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
The amendment filed 6/12/26 has been entered. Claims 1, 3-4, 7-8, and 12-21 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 3/27/26.
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.
Claim 21 is 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 21, the limitation of “anal probe wherein the proximal tip portion of the stem comprises support arms adapted to fold inwardly when the retention part is compressed” renders the claim unclear. The Examiner is unsure if the support arms are intended to be in reference to the foldable arms of claim 1, or new, separate arms that are also configured to fold. Based on the specification and drawings, the Examiner is interpreting “support arms” to be in reference to the “foldable arms” of claim 1.
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.
Claim(s) 1, 3, 7-8, 12, 17-18, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexandersen (US 20020019613 A1) in view of Shuffield (US 4516578 A).
Regarding claim 1, Alexandersen discloses an anal probe for use in an anal irrigation procedure (abstract & Fig. 1), the anal probe comprising:
a stem having a distal end and a proximal tip portion (catheter 2 having a distal end at connector part 8 and a proximal tip portion by eyes 7, [0036] & Fig. 1-3), the stem comprising; an internal lumen, the internal lumen extending from the distal end to the proximal tip portion (“The catheter 2 is a conventionally female or male urinary catheter, that is hollow…”, [0036] & Fig. 3 and 11), an eyelet, the eyelet within the proximal tip portion and in communication with the internal lumen (eyes 7 formed in the proximal tip and communicating with catheter 2 to deliver irrigation medium 4, [0036], [0044], and [0070] & Fig. 1-3 and 11);
a retention part, the retention part formed of a compressible material that is configured to be compressed to allow insertion of the retention part into a rectum and further allow the retention part to expand inside the rectum to press against a wall of the rectum (“fixation member 6 for fixation of the catheter 2 inside the body canal 21 and for providing a liquid tight seal between the catheter 2 and the body canal 21”, [0034] & Fig. 1-3 and 5; “the fixation member 6 is made of compressible material. This compressible material may e.g. be a foam or a molded elastic material.”, [0037] and [0040]-[0042] and [0044]; “the fixation member 6 comprises a resilient compressible plug-like body of molded material, which body, when inserted into the body canal, is self expandable to a cross-sectional dimension ensuring closure of the body canal 21, 22.”, [0039]; also see [0046] and [0049]), the retention part having a distal portion and a proximal portion, the distal portion having a first radial extent which is smaller than a second radial extent proximally of the distal portion (fixation member 6 having a bowl shape, the distal portion having a first radial extent smaller than a second radial extent proximally of the distal portion, see Fig. 3 and 11 & [0046] and [0056] and [0058]), and
the retention part comprising: a central bore, the central bore located within the distal portion of the retention part and fixedly attached to the stem distal of the eyelet (the distal portion of fixation member 6 having a bowl shape comprising a central bore, see Fig. 2-3 and 11 & [0046]; the distal portion of fixation member 6 is attached to catheter 2 distal to eyes 7 using, for example, members 26 or grooves 27 in the central bore, [0051] & Fig. 2-3, 6, 8, and 11).
However, Alexanderson fails to explicitly disclose the retention part comprising foldable arms attached to the proximal tip portion of the stem, wherein the foldable arms provide structure to the retention part.
However, Shuffield teaches an anal probe (abstract and Fig. 11) comprising a retention part (diaphragm part 14, col 5 lines 14-40 & Fig. 6 and 11) comprising foldable arms attached to the proximal tip portion of the stem, wherein the foldable arms provide structure to the retention part (diaphragm part 14 comprises fins 50, attached to the proximal top portion of tube 11, configured to fold inwardly when diaphragm 14 is compressed, see Col 6 last paragraph-Col 7 second paragraph & Fig. 11-12; “It has been found that these upstanding ribs provide a particularly advantageous balance between sufficient flexibility to facilitate and sufficient rigidity to remain in place during use.”, col 6 line 64-col 7 line 6 & Fig. 6 and 11).
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 anal probe of Alexandersen with Shuffield to include foldable arms attached to the proximal tip portion of the stem, wherein the foldable arms provide structure to the retention part, since such a modification would provide added rigidity to the retention part to help keep the retention part in place during use and yield predictable results pertaining to enhanced stiffening of the retention part for secure positioning (Col 2 lines 18-31 and Col 6 last paragraph-Col 7 first paragraph of Shuffield).
Regarding claim 3, Alexandersen discloses all the limitations of claim 1. Alexandersen further discloses the anal probe wherein a proximal-most tip of the stem is closed off to provide a closed tip, and the eyelet is formed in a sidewall of the stem (the proximal-most tip of catheter 2 is seen closed off creating a closed tip with eyes 7 formed in a sidewall of catheter 2, see Fig. 1-11 and [0036]).
Regarding claim 7, Alexandersen discloses all the limitations of claim 1. Alexandersen further discloses the anal probe wherein a proximal end of the retention part is circular (the proximal end of fixation member 6 is circular, see Fig. 2-3 and 11 & [0046] and [0058]).
Regarding claim 8, Alexandersen discloses all the limitations of claim 1. Alexandersen further discloses the anal probe wherein the distal portion and the proximal portion of the retention part form a conical retention part (the proximal and distal portions of member 6 form a conical retention part, see [0058] & Fig. 2-3 and 11).
Regarding claim 12, Alexandersen discloses all the limitations of claim 1. Alexandersen further discloses the anal probe wherein the retention part is made of foam ([0037] and [0080]).
Regarding claims 17-18, Alexandersen discloses all the limitations of claim 1. Alexandersen further discloses the anal probe further comprising a film-element configured to retain the anal probe in a storage configuration wherein the retention part of the anal probe is compressed and maintained inside of the film-element such that a diameter of the retention part in the storage configuration is smaller than a diameter of the retention part in a use configuration (film material 24 configured to retain fixation member 6 in a compressed state before insertion, [0041] and [0068] & Fig. 1-2 and 4; film material 24 is configured to maintain member 6 in a compressed state until inserted, upon which member 6 expands, [0042] & Fig. 2-3; “shown in FIG. 2 the fixation member 6 is kept compressed by a film of PVA. When the fixation member 6 comes into contact with the humidity of the rectum the PVA film will start to dissolve and the fixation member 6 will expand.”, [0046] and [0049]), wherein the film-element is made of a water-soluble film ([0043], [0081], and [0097]).
Regarding claim 20, Alexandersen discloses all the limitations of claim 1. Alexandersen further discloses the anal probe wherein a proximal-most tip of the proximal tip portion of the stem comprises a hemispherical cap (the proximal most tip of the proximal tip portion of catheter 2 is seen comprising a hemispherical end or cap, all of Figs. 1-15).
Regarding claim 21, Alexandersen discloses all the limitations of claim 1. Alexandersen, as modified, discloses the anal probe wherein the proximal tip portion of the stem comprises support arms adapted to fold inwardly when the retention part is compressed (fins 50 configured to fold inwardly when diaphragm 14 is compressed, see Col 6 last paragraph-Col 7 second paragraph & Fig. 11-12 of Shuffield).
Claim(s) 4 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexandersen (US 20020019613 A1) in view of Shuffield (US 4516578 A), and further in view of Montgomery (US 0724913 A).
Regarding claims 4 and 19, Alexandersen discloses all the limitations of claim 1. Alexandersen further discloses the anal probe wherein the proximal portion of the retention part comprises a rim located at a proximal end of the anal probe (proximal portion of fixation member 6 is seen comprising a rim located at a proximal end of the anal probe, see Fig. 3 and 11).
Alexandersen further discloses that “The length… of the catheter 2… can be chosen according to the actual need” ([0070]) but fails to explicitly disclose a proximal-most tip of the proximal tip portion of the stem does not extend proximally beyond the rim and the rim extends proximally beyond a proximal-most tip of the proximal tip portion of the stem.
However, Montgomery teaches anal probe (Col 1 second paragraph & Fig. 1-2 and 4) wherein a proximal-most tip of the proximal tip portion of the stem does not extend proximally beyond the rim and the rim extends proximally beyond a proximal-most tip of the proximal tip portion of the stem (stem 1 includes a discharge end forming a proximal-most tip of a proximal tip portion of stem 1, see Fig. 2 & col 2 first paragraph; disk 5, configured to come in contact with the inner surface of the sphincter, is seen including a rim at its end which extends past the discharge end of stem 1, see Fig. 1-2 and 5 & col 1 first paragraph).
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 retention part of Alexandersen with Montgomery to include a proximal-most tip of the proximal tip portion of the stem not extending proximally beyond the rim and the rim extending proximally beyond a proximal-most tip of the proximal tip portion of the stem since such a configuration is taught by Montgomery to be an art effective length for a retention part and catheter of an anal probe configured to inject fluid (col 2 second paragraph & Fig. 1-2 and 4 of Montgomery).
Additionally, 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 retention part of Alexandersen to have the rim of the retention part extend proximally beyond the proximal-most tip of the stem since Alexandersen places no criticality on the length of catheter 2, simply stating that “The length… of the catheter 2… can be chosen according to the actual need. Normally the length from the fixation member to the tip of the catheter is between one and a few centimeters…” (emphasis added) ([0070]), and
it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the retention part of Alexanderson would perform equally well with the rim extending proximally beyond the proximal-most tip of the stem since the proximal discharge end of the anal probe is still capable of injecting fluid. The anal probe would function appropriately having the claimed length of rim extension. Further, Applicant also appears to place no criticality on the length of extension of the rim of the retention part (see end of page 9 and top of page 10).
Alternatively, claim(s) 4 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexandersen (US 20020019613 A1) in view of Shuffield (US 4516578 A), and further in view of Norred (US 20200352602 A1).
Regarding claims 4 and 19, Alexandersen discloses all the limitations of claim 1. Alexandersen further discloses the anal probe wherein the proximal portion of the retention part comprises a rim located at a proximal end of the anal probe (proximal portion of fixation member 6 is seen comprising a rim located at a proximal end of the anal probe, see Fig. 3 and 11).
However, Alexandersen fails to explicitly disclose a proximal-most tip of the proximal tip portion of the stem does not extend proximally beyond the rim and the rim extends proximally beyond a proximal-most tip of the proximal tip portion of the stem.
However, Norred teaches a suction tube configured to be inserted into a body cavity (abstract and [0043] & Fig. 2A and 10) wherein a proximal-most tip of the proximal tip portion of the stem does not extend proximally beyond the rim and the rim extends proximally beyond a proximal-most tip of the proximal tip portion of the stem (proximal-most tip of tube 122 ending at opening 123 does not extend proximally beyond open mouth 129’ of shield 127’ and the rim of mouth 129’ of shield 127’ extends proximally beyond opening 123 of tube 122, [0047]-[0048] & Fig. 2A).
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 retention part of Alexandersen with Norred to include a proximal-most tip of the proximal tip portion of the stem not extending proximally beyond the rim and the rim extending proximally beyond a proximal-most tip of the proximal tip portion of the stem since such a modification would prevent internal bodily tissue from impinging upon the openings/eyelets of the stem ([0048] of Norred).
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alexandersen (US 20020019613 A1) in view of Shuffield (US 4516578 A), and further in view of Torstensen (US 20030074018 A1).
Regarding claim 13, Alexandersen discloses all the limitations of claim 1. Alexandersen further discloses the anal probe wherein the retention part is made of a compressible material (“the fixation member 6 is made of compressible material. This compressible material may e.g. be a foam or a molded elastic material.”, [0037]) but fails to explicitly disclose the anal probe wherein the retention part is made of silicone. However, Torstensen teaches an anal probe (catheter-like probe 1 and sealing element 2, [0034] & Fig. 1) wherein the retention part is made of silicone (sealing element 2 made of silicone, [0025] & Fig. 1). 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 retention part of Alexandersen with Torstensen to include the retention part made of silicone since Torstensen teaches silicone to be an art effective material for a compressible sealing element of an anal probe ([0025] of Torstensen).
Regarding claim 14, Alexandersen discloses all the limitations of claim 1. However, Alexandersen fails to explicitly disclose the anal probe, wherein an outer surface of the retention part is impermeable to liquid. However, Torstensen teaches an anal probe (catheter-like probe 1 and sealing element 2, [0034] & Fig. 1), wherein an outer surface of the retention part is impermeable to liquid (sealing element 2d is made throughout of a hydrophobic material, [0037] & Fig. 2d). 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 retention part of Alexandersen with Torstensen to include the retention part made of a hydrophobic material since Torstensen teaches a hydrophobic material to be an art effective material for a compressible sealing element of an anal probe ([0028] and [0037] of Torstensen). As modified, fixation member 6 of Alexandersen would be made of a hydrophobic material, rendering the outer surface of member 6 impermeable to liquid.
Regarding claim 15, Alexandersen discloses all the limitations of claim 1. However, Alexandersen fails to explicitly disclose the anal probe wherein an outer surface of the retention part is covered by a layer of film material configured to make the outer surface impermeable to liquid.
However, Torstensen teaches an anal probe (catheter-like probe 1 and sealing element 2, [0034] & Fig. 1) wherein an outer surface of the retention part is covered by a layer of film material configured to make the outer surface impermeable to liquid (outer surface 14 of sealing element 2a is covered by a liquid tight foil layer 11, [0027] and [0036] & Fig. 2a).
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 retention part of Alexandersen with Torstensen to include an outer surface of the retention part covered by a layer of film material since such a modification would include structure to prevent passage of bowel liquids through the retention part and aid in smooth retraction of the retention part from the user ([0027] and [0036] of Torstensen).
Regarding claim 16, Alexandersen discloses all the limitations of claim 1. However, Alexandersen fails to explicitly disclose the anal probe wherein an outer surface of the retention part is coated with a coating configured to make the outer surface impermeable to liquid.
However, Torstensen teaches an anal probe (catheter-like probe 1 and sealing element 2, [0034] & Fig. 1) wherein an outer surface of the retention part is coated with a coating configured to make the outer surface impermeable to liquid (outer surface 14 of sealing element 2a is covered by a liquid tight foil layer 11, [0027] and [0036] & Fig. 2a; the outer surface 14 can be interpreted as covered with an enclosing layer 11, or coated with a coating, which is liquid tight foil configured to make surface 14 impermeable to liquid, [0027] and [0036] & Fig. 2a).
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 retention part of Alexandersen with Torstensen to include an outer surface of the retention part coated with a coating since such a modification would include structure to prevent passage of bowel liquids through the retention part and aid in smooth retraction of the retention part from the user ([0027] and [0036] of Torstensen).
Response to Arguments
Applicant’s arguments with respect to the claims have 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.
Conclusion
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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