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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
This Action is responsive to the Reply filed 27 February 2026 (“Reply”). As directed in the Reply:
Claims 1, 3, and 10 have been amended;
No claims have been and/or remain cancelled; and
No claims have been added.
Thus, Claims 1-13 are presently pending in this application, with no claims having been previously withdrawn from consideration.
Applicant’s amendment to Claim 10 is sufficient to overcome the objection from the previous Action and are therefore withdrawn.
Response to Arguments
Applicant's arguments filed in the Reply have been fully considered but they are not fully persuasive.
Applicant argues (Reply, pg. 5, second full paragraph) that Sant cannot be read on, in pertinent part, by Claim 1, because its ratchet 38 extends ‘downward’ and therefore does not have a cylindrical shape, as required by Claim 1. But Claim 1 requires the ‘mounting section,’ mapped to element MS in AnnFig in the Action and below (which is the tubular/cylindrical ‘adjustable positioner’ 36), to have that cylindrical shape, not the ratchet which is on an interior surface of MS.
Applicant next argues (Reply, pg. 5, second full paragraph) that Sant cannot be read on, in pertinent part, by Claim 1, because its component F, as indicated in AnnFig, extends upwardly, while Claim 1 now requires that the corresponding feature be, “attached to the mounting section along a longitudinal axis” of the overall device. First, there are several structures in Sant’s device which, as indicated in the prior Action and below, are read on by the claimed “a flexible wing, a flag, a groove or a flute,” not just the upstanding element F - yet this is the only element Applicant addresses (Applicant misidentifies the upstanding portion as the entire positioner 36, which it is not). The critical portion of the foregoing limitation is “attached . . . along a longitudinal axis” - not that the “a flexible wing, a flag, a groove or a flute” extends along that axis, as appears to be what Applicant argues in substance. The claim therefore requires the attachment to be along that axis. Inasmuch as the multiple grooves G and the flutes FL in AnnFig are serially arranged along that axis, and are formed in the longitudinally extending mounting section, they are read on by the foregoing limitation. Additionally, Sant’s Fig. 6 shows that the ratchet members 38 extend from an unlabeled radial protrusion (P in AnnFig, and noted by Applicant in its Reply) on the inner surface of the cylindrical portion of 36 which, because of the longitudinally extending lines along the top of that cylindrical portion, includes a longitudinally extending groove - while this feature is not relied upon in this Action as evidence of unpatentability (and thus there is no new grounds of rejection), it may be in the future.
The balance of Applicant’s arguments rely on the foregoing, and are thus equally unpersuasive.
Claim Rejections - 35 USC § 103
Claims 1-4, 7, 8, 10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2004/0260152, by Sant et al. (“Sant”) in view of U.S. Patent App. Pub. No. 2010/0298773, by Nitsan et al. (“Nitsan”), as evidenced by Overview of materials for Polypropylene, Molded, MatWeb (2025) (accessed 11/21/25), www.matweb.com/search/DataSheet.aspx?MatGUID=08fb0f47ef7e454fbf7092517b2264b2 (“MatWeb”) (Claim 8 only).
Sant describes a device substantially as claimed by Applicant, as follows and with reference to the cropped, cleaned, and annotated version of its Fig. 6 below (“AnnFig”). The Examiner also notes that Nitsan is representative of a large number of disclosures of medical irrigation devices having irrigation holes (plural) for the purpose of directing the irrigation fluid in multiple directions and thus flush the area of interest more effectively, a few of which have been cited with this Action to substantiate that assertion.
Claim 1: A tubular surgical device (Figs. 4, 6-8) comprising:
a grasper receiving section (Fig. 7: 20+40) comprised of a biocompatible material ([0047]), the grasper receiving section including
a distal portion (20) comprising a diversion hole (AnnFig: DH; Fig. 8, 24) to provide an alternative fluid pathway during suction (24), and
a proximal portion (40) co-aligned with the distal portion (see Fig. 7 and AnnFig, showing they are aligned as claimed), the proximal portion including a male adaptor (Fig. 4, showing the tube 90 fits around connector 48) having a smaller outer diameter (AnnFig: SOD) than the distal portion (the rib 26 has a larger OD than that of connection 48, see Fig. 5, which is the same OD as the rest of the tube forming 20), wherein the male adaptor is configured to be disposed within a lumen of a tubing (tube 80 is fully capable of being disposed in a tube’s lumen); and
a graspable portion (AnnFig: DP) comprising
a mounting section (AnnFig: MS) mounted around the grasper receiving section ([0042]) wherein the mounting section has a cylindrical shape (it is like a cylinder, i.e., “cylindrical”), and
at least one of a flexible wing, a flag (AnnFig: F), a groove (AnnFig: G; [0042] describing tabs 37) or a flute (AnnFig: FL; [0042], describing tabs 37 and thus flutes between them) attached to the mounting section along a longitudinal axis of the tubular surgical device (same; see discuss above).
Sant does not, however describe plural holes in its distal portion.
Nitsan relates to medical irrigation/lavage devices and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Nitsan teaches that the irrigation device can be constructed to include a plurality of holes 94 in the distal portion of the device, to better distribute the irrigation fluid exiting from the device.
It 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, to construct Sant’s irrigation wand to include multiple holes in its distal portion, because Nitsan teaches doing so in a closely related device in order to better distribute the irrigation fluid at the site of interest.
Claim 2: (The tubular surgical device of claim 1) wherein the grasper receiving section comprises a material selected from polyurethanes, aliphatic or semialiphatic polyamides, polysulfone, silicone, polycarbonate, polyvinyl chloride, acrylonitrile butadiene styrene (ABS)([0047]), acrylic, and block copolymers made up of rigid polyamide blocks and soft polyether blocks (PEBAX@).
Claim 3: (The tubular surgical device of claim 1) (see treatment above) wherein the tubing comprises a suction tube, an irrigation tube, or both, and the male adapter is configured to be in fluid communication with the tubing (the male adapter 48 is in fluid communication with the tubing 90).
Claim 4: (The tubular surgical device of claim 1) wherein the graspable portion is friction fit over the grasper receiving section (friction between 38 and 37).
Claim 7: (The tubular surgical device of claim 1) wherein the graspable portion is of a lower durometer than is the grasper receiving section ([0042]: because the tabs 37 are part of positioner 36, and tabs 37 are capable of being “squeezed together,” without deforming the ratchet 38, it follows that the tabs are softer than the ratchet, and thus that its grasper portion is softer than the GRS).
Claim 8: (The tubular surgical device of claim 1) wherein the grasper receiving section has a Shore durometer of between 30D and 70D ([0047] states polypropylene is one material from which Sant’s GRS can be formed; MatWeb states that molded polypropylene has a Shore D hardness of between 30D and 83D, establishing a prima facie case of obvious of the claimed range, see M.P.E.P. § 2144.05(I)).
Claim 10: (The tubular surgical device of claim 1) wherein at least one of the diversion holes is a longitudinal slot (oval, as illustrated).
Claim 12: (The tubular surgical device of claim 3) wherein the graspable portion comprises a cylindrical section (AnnFig: CS) positioned outside the tubing and the distal portion of the grasper receiving section (AnnFig: GP is “like a cylinder” in shape).
Claim 13: (The tubular surgical device of claim 3) wherein the graspable portion is molded or extruded as part of the tubing (tubing 90 is fully capable of being molded or extruded with the tubing).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sant and Nitsan in view of Levin M., Radiological Anatomy of the Colon and Rectum in Children, SM J Pediatr Surg. 2019; 5(1): 1078 (“Levin”).
Sant and Nitsan together describe a device substantially as claimed by Applicant; see above. They do not, however, indicate the OD of its grasper receiving section.
Sant’s device is for use in irrigating the lower bowel, and therefore must be sized to be insertable through the anus into the rectum. Levin discloses (Table 1) that the diameter of the rectums of children between the ages of 1-11 months is 1.3 - 3.0 cm (0.51 - 1.18 inches), with the mean being 2.24±0.09 cm (0.88±0.04 inches). Therefore, in order to use Sant’s device with children, its GRS would have to be have an OD smaller than the child’s rectum’s interior diameter, i.e., smaller than 0.51 - 1.18 inches and thus overlapping the claimed range, establishing a prima face case of obviousness. See M.P.E.P. § 2144.05(I)). “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, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984). In the instant case, Sant’s device would not operate differently with the claimed OD and, because would be used for exactly its stated purpose, the device would function appropriately having the claimed OD, because this would permit it to be used with infants. Further, Applicant assigns no criticality to the OD claimed, indicating simply that the claimed OD is “exemplary” (Specification @ [00112]).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Sant and Nitsan.
Sant and Nitsan together disclose a device substantially as claimed by Applicant; see above. They do not, however, disclose that the graspable portion is bonded (Claim 5) or overmolded (Claim 6) to the grasper receiving section. Sant does, however, describe its first embodiment, that of Figs. 1-5, as having its corresponding GRS and grasper portion formed as a single piece, as demonstrated by the cross-sectional view of Fig. 5.
Bonding together, including overmolding, parts of a medical device is well known in the medical arts, particularly disposable irrigators such as Sant’s. See, e.g., Sant, at [0047]; U.S. Patent App. Pub. No. 2006/0100605, at [0025]; U.S. Patent App. Pub. No. 2011/0301572, at [0074]; and U.S. Patent App. Pub. No. 20190091388, at [0033].
It 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, to bond (Claim 5) or overmolded (Claim 6) the graspable portion to the grasper receiving section in Sant’s colonic irrigator, because both are extremely well-known methods of securing together subcomponents of medical devices, and a strong bond between the two would be immediately understood by a person of ordinary skill in the art to be an important performance criterion for its irrigator setup.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Sant.
Sant discloses a device substantially as claimed by Applicant; see above. It does not expressly disclose the size of its scalloped opening 24, and thus does not disclose that it has a length of 0.2 to 1.5 inch and a width of 0.01 to 0.15 inch.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of Sant to have the claimed dimensions, since 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, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984). In the instant case, Sant’s device would not operate differently with the claimed slot dimensions and, given that it is a suction and irrigation tool similar in general terms to that of Applicant’s disclosure, it would be fully capable of irrigating and suctioning, the device would function appropriately having the claimed slot dimensions. Further, Applicant assigns no criticality on the claimed slot dimensions, indicating at Table 1 (X10, X11) that the slot dimensions are “illustrative” ([00112]) and without criticality, and that other values are also suitable.
Conclusion
THIS ACTION IS MADE FINAL. 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 Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783