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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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, and 5 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.
The term “minimal” in claim 2 is a relative term which renders the claim indefinite. The term “minimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The terms “soft” and “minimal” in claim 3 are relative terms which render the claim indefinite. The terms “soft” and “minimal” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 5 recites “the tube cannot be occluded if inserted too far into the pellet”. The limitation “too far” renders the claim indefinite as the meets and bounds of “too far” are not defined as claimed.
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.
Claims 1, 2, 5, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dall et al. “Biochemical all properties of the human rectum. A study with impedance planimetry.” Gut, November 1993, vol. 34, no. 11, pages 1581-1586.
Regarding claim 1, Dall teaches a system (Figure 1), comprising: a pellet comprising a balloon or bag (“pellet” construed as balloon, Figure 1; pg. 1582, col. 1, paragraph 1); and a fill tube configured to be removably coupled to the pellet, the fill tube configured to permit selective filling of the balloon or bag (“fill tube” construed as infusion channel as shown in Figure 1; pg. 1582, col. 1, paragraph 1; Since “removably coupled” is not further defined, the infusion channel is considered “removably coupled” as the channel is capable of being severed, thus “removed” from its extension from the balloon, see Figure 1.).
Regarding claim 2, Dall teaches the fill tube is configured to be selectively removable from the pellet with minimal forces on the pellet so as not to move it from a chosen anatomical position within a gastrointestinal tract of a patient when the pellet is positioned therein (at least a portion of the inflation channel, i.e. “fill tube”, may be cut from the balloon, i.e. “pellet”, once placed in position within the patient: pg. 1582, col. 2, paragraphs 2-3; see rejection under 35 U.S.C. 112(b) above).
Regarding claim 5, Dall teaches the fill tube has one or more side holes defined therein and an angled tip so that an end of the tube cannot be occluded if inserted too far into the pellet (“side hole” construed as apertures of “I = infusion channels”, Figure 1 caption; “angled tip” construed as rounded tip of infusion channel tube at distal end of robe, Figure 1).
Regarding claim 14, Dall teaches the pellet comprises one or more electrical stimulating sensors configured to facilitate motility of the pellet within a gastrointestinal tract when positioned therein (“electrical stimulating sensors” construed as stimulating electrodes “E”, see Figure 1 and caption; pg. 1581, col. 2, paragraph 4).
Regarding claim 15, Dall teaches when the pellet is positioned within a gastrointestinal tract, expulsion of said pellet can be detected using one or more of pressure data, cross-sectional area data, and temperature data, said data obtained by said pellet (The limitation “expulsion of said pellet can be detected using one or more of pressure data, cross-sectional area data, and temperature data, said data obtained by said pellet” is functional language. Since the pellet has cross-sectional area detection electrodes, expulsion of the pellet can be detected: pg. 1582, col. 2, paragraph 3; abstract).
Claims 1-4, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2005/0033331 (Burnett et al.).
Regarding claim 1, Burnett teaches a system (Figures 1A and 6A; [0063]; [0079]), comprising: a pellet (4) comprising a balloon or bag (members 14, 16 of device 4 inflated, [0063]; [0079]; Figures 1A and 6A); and a fill tube (8) configured to be removably coupled to the pellet, the fill tube configured to permit selective filling of the balloon or bag (tubing 8 delivers fluid, such as saline, that causes self-expanding foam in members 14, 16 to expand, [0063]-[0064]; tubing 8 detaches from device 4, [0079]; Figure 6C).
Regarding claim 2, Burnett teaches the fill tube (8) is configured to be selectively removable from the pellet (4) with minimal forces on the pellet so not to move it from a chosen anatomical position within a gastrointestinal tract of a patient when the pellet is positioned therein ([0079]; Figure 6B-C).
Regarding claim 3, Burnett teaches the fill tube (8) comprises one or more soft and compliant materials with minimal structural rigidity so as to not impart mechanical sensations to an anus or rectum of a patient with the fill tube is positioned therein (The limitation “so as to not impart mechanical sensations to an anus or rectum of a patient with the fill tube is positioned therein” is functional language. The “fill tube” 8 is shown as flexible, thus is capable of performing the claimed intended use, Figures 6A-C).
Regarding claim 4, Burnett teaches the pellet (4) further comprises a resealable septum (6) at an end of the pellet, and wherein the fill tube (8) is further configured to pierce the resealable septum to permit filling the balloon or bag with saline or another fluid ([0063]).
Regarding claims 12 and 13, Burnett teaches the pellet (4) further comprises a passive self-inflating sponge positioned therein; wherein the self-inflating sponge is configured to expand when a liquid is introduced into the balloon or bag from the fill tube (8) (tubing 8 delivers fluid, such as saline, that causes self-expanding foam in members 14, 16 to expand, [0063]-[0064]).
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.
Claims 6, 7, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2005/0033331 (Burnett et al.).
Regarding claim 6, Burnett teaches all the limitations of claim 1. Burnett teaches the tubing (8) “may include any number of delivery tubes such as catheters, endoscopes, etc.” ([0063]), but does not expressly state the cited embodiment includes a removable exterior tube positioned around at least part of the fill tube, the removable exterior tube configured to protect and support the fill tube. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fill tube of the system of Figures 1A and 6A to include a removable exterior tube positioned around at least part of the fill tube, wherein the removable exterior tube is configured to protect and support the fill tube, based on the teachings of Burnett, in order to support the fill tube during insertion to its desired location within the patient.
Regarding claim 7, Burnett as modified teaches all the limitations of claim 6. Burnett, as cited, fails to disclose a tether coupled to the pellet, said tether positioned in an annular space between the removable exterior tube and the fill tube.
However, Burnett teaches an alternative embodiment wherein a tether is coupled to the pellet ([0083]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Figures 1A and 6A to include a tether coupled to the pellet as taught by the alternative teaching of Burnett, in order to facilitate retrieval of the device “if it does not deploy as desired” and/or for retaining the device in place ([0083]). Burnett as modified does not specify the tether is positioned in an annular space between the removable exterior tube and the fill tube. When the exterior tube is positioned around the fill tube and the tether is in place in the modified system, it would have been obvious to one of ordinary skill in the art to further modify the system of Burnett to direct the tether into the annular space between the fill tube and the exterior tube, such that the fluid channel of the fill tube is not obstructed and the tether is shielded from catching tissue or organ structures when the pellet is navigated along the gastrointestinal tract to be deployed in its final position.
Regarding claims 10 and 11, Burnett teaches all the limitations of claim 1. Burnett teaches the pellet further comprises one or more magnets therein, and wherein when the pellet is positioned within the gastrointestinal tract, said pellet can be moved along or held in place in the gastrointestinal tract using an external magnet.
However, Burnett teaches an alternative embodiment wherein the pellet is “removed” via a “magnetic tipped suction catheter or endoscope” (magnetic tip of catheter/endoscope 94 is construed as the “external magnet” as it is external relative to the “pellet”, thus in order to magnetically capture and remove the device, the device must include a magnetic element, [0084]; Figures 10A-D). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pellet of Figures 1A and 6A to include a magnet that may be manipulated, such as held in place or moved along, via an external magnet, as taught by the alternative teaching of Burnett in order to facilitate capture and retrieval of the pellet as needed ([0083]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Dall et al. “Biochemical all properties of the human rectum. A study with impedance planimetry.” Gut, November 1993, vol. 34, no. 11, pages 1581-1586. in view of U.S. Patent Application Publication No. 2008/0027358 (Gregersen et al.).
Regarding claim 16, Dall teaches all the limitations of claim 1. Dall does not specify the pellet is configured to receive power by way of radiofrequency or ultrasound energy external transmission.
However, Gregersen teaches a system for determining morphometric properties of the gastro intestinal tract (thus is analogous to Dall, [0001]; [0011]), comprising a pellet configured to receive power by radiofrequency external transmission ([0038]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pellet of Dall to receive power via radiofrequency transmission as taught by Gregersen, in order to wirelessly deliver power to the internal device (Gregersen: [0038]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2005/0033331 (Burnett et al.) in view of WO 2007/139920 (Binmoeller et al.).
Regarding claim 16, Burnett teaches all the limitations of claim 1. Burnett does not specify the pellet is configured to receive power by way of radiofrequency or ultrasound energy external transmission.
However, Binmoeller teaches a system for controlling a device for insertion at the pyloric valve (thus is analogous to Burnett, abstract), comprising: a pellet configured to receive power by way of radiofrequency or ultrasound energy external transmission (radiofrequency power, [00157]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Burnett such that the pellet is configured to receive power via radiofrequency transmission as taught by Binmoeller in order to wirelessly deliver power to the internal device (Binmoeller: [00157]).
Allowable Subject Matter
Claims 8, 9, and 17-20 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 following is a statement of reasons for the indication of allowable subject matter:
No prior art of record teach and/or fairly suggest the system of claim 8, comprising a tube valve configured to effectively seal a space between the removable exterior tube and the fill tube, within the context of all the limitations of parent claims 1, 6, and 7.
No prior art of record teach and/or fairly suggest the method of claim 17, comprising inserting the pellet of claim 8 into a patient’s anus using the fill tube, and tightening the tube valve such that the tether and fill tube may be used to position the pellet into a desired location within a gastrointestinal tract of the patient, within the context of all the limitations of parent claims 1 and 6-8.
The closest prior art of record, Dall and Burnett as cited above, each fail to disclose a tube valve configured to seal the space between the fill tube and a removable exterior tube, as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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, Alexander Valvis can be reached at 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CARRIE R DORNA/Primary Examiner, Art Unit 3791