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 Amendments
The Amendment filed 10/02/2024 has been entered.
Claims 3-5, 7, 8, 13, 17, and 18 are cancelled.
Claims 1, 2, 6, 9-12, and 14-16 remain pending in the application.
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, 2, 6, 9-12, and 14-16 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.
Claim 1 recites the limitation “the insertable portion” in line 3. There is insufficient antecedent basis for this limitation in the claim. The Examiner believes this is a typographical mistake and that the Applicant meant to recite “the proximal insertable portion”.
Claims 2, 6, 9-12, 14, and 15 are similarly rejected by virtue of their dependency upon claim 1.
Claim 16 recites the limitation “The anal irrigation probe of any of the preceding claims” in line 1. The phrase " of any of the preceding claims " renders the claim indefinite because it is unclear which claim the limitation following the phrase are part of dependent off of and further limit. See MPEP § 2173.05(d).
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.
Claims 1, 10, 11, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Falconer et al. (U.S. Publication No. 20030073974), hereinafter Falconer 1, in view of Falconer et al. (U.S. Publication No. 20030073963), hereinafter Falconer 2.
Regarding claim 1, Falconer 1 discloses an anal irrigation probe (probe 7) comprising (see FIGS. 3-5 the Examiner notes that all reference characters cited below refer to FIGS. 3-5 unless otherwise stated)
a proximal insertable portion (portion where outlet 13 is located) including a first interior lumen (proximal portion of tube 7A) configured for allowing irrigation liquid to flow through the proximal insertable portion and out of an eyelet (outlet 13) formed in a proximal end of the proximal insertable portion ([0018]),
a distal handle portion (portion where expandable cuff 14 is located) including a second interior lumen (distal portion of tube 7A) configured for allowing irrigation liquid to flow through the second interior lumen and into the first interior lumen (see FIG. 5);
wherein the distal handle portion includes an exterior wall (wall of cuff 14) and a partition wall (wall of tube 7A) disposed in the second interior lumen and attached to an interior surface of the exterior wall of the distal handle portion to form a cavity (chambers 18 and 19; see FIG. 5),
an absorbing material (absorbent material 20) disposed in the cavity (see FIG. 5), with the absorbing material having a first volume in a dry state and a second volume in a wetted state (the Examiner notes this limitation is inherently known of an absorbent material and is a result of the absorbing materials use under its intended conditions when exposed to liquid), with the second volume larger than the first volume and the cavity having a cavity volume exceeding the first volume of the absorbing material in the dry state (see FIG. 5),
an inlet (holes 21) formed in the partition wall and communicating with the absorbing material disposed in the cavity (see [0021]; see FIG. 5).
However, Falconer 1 does not expressly state an outlet formed in the exterior wall of the distal handle portion to expose the absorbing material to ambient atmosphere.
Falconer 2 teaches a bowel irrigation system having a probe (Abstract) comprising an outlet (valve 17) formed in the exterior wall of the distal handle portion (bulb 15) to expose the absorbing material to ambient atmosphere (see [0039]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the exterior wall of Falconer 1 to include an outlet formed in the exterior wall of the distal handle portion to expose the absorbing material to ambient atmosphere. Doing so would allow the device to go to an inflated condition from its deflated condition as taught by Falconer 2 (see [0039]).
Regarding claim 10, Falconer 1 in view of Falconer 2 teaches the claimed invention as discussed above concerning the rejection of claim 1, and Falconer 1 further teaches wherein the inlet (holes 21) formed in the partition wall (wall of tube 7A) comprises a distal inlet formed in the partition wall and communicating with the cavity (see FIG. 5).
Regarding claim 11, Falconer 1 in view of Falconer 2 teaches the claimed invention as discussed above concerning the rejection of claim 1, and Falconer 1 further teaches wherein the absorbing material comprises superabsorber comprising one of a polymer of acrylic acid and a carboxymethylcellulose (“Alternative absorbents can be chosen from a group comprising inorganic materials, such as liquid gels, or organic compounds, such as cross linked polymers, or alginates, reticular carboxymethylcelluloses, grafted starches, natural modified polysaccharides or synthetic derivatives of acrylamides, acrylonitriles or polyacrylates.”, [0022]).
Regarding claim 14, Falconer 1 in view of Falconer 2 teaches the claimed invention as discussed above concerning the rejection of claim 1, and Falconer 1 further teaches wherein the anal irrigation probe (probe 7) further comprises an inflatable balloon (cuff 14) that is inflatable to retain the anal irrigation probe in a rectum of a user (see [0027]).
Regarding claim 16, Falconer 1 in view of Falconer 2 teaches the claimed invention as discussed above concerning the rejection of claim 1, and Falconer 1 further teaches wherein the cavity volume is 20% larger than the first volume of the absorbing material in the dry state (“Instead of providing a tearing force to rupture the seal between the two chambers of the cuff 14A and 14B, a force can be exerted on a cuff-sealing member encircling the probe between the two chambers thereby causing the sealing member to slide coaxially along the probe and allowing the volume of the absorbent filled chamber to increase.”, [0030]).
However, neither Falconer 1 or Falconer 2 expressly slate 20% larger.
It would have been an obvious matter of design choice to increase the cavity volume 20%, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Falconer et al. (U.S. Publication No. 20030073974), hereinafter Falconer 1, in view of Falconer et al. (U.S. Publication No. 20030073963), hereinafter Falconer 2, in view of Henry et al. (U.S. Publication No. 20200206411), hereinafter Henry.
Regarding claim 2, Falconer 1 in view of Falconer 2 teaches the claimed invention as discussed above concerning the rejection of claim 1, and Falconer 1 further teaches irrigation liquid entering the cavity (chambers 18 and 19; see FIG. 5) and causes the absorbing material (absorbent material 20) to transition to the wetted state and increase from the first volume to the second volume (the Examiner notes this limitation is inherently known of an absorbent material and is a result of the absorbing materials use under its intended conditions when exposed to liquid).
However, Falconer 1 does not expressly state wherein the anal irrigation probe is configured for auto-priming where air entering the second interior lumen of the distal handle portion is vented through the inlet formed in the partition wall and out of the outlet formed in the exterior wall of the distal handle portion to provide an air bypass; and wherein the air bypass is closed to air passage by a portion of the irrigation liquid.
Henry teaches components for use in hollow organ irrigation systems (Abstract) wherein the anal irrigation probe (rectal catheter 46) is configured for auto-priming (priming configuration, see [0094]) where air entering the second interior lumen (tubing segment 54b) of the distal handle portion is vented through the inlet (the Examiner notes the fluid pathway of Folcaner 1 via holes 21 acting as the inlet would be the same pathway air would be vented through during the priming stage of Henry) formed in the partition wall and out of the outlet (57a) formed in the exterior wall of the distal handle portion to provide an air bypass; and wherein the air bypass is closed to air passage by a portion of the irrigation liquid (see [0094-0095]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the probe of Falconer 1 wherein it’s configured for auto-priming where air entering the second interior lumen of the distal handle portion is vented through the inlet formed in the partition wall and out of the outlet formed in the exterior wall of the distal handle portion to provide an air bypass; and wherein the air bypass is closed to air passage by a portion of the irrigation liquid. Doing so removes air from the system before the probe is inserted into the user/patient, as taught by Henry (see [0094]).
Claims 6, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Falconer et al. (U.S. Publication No. 20030073974), hereinafter Falconer 1, in view of Falconer et al. (U.S. Publication No. 20030073963), hereinafter Falconer 2, in view of Torstensen et al. (U.S. Publication No. 20030074018), hereinafter Torstensen.
Regarding claim 6, Falconer 1 in view of Falconer 2 teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Falconer 1 in view of Falconer 2 does not expressly state wherein the outlet formed in the exterior wall of the distal handle portion is one of a plurality of outlets formed in the exterior wall of the distal handle portion, and the plurality of outlets is provided by a porous foil.
Torstensen teaches a sealing device for sealing externally debouching, natural or artificial body canals (Abstract) wherein the outlet (openings 8) formed in the exterior wall of the distal handle portion is one of a plurality of outlets (see FIG. 1) formed in the exterior wall of the distal handle portion (portion of probe 1), and the plurality of outlets is provided by a porous foil (see [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the outlet of Falconer 1 and Falconer 2 wherein it is one of a plurality of outlets formed in the exterior wall of the distal handle portion, and the plurality of outlets is provided by a porous foil. Doing so facilitates easier extraction of the device due to smooth surface properties provided by the foil layer, as taught by Torstensen (see [0027]).
Regarding claim 12, Falconer 1 in view of Falconer 2 teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Falconer 1 in view of Falconer 2 does not expressly state wherein the absorbing material comprises a layer of foil on an exterior facing surface of the absorbing material.
Torstensen teaches a sealing device for sealing externally debouching, natural or artificial body canals (Abstract) wherein the absorbing material comprises a layer of foil (foil layer 11) on an exterior facing surface of the absorbing material (see [0027]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the absorbing material of Falconer 1 and Falconer 2 to comprise a layer of foil on an exterior facing surface of the absorbing material. Doing so facilitates easier extraction of the device due to smooth surface properties provided by the foil layer, as taught by Torstensen (see [0027]).
Regarding claim 15, Falconer 1 in view of Falconer 2 teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Falconer 1 in view of Falconer 2 does not expressly state wherein the anal irrigation probe further comprises a foam element that is inflatable to retain the anal irrigation probe in a rectum of a user.
Torstensen teaches a sealing device for sealing externally debouching, natural or artificial body canals (Abstract) wherein the anal irrigation probe further comprises a foam element that is inflatable to retain the anal irrigation probe in a rectum of a user (“The device is made from a resilient material e.g. a compressible open celled foam and can optionally be integrated with or include a sealing element.”, [0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the device of Falconer 1 and Falconer 2 to comprise a foam element that is inflatable to retain the anal irrigation probe in a rectum of a user. Doing so provides ease of insertion of the device while maintaining sufficient compressibility for use, as well as softness and conformability, as taught by Torstensen (see [0025]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Falconer et al. (U.S. Publication No. 20030073974), hereinafter Falconer 1, in view of Falconer et al. (U.S. Publication No. 20030073963), hereinafter Falconer 2, in view of Kalayci et al. (U.S. Publication No. 20090065436), hereinafter Kalayci.
Regarding claim 9, Falconer 1 in view of Falconer 2 teaches the claimed invention as discussed above concerning the rejection of claim 1, however, Falconer 1 in view of Falconer 2 does not expressly state wherein the inlet formed in the partition wall comprises a mesh-material porous to air and liquid.
Kalayci teaches webs, filters, and other flow-through/flow-by structures comprising a layer with superabsorbent particulate, fiber, or fabric ([0010]) wherein the inlet formed in the partition wall comprises a mesh-material porous to air and liquid (see [0016;0082]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the inlet of Falconer 1 and Falconer 2 to comprise a mesh-material porous to air and liquid. Doing so would absorb acidic, basic, and organic and water vapors, as well as several specific classes of compounds including reactive carbonyl compounds, including formaldehyde, acetaldehyde and acetone, as taught by Kalayci (see [0082]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON ALVARADO whose telephone number is (703) 756-5301. The examiner can normally be reached on M-F 8:30am-5pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/Nelson Alvarado/
Junior Examiner , Art Unit 3783
08/19/2026
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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