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 Request for Continued Examination filed 6/22/2026. Claims 1-9 and 21-32 are currently pending. Claims 10-20 have been previously canceled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/22/2026 has been entered.
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 Stewart (US 2019/0105881 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 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 a portion of the tubing is in an arcuate configuration (as can be seen in Fig. 7, the tubing is stored as a roll, hence a portion of the tubing is in an arcuate configuration); 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.
Stewart teaches that thermoplastic polyurethane may be annealed for at least 2 hours at 100 °C (para. 0116). Note that the temperature and duration Stewart is consistent with adding flexibility (para. 0116).
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 Stewart since Foley, Li, and Berenstein are silent with regard to the temperature and duration of the annealing step and Stewart 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 Stewart is materially the same as the claimed invention, the method of Foley, Li, Berenstein, and Stewart 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 Stewart, 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. 0116, Stewart).
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, Foley).
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 Stewart 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), Stewart (US 2019/0105881 A1), and Clarke (US 2017/0007802 A1).
Regarding claim 2, Foley, as modified by Li, Berenstein, and Stewart, teaches essentially all of the elements of the claimed invention in claim 1.
However, Foley, as modified by Li, Berenstein, and Stewart, 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 Stewart 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.
Claims 29-32 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), Stewart (US 2019/0105881 A1), and Stevens (DE 69632776 T2). Note for convenience, citations to the written description of Stevens refer to the attached translation.
Regarding claim 29, 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 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 a portion of the tubing is in an arcuate configuration (as can be seen in Fig. 7, the tubing is stored as a roll, hence a portion of the tubing is in an arcuate configuration); 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.
Stewart teaches that thermoplastic polyurethane may be annealed for at least 2 hours at 100 °C (para. 0116).
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 Stewart since Foley, Li, and Berenstein are silent with regard to the temperature and duration of the annealing step and Stewart 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 Stewart is materially the same as the claimed invention, the method of Foley, Li, Berenstein, and Stewart 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.
However, Foley, as modified by Li, Berenstein, and Stewart, does not teach that the annealing is carried out with a rod in a lumen of the thermoplastic polyurethane tubing.
Stevens discloses a method of making a catheter comprising the step of annealing with a rod (the mandrel, pg. 6, last line – pg. 7, line 5) in a lumen (329 – Fig. 2A) of a plastic tubing (322 – Fig. 2A; pg. 8 last paragraph; and pg. 6, last line – pg. 7, line 5). One of ordinary skill in the art would have recognized that placing a rod in the lumen during annealing provides the benefit of preventing the tubing from relaxing past the intended diameter, thereby improving the reliability of the manufacturing process.
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, as already modified by Li, Berenstein, and Stewart, to include the step of annealing with a rod in the lumen of the thermoplastic tubing as taught by Stevens in order to improve the reliability of the manufacturing process.
Foley, as modified by Li, Berenstein, Stewart, and Stevens, further teaches:
Claim 30, the thermoplastic polyurethane 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 31, the polymer tubing has been annealed for 24 hours at 100 °C (para. 0116, Stewart).
Claim 32, the substantially arcuate configuration comprises a substantially coiled configuration (see Fig. 7 where the tubing of C is coiled within 14, Foley).
Response to Arguments
Applicant's arguments filed 6/22/2026 have been fully considered but they are not persuasive.
Applicant’s arguments pertaining to Zhuang have been considered but are moot due to the new grounds of rejection set forth herein.
Regarding the claims, applicant argues that Berenstein does not disclose annealing thermoplastic polyurethane tubing to modify long-term mechanical recovery Berenstein is directed to manufacturing and structural integration concerns.
In response, it is noted that there may be other motivations to combine than applicant’s own stated motivation. In this case, Berenstein adds flexibility which is beneficial. Therefore, applicant’s argument is found to be not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ngoc (US 5969047) discloses annealing thermoplastic polyurethane for 24 hours at 100 degrees Celsius (col. 20, lines 18-27).
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.
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, Shelley Self can be reached at 571-272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THOMAS M WITTENSCHLAEGER/Primary Examiner, Art Unit 3731
8/14/2026
Prosecution Insights