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 .
Claim Status
This Office action is in response to the amendments filed 2/24/2026. Claims 1-9 and 21-28 are currently pending. The cancelation of claims 10-20 is acknowledged.
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 1, 3-9, 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Foley (US 2016/0136391 A1) in view of Li (US 2013/0158518 A1), Berenstein (US 5895378), and Zhuang (US 2013/0267639 A1).
Regarding claim 1, Foley discloses a method comprising: providing a catheter (C – Fig. 7) having a tubing (the unlabeled but clearly depicted tubing of C – Fig. 7); placing the catheter in an arcuate configuration within a cavity (the assembly of 14 and 16 – Fig. 7) of a package (see Fig. 7, the tubing of the catheter is coiled within 14); wherein at least a portion (the portion within 14 – Fig. 7) of tubing is in a substantially coiled configuration within the cavity (as noted above, see Fig. 7, the tubing of the catheter is coiled within 14), the portion of the tubing being defined between a proximal location (P – Fig. 7) on the tubing and a distal location (D – Fig. 9) on the tubing (see Fig. 7).
However, Foley does not expressly disclose the material of the tubing.
Li discloses a catheter (10 – Fig. 1) similar to the catheter of Foley that comprises a tubing (12 – Fig. 1) made of a thermoplastic polyurethane (para. 0140, the embodiment in which the tubing (catheter body), juncture hub, and extension lines are made of aromatic polyether thermoplastic polyurethanes, pg. 21, col. 2, lines 27-31). Since Li discloses a catheter similar to the catheter of Foley, one of ordinary skill in the art, upon reading the teaching of Li would have recognized that the tubing of Foley made be made of the same material as the tubing of Li.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of applicant’s claimed invention, to have made the tubing of Foley a thermoplastic polyurethane as taught by Li since Foley is silent with regard to the material of the tubing and Li teaches a known solution.
However, Foley, as modified by Li, does not expressly teach annealing the catheter.
Berenstein teaches a similar catheter (100 – Fig. 1) comprising a tubing (112 – Fig. 1) made of polyurethane (col. 3, lines 35-40), wherein the catheter is annealed (col. 5, line 58 – col. 6, line 4) in order to add flexibility and conformability (col. 5, line 58 – col. 6, line 4).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of applicant’s claimed invention, to have modified the method of Foley and Li to include a step of annealing the catheter, and thus the tubing, as taught by Berenstein in order to add flexibility and conformability.
However, Foley, as modified by Li and Berenstein, does not expressly teach the temperature and duration of the annealing step.
Zhuang teaches that polyether-based thermoplastic polyurethane may be annealed for at least 2 hours at 100 °C.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of applicant’s claimed invention, to have performed the annealing step of Foley, Li, and Berenstein for at least 2 hours at 100 °C as taught by Zhuang since Foley, Li, and Berenstein are silent with regard to the temperature and duration of the annealing step and Zhuang teaches a known solution for polyurethane materials.
Note that the limitation “wherein a percent shape recovery of the portion of the polymer tubing after about 1 month at room temperature is at least 35%” and the formula that follows this limitation is a result of performing the method. Since the method of Foley, Li, Berenstein, and Zhuang is materially the same as the claimed invention, the method of Foley, Li, Berenstein, and Zhuang would result in the portion of the tubing having a percent shape recovery of at least 35% after 1 month at room temperature, as calculated by the claimed formula.
Foley, as modified by Li, Berenstein, and Zhuang, further teaches:
Claim 3, the polymer tubing has a shore hardness of at least 80A (the hardness is in a range from 80A to 100A, para. 0140, lines 1-13, Li; note that Li does not expressly disclose the hardness of the tubing but in the embodiment in which the tubing (catheter body), juncture hub, and extension lines are made of aromatic polyether thermoplastic polyurethanes, pg. 21, col. 2, lines 27-31, if the juncture hub and extension lines have a shore hardness of at least 80A, then the tubing has a shore hardness of at least 80A).
Claim 4, the polymer tubing has a shore hardness of between 88A and 91A (the hardness is in a range from 80A to 100A, hence it is also between 88A and 91A, para. 0140, lines 1-13, Li; note that Li does not expressly disclose the hardness of the tubing but in the embodiment in which the tubing (catheter body), juncture hub, and extension lines are made of aromatic polyether thermoplastic polyurethanes, pg. 21, col. 2, lines 27-31, if the juncture hub and extension lines have a shore hardness between 88A and 91A, then the tubing has a shore hardness between 88A and 91A).
Claim 5, the polymer tubing has been annealed for 24 hours at 100 °C (para. 0075, Zhuang).
Claim 6, the polymer tubing comprises polyether thermoplastic polyurethane (pg. 2, col. 2, lines 27-31, Li).
Claim 7, the polymer tubing comprises an aromatic thermoplastic polyurethane (pg. 2, col. 2, lines 27-31, Li).
Claim 8, the polymer tubing comprises polyether aromatic thermoplastic polyurethane (pg. 2, col. 2, lines 27-31, Li).
Claim 9, the substantially arcuate configuration comprises a substantially coiled configuration (see Fig. 7 where the tubing of C is coiled within 14).
Claim 21, the thermoplastic polyurethane tubing has a shore hardness of at least 88A (the hardness is in a range from 80A to 100A, para. 0140, lines 1-13, Li; note that Li does not expressly disclose the hardness of the tubing but in the embodiment in which the tubing (catheter body), juncture hub, and extension lines are made of aromatic polyether thermoplastic polyurethanes, pg. 21, col. 2, lines 27-31, if the juncture hub and extension lines have a shore hardness of at least 80A, then the tubing has a shore hardness of at least 88A).
Claim 22, the thermoplastic polyurethane tubing has a shore hardness of at least 90A (the hardness is in a range from 80A to 100A, para. 0140, lines 1-13, Li; note that Li does not expressly disclose the hardness of the tubing but in the embodiment in which the tubing (catheter body), juncture hub, and extension lines are made of aromatic polyether thermoplastic polyurethanes, pg. 21, col. 2, lines 27-31, if the juncture hub and extension lines have a shore hardness of at least 80A, then the tubing has a shore hardness of at least 90A).
Claim 23, the storage modulus of the thermoplastic polyurethane tubing is greater than or equal to 19 MPa and less than or equal to 50MPa and the loss modulus of the thermoplastic polyurethane tubing is greater than or equal to 2.8 MPa and less than or equal to 8.9 MPa. Note that although neither reference expressly discloses the storage modulus or the loss modulus, since these moduli are properties of the material and the combination of Foley, Li, Berenstein, and Zhuang and teaches the material and annealing, the tubing of the combination would have these moduli.
Claim 24, placing a hydration medium (34 – Fig. 11, Foley) within the cavity of the package (para. 0078 and see Fig. 11, Foley).
Claim 25, the hydration medium comprises water (para. 0078, Foley).
Claim 26, the thermoplastic polyurethane tubing has a hydrophilic coating (para. 0010, Li).
Claim 27, the package comprises a foil (para. 0079, Foley, note that the package is interpreted to 36 – Fig. 4).
Claim 28, a sleeve at least partially covering the thermoplastic polyurethane tubing (as can be seen in Fig. 7 of Foley, T has a sleeve within which the distal end of P is placed).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Foley (US 2016/0136391 A1) in view of Li (US 2013/0158518 A1), Berenstein (US 5895378), Zhuang (US 2013/0267639 A1), and Clarke (US 2017/0007802 A1).
Regarding claim 2, Foley, as modified by Li, Berenstein, and Zhuang, teaches essentially all of the elements of the claimed invention in claim 1.
However, Foley, as modified by Li, Berenstein, and Zhuang, does not expressly teach a step of sterilizing.
Clarke teaches a method of manufacturing and packaging a catheter, wherein the method includes the step of sterilizing using e-beam radiation (para. 0177). One of ordinary skill in the art, upon reading the teaching of Clarke, would have recognized that sterilizing the catheter provides the benefit of killing any pathogens, thereby reducing the probability that a user will become ill from using the catheter.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of applicant’s claimed invention, to have modified the method of Foley, Li, Berenstein, and Zhuang to include the step of sterilizing as taught by Clarke in order to reduce the probability that a user will become ill from using the catheter.
Response to Arguments
Applicant's arguments filed 2/24/2026 have been fully considered but they are not persuasive.
Regarding claim 1, applicant argues that the combination of Zhuang with Foley, Li, and Berenstein lacks a reasonable expectation of success since nothing in Zhuang indicates that its annealing conditions are suitable for finished thermoplastic polyurethane catheter tubing.
However, it is noted that Zhuang is simply relied upon for the annealing time and temperature. Berenstein is relied upon to teach annealing a catheter. Since the combination of Foley, Li, and Berenstein already teaches annealing a catheter, there would be a reasonable expectation of success for the time and temperature of annealing as taught by Zhuang. Therefore, applicant’s argument is found to be not persuasive.
Regarding claim 1, applicant argues that Zhuang is not analogous prior art.
However, it is noted that Zhuang solves the problem with which applicant is concerned, that is, how long and at what temperature to anneal thermoplastic polyurethane. Therefore, applicant’s argument is found to be not persuasive.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS M WITTENSCHLAEGER whose telephone number is (571)272-7012. The examiner can normally be reached MON-FRI: 9:00-5:00.
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/THOMAS M WITTENSCHLAEGER/Primary Examiner, Art Unit 3731
3/19/2026