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 responsive to the amendment filed on 9/12/25. As directed by the amendment: claims 1, 6, 7, 9, 11, 13, 15, 16, 18, 21, 27, 31, and 32 have been amended, 2, 3, 5, 8, 10, 12, 14, 17, 20, 23, 24, 26, 28-30, and 33 have been cancelled, and no new claims have been added. Thus, claims 1, 4, 6, 7, 9, 11, 13, 15, 16, 18, 19, 21, 22, 25, 27, 31, and 32 are presently pending in this application.
Claim Objections
Claim 1 is objected to because of the following informalities: “the inflatable body” line 18 would be best amended as “the at least one inflatable body” to reflect the other claim amendments that have been made. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 4, 6, 7, 9, 11, 13, 15, 16, 18, 19, 21, 22, 25, 27, 31, and 32 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites the limitation “the insufflation conduit is disengaged from the port allowing the inflatable body to remain thereby occluding the lumen [of the patient] at the location of placement”. As worded, this limitation appears to recite a portion of a human organism by attempting to positively recite the placement of the body in the patient. Claim 11 goes further by reciting “the at least one inflatable body is positioned upstream to an anastomosis”, which similarly appears to recite a portion of a human organism by attempting to positively recite the placement of the body in the patient. The remainder of the claims incorporate a limitation identified above and are rejected for the same reason.
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 1, 4, 6, 7, 9, 11, 13, 15, 16, 18, 19, 21, 22, 25, 27, 31, and 32 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 1, lines 5-6 appear to begin to recite a conditional/temporal limitations utilizing the term “when”, but appear to be missing a connection to what is being claimed “when” the body is in the inflated state. It is also unclear if every limitation thereafter is supposed to be conditional on the inflated state, which would itself be indefinite. The limitations in option (iii) might be considered to complete the phrase, however, there is no clear connection between these two limitations and it would remain unclear how limitations (i), (ii), and (iv), and the insufflation conduit limitations from lines 7-9, should be interpreted relative to the “when” statement.
Further regarding claim 1, the limitation “the insufflation conduit is disengaged from the port allowing the inflatable body to remain thereby occluding the lumen at the location of placement”, as worded, appears to attempt to positively recite a method step within a product claim, and is therefore indefinite. For the purposes of examination, this limitation will be interpreted functionally.
Finally, regarding claim 1, it is unclear how the use of “and/or” in the next to last line is to be interpreted relative to the various limitations recited in the claim. For the purposes of examination, each of elements (i), (ii), (iii), and (iv) will be interpreted as alternative limitations, connected together by “and/or”.
Regarding claim 11, the claim appears to attempt to positively recite a method step within a product claim, and is therefore indefinite. For the purposes of examination, this limitation will be interpreted functionally.
The remaining claims rejected as they depend from a claim rejected above and inherit those deficiencies.
Claim Rejections - 35 USC § 102
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, 7, 9, 11, 13, 15, 16, 18, and 27, all as best understood, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miraki (US 5549554).
Regarding claim 1, as best understood, Miraki discloses an apparatus for occluding a lumen of a patient (fig. 1), comprising: at least one inflatable body (comprising 106b and 104b) for placement in a lumen of the patient, the at least one inflatable body comprising a first end (ending where 106b is located) and a second end (opposite end of 104b), the second end comprising a port (opening proximal end of 104b) for removably engaging an insufflation conduit (116 and 102) to inflate the at least one inflatable body to an inflated state, such that when the at least one inflatable body is in the inflated state (fully capable of achieving an inflated state, according to this limitation as best understood), an insufflation conduit (116 and 102) for affixing to the port (see fig. 1) said insufflation conduit for delivering a fluid to the at least one inflatable body to expand the at least one inflatable body to the inflated state; wherein (iii, chosen from among alternative limitations i-iv as best understood) the insufflation conduit is disengaged from the port allowing the inflatable body to remain thereby occluding the lumen at the location of placement (fully capable of disengagement at 108a).
Regarding claim 4, Miraki discloses the insufflation conduit is associated with an insufflator (inflation source to be connected to 178 of 116) for delivering a fluid (col. 1, ln. 57).
Regarding claim 6, Miraki discloses the at least one inflatable body comprises a flexible material (col. 11, ln. 7-18).
Regarding claims 7 and 13, Miraki discloses the limitations of alternative iii from claim 1, the limitations of claims 7 and 13 being further limiting with regard to one or more of alternatives i or ii.
Regarding claim 9, Miraki discloses the at least one inflatable body comprises a rigid portion that attaches to a scope (col. 11, ln. 47-64, which describes a rigid attachment portion fully capable of attachment to a scope).
Regarding claim 11, as best understood, Miraki discloses a device that is fully capable of use in conjunction with a surgical event comprising an anastomosis and positioning upstream relative to an anastamosis (see fig. 1).
Regarding claims 15, 16, and 18, Miraki discloses multiple inflatable bodies (106a/104a in addition to 106b/104b) both associated with the inflation conduit (116 and 102), such that fluid flow passes from the insufflation conduit through the multiple inflatable bodies to expand them (see fig. 1 and 2; 116 and 102 combine to deliver fluid into both inflatable bodies), the insufflation conduit comprising multiple inflation ports (110a and 110b); in addition to the inflatable body of claim 1 (104b/106b) having a first end (ending where 106b is located) and a second end (opposite end of 104b), additional inflatable body (104a/106a) having a first end (end opposite of 106a) and a second end (end where 106a is located), the first end of the second inflatable body connected to the second end of the first inflatable body (via mutual connection to either end of 116/102) by a connection mechanism (108a/b).
Regarding claim 27, Miraki discloses a kit (fig. 1) comprising: an apparatus 100; a placement tool (guidewire 114b); and an insufflation conduit (116 and 102) for delivering fluid.
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) 19, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Miraki in view of Liprie (US 6770058).
Regarding claim 19, Miraki discloses the apparatus as claimed, except for disclosing the connection mechanism comprises a luer lock mechanism. However, Miraki teaches that a variety of connections may be used to join the disclosed elements together (col. 6, ln. 16-18), and Liprie additionally teaches utilizing a luer lock mechanism to fluidly couple portions of a catheter system together (col. 4, ln. 9-22). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute a luer lock mechanism as taught by Liprie for the connectors as disclosed by Miraki, since such a modification is the result of simple substitution of one known element for another, as envisioned by Miraki, to achieve a predictable result of providing a fluidic connection.
Claim(s) 21, 22, and 25, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Miyaki in view of Nguyen et al. (US 20090204068).
Regarding claim 21, Miraki discloses a method for occluding a lumen in a subject, comprising: insertion of the apparatus of claim 1 into the lumen with a placement tool (guidewire; col. 15, ln. 8-23); placing the apparatus in the lumen at a point of placement upstream of a target area (col. 5, ln. 12-25; inflation assembly is maneuvered to a position across the target area, which will include at least a portion being at a point of placement both upstream and downstream of the target area; alternatively, the portion of the apparatus between balloon 106a/b and proximal elements 116/102 is considered to be at a point of placement upstream of the target area relative to the flow of inflation fluid); delivering a fluid to the apparatus via a port on the apparatus to inflate the apparatus, such that the apparatus contacts the lumen to occlude the lumen at the point of placement of the apparatus in the lumen (col. 5, ln. 12-25); except for disclosing removing the placement tool from the lumen, thereby leaving the apparatus in the lumen. However, Nguyen et al. teaches placing a balloon catheter utilizing a guidewire placed through a guidewire lumen, and the retracting the guidewire from the lumen to utilize the lumen to deliver another tool during placement of the balloon catheter (par. 0018). 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 method of Miyaki as taught by Nguyen et al. in order to provide additional treatment at or near the target area while the apparatus is in place.
Regarding claim 22, Miyaki discloses the delivery of fluid occurs by connecting an insufflation conduit to a port 178 of the apparatus.
Regarding claim 25, Miyaki discloses visualizing the placement of the apparatus with an imaging device (col. 1, ln. 48-54).
Claim(s) 31 and 32, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Miraki in view of Freyman (US 20030114793).
Regarding claims 31 and 32, as best understood, Miraki discloses the apparatus as claimed, except for the at least one inflatable body comprising one or more channels to provide a passage of fluid therethrough or one or more protrusions on an exterior portion thereof to interface with a lumen to secure the apparatus in the lumen. However, Freyman teaches providing a plurality of protruberances 83 on the exterior of an inflatable body which also provide channels (see fig. 5), in order to deliver therapeutic fluid to the treatment site (par. 0031). 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 inflatable body of Miraki to include protuberances and channels, as taught by Freyman, in order to provide sufficient structure to deliver beneficial agents at the treatment site.
Response to Arguments
Applicant's arguments filed 9/12/25 have been fully considered but they are not persuasive.
Regarding applicant’s arguments on page 7 of the Remarks, examiner notes that it does not appear that claim 1 requires all of (i)-(iv) as claimed. See the rejections above. In light of the alternative nature of these limitations, applicant argues with respect to limitation (iii), which is rejected above, that Miraki does not teach disengagement while the inflatable body is in the patient. Examiner notes that claim 1 is a product claim, and that this limitation can only be interpreted as being functional and/or reciting an intended use of the apparatus. As noted previously and in the rejection above, Miraki’s structure, due to its ability to disengage, is fully capable of being disengaged when placed as recited in claim 1.
Regarding claim 21, Applicant further argues on page 8 of the Remarks that there is no suggestion or purpose of leaving the apparatus of Miraki in the lumen based on the disclosure of Miraki. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached notice of references cited.
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 NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783