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 .
Amendment Entered
This Office action is responsive to the Amendment filed on July 21st, 2026. The examiner acknowledges the amendments to claims 1, 5, 7, 8, 10, 11, 12, 13, 15, 17, as well as the cancellation of claims 3, 4, 6, 16. Claims 1-2, 5, 7-15, and 17-20 remain pending in the application. New claim 26 has been added.
Response to Arguments
Applicant's arguments filed July 21st, 2026, with respect to the drawing objections have been fully considered. The drawing objections are withdrawn.
Applicant's arguments filed July 21st, 2026, with respect to the claim objections have been fully considered. The claim objections are withdrawn. However, additional objections are added.
Applicant's arguments filed July 21st, 2026, with respect to the rejections under 35 USC § 112 have been fully considered. The rejections under 35 USC § 112 are withdrawn. However, additional rejections are added in view of the amendments.
Applicant's arguments filed July 21st, 2026, with respect to the rejections under 35 USC § 103 with respect to claims 1-2, 5, and 7-14 have been fully considered and are persuasive. The rejections under 35 USC § 103 are withdrawn.
Applicant's arguments filed July 21st, 2026, with respect to the rejections under 35 USC § 103 with respect to claims 15 and 17-20 have been fully 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 Objections
Claims 1, 14, and 26 are objected to because of the following informalities:
Claim 1 line 18 should recite “the plurality of proximal pressure sensors”.
Claim 14 lines 1-2 should recite “the plurality of proximal pressure sensors”.
Claim 26 lines 1-2 should recite “wherein the manometer has a handle”.
Appropriate correction is required.
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 13 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.
Claim 13 recites the limitation "the sheath comprises an end cap which is configured to seat upon a distal tip of the probe in use, and which forms the seal between the proximal stem portion and the distal balloon portion, the inflation conduit extending through the end cap" in lines 1-4. It is unclear how the end cap configured to seat upon a distal tip portion of the probe forms the seal between the proximal stem portion and the distal balloon portion when the seal is already recited as being formed by the collar of the sheath engaging the location feature of the probe in claim 1. Furthermore, even if the end cap forms a seal, an end cap configured to be seated on a distal tip of the probe would seal the distal tip of the probe and the distal balloon portion of the sheath but it is unclear how the seal would be formed in relation to the proximal stem portion of the sheath.
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.
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.
Claims 15 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Grimm (US 6402695 B1) in view of Leonard (US 20040231772 A1), further in view of Coller, and further in view of Tiesma (US 20050222517 A1).
Regarding claim 15, Grimm discloses a sheath (probe cover 10) for use with an anal probe (probe 12) having a proximal portion (the probe from elastic band 22 to the second elastic band 23 as seen in figs. 1-2, “proximal end of the probe”, col. 1 lines 61-64) and a distal tip portion (the end of the probe from elastic band 22 to the distal end 24 of the cover as seen in figs. 1-2, “distal end of the probe”, col. 1 line 65 – col. 2 line 3 & col. 3 lines 24-33) which is insertable through an anus into a rectum (“insertion of the probe into the rectum”, col. 3 lines 50-54), the sheath being formed to receive the probe and to provide a continuous covering over the probe (as seen in figs. 1-2), and the sheath (10, figs. 1-2) comprising a proximal stem portion (cover 10 from elastic band 22 to the second elastic band 23 as seen in figs. 1-2) for receiving at least the proximal portion of the probe (as seen in figs. 1-2), a distal balloon portion (cover 10 from elastic band 22 to the distal end 24 of the cover as seen in figs. 1-2), flexible membranous material (“latex material”, col. 3 lines 1-5) so that pressure applied to the proximal stem portion of the sheath is transmitted through the sheath to the proximal portion of the probe (“very thin ... does not interfere with the normal insertion and retraction”, col. 3 lines 1-5), and a collar (elastic band 22, figs. 1-2) which has a through-going opening (as seen in figs. 1-2) and is configured to seat upon the distal tip portion of the probe (as seen in figs. 1-2, “elastic band 22 ... cover 10 is held tightly against the exterior surface of the ultrasound probe 12”, col. 3 line 6-49) and to form a seal against flow of the pressure medium from the distal balloon portion into the proximal stem portion of the sheath (“elastic band 22, holding the cover 10 on the probe 12 in a waterproof relationship”, col. 3 line 49-64).
Grimm does not disclose an anal manometer having a probe having a location feature between the proximal portion with a plurality of sensors and the distal tip portion.
the collar being configured to engage the location feature.
However, Leonard directed to an intelligent medical device barrier for a probe discloses a probe (probe head 11, fig. 1A) having a location feature (ledge 42, figs. 3A-3E) between a proximal portion (14, figs. 1A & 3A-E) and a distal tip portion (tip 8, fig. 1A), and a collar (collar 30, figs. 3A-3E), the collar being configured to engage the location feature (“collar 30 slides over ... until ... detail 40 fits into ledge 42 for snapping collar 30 in place ... cover 29 is in place properly on probe 11”, para. [0035]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Grimm such that the probe has a location feature between the proximal portion and the distal tip portion, and the collar being configured to engage the location feature, in view of the teachings of Leonard, as this would aid in releasably placing the cover and collar/elastic band properly in place on the probe.
Grimm, as modified by Leonard hereinabove, does not disclose an anal manometer having a probe having a proximal portion with a plurality of sensors.
However, Coller directed to a system for providing real-time measurements of constriction pressure applied by the inner surface of a body lumen discloses an anal manometer (myometer probe 10, claim 8, “adapted for insertion into an anal orifice”) having a probe (cylindrical sensor probe 12, fig. 1) having a proximal portion (sensor region 14, fig. 1) with a plurality of sensors (pressure transducer regions 28, figs. 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Grimm, as modified by Leonard hereinabove, such that sheath is for use with an anal manometer having the probe having the proximal portion with a plurality of sensors, in view of the teachings of Coller, as this would aid in measuring constriction pressure applied by the inner surface of an anal orifice.
Grimm further discloses that the probe cover is filled with approximately 20 cc of fluid (although this amount could vary to some extent) (col. 3 lines 7-22).
Grimm, as modified by Leonard and Coller hereinabove, does not expressly disclose an inflation conduit communicating with an interior of the distal balloon portion, enabling inflation of the distal balloon portion with a pressure medium introduced through the inflation conduit whilst the distal balloon portion is disposed in the rectum.
However, Tiesma directed to a reusable temperature sensing probe 10 for measuring temperature in a rectum discloses a sheath (balloon/sleeve assembly 14, figs. 1 & 5) having an inflation conduit (inflation tube 36, fig. 5) communicating with an interior of the distal balloon portion (as seen in fig. 5, para. [0020, 0029, 0034]), enabling inflation of the distal balloon portion with a pressure medium introduced through the inflation conduit whilst the distal balloon portion is disposed in the rectum (“Balloon portion 26 is sized to engage the rectal wall when an inflation medium is introduced via the inflation tube 36 between layers 74 and 76 of the balloon portion 26”, para. [0020, 0029, 0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Grimm as modified by Leonard and Coller hereinabove, such that an inflation conduit communicating with an interior of the distal balloon portion enables inflation of the distal balloon portion with a pressure medium introduced through the inflation conduit whilst the distal balloon portion is disposed in the rectum, in view of the teachings of Tiesma, as this would aid in introducing the inflation medium into the cover, engaging the balloon portion with the rectal wall when the inflation medium is introduced into the distal balloon portion, and enabling easier removal of the balloon portion by evacuation of the inflation medium by incorporating the inflation conduit of Tiesma into the cover of Grimm.
Regarding claim 17, Grimm, as modified by Leonard, Coller, and Tiesma hereinabove, discloses the sheath as claimed in claim 15. Grimm, as modified by Leonard, Coller, and Tiesma hereinabove, wherein the sheath comprises a closure comprising a flexible skin which forms a seal over the through-going opening of the collar, and which is able to receive the distal tip portion of the probe, so that the distal tip portion of the probe is able to extend into the distal balloon portion.
However, Tiesma discloses a sheath (balloon/sleeve assembly 14, fig. 5) and a collar (guide tube 80, fig. 5), wherein the sheath comprises a closure (as seen in fig. 5, para. [0027]) comprising a flexible skin (as seen in fig. 5, “flexible, biocompatible polymer”, para. [0019]) which forms a seal over the through-going opening of the collar (“layer 72 may be sized and shaped to define channel 30 and sealed about its perimeter to layer 70, with guide tube 80 positioned as previously described between layers 70 and 72”, para. [0028, 0030-0031]), and which is able to receive the distal tip portion of the probe, so that the distal tip portion of the probe is able to extend into the distal balloon portion (as seen in fig. 7, “80, which facilitates insertion of the temperature sensor array 18 into the balloon portion 26”; “12 is inserted through sleeve portion 28 and temperature sensor array 18 is positioned within guide tube 80”, para. [0028, 0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Grimm as modified by Leonard and Coller hereinabove, such that the sheath comprises a closure comprising a flexible skin which forms a seal over the through-going opening of the collar, and which is able to receive the distal tip portion of the probe, so that the distal tip portion of the probe is able to extend into the distal balloon portion, in view of the teachings of Tiesma, as this would aid in holding the collar in place and facilitating insertion of the probe.
Regarding claim 18, Grimm, as modified by Leonard, Coller, and Tiesma hereinabove, discloses the sheath as claimed in claim 15. Grimm, as modified by Leonard, Coller, and Tiesma hereinabove, does not disclose wherein the inflation conduit comprises a tube communicating with the distal balloon portion of the sheath and extending through an interior of the sheath.
However, Tiesma discloses wherein the inflation conduit comprises a tube (inflation tube 36, figs.5 & 7) communicating with the distal balloon portion of the sheath (as seen in figs. 5 & 7, para. [0020-0021, 0026]) and extending through an interior of the sheath (as seen in figs. 5 & 7, para. [0020-0021]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Grimm, as modified by Leonard, Coller, and Tiesma hereinabove, such that the inflation conduit comprises a tube communicating with the distal balloon portion of the sheath and extending through an interior of the sheath, in view of the teachings of Tiesma, as this would aid in introducing the inflation medium into the cover, engaging the balloon portion with the rectal wall when the inflation medium is introduced into the distal balloon portion, and enabling easier removal of the balloon portion by evacuation of the inflation medium by incorporating the inflation tube of Tiesma into the cover of Grimm.
Regarding claim 19, Grimm, as modified by Leonard, Coller, and Tiesma hereinabove, discloses the sheath as claimed in claim 18. Grimm, as modified by Leonard, Coller, and Tiesma hereinabove, does not expressly disclose wherein the tube is coupled to the collar.
However, Tiesma discloses wherein the tube (inflation tube 36, fig. 6) is coupled to the collar (80, fig. 6) (as seen in fig. 6, “adjacent to end 78 of layer 72 is a guide tube 80”; “adhesive layer 94 ... interconnecting end 78 ... inflation tube ... fluid-tight seal at end 78”, para. [0028, 0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Grimm as modified by Leonard and Coller hereinabove, such that the tube is coupled to the collar, in view of the teachings of Tiesma, as this would aid in creating a fluid tight seal and forming a distal balloon portion (Tiesma, para. [0032]).
Regarding claim 20, Grimm, as modified by Leonard, Coller, and Tiesma hereinabove, discloses the sheath as claimed in claim 15. Grimm, as modified by Leonard, Coller, and Tiesma hereinabove, wherein the collar is disposed within an envelope formed by the flexible membranous material of the sheath, a periphery of the collar being sealingly secured thereto.
However, Tiesma discloses a sheath (balloon/sleeve assembly 14, fig. 5) and a collar (guide tube 80, fig. 5), wherein the collar is disposed within an envelope (as seen in fig. 5, para. [0027]) formed by the flexible membranous material of the sheath (as seen in fig. 5, “flexible, biocompatible polymer”, para. [0019]) a periphery of the collar being sealingly secured thereto (“layer 72 may be sized and shaped to define channel 30 and sealed about its perimeter to layer 70, with guide tube 80 positioned as previously described between layers 70 and 72”, para. [0028, 0030-0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Grimm as modified by Leonard and Coller hereinabove, such that the collar is disposed within an envelope formed by the flexible membranous material of the sheath, a periphery of the collar being sealingly secured thereto, in view of the teachings of Tiesma, as this would aid in holding the collar in place and facilitating insertion of the probe.
Allowable Subject Matter
Claims 1-2, 5, 7-12, 14, and 26 are allowed.
Claim 13 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:
The closest prior art of record:
Tiesma (US 20050222517 A1) teaches a balloon/sleeve assembly 14 including a balloon portion 26, a waist 34, and a sleeve portion 28, a rectal temperature sensing probe 10, an inflation tube 36, and guide tube 80 (figs. 1 & 7). Tiesma does not teach a manometer, the probe comprising a location feature, and a collar having a through-going opening; wherein the distal tip portion of the probe is able to be advanced through the collar until the collar engages the location feature, blocking further advancement of the probe through the collar, whereupon the distal tip portion of the probe extends through the collar into the distal balloon portion of the sheath and a seal is formed against flow of the pressure medium from the distal balloon portion into the proximal stem portion of the sheath.
Grimm (US 6267726 B1) teaches an ultrasound probe cover and elastic bands 22,23 for holding the cover tightly against the probe and a distal end of the cover being filled with fluid (fig. 1).
Leonard (US 20040231772 A1) teaches an intelligent medical device barrier 10 comprising a cover 12 that is fixed over probe head 13 and retaining means 15 for expeditious attachment of cover 12 to probe head 13 (figs. 1A-1B, para. [0023]). Figs. 3A-3E teach a collar 30 for coupling cover 20 and a ledge 42 on probe handle 14 so that detail 40 of the collar fits into the ledge for snapping collar 30 in place (para. [0035]).
(FR 2652495 A10 – cited by IDS) teaches a balloon consisting of a cylindrical sleeve, coaxial with the tube (2) and which is attached to it at its two ends by means of a fastening system (31, 32), preferably removable such as silicone rings so that the balloon is interchangeable (fig. 1 & page 3 of the English Translation provided by Applicant).
Sarvazyan (US 5265612 A) teaches a probe assembly 14 having an ultrasonic transducer array 18 and a rubber sheath cylinder 22 surrounding the probe.
The prior art of record does not teach or fairly suggest “wherein the distal tip portion of the probe is able to be advanced through the collar until the collar engages the location feature, blocking further advancement of the probe through the collar, whereupon the distal tip portion of the probe extends through the collar into the distal balloon portion of the sheath and a seal is formed against flow of the pressure medium from the distal balloon portion into the proximal stem portion of the sheath”.
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.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/
Primary Examiner, Art Unit 3791
