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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
No IDS was provided in reference to this application however, international applications and additional references were provided. These references have not been considered.
Drawings
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:
-Fig. 3B element 27c
-Fig. 5B element 60b
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Specification
The disclosure is objected to because of the following informalities:
-Pg. 5, lines 21 should possibly read –FIGS. 4C AND 4D—
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 2, 7, 9, 10, 11, 12, 14, 16, 17, 19, 20 are objected to because of the following informalities:
-Claim 1 recites “the support zones” in line 14. Examiner recommends amending to –the at least one support zone—
- Claim 1 recites “the support zone” in line 16. Examiner recommends amending to –the at least one support zone—
-Claim 2 recites “the support member” in line 19. Examiner recommends amending to –the elongated support member—
-Claim 7 recites “the support member” in line 4. Examiner recommends amending to –the elongated support member—
-Claim 9 recites “the support member” in line 11. Examiner recommends amending to –the elongated support member—
-Claim 10 recites “the support member” in line 15. Examiner recommends amending to –the elongated support member—
-Claim 11 recites “wherein the at least” in line 26. Examiner recommends amending to –and wherein the at least—
-Claim 11 recites “extending away a support” in line 21. Examiner recommends amending to –extending away from a support—
-Claim 12 recites “the support member” in line 2. Examiner recommends amending to –the elongated support member—
-Claim 12 recites “the biofunctional member” in line 1. Examiner recommends amending to –the at least one biofunctional member—
-Claim 12 recites “the bioactivity” in line 4. Examiner recommends amending to –the rate of bioactivity—
-Claim 12 recites “wherein the bioactivity” in lines 3-4. Examiner recommends amending to –and wherein the bioactivity—
-Claim 14 recites “the biofunctional member” in line 12. Examiner recommends amending to –the at least one biofunctional member—
-Claim 16 recites “the biofunctional member” in line 15. Examiner recommends amending to –the at least one biofunctional member—
-Claim 17 recites “the biofunctional member” in line 18. Examiner recommends amending to –the at least one biofunctional member—
-Claim 19 recites “wherein different” in line 26. Examiner recommends amending to –and wherein different—
-Claim 20 recites “the bioactive zones” in line 1. Examiner recommends amending to –the overlapping bioactive zones—
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Claim 9 recites “a retaining member” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to be retained within and support the tissue bridge. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9 and 11-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no mention of a “retaining member” or a “biofunctional member” within the description. The images and figures provided are not sufficient because they also do not indicate what these members are. From the conventional definition, a retaining member could be anything from a fastener, interlocking structure or a structure that holds in place the superficial elements of the tissue bridge. For the biofunctional member, it’s also not described as to whether this is a portion of the implantable article, kit, zones. Biofunctional could also include various definitions and variation in structural entities and therefore, would require description as to what is required by the claim.
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 7, 9, 12, 13, 18, 19, 20 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 7 recites “overlapping accelerated ingrowth zones” in line 5. It is unclear whether this is the same or different from the overlapping accelerated ingrowth zones originally referenced in claim 1, line 13. Further clarification should be provided.
-Claim 12 recites “the implantable article” in line 6. There is insufficient antecedent basis for this limitation in the claim.
-Claim 13 recites “the implantable article” in line 10. There is insufficient antecedent basis for this limitation in the claim.
-Claim 18 recites “overlapping bioactive zones” in line 22. It is unclear whether this is the same or different from the at least one bioactive zone originally referenced in claim 11, line 24. Further clarification should be provided.
-Claim 19 recites “overlapping bioactive zones” in line 25. It is unclear whether this is the same or different from the at least one bioactive zone originally referenced in claim 11, line 24. Further clarification should be provided.
-Claim 20 recites “the bioactive zones” in line 1. It is unclear whether the zones referenced are referring to the at least one bioactive zone originally referenced in claim 11, line 24 or a separate overlapping bioactive zones referenced in claim 19, line 25. Further clarification should be provided
Claim limitation “retaining member” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The retaining member is not mentioned within the description or provided figures. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 (i.e., changing from AIA to pre-AIA ) 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) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arcand (U.S. 20140088343).
Regarding Claim 1, Arcand teaches an implantable article to support a tissue or organ [0011]—describes an implant with support portions for tissue or anatomical structures, the implantable article comprising:
an elongated support member [0014]—reference to the implant being generally elongate and [Figs. 1-2 elements 12 and 12a]—specifically referenced in [0028] composed of one or more interconnected and at least partially absorbable fibers [0028]—describes woven and knitted filament members and [0037]—which discloses the implant being absorbed upon implantation, the elongated support member comprising:
at least one support zone configured to support the tissue or organ [Fig. 14, element 12 (mesh/implant)];
at least two anchor zones [Fig. 14, element 19 (anchoring portions)], each of the at least two anchor zones being connected to and extending from opposed ends of the at least one support zone [0028];
at least two accelerated ingrowth zones connected to and positioned between the at least two anchor zones and the support zones [Fig. 14, element 13 (film/localized coatings)]; and wherein the at least two accelerated ingrowth zones are configured to accelerate tissue ingrowth faster than the at least two anchor zones and the support zone to provide faster anchoring of the implantable article during formation of a tissue bridge [0046] and [0048].
Regarding Claim 2, Arcand teaches wherein the support member is at least partially enclosed in a sleeve that is removable after implantation of the implantable article [0045].
Regarding Claim 3, Arcand teaches further comprising a tissue growth accelerant disposed on at least a portion of the at least two accelerated ingrowth zones [Abstract], [0046] and [0051].
Regarding Claim 4, Arcand teaches wherein the tissue growth accelerant comprises hyaluronic acid [Table 2; “Hyaluronic Acid”].
Regarding Claim 5, Arcand teaches wherein the at least two accelerated ingrowth zones have a density greater than a density of the at least two anchor zones and the at least one support zone [0043], [0044], [0046].
Regarding Claim 6, Arcand teaches wherein the at least two accelerated ingrowth zones have a porosity greater than a porosity of the at least two anchor zones and the at least one support zone [0031].
Regarding Claim 7, Arcand teaches wherein the support member has at least one z-configuration along its length [Fig. 17, element 28]—depicting a z shape of the support member, with overlapping accelerated ingrowth zones configured to increase a rate of tissue ingrowth [0045]—describes encapsulation of the implant in a film which would include overlapping sections as this sections states that the implant bunches up and curls.
Regarding Claim 8, Arcand teaches wherein the at least two accelerated ingrowth zones comprise one or more fibers having a degradation rate faster than a degradation rate of the at least two anchor zones and the at least one support zone. [0037]—describes the film degrading upon implantation and the mesh components freeing from one another and [0048].
Regarding Claim 9, Arcand teaches further comprising a retaining member connected to and extending along at least a portion of a length of the support member, wherein the retaining member is configured to be retained within and supports the tissue bridge [0040]—where retaining member is interpreted as properties of the film such as hydrophilicity and stiffness, also [0045]—describes the sheath or sleeve as holding the sleeve which could also be interpreted as a retaining member.
Regarding Claim 10, Arcand teaches further comprising at least one delivery tool connectable to a portion of the sleeve to deliver the support member to a therapeutic location [0055].
Regarding Claim 11, Arcand teaches an implantable article kit to support a tissue or organ, the implantable article kit comprising:
an elongated support member composed of one or more interconnected fibers [0014]—reference to the implant being generally elongate and [Figs. 1-2 elements 12 and 12a]—specifically referenced in [0028]—describes woven and knitted filament members, the elongated support member having at least two anchor regions connected to and extending away a support region [Fig. 14, element 19 (anchoring portions)] and [0028];
at least one biofunctional member comprising one or more interconnected filaments being positionable or connected to at least a portion of the elongated support member and defining at least one bioactive zone on the elongated support member [Fig. 14, element 13 (film/localized coatings)] and [0048]—which describes biodegradability and biocompatibility of films and polymers;
wherein the at least one biofunctional member is configured to at least increase a rate of bioactivity in the at least one bioactive zone [0048]—reference to varying degradation rates.
Regarding Claim 12, Arcand teaches wherein the biofunctional member comprises at least one accelerated ingrowth zone disposed on the support member between the at least two anchor regions and the support region [Fig. 14, element 13 (film/localized coatings)], wherein the bioactivity of at least one accelerated ingrowth zone is to accelerate tissue ingrowth faster than an ingrowth at the least two anchor regions and the support region to provide faster anchoring of the implantable article during formation of a tissue bridge [0046] and [0048].
Regarding Claim 13, Arcand teaches wherein the elongated support member and the at least one biofunctional member are at least partially enclosed in a sleeve that is removable after implantation of the implantable article [0045].
Regarding Claim 14, Arcand teaches further comprising a tissue growth accelerant disposed on at least a portion of the biofunctional member [Abstract], [0046] and [0051].
Regarding Claim 15, Arcand teaches wherein the tissue growth accelerant comprises hyaluronic acid, collagen, growth factors, or hormones [Table 2; “Hyaluronic Acid”].
Regarding Claim 16, Arcand teaches wherein the biofunctional member comprises at least one patch that can be connected to a portion of the elongated support member [Fig. 10, element 13]—depicting a patch-like element [0042].
Regarding Claim 17, Arcand teaches wherein the biofunctional member comprises at least one sheath slidable over a portion of the elongated support member [0045] to a desired location of increased bioactivity [0048]—reference to varying degradation rates.
Regarding Claim 18, Arcand teaches wherein the elongated support member has at least one z-configuration portion with overlapping bioactive zones configured to increase a rate of bioactivity [Fig. 17, element 28]—depicting a z shape of the support member and [0045]—describes encapsulation of the implant in a film which would include overlapping sections as this sections states that the implant bunches up and curls.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arcand (U.S. 20140088343) in view of Ragheb (U.S. 5873904).
Regarding Claim 19, Arcand teaches wherein the elongated support member has at least one z-configuration portion with overlapping bioactive zones Fig. 17, element 28]—depicting a z shape of the support member and [0045].
Arcand is silent on with each bioactive zone having a different bioactivity, wherein different bioactive conditions are combined in a particular location. Ragheb teaches with each bioactive zone having a different bioactivity [Col 19, lines 11-21], wherein different bioactive conditions are combined in a particular location and [Fig. 5, element 18 (at least one layer of a bioactive material)]—particular location is interpreted to be between layers 20 and 16.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to promote and accelerate tissue ingrowth as taught by Ragheb through the use of a bioactive agent as suggested by Arcand, as Arcand discusses the use of mechanical properties of the mesh for early in-growth period during incorporating into the surrounding tissues [0029] with Ragheb because Ragheb teaches controlled release of bioactive materials when the implant is positioned in the patient [Col 20, lines 45-53].
Regarding Claim 20, Arcand further teaches wherein the bioactive zones are configured to exhibit a bioactivity selected from the group consisting essentially of accelerated tissue ingrowth, accelerated fiber degradation, reduced fiber degradation, and rate of an eluding material [0046]—reference to the film promoting tissue in-growth.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Williams (U.S. 20190269822)—includes woven implants that use bioactive agents such as hyaluronic acid.
Knipfer (U.S. 9492259)—discloses implant systems that can be folded and bent in z-configurations
Frigstad (WO 2012116182)—describes mesh/implant systems for use in treating pelvic conditions with therapeutic agents
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE NICOLE KOHUTKA whose telephone number is (571)272-5583. The examiner can normally be reached Monday-Friday 7:30am-5:00pm EST.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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