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, Claims 1-13 in the reply filed on 04/15/2026 is acknowledged. Claims 14-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim.
Status of Claims
Claim(s) 1-23 is/are pending in the application.
Claim(s) 14-23 is/are withdrawn from further consideration.
Claim(s) 1-13 is/are examined on the merits.
Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/31/2023, 01/08/2024, 03/19/2025, and 02/16/2026 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
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 § 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 nonstatutory 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.
Claim(s) 1 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 of U.S. Patent No. 12420058.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference patent contain a reusable urinary catheter assembly comprising a storage container defining a cavity; a hydration liquid within the cavity, the hydration liquid comprising a disinfection medium and at least one hydrophilic polymer, and wherein a viscosity of the hydration liquid is 40 cP or lower; a reusable urinary catheter including a shaft, wherein at least a part of the shaft is provided with a hydrophilic surface, the shaft being enclosed within the cavity in a storage position, wherein the hydration liquid fluid hydrates and regenerates the hydrophilic surface and disinfects the catheter, the catheter being configured to be repeatedly inserted into and removed from the storage container.
The scope of the claimed limitations in the reference patent encompasses the claimed limitations in the instant application.
Regarding instant claim 1, claim 1 of the reference patent discloses all of the limitations of instant claim 1.
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, 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.
Claim(s) 1 and 13 is/are rejected under 35 U.S.C 103 as being unpatentable over Murray (US PGPUB 20220226605) in view of and Belt (US PGPUB 20140190846).
Regarding claim 1, Murray discloses a reusable urinary catheter assembly (a reusable urinary catheter product: ¶0017 and Figs. 1-4), comprising:
a storage container defining a cavity (a case 12 defining a cavity: ¶0017 and Figs. 1-3);
a hydration liquid within the cavity (a hydration fluid 18 within the cavity 12: ¶0017 and Figs. 1-3), the hydration liquid (18) comprising a disinfection medium (a sterilization medium for sterilizing the catheter 14 in between uses: ¶0007 and 0019) and at least one hydrophilic polymer (18 comprises hydrophilic polymer such as polyvinyl pyrrolidone (PVP): ¶0019, 0035, and claim 2);
a reusable urinary catheter (a multiuse/reusable catheter 14: ¶0007, 0018, Figs. 2, and 5) including a shaft (a shaft 20: ¶0018, 0042, Figs. 2, and 5), wherein at least a part of the shaft is provided with a hydrophilic surface (the shaft 20 has a hydrophilic coating: ¶0007 and 0018), the shaft being enclosed within the cavity in a storage position (¶0018 and Figs. 1-4), wherein the hydration fluid (18) hydrates and regenerates the hydrophilic surface and disinfects the reusable urinary catheter (¶0019), the reusable urinary catheter (14) being configured to be repeatedly inserted into and removed from the storage container (¶0007 and claim 1).
Murray does not disclose a viscosity of the hydration liquid is 40 cP or lower.
In an analogous art for being directed to solve the same problem, providing wetting fluid in a package to keep medical devices wetted prior to use, Belt discloses a medical device comprising a hydrophilic polymer coating that is wetted by a wetting agent (Abstract). Belt further discloses the wetting agent has a low viscosity and wherein the viscosity is lower than 500 mPa.s (lower than 500 cP: ¶0008 and 0013; thus, the taught viscosity range overlaps the claimed viscosity range) for the benefit of providing a low amount of friction between the hydrophilic coating and another surface (¶0013).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the reusable urinary catheter assembly of Murray in view of Belt by selecting viscosity of the hydration liquid as claimed, in order to provide a low amount of friction between the hydrophilic coating of the catheter and another surface, as suggested in ¶0013 of Belt and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art (See MPEP 2144.05 (I)).
Regarding claim 13, Murray discloses a method for preparing a reusable urinary catheter for repeated use (a reusable urinary catheter: ¶0016-0017 and Figs. 1-4), comprising:
inserting a hydration liquid within a cavity of a storage container (a hydration fluid 18 within a case 12: ¶0017 and Figs. 1-3), the hydration liquid (18) comprising a disinfection medium (a sterilization medium for sterilizing the catheter 14 in between uses: ¶0007 and 0019) and at least one hydrophilic polymer (18 comprises hydrophilic polymer such as polyvinyl pyrrolidone (PVP): ¶0019, 0035, and claim 2);
inserting the catheter into the storage container (a multiuse/reusable catheter 14: ¶0007, 0018, Figs. 2, and 5), before or after insertion of the hydration liquid (¶0007 and claim 1), wherein the hydration fluid (18) hydrates and regenerates a hydrophilic surface of the catheter and disinfects the catheter (¶0019).
Murray does not disclose a viscosity of the hydration liquid is 40 cP or lower.
In an analogous art for being directed to solve the same problem, providing wetting fluid in a package to keep medical devices wetted prior to use, Belt discloses a medical device comprising a hydrophilic polymer coating that is wetted by a wetting agent (Abstract). Belt further discloses the wetting agent has a low viscosity and wherein the viscosity is lower than 500 mPa.s (lower than 500 cP: ¶0008 and 0013; thus, the taught viscosity range overlaps the claimed viscosity range) for the benefit of providing a low amount of friction between the hydrophilic coating and another surface (¶0013).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the reusable urinary catheter assembly of Murray in view of Belt by selecting viscosity of the hydration liquid as claimed, in order to provide a low amount of friction between the hydrophilic coating of the catheter and another surface, as suggested in ¶0013 of Belt and as it has been held that a prima facie case of obviousness exists when the claimed ranges overlap with ranges disclosed by the prior art (See MPEP 2144.05 (I)).
In addition, since the catheter of Murray in view of Belt meets the structural limitations of the claimed catheter, it follows naturally that the structure suggested by Murray in view of Belt will perform the method steps as presented by Applicant.
Claim(s) 2 is/are rejected under 35 U.S.C 103 as being unpatentable over Murray (US PGPUB 20220226605) in view of and Belt (US PGPUB 20140190846), as applied to claim 1 above, and further in view of Harding (US PGPUB 20210138221).
Regarding claim 2, Murray/Belt does not disclose the disinfection medium comprises methylparaben.
In an analogous art for being directed to solve the same problem, providing disinfectant medium/liquid for medical devices, Harding discloses a device for connection to a medical connector, the device includes a cap, a barrier wall, a first seal, a second seal, a first annular wall including a plurality of internal threads, and a second annular wall including a plurality of external threads and wherein the cap comprising disinfectant/antimicrobial agent (Abstract). Harding further discloses the disinfectant/antimicrobial agent comprises methylparaben (¶0012 and 0064) for the benefit of disinfecting and sterilizing devices (¶0001 and 0007).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the reusable urinary catheter assembly of Murray/Belt in view of Harding by selecting methylparaben as the disinfection medium, in order to disinfect and sterilize medical device or catheter, as suggested in ¶0001 and 0007 of Harding and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Claim(s) 3-5 is/are rejected under 35 U.S.C 103 as being unpatentable over Murray (US PGPUB 20220226605) in view of and Belt (US PGPUB 20140190846), as applied to claim 1 above, and further in view of Finch (US PAT 6679870).
Regarding claims 3-5, Murray/Belt does not disclose the disinfection medium comprises a phenol and an alcohol; the phenol is triclosan; and wherein the alcohol is ethylhexylglycerin or isopropanol.
In an analogous art for being directed to solve the same problem, providing disinfectant medium/liquid for medical devices, Finch discloses methods and kits for the improved locking and/or disinfection of subcutaneously and transcutaneously implanted catheters (Col. 2, lines 35-37). Finch further discloses a disinfectant medium/solution for disinfecting catheter comprising an alcohol such as isopropanol and at least one anti-microbial such as triclosan (Col. 4, lines 9-24) for the benefit of disinfecting catheter to inhibit or prevent infection (Col. 4, lines 9-24). In addition, a person having ordinary skill in the art would have understood/recognized that triclosan is a phenol.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the reusable urinary catheter assembly of Murray/Belt in view of Finch by selecting a phenol and an alcohol as the disinfection medium, wherein the phenol is triclosan and wherein the alcohol is isopropanol, in order to disinfect catheter, as suggested in Col. 4, lines 9-24 of Finch and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Claim(s) 6-8 and 10-12 is/are rejected under 35 U.S.C 103 as being unpatentable over Murray (US PGPUB 20220226605) in view of and Belt (US PGPUB 20140190846), as applied to claim 1 above, and further in view of McGeechan (US PGPUB 20200305437).
Regarding claims 6-8 and 10, Murray/Belt does not disclose the disinfection medium comprises at least two different alcohols, a first alcohol and a second alcohol; the first alcohol is phenoxyethanol; and wherein the second alcohol is ethanol or isopropanol.
In an analogous art for being directed to solve the same problem, disinfectant compositions/solutions for medical instruments, McGeechan discloses a composition having biocidal properties and wherein the composition is suited for use in disinfectant products and for use as a preservative (Abstract). McGeechan further discloses the disinfectant composition comprising a first alcohol and a second alcohol such as phenoxyethanol and isopropanol/ethanol (¶0068) for the benefit of disinfecting medical instruments (¶0087).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the reusable urinary catheter assembly of Murray/Belt in view of McGeechan by selecting phenoxyethanol and isopropanol/ethanol as the first alcohol and second alcohol of the disinfection medium, in order to disinfect catheter, as suggested in ¶0087 of McGeechan and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Regarding claims 11-12, Murray/Belt does not disclose the first alcohol is ethanol and wherein the second alcohol is phenoxyethanol.
McGeechan further discloses the disinfectant composition comprising a first alcohol and a second alcohol such as ethanol and phenoxyethanol (¶0068) for the benefit of disinfecting medical instruments (¶0087).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the reusable urinary catheter assembly of Murray/Belt in view of McGeechan by selecting ethanol and phenoxyethanol as the first alcohol and second alcohol of the disinfection medium, in order to disinfect catheter, as suggested in ¶0087 of McGeechan and as it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Claim(s) 9 is/are rejected under 35 U.S.C 103 as being unpatentable over Murray (US PGPUB 20220226605) in view of and Belt (US PGPUB 20140190846) and McGeechan (US PGPUB 20200305437), as applied to claim 7 above, and further in view of Modak (US PGPUB 20140322147).
Regarding claim 9, Murray/Belt/McGeechan does not disclose the second alcohol is ethylhexylglycerin.
McGeechan further discloses the disinfectant composition comprising a first alcohol and a second alcohol such as phenoxyethanol and ethanol (¶0068) for the benefit of disinfecting medical instruments (¶0087).
In an analogous art for being directed to solve the same problem, disinfectant compositions for medical instruments, Modak discloses antimicrobial compositions and methods of producing an antimicrobial effect used in medical supplies, household cleaning, and personal care products (Abstract and ¶0003). Modak further discloses disinfectant composition comprising octoxyglycerin (which is an alternative name for ethylhexylglycerin) and wherein ethanol and octoxyglycerin are interchangeable (¶0222) for the benefit of inhibiting growth of microbes (¶0058).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the reusable urinary catheter assembly of Murray/Belt/McGeechan in view of Modak by substituting ethanol with ethylhexylglycerin/octoxyglycerin as the second alcohol of the disinfectant medium, in order to disinfect catheter and inhibit growth of microbes, as suggested in ¶0087 of McGeechan and ¶0058 of Modak, and as it has been held that the substitution of a known material/element for another exchangeable material/element supports a prima facie obviousness determination (See MPEP § 2143 (I) (B)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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