DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Disposition of Claims
Claims 1, 3-9, 11, 15, 17-18 and 21-23 are pending in the application. Claims 2, 10, 12-14, 16 and 19-20 have been cancelled.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites the limitation “to form single layer.” 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.
Claims 3, 15 and 21-22 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “the non-absorbable synthetic monofilament polymeric fiber.” There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation “said non-absorbable synthetic monofilament polymeric fiber.” There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation “the non-absorbable synthetic monofilament polymeric fiber.” There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation “the non-absorbable synthetic monofilament polymeric fiber.” There is insufficient antecedent basis for this limitation in the claim.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-8 of U.S. Patent No. 11,959,207 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 is anticipated by claims 6-8 of U.S. Patent No. 11,959,207 B2.
Claims 3-9, 11, 15, 17-18 and 21-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-5 and 10-17 of U.S. Patent No. 11,959,207 B2 in view of US 2005/0070930 A1 (“Kammerer”).
Claims 2-5 and 10-17 of U.S. Patent No. 11,959,207 B2 meet all the limitations of claims 3-9, 11, 15, 17-18 and 21-23 of the current application except for the absorbable polymeric multifilament fiber of a segmented biodegradable copolyester or an absorbable homopolymer of polydioxanone (as recited in claim 1 of the current application).
In addition, Kammerer teaches an implantable surgical mesh in which the absorbable filaments are selected from the group consisting of polyglactin, polydioxanone, polycaprolactone, polylactic acid, and polylactide (Abstract and [0011]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have selected polydioxanone as the material of the absorbable fiber in order to provide a biocompatible absorbable filament that can be used to obtain an implantable surgical mesh with a desired structure integrity time, as suggested by Kammerer (see [0037], including the Table following this paragraph).
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Greenawalt (US 2005/0244455 A1) teaches a surgical prosthesis that includes a three dimensional mesh including at least two types of yarn interlooped or intertwined to define at least two layers, wherein the mesh is any woven or knitted structure that includes biodegradable yarns and non-biodegradable yarns ([0004], [0023], [0039] and [0069]). The biodegradable yarn is selected from poly(glycolic) acid, polylactic acid, polydioxanone, polycaprolactone, calcium alginate or a combination thereof ([0006]). Greenawalt teaches that, typically, the ratio of non-biodegradable yarns to biodegradable yarns in the mesh ranges from about 0.1 to 9, or in certain embodiments, the ratio of non-biodegradable yarns to biodegradable yarns is 1 to 2.33 (biodegradable yarns = 10% to 91%, or 30 to 50%, as calculated by the Examiner) (see [0040]). Greenawalt teaches that the non-biodegradable yarn is selected from polypropylene, polyethylene terephthalate or a combination thereof, and has a diameter of about 0.001 to about 0.010 inches, preferably about 0.005 inches (see [0005] and [0041]). As calculated by the examiner for polypropylene, which has a density of about 0.9 g/cm3, the denier for a 0.006 inch diameter yarn of circular cross-section is about 148 g/9000m. Greenawalt also teaches that the biodegradable and non-biodegradable yarns ‘32’ and ‘34’ are threaded into an industrial knitting machine, such as a double-needle bar knitting machine ([0069], [0072] and Table 1). Greenawalt does not explicitly disclose a single-layer polymeric mesh consisting of one layer having essentially identical first and second sides, wherein said non-absorbable synthetic monofilament fiber has an ultimate elongation of greater than 30%, and wherein the absorbable fiber is knit in a 2 bar marquisette pattern and the polypropylene fiber is knit in a 2 bar sand-fly net pattern with all guide bars for each pattern threaded 1-in and 1-out.
Sander (US Patent No. 7,875,063 B1) teaches a tissue repair device that comprises a flexible linking member which can be knitted and fabricated from bioresorbable and/or non-resorbable fibers, wherein the non-bioabsorbable materials in filamentous form are preferably elastic and exhibit an elongation at break of at least about 30 percent, preferably at least about 40 or 50 percent, and wherein such materials include polyethylene and polypropylene (see especially column 8 lines 45-57, also column 8 lines 4-44 and column 10 lines 17-18). Like Greenawalt, Sander does not explicitly disclose wherein an absorbable fiber is knit in a 2 bar marquisette pattern and an nonabsorbable fiber is knit in a 2 bar sand-fly net pattern with all guide bars for each pattern threaded 1-in and 1-out.
Bayon (US 2010/0016872 A1) teaches wherein the elongation at break of a mesh in its longitudinal axis is less than about 100%, in embodiments less than about 20% (as determined by ISO 13934-1) ([0108]). Like Greenawalt and Sander, Bayon does not explicitly disclose wherein an absorbable fiber is knit in a 2 bar marquisette pattern and a nonabsorbable fiber is knit in a 2 bar sand-fly net pattern with all guide bars for each pattern threaded 1-in and 1-out.
Shalaby (US 2008/0119848 A1) teaches two examples wherein an absorbable yarn is knitted in a 2 bar marquisette pattern and is combined with a non-absorbable yarn knitted in a 2 bar sand-fly net pattern with all guide bars for each pattern threaded 1-in and 1-out (see Example 13 at [0078]-[0088]; also Example 10). Shalaby does not does not explicitly disclose, in these embodiments, two-fiber types consisting of the components claimed in the claimed amounts.
There is nothing showing that it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the invention to have modified the absorbable and non-absorbable fibers of Greenawalt and either Sander or Bayon with the specific knit patterns taught by Shalaby to meet the claimed limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kevin Worrell whose telephone number is (571)270-7728. The examiner can normally be reached Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marla McConnell can be reached at 571-270-7692. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Kevin Worrell/Examiner, Art Unit 1789
/MARLA D MCCONNELL/Supervisory Patent Examiner, Art Unit 1789
Prosecution Insights