DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1-8 are objected to because of the following informalities:
In claim 1 (and thereby dependent claims 2-8), there is a typographical error in line 1 at “a mini mum density” wherein a minor amendment such as “a minimum density” will moot this objection.
In claim 1 (and thereby dependent claims 2-8), there is a typographical error in line 3 at “a slow-absorbing, biodegradable multifilament yam component” wherein a minor amendment such as “a slow-absorbing, biodegradable multifilament yarn component” will moot this objection.
In claim 2 (and thereby dependent claim 4), there is a typographical error in line 3 at “al l guide bars” wherein a minor amendment such as “[[al l]] all guide bars” will moot this objection.
In claim 2 (and thereby dependent claim 4), there is a typographical error in line 4 at “and l -out” wherein a minor amendment such as “and [[l -out]] 1-out” will moot this objection.
In claim 3 (and thereby dependent claim 5), there is a typographical error in line 4 at “and l -out” wherein a minor amendment such as “and [[l -out]] 1-out” will moot this objection.
In claim 4, there is a typographical error in line 2 at “about l 30 g/m2” wherein a minor amendment such as “about [[l 30]] 130 g/m2” will moot this objection.
In claim 4, there is a typographical error in line 3 at “less than I 0 percent” wherein a minor amendment such as “less than [[I 0]] 10 percent” will moot this objection.
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 2-5, 12-13 and 17-19 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 2 (and thereby dependent claim 4) recites the limitation "guide bars" in line 3. There is insufficient antecedent basis for this limitation in the claim. Use of the phrase “all guide bars” infers that a plurality of guide bars was previously introduced in the claim, and now an additional limitation is being claimed for “all” of the previously introduced guide bars. However, more than one/a plurality of “guide bars” was not previously introduced in the claim. Appropriate correction is required.
Claim 3 (and thereby dependent claim 5) recites the limitation "guide bars" in line 3. There is insufficient antecedent basis for this limitation in the claim. Use of the phrase “all guide bars” infers that a plurality of guide bars was previously introduced in the claim, and now an additional limitation is being claimed for “all” of the previously introduced guide bars. However, more than one/a plurality of “guide bars” was not previously introduced in the claim. Appropriate correction is required.
Claim 12 recites the limitations "the core and sheath" in line 2. There is insufficient antecedent basis for each of these limitations in the claim. Appropriate correction is required.
Claim 13 recites the limitations "the sheath and core" in line 3. There is insufficient antecedent basis for each of these limitations in the claim. Appropriate correction is required.
Claim 17 (and thereby dependent claims 18-19) recites the limitations "the uncoated suture weight" in line 2. There is insufficient antecedent basis for each of these limitations in the claim. Appropriate correction is required.
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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 8,709,023 and claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 8,709,023 in view of Kurtz (US 3,642,003). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 8,709,023
1
1-17
2
2-8
3
9-13
4
4-6
5
10
6
14-16
7
15
8
16
9
1-17
Regarding claim 9, U.S. Patent No. 8,709,023, as applied above, claims a surgical mesh comprising all the limitations of the claim except for the slow-absorbing, biodegradable component comprising degummed silk.
However, Kurtz teaches a similar surgical mesh comprising an absorbable surgical mesh component comprising degummed silk (col. 4, line 62-col. 5, line 23) in order to beneficially provide an absorbable mesh that can incorporate anti-germicidal properties to protect against infection during surgery (col. 4, line 62-col. 5, line 23). Accordingly, Kurtz teaches that it is known that degummed silk and a segmented copolymer comprising at least 80 percent of l-lactide-based sequences are elements that are functional equivalents for providing an absorbable layer component within implantable surgical meshes. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the degummed silk layer taught by Kurtz for the segmented copolymer layer comprising at least 80 percent of l-lactide-based sequences of U.S. Patent No. 8,709,023 because both elements were known equivalents for providing an absorbable layer component within the implantable surgical mesh art. The substitution would have resulted in the predictable results of providing an absorbable layer component to the surgical mesh of U.S. Patent No. 8,709,023.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,085,826 in view of Goldmann et al. (US 2003/0040809). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below.
Present Invention
U.S. Pat. No. 10,085,826
1
1-6
U.S. Patent No. 10,085,826, as applied above, claims a knitted surgical implant/mesh comprising all the limitations of the claim except for the yarn components comprising multifilaments. However, Goldmann teaches a similar knitted surgical implant/mesh comprising either monofilaments or multifilaments ([0029]). Accordingly, Goldmann teaches that it is known that monofilament yarn components and multifilament yarn components are elements that are functional equivalents for providing implantable surgical textiles. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the multifilaments taught by Goldmann for the monofilaments of U.S. Patent No. 10,085,826 because both elements were known equivalents for providing implantable surgical textiles within the surgical implant art. The substitution would have resulted in the predictable results of providing an implantable surgical textile to the device of U.S. Patent No. 10,085,826.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,098,722. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 10,098,722
1
1-17
2
2-8
3
9-13
4
3
5
10
6
14-16
7
15
8
16
Claim 11-12 and 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,161,541 in view of Goldmann et al. (US 2003/0040809) and claims 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,161,541 in view of Goldmann et al. (US 2003/0040809) and D’Aversa (US 2001/0018599). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. Additionally, U.S. Patent No. 12,161,541 discloses that the specific materials claimed and/or disclosed in the patent expressly provide the functionality claimed in the present invention (see col. 3, lines 7-37).
Present Invention
U.S. Pat. No. 12,161,541
11
1-10
12
2
14
1-10
15
1-10
16
1-10
17
1-10
18
1-10
19
1-10
U.S. Patent No. 12,161,541, as applied above, claims a similar composite surgical suture comprising all the limitations of the claim except for the respective yarn components comprising multifilaments. However, Goldmann teaches a similar composite surgical implant comprising either monofilaments or multifilaments ([0029]). Accordingly, Goldmann teaches that it is known that monofilament yarn components and multifilament yarn components are elements that are functional equivalents for providing implantable surgical devices. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the multifilaments taught by Goldmann for the monofilaments of U.S. Patent No. 12,161,541 because both elements were known equivalents for providing implantable surgical devices within the surgical implant art. The substitution would have resulted in the predictable results of providing an implantable surgical material to the device of U.S. Patent No. 12,161,541.
Regarding claims 17-18, U.S. Patent No. 12,161,541 in view of Goldmann, as applied above, teaches a composite surgical suture comprising all the limitations of the claim except for an absorbable polymer coating comprising a polyaxial copolyester made of molecular chains comprising about 95/5 ε-caprolactone/glycolide derived sequences. However, D’Aversa teaches a similar composite surgical suture comprising an absorbable polymer coating comprising a polyaxial copolyester made of molecular chains comprising about 95/5 ε-caprolactone/glycolide derived sequences ([0012]-[0014]; [0024]; [0028]; [0044]; ε-caprolactone/glycolide coatings with a molar percent of ε-caprolactone preferably in the range of 95-85 expressly disclosed) in order to beneficially produce a multifilament suture with an improved knot tensile strength ([0004]-[0005]; [0009]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of U.S. Patent No. 12,161,541 in view of Goldmann to have an absorbable polymer coating comprising a polyaxial copolyester made of molecular chains comprising about 95/5 E- caprolactone-/glycolide-derived sequences in order to beneficially produce a multifilament suture with an improved knot tensile strength, as taught by D’Aversa.
Regarding claim 19, U.S. Patent No. 12,161,541 in view of Goldmann and D’Aversa, as applied above, teaches a composite surgical suture comprising all the limitations of the claim except for the absorbable polymer coating contains at least one bioactive agent selected from antineoplastic agents, anti- inflammatory agents, antimicrobial agents, anesthetic agents and cell growth-promoting agents. However, Goldmann teaches a similar composite surgical implant incorporating at least one bioactive agent selected from antineoplastic agents, anti- inflammatory agents, antimicrobial agents, anesthetic agents and cell growth-promoting agents ([0049]; incorporating one or more agents including antibiotics, antimicrobiotics, growth factors, and the like is expressly disclosed) in order to beneficially prevent infection and/or enhance regeneration and healing ([0049]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of U.S. Patent No. 12,161,541 in view of Goldmann and D’Aversa to incorporate at least one bioactive agent selected from antineoplastic agents, anti- inflammatory agents, antimicrobial agents, anesthetic agents and cell growth-promoting agents in order to beneficially prevent infection and/or enhance regeneration and healing, as taught by Goldmann.
Allowable Subject Matter
Claim 10 is allowed.
The following is an examiner’s statement of reasons for allowance: the art of record does not teach or render obvious a warp-knitted composite mesh as claimed that includes, in combination with the claim(s) as a whole, a slow-absorbing yarn component comprising poly-3-hydroxyalkanoate made of molecular chains of at least 50 percent of 3- hydroxybutyric acid-derived sequences. It is noted that claims 1-9 and 11-19 are only subject to double patenting rejections that may be resolved with the filing of a terminal disclaimer.
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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771