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 .
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-6, 8, 10-12 and 14-15 are objected to because of the following informalities:
In claim 1, line 3, the phrase “the bioabsorbable fiber and the biostable fiber” should read “the at least one bioabsorbable fiber and the at least one biostable fiber” to remain consistent in referring to the fibers previously introduced.
In claim 1, line 9, the phrase “the bioabsorbable fiber” should read “the at least one bioabsorbable fiber”.
In claim 2, the phrase “the bioabsorbable fiber… the biostable fiber” should read “the at least one bioabsorbable fiber… the at least one biostable fiber”.
In claim 3, the phrase “the bioabsorbable fiber” should read “the at least one bioabsorbable fiber”.
In claim 4, the phrase “the biostable fiber” should read “the at least one biostable fiber”.
In claim 5, the phrase “the biostable fiber” should read “the at least one biostable fiber”.
In claim 6, the phrase “the bioabsorbable fiber… the biostable fiber… the bioabsorbable fiber” should read “the at least one bioabsorbable fiber… the at least one biostable fiber… the at least one bioabsorbable fiber”.
In claim 8, the phrase “the bioabsorbable fiber” should read “the at least one bioabsorbable fiber”.
In claim 10, the phrase “the bioabsorbable fiber” should read “the at least one bioabsorbable fiber”.
In claim 11, the phrase “the bioabsorbable fiber” appears to misspell the term “bioabsorbable”.
In claim 11, the phrase “the bioabsorbable fiber” should read “the at least one bioabsorbable fiber”.
In claim 12, the phrase “the bioabsorbable fiber” appears to misspell the term “bioabsorbable”.
In claim 12, the phrase “the bioabsorbable fiber” should read “the at least one bioabsorbable fiber”.
In claim 14, the phrase “the biostable fiber” should read “the at least one biostable fiber”.
In claim 15, the phrase “the bioabsorbable fiber” should read “the at least one bioabsorbable fiber”.
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 8 and 13 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.
Regarding claim 8, the claim recites “the biostable mesh” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim, since a biostable mesh has not been previously introduced. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to a biostable mesh component of the partially absorbable mesh.
Regarding claim 13, the claim recites “both colored and uncolored bioabsorbable fiber”. It is unclear whether the phrase includes the at least one bioabsorbable fiber previously introduced, or is introducing new, separate fibers. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the at least one bioabsorbable fiber including a colored bioabsorbable fiber and an uncolored bioabsorbable fiber.
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 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) 1-4, 7-8, 11-12, and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sheu (US 2007/0282160 A1).
Regarding claim 1, Sheu discloses (see abstract; paras. [0018]-[0044]; figs. 1-4) a partially absorbable mesh (paras. [0019]-[0025]; fig. 2) comprising:
at least one bioabsorbable fiber (biodegradable fibers 112, para. [0025]; fig. 2) and at least one biostable fiber (non-degradable fibers 110a and 110b);
wherein the bioabsorbable fiber and the biostable fiber are combined to form a partially absorbable mesh (fig. 2), the partially absorbable mesh having an X-direction and a perpendicular Y-direction (para. [0025]; annotated fig. 2);
wherein the partially absorbable mesh comprises pores (holes 108), and a plurality of the pores are characterized as having an average diameter (encompasses diameter of at least two holes 108 formed by 110a and 110b, which are considered to have an average diameter); and
wherein the average diameter of the pores changes by less than 25% after removal of the bioabsorbable fiber (fibers 112 extend under and over strands 110a and 110b forming base mesh 110, and degrade over time allowing the remaining mesh to become less restricted, such that the degradation of fibers 112 is considered to not substantially change the pore size of holes 108 (i.e. base mesh 110 would still have the same diameter of pores when fibers 112 degrade, see fig. 2 depicting fibers 112 randomly dispersed around mesh 110 such that the pore size of holes 108 would remain unchanged, further note fibers 112 do not surround every single hole 108 of the mesh), para. [0025]).
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Annotated Figure 2 of Sheu
Regarding claim 2, Sheu discloses the mesh of claim 1. Sheu further discloses wherein the bioabsorbable fiber is interwoven with the biostable fiber (fibers 112 woven through holes 108, para. [0025]; fig. 2).
Regarding claim 3, Sheu discloses the mesh of claim 1. Sheu further discloses wherein the bioabsorbable fiber reinforces a periphery of the pores (at least one fiber 112 considered to reinforce a periphery of holes 108 by being woven into them).
Regarding claim 4, Sheu discloses the mesh of claim 1. Sheu further discloses wherein the biostable fiber forms a biostable mesh (forms mesh 110), and the biostable mesh is a component of the partially absorbable mesh (considered to be a component of mesh including fibers 112, para. [0025]; fig. 2).
Regarding claim 7, Sheu discloses the mesh of claim 1. Sheu further discloses the mesh which is anisotropic (considered to be anisotropic due to presence of degradable fibers 112 extending in the x-direction, therefore providing mesh properties in the x-direction different from mesh properties in the y-direction, annotated fig. 2).
Regarding claim 8, Sheu discloses the mesh of claim 1. Sheu further discloses wherein the bioabsorbable fiber induces an increased degree of anisotropy in the partially absorbable mesh compared to an anisotropy of the biostable mesh component of the partially absorbable mesh (degradable fibers 112 considered to induce an increased degree of anisotropy due to having different properties relative to non-degradable fibers 110, because fibers 112 run in the x-direction, causing the x-direction to have different properties relative to the y-direction, fig. 2).
Regarding claim 11, Sheu discloses the mesh of claim 1. Sheu further discloses wherein the bioabsorbable fiber runs in the X-direction of the mesh (see annotated fig. 2 depicting fibers 112 extending in the X-direction of mesh 110).
Regarding claim 12, Sheu discloses the mesh of claim 1. Sheu further discloses wherein the bioabsorbable fiber runs in the X-direction of the mesh and does not run in the Y-direction of the mesh (see annotated fig. 2 depicting fibers 112 only extending in the X-direction of mesh 110).
Regarding claim 14, Sheu discloses the mesh of claim 1. Sheu further discloses wherein the biostable fiber is prepared from a polymer selected from the group consisting of polyethylene, polyethylene terephthalate, and polypropylene (mesh materials include polypropylene, para. [0032]; fig. 2).
Regarding claim 15, Sheu discloses the mesh of claim 1. Sheu further discloses wherein the bioabsorbable fiber has completely dissolved after immersion of the partially absorbable mesh after 12 weeks in a phosphate buffer at 7.4 pH and 37°C (note this limitation recites a method step within an apparatus claim and is therefore treated functionally, such that fibers 112 are considered to be capable of degrading as claimed; as evidenced by paras. [0029] and [0055] of US 2016/0058533 A1 to Schuldt-Hempe, a degradable implant may be incubated to obtain degradation at an appropriate pH and temperature; see also US 2008/0119848 A1 to Shalaby, describing an appropriate phosphate buffer in para. [0040]).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sheu in view of Schuldt-Hempe (US 6966918 B1).
Regarding claim 5, Sheu discloses the mesh of claim 1.
Sheu further discloses wherein the biostable mesh is a component of the partially absorbable mesh (fibers 110a and 110b considered to be components of mesh 110, para. [0025]; fig. 2).
However, Sheu fails to explicitly disclose wherein the biostable fiber forms a biostable mesh having a weight of 35-70 g/m2.
Schuldt-Hempe teaches (col. 2 lines 8-20; fig. 1), in the same field of endeavor, a mesh (fig. 1) comprising at least one bioabsorbable fiber (strengthening element which may be absorbable, col. 3 lines 7-15; fig. 1) and at least one biostable fiber (basic structure includes slowly absorbed material, col. 2 lines 45-54), wherein the mesh has a weight of 35-70 g/m2 (weight in the range of 50-150 g/m2, falling within the claimed range, col. 2 lines 8-20), for the purpose of providing a low-weight implant so there are less foreign-matter reactions after surgery, and the implant heals in well (col. 2 lines 8-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the weight of the implant of Sheu to be in the range of 35-70 g/m2, in order to provide the implant having low-weight, so there are less foreign-matter reactions after surgery, and the implant heals in well, based upon the suggestions and teachings of Schuldt-Hempe (col. 2 lines 8-20).
Regarding claim 13, Sheu discloses the mesh of claim 1.
However, Sheu fails to explicitly disclose the mesh comprising both colored and uncolored bioabsorbable fiber, where the colored bioabsorbable fiber runs in the X-direction of the mesh and does not run in the Y-direction of the mesh.
Schuldt-Hempe teaches (col. 3 lines 7-25; fig. 1), in the same field of endeavor, a reinforced implant including non-absorbable fibers (basic structure comprises non-absorbable material, col. 2 lines 46-54) and absorbable fibers (strengthening elements are completely absorbable, col. 3 lines 9-11), wherein the implant comprises both colored and uncolored bioabsorbable fibers ( strengthening elements have several components in which a mono-filament part or multi-filament part may be colored, such that at least part of the strengthening elements are considered to be colored and encompass other uncolored filaments, col. 3 lines 17-25), for the purpose of making it easier for the surgeon during surgery to assess any distortion of the implant (col. 3 lines 17-25).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the biodegradable fibers of Sheu to include colored and uncolored fibers, in order to allow the surgeon to assess any distortion of the implant during surgery.
Sheu (as modified) further teaches where the colored bioabsorbable fiber runs in the X-direction of the mesh and does not run in the Y-direction of the mesh (combination considered to further teach colored biodegradable fiber 112 running in the x-direction of the mesh as depicted in fig. 2 of Sheu).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Sheu in view of Schuldt-Hempe (US 2016/0058533 A1) (hereinafter ‘Schuldt-Hempe2’).
Regarding claim 6, Sheu discloses the mesh of claim 1.
Sheu further discloses wherein the bioabsorbable fiber is interwoven into a biostable mesh formed from the biostable fiber (fibers 112 woven into holes 108 of mesh 110, which is formed of non-degradable fibers 110a and 110b, para. [0025]; fig. 2).
However, Sheu fails to disclose where the bioabsorbable fiber is interwoven specifically via a pillar stitch.
Schuldt-Hempe2 teaches (paras. [0017] and [0042]), in the same field of endeavor, a partially absorbable mesh comprising a bioabsorbable fiber interwoven into a mesh via a pillar stitch (absorbable monofilaments knitted into chains 10 via a pillar stitch, paras. [0045] and [0047]), for the purpose of providing a chain strong enough to resist suture pull-out due to rupture of the material of the mesh pore (paras. [0017] and [0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biodegradable fibers of Sheu to be interwoven via a pillar stitch, in order to provide a mesh that is strong enough to resist suture pull-out due to rupture of the material of the mesh pore, based on the teachings of Schuldt-Hempe2 (paras. [0017] and [0042]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sheu in view of Peniston (US 2013/0267137 A1).
Regarding claim 9, Sheu discloses the mesh of claim 1.
Sheu further discloses having a greater elongation in the Y-direction than in the X-direction (elongation considered to be greater in the y-direction relative to the x-direction due to mesh 110 extending in y-direction, para. [0025]; fig. 2).
However, Sheu fails to disclose having a greater elongation in the y-direction than in the x-direction when measured at 16 N/cm.
Peniston teaches (para. [0009]; figs. 2A-D), in the same field of endeavor, a mesh (polymeric mesh, para. [0014]) undergoing testing when measured at 16 N/cm (para. [0009]), for the purpose of providing testing of the mesh product before implantation and at various times after being exposed to conditions simulating the in vivo environment (para. [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mesh of Sheu to have a greater elongation in the y-direction than in the x-direction when measured at 16 N/cm, in order to provide standard test conditions of the mesh before implantation and at various times after being exposed to conditions simulating the in vivo environment, to simulate how the mesh would behave in vivo, based upon the suggestions and teachings of Peniston (para. [0009]).
Regarding claim 10, Sheu discloses the mesh of claim 1.
Sheu further discloses having an elongation in the X-direction (via mesh 110 extending in x-direction, fig. 2).
However, Sheu fails to disclose having an elongation in the X-direction when measured at 16 N/cm, the elongation increasing by at least 50% after removal of the bioabsorbable fiber.
Peniston teaches (para. [0009]; figs. 2A-D), in the same field of endeavor, a mesh (polymeric mesh, para. [0014]) undergoing testing when measured at 16 N/cm (para. [0009]), for the purpose of providing testing of the mesh product before implantation and at various times after being exposed to conditions simulating the in vivo environment (para. [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mesh of Sheu to have an elongation in the x-direction when measured at 16 N/cm, in order to provide standard test conditions of the mesh before implantation and at various times after being exposed to conditions simulating the in vivo environment, to simulate how the mesh would behave in vivo, based upon the suggestions and teachings of Peniston (para. [0009]).
Sheu (as modified) still fails to teach the elongation increasing by at least 50% after removal of the bioabsorbable fiber.
Note Sheu discloses the remaining mesh strands becoming less restricted and more elastic upon degradation of the degradable fibers (para. [0025]), but is silent to the specific increase in elongation of the mesh.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the mesh of Sheu (as modified) to have an elongation increasing by at least 50% after removal of the bioabsorbable fiber, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the mesh of Sheu (as modified) would not operate differently with the claimed elongation and since the mesh includes degradable strands that cause the mesh to become less restricted as the strands degrade, the mesh would function appropriately having the claimed elongation after degradation of the bioabsorbable fiber. Further, applicant places no criticality on the range claimed, indicating examples of the elongation, or the elongation optionally within the claimed range (paras. [0017] and [0075] of the instant spec.).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Sheu in view of Stopek (US 2013/0184722 A1).
Regarding claims 16-17, Sheu discloses the mesh of claim 1.
However, Sheu fails to explicitly disclose the mesh which is sterile; and the mesh which is packaged in a foil pouch.
Stopek teaches (para. [0080]; fig. 11), in the same field of endeavor, an implantable mesh (fig. 11), wherein the mesh is sterile (medical device may be sterilized, para. [0080]) and packaged in a foil pouch (may be packaged in a foil pouch, para. [0080]), for the purpose of providing appropriate sterilization to the medical device for use (para. [0080]).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mesh of Sheu to be sterile and packaged in a foil pouch, in order to properly sterilize the mesh and provide suitable sterilization processes to effectively carry out surgical procedures, based on the teachings of Stopek (para. [0080]).
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.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,197,749 B2 to Taylor. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-13 would anticipate current claims 1-17.
19/197,122 claims
Corresponding U.S. 11,197,749 B2 claims
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Claims 1-13 and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-11, 13 and 15-16 of U.S. Patent No. 12,290,430 B2 to Taylor. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3-11, 13 and 15-16 would anticipate current claims 1-13 and 15-17.
19/197,122 claims
Corresponding U.S. 12,290,430 B2 claims
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Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 12,290,430 B2 to Taylor in view of Sheu.
Regarding claim 14, Taylor claims the mesh of claim 14 (claim 12), but fails to specifically claim wherein the biostable fiber is prepared from a polymer selected from the group consisting of polyethylene, polyethylene terephthalate, and polypropylene.
Sheu teaches, in the same field of endeavor, a biostable fiber prepared from a polymer selected from the group consisting of polyethylene, polyethylene terephthalate, and polypropylene (mesh materials include polypropylene, para. [0032]; fig. 2), for the purpose of providing a suitable non-degradable material for the mesh (para. [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein the biostable fiber is prepared from a polymer selected from the group consisting of polyethylene, polyethylene terephthalate, and polypropylene, in order to form the biostable fiber from a suitable polymer material for the mesh, based on the teachings of Sheu (para. [0032]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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