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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12, in the reply filed on 7/24/26 is acknowledged.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (20090281558).
Li teaches surgical meshes with radiopaque coatings.
Li, abstract, teaches implantable medical articles which comprise a surgical mesh that is at least partially covered with a coating that comprises a radiopaque material such as a metal or a metallic compound. The radiopaque material is present in the coating in an amount such that the coated portions of the mesh are visible using radiographic imaging techniques.
Li, paragraph 15 of the PGPUB, teaches the radiopaque material may be present in the coating in an amount such that the coated portions of the mesh are visible under x-ray fluoroscopy.
Li, paragraph 19 of the PGPUB, teaches the coating may comprise gold.
Li, paragraph 23 of the PGPUB, teaches at least one dimension may range, for example, from 100 microns to 50 microns to 25 microns to 10 microns to 5 microns to 2 microns to 1 micron to 1000 nm to 500 nm to 250 nm to 100 nm to 50 nm to 25 nm to 10 nm or less.
Li, paragraph 42 of the PGPUB, teaches coatings are applied in the form of a fluid.
A 20 nm gold nanoparticle contains about 247,000-250,000 gold atoms.
Regarding claim 2, Li, paragraph 42 of the PGPUB, teaches coatings are applied in the form of a fluid (e.g., a solution, dispersion, melt, etc.) using a suitable application technique, which may be selected, for example, from techniques in which fluid is selectively applied to only to certain regions of the mesh, for example, through the use of a suitable application device such as a printer (e.g., screen printing device, ink jet printer, etc.).
It 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 to choose a viscosity on the coating so that it can be applied effectively with an ink jet printer.
Regarding claim 3, Li teaches surgical mesh that is at least partially covered with a coating that comprises a radiopaque material such as a metal or a metallic compound.
The mesh as taught by Li reads on a substrate as claimed in claim 3.
The mesh coated with the coating as taught by Li reads on a label as claimed in claim 3.
Claims 4-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (20090281558) as applied to claim 1 and further in view of Watanabe et al (20100054404).
Although Li teaches the radiopaque material is present in the coating in an amount such that the coated portions of the mesh are visible using radiographic imaging techniques, Li does not teach a specific technique.
Watanabe, paragraphs 32-33 of the PGPUB, teaches the X-ray imaging apparatus 80 includes an X-ray generator 81, an X-ray image detector 10, a control unit 82, and a display unit (monitor) 83.
The X-ray generator (i.e., radiation generator) 81 emits radiation (X-rays) toward an object (e.g., human body). The X-ray image detector 10 shoots an X-ray image based on the object by detecting the radiation emitted by the X-ray generator 81 and transmitted through the object. The control unit 82 collectively controls processing of the X-ray imaging apparatus 80. For example, the control unit 82 controls radiographic imaging (X-ray imaging) by the X-ray generator 81 and the X-ray image detector 10. The control unit 82 also controls read drive of the X-ray image detector 10 and image transfer. The display unit 83 displays the X-ray image of the object shot by the X-ray image detector 10.
It 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 to use this apparatus (system) as taught by Watanabe as the technique as taught by Li as Watanabe teaches this radiographic imaging apparatus is capable of realizing both convenience when portably using a detector and high performance when stationarily using the detector and a control method thereof.
Regarding claims 5-6, Li teaches one mesh can comprise a silver coating and other mesh can comprise a gold coating.
It 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 that these meshes can be arranged in front or in back of one another as they will have different radiodensities and therefore they will appear differently on x-rays.
Regarding claim 7, Li, paragraph 36 of the PGPUB, teaches a popular treatment of stress urinary incontinence (SUI) is via the use of a surgical mesh, commonly referred to as a sling, which is placed under a patient's bladder neck or mid-urethra to provide a urethral platform.
Li, paragraph 38 of the PGPUB, teaches as with SUI, treatment of pelvic floor disorders are commonly treated by implanting a surgical mesh within the patient's pelvis to support the organ or organs that require support.
Regarding claim 8, Watanabe, paragraph 13 of the PGPUB, teaches a radiographic imaging apparatus capable of realizing both convenience when portably using a detector and high performance when stationarily using the detector and a control method thereof.
Li teaches surgical meshes with radiopaque coatings which are considered a consumer product.
Regarding claim 9, Watanabe, paragraph 13 of the PGPUB, teaches a radiographic imaging apparatus capable of realizing both convenience when portably using a detector and high performance when stationarily using the detector and a control method thereof which is associated with a point of sale terminal or an autonomous robot in the retail facility as claimed in claim 9.
Li teaches surgical meshes with radiopaque coatings which are considered a consumer product in a retail facility as claimed in claim 9.
Regarding claim 10, Li teaches surgical meshes with radiopaque coatings.
Regarding claim 12, it 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 to have a database of x-ray images to compare the x-ray images as taught by the references to the database images.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al (20090281558) in view of Watanabe et al (20100054404) as applied to claim 4 and further in view of Rogers et al (20120065503).
Although the references teach a surgical mesh that is at least partially covered with a coating, the references do not teach the coating printed on a label which is affixed to the mesh.
Rogers teaches an implantable medical device (IMD) may comprise one or more radiopaque articles selected from a predetermined set of radiopaque articles.
Rogers, paragraph 4 of the PGPUB, teaches the radiopaque marker may be adhered to, molded into, embedded within, or otherwise affixed to the molded desiccant article.
Rogers, paragraph 12 of the PGPUB, teaches carrying the one or more radiopaque articles may comprise embedding the one or more radiopaque articles within a desiccant article or polymer article carried by the IMD and/or affixing the one or more radiopaque articles with an adhesive or a tape.
It 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 that the coating as taught by the references can be adhered to the mesh via tape as taught by Rogers as this is one method to adhere radiopaque materials to a surface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20050085723 teaches a medical device includes a body comprised substantially of radiolucent material and a radiopaque marker.
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/STEFANIE J COHEN/Examiner, Art Unit 1732 9/16/26
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