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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
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. PCT/US2024/036184, 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. PCT/US2024/036184 does not disclose the limitation of claims 6-7, 14-15 of the stitch configuration being a Jersey knitting stitch. PCT/US2024/036184 does not disclose the limitation of claim 16 that the expansion rations are a function of the strand configuration.
The disclosure of the prior-filed application, Application No. 63/523,902, 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. 63/523,902 does not disclose the limitations of claims 5-9, 13-17 of two differently configured mesh strands making up the first chamber segment and second chamber segment. 63/523,902 does not disclose the limitation of claim 11 and 19 that the chambers are lateral segments.
Accordingly, claims 6-7, 14-16 have an effective filing date of 8/25/25; claims 5, 8, 9, 11, 13, 17, 19 have an effective filing date of 6/28/24; and claims 1-4, 10, 12, 18, 20 have an effective filing date of 6/28/23.
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.
(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) 12, 18-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Liauw et al. (US Publication No. 2023/0363928 A1).
Regarding Claim 12, Liauw discloses a spinal implant (“spine expansile filamentous interbody implant” [0089, 0117]) configured to receive a fill material (“load bearing filler material”, [0089]), comprising:
a wall (knit material shown in Fig. 17 and described in [0089]) that defines an interior chamber, wherein the wall has an interior side, an exterior side, and a wall thickness that extends between the interior side and the exterior side, wherein the wall has a porosity that permits fluid passage through the wall thickness and permits blood vessels and fibrous tissue to extend through the wall thickness ([0089-0092] describes that the filler material (which is contained in the knit material) is a substance promoting bone ingrowth, therefore it is inherent that the wall of the knit be capable of permitting fluid, blood vessels and fibrous tissue to extend therethrough because it would be necessary for the interior filler material to exhibit bone growth therein as the bone would have to grow through the outer wall material into the filler) ; and
wherein the interior chamber has a first chamber segment and a second chamber segment (posterior and anterior segments) , and in the first chamber segment the wall has a first mesh of strands configuration (wall is a knit material so the anterior end has the material characteristic of a mesh of strands configuration), and in the second chamber segment the wall has a second mesh of strands configuration (wall is a knit material so the posterior end has the material characteristic of a mesh of strands configuration) (further, the knits of the anterior and posterior wall segments are shown with different heights in Fig. 18).
Regarding Claim 18, the first chamber segment is a posterior chamber segment and the second chamber segment is an anterior chamber segment (described in the rejection of claim 1 and shown in Fig. 18).
Regarding Claim 19, the first and second chambers are disposed opposite each other and they are fully capable of being considered a lateral orientation depending on the perspective of the user.
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) 1-4, 10-11, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liauw et al. (US Publication No. 2023/0363928 A1).
Regarding Claim 1, Liauw discloses a spinal implant (“spine expansile filamentous interbody implant” [0089, 0117]) configured to receive a fill material (“load bearing filler material”, [0089]), comprising:
a wall (knit material shown in Fig. 17 and described in [0089]) that defines an interior chamber, wherein the wall has an interior side, an exterior side, and a wall thickness that extends between the interior side and the exterior side, wherein the wall has a porosity that permits fluid passage through the wall thickness and permits blood vessels and fibrous tissue to extend through the wall thickness ([0089-0092] describes that the filler material (which is contained in the knit material) is a substance promoting bone ingrowth, therefore it is inherent that the wall of the knit be capable of permitting fluid, blood vessels and fibrous tissue to extend therethrough because it would be necessary for the interior filler material to exhibit bone growth therein as the bone would have to grow through the outer wall material into the filler) ; and wherein the interior chamber has a first chamber segment and a second chamber segment (posterior and anterior segments) , and in the first chamber segment the wall has a first wall configuration, and in the second chamber segment the wall has a second wall configuration (posterior wall segment is shorter than anterior wall segment, see Fig. 18).
Although the anterior section of the structure is shown in Fig. 18 as larger than the posterior section, Liauw is silent to the wall or knit structure filled with load bearing filler material having a greater volumetric expansion ratio in the anterior section than the posterior section.
However, Liauw discloses that a different component, an expansion balloon shown in Fig. 15 is specifically pre-shaped to enable preferential expansion of different sections, in particular expanding more in the anterior portion to mimic the natural lordotic angle [0048, 0086]. It would have been obvious to one having ordinary skill in the art before the effective filing date to pre-shape the expandable structure of the filamentous implant such that it has a larger expansion in the anterior portion than the posterior portion in order to provide a shape that corresponds with the natural lordotic angle which the implant will assume when installed (shown in Fig. 18). In modifying the expandable structure of knit of the filamentous implant to have a larger expansion in the anterior section than the posterior section, the anterior section has a greater volumetric expansion ratio than the posterior section because the knit completely starts out empty (having no volume in either section) and then the anterior section has a larger final volume than the posterior section when filled.
Regarding claim 2, the first volumetric expansion ratio is a first chamber segment fill expanded state volume over a first chamber segment unfilled state volume; and wherein the second volumetric expansion ratio is a second chamber segment fill expanded state volume over a second chamber segment unfilled state volume. (In modifying the expandable structure of knit of the filamentous implant to have a larger expansion in the anterior section than the posterior section, the anterior section has a greater volumetric expansion ratio than the posterior section because the knit completely starts out empty (having no volume in either section) and then the anterior section has a larger final volume than the posterior section when filled.)
Regarding Claim 3, since the implantable filamentous device is a single inflatable structure, and the anterior and posterior (second and first chamber segments) are fluidly connected, the first chamber segment fill expanded state volume is a volume of the first chamber segment when the first chamber segment is subject to a first pressure produced by a fill material disposed within the first chamber segment, and the second chamber segment fill expanded state volume is a volume of the second chamber segment when the second chamber segment is subject to a second pressure produced by the fill material disposed within the second chamber segment, wherein the first pressure equals the second pressure.
Regarding Claim 4, the implant is disposable in a collapsed state and in a fill expanded state. Disposable can mean single use, which the implant is fully capable of being if necessary to remove the implant after installation. Further, disposable can mean disposed in which the implant is disposed or placed in the both a collapsed and filled state (see fig 16-18).
Regarding Claim 10, the first chamber segment is a posterior chamber segment and the second chamber segment is an anterior chamber segment (described in the rejection of claim 1 and shown in Fig. 18).
Regarding Claim 11, the first and second chambers are disposed opposite each other and they are fully capable of being considered a lateral orientation depending on the perspective of the user.
Regarding Claim 20, Liauw discloses a spinal implant system, comprising: a fill material(“load bearing filler material”, [0089]); an implant (“spine expansile filamentous interbody implant” [0089, 0117]) that comprises a wall (knit material shown in Fig. 17 and described in [0089]) that defines an interior chamber, wherein the wall has an interior side, an exterior side, and a wall thickness that extends between the interior side and the exterior side, wherein the wall has a porosity that permits fluid passage through the wall thickness and permits blood vessels and fibrous tissue to extend through the wall thickness([0089-0092] describes that the filler material (which is contained in the knit material) is a substance promoting bone ingrowth, therefore it is inherent that the wall of the knit be capable of permitting fluid, blood vessels and fibrous tissue to extend therethrough because it would be necessary for the interior filler material to exhibit bone growth therein as the bone would have to grow through the outer wall material into the filler); and wherein the interior chamber has a first chamber segment and a second chamber segment(posterior and anterior segments), and in the first chamber segment the wall has a first wall configuration, and in the second chamber segment the wall has a second wall configuration(posterior wall segment is shorter than anterior wall segment, see Fig. 18).
The pressure applied to both chamber segments is substantially equal because the implantable filamentous device is a single inflatable structure and the anterior and posterior (second and first chamber segments) are fluidly connected. Although the anterior section of the structure is shown in Fig. 18 as larger than the posterior section, Liauw is silent to the wall or knit structure filled with load bearing filler material having a greater volumetric expansion ratio in the anterior section than the posterior section.
However, Liauw discloses that a different component, an expansion balloon shown in Fig. 15 is specifically pre-shaped to enable preferential expansion of different sections, in particular expanding more in the anterior portion to mimic the natural lordotic angle [0048, 0086]. It would have been obvious to one having ordinary skill in the art before the effective filing date to pre-shape the expandable structure of the filamentous implant such that it has a larger expansion in the anterior portion than the posterior portion in order to provide a shape that corresponds with the natural lordotic angle which the implant will assume when installed (shown in Fig. 18). In modifying the expandable structure of knit of the filamentous implant to have a larger expansion in the anterior section than the posterior section, the anterior section has a greater volumetric expansion ratio than the posterior section because the knit completely starts out empty (having no volume in either section) and then the anterior section has a larger final volume than the posterior section when filled.
Claim(s) 5-8, 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liauw et al. (US Publication No. 2023/0363928 A1) in view of Mortarino (US Patent No. 9326840 B2).
Regarding Claim 5 -8, the implant of Liauw is disclosed above in the rejection of claim 1. The knitted wall - which is a wall of mesh strands- of the Liauw was modified to have a lordotic expansion profile. However, Liauw is silent to the difference in expansion from the anterior to posterior end could be a result of differently configured mesh strands at the ends.
Mortarino discloses knitted prosthetic mesh materials for use as in situ bone reparation materials. Mortarino discloses that varying the yarn size in sections of the mesh will achieve different mechanical and physical characteristics such as percent elongation (col. 11; ln. 43-67).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to generate the difference in anterior height relative to posterior height of the knitted implant of Liauw by using the concept of varying yarn size as taught by Mortarino in order to use a known technique to predictably generate a mesh with different sections expanding to different heights.
Regarding Claim 6, Mortarino discloses a type of knitting stitch suitable for the prosthetic mesh is a jersey knit (col. 4; ln. 17-29). It would have been obvious to use Jersey stitches in the different sections of the implant of Liauw since Mortarino shows that this is a know and suitable stitch type to create a prosthetic mesh implant. Regarding Claim 7, the difference in yarn size using a Jersey knit is a difference in stitch parameter. Regarding Claim 8, the first mesh of strands is a first knitting stitch configuration, and the second mesh of strands is a second knitting stitch configuration (different sized yarns result in a different stitch configuration).
Regarding Claims 13-16, the implant of Liauw is disclosed above in the rejection of claim 12. The knitted wall - which is a wall of mesh strands- of the Liauw was modified to have a lordotic expansion profile. However, Liauw is silent to the difference in expansion from the anterior to posterior end could be a result of differently configured mesh strands at the ends.
Mortarino discloses knitted prosthetic mesh materials for use as in situ bone reparation materials. Mortarino discloses that varying the yarn size in sections of the mesh will achieve different mechanical and physical characteristics such as percent elongation (col. 11; ln. 43-67).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to generate the difference in anterior height relative to posterior height of the knitted implant of Liauw by using the concept of varying yarn size as taught by Mortarino in order to use a known technique to predictably generate a mesh with different sections expanding to different heights. This would result in the first mesh of strands configuration is a first knitting stitch configuration, and the second mesh of strands configuration is a second knitting stitch configuration that is different than the first knitting stitch configuration due to the different yarn sizes.
Regarding Claim 14, Mortarino discloses a type of knitting stitch suitable for the prosthetic mesh is a jersey knit (col. 4; ln. 17-29). It would have been obvious to use Jersey stitches in the different sections of the implant of Liauw since Mortarino shows that this is a known and suitable stitch type to create a prosthetic mesh implant. Regarding Claim 15, the difference in yarn size using a Jersey knit is a difference in stitch parameter. Regarding Claim 16, the first chamber segment has a first volumetric expansion ratio that is a function of the first mesh of strands configuration, and the second chamber segment has a second volumetric expansion ratio that is a function of the second mesh of strands configuration, wherein the first volumetric expansion ratio is different than the first volumetric expansion ratio (as taught by Mortarino that the yarn size effects the percent elongation).
Allowable Subject Matter
Claims 9, 17 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
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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