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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 13, 2025 has been entered.
Claim Objections
Claims 1 and 20 are objected to because of the following informalities: claim 1 recites “the the first, inner layer” in the second to last line, claim 20 recites “in in” which requires correction. Appropriate correction is required.
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 5 and 16 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. Claim 5 recites “an adjoining layer or wall of the outer part.” Claim 1 recites the outer part has a second, outer layer, it is not clear if the adjoining layer is the same or different than the second, outer layer. For purposes of examination, it is taken as the same layer.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-1, and 17-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Auerbach et al. (US 2018/0207324 A1).
With regard to claim 1, Auerbach et al. teach a syringe body for a medical syringe, comprising: a nozzle (Figs. 5 tip outlet of 403, see Reference Figure 1 below), a threaded connection (Figs. 5 member 412), and a side wall having a first, inner layer and a second, outer layer, wherein an inner part forms the nozzle and the first, inner layer of the side wall, the inner part comprising, at least in regions, a cycloolefin as a first material (see Reference Figure 1 below, the portion indicated as forming the side wall has an inner layer which extends to form the nozzle, [0021], [0038]), wherein an outer part forms the threaded connection and the second, outer layer of the side wall, the outer part comprising a plastic, which comprises, at least in regions, a material different from the cycloolefin as a second material (see Reference Figure 1 below, the material forming the outer layer of the side wall also forms the threaded connection, [0020], [0023], [0046]), and wherein the second, outer layer of the side wall extends, at least in regions, circumferentially around the first, inner layer of the side wall (see Reference Figure 1 below).
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With regard to claims 2 and 21, see Reference Figure 1 above, 410 forms a grip of the syringe and is part of the outer part.
With regard to claims 3 and 4, see [0028] and [0038], the components may be over-molded. Further, the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113.
With regard to claims 6-8 and 17, see Reference Figure 1 above and Reference Figure 2 below.
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With regard to claim 9, see Reference Figure 1 above.
With regard to claims 10, 11, 18, and 19, as the same materials are used as disclosed by Applicant ([0021], [0023]), they are expected to have the same relationship.
With regard to claim 12, see Reference Figure 2 above.
With regard to claim 20, Auerbach et al. teach a syringe body for a medical syringe, comprising: a nozzle (Figs. 5 tip outlet of 403, see Reference Figure 1 below), a threaded connection (Figs. 5 member 412), and an inner part and an outer part (see Reference Figure 1 above, inner and outer layer of the indicated side wall), wherein the inner part forms the nozzle and an inner wall of the syringe body, the inner wall including a side wall, and the inner part comprises, at least in regions, a cycloolefin as a first material (see Reference Figure 1 above, the portion indicated as forming the side wall has an inner layer which extends to form the nozzle, [0021], [0038]), wherein the outer part forms the threaded connection and an outer wall of the syringe body, the outer wall including a side wall, and the outer part comprises a plastic, which comprises, at least in regions, a material different from the cycloolefin as a second material (see Reference Figure 1 below, the material forming the outer layer of the side wall also forms the threaded connection, [0020], [0023], [0046]); and a side wall, wherein the side wall is formed in in first and second layers, the first layer comprising the side wall of the inner wall of the inner part and the second layer comprising the side wall of outer wall of the outer part, wherein the outer part extends, at least in regions, circumferentially around the side wall of the inner part relative to a longitudinal axis of the syringe body (see Reference Figure 1 above).
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.
Claim(s) 5 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auerbach et al. (US 2018/0207324 A1) as applied to claim 1 above.
With regard to claim 5, Auerbach et al. show the relative thickness in Reference Figure 1 above but do not disclose explicit dimensions although it would appear to be within the claimed range. Auerbach et al. disclose the purpose of the material of this portion is to provide a buffer to absorb the load. As such, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have relative thickness as claimed 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. One of ordinary skill would be able to select the thickness as needed to provide the load buffer.
With regard to claim 16, Auerbach et al. show the relative thickness in Reference Figure 1 above but do not disclose explicit dimensions although it would appear to be within the claimed range. Auerbach et al. disclose the purpose of the material of this portion is to provide a buffer to absorb the load. As such, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have relative thickness as claimed 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. One of ordinary skill would be able to select the thickness as needed to provide the load buffer.
Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auerbach et al. (US 2018/0207324 A1) as applied to claim 13 above, and further in view of Baldauf et al. (US 2018/0050158 A1).
With regard to claims 13 and 15, Auerbach et al. teach a syringe comprising a syringe body according to claim 1 (see the rejection of claim 1 above). Auerbach et al. do not show the full syringe showing the plunger and rod. However, Baldauf et al. teach plungers and rods are known in the art to eject fluid and close a syringe (abstract, [0009], Fig. 1b 12 and 15’). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a plunger and rod in Auerbach et al. as Baldauf et al. teach such is an effective means in the art for ejecting fluid through a syringe and would yield the same predictable result. Further, Auerbach et al. do not disclose packaging. However, Baldauf et al. teach using oxygen impermeable packaging to protect substances within the syringe ([0012]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use packaging in Auerbach et al. as in Baldauf et al. as this would protect the device prior to use and enhance safety.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auerbach et al. (US 2018/0207324 A1) and Baldauf et al. (US 2018/0050158 A1) as applied to claim 13 above, and further in view of Fischer et al. (US 2014/0358/078 A1).
With regard 14, Auerbach et al. teach a device substantially as claimed. Auerbach et al. do not disclose a seal. However, Fischer et al. teach a cap to engage a nozzle and seal a syringe prior to use to ensure sterility ([0010], exemplary Figs. 1A and 2A). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a seal in Auerbach et al. as Fischer et al. teach this is beneficial for sterility.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The interpretation of Auerbach et al. has been updated in light of the claim amendments. The claim does not recite any particular extent, structure, or orientation of the side wall that would negate the position as rejected above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gutierrez (US 2016/0175532 A1) which discloses a grip made of a different material surrounding a syringe barrel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783