DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed January 12, 2026.
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 12, 2026 has been entered.
Status of Claims
2. Claims 35, 36, 39, 40 and 45-54 are pending and currently under consideration for patentability.
Claims 1-34 are canceled as of the August 27, 2021 preliminary amendment.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 35, 36, 39-40 and 45-54 have been considered but are moot because the new ground of rejection does not rely on the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Carleo (US PGPUB 2012/0168324 A1) which was utilized in the first Office action on the merits, is being reintroduced as a primary reference of rejection due to applicant amending the claims to revert back to the original claim language which could be anticipated by Carleo.
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.
4. Claim(s) 35, 36, 39, 46, 47 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carleo (US PGPUB 2012/0168324).
5. With regard to claim 35, Carleo discloses a urinary catheter assembly (Figs. 1, 2; abstract; [0023]; [0054]), comprising: a proximal portion (elongated outer member, 10) configured to be fully received within a urethra during use of the urinary catheter assembly (1; [0062]; [0067]; [0072]); an intermediate portion (elongated inner member, 12) positioned distally of the proximal portion (10; Fig. 2) and configured to be at least partially received within the urethra during use of the urinary catheter assembly (1; [0062]; [0067]; [0072]); and a distal portion (funnel, 26) positioned distally of the intermediate portion (12) and configured to be positioned outside of the urethra during use of the urinary catheter assembly (1; [0059]; “connected to any type fluid collection system or bag that is typically utilized in catheters”), wherein the proximal portion (10) includes at least one opening (one or more drainage eyelet-shaped apertures or openings, 14) configured to allow urine to flow from a bladder into an interior of the proximal portion (10) during use of the urinary catheter assembly (1; [0062]), the intermediate portion (12) is configured to receive urine from the interior of the proximal portion (10) during use of the urinary catheter assembly (1) and to direct the urine to the distal portion (26; [0058]), and the urinary catheter assembly (1) is configured to be movable from a compact configuration (Fig. 1; “closed/retracted/original/pre-use configuration”) in which the intermediate portion (12) is partially received by the proximal portion (10) to an extended configuration (Fig. 2; “open/extended/use configuration”) in which the intermediate portion (12) is substantially positioned outside of the proximal portion (10), with the urinary catheter assembly (1) having a greater length when in the extended configuration (Fig. 2) than when in the compact configuration (Fig. 1; [0055]; [0065]), with a proximal end (having external threads, 18) of the intermediate portion (12) remaining within the proximal portion (10) when the urinary catheter assembly (1) is in the extended configuration (Fig. 2), and with the proximal end (having 18) of the intermediate portion (12) being movable (between Figs. 1, 2) within the proximal portion (10) without deforming the proximal portion (10; [0059]; [0060-0061]; [0065]).
6. With regard to claim 36, Carleo discloses that a majority of the intermediate portion (12) is received by the interior of the proximal portion (10) when the urinary catheter assembly (1) is in the compact configuration (Fig. 1; [0058]; [0062]).
7. With regard to claim 39, Carleo discloses that the proximal portion (10) comprises a catheter member extending between proximal (closer to end, 16) and distal ends (end including internal threads, 20; [0058]; [0062]; [0067]; [0072]).
8. With regard to claim 46, Carleo discloses that the distal portion (26) comprises a drainage member ([0058-0059]; “connected to any type fluid collection system or bag that is typically utilized in catheters”).
9. With regard to claim 47, Carleo discloses a gripper member (handle/grip member, 24; Figs. 1, 2) surrounding a distal end (end closest to thread, 20) of the proximal portion (10) when the urinary catheter assembly (1) is in the compact configuration (Fig. 1) and spaced distally of the distal end (end with 20) of the proximal portion (10) when the urinary catheter assembly (1) is in the extended configuration (Fig. 2; [0059]).
10. With regard to claim 50, Carleo discloses that the intermediate portion (12) is rotatable with respect to the proximal portion (10; [0061]).
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.
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.
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.
11. Claim(s) 52 is rejected under 35 U.S.C. 103 as being unpatentable over Carleo.
12. With regard to claim 52, while Carleo fails to explicitly disclose the assembly as having a length of approximately 20 cm when in the compact configuration, Carleo discloses the assembly (1) as having a length of at least about 9 cm when in the compact configuration (Fig. 1; each member 10 and 12 may have a length of about 9 cm, plus the additional length provided by handle 24 and distal portion 26; [0072]), and suggests that different lengths are possible for each of the proximal (10) and intermediate (12) portions depending on the user’s anatomy, noting an insertable catheter length of 26 cm in male users ([0072]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the effective length of the assembly disclosed by Carleo, when in the compact configuration, to be approximately 20 cm, 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, 220 USPQ 777 (Fed. Cir. 1984). MPEP2144.04(IV)(A). In the instant case, one having ordinary skill in the art would look to select an assembly length in the compact configuration sufficient to perform the desired procedure in males, where the insertion length can be as long as 26 cm, as suggested by Carleo in paragraph [0072].
13. Claim(s) 40, 45, 51, 53 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Carleo in view of Snell et al. (US PGPUB 2005/0049576).
14. With regard to claim 40, while Carleo discloses that the proximal portion (10) comprises a catheter member (Figs. 1, 2; [0056]; [0058]), Carleo is silent in regard to the intermediate portion comprising a stylet.
However, Snell discloses a urinary catheter assembly (medical device, 10; abstract; [0002]; Figs. 4-6) comprising: a proximal portion (drainage section, 13); an intermediate section (deployment mechanism, 3) positioned distally of the proximal portion (13); a distal portion (means for connection to a collection bag on other end, 16; [0052]); and a stylet (deployment member, 14) extending between proximal-most (end of 14 closest to proximal end, 11b) and distal-most ends (end of 14 closest to 16; Fig. 4; [0048]), with the proximal-most end being irremovably positioned (due to attachment at 11b; [0057-0058]) within the catheter member (13) and a distal portion of the stylet (14) being irremovably positioned outside of the catheter member (at 16; Figs. 1, 4); wherein the proximal-most end of the stylet (14) is positioned adjacent to a proximal end (proximal-most end of 11) of the catheter member (13) when the urinary catheter assembly (10) is in the compact configuration (Fig. 4), and the proximal-most end of the stylet (14) is positioned farther from the proximal end (proximal-most end of 11) of the catheter member (13) when the urinary catheter assembly (10) is in the extended configuration (Fig. 6); wherein the proximal-most end (at tip, 15) of the stylet (14) is at least temporarily locked in place within the catheter member (13) when the urinary catheter assembly (10) is in the extended configuration (Fig. 6; by virtue of connection between 15 and 11b; [0057-0058]); and wherein the distal portion of the stylet (14) is positioned outside of the catheter member (at 16) when the urinary catheter assembly (10) is in the compact configuration (Fig. 4), and a larger distal portion of the stylet (14) is positioned outside of the catheter member (at 16) when the urinary catheter assembly (10) is in the extended configuration (Fig. 6; [0057-0063]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the assembly disclosed by Carleo to further include a stylet, similar to that disclosed by Snell, in order to facilitate manipulation of the proximal portion, between the compact and extended configurations, from outside of the body, as suggested by Snell in at least paragraph [0016].
15. With regard to claims 45 and 51, while Carleo as modified by Snell in claim 40 renders obvious that the intermediate portion comprises a stylet (see claim 40 rejection above), the specific combination of Carleo and Snell in the rejection to claim 40 above fails to explicitly disclose that the proximal-most end of the stylet has a larger diameter than an intermediate portion of the stylet; and that the stylet includes a support formation associated with an intermediate portion of the stylet and having a larger diameter than the remainder of the intermediate portion of the stylet.
However, in an alternate embodiment (Figs. 11-16), Snell discloses that the proximal-most end (tip for facilitating insertion, 110) of the stylet (130) has a larger diameter than an intermediate portion of the stylet (130; see Fig. 16; [0080]); and that the stylet (130) includes a support formation (slidable coupling, 118) associated with an intermediate portion of the stylet (130) and having a larger diameter than the remainder of the intermediate portion of the stylet (130; Figs. 12, 13, 15, 16; [0081]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the stylet disclosed by Carleo in view of Snell to include a larger diameter proximal-most end and a larger diameter intermediate support formation, similar to that disclosed by Snell, in order to facilitate insertion while also providing a tactile indication allowing the user to sense with their fingertips, relative position of the tip during use, as suggested by Snell in paragraphs [0080-0081].
16. With regard to claims 53 and 54, while Carleo suggests that the proximal portion (10) and intermediate portion (12) may be made from any number of well-known materials ([0069-0070]), Carleo fails to explicitly disclose that the rigidity of the proximal portion is different from the rigidity of the intermediate portion; and that the proximal portion and the intermediate portion are at least partially formed of different materials.
However, Snell discloses that the material and rigidity of the proximal portion (13; [0076]) is different from the material and rigidity of the intermediate portion (3; Fig. 4, 6; [0068-0070]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the material of the proximal and intermediate portions disclosed by Carleo to be at least partially formed of different materials having different rigidity, similar to that disclosed by Snell, in order to facilitate insertion of the catheter assembly at the proximal portion, while provided a relaxed and corrugated intermediate portion allowing for ease of extension into and out of the extended configuration, as suggested by Snell in at least paragraphs [0070-0071].
17. Claim(s) 48 is rejected under 35 U.S.C. 103 as being unpatentable over Carleo in view of Hannon et al. (US PGPUB 2014/0276661).
18. With regard to claim 48, Caleo is silent in regard to an introducer tip defining an interior chamber between proximal and distal ends of the introducer tip, wherein the proximal portion of the urinary catheter assembly is partially positioned within the interior chamber when the urinary catheter assembly is in the compact configuration.
However, Hannon discloses a urinary catheter assembly (64; Fig. 11; abstract) comprising: an introducer tip (protective tip, 60) defining an interior chamber (interior cavity, 76) between proximal and distal ends of the introducer tip (60), wherein a proximal portion (catheter, 62) of the urinary catheter assembly (64) is partially positioned within the interior chamber (76) when the urinary catheter assembly (64) is in the compact configuration (Figs. 11, 14; [0007]; [0060]; [0066]).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the assembly disclosed by Carleo to further include an introducer tip, similar to that disclosed by Hannon, in order to isolate the proximal portion from the outside environment and potential contamination prior to insertion into the urethra, as suggested by Hannon in paragraph [0007].
19. Claim(s) 49 is rejected under 35 U.S.C. 103 as being unpatentable over Carleo in view of Herweck et al. (US PGPUB 2006/0058737).
20. With regard to claim 49, while Caleo suggests that the shape of the catheter (1) can be variable along its length ([0072]), Caleo is silent in regard to the intermediate portion having a curved configuration.
However, Herweck discloses a catheter assembly (200; abstract; Figs. 1, 2) comprising a proximal portion (catheter, 250) and an intermediate portion (catheter treatment stylet, 150) positioned distally of the proximal portion (250); wherein the intermediate portion (150) may have a curved configuration ([0060]; claim 37).
Therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the intermediate portion disclosed by Carleo to have a curved configuration, similar to that disclosed by Herweck, in order to utilize known shapes and configurations that accommodate easier insertion of the catheter assembly by a user in the sitting or standing position, where linear configurations may be more uncomfortable to insert.
Conclusion
21. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Neil (US 4,652,259) discloses a telescopic catheter assembly.
Okada (US 4,798,591) discloses a catheter obturator.
Gold (US 4,871,358) discloses an externally-based inversionary tube.
Berthiaume (US 5,591,194) discloses a telescoping balloon catheter and method of use.
Murray et al. (US PGPUB 2006/0163097 A1) discloses vapor hydration of a hydrophilic catheter in a package.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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, Sarah Al-Hashimi can be reached on (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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/ANDREW J MENSH/Primary Examiner, Art Unit 3781