (if one so chooses to insert such an appropriately sized implant therein, Figs. 1, 4, and 5).
As to claim 12, Castro discloses that the apparatus is capable of use with a fusion implant that comprises an implant body having a distal end, a proximal end and a lumen extending between the distal end and the proximal end (if one so chooses to insert such an appropriately sized implant therein, Figs. 1, 4, and 5).
As to claim 13, Castro discloses that the apparatus is capable of use with the distal end of the implant body comprises a cutting edge (if one so chooses to insert such an appropriately sized implant therein, Figs. 1, 4, and 5).
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 of this title, 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) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Castro in view of LaNeve et al. (US 2022/0031461, hereinafter “LaNeve”).
As to claim 7, Castro discloses the invention of claim 1 as well as that the lumen of the directional cannula comprises a transverse profile (Figs. 4 and 5) characterized by a first lateral dimension (Figs. 4 and 5) and a second lateral dimension (Figs. 4 and 5) disposed perpendicular to the first lateral dimension (Figs. 4 and 5); wherein the implant composes a generally cylindrical shape (Fig. 8).
Castro is silent to the first lateral dimension is larger than the second lateral dimension.
LaNeve teaches a similar apparatus (10, 20, Figs. 1-26; ¶38 discloses that 13 is rectilinear) capable of use for positioning a fusion implant (5) into a sacroiliac joint (¶37), the apparatus comprising: a directional cannula (10) comprising: a main body (Figs. 5-12) having a distal end (Figs. 6-9), a proximal end (Fig. 10) and a lumen (13) extending between the distal end and the proximal end (¶38 discloses that 13 is rectilinear); two cannula prongs (14s) extending distally from the distal end of the main body (Figs. 6-9); a distal cut-out (shown to the right of the prongs in Fig. 7 and to the above 16, Figs. 6-9) formed in the distal end of the main body (Figs. 6-9); and a proximal notch (17) formed in the proximal end of the main body (Fig. 10); and a combined implant tamp and joint locator (20, Figs. 4, 11, and 12, where the structure shown in Fig. 4 is capable of use both as an implant tamp and a joint locator) capable of being disposed in the lumen of the directional cannula (Figs. 11 and 12), the combined implant tamp and joint locator comprising: a tamp body (Figs. 4, 11, and 12) having a distal end (left end as shown in Fig. 4, Fig. 4) and a proximal end (right end as shown in Fig. 4, Fig. 4); two tamp prongs (portion above 26, portion below 26 as shown in Fig. 4, Fig. 4) extending distally from the distal end of the tamp body (Fig. 4);and a proximal stop (28) formed at the proximal end of the tamp body (Fig. 4, ¶44); wherein the lumen of the directional cannula comprises a transverse profile (¶38 discloses that 13 is rectilinear) characterized by a first lateral dimension (¶38 discloses that 13 is rectilinear) and a second lateral dimension (¶38 discloses that 13 is rectilinear) disposed perpendicular to the first lateral dimension (Fig. 4, ¶38 discloses that 13 is rectilinear), wherein the first lateral dimension is larger than the second lateral dimension (¶38 discloses that 13 is rectilinear); wherein the implant composes a generally rectilinear shape (Figs. 2, 3, and 24-26).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the implant, the directional cannula distal end, and the first lateral dimension and second lateral dimension as disclosed by Castro to have the implant shape, adding the cut-out adjacent the prongs, and have the first lateral dimension being larger than the second lateral dimension as taught by LaNeve in order to aid in joint repair (Castro ¶s 37 and 40) of the sacroiliac joint (LaNeve ¶37) for fusing a sacroiliac joint in the pelvis of a human (LaNeve ¶37) and for seating the directional cannula in and against sacroiliac joint (LaNeve ¶39).
As to claim 8, Castro discloses the invention of claim 1.
Castro is silent to the tamp body comprises a guidewire lumen extending from the distal end of the tamp body to the proximal end of the tamp body.
LaNeve teaches a similar apparatus (10, 20, Figs. 1-26; ¶38 discloses that 13 is rectilinear) capable of use for positioning a fusion implant (5) into a sacroiliac joint (¶37), the apparatus comprising: a directional cannula (10) comprising: a main body (Figs. 5-12) having a distal end (Figs. 6-9), a proximal end (Fig. 10) and a lumen (13) extending between the distal end and the proximal end (¶38 discloses that 13 is rectilinear); two cannula prongs (14s) extending distally from the distal end of the main body (Figs. 6-9); a distal cut-out (shown to the right of the prongs in Fig. 7 and to the above 16, Figs. 6-9) formed in the distal end of the main body (Figs. 6-9); and a proximal notch (17) formed in the proximal end of the main body (Fig. 10); and a combined implant tamp and joint locator (20, Figs. 4, 11, and 12) capable of being disposed in the lumen of the directional cannula (Figs. 11 and 12), the combined implant tamp and joint locator comprising: a tamp body (Figs. 4, 11, and 12) having a distal end (left end as shown in Fig. 4, Fig. 4) and a proximal end (right end as shown in Fig. 4, Fig. 4); two tamp prongs (portion above 26, portion below 26 as shown in Fig. 4, Fig. 4) extending distally from the distal end of the tamp body (Fig. 4);and a proximal stop (28) formed at the proximal end of the tamp body (Fig. 4, ¶44); wherein the tamp body comprises a guidewire lumen (26) extending from the distal end of the tamp body to the proximal end of the tamp body (¶44 discloses use of 26 for receiving a k-wire).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the tamp body as disclosed by Castro to have a guidewire lumen as taught by LaNeve in order to aid in joint repair (Castro ¶s 37 and 40, LaNeve ¶37) for inserting a guidewire into the apparatus and advancing the apparatus thereover (LaNeve ¶55) to assist in achieving the desired positioning within the joint.
Allowable Subject Matter
Claims 3 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 14-26 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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