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 .
Response to Amendment
In response to the amendment filed on 12/30/2024, Claims 4, 16-19, 21, 23-24, 26-34, 36, and 38-53 have been cancelled, and Claims 1-3, 5-15, 20, 22, 25, 35, 37, and 54 are pending.
Claim Objections
Claim 9 is objected to because of the following informalities:
Claim 9 recites the limitation “with thru deployment” in line two however this limitation should read “with through deployment” to correct a typographically error.
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:
“deployment mechanism” in claims 2, 3, 5-14, and 20. The Examiner notes that sufficient structure to overcome a 112(f) interpretation is recited in Claim 15.
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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 3, 5-15 and 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.
Regarding claim 2, the phrase "for example" or “e.g.” renders the claim indefinite because it is unclear whether the limitation(s) (a “shaft”) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 3, 5-15 and 20 are rejected for incorporating errors from the parent claim by dependency.
Claim 20 contains the trademark/trade name “OTOLoc TM”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe otomy control device and, accordingly, the identification/description is indefinite.
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, 5-7, 11, 12, 15, 20, 22, 25, 35, 37, and 54 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma (US PGPub 2020/0323530).
Regarding Claim 1, Sharma teaches a system (5100; Figure 51A; Paragraph 0449) for delivery of one or more implants used in the protection of otomies and the creation of magnetic compression anastomoses in a target anatomy (abstract; Figure 51A; Paragraph 0449), comprising
a reloadable handpiece (5119; Figure 51A; Paragraph 0449 which states that system comprises an outer catheter portion which is considered to be the handpiece and its reloadable with the inner catheter and disclosed in Paragraph 0450) and
one or more cartridges (5114; Figure 51A which is the inner catheter delivery device; Paragraph 0450) containing the one or more implants (anastomosis device 5000 which includes magnetic elements 5004 and drainage mechanism 5014 which is the otomy control device; see Paragraph 0441 and Figures 50A-50F).
Regarding Claim 2, Sharma teaches the system of claim 1, wherein:
each cartridge (5114; delivery device) contains at least one implant selected from the group consisting of an otomy control device and a magnetic compression anastomosis device ((anastomosis device 5000 which includes magnetic elements 5004 and drainage mechanism 5014 which is the otomy control device; see Paragraph 0441 and Figures 50A-50F); and
the reloadable handpiece (5119) has an interface (5124; Figure 51A; Paragraph 0450) through which each of the one or more cartridges (inner shaft 5114) can be attached to and operated by the handpiece (5119), the handpiece including a deployment mechanism (5113) configured to control deployment of the at least one implant (5000) from a distal end of an attached cartridge (5114) and at least one actuator (5118) allowing a user to operate the deployment mechanism (5113; Figure 51A; Paragraph 0450).
Regarding Claim 3, Sharma teaches the system of claim 2, wherein at least one cartridge includes only one implant selected from the group consisting of an otomy control device and a magnetic compression anastomosis device (4700; Figures 47A-47T; Paragraph 0432).
Regarding Claim 5, Sharma teaches the system of claim 2, wherein at least one cartridge includes a distal implant (5010; Figures 50A-50B) and a proximal implant (5008; Figures 50A-50D), wherein the deployment mechanism (5113) is configured to deploy the distal implant (5010) followed by the proximal implant (5008; see Figure 50B which shows element 5018 which screws onto the deployment mechanism and is the last to be deployed and see element 5016 which is on the distal end on the distal implant 5010 and is the first to be deployed; Paragraph 0441).
Regarding Claim 6, Sharma teaches the system of claim 5, wherein the deployment mechanism (5113) is configured to perform a first deployment operation (5113) that deploys the distal implant (distal loop in Paragraph 0450) and to perform a second deployment operation that deploys the proximal implant (proximal loop in Paragraph 0450), wherein the second deployment operation requires a separate actuation from the first deployment operation (Paragraph 0450 states “the inner pusher catheter 5113 comprises three distinct portions separated by two discrete stopping mechanisms. In this embodiment, the three portions separately control deployment of the distal coil loop, ‘s’ shaped connecting segment, and the proximal coil loop of the anastomosis device” which reads on a second deployment operation separate from the first deployment operation)
Regarding Claim 7, Sharma teaches the system of claim 5, wherein the distal implant is an otomy control device (in this interpretation the distal implant is both 5010 and 5014 since element 5014 is the device for controlling the otomy for drainage purposes; Figure 50A-50B) and the proximal implant is a magnetic compression anastomosis device (5008; see Figures 50A-50B).
Regarding Claim 11, Sharma teaches the system of claim 5, wherein the distal implant (5010) is a magnetic compression anastomosis device and the proximal implant (5014) is an otomy control device (Figures 50A-50B; Paragraph 0041)
Regarding Claim 12, Sharma teaches the system of claim 2, wherein at least one cartridge includes a plurality of otomy control devices (5015A and 5015B Figures 50L and 50M; Paragraph 0447 or alternatively Paragraph 0439; Figure 48C and Figures) and/or a plurality of magnetic compression anastomosis devices (5010 and 5008; Figures 50A-50B).
Regarding Claim 15, teaches the system of any one of claims 2-14 claim 2,wherein the deployment mechanism comprises at least one of:
pusher configured to push the at least one implant from the distal end of the deployment channel (pusher element 5113 which moves the coil out of the catheter as described in Paragraph 0449; Figure 51A);
a ratcheting feature to control advancement of the at least one implant;
a linkage drive mechanism for controlling actuation and release operations;
a cable drive mechanism for controlling actuation and release operations; or
one or more motors for controlling actuation and release operations.
Regarding Claim 20, Sharma teaches the system of claim 2,wherein the magnetic compression anastomosis device is a self-assembling magnetic compression anastomosis device having a substantially linear configuration (as seen in Figure 50D) within the cartridge and an annular deployed configuration (Figure 50E), and wherein the otomy control device is an OTOLoc TM otomy control device (in view of the 112b rejection above, the Examiner is not giving patentable weight to the trademarked device).
Regarding Claim 22, Sharma teaches an anastomosis procedure cartridge (5114; Figure 51A which is the inner catheter delivery device; Paragraph 0450) comprising at least one implant (5000; Figure 50D) selected from the group consisting of an otomy control device (5014) and a magnetic compression anastomosis device (5010) (magnetic elements 5004 are the magnetic compression anastomosis device and drainage mechanism 5014 is the otomy control device; see Paragraph 0441 and Figures 50A-50F), wherein the cartridge (5114) is configured to attach to an interface (5124; Figure 51A; Paragraph 0450) of a reloadable handpiece (5119) by which the cartridge (5114) can be operated to deliver and release the at least one implant (5000) from a distal end of the cartridge (5114; Paragraph 0450; Figure 51A)
Regarding Claim 25, Sharma teaches the cartridge of claim 22, wherein the at least one implant (5000) includes a distal implant (5010) and a proximal implant (5014; Figure 50D).
Regarding Claim 35, Sharma teaches a reloadable handpiece (5119) comprising an interface (5124; Figure 51A; Paragraph 0450) configured to attach to and operate an anastomosis procedure cartridge (5114; Figure 51A; Paragraph 0450) containing at least one implant (5000; Figure 50D) selected from the group consisting of an otomy control device (5014; Figure 50D) and a magnetic compression anastomosis device (5010 or 5008; Figure 50D), the handpiece (5119) including a deployment mechanism (5113) configured to control deployment of the at least one implant (5000) from a distal end of an attached cartridge (5114) and at least one actuator (5118) allowing a user to operate the deployment mechanism (5113; Figure 51A; Paragraph 0450).
Regarding Claim 37, Sharma teaches the handpiece of claim 35, wherein the cartridge includes a distal implant (5010; Figure 50D) and a proximal implant (5014; Figure 50D), and wherein the deployment mechanism (5113; Paragraph 0450) is configured to perform a first deployment operation (5113) that deploys the distal implant (distal loop in Paragraph 0450) and to perform a second deployment operation that deploys the proximal implant (proximal loop in Paragraph 0450), wherein the second deployment operation requires a separate actuation from the first deployment operation (Paragraph 0450 states “the inner pusher catheter 5113 comprises three distinct portions separated by two discrete stopping mechanisms. In this embodiment, the three portions separately control deployment of the distal coil loop, ‘s’ shaped connecting segment, and the proximal coil loop of the anastomosis device” which reads on a second deployment operation separate from the first deployment operation)
Regarding Claim 54, Sharma teaches the handpiece of claim 35, wherein the handpiece (5119) is configured for robotic operation in addition to or in lieu of manual operation (the Examiner notes that there is no structure in the claim presented which prevents handle 5119 to be held and manipulated by a robotic arm and thus it is the Examiners position that the tubular handle taught by Sharma is indeed configured for robotic operation as a robot can grab the actuator of Sharma in lieu of manual operation).
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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharma (US PGPub 2020/0323530) as applied to claim 2 above, and further in view of Moehle (US PGPub 2020/0022699)
Regarding Claim 14, Sharma teaches the system of claim 2, wherein the at least one actuator includes an implant delivery actuator (5124; Figure 51A; Paragraph 0450) but fails to disclose a suture release actuator.
Moehle teaches a system for delivering one or more implants (abstract) comprising a suture release actuator (206) on a handpiece (204) for the purpose of releasing a suture (S) attached to an implant (250) (Figures 14A-14B and Figures 17D-17E).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the handpiece of Sharma to include a suture release actuator, as taught by Moehle, for the advantage of providing suture deployment of the suture that’s attached to the implant, prior to delivering the implant, to stabilize the implant from migration.
Allowable Subject Matter
Claim 8-10 and 13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The prior art of record fails to disclose:
Regarding Claim 8, Sharma teaches the system of claim 7, but fails to disclose wherein the cartridge contains the otomy control device distal to the magnetic compression anastomosis device without otomy alignment, wherein the cartridge deploys the otomy control device and then requires access of the otomy control device prior to deployment of the magnetic compression anastomosis device through the otomy control device.
Regarding Claim 9, Sharma teaches the system of claim 7, but fails to disclose wherein the cartridge contains the otomy control device distal to the magnetic compression anastomosis device with thru deployment, wherein the cartridge deploys a distal flange of the otomy control device and then deploys the magnetic compression anastomosis device through the otomy control device and then deploys a proximal flange of the otomy control device.
Regarding Claim 10, Sharma teaches the system of claim 7, but fails to disclose wherein the cartridge contains the otomy control device distal to the magnetic compression anastomosis device with alignment, wherein the cartridge deploys the otomy control device and maintains a connection with the otomy control device for deployment of the magnetic compression anastomosis device through the otomy control device and subsequent release of the otomy control device.
Regarding Claim 13, Sharma teaches the system of claim 12, but fails to disclose wherein the cartridge includes in order a distal otomy control device, a distal magnetic compression anastomosis device, a proximal otomy control device, and a proximal magnetic compression anastomosis device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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