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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4 March 2026 has been entered.
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 1-15 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.
The term “heat sensitive” in claim 1 is a relative term which renders the claim indefinite. The term “heat sensitive” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. If the claim were allowed to issue, one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the term so as to understand how to avoid infringement. For the purpose of examination, the term has been given the broadest reasonable interpretation.
Claims 2-15 are rejected as being dependent on claim 1.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Pommereau et al. (US 2012/0195182; hereinafter “Pommereau”) in view of Zhao (US 2007/0053788).
In regard to claims 1-4, Pommereau discloses a method of manufacturing a medicament container (cartridge 10), the method comprising: embedding at least one heat sensitive electronic device (electronic coding feature 30 which is disclosed to be an integrated circuit, RFID-member or a solid state memory which would all be “heat sensitive” to some degree; see [0027]) into a core (comprised of second material 42 which surrounds the electronic coding feature 30) of a stopper (bung 20); coupling the core of the stopper with a shell (first material 40 which covers the entire surface of the bung 20) of the stopper, the shell necessarily providing heat resistance to the at least one heat sensitive electronic device embedded in the core to as the first material is disclosed to be any elastomer such as silicone rubber or acrylic rubber ([0050]) and would necessarily limit heat transfer to the at least one electronic device as the material of the shell necessarily has a heat capacity and necessarily would limit or reduce thermal conduction to the core; and inserting the stopper into the medicament container (cartridge 10) as depicted in Figure 3. See Figure 3 and [0175]-[0178].
Pommereau does not disclose a step of heat sterilizing the stopper while the at least one heat sensitive electronic device is embedded in the core of the stopper and the core is coupled to the shell of the stopper prior to the step of inserting.
Zhao discloses methods of sterilizing elastomeric sealing articles used in syringes or medical containers. Zhao teaches that a common sterilization technique for such articles is steam sterilizing which uses saturated steam at temperatures of over 120 degrees Celsius for a minimum of 20 minutes as recited in the limitations of claims 2-4. See [0008]. Zhao also discloses that the article can be sterilized in an autoclave having steam in the temperature range of 120 to 130 degrees Celsius at a time period of 30 to 40 minutes. See [0042].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the sterilizing step of Zhao with the method of manufacturing of Pommereau as Zhao recognizes that elastomeric stealing articles of medical containers can be sterilized using heat sterilization prior to insertion into a medicament container and one of ordinary skill would have looked to the prior art in order to find an appropriate sterilization process for the stopper as it is well understood that all components of a medicament container need to be sterilized. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.). Therefore, it would have been at least obvious to try to sterilize of the cartridge of Pommereau using the sterilization technique of Zhao without creating any new or unexpected results. The Supreme Court decided that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. Therefore, choosing from a finite number of identified, predictable solutions, with a reasonable expectation for success, is likely to be obvious to a person if ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, E.). Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, F.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143 and 2143.02).
In regard to claim 6, Pommereau disposing the medicament container within a housing of an injection device (drug delivery device 48) with the stopper inserted into the medicament container. See Figure 4b and [0181].
Claims 5 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Pommereau in view of Zhao and further in view of Mirov et al. (US 2017/0316177; hereinafter “Mirov”).
In regard to claims 5 and 10-12, Pommereau discloses wherein the electronic coding feature can interact with an electromagnetic sensing device to share information such as the position of the bung inside the cartridge such that conclusions concerning the liquid level of the contents of the cartridge can be made. See [0068].
Pommereau and Zhao are silent in regard to the electronic device including a processor or a sensor.
Mirov discloses a stopper (plunger head 22) which includes an embedded electronic device comprising a processor (microcontroller 26), as recited in claim 5, and a sensor, as recited in claim 10. The processor is capable of determining a position of the stopper within a medicament container (barrel 12) after the stopper has been inserted into the medicament container, as recited in claims 5 and 11, by measuring the travel distance of a reflected portion (see [0040]) of a sensing signal (see Figure 5 and [0039]-[0045]) through a shell (elastomer 21 which encapsulates the plunger head 22; [0026]) of the stopper when disposed in the housing of an injection device (syringe 10) as recited in claim 10. Thus, the determination of the position of the stopper can be performed after a quantity of medicament has been dispensed ([m]icrocontroller 26 may be programmed with instructions to calculate data representative of the quantity of medication 20 dispensed;” see [0043]) as recited in claim 12.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the electronic device within a plunger head as disclosed by Mirov for the electronic device of Pommereau in the method of the above combination for the purpose of internally sensing and calculating the position of the stopper in the medicament container to enable the device to be capable of determining the amount of medicament which has been dispensed and/or the position of the stopper without external sensors.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Pommereau in view of Zhao and further in view of Dette et al. (US 2009/0264828; hereinafter “Dette”).
In regard to claims 7-9, Pommereau and Zhao do not disclose wherein the injection device is an auto injector or wherein the injection device further comprises a dosage knob and an injection button.
Dette wherein a drug delivery device 1 which is an auto-injector (claim 7) because Dette discloses that the device includes a rotatable dosage knob (dose dial grip 76) as recited in claim 8 which can be used to select a quantity of a medicament dose to be administered by device and an injection button (button 82) as recited in claim 9 to automatically eject the selected quantity of the medicament dose from the medicament container when depressed. See [0054]-[0066] and Figures 1-4, 15 and 19.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the injector structure of the above combination in the drug delivery device of Dette with the injector of the above combination for the purpose of providing drug delivery device which can adjust the dose and automatically dispense medicament at the touch of a button and a stopper which is capable of sharing information regarding its position within the cartridge.
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Pommereau in view of Zhao and further in view of Schleicher et al. (US 2018/0193567; hereinafter “Schleicher”).
In regard to claims 13-14, Pommereau and Zhao are silent in regard to impacting the stopper while the stopper is inserted into the medicament container to switch the at least one electronic device from a powered-off state to a powered-on state.
Schleicher discloses a stopper 609 with electronic devices (such as a sensor and a power source) within the stopper. Schleicher teaches that impacting (i.e. increasing the pressure thereupon) the stopper while the stopper is inserted into a medicament container (barrel 601) to switch the at least one electronic device from a powered-off state to a powered-on state as recited in claim 13. Schleicher teaches that the pressure (i.e. a force) on the stopper is provided by a drive mechanism (dispensing mechanism 607) of an injection device (syringe 600) to switch the at least one electronic device from the powered-off state to the powered-on state as recited in claim 14. See Figure 6 and [0061].
It would have been obvious to one of ordinary skill in the art before the effective filing date to have combined the operation of turning on the stopper by providing a force from the drive mechanism of an injection device as taught by Schleicher with the stopper of the above combination for the purpose of providing a manner of selectively powering on the stopper when operation is desired.
In regard to claim 15, Pommereau and Zhao do not explicitly disclose wherein the shell comprises a first portion and a second portion, the first portion and the second portion comprising different materials.
Schleicher discloses a stopper 500 having a core (potting or backfill to secure the plurality electronics 501) and a shell comprises a first portion (rigid casing 503) and a second portion (one or more elastomeric seals such as o-rings 507 and 509), wherein the first portion (rigid casing) and the second portion (elastomer) comprise different materials. See Figure 5 and [0056]-[0058]. Schleicher teaches that the shell uses a rigid casing in order to have the material function as an effective soundboard to increase the range of the transducer. See [0028].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the shell configuration comprising two portions of different materials as taught by Schleicher for the shell of the above combined method for the purpose of allowing for the shell of the stopper to act as an effective soundboard to increase a range of a transducer therein while also maintaining a seal with the wall of the drug delivery device.
Response to Arguments
Applicant's arguments filed 7 April 2026 have been fully considered but they are not persuasive.
Applicant argues that Zhao teaches that “autoclaving can lead to hydrolysis, softening or degradation of many biomedical polymers leading to unacceptable changes in mechanical properties,” therefore, it would not have been obvious to one of ordinary skill in the art to have used steam autoclaving to sterilize the stopper of Pommereau. The Examiner has fully considered the argument but has not found it to be persuasive. There is no evidence to believe that silicone or acrylic rubber disclosed by Pommereau would be one of the “many biomedical polymers” discussed in Zhao. Therefore, it would have still been obvious to try the sterilization technique disclosed by Zhao to sterilize the stopper of Pommereau. Further, it is noted that the instant specification teaches that silicone rubber, which is disclosed as a shell material in Pommereau, is appropriate for the shell of the stopper. Thus, as no evidence in regard to how silicone rubber is insufficient has been provided, the argument amounts to an argument of counsel which cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Applicant argues that the prior art does not teach or suggest a shell that would provide thermal insulation to the electronic device embedded in the core to a degree that the stopper could be heat-sterilized. The Examiner has fully considered the argument but has not found it to be persuasive. It is noted that the claims are merely limited to wherein the shell limits heat transfer to the at least one electronic device, and it is viewed that a shell would necessarily function to limit heat transfer to the at least one electronic device as the shell would necessarily have a heat capacity and a defined rate of thermal conductivity. Therefore, an outer layer of material would always limit heat transfer to at least some degree to an inner core of the object, and it would have been obvious to one of ordinary skill in the art to have tried heat sterilizing the stopper.
Applicant argues that a “skilled person would be aware of the heat sensitivity of the electronic component and would only and exclusively consider conducting heat sterilization of the material of the stopper before the heat sensitive electronic component is embedded therein” but “such a procedure is particularly disadvantageous because the individual steps of assembly for embedding or arranging the electronic component within the interior of the stopper would then have to be conducted under sterile conditions. The Examiner has fully considered the statement but has not found it to be persuasive. Applicant’s argument is not persuasive as no evidence has been provided to show that the electronic component is heat sensitive to a temperature which is equivalent or less than the sterilization temperature. Thus, the argument is merely an argument of counsel which does not take the place of evidence in the record. As it is noted that Pommereau does not disclose a manner of sterilizing the stopper, one of ordinary skill in the art would have looked to the prior art to determine a technique to sterilize the stopper. Thus, it would have been at least obvious to try heat sterilization as disclosed by Zhao to sterilize the stopper of Pommereau.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As stated above, one of ordinary skill in the art would recognize that the cartridge of Pommereau would require sterilization and would have looked to the prior art to determine appropriate sterilization techniques. It would have thereby been obvious to have tried using the sterilization technique of Zhao without creating any new or unexpected results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY C CLEVELAND whose telephone number is (571)270-5041. The examiner can normally be reached M-F 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at (571) 270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY C CLEVELAND/Primary Examiner, Art Unit 1774
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