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 .
This action is in response to the Election/Restriction response filed on 01/26/2026. Claims 1-25, 28, and 30 are pending. Claims 1, 16, and 30 are pending. Claims 16-25 and 28 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-15 and 30) in the reply filed on 01/26/2026 is acknowledged.
Claims 16-25 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/26/2026.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because many figures include dark areas (solid black shading areas are not permitted, see MPEP 1.84). Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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, none of the claim limitations are interpreted under 35 U.S.C. 112(f).
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) 1-3, 7, 8, 11, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aydinuraz (Innovative Modification for Preventing Mesh Infections) as evidenced by Maas (Carbon Nanomaterials as Antibacterial Colloids).
Regarding claims 1-3, 7, 8, and 11, Aydinuraz discloses [claim 1] an implantable mesh device (prosthetic mesh, pg 1, col 1, para 4 ), comprising: a surface layer on at least a portion thereof (antibacterial surface, pg 3, col 1, para 2), the surface layer comprising a plurality of extending members that mechanically interact with microbiota to disable the microbiota (carbon nanotubes have antibacterial properties to puncture the membrane as shown by Maas, pg 5, col 2, para 4; the antibacterial properties are due to carbon nanotubes deposited on the substrate surface to interact with bacteria as evidenced by the article entitled "Carbon nanomaterials as antibacterial colloids" to Maas, pg 6, para 1 ); [claim 2] wherein the surface layer comprises graphene or of a graphitic material other than graphene (carbon nanotubes are formed by rolled graphene sheets, pg 5, col 2, para 4); [claim 3] the implantable mesh device of claim 2 wherein the plurality of extending members comprise edges which are configured to interact with a membrane of a cell of the microbiota (the edges of the carbon nanotubes puncture the membrane of the bacteria, pg 5, col 2, para 4); [claim 7] wherein the implantable mesh device comprises a polymeric material (the mesh comprises a polymer, pg 2, col 2, para 2); [claim 8] wherein the surface layer is formed via direct or indirect carbonization to form the surface layer on at least a portion of the polymeric material (the mesh comprises a polymer, pg 2, col 2, para 2; the mesh includes an antibacterial surface, pg 3, col 1, para 2; the antibacterial surface comprises carbon nanotubes which are formed via either direct or indirect carbonization of the polymer mesh, pg 5, col 2, para 4), the surface layer comprising graphene (carbon nanotubes are formed by rolled graphene sheets, pg 5, col 2, para 4); [claim 11] wherein the mesh is a hernia mesh or a urogynecologic mesh (hernia repair mesh, pg 1, col 1, para 4).
Regarding claim 30, Aydinuraz disclosesAydinuraz discloses an implantable device, comprising: a polymeric material (the mesh comprises a polymer, pg 2, col 2, para 2), a surface layer on at least a portion of the polymeric material (the mesh includes an antibacterial surface, pg 3, col 1, para 2) comprising a plurality of extending members that mechanically interact with microbiota to disable the microbiota (carbon nanotubes have antibacterial properties to puncture the membrane as shown by Maas, pg 5, col 2, para 4; the antibacterial properties are due to carbon nanotubes deposited on the substrate surface to interact with bacteria as evidenced by the article entitled "Carbon nanomaterials as antibacterial colloids" to Maas, pg 6, para 1 ).
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.
The factual inquiries 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.
Claim(s) 4, 5, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aydinuraz (Innovative Modification for Preventing Mesh Infections) as evidenced by Maas (Carbon Nanomaterials as Antibacterial Colloids).
Regarding claim 4, Aydinuraz discloses the implantable mesh device of claim but does not explicitly teach wherein the edges have a width of 100 nm or less. Another embodiment specifies a mesh with metal oxide nanoparticles with a width of less than 100 nm (the size is 1-100 nm, pg 4, col 2, para 5) in order to optimize the particle volume/surface area ratio (pg 4, col 2, para 5). Accordingly, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention for the carbon nanotube embodiment to also have edges with a width of less than 100 nm in order to obtain the advantage of optimizing the particle volume/surface area ratio.
As to claim 5, Aydinuraz discloses the implantable mesh device of claim 3 but does not explicitly teach wherein the edges have a width of 10 to 100 nm. Another embodiment specifies a mesh with metal oxide nanoparticles with a width between 10-100 nm (the size is 1-100 nm, pg 4, col 2, para 5) in order to optimize the particle volume/surface area ratio (pg 4, col 2, para 5). Accordingly, it would have been obvious to a person having ordinary skill in the art for the carbon nanotube embodiment to also have edges with a width of 10-100 nm in order to obtain the advantage of optimizing the particle volume/surface area ratio.
As to claim 10, Aydinuraz teaches the implantable mesh device of claim 8 but does not explicitly teach wherein the polymeric material comprises polypropylene. Aydinuraz does not specify the polymeric material of the mesh with the carbon nanotube surface layer. Another embodiment specifies the polymeric mesh material is polypropylene mesh (pg 5, col 1, para 4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include that the polymeric material comprises polypropylene, since it has been held within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. See MPEP 2144.07
Claim(s) 6 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aydinuraz (Innovative Modification for Preventing Mesh Infections) as evidenced by Maas (Carbon Nanomaterials as Antibacterial Colloids) as applied to claim 3 above, and further in view of Ziarani et al. (The role of carbon nanotubes in antibiotics drug delivery)
Regarding claim 6, Aydinuraz discloses the implantable mesh device of claim 3 but does not explicitly teach wherein the surface layer comprises interactive chemical groups to interact with therapeutic molecules or therapeutic nanoparticles. In another embodiment. Aydinuraz teaches where metal oxide nanoparticles are carriers for antibiotics (pg 5, col 1, para 1).
Ziarani teaches, in the same field of endeavor (nonotube in medical device), that carbon nanotubes can also be modified chemically to serve as carriers for antibiotics (carbon nanotubes can be inherently be functionalized to carrier antibiotics pg 1, col 2, para 1).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify the surface layer of Aydinuraz to include an interactive chemical group in order to obtain the advantage of serving as a carrier for therapeutic molecules such as antibiotics.
Regarding claim 12, Aydinuraz teaches the implantable mesh device of claim 8 but does not explicitly teach wherein the surface layer comprises oxygen-containing chemical group or nitrogen-containing chemical groups. In another embodiment Aydinuraz teaches where metal oxide nanoparticles are carriers for antibiotics (pg 5, col 1, para 1).
Ziarani teaches, in the same field of endeavor (nonotube in medical device), that carbon nanotubes can also be modified chemically to serve as carriers for antibiotics (carbon nanotubes can be inherently be functionalized to carrier antibiotics pg 1, col 2, para 1).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify the surface layer of Aydinuraz to include an oxygen-containing chemical group to serve as a carrier for antibiotics.
Regarding claim 13, Aydinuraz teaches the implantable mesh device of claim 12 wherein therapeutic molecules or therapeutic nanoparticles are associated with a plurality of the oxygen-containing chemical groups or a plurality of the nitrogen-containing chemical groups (as modified the carbon nanotubes also have an oxygen-containing chemical group to carry antibiotics like the metal oxide nanoparticles, pg 5, col 1, para 1).
As to claim 14, Aydinuraz teaches the implantable mesh device of claim 13 wherein the therapeutic molecules or therapeutic nanoparticle are antimicrobial molecules (the surface carries antibiotics, pg 5, col 1, para 1).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aydinuraz (Innovative Modification for Preventing Mesh Infections) as evidenced by Maas (Carbon Nanomaterials as Antibacterial Colloids) as applied to claim 7 above, and further in view of Yee et al. (US Pub. No.: 2019/0082540)
Regarding claim 9, Aydinuraz as evidenced by Maas discloses substantially all the limitations of the claim and further disclose that but fails to disclose that the surface layer is formed by either direct or indirect carbonization (the mesh comprises a polymer, pg 2, col 2, para 2; the mesh includes an antibacterial surface, pg 3, col 1, para 2; the antibacterial surface comprises carbon nanotubes which are formed or capable of being formed via either direct or indirect laser carbonization of the polymer mesh, pg 5, col 2, para 4);
. However, Aydinuraz does not disclose that the surface layer is formed via direct or indirect laser carbonization. However, the limitation “the surface layer is formed via direct or indirect laser carbonization” is a product-by-process limitation.
Yee teaches, in the same field of endeavor, a surface layer formed via direct laser carbonization (Para. [0002]).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify the mesh device of Aydinuraz to include the surface layer formed via direct laser carbonization as taught by Yee since direct laser carbonization was recognized as a useful technique for forming a carbonization layer.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aydinuraz (Innovative Modification for Preventing Mesh Infections) as evidenced by Maas (Carbon Nanomaterials as Antibacterial Colloids) as applied to claim 1 above, and further in view of Bell et al. (Carbon nanotubes by plasma-enhanced chemical vapor deposition)
As to claim 15, Aydinuraz discloses the implantable device of claim 1 wherein the surface layer comprises graphene (carbon nanotubes are formed by rolled graphene sheets, pg 5, col 2, para 4) but does not teach and is formed via Plasma Enhanced Chemical Vapor Deposition. Aydinuraz teaches where the carbon nanotubes are deposited on the surface (carbon nanotubes have antibacterial properties to puncture the membrane as shown by Maas, pg 5, col 2, para 4; the antibacterial properties are due to carbon nanotubes deposited on the substrate surface to interact with bacteria as evidenced by the article entitled "Carbon nanomaterials as antibacterial colloids" to Maas, pg 6, para 1) but does not specify how they are deposited.
Bell further teaches a method of using plasma enhanced chemical vapor deposition to produce carbon nanotubes (pg 1117, para 1-2) in order to precisely determine the location and diameter of the deposited nanotubes (see vertically deposited carbon nanotubes using plasma, Fig 1 b, pg 1118, para 1 ).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify the carbon nanotubes of Aydinuraz to be formed via Plasma Enhanced Chemical Vapor Deposition as taught by Bell in order to precisely determine the location and size of the deposited nanotubes to better function as an antibacterial surface.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20040111141 A1 Brabec, Scott J. et al. discloses a medical device incorporating carbon nanotube material.
US 20050096509 A1 Olson, Greg discloses a medical device having carbon nanotubes on its surface.
US 20090104474 A1 Schwartz; Jeffrey et al. disclose a functionalized substrate.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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