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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/12/2025 has been entered.
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
Applicant argues that the cited references do not teach the amendments to claim 1 including the cooling step where the material is cooled to 50-100°C. While Examiner agrees that none of the references explicitly disclose a cooling step to the claimed temperature, the method described in Altonen necessarily includes a curing step. Altonen performs an injection molding process and then an annealing process approximately 1°C below the glass transition temperature, see Altonen [0074]. Since the glass transition temperature is always below the melting temperature, the material is necessarily cooled between the injection molding an annealing steps. Depending on the selected polymer and the glass transition temperature thereof, see Altonen [0066], this cooling necessarily includes the material being cooled to the claimed range for a number of the polymers described within Altonen.
With respect to claim 18, Applicant argues that the cited references do not describe the claimed materials. After further search and consideration, an additional reference, Moser, is cited which describes cellulose acetate for use in similar products. Similarly, claim 2 is also rejected using Moser.
With respect to new claims 29-31, claim 29 is rejected but claims 30-31 have been indicated as containing allowable subject matter. Similarly, claim 5 is also indicated to have allowable subject matter.
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.
Claims 1-8, 12-13, 17-18, and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Knutsson (US 2018/0304048, made of record on the IDS dated 9/1/2023) modified by Bierman (US 20150038944) and Altonen (US 2005/0060953.)
Regarding claim 1, Knutsson meets the claimed, A method for manufacturing a vascular catheter system, comprising: injecting a thermoplastic material into a mold cavity; curing the thermoplastic material to form a needle shield (Knutsson [0060] describes injection molding a needle shield 100 made of a thermoplastic polymer) including at least one resilient arm; (Knutsson [0033] describes a resilient arm 102).
Knutsson does not disclose an annealing step and does not meet the claimed, and annealing the needle shield, after curing.
Analogous in the field of needle or catheter devices, Bierman meets the claimed, and annealing the needle shield, after curing (Bierman [0009] and [0039]-[0040] describe annealing a needle sheath after previous molding steps, see [0044].)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of making the shield of Knutsson with the annealing step described in Bierman in order to allow for increased flexibility, see Bierman [0009].
Bierman does not disclose the glass transition temperature and does not describe, annealing at an annealing temperature under a glass transition temperature (Tg} of the thermoplastic material, wherein curing the thermoplastic material includes cooling the thermoplastic material to a temperature of 50 to 100°C.
Analogous in the field of thermoplastic injection molding and annealing, Altonen meets the claimed, at an annealing temperature under a glass transition temperature (Tg} of the thermoplastic material (Altonen [0069]-[0070] describes annealing just below the glass transition temperature) wherein curing the thermoplastic material includes cooling the thermoplastic material to a temperature of 50 to 100°C (Altonen [0015] describes cooling inherently occurs in the mold after the initial molding step and [0066] describes the glass transition temperatures which are close to the annealing temperatures many of which are within the claimed range. Therefore, the material must be cooled to at least these temperatures before the annealing process begins.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of annealing as described in Bierman with the method of cooling the plastic down and then annealing below the glass transition temperature as described in Altonen in order to relieve retained stresses in the part, see Altonen [0086].
Regarding claim 3, Knutsson and Bierman do not describe the Tg of the thermoplastic polymer and do not meet the claimed, The method according to claim 1, wherein: the Tg of the thermoplastic material is from 100 to 200 0C and the annealing temperature is 5 to 50 0C below the Tg.
Altonen further meets the claimed, The method according to claim 1, wherein: the Tg of the thermoplastic material is from 100 to 200 0C; (Altonen Table 1 says the Tg of amorphous polyamide is 92-192°C) and the annealing temperature is 5 to 50 0C below the Tg (Altonen [0074] describes the annealing temperature is between 1°-30° below the Tg.)
The ranges of both the annealing temperature and the glass transition temperature as disclosed in Altonen overlap the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP §2144.05 (I).
Regarding claim 4, Altonen further meets the claimed, The method according to claim 3, wherein the Tg of the thermoplastic material is from 120 to 170 0C (Altonen Table 1 says the Tg of amorphous polyamide is 92-192°C);and the annealing temperature is 10 to 40 0C below the Tg (Altonen [0074] describes the annealing temperature is between 1°-30° below the Tg.)
The ranges of both the annealing temperature and the glass transition temperature as disclosed in Altonen overlap the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP §2144.05 (I).
Regarding claim 6, Knutsson does not disclose annealing and does not meet the claimed, The method according to 1,wherein the thermoplastic unit is annealed for 30 to 180 minutes
Bierman meets the claimed, The method according to 1,wherein the thermoplastic unit is annealed for 30 to 180 minutes (Bierman [0009] describes annealing for one hour.)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of Knutsson with the annealing step for one hour as described by Bierman in order to allow for increased flexibility, see Bierman [0009].
Regarding claim 8, Knutsson meets the claimed, The method according to claim 1, wherein the thermoplastic material includes at least one of polyoxymethylene (POM), polybutylene terephthalate (PBTP), liquid crystal polymer (LCP), polyamide (PA), polysulfone (PSU), polyetherimide (PEI), polycarbonate (PC), polyphenylene oxide/styrene butadiene (PPO/SB), a styrenic block copolymer, a polyolefinic mixture, an elastomeric alloy, a thermoplastic polyurethane, a thermoplastic copolyester, and a thermoplastic polyamide (Knutsson [0060] describes POM, PBTP, LCP, PA, PSU, PEI, PC, and PPO/SB.
Regarding claim 12, Knutsson meets the claimed, The method according to claim 1, further comprising placing the needle shield in a flexed state and/or a tensioned state via flexing the at least one resilient arm into a tension state (Knutsson [0034] describes tensioning the arm 103.)
Regarding claim 13, Bierman further meets the claimed, The method according to claim 12, wherein the thermoplastic unit is annealed before placing the thermoplastic unit in the at least one of the flexed state and the tensioned state (Bierman discloses annealing as part of the manufacturing process. The bending in Knutsson does not take place until assembly.)
Regarding claim 24, Knutsson meets the claimed, The method according to claim 1, wherein the needle shield further includes a base plate from which the at least one resilient arm protrudes forming the needle shield further includes providing the base plate with a through-hole (Knutsson [0033] describes a base plate with a through hole 102.)
Regarding claim 25, Knutsson meets the claimed, The method according to claim 24, further comprising flexing the at least one resilient arm from a resting state to a tension state, (Knutsson [0034] describes tensioning the arm 103) wherein: the at least one resilient arm is intersected by a central longitudinal axis of the through-hole of the base plate when in the resting state; and the at least one resilient arm is offset from the central longitudinal axis of the through-hole of the base plate when in the tension state (see Knutsson Figures 6 and 7 showing the tensioned and relaxed states, see Figure 7 showing the axis of the hole intersecting the arm 103.)
Regarding claim 26, Knutsson meets the claimed, The method according to claim 25, wherein: the at least one resilient arm includes a hook element projecting from a distal end of the at least one resilient arm disposed opposite the base plate; (Knutsson Figures 6 and 7 show the arm 103 is hooked on the end) and the hook element is intersected by the central longitudinal axis of the through-hole of the base plate when the at least one resilient arm is in the resting state (Knutsson Figure 7 shows the hook overlapping the axis.)
Regarding claim 27, Knutsson meets the claimed, The method according to claim 25, further comprising: arranging a needle in the through-hole of the base plate; (Knutsson [0032] describes arranging the needle through the hole) and maintaining the at least one resilient arm in the tension state with the needle such that upon withdrawal of the needle the at least one resilient arm snaps into the resting state (Knutsson Figures 6 and 7 and [0048]-[0049] describe the operation of the shielding apparatus and how the arms move to a relaxed position.)
Regarding claim 28, Knutsson meets the claimed, The method according to claim 27, further comprising :arranging the needle shield in an interior cavity of a catheter hub; (Knutsson [0033] describes the needle is within the catheter hub) and when the at least one resilient arm in the tension state, urging the at least one resilient arm against the catheter hub with the needle (Knutsson Figure 6 shows the arm 103 biased against the catheter hub 201.)
Claims 2 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Knutsson, Bierman, and Altonen as applied to claim 1 above, and further in view of Moser (US 2021/0046255) and claims 17-18 and 21 are rejected in view of Knutsson, as modified by Bierman, Altonen, and Moser.
Regarding claim 2, modified Knutsson does not described the claimed materials and does not meet the claimed, The method according to claim 1, wherein the thermoplastic material includes cellulose acetate (CA), polyethersulfone (PES), polyamideimide (PAI) and/or an elastomeric alloy.
Analogous in the field of needle assemblies, Moser meets the claimed, The method according to claim 1, wherein the thermoplastic material includes cellulose acetate (CA), polyethersulfone (PES), polyamideimide (PAI) and/or an elastomeric alloy (Moser [0085] describes a needle retention device made out of cellulose acetate.)
The courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143. It would have been obvious to a person of ordinary skill in the art before the filing date to substitute the plastic in Knutsson for the cellulose acetate described in Moser because Moser describes that cellulose acetate is a commonly used plastic and is approved for use in the medical field, see Moser [0085]
Regarding claim 17, Knutsson meets the claimed, The method according to claim 18, wherein the thermoplastic unit is a spring-loaded needle shield for a vascular catheter system including at least one resilient arm. (Knutsson [0034] describes a spring clip needle tip shielding device and resilient arm 103.)
Regarding claim 18, Knutsson meets the claimed, A method for manufacturing a vascular catheter system, thermoplastic unit, the method comprising: injecting a thermoplastic material into a mold cavity; curing the thermoplastic material to form a thermoplastic unit; (Knutsson [0060] describes injection molding a needle shield 100 made of a thermoplastic polymer) placing the thermoplastic unit in at least one of a flexed state and/or a tensioned state (Knutsson [0034] describes tensioning the arm during the final assembly.)
Knutsson does not disclose an annealing step and does not meet the claimed, after curing the thermoplastic material, annealing the thermoplastic unit
Analogous in the field of needle or catheter devices, Bierman meets the claimed, after curing the thermoplastic material, annealing the thermoplastic unit (Bierman [0009] and [0039]-[0040] describe annealing a needle sheath after previous molding steps, see [0044].)
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of making the shield of Knutsson with the annealing step described in Bierman in order to allow for increased flexibility, see Bierman [0009].
Bierman does not disclose the glass transition temperature and does not describe, annealing at an annealing temperature that is 5 to 50 °C below a glass transition temperature (Tg) of the thermoplastic material; and after annealing the thermoplastic unit,
Analogous in the field of thermoplastic injection molding and annealing, Altonen meets the claimed, at an annealing temperature that is 5 to 50 °C below a glass transition temperature (Tg) of the thermoplastic material; and after annealing the thermoplastic unit, (Altonen [0074] describes the annealing temperature is between 1°-30° below the Tg.)
The ranges of both the annealing temperature and the glass transition temperature as disclosed in Altonen overlap the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP §2144.05 (I).
It would have been obvious to a person of ordinary skill in the art before the filing date to combine the method of annealing as described in Knutsson as modified by Bierman with the method of annealing below the glass transition temperature as described in Altonen in order to relieve retained stresses in the part, see Altonen [0086].
Modified Knutsson does not described the claimed materials and does not meet the claimed, wherein the thermoplastic material includes cellulose acetate (CA), polyethersulfone (PES), polyamideimide (PAI) and/or an elastomeric alloy.
Analogous in the field of needle assemblies, Moser meets the claimed, wherein the thermoplastic material includes cellulose acetate (CA), polyethersulfone (PES), polyamideimide (PAI) and/or an elastomeric alloy. (Moser [0085] describes a needle retention device made out of cellulose acetate.)
The courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143. It would have been obvious to a person of ordinary skill in the art before the filing date to substitute the plastic in Knutsson for the cellulose acetate described in Moser because Moser describes that cellulose acetate is a commonly used plastic and is approved for use in the medical field, see Moser [0085]
Regarding claim 21, Knutsson meets the claimed, The method according to claim 18, wherein placing the thermoplastic unit in the flexed state and/or the tensioned state includes flexing at least one resilient arm of the thermoplastic unit into a tension state. (Knutsson [0034] describes tensioning the arm 103.)
Regarding claim 29, Altonen further meets the claimed, The method according to claim 1, wherein the annealing temperature is 80°C to 100 °C, Altonen [0074] describes performing the annealing at 1° below the glass transition temperature. Altonen [0066] describes the glass transition temperature of various polymers, several of which describe temperatures in this range. The ranges of the annealing temperatures as disclosed in Altonen overlap the claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP §2144.05 (I).
Modified Knutsson does not meet the claimed, the thermoplastic material includes cellulose acetate (CA). Analogous in the field of needle assemblies, Moser meets the claimed, the thermoplastic material includes cellulose acetate (CA). (Moser [0085] describes a needle retention device made out of cellulose acetate.)
The courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143. It would have been obvious to a person of ordinary skill in the art before the filing date to substitute the plastic in Knutsson for the cellulose acetate described in Moser because Moser describes that cellulose acetate is a commonly used plastic and is approved for use in the medical field, see Moser [0085].
Allowable Subject Matter
Claims 5 and 30-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With respect to claim 5, the combination of Knutsson, Bierman and Altonen describe a needle shielding device that is injection molded from a thermoplastic material, cooled, then annealed at a temperature slightly below the glass transition temperature. Claim 5 further specifies that the glass transition temperature of the thermoplastic material is between 140-160°C and the annealing temperature is 25-35°C below the glass transition temperature, i.e., 105-135°C. In claim 1, the step of cooling the thermoplastic material to 50-100°C is taught by Altonen. While Altonen does not teach an explicit cooling step, Altonen [0015] teaches that cooling occurs during injection molding and Altonen [0066]/[0074] describe the annealing temperatures. Since the glass transition temperature is always lower than the melting temperatures at which injection molding would occur, cooling must occur to at least the glass transition temperature before annealing process begins. Since the cooling is at least as cold as the glass transition temperatures listed in [0066] and several of those temperatures overlap the claimed range, claim 1 is met by Altonen.
Claim 5, however, further specifies that the glass transition temperature of the thermoplastic material is between 140-160°C and the annealing temperature is 25-35°C below the glass transition temperature, i.e., 105-135°C. In this scenario, Altonen would not meet the claim because Altonen does not explicitly teach that the plastic is cooled to 100°C or lower. Altonen can only teach that the glass transition temperature or slightly below is reached in view of Altonen [0074]. This does not guarantee that 50°-100°C is reached during the cooling stage when the glass transition temperature is between 140-160°C. Therefore, Altonen does not meet all of the limitations of both claims 1 and 5 in the particular claimed Tg and annealing temperature range described in claim 5. Additionally, typically annealing contains a cooling step and it is not immediately obvious why cooling would take place to a relatively low temperature to then subsequently be heated in an annealing step. Therefore, claim 5 contains allowable subject matter. Examiner notes that if claim 5 is included in claim 1, other claims such as 2-4, 8, 29-31, should be checked and amended as needed to ensure compliance under 112(d).
The same logic can be applied to claims 30 and 31. In each of claims 30 and 31, the annealing temperature is well above the 100°C cooling temperature described in claim 1. Any inherent cooling that occurs between injection molding and annealing as described in Altonen would not necessarily reach 50-100°C if the annealing temperature was 190 or 240°C as claimed in claims 30 and 31. Therefore, claims 30 and 31 also contain allowable subject matter. Examiner notes that if claims 30 or 31 are included in claim 1, other claims such as 2-4, 8, and 29 should be checked and amended as needed to ensure compliance under 112(d).
Conclusion
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/V.B./Examiner, Art Unit 1744
/XIAO S ZHAO/Supervisory Patent Examiner, Art Unit 1744