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 1-16, 19 and 20 in the reply filed on 12/2/2025 is acknowledged. Claims 17 and 18 are withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “30” has been used to designate both stitches in Figs. 1-2 and anti-adhesive layer in Figs. 10-12.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 141 in Fig. 14.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: attachment sites 149 in [0101].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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
Claim 8 is objected to because of the following informalities: “comprise one or more of: comprise chitosan” in line 2 should instead recite - - comprise one or more of: chitosan - - as the term “comprise” appears twice in the sentence. 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 15 and 16 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 15 recites “the second layer comprises one sheet of the material having anti-adhesion properties.” Claim 1, from which claim 15 is dependent upon, recites “a second layer comprising one or more sheets of material having anti-adhesion properties”. It is unclear in claim 15 if the claim is requiring 1) the second layer to comprise an additional sheet of the material having anti-adhesion properties; or 2) the one or more sheets of material in claim 1 comprises just one sheet of material. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 15 as interpretation 2) - - wherein the one or more sheets of material having anti-adhesion properties comprises one sheet of the material having anti-adhesion properties.
Similar to claim 15, claim 16 recites “the second layer comprises two or more sheets of the material having anti-adhesion properties.” Claim 1, from which claim 16 is dependent upon, recites “a second layer comprising one or more sheets of material having anti-adhesion properties”. It is unclear in claim 16 if the claim is requiring 1) the second layer to comprise two or more additional sheets of the material having anti-adhesion properties; or 2) the one or more sheets of material in claim 1 comprises two or more sheets of the material. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 16 as interpretation 2) - - wherein the one or more sheets of material having anti-adhesion properties comprises two or more sheets of the material having anti-adhesion properties.
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.
Although the claims at issue in the following obviousness-type double patenting rejections are not identical, they are not patentably distinct from each other because the elements of the claims of the instant application are to be found in the claims of the patents. Thus, the difference between the claims of the instant application and the claims of the patents lies in the fact that the patent claims include many more elements and is thus much more specific. Thus, the inventions of the claims of the patent are in effect a “species” of the “generic” invention of the claims of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the claims are anticipated by the claims of the patents, they are not patentably distinct from the claims of the patents.
The following chart illustrates where the corresponding limitations of the instant application claims may be found in the patent claims.
Claims 1-6, 9-16, 19 and 20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9820843.
Instant application claims
Corresponding patent claims
1
1, 22, 30
2
1, 22, 30
3
1, 22, 30
4
1, 22, 30 (“mesh”)
5
1, 22, 30
6
1, 22, 30 (ECM biodegrades)
9
1, 22, 30
10
3, 11, 12, 16, 26, 27
11
1, 22, 30
12
4, 8-10, 25
13
5, 6, 23
14
7, 24
15
1, 13, 30
16
14, 22
19-20
The hernia graft of claims 22 and 30 in the patent claims would have been obviously formed by the method as recited in instant claims 19-20 as the structure of the patent claims are encompassed in the method of claims 19-20 (i.e. the stitching in patent claims 22 and 30 would have been obviously formed by the method step of “embroidering” as recited in instant application claims 19-20.
Claims 1-6, 9-16, 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10561485.
Instant application claims
Corresponding patent claims
1
1, 20, 28
2
22, 28
3
20, 28
4
1, 20, 28 (“mesh”)
5
1, 20, 28
6
1, 20, 28 (ECM biodegrades)
9
1, 20, 28
10
10, 11, 15, 20, 24, 25
11
1, 20, 28
12
3, 7-9, 23
13
4, 5, 21
14
6, 22
15
1, 28
16
20
19-20
The hernia graft of claims 1, 2, 10, 11, 14, 15, 20, 24, 25, 27 in the patent claims would have been obviously formed by the method as recited in instant claims 19-20 as the structure of the patent claims are encompassed in the method of claims 19-20 (i.e. the stitching in the patent claims would have been obviously formed by the method step of “embroidering” as recited in instant application claims 19-20. Furthermore, claim 1 of the patent explicitly recites a pattern “embroidered” into the mesh.
Claims 1-6, 9-16, 19 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12070380.
Instant application claims
Corresponding patent claims
1
1, 18, 19
2
19
3
19
4
1, 18, 19
5
2, 13
6
2, 13 (ECM biodegrades)
9
1, 18
10
10, 11, 17, 18, 19
11
1, 18, 19
12
3, 7-9
13
4, 5
14
6
15
1, 18
16
13, 19
19-20
The hernia graft of claims 1, 10, 11, 14, 15, 18, 19 in the patent claims would have been obviously formed by the method as recited in instant claims 19-20 as the structure of the patent claims are encompassed in the method of claims 19-20 (i.e. the stitching in the patent claims would have been obviously formed by the method step of “embroidering” as recited in instant application claims 19-20. Furthermore, claims 1 and 18 of the patent explicitly recites a pattern “embroidered” into the mesh.
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9820843 in view of Lecuivre (US 9554887).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10561485 in view of Lecuivre (US 9554887).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12070380 in view of Lecuivre (US 9554887).
Claim 7 of the instant application recites the additional feature of the one or more sheets of material having anti-adhesion properties comprises a non-resorbable material absent from the patent claims.
However, Lecuivre teaches various suitable materials are known in the art for forming an anti-adhesion material. The materials can include non-resorbable materials (col. 6, ll. 17-20). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the claims of each of the three patents listed above to have the one or more sheets of material having anti-adhesion properties comprises a non-resorbable material as taught Lecuivre as such material will protect the first layer (mesh) before and after implantation, over the whole period of implantation of the prosthesis (col. 7, ll. 4-7).
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9820843 in view of Dong.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10561485 in view of Dong.
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12070380 in view of Dong.
Claim 8 of the instant application recites the additional feature of the one or more sheets of material having anti-adhesion properties comprise one or more of: comprise chitosan, collagen, hyaluronic acid, icodextrin, fibrin, poly(L-lactide-co-D,L-lactide)/polylactic acid, polydioxanone, polytetrafluoroethylene, oxidized regenerated cellulose (ORC) and a hydrogel absent from the patent claims.
However, Dong teaches various suitable materials for a sheet of material (11) having anti-adhesion properties (adhesion resistant material), comprising polytetrafluoroethylene (col. 5, ll. 3-13). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the claims of each of the three patents listed above to have the one or more sheets of material having anti-adhesion properties to comprise polytetrafluoroethylene as taught by Dong to provide a known and predictable material in the art that will serve to prevent any adhesion of the internal body viscera to the hernia repair graft (col. 5, ll. 3-13).
Allowable Subject Matter
Claims 1-16, 19 and 20 would be allowable if the double patenting rejections above are obviated and if the claims rejected under 35 U.S.C. 112 as amended as interpreted by the Examiner.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior arts of record are Patel et al (US 2009/0306688) and Dong (US 6383201).
Patel et al discloses a hernia repair graft (10), a method for repairing a hernia in a subject and a method of forming a hernia repair graft, wherein the hernia repair graft comprises: a multiple layered structure, comprising: a first layer (34), a first stitching (20) embroidered into the first layer in a first pattern ([0033], [0041], Figs. 1 and 9); a second layer (36) comprising one or more sheets of material having anti-adhesive properties ([0012], [0026], [0034]; e.g. ECM material); and a second stitching (16) embroidered into the first and second layers in a second pattern (Fig. 5; [0037]) wherein the second stitching attaches the first layer to the second layer at a plurality of discrete attachment sites (each knot is a discrete stitch island).
In regards to independent claims 1, 17 and 19, Patel et al does not disclose or fairly suggest either singly or combination the claimed hernia repair graft, method for repairing a hernia in a subject or method of forming a hernia repair graft comprising, inter alia, adjacent regions of the first and second layers between the plurality of discrete attachment sites may slide relative to each other. Instead, Patel et al discloses the first pattern (20) extends across both the first (34) and second layers (36) to prevent delamination or separation of the layers ([0041]). The first layer (34) of Patel et al is laminated in between the second layer (36) and an additional layer (35) of biomaterial ([0041]). Therefore, since adjacent regions of the two layers between the discrete attachment sites are stitched to one another, sliding cannot occur and the adjacent regions are instead attached or laminated to each other in these adjacent regions. It would not have been obvious to one of ordinary skill in the art to modify Patel et al to allow for adjacent regions of the first and second layers between the plurality of discrete attachment sites to slide as this would fundamentally alter the purpose of the first pattern (20) in Patel et al (i.e. sliding of adjacent regions between the two layers would separate the two layers). Patel et al explicitly discloses delamination and separation of the layers can result in pockets for the formation of a seroma, which can inhibit the remodeling process of the hernia ([0005]). In contrast, Applicant’s first pattern (133) is embroidered only into the first layer (Fig. 14A), allowing for sliding at the adjacent regions ([0101]). Applicant discloses this configuration advantageously allows for the second layer having anti-adhesion properties (adhesion barrier layer) to be more freely movable or flexible relative to the first layer (substrate layer) ([0077]) as the graft material is bent or pulled ([0019]). Therefore, the disclosure of Patel et al is directly in contrast to Applicant’s invention.
Dong discloses hernia repair graft, a method for repairing a hernia in a subject , and a method of forming a hernia repair graft, the hernia repair graft comprising: a multiple layered structure (10) (Fig. 5), comprising: a first layer (13); a first stitching (46) embroidered into the first layer in a first pattern (Fig. 5; wherein stitching 46 is akin to stitching 36 and 37 in Figs. 3C-3D; col. 4, ll. 26-36); a second layer (11) comprising one or more sheets of material having anti-adhesion properties (col. 5, ll. 3-13; adhesion resistant layer); and a second stitching (14) embroidered into the first and second layers in a second pattern, wherein the second stitching attaches the first layer to the second layer at a plurality of discrete attachment sites (each opening the in the graft the thread extends through is considered a discrete attachment site).
In regards to independent claims 1, 17 and 19, Dong does not disclose or fairly suggest either singly or combination the claimed hernia repair graft, method for repairing a hernia in a subject or method of forming a hernia repair graft comprising, inter alia, adjacent regions of the first and second layers between the plurality of discrete attachment sites may slide relative to each other. The graft of Dong contains other regions of the graft that may move/slide relative to one another as seen in Fig. 4, wherein the left and right unsecured sides of first layer (13) and second layer (11) may move relative to one another since the first stitching (36, 37, 46) is only in the first layer and does not bind the first and second layers together. However, these regions are not adjacent regions of the first and second layers between the plurality of discrete attachment sites (14). Instead, the adjacent regions of the first and second layers between the plurality of discrete attachment sites are not movable relative to one another as the second stitching (14) forms a seam of closely positioned stitches as seen in Fig. 5 (col. 2, ll. 58-63). In other words, a continuous thread (14) is interwoven to form a line (seam) and the regions between each stitch of the stitching pattern is fixed (Fig. 5).
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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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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/KATHERINE M SHI/Primary Examiner, Art Unit 3771