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
This office action is in response to the amendment filed July 21, 2025. Claims 1 is amended. Claim 3-6, 8-11, 13-15, 17-20, 22-25, 27-51, 54-56, 59-62, and 67 stand canceled. Claims 52, 53, 57, 58, 63-66, 68, 69 and 71 stand withdrawn. Claims 1-2, 7, 12, 16, 21 and 26 are pending and addressed below.
Response to Argument
Applicant’s arguments with respect to claim(s) 1 has been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouasaysy et. al. (U.S. Pub. No. 2014/0031850)(cited in ISR for PCT/US19/55364) hereafter, “Bouasaysy,” in view of Pattison et. al. (U.S. Pub. No. 2015/0150699), hereinafter, “Pattison,” and further in view of Levy et. al. (U.S. Pub. No. 2005/0273060), hereinafter, “Levy.”
Regarding claim 1, Bouasaysy teaches a bariatric balloon system (10; Fig. 1) for reducing a volume of a stomach having a stomach wall of a patient having a body, said system (10) comprising:
a. a tube (300; Fig. 5) configured to be directed from external to the body into the stomach (pp. [0026]),
b. a first balloon (30a; Fig. 3) fluidly connected to the tube (300) by a first sub-port (46a); and
c. a second balloon (30b; Fig. 3) fluidly connected to the tube (300) by a second sub-port (46b) disposed below the first balloon (30a);
wherein the first balloon (30a) and the second balloon (30b) are inflatable by inserting fluid into the tube (300, pp. [0026]).
However, Bouasaysy does not explicitly disclose the tube deliverable to the stomach through the stomach wall with a port disposed external to the body of a patient as claimed.
Pattison teaches a bariatric balloon system (Fig. 5) with a tube (450; Fig. 5) configured to be directed from external to the body through the stomach wall, and into the stomach (see Fig. 5), the tube (450) comprising a port (10; Figs. 2 & 5) at a first end, the port (10) comprising a flange (48; Fig. 2) having a diameter greater than the tube (450, see Fig. 5), wherein the port (10) is configured to be disposed external to the body of the patient (see Fig. 5), and
a balloon (400; Fig. 4) that is inflatable by inserting fluid into the tube (450) via the port (10, pp. [124]).
Pattison is considered to be analogous to the claimed invention because it is in the same field of bariatric balloon systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tube of Bouasaysy to incorporate the teachings of Pattison by providing the tube with a port with a flange configured to be placed external to the body. It is well known in the art that gastric balloons can be inflated via a tube inserted either through the esophagus or stomach wall. Proving a port on the stomach wall to insert fluid into the tube would be a simple substitution of one known method of supplying inflation fluid for another to obtain the predictable results of providing an inflatable bariatric balloon.
Further, Bouasaysy does not explicitly disclose the second balloon is fluidly connected the first balloon by the second sub-port, wherein the first balloon reaches its maximum volume before the second balloon reaches its maximum volume.
Levy teaches a bariatric balloon device (Fig. 12) with a similar configuration to that of Fig. 3 in Bouasaysy with a first balloon (30’; Fig. 12) fluidly connected by a first sub-port (34’; Fig. 12); and a second balloon (40’; Fig. 12) fluidly connected a second sub-port (44’; Fig. 12) disposed below the first balloon (30’), but likewise does not explicitly disclose the two balloons fluidly connected via the second sub-port.
Levy also teaches an alternative configuration of a bariatric balloon device (Fig. 10) with a first balloon (30; Fig. 10) fluidly connected to a tube (24; Fig. 10) by a first sub-port (34; Fig. 10); and a second balloon (40; Fig. 10) fluidly connected to the first balloon (30) by a second sub-port (44; Fig. 10) disposed below the first balloon (30); wherein the first balloon (30) and the second balloon (40) are inflatable by inserting fluid into the tube (24, pp. [0120]); and the first balloon (30) reaches its maximum volume before the second balloon (40) reaches its maximum volume (it is noted, there is no description in Applicant’s Specification that describes how or why the first balloon reaches its maximum volume before the second balloon reaches its maximum volume. Based on Fig. 1 of Applicant’s disclose, one of ordinary skill in the art would expect first ballon 110a to reach its maximum volume before second balloon 110b due to how they’re coupled to one fill tube and sequentially oriented in an axial manner. Likewise, given the similar structure of Levy, one of ordinary skill in the art would expect the first balloon 30 to reach its maximum volume before the second balloon 40 because balloons 30 and 40 are sequentially oriented along the length of the same fill tube 24, and therefore, fluid going in the fill tube 24 would travel mainly through sub-port 34 first into balloon 30 to fill before moving further down into sub-port 44.
Levy is considered to be analogous to the claimed invention because it is in the same field of bariatric balloon systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bariatric balloon configuration of Bouasaysy to incorporate the teachings of Levy by having both sub-ports fluidly connect both balloons to the same fill tube. Doing so would be a simple substitution of one known bariatric balloon configuration for another to obtain predictable results of providing a bariatric balloon system with a reasonable expectation of success.
Regarding claim 26, Bouasaysy in view of Pattison and further in view of Levy teaches the invention as discussed above in claim 1. However, Pattison does not explicitly disclose that at least a portion of the tube (450) is flexible. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the invention of Bouasaysy in view of Pattison and further in view of Levy to have at least a portion of the tube be flexible since it has been held that “in considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968); MPEP 2144.01. Paragraph [0116] of Pattison teaches that the tube (fluid conduit) does not affect the balloon’s ability to be positioned and inflated/deflated. One of ordinary skill in the art would reasonably infer that at least a portion of the tube is flexible to allow for movement and inflation of the balloon.
Claim(s) 2, 7, 12, 16, and 21 /are rejected under 35 U.S.C. 103 as being unpatentable over Bouasaysy, in view of Pattison, in view of Levy, and further in view of Schwab et. al. (U.S. Pub. No. 2013/0035711) hereinafter, “Schwab.”
Regarding claim 2, modified Bouasaysy teaches the invention as discussed above in claim 1. Bouasaysy further teaches the bariatric balloon system can include additional balloons (pp. [0018]) but does not explicitly teach a third balloon as claimed.
Scwab teaches bariatric balloon systems can alternatively have two balloons (Figs. 6F & 6G) or three balloons (Figs. 6A-6E).
Scwab is considered to be analogous to the claimed invention because it is in the same field of bariatric balloon systems. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bouasaysy to incorporate the teachings of Scwab by adding a third balloon below the second balloon. Adding an additional balloon can add certain benefits such as increased conformance of anatomy or reduced patient adverse events as taught by Schwab (pp. [0048]).
Further, one having ordinary skill in the art would understand adding a third balloon to the balloon system of Bouasaysy would include filling the third balloon via the same port as the first and second balloons.
Regarding claim 7 modified Bouasaysy teaches the invention as discussed above in claim 2. Scwab further teaches the third balloon (e.g. the bottom balloon; Fig. 6D) is below the second balloon (e.g. the middle balloon; Fig. 6D).
Regarding claim 12 modified Bouasaysy teaches the invention as discussed above in claim 2. Further, one of ordinary skill in the art would expect an added third balloon to reach its maximum volume before the second balloon for the same reason the first balloon would reach its maximum volume before the second balloon. Sequentially adding a third balloon along the same fill tube as the second balloon would lead to fluid moving through the second sub-port into the second balloon to fill before moving further down into a third sub-port connected to the third balloon.
Regarding claims 16 and 21, modified Bouasaysy teaches the invention as discussed above in claims 1 and 2. Scwab further teaches the first balloon (e.g. the top balloon; Fig. 6D) has a maximum volume larger than that of the second balloon (e.g. the middle balloon; Fig. 6D) and the second balloon (middle balloon) has a maximum volume larger than that of the third balloon (e.g. the bottom balloon; Fig. 6D).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Bouasaysy to incorporate the teachings of Scwab by having the first balloon have a greater volume than the second balloon and the second balloon have a volume greater than the third balloon. Changing the sizes of the balloon can add certain benefits such as increased conformance of anatomy, reduced balloon stresses, or reduced patient adverse events as taught by Schwab (pp. [0048]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sosnowski (US-20080319471-A1)(Fig. 1) teaches a bariatric balloon with a similar configuration to that shown in Fig. 3 of Bouasaysy.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771