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 .
The examiner acknowledges receipt of amendment and remarks filed 03/30/2026.
Claims 1 and 14 are amended.
Claims 15-16 are canceled.
Claims 1, 3, 14, 26-33 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 was entered.
Priority
This application is a Continuation of PCT/GB2022/051923 filed 07/22/2022 and which claims benefit of 62/203,594 filed 07/27/2021.
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered but they are not persuasive.
Obviousness type double patenting rejection: Applicant states of taking no position now but would take a position when the claims are found allowable.
Response: The rejection will be reiterated below because the rejection is not overcome and the obviousness type rejection is not the only rejection.
In the paragraph bridging page 5 of 10 and 6 of 10, applicant cites KSR Int’l v. Teleflex inc., 127 S. Ct. 1727, 1741 (2007) quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), argues that the obviousness rejections cannot be sustained by mere conclusory statements, but rather, reasons for the obviousness must be articulated and it was settled in In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) that the prior art does not have to suggest the same advantage or result discovered by applicant.. Further citing MPEP 706.02(j), applicant argues every limitation in the claim must be considered.
Response: With regards to KSR Int’l v. Teleflex inc., 127 S. Ct. 1727, 1741 (2007), the rejection was not mere conclusions but careful articulation of the teachings of Madsen in combination with Woodward rendering the claims prima facie obvious. The rejection considered every limitation of the claims.
Starting from the second full paragraph of page 6 of 10 to page 9 of 10, applicant has provided paragraphs of the specification as published to show support for amendment to the claims; applicant argues that the cited references alone or in combination does not render the claims obvious because storing the catheter in aqueous medium containing lubricious additive provides lubricated catheter surface that does not require additional wetting step before application and that applicant believes that the presence of salt within the aqueous salt solution in contact with the catheter surface prevents migration of the amphiphilic additive out of the tubular body; that claims 26-29 depend directly form claim 1 and are also patentable over the cited art; that claims 30-33 are also patentable over the cited art for the reasons presented for claim 1 and that claims dependent thereon.
Response: For the lubricious additive being in the base polymer of the tubular body, there is no literal support. For the patents, US 10058638 B2 and US 9186438 B2 were never incorporated by reference and as such applicant cannot rely on disclosures from these patents to support limitations of the examined claims. The packaged intermittent catheter comprises a base polymer and amphiphilic lubricious additive. The amendment says that the lubricious additive is in the base polymer. While there is no literal support for this new limitation, the examiner interprets the body of the catheter as comprising lubricious additive and base polymer because the lubricious additive and the base polymer are in contact. The catheter in Madsen comprises amphiphilic lubricious additive and is packed in water/aqueous medium. Madsen teaches the presence of salt in the coating (page 19, lines 19-27 and claim 12). The coating in Madsen contains amphiphilic lubricious additive. Madsen does not say that the amphiphilic lubricious additive migrates out of the catheter. It is settled in composition in In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) that the prior art does not have to suggest the same advantage or result discovered by applicant. Nonetheless, Madsen and Woodward do not teach that lubricious additive migrates out of the catheter. Furthermore, Madsen’s coating contains salt. Therefore, claims 3, 14 and 26-33 are not patentable over the cited art.
New Rejections
Necessitated by Amendment
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 1, 3, 14. 26-33 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 30 are amended to say that the lubricious additive is in the base polymer of the tubular body. It is unclear and the specification does not direct as to what it means by the lubricious additive being in the base polymer. The examiner examines this limitation as the tubular body comprising a base polymer and amphiphilic lubricious additive in the base polymer of the tubular body and because the catheter body comprises the base polymer and amphiphilic lubricious additive, the base polymer and amphiphilic lubricious additive are in contact and could be interpreted as the lubricious additive being in the base polymer.
Correction is respectfully requested.
Maintained Rejections
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.
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.
Claim(s) 1, 3, 14 and 26-33 remain rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al. (WO 2006037321 A1) in combination with Woodward in the paper “Intermittent self-catheterization: making it safer and easier Clinical and patient benefits of GentleCath Glide” in British Journal of Neuroscience Nursing, 2018, and Wolff et al. (US 5416131) and further in view of Gravesen et al. (US 9186438 B2).
Claims 1 and 30 have been amended to say that the amphiphilic lubricious additive is in the base polymer of the tubular body and that the aqueous solution is in contact with the tubular body and where the at least one salt is at 5-50% (for claim 1). The combination of amphiphilic lubricious additive and base polymer implies that the amphiphilic lubricious additive and base polymer are in contact and being in contain would mean that the lubricious additive is in the base polymer.
Madsen discloses catheters/urinary catheters (page 4, lines 7-15) that is for insertion into a body cavity (page 4, lines 3-5) packed and stored in container (page 1, lines 3-11; page 3, lines 4-5; page 26, lines 14-23; page 27, lines 4-11; claims 17-20). The catheter medical device is coated with hydrophilic amphiphilic block copolymer and wetting agent comprising water and one or more lubricant affording the catheter lubricious and wetted (page 3, lines 20-32). The lubricant is poloxamer or ethylene oxide/propylene Oxide-copolymerisates such as polyglycol P-41, or ethylene oxide/Propylene Oxide-copolymerisate-Monobutyl Ethers such as Polyglykol B-11 types, or Polyglykol PR-types such as PR 300, PR 450, PR600, PR 1000 (page 6, lines 1-25). The coating composition also contains polyethylene oxides having molecular weight between 100,000 and 5,00,000 namely POLYOX WSR N-80 having molecular weight of 200,000 and POLYOX WSR 301 having molecular weight of 4,000,000 (page 17, lines 11-14). The hydrophilic coating also contains salt or urea as osmolality increasing agent (page 19, lines 19-27; claim 12). In the background of Madsen (see page 2, lines 1-10), it is taught that inorganic salts such as sodium chloride, potassium chloride, potassium iodide and organic salts such as sodium citrate, sodium benzoate and monosaccharides such as glucose and sugar alcohols such as sorbitol and glycerol are known to increase osmolality; specifically, US 5416131 was cited to teach these osmolality increasing salts to reduce friction in wetted coating.
Poloxamer is a surfactant meeting the requirement for surfactant. The POLYOX is polyethylene oxide meeting the requirement for polyethylene oxide. The polyethylene oxide is present at 18-20% w/w (page 20, lines 18-19); and in example A, POLYOX WSR N-80 is at 24%, POLYOX WSR 301 is at 1%; example B, POLYOX WSR N-80 is at 20%; example C, POLYOX WSR N-80 is at 18%. 24% POLYOX WSR N-80 is about 1.2 mmol/L and 1% POLYOX WSR 301 is about 0.0025 mmol/L for a total of 1.2025 (example A); 20% POLYOX WSR N-80 is about 1 mmol/L (example B); 18% POLYOX WSR N-80 is about 0.9 mmol/L (example B). All these values are at least 0.005 mmol/L as required by claim 3..
For claims 1, 3, and 30-33 Madsen does not disclose that the urinary catheter is an intermittent catheter. However, it is known in the art that practicing intermittent catheterization avoids some of the risks associated with an indwelling catheter (see the whole document of Woodward in the paper “Intermittent self-catheterization: making it safer and easier Clinical and patient benefits of GentleCath Glide” in British Journal of Neuroscience Nursing, 2018, with emphasis on the conclusion. Therefore, before the effective date of the invention the artisan would be motivated to adopt intermittent self-catheterization with the motivation of expecting that the risks associated with indwelling catheter would be predictably avoided.
While Madsen teaches A-B block copolymers (page 24, lines 16-28) and teaches that the hydrophobic A block is polyethylene, polypropylene, poly-1-butene or polyisobutylene poly alpha olefin (see at least lines 12-14 of page 9) or polymerized styrene (lines 20-23 of page 9), Madsen does not say that the polyethylene hydrophobic block is CH3CH2(CH2CH2)a where a is 5-26. It is known in the art that hollow medical article (column 1, lines 13-14 of ) such as catheter (column 2, lines 48-50, claim 5) that comprises amphiphilic block copolymer having hydrophobic A block and hydrophilic B block with the hydrophobic A block being CH3CH2(CH2CH2)a where a is 10, 11, 12, 13, .. 25 (column 1, lines 51-55 of Gravesen). CH3CH2(CH2CH2)a is a polyolefin/polyethylene. Therefore, before the effective date of the invention the ordinary skilled artisan looking to Gravesen would use the polyolefin of Gravesen for the catheter of Madsen as specific polyethylene/polyolefin hydrophobic block that would be predictably be amphiphilic block copolymer with the hydrophilic block with the expectation that the catheter would be lubricious.
With respect to %salt associated with the catheter as required by claim 1, Madsen while referring to US 5416131 as teaching that osmolality increasing salts reduce friction in wetted coating, US 5416131 teaches that salts such as sodium chloride, potassium chloride, potassium iodide and sodium citrate in amounts of 10-40% increase osmolality and reduce friction in coated catheter (column 4, lines 40-52) and 10% is a point between 5-50% and 10-40% is a species of 5-50% Therefore, before the effective date of the invention, the artisan would look to US 5416131 to use salt in amounts of 10-40% that would predictably reduce friction. The coating composition on the catheter contains poloxamer and POLYOX (page 6, lines 1-25). Poloxamer is a surfactant. Madsen lists poloxamer and polyethylene oxide as lubricants (page 5, lines 28-30; page 6, lines 1-25). The total amount of lubricants ranges from 1-70% (page 23, lines 17-21) and this range allows for the claimed amount of 0.005 mmol/L for the surfactant and polyethylene oxide.
For claim 14, the coating composition of Madsen contains water (see at least the abstract; page 3, lines 20-23; page 5, lines 28-30) and since the coating composition contains water it is reasonable to expect that the catheter is submerged in the coating composition and hence in the composition containing water (page 26, lines 20-23).
For claims 26-29, 10% is at least 5% and artisan would optimize the coating composition of Madsen that would predictably result in lubricious catheter. There is no factual showing that the claimed range of 5-9% (claim 26, with the 9% being close to the lower range 10%), 5-8% (claim 27), 5-7% (claim 28) and 5-6% (claim 29) provides unexpected results.
Madsen in combination with Woodward, Gravesen and Wollf renders claims 1, 3, 14 and 26-33 prima facie obvious.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a non-statutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 14-16 and 26-33 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-8, 12-13 and 17-25 of co-pending Application No. 17871440 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending intermittent catheter having lubricious additive comprising amphiphilic molecule having hydrophilic-lipophilic balance (HLB) below 8 includes hydrophilic-lipophilic balance of at least 7 of the examined intermittent catheter of the examined claim 6 because HLB of below 8 includes HLB of at least 7.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9 and 13-16 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-5, 9-12 and 15-22; 1, 3, 5, 8-9, 11-13, 15, 17-19 and 24-25; 1-2, 4, 6, 8, 9, 11, 14-19, 21-22 and 24-25; and 2-8, 11-13, 16-25 of co-pending Application Nos. 17871406; 17/871328; 18827220; and 18827101 (reference application) respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims teach the intermittent catheter of the examined claims and the composition in co-pending claims 2-7 of co-pending 18827101 is used in the intermittent catheter of the examined claims..
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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