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 .
Information Disclosure Statement
The information disclosure statement(s) (IDSs) submitted on 7/30/24 and 6/2/25, is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner, but where the documents in the IDS(s) will be considered in the same manner as other documents in Office search files while conducting a search of the prior art in a proper field of search.
Status of the Application
This application has priority to GB 2115928.0, filed 11/5/21, and is a 371 of PCT/GB2022/052790, filed 11/4/22.
Status of the Claims
Claims 1-18 and 22 are pending in the application, with claims 1-18 under consideration and claim 22 withdrawn.
Election/Restriction Applicant's election without traverse of claims 1-18 in the 8/11/26 Restriction Response is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Claim 22 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. A complete reply to a final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP § 821.01.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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 2, 8, 14, and 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 pre-AIA the applicant regards as the invention.
Claims 2, 8, 14, and 16 use the term “optionally” or “preferably”, rending these claims indefinite, as it is unclear where the limitations recited after these terms are intended to be included in the claims or not. See MPEP 2173.
Appropriate correction is required, e.g., deleting these terms or deleting these terms along with the corresponding limitations.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for ‘establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103 and potential 35 U.S.C. 102(a)(2) prior art under 35 U.S.C. 103. Claims 1-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mansur et al. (US 2014/0276284 A1).
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As to claim 1, Mansur discloses: a connector (110:Figs. 1-5; 210:Fig. 6; 310: Fig. 7; 410:Fig. 8; 510: Fig. 9; ¶0009-0010, 0027, 0041-0045) including: a conduit 110-510 (Fig. 1-5: 110; Fig. 6: 210; Fig. 7: 310; Fig. 8: 410; Fig. 9: 510) having: an entrance and an exit (as adjacent to connector ends 118 Fig.1; [0028],ll.10-11) connected by an internal passage through which waste from an ostomy appliance is permitted to flow (Fig.1-5:120: ¶0031; Fig.6-9: 220, 320, 420, 520: ¶0041-0045: as internal passages within conduit 110-510 allowing liquid waste to flow through them), and a structural member 116-516 extends along the passage (116: Fig.1, ¶0028-0031; 216, 316, 416, and/or 516; ¶0041-0045: where structural member comprises anti-occlude strips 116:Fig.1-3, Fig.6-9: 216, 316, 416, and 516 that 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 ¶0009, 0042-0045).
Mansur does not explicitly teach that the connector is for connecting to an ostomy appliance, as recited in the preamble of claim 1. However, 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: MPEP §2111.02(II). 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 (See Applicants’ specification: p.1,ll.6-28 and p.2,ll.25 – p.3,ll.12). Therefore, the body of claim 1 fully sets forth all of the limitations of the claimed invention, and the preamble limitation for connecting to an ostomy appliance is of no patentable significance to the claim as a statement of intended use. Alternatively, the connector of Mansur is capable of being used for: connecting to an ostomy appliance, where the quick connect 118 ends are capable of being used to connect an ostomy appliance with a quick connect connector to a drainage collection container/pump 108 (Fig.1-2), such that it would be obvious to on of skill in the art to use the conduit 110 and container/pump 108 of Mansur as a connector for an ostomy appliance, and one of skill would have been motivated to do so, in order to provide a self-supporting connector (conduit/structural member) for use to connect an ostomy applicant to a drainage container, that would provide the advantage of preventing the drainage conduit from kinking or folding, which would block the flow of waste thru the conduit.
As to claim 2, Mansur teaches that the structural member extends along half or more than the length of the [internal] passage (where structure member as the anti-occlude strips have a major dimension [length] sized to a length determined by the application [0010],ll.1-2 and to be received within the lumen of the conduit/tube, [0050],ll.4-8, Claim 1); in order to provide flexibility of the conduit/tube while reducing occlusion potential [0005],ll.6-9 by providing an anti-occlude strip [as the structural support member] to provide the advantage of preventing occlusion [0008],ll.1-3. While Mansur does not specifically teach that the member extends along half of the passage length, Mansur teaches that the structural member as the anti-occlude strips can be varyingly sized according to the application, as the major dimension, such that it would have been obvious to one of skill to provide different sizes and where such a length would support half of the length of the conduit, in order to provide flexibility of the conduit/tube while reducing occlusion potential by providing an anti-occlude strip [as the structural support member] to provide the advantage of preventing occlusion.
As to claim 3, Mansur teaches wherein a longitudinal axis is defined along a length of the conduit (as major dimension Fig.1-3) and the structural member is permitted to move generally transversely to the axis (as minor dimension; Fig.1-3) (where structure member as the anti-occlude strips have a major dimension [length] sized to a length determined by the application [0010],ll.1-2; and a minor dimension [traverse to major dimension] Fig.1; Claim 1).
As to claims 4-5, Mansur teaches wherein the structural member is free to move within the conduit and/or is unanchored to any part of the conduit (where structural member 116 is inserted into conduit 110 before use such that 116 is free to move and unanchored ¶0010,ll.2-4).
As to claim 6, Mansur teaches wherein in the structural member is a filament 116 (116: ¶0028-0031; 216, 316, 416, and/or 516; ¶0041-0045: where filament 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; ¶0028-0031 and 0041-0045).
As to claim 7, Mansur teaches wherein the filament 116 is flexible (filament/strip 116 flexible [0030],ll.1-2).
As to claims 8-10, Mansur does not specifically teach: wherein the filament is between around 1mm and 2mm in diameter; wherein a ratio of the diameter of the conduit to a diameter of the filament is around 32 to 7 or around 40 to 7; and wherein the diameter of the conduit is around 8mm or 10mm. However, it would have been obvious to one of ordinary skill to in the art before the effective filing date to optimize the relative dimensions of the filament and conduit, and one of skill would have been motivated to do so, in order to provide the recited functions of supporting the conduit, e.g., to keep from kinking, while allowing waste to flow through the lumen of the conduit, since such relative dimensions are known in the art and since finding optimum relative dimensions of the angle, depending on its intended use, is within the skill of those skilled in the art, and where it has been held that 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. MPEP 2144.04(IV)(A).
As to claim 11, Mansur teaches wherein the structural member 116/216/316/416/516 is formed and/or positioned to split the passage into two or more channels (Fig.5-9 show the structural member 116/216/316/416/516 forming between 2 and 5 channels).
As to claim 12, Mansur teaches wherein the structural member 116/216/316/416/516 extends radially across the passage [within conduit] (Fig.5-9).
As to claim 13, Mansur teaches wherein the structural member 116/216/316/416/516 contacts an interior surface of the conduit 110/210/310/410/510 in at least two locations (Fig.5-9).
As to claim 14, Mansur teaches wherein the structural member 316 forms a three-pointed star shape (Fig.7) and preferably two or more of the points of the star contact an interior surface of the conduit 310 (Fig.7).
As to claim 15, Mansur teaches wherein the conduit is flexible and/or the conduit 110 has a substantially constant interior diameter along its length (Fig.1-2, 3, 4A, 4B, 5B, and 6-9).
As to claim 17, Mansur teaches wherein at least one end of the conduit is adapted to receive an adaptor device 118 (quick connect 118; Fig.1) that is inserted into the entrance and/or exit of the conduit 110 (Fig.1; [0028],ll.3-4,9-13).
As to claim 18, Mansur teaches wherein the length of the structural member is shorter than the length of the conduit, so that the adaptor device extends into the entrance and/or exit without being interrupted by the structural member (where quick connectors 118, 118, at each end of conduit 110, extend beyond structural member 116 as not as long as conduit 110; Fig.1) that is inserted into the entrance and/or exit of the conduit 110 (Fig.1; [0028],ll.3-4,9-13).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mansur in view of Siddhamalli (WO 2014/018877 A1).
As to claim 16, Mansur teaches that the structural member can be made of an elastic polymer (¶0030), while the conduit (110, 210, 310, 410) may be any medical grade tubing (¶0031). Mansur does not teach wherein the conduit is made from a thermoplastic elastomer (TPE) and/or the structural member is made from a TPE and optionally specifically Styrene-ethylene-butylene-styrene (SEBS).
However, Siddhamalli teaches a multilayer flexible medical tube 100 (Fig.1: 100; p.11,ll.23-36) comprising an outer second polymer layer 102 which may advantageously be directly bonded to each other without an adhesive (p.11,ll.27-30). Siddhamalli teaches that the outer second polymer layer 104 of the conduit/tube 100 may be any thermoplastic elastomer (TPE) (p.8,ll.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 obvious to one of ordinary skill in the art prior to the effective filing date to modify the connector disclosed by Mansur so that the structural member is formed from EVA and the conduit is formed from a TPE, in order to enable the structural member to be directly bonded to the conduit without an adhesive as taught by Siddhamalli.
Double Patenting
Non Statutory Obviousness Type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to:
www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting over claim 1 of US Patent Application No. 18/707488 (‘488). This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
As to claim 1, claim 1 of ‘488 discloses or suggests the claimed connector including a conduit and structural member, as claimed.
The differences between present claims and the claims of ‘488 claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements).
However, claim 1 of ‘488 teaches or suggests each element of current claim 1, such that the present claims would have been obvious over the ‘488 claims to one of ordinary skill in the art at the time of the present invention. A two-way test is not to be applied in the present cases as Applicant could have filed the claims in a single application and there was no administrative delay. In re Berg, 46 USPQ2d 1226 (Fed. Cir. 1998) (“The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution.”). In the absence of administrative delay, a one-way test is appropriate. In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993). Unless the record clearly shows administrative delay by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way obviousness determination and shift the burden to applicant to show why a two-way obviousness determination is required.
One would be motivated to provide each element of the present claims from the ‘488 claims, as they both relate to the same type of device with the same elements for the same purpose and function in the same field of endeavor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO Form 892 are considered relevant to Applicants’ disclosure and are cited to show further the general state of the art, e.g., Guldfeldt (US 2005/0171496 A1) (Fig.10: a conduit with a cord); Tussy (US 2015/0053298 A1) (Figs.4A-B: a conduit with anti-kink partitions); Pagan (US 6,148,818 A) (medical tube with a reinforcement member); Yamazaki (WO 2014/050570 A1) (Figs.1-3: medical tube with a spanning formation); and Nicola (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: GUY K. TOWNSEND whose telephone number is (571) 270-3689. The examiner can normally be reached Mon. - Fri., 11 am to 6 pm Eastern Time. The direct fax number is (571) 270-4689.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA EISENBERG, can be reached on 571-270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781
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