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 species 1 (Figs. 14A-C) in the reply filed on 01/16/2026 is acknowledged.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, provisional application 63/295,642 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Regarding claims 129-136 which introduces the deployment tool embodiments shown in Figs. 32A-33E and described in para. 267-280 in the instant application does not have support for a priority date of 12/31/2021 which is associated with the provisional application of 63/295,642. However, PCT US 2022/054351 includes the new claimed subject matter with a priority date of 12/30/2022. Therefore, new claims 129-136 have a priority date of 12/30/2022.
Claim Objections
Claim 121 is objected to because of the following informalities:
Claim 121, line 9: “sump” should recite “stump”.
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:
“a release mechanism” in claim 131. The limitation describing the release mechanism in claim 131 fails to include sufficient structure to perform the recited function of “releasing”. The specification fails to describe the specific structure of the release mechanism. Therefore, the limitation will be interpreted as any structural equivalent that is a part of a release trigger that is capable of or designed to "release" the mesh cuff aligning element.
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.
Claim 131 is 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 131 recites “whereby the deployment tool is further comprised of a release trigger operating a release mechanism for the mesh cuff alignment” invokes 35 U.S.C. 112(f) or preAIA 35 U.S.C. 112, sixth paragraph. The written description of the instant application fails to describe or provide sufficient structure for the “release mechanism” other than “a release mechanism configured to release aligning element 160 from housing 216” (para. 275 of the instant application) which is the only time that the release mechanism is mentioned in the specification.
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 131 and 135 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 131 recites “whereby the deployment tool is further comprised of a release trigger operating a release mechanism for the mesh cuff alignment” invokes 35 U.S.C. 112(f) or preAIA 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 written description of the instant application fails to describe or provide sufficient structure for the “release mechanism” other than “a release mechanism configured to release aligning element 160 from housing 216” (para. 275 of the instant application) which is the only time that the release mechanism is mentioned in the specification. As would be recognized by those of ordinary skill in the art, there are many different ways to construct a release mechanism for a trigger. The specification does not provide sufficient details such that one of ordinary skill in the art would understand which mechanical structures perform(s) the claimed function. 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.
Claim 135 recites the limitation "extendable arms" in line 2. It is unclear to the examiner if the “extendable arms” limitation is meant to further define the “at least three extendable arms” introduced in claim 134. For examination purposes, “extendable arms” is interpreted as “the at least three extendable arms”.
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) 121-122, 125, and 127 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kahana et al. (US 20150351768) [hereinafter Kahana].
Regarding claim 121, Kahana discloses a system for connecting two nerve stumps (Fig. 1, para. 0007, 0060), comprising:
a mesh cuff aligning element 10 (Fig. 1, para. 0060-0061), the mesh cuff aligning element 10 being comprised of a lumen 22 with an internal diameter (Fig. 1, para. 0060), a length (Fig. 1, para. 0060), a first end opening 16 (Fig. 1, para. 0060), and a second end opening 20 (Fig. 1, para. 0060), the mesh cuff aligning element 10 being capable of slidingly receiving and surrounding a portion of a proximal nerve stump at the first end opening within the lumen and being capable of slidingly receiving and surrounding a portion of a distal nerve stump at the second end opening within the lumen (Figs. 1, 6c, para. 0060, 0071, 0075),
wherein the mesh cuff aligning element 10 maintains approximation and alignment between the proximal nerve stump and the distal nerve stump without the use of sutures or glues (Figs. 3a-c, para. 0060-0061, 0093), thereby improving the nerve functional recovery, and/or ease, and/or reproducibility, and/or speed of connecting the proximal nerve stump and the distal nerve stump (para. 0006-0007, 0071-0072);
wherein the mesh cuff aligning element 10 is configured to controllably and predictably alter its internal diameter of the lumen when longitudinal/axial tension and stretch are applied to the mesh cuff aligning element (Figs. 3a-3c, para. 0064) allowing the mesh cuff aligning element to be capable of resisting longitudinal and torsional forces, thereby keeping the proximal nerve stump and the distal nerve stump at a defined distance and alignment (Figs. 3a-3c, para. 0061, 0064).
Regarding claim 122, Kahana discloses wherein axial compression of the mesh cuff aligning element 10 enables the first end opening 16 to receive the proximal nerve stump and upon the second end opening 20 to receive the distal nerve stump (Fig. 3c, para. 0060-0061, 0064), wherein a release of said axial compression while maintaining desired rotational alignment and distance between the proximal nerve stump and the distal nerve stump allows the mesh cuff aligning element 10 to return to a neutral state in which the length of the mesh cuff aligning element is sufficient to concurrently overlap portions of the proximal nerve stump and the distal nerve stump (Fig. 3b, para. 0060-0061, 0064); and the resulting internal diameter is smaller than that of either the proximal nerve stump or the distal nerve stump, whereby the proximal nerve stump and the distal nerve stump have sufficient stability to support longitudinal and torsional forces and maintain geometric alignment between the proximal nerve stump and the distal nerve stump (Fig. 3b, para. 0061, 0064, 0107-0108).
Regarding claim 125, Kahana discloses wherein the mesh cuff aligning element is configured to maintain a calculated gap length between the proximal and distal nerve stumps to promote or to facilitate nerve growth and/or axonal alignment between the proximal nerve stump and the distal nerve stump, whereby the calculated gap length maybe a zero gap length or the calculated gap length may be a gap length that is greater than zero (para. 0060, 0071, 0074).
Regarding claim 127, Kahana discloses where the mesh cuff aligning element 10 further comprises anchoring elements 54 to support longitudinal and/or torsional holding forces between the mesh cuff aligning element and both the proximal nerve stump and the distal nerve stump (Figs. 5a-b, para. 0070-0072).
Claim Rejections - 35 USC § 103
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.
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) 123 is rejected under 35 U.S.C. 103 as being unpatentable over Kahana et al. (US 20150351768) [hereinafter Kahana].
Regarding claim 123, Kahana discloses all of the limitations set forth above in claim 121. Kahana discloses wherein the mesh cuff aligning element is constructed from suture strands of size between 2-0 and 6-0 (para. 0062 discloses that the filaments may be about 0.01 mm to about 4 mm which is within the range of suture strands sized between 2-0 and 6-0. The examiner notes that it is known in the art for a suture strand of 2-0 to have a thickness of 0.3 mm and 6-0 thickness of 0.1 mm.), wherein the mesh cuff aligning element 10 is constructed from suture strands of degradable and/or non-degradable sutures of biologic and/or synthetic material (Fig. 2a-b, para. 0061-0062) by braiding 8, 16, 24, 32, or 48 suture threads in a 1:1 relation (para. 0063).
Kahana further discloses wherein the mesh cuff aligning element is constructed in a tubular braid configuration (Figs. 2a-b, para. 0061-0062) with a braid angle ‘a’ which defines a braid pick per unit length (see Figs. 2a-b, para. 0063-0064 which discloses a repeat of a braiding pattern formed by parts 28a and 28b along a central braid axis).
However, Kahana fails to disclose wherein the mesh cuff aligning element 10 is constructed with a braid angle of between 5 and 85 degrees.
There is no evidence of record that establishes that changing the braid angle would result in a difference in function of the Kahana device. Further, a person having ordinary skill in the art, being faced with modifying the mesh cuff aligning element of Kahana such that it has a braid angle of between 5 and 85 degrees would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ranges (the mesh cuff aligning element of Kahana is intended to slidingly receive biological structure and configured to alter its internal diameter of the lumen when longitudinal/axial tension are applied to secure the biological structures during an anastomosis procedure (Figs. 3a-c, para. 0060-0061, 0064, 0107-0108 of Kahana) which is analogous to the intended use of applicant’s mesh cuff aligning element).
Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “Aligning element 160 can comprise a cylindrical braid constructed by braiding 8, 16, 24, 32, and/or 48 suture threads in 1:1, 1:2, 2:2, and/or other number of suture threads and braiding patterns based on the size of nerves and intended application. The cylindrical braid can comprise a braid angle (e.g. half the angle made by crossing filaments in the braid, or the positive angle between the central axis of the braid and the crossing filaments of the braid) comprising an angle of between 5 and 85 degrees ” (para. 210 of the instant application) and does not include any additional language on the benefits of having the claimed ranges such that it produces an unexpected result that the device would not perform differently than the prior art device. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the mesh cuff aligning element of Kahana to include the braid angle of between 5 and 85 degrees as an obvious matter of design choice within the skill of the art.
Modified Kahana further discloses wherein the mesh cuff aligning element comprises a porosity (see Fig. 2b which illustrates pore 29 in between the braided filaments 28a-b, para. 0063 of Kahana). However, modified Kahana fails to disclose wherein the mesh cuff aligning element comprises a porosity between 20% and 60%.
There is no evidence of record that establishes that changing the porosity would result in a difference in function of the modified Kahana device. Further, a person having ordinary skill in the art, being faced with modifying the mesh cuff aligning element of modified Kahana such that it has a porosity between 20% and 60% would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ranges (the mesh cuff aligning element of Kahana is intended to slidingly receive biological structure and configured to alter its internal diameter of the lumen when longitudinal/axial tension are applied to secure the biological structures during an anastomosis procedure (Figs. 3a-c, para. 0060-0061, 0064, 0107-0108 of Kahana) which is analogous to the intended use of applicant’s mesh cuff aligning element).
Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that “Different combinations of the braiding parameters, as described herein, can result in braid porosities within aligning element 160 of between 10% and 90%.” (para. 211 of the instant application) and does not include any additional language on the benefits of having the claimed ranges such that it produces an unexpected result that the device would not perform differently than the prior art device. Therefore, there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Hence, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the mesh cuff aligning element of modified Kahana to include the porosity between 20% and 60% as an obvious matter of design choice within the skill of the art.
Claim(s) 124 is rejected under 35 U.S.C. 103 as being unpatentable over Kahana et al. (US 20150351768) [hereinafter Kahana] as applied to claim 121 above, and further in view of Simmons et al. (US 20090163951) [hereinafter Simmons].
Regarding claim 124, Kahana discloses all of the limitations set forth above in claim 121. Kahana further discloses wherein the mesh cuff aligning element 10 is constructed from a plurality of threads (Figs. 2a-b, para. 0062) and biologic material such as gut or tissue graft (para. 0061). However, Kahana fails to disclose that the mesh cuff aligning element 10 is constructed from a plurality of monofilament threads obtained from extracellular matrices.
Simmons teaches in the same field of endeavor of implantable medical devices that monofilament sutures obtained from extracellular matrices are known in the art (para. 0023) for the purpose of encouraging attachment, or cell growth (i.e., tissue ingrowth or proliferation), in places of contact of the sutures when used in a human body (para. 0012).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of threads in Kahana to include the monofilament sutures obtained from extracellular matrices of Simmons since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07)
Claim(s) 126 is rejected under 35 U.S.C. 103 as being unpatentable over Kahana et al. (US 20150351768) [hereinafter Kahana] as applied to claim 121 above, and further in view of Kubiak (US 20110288566).
Regarding claim 126, Kahana discloses all of the limitations set forth above in claim 121. Kahana further discloses wherein the mesh cuff aligning element 10 comprises at least one surface 46 treated with a texture configured to improve frictional properties to maintain relative positioning between the mesh cuff aligning element and both the proximal nerve stump and the distal nerve stump (Figs. 5a-b, para. 0070-0072). However, Kahana fails to disclose other surfaces treated to reduce frictional properties to enable relative motion with minimal mechanical resistance between the mesh aligning element and surrounding tissues.
Kubiak in the same field of endeavor of devices for connecting biological structures (Fig. 1, para. 0075) teaches that it is known in the art to treat an outer surface 20 of the device with a lubricious material to reduce frictional properties to enable relative motion with minimal mechanical resistance between the device and surrounding tissues (para. 0112).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify an outer surface of the mesh cuff aligning element in Kahana to include the lubricious material of Kubiak in order to prevent non-desirable adhesion formations against surrounding tissue surfaces (para. 0112 of Kubiak).
Claim(s) 129 and 133 are rejected under 35 U.S.C. 103 as being unpatentable over Kahana et al. (US 20150351768) [hereinafter Kahana] as applied to claim 121 above, and further in view of Drochner (US 20200205834).
Regarding claims 129 and 133, Kahana discloses all of the limitations set forth above in claim 121. However, Kahana fails to disclose further comprising a deployment tool, whereby the deployment tool is capable of holding the mesh cuff aligning element in a compressed state along its main longitudinal axis and whereby the deployment tool is capable of controlling the extension in length and the resulting reduction in diameter of the mesh cuff aligning element, and whereby the deployment tool is capable of releasing a proximal and/or distal portion of the mesh cuff aligning element, whereby when both portions are released, the mesh cuff aligning element is no longer mechanically engaged with the deployment tool (claim 129) / a deployment tool, whereby the deployment tool is capable of being positioned to approximate, align, and maintain a calculated gap length between the proximal nerve stump and the distal nerve stump, whereby the calculated gap length may be a zero gap length or the calculated gap length may be a gap length that is greater than zero (claim 133).
Drochner in the same field of endeavor of anastomosis devices teaches a deployment tool 10 (Fig. 1, para. 0026), whereby the deployment tool 10 is capable of holding a mesh cuff aligning element in a compressed state along its main longitudinal axis (see Fig. 3B which illustrates the deployment tool in a closer position for holding the element in the compressed state, para. 0026) and whereby the deployment tool 10 is capable of controlling an extension in length and a resulting reduction in diameter of a mesh cuff aligning element (see Figs. 1 and 3A-B which illustrates the deployment tool transitioning from a spaced apart position to the closer position and therefore capable of controlled extension, para. 0026), and whereby the deployment tool is capable of releasing a proximal and/or distal portion of the mesh cuff aligning element, whereby when both portions are released, the mesh cuff aligning element is no longer mechanically engaged with the deployment tool (see Figs. 5-6, para. 0028, 0033-0034), whereby the deployment tool 10 is capable of being positioned to approximate, align, and maintain a calculated gap length between the proximal nerve stump and the distal nerve stump (see Figs. 1 and 3A-B which illustrates the deployment tool transitioning from a spaced apart position to the closer position and therefore capable of controlled extension to approximate, align, and maintain a calculated gap length between the proximal nerve stump and the distal nerve stump during deployment of the mesh cuff aligning element , para. 0026), whereby the calculated gap length may be a zero gap length or the calculated gap length may be a gap length that is greater than zero (see note below).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the mesh cuff aligning element in Kahana to include a deployment tool, as taught by Drochner in order to sufficiently hold and deploy the mesh cuff aligning element (para. 0026, 0028, 0033-0034 of Drochner).
Note: Modified Kahana discloses wherein the mesh cuff aligning element is capable of maintaining a calculated gap length between the proximal and distal nerve stumps, whereby the calculated gap length maybe a zero gap length or the calculated gap length may be a gap length that is greater than zero (para. 0060, 0071, 0074 of Kahana). Therefore, deployment of the mesh cuff aligning element of Kahana would result in maintaining the calculated gap length as described above.
Claim(s) 130 and 132 are rejected under 35 U.S.C. 103 as being unpatentable over Kahana et al. (US 20150351768) [hereinafter Kahana] as applied to claim 121 above, and further in view of Manolidis (US 20230026939).
Regarding claim 130, Kahana discloses all of the limitations set forth above in claim 121. However, Kahana fails to disclose a deployment tool, whereby the deployment tool comprises a housing and at least two extendable arms, the housing being configured to be slidingly received via the lumen of the mesh cuff aligning element such that the mesh cuff aligning element is preloaded onto the deployment tool, the least two extendable arms being controlled by a set of handles, said set of handles controlling the positioning of the deployment tool.
Manolidis in the same field endeavor of device delivery teaches a deployment tool 720 comprises a housing 726 and at least two extendable arms 728 (Figs. 7A-B, para. 0105-0106), the housing 726 being configured to be slidingly received via a lumen of a mesh cuff aligning element such that the mesh cuff aligning element is preloaded onto the deployment tool 720 (see Figs. 7A-B which illustrates the housing slidingly received within a lumen with a stent 710 such that the housing is capable of doing the same function with the mesh cuff aligning element, para. 0106-0108), the least two extendable arms 728 being controlled by a set of handles 724A-B (Figs. 7A-B, para. 0105), said set of handles 724A-B controlling the positioning of the deployment tool (para. 0105-0106).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the mesh cuff aligning element in Kahana to include a deployment tool, as taught by Manolidis in order to sufficiently hold and deploy the mesh cuff aligning element (para. 0105-0106 of Manolidis).
Regarding claim 132, modified Kahana discloses whereby the housing 726 is comprised of a hollow cylinder with at least one tapered end (best shown in Fig. 7B, para. 0106 of Manolidis).
Claim(s) 134-136 are rejected under 35 U.S.C. 103 as being unpatentable over Kahana et al. (US 20150351768) [hereinafter Kahana] as applied to claim 121 above, and further in view of Drochner (US 20200205834) and Peterson (US 20060135988).
Regarding claim 134, Kahana discloses all of the limitations set forth above in claim 121. However, Kahana fails to disclose further comprising a deployment tool, whereby the deployment tool comprises at least three extendable arms, at least two handles, and a central static support.
Drochner in the same field of endeavor of anastomosis devices teaches a deployment tool 10 (Fig. 1, para. 0026), whereby the deployment tool comprises at least two extendable arms 31a, 31b, at least two handles 22a, 22b (Fig. 1, para. 0026, 0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the mesh cuff aligning element in Kahana to include a deployment tool, as taught by Drochner in order to sufficiently hold and deploy the mesh cuff aligning element (para. 0026, 0028, 0033-0034 of Drochner).
However, Kahana in view of Drochner fails to disclose a third extendable arm and a central static support.
Peterson in the same field of endeavor of forceps teaches that it is known in the art to include a third extendable arm 106 as a central static support (Figs. 6-8, para. 0041-0042; see para. 268 of the instant application which states that the third extendable arm is the central static support) for the purpose providing sequentially grasping of an object (para. 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the deployment tool in modified Kahana to include an additional extendable arm as a central static support, as taught by Peterson, in order to sequentially grasp and thereby release the mesh cuff alignment element (para. 0008 of Peterson), thereby providing controlled compression and extension of the mesh cuff alignment element.
Regarding claim 135, modified Kahana discloses whereby the deployment tool is further comprised of one, two, or more fixation elements 16a, 16b connected to extendable arms (interpreted as the at least three extendable arms defined above in claim 134; see 112b rejection above) to hold mesh cuff aligning element (Figs. 3A-5, para. 0028-0029 of Drochner).
Regarding claim 136, modified Kahana discloses whereby the deployment tool is further comprised of a release trigger 35a, 35b (Figs. 5-6, para. 0029, 0033 of Drochner).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached 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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/LAUREN DUBOSE/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771