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 08/17/2026. Claims 21-40 are pending. Claims 21 and 30 are independent.
Election/Restrictions
Applicant’s election without traverse of Species A (Figure 3) in the reply filed on 08/17/2026 is acknowledged.
Claim Objections
Applicant is advised that should claim 34 be found allowable, claim 38 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 § 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 27, 28, 34, 38, and 39 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 27 recites the limitation “the second layer is a polymer having the microstructured surface formed into the polymer.” Based on the disclosure, the second layer is formed of a polymer and has a microstructure surface. It is unclear what it means by that the second layer is a polymer having the microstructured surface formed into the polymer because it is unclear how the microstructured surface is formed into the polymer (which is the material for forming the second layer). Claim 28 is rejected because it depends on claim 27.
Claim 34 recites the limitation “the second layer is a polymer having the microstructured surface formed into the polymer.” Based on the disclosure, the second layer is formed of a polymer and has a microstructure surface. It is unclear what it means by that the second layer is a polymer having the microstructured surface formed into the polymer because it is unclear how the microstructured surface is formed into the polymer (which is the material for forming the second layer).
Claim 38 recites the limitation “the second layer is a polymer having the microstructured surface formed into the polymer.” Based on the disclosure, the second layer is formed of a polymer and has a microstructure surface. It is unclear what it means by that the second layer is a polymer having the microstructured surface formed into the polymer because it is unclear how the microstructured surface is formed into the polymer (which is the material for forming the second layer). Claim 39 is rejected because it depends on claim 38.
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 22, 24, 25, 27-29, 32, 34, 35, and 38-40 which were added in the preliminary amendment) 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.
Claim 22 recites the limitation “the first layer comprises a polypropylene mesh” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the first layer comprises a polypropylene mesh.
Claim 24 recites the limitation “wherein the first surface energy is juxtaposed to the second surface energy capable of creating a shear force between the second layer and a target surface” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the first surface energy is juxtaposed to the second surface energy capable of creating a shear force between the second layer and a target surface.
Claim 26 recites the limitation “the first layer is non-bioabsorbable” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the first layer is non-bioabsorbable.
Claim 27 recites the limitation “the second layer is a polymer having the microstructured surface formed into the polymer” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the second layer is a polymer having the microstructured surface formed into the polymer. Secondly, it is unclear what it means by that the second layer is a polymer having the microstructured surface formed into the polymer because it is unclear how the microstructured surface is formed into the polymer (which is the material for forming the second layer).
Claim 28 recites the limitation “wherein the polymer is capable of being heated by high frequency electromagnetic energy” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the polymer is capable of being heated by high frequency electromagnetic energy.
Claim 29 recites the limitation “wherein the first layer comprises a hernia repair mesh” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the first layer comprises a hernia repair mesh.
Claim 32 recites the limitation “the first layer comprises a polypropylene mesh” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the first layer comprises a polypropylene mesh.
Claim 34 recites the limitation “the second layer is a polymer having the microstructured surface formed into the polymer” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the second layer is a polymer having the microstructured surface formed into the polymer. Secondly, it is unclear what it means by that the second layer is a polymer having the microstructured surface formed into the polymer because it is unclear how the microstructured surface is formed into the polymer (which is the material for forming the second layer).
Claim 35 recites the limitation “the first layer is non-bioabsorbable” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the first layer is non-bioabsorbable.
Claim 38 recites the limitation “the second layer is a polymer having the microstructured surface formed into the polymer” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the second layer is a polymer having the microstructured surface formed into the polymer. Secondly, it is unclear what it means by that the second layer is a polymer having the microstructured surface formed into the polymer because it is unclear how the microstructured surface is formed into the polymer (which is the material for forming the second layer).
Claim 39 recites the limitation “wherein the polymer is capable of being heated by high frequency electromagnetic energy” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the polymer is capable of being heated by high frequency electromagnetic energy.
Claim 40 recites the limitation “wherein the first layer comprises a hernia repair mesh” which does not have sufficient support in the original disclosure and is considered as new matter. The original disclosure is silent on that the first layer comprises a hernia repair mesh.
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 30 and 40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,083,005. Although the claims at issue are not identical, they are not patentably distinct from each other because the all the limitations of claim 30 are contained in claim 10 of U.S. Patent No. 12,083,005 and the first layer of claim 10 of U.S. Patent No. 12,083,005 is fully capable to serve as a hernia repair mesh.
Claim 31 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,083,005 in view of Shalev et al. (US Pub. No.: 2008/0208316).
Regarding claim 31 of the instant application, claim 10 of U.S. Patent No. 12,083,005 recites all the limitation of claim 30 of the pending application but fails to recite that the fibrous layer comprises an electrospun layer.
Shalev teaches, in the same field of endeavor (implantable device), a fibrous layer comprising an electrospun layer (Para. [0012]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the fibrous layer of claim 10 of U.S. Patent No. 12,083,005 to be an electrospun layer as taught by Shalev in order to obtain the advantage of achieving exceptional homogeneity, smoothness and desired porosity distribution along layer (Shalev, Para. [0012]).
Claims 32 and 35 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,083,005 in view of Meneghin et al. (US Pub. No.: 2013/0158571).
Regarding claims 32 and 35 of the instant application, claim 10 of U.S. Patent No. 12,083,005 recites all the limitation of claim 30 of the pending application but fails to recite that the first layer comprises a polypropylene mesh and is non-bioabsorbable.
Meneghin teaches, in the same field of endeavor (implantable device), a first layer of an implantable mesh device comprises a polypropylene mesh and is non-bioabsorbable (2, Fig. 3 and Paras. [0023] and [0028], polypropylene is non-bioabsorbable).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the first layer of claim 10 of U.S. Patent No. 12,083,005 to include a non-bioabsorbable polypropylene mesh as taught by Meneghin, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability of the intended use. See MPEP 2144.07
Claims 33 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,083,005 in view of Milbocker et al. (US Pub. No.: 2018/0236511).
Regarding claims 33 and 37 of the instant application, claim 10 of U.S. Patent No. 12,083,005 recites all the limitation of claim 30 of the pending application but fails to recite that the microstructured surface comprises a plurality of hierarchical microfeatures, each of the plurality of hierarchical microfeatures having a first microfeature disposed about a second microfeature; and wherein the plurality of hierarchical microfeatures are configured to generate a Wenzel-Cassie interface between the microstructured surface and a target surface.
Milbocker teaches, in the same field of endeavor (implantable device), a microstructured surface comprising a plurality of hierarchical microfeatures (combination of all 120, 122, and 124, Fig. 1A), each of the plurality of hierarchical microfeatures having a first microfeature (124, Fig. 1A) disposed about a second microfeature (122, Fig. 1A); and wherein the plurality of hierarchical microfeatures are configured to generate a Wenzel-Cassie interface between the microstructured surface and a target surface (Paras. [0062], [0070], and [0071]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the microstructured surface of 10 of U.S. Patent No. 12,083,005 to include a plurality of hierarchical microfeatures, each of the plurality of hierarchical microfeatures having a first microfeature disposed about a second microfeature; and wherein the plurality of hierarchical microfeatures are configured to generate a Wenzel-Cassie interface between the microstructured surface and a target surface as taught by Milbocker in order to enhance tissue bonding hydrophobic properties of the surface (Milbocker, Para. [0071]).
Claim 36 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,083,005 in view of Karp et al. (US Pub. No.: 2013/0331792).
Regarding claim 36 of the instant application, claim 10 of U.S. Patent No. 12,083,005 recites all the limitation of claim 30 of the pending application but fails to recite that the second layer is bioabsorbable.
Karp teaches, in the same field of endeavor (implantable device), a second layer (Fig. 1, barb layer) is bioabsorbable (Para. [0062]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the second layer of claim 10 of U.S. Patent No. 12,083,005 to be bioabsorbable as taught by Karp, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability of the intended use. See MPEP 2144.07
Allowable Subject Matter
Claims 21, 23, and 26 are allowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20130158572 A1 Meneghin; Alfredo et al. discloses an implantable mesh device having microstructured surface.
US 20140148827 A1 Odermatt; Erich et al. discloses an implantable device having microstructured surface
US 20170014111 A1 Hulseman; Ralph A. et al. discloses a device having hierarchical microstructured surface.
US 20190117849 A1 Bluecher; Lukas et al. discloses a device having hierarchical microstructured surface.
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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/JING RUI OU/Primary Examiner, Art Unit 3771
