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 Objections
Claim 7 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 and 11-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, “said syringe”, “the needle”, and “the cone” lack antecedent basis.
Regarding claim 2, “said treatment step” lacks antecedent basis.
Regarding claim 3, “said treatment step”, “the following methods”, and “the vacuum bell” lack antecedent basis.
Regarding claim 4, “said treatment step” lacks antecedent basis.
Regarding claim 5, claim 5 is rejected because it depends from a rejected claim.
Regarding claim 6, “the treatment time” lacks antecedent basis.
Regarding claim 7, “the needle”, “the cone”, “the steps”, and “the base” lack antecedent basis. Additionally, “a method” in line 5 is indefinite because it is unclear if “a method” in line 5 is the same as “a method” in line 1. For examination purposes, “a method” in line 5 is being interpreted to be “the method”.
Moreover, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the limitation “cross-linking the glue with UV LED or mercury lamps, for example” is being treated as an optional limitation.
Regarding claim 8, “the pre-assembly step” and “the needle” lack antecedent basis.
Regarding claim 9, “the needle” and “the cone” lack antecedent basis.
Regarding claim 11, “the needle”, “the cone”, “the method”, “the following steps”, “the sample”, “the needle portion”, “the solution”, “the cylindrical body”, “the protruding needle portion”, “the syringe portion”, “the needle portion”, and “said syringe portion” lack antecedent basis.
Additionally, “the needle portion inserted in it” is indefinite because it is unclear what “it” refers to. For examination purposes, “the needle portion inserted in it” is being interpreted to mean “the needle portion inserted in the sample”.
Regarding claim 12, “the method”, “the step”, “the steps”, and “the suspension” lack antecedent basis. Additionally, “water/acetonitrile/derivatization” is indefinite because it is unclear if the limitation should be treated as “water or acetonitrile or derivatization” or “water and acetonitrile and derivatization”. For examination purposes, “water/acetonitrile/derivatization” is being interpreted as “water and acetonitrile and derivatization”.
Regarding claim 13, “the method” lacks antecedent basis.
Regarding claim 14, “the method” and “the derivatization solution” lack antecedent basis. Additionally, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 15, “the method” lacks antecedent basis.
Regarding claim 16, “the method”, “the aldehydes”, “the steps”, “said sample solution”, “said calibrated HPLC column”, “the area”, “the UV absorption peak”, and “the residual quantity” lack antecedent basis.
Additionally, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 17, “the method” and “the eluent” lack antecedent basis.
Regarding claim 18, “the method”, “the operating values”, “the columns” lack antecedent basis.
Additionally, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 19, “the method”, “the calculation”, “the following equation”, “the factors”, and “the following table” lack antecedent basis.
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.
Allowable Subject Matter
Claims 11-19 are currently free from prior art, however a subsequent prior art rejection may be made in view of Applicant’s amendments submitted to overcome the above 35 USC 112(b) rejections.
Conclusion
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/VERONICA MARTIN/Primary Examiner, Art Unit 3731