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 § 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) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. (US 20160151233 A1) in view of Baker et al. (US 20150025313 A1) and Stack et al. (US 20050096673 A1).
Regarding Claim 1, Baker discloses a method of applying stress with an intraluminal device to the cardiac region of the stomach to engage barro or stretch receptors in the stomach wall ("stress may be a force or pressure to stimulate receptors, such as stretch receptors, baroreceptors … cardiac portion of the stomach" [0033]), the device comprising a wall defining a surface with an open portion ("wall 24" [0036]; FIG. 2), said surface adapted to conform with the cardiac portion of the stomach ("surface may have a size and shape of the cardiac portion of the stomach" [0022]) with said open portion adapted to align with the gastroesophageal junction ("aligning the opening with the gastro-esophageal junction" [0045]), wherein said wall has a mean radius measured from said open portion (inherent physical property) and wherein said fastening is within a half of the radius closest to said open portion (see FIG. 17). Baker is silent regarding the remaining limitations.
Baker’313 teaches “a method of deploying an intraluminal device in a mammalian lumen” ([0004]), said method comprising: deploying the intraluminal device trans-orally to the stomach ("deployment device may be guided transorally into the stomach" [0009]). 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 incorporate the teachings of Baker’313 to safely and reliably deploy the intraluminal device “without the bulky and expensive equipment associated with radiography, such as fluoroscopy” and “eliminates the need for shielding of the patient and practitioners” ([0019]).
Baker/Baker’313 is silent regarding the remaining limitations. Stack teaches “methods and devices are described for retaining a medical implant within a body cavity” ([0014]) wherein said method comprises: fastening the intraluminal device to the cardiac portion of the stomach from within the abdominal cavity with at least one laparoscopic instrument ("Laparoscopic incisions are next formed into the abdominal cavity" [0126-0131]; FIG. 17); and wherein said fastening comprises at least one magnet magnetically attracting a metallic member, including the at least one magnet or the metallic member being on the wall of the intraluminal device and positioning the other of the at least one magnet or the metallic member in the abdominal cavity with the laparoscopic instrument ("fastener 96 may be magnetized to opposite polarities such that the attraction between them holds both the pledget, implant, and fastener against the stomach tissue" [0174]; FIG. 29D). Therefore, it would have been obvious to modify the device of Baker/Baker’313 to suitably “provide an anchoring mechanism that will retain an implant within the stomach and/or esophagus over an extended period of time” ([0013]).
Regarding Claims 2-4, Baker is silent regarding the limitations. However, Baker’313 teaches deploying comprises deploying the intraluminal device from a deployment device in the stomach ("cardiac member is deployed from said deployment device" [0008]) and retaining the intraluminal device comprises positioning the deployment device within the open portion of the wall in order to generally align the open portion with the GE junction ([0042]; FIG. 5); said retaining the device further comprises applying a proximal force on at least one retention filament ("attachment filament 58" [0045]) connected with the wall and the retention filament passing through the esophagus ([0045]; FIG. 8); and said deployment device comprises said intraluminal device position at an exterior surface of an endoscope ("fit over an endoscope shaft" [0050]; FIG. 18). Therefore, it would have been obvious to modify the device of Baker to safely and reliably deploy the intraluminal device “without the bulky and expensive equipment associated with radiography, such as fluoroscopy” and “eliminates the need for shielding of the patient and practitioners” ([0019]).
Regarding Claims 5-11 and 13-14, Baker discloses said fastening is within a third of the radius closest to said open portion (see FIG. 17); said fastening is within a quarter of the radius closest to said open portion (see FIG. 17); said intraluminal device has a plurality of structural members ("Esophageal wall 24 is defined by a support, such as a mesh" [0036]; FIG. 3) and has a higher density of said structural members proximal said opening than distal said opening (see FIG. 3); adjusting stress applied to the cardiac portion of the stomach with said intraluminal device ("titrating stress" [0040]); said adjusting stress comprises varying an amount of surface contact between the device wall and the stomach wall ("adjusted to make contact with the cardia or not make contact" [0046]); aid adjusting stress comprises at least one bladder between the intraluminal device and the cardiac portion of the stomach ("expandable device may include a bladder" [0016]); said at least one bladder connected with an external port or an internal control system ("control 236, 238" [0045]; FIG. 4); said wall includes an involute collar around said open portion ("Cardiac member 230 includes a collar 231 around an opening" [0045]; FIG. 4); and said intraluminal device is used to treat at least one chosen from obesity, a metabolic disease, gastric reflux and hiatal hernia ("treat the metabolic disease" [0011]).
Regarding Claim 12, Baker/Baker’313 is silent regarding the limitations. However, Stack teaches said intraluminal device is made at least in part from a bio-absorbable material ("bio-absorbable materials" [0010]). Therefore, it would have been obvious to modify the device of Baker/Baker’313 to “give different regions of the pouch different degrees of compliance so as to allow/limit expansion of the pouch in various locations” or “to provide a pouch with a fairly elastic exit port to as to prevent occlusion in the event a large piece of food is ingested and/or to control the exit pressure of food from the pouch” ([0010]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. (US 20160151233 A1) in view of Baker et al. (US 20150025313 A1), Stack et al. (US 20050096673 A1), and further in view of Foote et al. (US 20170360550 A1).
Regarding Claim 15, Baker/Baker’313/Stack is silent regarding the limitations. However, Foote teaches “an intraluminal device and method of fixation of an intraluminal device” ([0001]) including explanting the intraluminal device including withdrawing the intraluminal device through the esophagus ("device can be explanted by … withdrawing the esophageal member from the esophagus" [0087]). Therefore, it would have been obvious to modify the device of Baker/Baker’313/Stack to safely and easily retrieve the intraluminal device from the stomach ([0087]).
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
Prosecution Insights