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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to claims 1-11 in the reply filed on 05/18/26 is acknowledged.
Status of Claims
Claims 1-19 are currently pending, with claims 12-19 being withdrawn from consideration.
Claim Rejections - 35 USC § 102
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 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 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mansur et al. (US 2014/0276284 A1).
Regarding claim 1, Mansur discloses a connector (Figs. 1-3, feat. 110; Fig. 6, feat. 210; Fig. 7, feat. 310; Fig. 8, feat. 410; Fig. 9, feat. 510; ¶0009-0010, 0027, 0041-0045) including: a conduit (Fig. 3, feat. 110; Fig. 6, feat. 210; Fig. 7, feat. 310; Fig. 8, feat. 410; Fig. 9, feat. 510) having an entrance and an exit connected by an internal passage through which waste from an ostomy appliance is permitted to flow (120; ¶0031; 220, 320, 420, 520; ¶0041-0045: the conduits allow liquid waste to flow through them), and a structural member including a filament, which extends along the passage (116; ¶0028-0031; 216, 316, 416, 516; ¶0041-0045: anti-occlude strips 116, 216, 316, 416, and 516 are sized to have a length similar to the conduits 110, 210, 310, 410, 510 that they are in, and span the diameters of the corresponding conduits, and therefore have a thread or filament-like aspect ratio), and a spanning formation that extends radially along an increased width of the passage (126; ¶0031; 226, 326, 426, 526; ¶0041-0045).
Mansur does not explicitly disclose that the connector is for connecting to an ostomy appliance as claimed in the preamble of claim 1. The courts have held that “if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. Please see MPEP §2111.02(II) with respect to Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). In this case, the present specification does not indicate that the connector includes any particular structural features required for connecting to an ostomy appliance, beyond what is recited in the body of the claim. Please see Page 1, lines 6-28 and Page 2, line 25 – Page 3, line 12 of the present specification. Therefore, the body of claim 1 fully sets forth the limitations of the claimed invention, and the preamble limitation for connecting to an ostomy appliance is of no patentably significance to the claim as a statemen of intended use.
Regarding claim 2, Mansur discloses the connector of claim 1. As discussed above, Mansur discloses that the anti-occlude strips are sized to have a length similar to the conduits that they are in, and also span the diameters of those conduits, making them have a thread or filament-like aspect ratio (¶0028-0031 and 0041-0045). Therefore, Mansur further discloses that the spanning formation is formed from a length of shaped filament.
Regarding claim 6, Mansur discloses the connector of claim 1, and further discloses that the spanning formation is generally formed in a single plane (Fig. 8, feat. 426; ¶0044).
Regarding claim 7, Mansur discloses the connector of claim 1, and further discloses that the spanning formation extends axially along the passage (¶0028-0031: the anti-occlude strips, and their corresponding spanning formations, are sized to extend along the whole length of the conduit).
Regarding claim 8, Mansur discloses the connector of claim 1, and further discloses that the structural member includes a further, second spanning formation (Fig. 3, feat. 116: anti-occlude strip/structural member 116 is cross-shaped with two branches/spanning formations 126 that span the conduit 110 which are spaced 90° from each other).
Regarding claim 9, Mansur discloses the connector of claim 8, and further discloses that the first and second spanning formations are spaced from each other (Fig. 3, feat. 126: anti-occlude strip/structural member 116 is cross-shaped with two branches/spanning formations 126 that span the conduit 110 which are spaced 90° from each other).
Regarding claim 10, Mansur discloses the connector of claim 1. Mansur further discloses that the major dimension of the anti-occlude strips (116, 216, 316, 416, 516) corresponding to the spanning formation (126, 226, 326, 426, 526) is slightly less than the interior diameter of the conduit (¶0009), or in other words, about 100% of the diameter of the passage. Therefore, Mansur further discloses that the spanning formation extends across at least 80% of the diameter of the passage and below 105% of the diameter of the passage.
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.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Mansur in view of Christian et al. (WO 2017/127074 A1).
Regarding claim 3, Mansur discloses the connector of claim 2, but does not disclose that the shaped filament is formed into a wave-like formation.
Christian teaches a catheter assembly (Fig. 1, feat. 10; ¶00045) comprising a catheter tube (Figs. 1-3C and 10-11B, feat. 12; ¶00045-00046 and 00069-00070) with a septum (15) which spans the internal passage (14) of the tube. In the distal portion of the tube (Fig. 10, feat. 30), the septum (15) may include a plurality of wave formations (46) that define an undulating pattern (¶00069-00070). Christian teaches that this stabilizes the distal portion of the tube during fluid transfer while also allowing the distal portion to be trimmed to a desired length (¶00069-00070). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the connector disclosed by Mansur so that the shaped filament is formed into a wave-like formation so that the connector is stabilized during fluid transfer while also allowing the connector to be trimmed to a desired length as taught by Christian.
Regarding claim 4, Mansur in view of Christian suggests the connector of claim 3. As discussed above, Christian teaches that the septum has a plurality of wave formations (Fig. 10, feat. 46; ¶00069-00070). Therefore, Mansur in view of Christian further suggests that the shaped filament has a plurality of bends formed into it.
Regarding claim 5, Mansur in view of Christian suggests the connector of claim 3, and Mansur further discloses that the shaped filament is substantially centered about an axis along the filament (Fig. 3, feat. 116; Fig. 6, feat. 216; Fig. 7, feat. 316; Fig. 8, feat. 416).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mansur in view of Siddhamalli et al. (WO 2014/018877 A1).
Regarding claim 11, Mansur discloses the connector of claim 1, but does not disclose that the structural member has a lower permanent deformation temperature than that of the conduit. Mansur teaches that the structural member (Fig. 3, feat. 116; Fig. 6, feat. 216; Fig. 7, feat. 316; Fig. 8, feat. 416) may be made of an elastic polymer (¶0030), while the conduit (110, 210, 310, 410) may be any medical grade tubing (¶0031).
Siddhamalli teaches a multilayer flexible tube (Fig. 1, feat. 100; Page 11, lines 23-36) comprising an inner first polymer layer (102) and an outer second polymer layer (102) which may advantageously be directly bonded to each other without an adhesive (Page 11, lines 27-30). Siddhamalli teaches that the inner first polymer layer (102) may be EVA (Page 6, lines 3-20) and that the outer second polymer layer (104) may be any thermoplastic elastomer (TPE) as long as it is different from the inner first polymer layer (Page 8, lines 15-29). Modifying the connector disclosed by Mansur so that the structural member is formed from EVA like the inner first polymer layer of Siddhamalli and so that the conduit is a TPE like the outer second polymer layer of Siddhamalli would advantageously enable the structural member to be directly bonded to the conduit without an adhesive like in the multilayer tube of Siddhamalli. As noted by the present specification, EVA is a material with a lower permanent deformation temperature than TPE (Present specification: Page 9, lines 27-31). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the connector disclosed by Mansur so that the structural member is formed from EVA and the conduit is formed from a TPE such that the structural member has a lower permanent deformation temperature than that of the conduit in order to enable the structural member to be directly bonded to the conduit without an adhesive as taught by Siddhamalli.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Guldfeldt et al. (US 2005/0171496 A1) Fig. 10 discloses a conduit with a cord.
Tussy et al. (US 2015/0053298 A1) Figs. 4A-B discloses a conduit with anti-kink partitions.
Pagan (US 6,148,818 A) discloses a medical tube with a reinforcement member.
Yamazaki (WO 2014/050570 A1) Figs. 1-3 discloses a medical tube with a spanning formation.
Nicola et al. (WO 2008/061794 A1) discloses a tube with a stabilization filament.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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