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 .
Response to Arguments
Applicant's arguments filed 4/30/2026 have been considered and are partially 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 and then the annealing step occurring after occurring at “at least 110°C” because Altonen only discloses cooling to the annealing temperature and the annealing temperature is higher than the claimed cooling temperatures. Applicant also present similar arguments to claim 18 since the annealing temperature is 5 to 50°C below the Tg of “at least 140°C” and Altonen only discloses 1-30°C below the annealing temperature meaning Altonen would disclose an annealing range of 110-135°C for a Tg of 140°C. While these arguments and amendments theoretically overcome the rejection in view of Altonen, the ranges in the amendments are not supported by the specification. The specification does not support “at least 110°C” or “at least 140°C” because these ranges contain no upper limit and the specification does not support either of these ranges having no upper limit, see 112(a) section below.
Applicant argues claim 34 is allowed because it contains the subject matter of the previously indicated allowable claim 5. Examiner agrees and this claim is allowable.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 12-13, 18, 21, 24-28, and 30-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 33 each recite “the annealing temperature is at least 110°C” which is not supported by the specification. Applicant notes that this is supported by Table 1 which describes that polycarbonate is annealed at 120 ± 10°C however this does not provide adequate support for “at least 110°C.” The highest number on the chart is 260°C and there is no support for any annealing temperature beyond 260°C even though numbers beyond that are within the claim scope. When claiming a particular range or narrowing a range, there must be adequate support for that range in the specification, see MPEP §2163.05(III).
Claims 18 and 32 recite the limitation “the Tg of the thermoplastic material is at least 140°C” which is not supported by the specification. At page 4 line 13 of the instant specification as filed, the Tg is disclosed as being 140°- 160°C but this does not provide adequate support for numbers higher than this range, see MPEP §2163.05(III).
Claims 2-6, 12-13, 21, and 24-28 are rejected as being dependent from claims 1 or 18.
Allowable Subject Matter
Claim 34 is allowed.
The following is an examiner’s statement of reasons for allowance:
The most relevant references of record are Knutsson (US 2018/0304048, made of record on the IDS dated 9/1/2023), Bierman (US 20150038944), and Altonen (US 2005/0060953.)
With respect to claim 34, 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 34 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 34, 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 34. 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 34 contains allowable subject matter. Examiner notes that if claim 34 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).
Claims 1 and 18 are rejected under 112(a) but are not rejected with prior art. With respect to claim 1, Examiner agrees that Altonen does not describe first cooling to 50-100°C and then annealing at a temperature higher than 110°C but the annealing temperature being “at least 110°C” is not supported by the specification and therefore the claim is not allowed. Claim 18 describes a similar limitation but also specifies the annealing temperature is 5 to 50°C below the Tg and the Tg is “at least 140°C.” None of the disclosed examples in Altonen describe an annealing temperature of 140°C or higher and also cool to 50-100higher and also cool to 50-100°C. The limitation of the Tg being “at least 140°C” is not supported by the specification and is rejected under 112(a) so claim 18 is not allowed at this time. Claims 2-6, 12-13, 21, 24-28, 30-33 are all rejected under 112(a) themselves or as depending from a rejected claim.
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.
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/V.B./Examiner, Art Unit 1744
/XIAO S ZHAO/Supervisory Patent Examiner, Art Unit 1744
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