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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-9 and 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,389,281. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1 and 8, US Patent 11,389,281 teaches a range that encompasses the claimed ranges of the instant application. A POSITA looking to manipulate the characteristics of the mesh produced by the method of 11,389,281 would look to changing the temperature of the heat treating of the mesh, as such, the broader range of 11,389,281 renders the more narrow range of the instant application patentably indistinct.
Instant Application
11,389,281
Rationale
1. A method for creating a surgical mesh, the method comprising: heat treating a mesh by applying heat at a temperature between 60% and 100% of a melting point in Celsius of a material out of which the mesh is made, while subjecting the mesh to a tension between 4.0 Newtons per centimeter (N/cm) to 32.0 N/cm for a period of time.
5. The method of claim 1, wherein the period of time is between 1 hour and 9 hours.
1. A method for creating a surgical mesh, the method comprising: (a) heat treating a plurality of fibers; (b) knitting the plurality of fibers into a mesh; and (c) heat treating the mesh by applying heat at a temperature that falls within 40% of but does not exceed the a melting point of a material out of which the plurality of fibers are made, while subjecting the mesh to a tension that falls in a range of 4.0 Newtons per centimeter (N/cm) to 32.0 N/cm for a period of time that falls in a range of 1 hour to 9 hours.
The instant application claims a range of temperature that is encompassed by 11,389,281 and therefore includes the claimed range.
2. The method of claim 1, wherein the mesh has a plurality of pores, each of which is large enough to circumscribe a circle that is at least 800 micrometers in diameter.
7. The method of claim 1, wherein the mesh has a plurality of pores, each of which is large enough to circumscribe a circle that is at least 800 micrometers in diameter.
3. The method of claim 1, wherein the material comprises a thermoplastic polymer.
3. The method of claim 1, wherein the material is poly-p-dioxanone (PDO).
PDO is a thermoplastic polymer.
4. The method of claim 1, wherein the material comprises a hydrolytically- degradable polymer.
3. The method of claim 1, wherein the material is poly-p-dioxanone (PDO).
PDO is a hydrolytically- degradable polymer.
6. The method of claim 1, wherein the material comprises poly-p-dioxanone (PDO).
3. The method of claim 1, wherein the material is poly-p-dioxanone (PDO).
7. The method of claim 6, wherein the temperature is between 65 degrees Celsius and 85 degrees Celsius.
4. The method of claim 3, wherein the temperature falls within a range of 65 degrees Celsius to 75 degrees Celsius.
5. The method of claim 3, wherein the temperature falls within a range of 75 degrees Celsius to 85 degrees Celsius.
8. The method of claim 1, wherein the temperature is between 65 degrees Celsius and 85 degrees Celsius.
6. The method of claim 1, wherein heat treating the mesh comprises applying heat to the mesh at a temperature that is within a range of 65 degrees Celsius to 110 degrees Celsius.
9. The method of claim 1, wherein the material comprises a plurality of fibers.
See claim 1.
11. The method of claim 9, wherein the plurality of fibers are heat treated.
See claim 1.
12. The method of claim 9, further comprising, prior to the heat treating the mesh step, forming the plurality of fibers into the mesh.
See claim 1.
13. The method of claim 12, further comprising, prior to the forming step, heat treating the plurality of fibers.
See claim 1.
14. The method of claim 13, wherein the heat treating the plurality of fibers step comprises subjecting each of the plurality of fibers to a tension between 0.5 Newtons and 6.0 Newtons.
2. The method of claim 1, further comprising: while heat treating the plurality of fibers, subjecting each of the plurality of fibers to a tension that falls within a range of 0.5 Newtons and 6.0 Newtons.
15. The method of claim 12, wherein the forming step comprises knitting, weaving, or spinning.
See claim 1.
16. The method of claim 1, wherein the heat treating the mesh step comprises applying heat to the mesh at a temperature between 65 degrees Celsius and 110 degrees Celsius.
6. The method of claim 1, wherein heat treating the mesh comprises applying heat to the mesh at a temperature that is within a range of 65 degrees Celsius to 110 degrees Celsius.
17. The method of claim 1, wherein the mesh after the heat treating the mesh step has a basis weight between 30 grams per square meter and 140 grams per square meter.
8. The method of claim 1, wherein the mesh after heat treatment has a basis weight that falls within a range of approximately 30 grams per square meter to approximately 140 grams per square meter.
18. The method of claim 1, wherein the mesh is subjected to the tension over a surface to shape the mesh into a three-dimensional form.
9. The method of claim 1, wherein the mesh is subjected to the tension over a curved surface to shape the mesh into a three-dimensional form.
Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,389,281 in view of Gingras (US20050222591A1). US patent 11,389,281 discloses in claims 1 and 2, a method comprising knitting a plurality of PDO fibers into a mesh. Claim 10 of the instant application claims that the plurality of fibers comprise monofilament fibers, which 11,389,281 fails to disclose. Gingras discloses a soft tissue implant (Abstract), wherein the fibers comprise a PDO monofilament fibers (Paragraph [0120]), wherein the fibers are knit into a mesh (Paragraph [0012]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by US patent 11,389,281, with the plurality of fibers comprising monofilament fibers as taught by Gingras, since such a modification would provide the predictable results of a mesh that is less likely to cause inflammation (Paragraph [0009]).
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,389,281 in view of Martin (US20040234576A1).
US patent 11,389,281 discloses in claims 1 and 6, a method comprising a mesh made of a material wherein that material is PDO. Claim 19 of the instant application claims the mesh is capable of fully degrading under physiological conditions within one year, which 11,389,281 fails explicitly disclose. Martin discloses a division of Johnson and Johnson (Ethicon) first introduced a monofilament synthetic absorbable suture known as PDS, made from polydioxanone. This suture retains about 50% of its strength up to 6 weeks after implantation, and is completely absorbed in the body within 6 months (Paragraph [0026]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art that the method as taught by US patent 11,389,281, wherein the method comprises a mesh comprising PDO would be fully degraded under physiological conditions within one year since that is a characteristic of PDO.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,389,281 in view of Bringman (“Hernia repair: The search for Ideal Meshes”, 2009).
US patent 11,389,281 discloses in claim 1, a method comprising a surgical mesh. Claim 20 of the instant application claims the mesh has a thickness of between 0.5 mm and 1 mm, which 11,389,281 fails explicitly disclose. Bringman discloses in a study for optimizing hernia meshes, that meshes can be grouped as lightweight, where the thickness is <0.5 mm and heavy weight >0.5 mm and with pore size differing between the two (Page 82). As meshes that are between 0.5 mm and 1 mm are already in use, it would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art that the method as taught by US patent 11,389,281, wherein the method comprises a mesh that has a thickness of between 0.5 mm and 1 mm because the thickness would be dependent on the use (Page 86).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hu (US20140205795A1) discloses heat treating a knitted textile fabric while it is being stretched to a negative Poisson's ratio, but is silent on the amount of force applied to the stretch. Peniston (US20130267137A1) discloses heat setting a PDO knitted mesh at the disclosed temperature and time, and discloses tension applied during the heating setting affects the heating setting effect, but is silent on the amount of force or tension applied. Gingras (WO2005094741A1) discloses applying a tension of 75 N/cm and 100 N/m while heat treating a mesh, but is silent to the range disclosed in the instant application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./Examiner, Art Unit 3791