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 .
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, 4-6, and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baker et al. (US 20150025313 A1).
Regarding Claim 1, Baker discloses a system that is adapted to deploy an intraluminal device ("intraluminal device, such as a bariatric device 14" [0039]) to the stomach ([0008]), the system comprising:
an endoscope ("endoscope 16" [0039]; FIG. 8) that is adapted to visualize the intraluminal device in the stomach while the intraluminal device is being fastened to the cardiac portion of the stomach ("The at least partially deployed intraluminal device is positioned at the deployment site with said deployment device while visualizing a position of the intraluminal device with the visualization device" [0004]);
an endoscopic deployment device that is adapted to deploying the intraluminal device trans-orally to the stomach ("deployment device may be guided transorally into the stomach with the visualization device" [0009]), wherein said deployment device comprises said endoscope with said intraluminal device positioned at an exterior surface of said endoscope (see FIG. 1);
wherein said intraluminal device comprises a self-expandable wall and wherein said self-expandable wall is compressed to said endoscope shaft ("resilient mesh 43 in wall 42 provides structure to the wall while allowing it to be compressed for deployment and to be self-unfurling for use … resilient mesh 49 allows esophageal member 46 to be compressed for deployment and to be self-unfurling for use" [0041]; FIG. 14) including a compression device adapted to maintain said wall compressed to said endoscope ("deployment sheath in the form of a ripcord 35 from wrapping filament 36 wound around the cardiac member" [0043]), including a deploying filament adapted to extend external the patient, said deploying filament adapted to release said compression device to allow said intraluminal device to self-expand in the patient's stomach ("ripcord actuator 34 associated with the cardiac member is pulled. This retracts a deployment sheath in the form of a ripcord 35 from wrapping filament 36 wound around the cardiac member, thus freeing the wrapping filament to fall away and the cardiac member to unfurl under its own outward bias" [0043]; FIGs. 1-4).
Regarding Claim 4, Baker discloses endoscope shaft having a distal end portion that is adapted to be retroflexed ("endoscope is retroflexed to view the EG region" [0043]; FIG. 3) and wherein said intraluminal device is positioned proximal of said distal end portion (see FIG. 3).
Regarding Claim 5, Baker discloses compression device comprising at least one chosen from a sleeve ("deployment sheath 172" [0051]; FIG. 17) and a wrapped filament ("wrapping filament 36" [0043]; FIG. 5) over said intraluminal device.
Regarding Claim 6, Baker discloses a deploying filament adapted to extend external the patient, said deploying filament adapted to release said compression device to allow said intraluminal device to self-expand in the patient's stomach ("ripcord actuator 34 associated with the cardiac member is pulled. This retracts a deployment sheath in the form of a ripcord 35 from wrapping filament 36 wound around the cardiac member, thus freeing the wrapping filament to fall away and the cardiac member to unfurl under its own outward bias" [0043]; FIGs. 1-4).
Regarding Claim 10, Baker discloses deploying filament is adapted to extend external the patient through a working channel of said endoscope ("Shaft 18 further includes a proximal portion 24 that has a larger diameter than deployment portion 20 in order to provide ripcord openings 26 and plenum-space 28 for passage of wrapping filament 29" [0040]; FIG. 6).
Regarding Claim 11, Baker discloses deployment device is adapted to align the intraluminal device in the stomach by positioning the deployment device within the open portion of the wall in order to generally align the open portion with the GE junction ("position cardiac member 40 in a desired orientation and tensioned against the cardiac region of stomach S" [0044]).
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.
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) 2-3 & 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Angel et al. (US 20150148889 A1).
Regarding Claims 2-3 & 7-9, Baker discloses at least one retaining filament ("attachment filament 58" [0045])adapted to extend from said intraluminal device to external the patient ([0045]; FIG. 9) but fails to specify the remaining claim limitations. However, Angel teaches “a delivery device and a delivery method which allow to avoid a continued grow of aneurysms and which allow in particular to use thrombogenic materials easily and without risks to the patient” ([0007]) including at least one filament guide ("loops or eyelets 34" [0063]; FIG. 2) positioned on said endoscope shaft proximal said intraluminal device (FIG. 1) and adapted to guide movement of said deploying filament ([0062-0065]); wherein said at least one filament guide comprises a plurality of said filament guides spaced along said endoscope shaft (FIGs. 1-3); wherein said at least one filament guide is adapted to guide movement of said at least one retaining filament ([0062-0065]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Baker to suitably allow for “selectively release” “while at the same time ensuring that they are maintained against the body … prior to and in particular during, the placement” of the implant ([0062]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781