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 Rejections - 35 USC § 103
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al (US 2020/0009329), hereinafter Daniel.
Regarding claim 1, Daniel discloses a method for extracting residual aldehydes from syringes (Fig. 1, item 7), comprising a step of treating said syringes (Para. 0059, 0061, 0064) at a temperature (Para. 0059, 0061, 0064), wherein said syringe is a syringe-needle assembly (Fig. 7, item 7), wherein the needle (Fig. 7, item 73) is coupled to the cone (Fig. 7, item 72) of the syringe by means of an adhesive or glue (Para. 0080) containing residual aldehydes (Para. 0080).
Daniel does not expressly disclose the temperature is higher than or equal to 50° C. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to treat the syringes at a temperature higher than or equal to 50° C, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Daniel does not expressly disclose wherein the syringe does not comprise rubber parts. However, Daniel does disclose that the syringe is made of glass (Daniel, Para. 0058-0059), so a person of ordinary skill in the art would understand that a syringe made of glass does not comprise rubber parts. Additionally, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to not use rubber parts when forming the syringe, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claim 2, Daniel discloses the method according to claim 1, wherein said treatment step is carried out under vacuum (Para. 0045), at atmospheric pressure in a liquid or gaseous fluid or under vapor pressure.
Regarding claim 3, Daniel discloses the method according to claim 2, wherein said treatment step is carried out according to one of the following methods:
Autoclave under water vapor pressure;
Ultrasonic heated bath;
Storage (Para. 0059, 0061, 0064);
Vacuum storage at T>50° C. with continuous extraction to balance the vacuum, and prevent the vacuum bell from becoming saturated with volatile compounds;
Washing with water at T=90° C. or at boiling point.
Daniel does not expressly disclose storage at 50° C. for 24 hours. However, it would have been obvious to one having ordinary skill in the art at the time the effective filing date of the invention to store the syringe at 50° C. for 24 hours, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 4, Daniel does not expressly disclose the method according to claim 3, wherein said treatment step is carried out at a temperature between 110° C. and 130° C. and at a water vapor pressure between 1.2 and 3 bar.
However, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to carry out the treatment step at a temperature between 110° C. and 130° C. and at a water vapor pressure between 1.2 and 3 bar, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 5, Daniel does not expressly disclose the method according to claim 4, wherein the temperature is between 118° C. and 123° C. and the pressure is between 1.8 and 2.3 bar.
However, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to carry out the treatment step at a temperature between 118° C. and 123° C. and at a water vapor pressure between 1.8 and 2.3 bar, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 6, Daniel does not expressly disclose the method according to claim 4, wherein the treatment time is between 5 and 50 minutes, or between 15 and 40 minutes, or between 15 and 25 minutes, or between 20 and 35 minutes, or between 25 and 30 minutes.
However, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to set the treatment time between 5 and 50 minutes, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 7, Daniel discloses a method of producing a syringe (Fig. 1, item 7) consisting of a syringe-needle (Fig. 7, item 7, 72, 73) assembly, wherein the needle (Fig. 7, item 73) is coupled to the cone (Fig. 7, item 72) of the syringe by means of an adhesive or glue (Para. 0080) containing residual aldehydes (Para. 0080), the cone having a flange (Fig. 7, cone 72 has a flange) (Para. 0059, 0061, 0064), such a method comprising the steps of:
a) preassembling the needle in the cone (Para. 0059, 0061, 0064),
b) dosing the glue in the cone (Para. 0080),
c) drawing the glue from the base of the flange (Para. 0059, 0061, 0064) (Para. 0080),
d) cross-linking the glue with UV LED or mercury lamps, for example (Optional limitation, see above 35 USC 112(b) rejection), and comprising a final treatment step according to any one of claims 1 to 7 (Para. 0059, 0061, 0064).
Daniel does not expressly disclose wherein the syringe does not comprise rubber parts. However, Daniel does disclose that the syringe is made of glass (Daniel, Para. 0058-0059), so a person of ordinary skill in the art would understand that a syringe made of glass does not comprise rubber parts. Additionally, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to not use rubber parts when forming the syringe, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claim 8, Daniel discloses the method according to claim 7, wherein the pre-assembly step a) is preceded by a plasma treatment (Para. 0059, 0061, 0064) under an oxygen atmosphere (Para. 0059, 0061, 0064) on the needle to be glued (Para. 0059, 0061, 0064).
Regarding claim 9, Daniel discloses a syringe (Fig. 1, item 7) consisting of a syringe-needle assembly (Fig. 7, item 7, 72, 73), wherein the needle (Fig. 7, item 73) is coupled to the cone (Fig. 7, item 72) of the syringe by means of an adhesive or glue (Para. 0080) containing residual aldehydes (Para. 0059, 0061, 0064).
Daniel does not expressly disclose wherein the syringe does not comprise rubber parts. However, Daniel does disclose that the syringe is made of glass (Daniel, Para. 0058-0059), so a person of ordinary skill in the art would understand that a syringe made of glass does not comprise rubber parts. Additionally, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to not use rubber parts when forming the syringe, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Daniel does not expressly disclose the syringe having a releasable aldehyde content as follows: Formaldehyde<60 ng/syringe, Acetaldehyde<200 ng/syringe, Acrolein<20 ng/syringe, preferably <10 ng/syringe.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize Formaldehyde, Acetaldehyde, and Acrolein in the syringe, since it has been held to be within general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. Additionally, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to utilize at least 60 ng/syringe of Formaldehyde, at least 200 ng/syringe of Acetaldehyde, and at least 20 ng/syringe of Acrolein, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s arguments, see page 7, filed 04/20/2026, with respect to the 35 USC 112(b) rejection of claims 1-9 and 11-19 have been fully considered and are persuasive, as Applicant has amended the claims to overcome the rejection. The 35 USC 112(b) rejection of claims 1-9 and 11-19 has been withdrawn.
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive for the following reason:
Regarding Applicant’s argument that Daniel does not teach a syringe having aldehydes, Examiner disagrees. Daniel teaches treating a syringe which contains adhesive/glue. Adhesives and glues are commonly known to contain aldehydes, such that a person of ordinary skill in the art would recognize the adhesive or glue contains aldehydes. Examiner recommends incorporating claim language to further define and specify the steps of specifically removing aldehydes. Therefore the rejection is maintained.
Allowable Subject Matter
Claims 11-19 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 11, the prior art of record fails to disclose, teach, or fairly suggest an analytical method for detecting residual aldehydes releasable from a syringe, wherein said syringe is a syringe-needle assembly, wherein a needle is coupled to a cone of the syringe by means of an adhesive or glue containing residual aldehydes, the analytical method comprising the following steps: i) preparation of a sample to be analysed by isolating the cone of the syringe comprising a needle portion inserted in the cone and the glue; ii) derivatization treatment of the sample of step i) with a compound of formula Ar-NH- NH2, wherein Ar is a phenyl substituted with one or more electron-attractant groups; iii) analysis of a solution resulting from step ii) by reverse-phase HPLC coupled to UV detector, wherein step i) of preparing the sample comprises detaching the cone from a cylindrical body of the syringe and removing the a protruding needle portion, and wherein the a syringe portion thus obtained, constituted by the cone, the protruding needle portion inside the cone and the glue therein, further undergoes a treatment of crushing said syringe portion to give said sample.
The prior art of record that comes closest to teaching these limitations is Daniel et al (US 2020/0009329). Daniel teaches an analytical method for detecting residual aldehydes releasable from a syringe, wherein said syringe is a syringe-needle assembly, wherein a needle is coupled to a cone of the syringe by means of an adhesive or glue containing residual aldehydes, wherein step i) detaching the cone from a cylindrical body of the syringe and removing a protruding needle portion. However, Daniel fails to teach the analytical method comprising the following steps: i) preparation of a sample to be analysed by isolating the cone of the syringe comprising a needle portion inserted in the cone and the glue; ii) derivatization treatment of the sample of step i) with a compound of formula Ar-NH- NH2, wherein Ar is a phenyl substituted with one or more electron-attractant groups; iii) analysis of a solution resulting from step ii) by reverse-phase HPLC coupled to UV detector, and wherein a syringe portion thus obtained, constituted by the cone, the protruding needle portion inside the cone and the glue therein, further undergoes a treatment of crushing said syringe portion to give said sample. Additionally, it would require an unreasonable combination of references that would not suffice for a realistic case of obviousness.
Regarding claims 12-19, claims 12-19 are allowed because they depend from allowed claim 11.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 VERONICA MARTIN whose telephone number is (571)272-3541. The examiner can normally be reached Monday-Thursday 8:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at (571)270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VERONICA MARTIN/Primary Examiner, Art Unit 3731
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