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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 205. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Pg. 5 line 19 “111mounted” needs a space.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1, 3, and 5 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 1 recites “the safety plunger” in the last line. There is a lack of antecedent basis and it is not clear if this is the same or a different plunger than the previously recited “a syringe plunger.” For purposes of the rejection, it is considered as different. Claims 3 and 5 recite “the plunger” it is not clear if this refers to the safety plunger or the syringe plunger or is a third different member. For purposes of the rejection in claim 3, it is considered as the syringe plunger. For purposes of the rejection for claim 5, it is considered as the safety plunger as that appears consistent with the amendments to claim 1, however, in this case claim 5 appears to repeat limitations now in claim 1.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. As noted above it is not clear what “the plunger” refers to in claim 5. However, this appears to repeat limitations in claim 1 and as such does not further limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 and 5-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirschman et al. (US 2001/0034506 A1).
With regard to claims 1 and 5, Hirschman et al. teach a syringe comprising a barrel (Fig. 1A member 15) and a needle at an end thereof (Fig. 1A tapered outlet is taken as a needle), a syringe plunger configured to move within the barrel to cause a medicament within the barrel to be expelled from the needle (Fig. 1C member 50); and an electrically erasable programmable read-only memory (EEPROM) configured to store information related to the syringe (Fig. 1B and 6, member 115); and a printed circuit board comprising one or more electrically conductive contact pads electrically connected to one or more input or output pins of the EEPROM wherein the printed circuit board is arranged on a rearward facing surface of the safety plunger (Fig. 6 board 110 with pins attached to members 150 on the rear of plunger 120, [0086]).
With regard to claims 6 and 7, Hirschman et al. teach an auto-injector for receiving and operating a syringe to facilitate the injection of a medicament into a subject, the autoinjector comprising: a plunger driver (Fig. 1C member 40) configured on activation of the auto-injector to drive a plunger of the syringe received in the auto-injector forward within the auto-injector to operate the syringe; and one or more electrically conductive contact pads configured to contact one or more electrically conductive contact pads on the syringe to establish an electrical connection between an integrated circuit of the auto-injector and an electrically erasable programmable read-only memory (EEPROM) of the syringe (Fig. 1C microprocessor of the injector, Fig. 2A contact pads of the injector members 60, Fig. 6 eeprom 115, contact pads 150 on syringe, [0086]).
With regard to claim 8, upon connection data from the EEPROM is read out ([0088]), see Fig. 1A showing connection to external device comprising the main control and service control unit and additionally Fig. 13A showing connection to export information to an external device via 415 ([0115]).
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirschman et al. (US 2001/0034506 A1) as applied to claim 6 above, and further in view of O’Connor (US 2012/0249294 A1).
With regard to claim 9, Hirschman et al. teach a device substantially as claimed but does not specifically disclose communication via an I2C bus. However, O’Connor teaches using an I2C bus to access an EEPROM in a drug delivery device ([0027]). 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 an I2C bus in Hirschman et al. as O’Connor teaches such is effective for communication and would yield the same predictable result. Such electronics are well known in the art.
Claim(s) 1, 3, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watts et al. (US 2020/0030540 A1) in view of Biondi et al. (US 2019/0321555 A1) Hirschman et al. (US 2001/0034506 A1).
With regard to claims 1, 3, and 5, Watts et al. teach a syringe comprising a barrel (Fig. 2 barrel 214) and a needle (needle visible in Fig. 8) at an end thereof, a syringe plunger (Fig. 2 member 222) configured to move within the barrel to cause a medicament within the barrel to be expelled from the needle; a safety plunger (Fig. 2 member 206) coupled to the syringe plunger such that an inward stroke of the safety plunger causes the syringe plunger to move within the barrel ([0053]); a sheath (Fig. 2 member 216, [0073]) configured to cover the needle after use of the syringe; wherein the safety plunger is configured to couple to the sheath at a first point on the inward stroke, and is configured to decouple from the syringe plunger at a second point on the inward stroke such that the safety plunger is moveable independently of the syringe plunger ([0053]), and wherein further movement of the safety plunger after the first and second points on the inward stroke causes the sheath to cover the needle ([0053]). Watts et al. do not disclose an EEPROM or circuit board. However, Biondi et al. teach an auto-injector with a memory integrated into a circuit board with contacts arranged on a rearward facing surface of a plunger (Fig. 2, [0061]). The memory can provide drug identification characteristics and the system aids in ensuring proper use ([0005], [0013], [0128]). Further, Hirschman et al. teach using EEPROM as one of equivalent memory types ([0086]). 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 electronics with a circuit and memory on the rear of the safety plunger in Watts as Biondi et al. teach this is beneficial for providing drug characteristic information and ensuring proper use and further to use an EEPROM as Hirschman et al. teach such is an art effective memory and would yield the same predictable result.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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