DETAILED ACTION
Notice of 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 .
This is the first office action in response to Claims filed on 01/08/24.
Claims 24-43 are pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application also includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f), because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation is/are: “latching device” in Claim 24, and “heating device” in Claim 32.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f), it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Correspondingly, the term “latching device” in Claim 24, is interpreted as push button latch, pin latch, electrical latch, or equivalent system like a latch.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Objections
Claims 24, 27, 38-40, 40, and 43 are objected to because of the following informalities:
Claim 24, L. 3 “latching device” should be “a latching device”;
Claim 27, L. 4 “the hypodermic needle’s hub” should be “a hypodermic needle’s hub”, L. 8 “its hub” should be “the hub”;
Claim 38, L. 2-3 “claim 13” and “claim 14” should be “claim 36” and “claim 37”;
Claim 39, L. 1 “claim 28” should be “claim 38”;
Claim 40, L. 6-7 “a total number of uses of the hypodermic needle destruction device; a total number of uses of the needle destruction module” should be “a total number of uses of the hypodermic needle destruction device”;
Claim 43, L. 6 “the data logging module” should be “a data logging module”.
Appropriate correction 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.
Claim 32 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding Claim 32: Claim 32 recites the limitation “heating device” invokes 35 U.S.C. 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b). To further advance prosecution the Examiner interpret the term “heating device” as a heater.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 24-32, 36-38, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Kirby (US 2016/0175542) in view of Truesdale (US 5,637,238).
Regarding Claim 24: Kirby discloses a hypodermic needle destruction device (Fig. 8) comprising a main body housing (12; Fig. 8), a power source (“battery”; [0100]) and a controller (“electronic control system”; [0072]), the main body having a recess (see annotated figure ‘542) for receiving, in use, a sub- housing (see annotated figure ‘542) containing a needle destruction module (see annotated figure ‘542),but is silent regarding a latching device for releasably retaining the sub-housing, and hence the needle destruction module, at least partially within the recess, i.e. to have the sub housing being detachable with a latching device for releasably retaining the sub-housing.
However, Truesdale teaches a medical device destruction device (see Fig. 2), having a sub housing (118; Fig. 2) being detachable with a latching device (see pin system in Fig. 2) for for releasably retaining the sub-housing (see Figs. 1-2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirby to have the sub housing being detachable with a latching device for releasably retaining the sub-housing, as taught by Truesdale. Such a modification would enable to easily disassembly the needle destruction device.
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Regarding Claim 25: Kirby in view of Truesdale teaches all the limitations of Claim 24, as stated above, and Kirby further teaches wherein the controller comprises a control circuit and/or a microprocessor ([0089]) adapted, in use, to control the needle destruction module.
Regarding Claim 26: Kirby in view of Truesdale teaches all the limitations of Claim 24, as stated above, and Kirby further discloses a sensor ([0062]) for detecting the presence of a hypodermic needle within the needle destruction module ([0062]).
Regarding Claim 27: Kirby in view of Truesdale teaches all the limitations of Claim 24, as stated above, and Kirby further discloses wherein the needle destruction module comprises: a clamping electrode (16; Fig. 13) arranged to clamp a hypodermic needle (2; Fig. 9) inserted therein at, or near to, the hypodermic needle's hub (element around the needle; see Fig. 12); a containment tube (118; Fig. 20) into whose bore the hypodermic needle is receivable; a tip electrode (20; Fig. 13) located within the containment tube and being arranged to slide axially therewithin to contact a tip (tip of the needle, see Fig. 12) of the needle and apply an axially compressive stress to the needle towards its hub (see Figs. 13-15); and a power module (element providing electricity to the electrode 16) adapted, when the clamping and tip electrodes contact the needle, to pass an electric current through the needle thereby heating and/or softening (see [0043-45]) and/or melting the needle such that the said axial stress axially compresses and blunts the needle whilst the containment tube inhibits or prevents bowing or breaking-up of the needle under the application of the said compressive stress (see [0043-45], the tube will necessarily prevent bowing).
Regarding Claims 28-29: Kirby in view of Truesdale teaches all the limitations of Claim 27, as stated above, and Truesdale further teaches wherein the power module is a DC power source (see Abstract) (for Claim 28), wherein the power module is an AC power source (see Abstract) (for Claim 29).
Regarding Claim 30: Kirby in view of Truesdale teaches all the limitations of Claim 27, as stated above, and Kirby further discloses wherein the controller comprises a voltage and/or current sensor ([0098]) connected to the clamping and tip electrodes, and wherein the controller is adapted, in use, to control the voltage across and/or the current between, clamping and tip electrodes ([0098]).
Regarding Claim 31: Kirby in view of Truesdale teaches all the limitations of Claim 27, as stated above, and Kirby further discloses wherein the tip electrode is driven for axial movement by a motor ([0075]) and lead screw (lead screw necessarily present to convert rotational motion form motor to axial motion), the speed and direction of the motor being controlled by the controller so as to maintain the tip electrode in electrical contact with the needle tip during the heating and/or softening and/or melting thereof ([0076]).
Regarding Claim 32: Kirby in view of Truesdale teaches all the limitations of Claim 27, as stated above, and Kirby further discloses wherein the containment tube is equipped with a heating device (300; Fig. 20) adapted, in use, to pre-heat the containment tube prior to the application of the current and/or the axial compressive stress ([108]).
Regarding Claim 36: Kirby in view of Truesdale teaches all the limitations of Claim 24, as stated above, and Kirby further discloses wherein the power source comprises a rechargeable battery ([0099]).
Regarding Claim 37: Kirby in view of Truesdale teaches all the limitations of Claim 24, as stated above, and Kirby further discloses wherein the power source comprises a supercapacitor ([0097]).
Regarding Claim 38: Kirby in view of Truesdale teaches all the limitations of Claim 24, as stated above, and Kirby further discloses further comprising power input module (module in the docking station permitting electrical connection, see [0099]) and a charge controller for charging the rechargeable battery of claim 36 (charge controller necessarily present to provide battery charge level, see [0100]), or the supercapacitor of claim 137.
Regarding Claim 43: Kirby in view of Truesdale teaches all the limitations of Claim 24, as stated above, and Kirby further discloses further comprising a docking station ([0099]) for receiving the main body portion, the docking station comprising any one or more of: a power output module that is complementary with the power input module of the hypodermic needle destruction device (see [0099] wherein the docking station is used to recharge the battery, thus an output module complementary of an input module is present).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Kirby (US 2016/0175542) in view of Truesdale (US 5,637,238), and further in view of Banik (US 2014/0238990).
Regarding Claim 33: Kirby in view of Truesdale teaches all the limitations of Claim 24, as stated above, but is silent regarding wherein the latching device comprises a push-button operated latching device.
However, Banik teaches a latching device ([0024]) comprising a push-button operated latching device ([0024]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirby to have the latching device comprises a push-button operated latching device, as taught by Banik. Such a modification would enable to easily open the device.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Kirby (US 2016/0175542) in view of Truesdale (US 5,637,238), and further in view of Partovi (US 2020/0044482).
Regarding Claim 39: Kirby in view of Truesdale teaches all the limitations of Claim 38, as stated above, but is silent regarding wherein the power input module comprises an induction coil.
However, Partovi teaches a docking station ([0028]) for medical device ([002]) having a power input module (electrical equipment connected to coil, see [0028]) comprises an induction coil ([0028]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirby to have the power input module comprises an induction coil, as taught by Partovi. Such a modification would enable to provide wireless charging.
Claims 40-41 is rejected under 35 U.S.C. 103 as being unpatentable over Kirby (US 2016/0175542) in view of Truesdale (US 5,637,238), and further in view of Sall (US 2018/0078326).
Regarding Claim 40: Kirby in view of Truesdale teaches all the limitations of Claim 24, as stated above, but is silent regarding wherein the controller further comprises a data logging module for logging any one or more of the group comprising: a unique ID of the hypodermic needle destruction device; a unique ID of the needle destruction module; a total number of uses of the hypodermic needle destruction device; a total number of uses of the needle destruction module; a number of successful uses of the needle destruction module; a number of unsuccessful uses of the needle destruction module; the date of each use of the needle destruction module; the time of each use of the needle destruction module; a current profile associated with each use of the needle destruction module; and a voltage profile associated with each use of the needle destruction module.
However, Sall teaches a device for handling medical waste (see title), having a data logging module ([0011]) for logging any one or more of the group comprising: a unique ID of the hypodermic needle destruction device; a unique ID of the needle destruction module; a total number of uses of the hypodermic needle destruction device; a total number of uses of the needle destruction module; a number of successful uses of the needle destruction module; a number of unsuccessful uses of the needle destruction module; the date of each use of the needle destruction module; the time of each use of the needle destruction module ([0016-17]); a current profile associated with each use of the needle destruction module; and a voltage profile associated with each use of the needle destruction module.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirby to have a data logging module for logging any one or more of the group comprising: a unique ID of the hypodermic needle destruction device; a unique ID of the needle destruction module; a total number of uses of the hypodermic needle destruction device; a total number of uses of the needle destruction module; a number of successful uses of the needle destruction module; a number of unsuccessful uses of the needle destruction module; the date of each use of the needle destruction module; the time of each use of the needle destruction module; a current profile associated with each use of the needle destruction module; and a voltage profile associated with each use of the needle destruction module, as taught by Sall. Such a modification would enable to provide information on the adherence of a user to a treatment scheme, as recognized by Sall (see [0016])
Regarding Claim 41: Kirby in view of Truesdale and Sall teaches all the limitations of Claim 40, as stated above, and Sall further teaches wherein the controller further comprises an input-output module for exporting data from the data logging module to an external database ([0036]).
Claims 34-35 are rejected under 35 U.S.C. 103 as being unpatentable over Kirby (US 2016/0175542) in view of Truesdale (US 5,637,238), and further in view of Wischmeyer (US 2011/0241838).
Regarding Claim 34-35: Kirby in view of Truesdale teaches all the limitations of Claim 24, as stated above, but is silent regarding wherein the latching device comprises an electronically unlockable latching device, the electronically unlockable latching device comprises an RFID reader adapted, in use, to receive an unlocking code from an RFID tag of an unlocking key.
However, Wischmeyer teaches a latching device ([0036]) for medical system ([0023]) comprises an electronically unlockable latching device ([0036]), the electronically unlockable latching device comprises an RFID (tittle) reader adapted ([0036]), in use, to receive an unlocking code from an RFID tag of an unlocking key ([0036]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirby to have the latching device comprises an electronically unlockable latching device, the electronically unlockable latching device comprises an RFID reader adapted, in use, to receive an unlocking code from an RFID tag of an unlocking key, as taught by Wischmeyer Such a modification would enable to safely open the device.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Kirby (US 2016/0175542) in view of Truesdale (US 5,637,238), Sall (US 2018/0078326), and further in view of Bakos (US 2022/0336074).
Regarding Claim 42: Kirby in view of Truesdale and Sall teaches all the limitations of Claim 40, as stated above, but is silent regarding wherein the controller further comprises an encryption module for encrypting data stored by the data logging module, i.e. encrypt the medical data.
However, Bakos teaches that medical device can be encrypted (see [0146]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kirby to encrypt the medical data, as taught by Barkos, and thus to have wherein the controller further comprises an encryption module for encrypting data stored by the data logging module. Such a modification would enable avoid unauthorize use of the data, as recognized by Bakos, (see [0146]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see notice of references cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RODOLPHE ANDRE CHABREYRIE whose telephone number is (571)272-3482. The examiner can normally be reached on 8:30-18:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Steven Crabb can be reached on (571) 270-5095. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RODOLPHE ANDRE CHABREYRIE/Primary Examiner, Art Unit 3761
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