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 .
Response to Arguments
Applicant’s amendment filed 12/04/2025 is accepted and entered.
Applicant's arguments filed 12/04/2025 have been fully considered but they are not persuasive.
Applicant alleges, on page 5 of the Remarks, that Stewart fails to teach or reasonably disclose a detectable element that is a single structure that forms an elongated strip of material that is detectable via magnetic resonance imaging, wherein the elongate strip of material comprises a magnetic permeability higher than water and does not have any three dimensional objects along its length. Applicant alleges that Stewart only teaches that titanium is used as a bead forming a three dimensional object and only in the context of such a bead, and thus Stewart does not teach the tethered construct or filament itself being made of titanium (Remarks, pgs. 4-5). Applicant further alleges that Stewart teaches that the ribbon is rigid and made of a custom, compounded polymer, which teaches away from the ribbon being made of titanium (Remarks, pg. 6). These arguments are not found persuasive.
As set forth below, Stewart discloses a detectable element, such as a ribbon or other elongated substrate. The ribbon or elongated substrate is described as “containing radiopaque material”, where the “radiopaque material used may be a material providing a higher radio-opacity (hence a brighter contrast under x-ray) than barium sulfate” and having the goal of “[improving] the human visual recognition of said substrate” (¶ [0034]). Although Stewart does indicate in ¶ [0067] that the ribbon is typically comprised of custom compounded polymer, this is not a requirement – the only material requirement is that the ribbon is made of a radiopaque material. Additionally, Stewart indicates in ¶ [0017] that “the three dimensional objects will be comprised entirely of materials making them more easily recognized with human visualization when using medical imaging technologies. Such materials may include steel, titanium or another alloy.” This demonstrates that steel and titanium are materials that make objects more easily recognized with human visualization when using medical imaging technologies. While ¶ [0017] only specifically indicates that the three dimensional objects could be formed with steel or titanium, it is clear when reading ¶ [0032], which indicates that the ribbon is made of radiopaque material, that steel and titanium could be used for the ribbon as they have previously been acknowledged by Stewart as radiopaque materials.
Applicant’s arguments regarding Claim 25 have been found persuasive, however, Mesek is cited to teach the limitations of Claim 25 as set forth below.
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.
Claim(s) 1, 2, 5, 8-13, 16, 19, 20, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stewart (US 2018/0344429) as evidenced by AZOM (Titanium Alloys – Physical Properties, April 2 2002, www.azom.com/article.aspx?ArticleID=1341).
Regarding Claims 1, 2, and 5, Stewart discloses a surgical material for use in surgery (Figs. 11A-14, ¶ [0002-0003, 0034-0036]), comprising:
a planar material, specifically gauze, configured to be used in a surgical procedure (gauze, as seen in Figs. 12A-14; ¶ [0034-0036, 0050]);
a detectable element (ribbon, Figs. 11A-14; ¶ [0034-0036]) coupled to the planar material (Figs. 11A-14; ¶ [0034-0036]), wherein the detectable element is detectable via magnetic resonance imaging (¶ [0017, 0034-0036]), wherein the detectable element is a single structure that forms an elongated strip of material that is detectable via magnetic resonance imaging (¶ [0034-0036]; the ribbon can be applied in a continuous fashion as seen in Fig. 11A), wherein the elongated strip of material comprises a magnetic permeability higher than water (¶ [0017, 0034-0036]; since the ribbon can be formed of titanium, which is a paramagnetic material as evidenced by AZOM (see page 6), the magnetic permeability of the elongated strip will be higher than the magnetic permeability of water which is a diamagnetic material) and does not have any three dimensional objects along its length (Fig. 11A, ¶ [0034-0036] indicate the elongated strip may have cut out portions, but there are no three dimensional objects along the ribbon), wherein the elongated strip of material extends from a first edge of the planar material to a second, opposite edge of the planar material (Fig. 14 shows gauze with a continuous ribbon that extends from one edge to the second opposite edge of the gauze) and wherein the elongated strip of material is MRI compatible (¶ [0017, 0034-0036]), wherein the elongated strip of material that is detectable by MRI comprises barium (¶ [0017, 0034-0036, 0068]; the ribbon can be made with a barium sulfate additive).
Regarding Claim 8, Stewart discloses the detectable element comprises a magnetic permeability of higher than 0.05 (as evidenced by AZOM, titanium has a higher magnetic permeability than 0.05).
Regarding Claims 9 and 10, Stewart discloses the detectable element is further detectable by an imaging modality other than MRI, such as X-ray (¶ [0017, 0034-0036]).
Regarding Claims 11, 13, and 16, Stewart discloses a method of using a surgical material, comprising:
coupling a surgical material to a patient (¶ [0002-0003]), the surgical material comprising:
a planar material, specifically gauze, configured to be used in a surgical procedure (gauze, as seen in Figs. 12A-14; ¶ [0034-0036, 0050]);
a detectable element (ribbon, Figs. 11A-14; ¶ [0034-0036]) coupled to the planar material (Figs. 11A-14; ¶ [0034-0036]), wherein the detectable element is detectable via magnetic resonance imaging (¶ [0017, 0034-0036]), wherein the detectable element is a single structure that forms an elongated strip of material that is detectable via magnetic resonance imaging (¶ [0034-0036]; the ribbon can be applied in a continuous fashion as seen in Fig. 11A), wherein the elongated strip of material comprises a magnetic permeability higher than water (¶ [0017, 0034-0036]; since the ribbon can be formed of titanium, which is a paramagnetic material as evidenced by AZOM (see page 6), the magnetic permeability of the elongated strip will be higher than the magnetic permeability of water which is a diamagnetic material) and does not have any three dimensional objects along its length (Fig. 11A, ¶ [0034-0036] indicate the elongated strip may have cut out portions, but there are no three dimensional objects along the ribbon), wherein the elongated strip of material extends from a first edge of the planar material to a second, opposite edge of the planar material (Fig. 14 shows gauze with a continuous ribbon that extends from one edge to the second opposite edge of the gauze) and wherein the elongated strip of material is MRI compatible (¶ [0017, 0034-0036]), wherein the elongated strip of material that is detectable by MRI comprises barium (¶ [0017, 0034-0036, 0068]; the ribbon can be made with a barium sulfate additive);
using an imaging system to detect a presence of the surgical material (¶ [0017]).
Regarding Claim 12, Stewart discloses coupling the surgical material to the patient comprises inserting the surgical material into the patient (¶ [0002-0003]).
Regarding Claim 19, Stewart discloses the detectable element comprises a magnetic permeability of higher than 0.05 (as evidenced by AZOM, titanium has a higher magnetic permeability than 0.05).
Regarding Claim 20, Stewart discloses the detectable element is further detectable by an imaging modality other than MRI (¶ [0017, 0034-0036]; detectable by X-ray).
Regarding Claim 23, Stewart discloses the elongated strip of material is a monolithic structure (¶ [0034-0036, 0068]; the ribbon is made by extrusion and as such would be a monolithic structure).
Regarding Claim 24, Stewart discloses the elongated strip of material is an uninterrupted planar structure without any cut outs (¶ [0034-0036, 0068] the ribbon can be formed with regions with lesser radiopacity so that regions are not cut out of the ribbon, and as such the ribbon will be an uninterrupted planar structure without any cut outs).
Claim(s) 25 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mesek (US 2698270) as evidenced by Jones et al (US 2011/0184280) and Schenck (The role of magnetic susceptibility in magnetic resonance imaging: MRI magnetic compatibility of the first and second kinds, June 1996, Medical Physics, Vol. 23).
Regarding Claim 25, Mesek discloses a surgical material for use in surgery (Col. 1 lines 15-20, Col. 2 lines 3-14), comprising:
a planar material (gauze section 14, Fig. 1) configured to be used in a surgical procedure (Col. 1 lines 15-20, Col. 2 lines 3-14);
a detectable element (monofilament 12, Fig. 1; Col. 2 lines 3-24) coupled to the planar material (14, Fig. 1; Col. 2 lines 3-24), wherein the detectable element is detectable via magnetic resonance imaging (Col. 2 lines 3-24, Col. 3 lines 33-45; the monofilament can comprise tungsten, which is evidenced by Jones ¶ [0019] as being detectable by MRI), wherein the detectable element (12, Fig. 1) is a single structure that forms an elongated strip of material (Col. 2 line 3 – Col. 3 line 30) that is detectable via magnetic resonance imaging (Col. 2 lines 3-24, Col. 3 lines 33-45; the monofilament can comprise tungsten, which is evidenced by Jones ¶ [0019] as being detectable by MRI), wherein the elongated strip of material (12, Fig. 1) comprises a magnetic permeability higher than water (Col. 2 lines 3-24, Col. 3 lines 33-45; the monofilament can comprise tungsten, which is evidenced by Schenck pg. 818 and 824 as having a higher magnetic permeability than water – adding 1 to the magnetic susceptibility equals the magnetic permeability, and the magnetic permeability of water is shown in Schenck to be 0.99999095 and the magnetic permeability of tungsten is calculated to be 1.000772) and does not have any three dimensional objects along its length (Col. 2 line 3 – Col. 3 line 30; the filament is only a filament, no three dimensional objects such as beads or bulges are present on the filament), wherein the elongated strip of material (12, Fig. 1) extends from a first edge (left edge, Fig. 1) of the planar material (14, Fig. 1) to a second, opposite edge (right edge, Fig. 1) of the planar material (14, Fig. 1).
wherein the detectable element (12, Fig. 1) is threaded (Col. 2 line 3 – Col. 3 line 30; since the monofilament is a thread, it can be described as threaded) and the planar material (14, Fig. 1) is at least partially woven (Col. 2 lines 21-24; cotton gauze is well known in the art of medical devices to be a woven material).
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.
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781