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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/14/2026 has been entered.
Status of the Claims
Claims 28-30 are newly cancelled. Claims 2, 6, 8-13, 17, 19-20, 24-26, and 28-30 are cancelled. Claims 35-36 are newly added. Claims 1, 3-5, 7, 14-16, 18, 21-23, 27, and 31-36 are currently pending. Claims 1, 3-5, 7, 14-16, 18, 21-23, 27, and 31-36 are currently rejected.
Response to Arguments
Applicant's arguments filed 01/14/2026 have been fully considered but they are not persuasive.
The previous 112b and 102 rejections were overcome by the most recent claim amendments.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the modification of Biondi to include an electrical contact in order to signal the end of delivery, as taught by Hautaviita, would have been an obvious alternative way to close the circuit and trigger a signal. Furthermore, Biondi discloses a proximal movement of a switch key causing a circuit to signal the end of delivery, and Hautaviita teaches a proximal movement of an electrical contact causing a circuit to signal the end of delivery. The method and structure of the signalling devices are thus similar and it would have been obvious, as previously described, to modify Biondi to have an electrical contact which closed a circuit instead of just pressing on a circuit.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Claim Objections
Claims 1 and 23 are objected to because of the following informalities:
Claim 1 line 26 reads “contact applicator plate of disk”. This should read “contact applicator plate or disk”.
Claim 23 line 2 reads “is near field communications (NFC) circuit”. This should read “is a near field communications (NFC) circuit”.
Appropriate correction is required.
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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(s) is/are:
“plunger travel locking assembly” in claims 3 and 4 is interpreted to be either at least one radially outwardly projecting tine (pg. 7 para. 3) or at least one pair of cooperating and opposite abutment surfaces (pg. 10 para. 2)
Prong A: “assembly” is a generic placeholder
Prong B: “plunger travel locking” is functional language which modifies “assembly”
Prong C: “assembly” is not modified by sufficient structure for performing “plunger travel locking”
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-31, 33, and 35-36 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 “a first contactless position” on line 20. This limitation was previously recited on line 15, and thus it is unclear whether this second instance is meant to refer back to the same limitation (in which case “a” should be changed to “the”), or a different position associated with the same structure, or a different position associated with a different structure. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 1 recites the limitation “adjacent to end point signalling circuit” on lines 21-22. This limitation was previously recited on line 12, and thus it is unclear whether this second instance is meant to refer back to the same limitation (in which case “the” should be added so that this limitation reads “adjacent to the end point signalling circuit), or introduce a different structure. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 1 recites “a permitted extend” on line 27. This limitation was previously recited on line 23, and thus it is unclear whether this second instance is meant to refer back to the same limitation (in which case “a” should be changed to “the”), or a different position associated with the same structure, or a different position associated with a different structure. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 1 line 25 recites the limitation “constrained in the direction opposite the direction of travel of the plunger body”. It is unclear whether this limitation means constrained so that the structure (1) can move only in the direction opposite the direction of travel or, alternatively, (2) is prevented from moving in the direction opposite the direction of travel. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 27 recites the limitation “and electric contact” on lines 4-5. This limitation was previously recited in claim 1, and thus it is unclear whether this second instance is meant to refer back to the same limitation (in which case “the” should be added so that this limitation reads “and the electrical contact”), or introduce a different structure. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 31 line 1 reads “The syringe assembly of claim 28”. Claim 28 is cancelled. For the purposes of examination, claim 31 is interpreted to be dependent on claim 1.
Claim 33 recites “the limit” on line 4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation is interpreted to read “a limit”.
Claims 2-31 and 35-36 are rejected at least for depending, directly or indirectly, on a claim rejected under 112b since claims inherit the deficiencies of those claims on which they depend.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 14-16, 18, 22-23, and 27-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright (US-20050070854-A1; hereafter Wright) in view of Biondi et al (WO-2018125887-A2; hereafter Biondi) and further in view of Hautaviita et al (US-20180008779-A1; hereafter Hautaviita). Note that references are made to the copy of Biondi included in the previous Office Action.
Regarding claim 1, Wright discloses a syringe assembly comprising:
an elongated hollow syringe body (hollow glass barrel 2, fig. 1A, [0049]), having a proximal extremity (see fig. 1E) and a distal extremity (see fig. 1C), with a first opening (see fig. 1E) at the proximal extremity and a collar (radially outwardly projecting rim 51, fig. 1E, [0066]) projecting outwardly of the hollow syringe body (2) at said proximal extremity around said first opening (see fig. 1E);
a plunger (plunger 36, plunger seal 40, and grip 50; see fig. 1A) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) and dimensioned to be inserted into said hollow elongated syringe body (2) via the proximal extremity and corresponding proximal opening of the hollow syringe body (2) ([0061] exterior circumference of the plunger 36 is slightly smaller than the interior circumference of the hollow syringe body/barrel 2), the plunger having a plunger body (plunger 36, fig. 1, [0064]) comprising a stopper (plunger seal 40, fig. 1D, [0061]) located at a distal extremity of the plunger body (see fig. 1A), and a plunger head (grip 50, fig. 1A, [0065]) located at a proximal extremity of said plunger body (see fig. 1A);
and signalling of the injection end point when the plunger has reached a limit of a permitted extent of the direction of injection travel ([0079] plunger cannot be retracted once fully depressed).
Wright is silent to a plunger head cavity, an end point signalling circuit, and contact applicator located within the plunger head.
Biondi, also in the field of syringes, teaches wherein a plunger head (thumb pad and sensor housing, fig. 2, [00129]) includes a plunger head cavity (see fig. 3 which shows cavity in sensor housing, note that sensor components reside in the cavity formed by coupling the thumb pad and the sensor housing) formed between a base of the plunger head (sensor housing, fig. 2) and a plunger head cap (thumb pad, fig. 2) coupled to the base of the plunger head ([00129] The thumb pad is removably coupled to the sensor housing to allow access to the sensor component.) and the plunger head cap having a proximal surface (see proximal end of thumb pad in fig. 3) for engaging the plunger head to move the plunger along the hollow syringe body for injection ([0097] thumb pad is attached to the syringe stopper rod; see fig. 1 which shows assembled device; see fig. 12 which shoes that the thumb pad is positioned to allow the plunger to be moved through the hollow syringe body/drug reservoir);
an end point signalling assembly including an end point signalling circuit (PCBA, fig. 2, [0078]) disposed in the cavity of the plunger head (see fig. 5 and fig. 6 which show that the PCBA is disposed within the plunger head cavity) and a contact applicator (switch key and light pipe, fig. 2) including a contact applicator plate or disk (cylindrical part of switch key and light pipe, see fig. 2, contact applicator/switch key is shown to have a cylindrical section adjacent to the PCBA/circuit), the contact applicator plate or disk being moveable within the cavity of the plunger head relative to the plunger in a direction opposite to a direction of injection travel of the plunger ([00131] switch key is pushed in the direction opposite the direction of injection by extension tabs, fig. 5) from the first contactless position ([00131] momentary switch is inactive prior to activation cam pushing on switch key) to a second contact position ([00131] momentary switch is active after activation cam pushes on switch key) adjacent to end point signalling circuit (PCBA; see fig. 4 and fig. 5 which show that the second contact position is closer to the PCBA) to activate the end point signalling circuit to enable signalling of the injection end point ([00131] activation of the momentary switch triggers the sensor component to transmit a report comprising a drug dose completion signal to the data management component) when the plunger has reached a limit of a permitted extent of the direction of injection travel ([0079] plunger cannot be retracted once fully depressed).
and the contact applicator plate or disk (cylindrical part of switch key and light pipe, see fig. 2) being constrained (see 112b interpretation above) in the direction opposite the direction of injection travel of the plunger ([00131] switch key is pushed in the direction opposite the direction of injection by extension tabs, fig. 5) through a constraint (light-pipe diffuser, fig. 2; Examiner notes that the light-pipe diffuser engages the most distal end of the light pipe and thus would constrain movement in the distal direction) connected to the contact applicator plate of disk (cylindrical part of switch key and light pipe, see fig. 2) until the plunger has reached the limit of the permitted extent of the direction of injection travel ([00131] upon completion of the delivery stroke, the activation cam abuts the distal end of the syringe and the extension tabs of the activation cam exert a force on the switch key); and
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an actuation assembly including a displacement surface or feature on a second side of the contact applicator plate or disk (see Modified Fig. 2 above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function) to interface with a displacement surface or feature (extension tabs and activation cam, fig. 5, see Modified Fig. 2 above) coupled to the syringe body through an opening in the base of the plunger head (see opening noted in Modified fig. 2 above through which extension tabs engage with the switch key) to move the contact applicator plate or disk (cylindrical part of switch key and light pipe, see fig. 2) thereon from the contactless position to the contact position ([00131] extension tabs of activation cam exert force on the switch key/contact applicator and move the switch key so that the momentary switch is activated) when the plunger has reached the limit of the permitted extent of the direction of injection travel ([00131] completion of delivery stroke causes activation cam to abut distal end of syringe housing and the extension tabs to move toward the sensor housing away from the injection site relative to the sensor housing).
Wright and Biondi are silent to the contact applicator including an electrical contact formed of an electrically conductive material on a first side of the contact applicator plate or disk and electrical contact is established between the electrical contact and the end point signalling circuit.
Hautaviita, in the art of medicament delivery devices with usage monitoring, teaches a contact applicator (switch tongue 152, fig. 13a/b) including a contact applicator plate or disk (flat face of switch tongue 152 as indicated in annotated fig. 13a/b below) and an electrical contact (end portion of flat face of switch tongue as shown in annotated fig. 13a/b) is formed of an electrically conductive material ([0054] switch tongue 152 is electrically conductive) on a first side (rightmost face of the contact applicator plate or disk, see annotated fig. 13 below) of the contact applicator plate or disk (flat face of switch tongue 152 as indicated in annotated fig. 13a/b below) and electrical contact (see 112b interpretation above) is established between the electrical contact (end portion of flat face of switch tongue as shown in annotated fig. 13a/b) and the end point signalling circuit ([0054] movement of the switch tongue 152 closes a switch at the end of dose delivery activation of the momentary switch triggers the sensor component to transmit a report comprising a drug dose completion signal).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to make the contact applicator of Wright modified by Bondi include an electrical contact formed of an electrically conductive material on the face of the contact applicator plate or disk closest to the PCBA/circuit as taught by Hautaviita since all three references deal with syringes. As noted above, the modification of Biondi to include an electrical contact in order to signal the end of delivery, as taught by Hautaviita, would have been an obvious alternative way to close the circuit and trigger a signal. Furthermore, Biondi discloses a proximal movement of a switch key causing a circuit to signal the end of delivery, and Hautaviita teaches a proximal movement of an electrical contact causing a circuit to signal the end of delivery. The method and structure of the signalling devices are thus similar and it would have been obvious, as previously described, to modify Biondi to have an electrical contact which closed a circuit instead of just pressing on a circuit. One would have been motivated to make the modification because switches which trigger electrical activity are often electrically conductive so that their movement can close or open a circuit. As modified, it would only be necessary for the contact applicator plate or disk to make contact with the electrical circuit to trigger recognition, because the electrical contact would be able to close the circuit without moving any element on the PCBA.
Regarding claim 14, Wright modified by Biondi and Hautaviita discloses the syringe assembly according to claim 1, as described above, including the displacement surface or feature (Biondi: extension tabs and activation cam, fig. 5) and the collar (Wright: radially outwardly projecting rim 51, fig. 1E, [0066]) of the hollow syringe body (Wright: barrel 2, fig. 1A, [0049]) located at the proximal end of the hollow syringe body (Wright: see fig. 1A). Wright further discloses a syringe backstop (trailing leg 55, fig. 1E, [0066]).
Wright modified by Biondi and Hautaviita teaches the claimed invention except for wherein the displacement surface or feature is at least partly located on, or integrated into, the collar of the hollow syringe body. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the displacement surface or feature such that it was located at least partly on or integrated into the collar of the hollow syringe body since it has been held that rearranging parts of an invention involves only routine skill in the art. One would have been motivated to make the modification because locating the displacement surface or feature on the collar or backstop would ensure that the displacement surface or feature could not trigger an end-of-dose signal prematurely, since the plunger would have to be fully depressed before the activation cam/displacement surface or feature could interact with the switch key portion/contact applicator plate or disk. See MPEP 2144.04 (VI-C). The modified device could still perform the function of delivery fluid and the displacement surface or feature could still perform the function of pushing against the switch key of Biondi to register the complete depression of the syringe and thus the end of the dose delivery.
Regarding claim 15, Wright modified by Biondi and Hautaviita discloses the syringe assembly according to claim 1, as described above, including the displacement surface or feature (Biondi: extension tabs and activation cam, fig. 5). Wright further discloses a syringe backstop (trailing leg 55, fig. 1E, [0066]) removably mounted ([0066] plastic collar 52 of which trailing leg 55 is a part is clipped onto the rim 51 of the syringe barrel 2) onto the collar of the hollow syringe body (radially outwardly projecting rim 51, fig. 1E, [0066]).
Wright modified by Biondi and Hautaviita teaches the claimed invention except for the displacement surface or feature located on the syringe backstop. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the displacement surface or feature such that it was located on the syringe backstop since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of delivery fluid and the displacement surface or feature could still perform the function of pushing against the switch key of Biondi to register the complete depression of the syringe and thus the end of the dose delivery.
Regarding claim 16, Wright modified by Biondi and Hautaviita discloses the syringe assembly according to claim 1, as described above, including wherein the displacement surface or feature (Biondi: extension tabs and activation cam, fig. 5) comprises a raised arcuate profile (Biondi: see wall of activation cam in fig. 3) located coaxially around a longitudinal axis of the plunger (Biondi: see fig. 2, activation cam is centered on longitudinal axis defined by the stopper rod) and the collar (Wright: radially outwardly projecting rim 51, fig. 1E, [0066]) Wright further discloses a syringe backstop (trailing leg 55, fig. 1E, [0066]).
Wright modified by Biondi and Hautaviita teaches the claimed invention except for the displacement surface or feature located on either a proximal surface of the collar, or a proximal surface of a syringe backstop. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the displacement surface or feature such that it extended proximally from the collar or the syringe backstop since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of delivery fluid and the displacement surface or feature could still perform the function of pushing against the switch key of Biondi to register the complete depression of the syringe and thus the end of the dose delivery.
Regarding claim 18, Wright modified by Biondi and Hautaviita discloses the syringe assembly according to claim 1, as described above, including a wall (Biondi: activation cam has annular wall as shown in fig. 2 and 3) located radially outwardly of a displacement surface or feature (Biondi: extension tabs shown in fig. 2 and 3, labeled in fig. 3) around the longitudinal axis of the plunger, and projecting in a proximal direction (Biondi: see fig. 3).
Wright further discloses a wall (annular wall 56, fig. 1A, [0067]) located around the longitudinal axis of the plunger (see fig. 1A plunger portion 36 establishes a longitudinal axis), and projecting in a proximal direction (see fig. 1A); and wherein the projecting wall (56) has a proximal extremity that is located adjacent or substantially flush with a proximal surface of the plunger head (grip 50) to restrict tampering ([0079] once plunger 36 is depressed to the point that grip 50 has passed into annular recess 57 the plunger 36 cannot be retracted).
Regarding claim 22, Wright modified by Biondi and Hautaviita discloses the syringe assembly according to claim 1, as described above.
Biondi further teaches wherein the injection end point assembly further comprises a wireless communications unit ([0069] sensor component comprises a near-field communication (NFC) component, sensor component shown in fig. 5 and shown assembled within plunger head/sensor housing in fig. 1; [00131] sensor component transmits a report including a drug dose completion signal).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include the electronics of Biondi, including the displacement surface or feature and electrical contact, with the device of Wright since both deal with syringes. One would have been motivated to make the modification because the electronics of Biondi including the displacement surface or feature allows for electronic registration of the event of dose completion (see Biondi [00131]). This electrical signal allows for record of the injection event to be transmitted and stored which can be helpful for clinicians tracking patient compliance with dosing regimens.
Regarding claim 23, Wright modified by Biondi and Hautaviita discloses the syringe assembly according to claim 22, as described above, including wherein the wireless communications unit is near field communications (NFC) circuit ([0069] sensor component comprises a near-field communication (NFC) component, as noted in rejection of claim 22 above).
Regarding claim 27, Wright modified by Biondi and Hautaviita discloses the syringe assembly according to claim 1, as described above, wherein the constraint (Biondi: light pipe, fig. 2) includes a central rod slidably supported within a bore of the plunger body (Biondi: stopper rod, fig. 2) (Biondi: [00129] light pipe is located inside the hollow elongated rod element of the syringe stopper rod; see fig. 2) coupled to the second side (see modified fig. 2 above) of the contact applicator plate or disk (Biondi: cylindrical part of switch key and light pipe, fig. 2) and the central rod is sized to restrict movement of the contact applicator plate or disk and electric contact before the plunger has reached the limit of the permitted extent of the direction of injection travel (Biondi: see fig. 2 which shows that light pipe contacts the switch key; since the two elements are in contact then the central rod/light-pipe could restrict the movement of the contact applicator/switch key).
Regarding claim 31, Wright modified by Biondi and Hautaviita discloses the syringe assembly according to claim 28 (see 112b interpretation above), as described above, including wherein the displacement surface or feature (Biondi: activation cam, fig. 2) is formed of a raised profile surface (see fig. 2 which shows extension tabs are a raised profile) and the collar (Wright: radially outwardly projecting rim 51, fig. 1E, [0066]). Wright further discloses a syringe backstop (trailing leg 55, fig. 1E, [0066]).
Wright modified by Biondi and Hautaviita teaches the claimed invention except for wherein the displacement surface or feature is located on the collar or syringe backstop. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the displacement surface or feature such that it was located the collar or syringe backstop since it has been held that rearranging parts of an invention involves only routine skill in the art. One would have been motivated to make the modification because locating the displacement surface or feature on the collar or backstop would ensure that the displacement surface or feature could not trigger an end-of-dose signal prematurely, since the plunger would have to be fully depressed before the activation cam/displacement surface or feature could interact with the switch key portion/contact applicator plate or disk. See MPEP 2144.04 (VI-C). The modified device could still perform the function of delivery fluid and the displacement surface or feature could still perform the function of pushing against the switch key of Biondi to register the complete depression of the syringe and thus the end of the dose delivery.
Regarding claim 35, Wright modified by Biondi and Hautaviita discloses the syringe assembly of claim 1, as described above, including wherein the plunger head cavity (Biondi: fig. 3 see plunger head cavity formed between thumb pad and sensor housing) is formed via a peripheral annular wall (see Biondi Modified Fig. 3) extending from the base of the plunger head and the plunger head cap connects to the annular wall to close the cavity (see Biondi fig. 6 which shows assembled version) and the applicator plate or disk (cylindrical part of switch key and light pipe, see fig. 2, contact applicator/switch key is shown to have a cylindrical section adjacent to the PCBA/circuit) is supported in a well recession (see Biondi Modified Fig. 3) formed by the annular wall and a disc of the end point signaling circuit (Biondi: disk of PCBA in fig. 3) is supported on the annular wall spaced (see figs. 5 and 6 which show that annular wall surround and supports the sensor component including the end point signaling circuit) from the applicator plate or disc to cover the well recession (see Biondi Modified Fig. 3, note that the PCBA disc is larger than the well recession and covers the well recession when assembled as shown in fig. 6) ([00131] extension tabs of activation cam exert force on the switch key/contact applicator and move the switch key so that the momentary switch is activated, note this requires the switch key to be able to move toward the end point signalling circuit/PCBA and thus must start spaced apart).
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Regarding claim 36, Wright modified by Biondi and Hautaviita discloses the syringe assembly of claim 35, as described above, including wherein the applicator plate or disk (cylindrical part of switch key and light pipe, see fig. 2) includes a peripheral annular rim extending from the first side of the applicator plate or disk (see Biondi Fig. 2 Detail below) and an outer perimeter dimension of the annular rim is sized to fit within the well recession (see fig. 2/3, annular rim fits within well recession) abutting the annular wall.
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Wright modified by Biondi and Hautaviita discloses all claim limitations except for the outer perimeter dimension of the annular rim abutting the annular wall. It would have been an obvious matter of change in size/shape to modify the annular rim to extend to abut the annular wall, thereby yielding predictable results without change to inventive function. See MPEP 2144.04(IV)(A/B). One would have been motivated to make the modification because having a portion of the switch key engage directly with the annular wall would provide better support to the switch key, ensuring that the switch key would be less likely to move toward the contact switch prematurely, since there would be more friction/support between the annular wall and the switch key, thus decreasing the possibility of obtaining a false positive signal. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the device of Wright modified by Biondi and Hautaviita would still function the same way.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright modified by Biondi and Hautaviita and further in view of Botich et al (US-6096005-A; hereafter Botich).
Regarding claim 3, Wright modified by Biondi and Hautaviita discloses the syringe assembly according to claim 1, as described above, including wherein a plunger travel locking assembly prevents the plunger (36/40/50, fig. 1A) from moving in a direction of travel different to the direction of injection travel once the limit of the permitted extent of the direction of injection travel has been reached ([0079] plunger cannot be retracted once the plunger head 50 passes within cylindrical recess 57, [0067] snug fit between recess 57 and plunger head 50 retains plunger head).
Wright is silent to the plunger travel locking assembly as interpreted under 112f.
Botich, also in the field of syringes, teaches wherein a syringe assembly comprises plunger travel locking assembly (see 112f interpretation above; raised circumferential band 249 and internal recess 250, fig. 4 and 5; col. 5 ln. 64 – col. 6 ln. 8 band 249 snaps into recess 250 locking plunger 224 in place) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to prevent the plunger from moving in a direction of travel different to the direction of injection travel once the limit of the permitted extent of the direction of injection travel has been reached (col. 5 ln. 64 – col. 6 ln. 8 once plunger 224 is fully depressed and flush with the rear end of the barrel 222, plunger 224 is prevented from being withdrawn).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to add the plunger travel locking assembly of Botich to the device of Wright modified by Biondi and Hautaviita since Botich also deals with single use syringes, like Wright. One would have been motivated to make the modification because the locking band and recess of Botich (col. 5 ln. 64 – col. 6 ln. 8) would augment the single-use safety mechanism of Wright ([0079]) which keeps the syringe from being reused. The locking band and recess would make the plunger even more difficult to retract, making the syringe harder to compromise.
Regarding claim 4, Wright modified by Biondi, Hautaviita, and Botich discloses the syringe assembly according to claim 3, as described above, including wherein the electrical contact (Hautaviita: end portion of flat face of switch tongue as shown in annotated fig. 13a/b) on the contact applicator forms an electrical contact (Biondi: ([00131] Upon completion of the delivery stroke, the activation cam abuts the distal end of the syringe and the extension tabs of the activation cam exert a force on the switch key, causing it to activate the momentary switch on the sensor component; Hautaviita: [0054] movement of the switch tongue 152 closes a switch at the end of dose delivery activation of the momentary switch triggers the sensor component to transmit a report comprising a drug dose completion signal) at the same time as the plunger travel locking assembly (Botich: raised circumferential band 249 and internal recess 250, fig. 4 and 5) (Botich: col. 5 ln. 64 – col. 6 ln. 8 once plunger 224 is fully depressed and flush with the rear end of the barrel 222, plunger 224 is prevented from being withdrawn) is engaged (note that both establishing electrical contact and engaging the plunger travel locking assembly occur at the completion of dose delivery).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright modified by Biondi, Hautaviita, and Botich as applied to claim 3 above and further in view of Brereton et al (EP-2585142-B1; hereafter Brereton). Note that reference is made to the copy of Brereton included in the previous Office Action.
Regarding claim 5, Wright modified by Biondi, Hautaviita, and Botich discloses the syringe assembly according to claim 3, as described above.
Wright as modified is silent to the plunger travel locking assembly comprising a radially projecting tine.
Brereton, directed to an autoinjector, teaches wherein the plunger travel locking assembly comprises at least one radially outwardly projecting tine, or a plurality of radially outwardly projecting tines (outwardly protruding dogs 7.3, fig. 5), connected to the plunger body (plunger 7, fig. 3); and wherein the one or plurality of radially outwardly projecting tines (7.3) is connected to the plunger body (7) via an elastically deformable arm (plunger arms 7.2, fig. 3 and 5).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Wright as modified to include the tine of the plunger travel locking assembly of Brereton since Brereton also deals with handheld injection devices. One would have been motivated to make the modification because the tines of Brereton would further ensure that the plunger could not be retracted after use, making the syringe harder to compromise.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright modified by Biondi, Hautaviita, and Botich as applied to claim 3 above, and further in view of Boris (US-5259840-A; hereafter Boris).
Regarding claim 7, Wright as modified discloses the syringe assembly according to claim 3, as described above.
Wright as modified is silent to the plunger travel locking assembly comprising two opposite ridged abutment surfaces.
Boris, also in the field of single-use syringes, teaches a plunger travel locking assembly comprising at least one pair of cooperating and opposite abutment surfaces (annular ridges 70 and annular ridges 72, fig. 1, col. 3 ln. 28-46 ridges 70 and 72 cooperate to lock syringe after completion of injection); and wherein the at least one pair of cooperating and opposite facing abutment surface each comprise a ridged portion of material (col. 3 ln. 28-46 ridges 70 and 72 make up opposite abutment surfaces).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to add the plunger travel locking assembly of Boris to the device of Wright as modified since Boris also deals with single use syringes. One would have been motivated to make the modification because the ridged abutment surfaces of Boris (col. 3 ln. 28-46) would augment the single-use safety mechanism of Wright ([0079]) which keeps the syringe from being reused. The combination would make the plunger even more difficult to retract, making the syringe harder to compromise.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright modified by Biondi and Hautaviita and further in view of Summerville et al (US-20070129675-A1; hereafter Summerville).
Regarding claim 21, Wright modified by Biondi and Hautaviita discloses the syringe assembly according to claim 1, as described above. Wright further discloses wherein a syringe backstop (trailing leg 55, fig. 1E, [0066]) is movable relative to a plunger head (grip 50, fig. 1A, [0065]) in the direction of injection travel and restricted relative to the plunger head in the direction opposite to the direction of injector travel ([0079] plunger cannot be retracted once fully depressed).
Wright is silent to first and second cooperating abutment surfaces.
Summerville, in the field of syringes, teaches wherein a first cooperating abutment surface (see annotated fig. 10 below) is located on an inner surface of a projecting wall of a syringe backstop (see annotated fig. 10 below), and a second cooperating abutment surface (see annotated fig. 10 below) is located on an outer surface of the plunger head (see annotated fig. 10 below) and the second cooperating abutment surface is movable relative the first cooperating abutment surface in the direction if injection travel (see fig. 3 which shows the syringe prior to completion of injection, fig. 3, [0016]; see fig. 10 which shows the syringe after completion of injection, fig. 10, [0021]-[0023]) and restricted relative to the first cooperating abutment surface in the direction opposite to the direction of injection travel (see fig. 10).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to add the abutment surfaces taught by Summerville to the device of Wright modified by Biondi and Hautaviita since Summerville also deals with syringes. One would have been motivated to make the modification because the abutment surfaces of Summerville would augment the single-use safety mechanism of Wright ([0079]) which keeps the syringe from being reused, thus making the syringe harder to compromise.
Claim(s) 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biondi in view of Hautaviita.
Regarding claim 32, Biondi discloses a kit for providing an end point signalling for a prefilled syringe ([00105] syringe is a pre-filled syringe) comprising:
an end point signalling circuit (PCBA, fig. 2, [0078]);
a contact applicator (switch key and light pipe, fig. 2) including a moveable contact applicator plate or disc (cylindrical part of switch key and light pipe, see fig. 2, contact applicator/switch key is shown to have a cylindrical section adjacent to the PCBA/circuit) having a projection (see annotated fig. 2 Biondi) extending from a second side of the contact applicator plate or disk and configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to extend through an opening in a plunger head (sensor housing, fig. 2) of a plunger (sensor housing, thumb pad, battery, and stopper rod shown in fig. 2) of the pre-filled syringe (see annotated fig. 2, note that the holes in the sensor housing match shape with the projections of the switch key and thus the switch key projections could extend through the housing); and
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at least one of a syringe backstop or collar (activation cam, fig. 2) having a displacement surface or feature (extension tab, fig. 2) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to interface with the displacement surface or feature on the contact applicator plate or disk (see Modified Fig. 2 above) through an opening in a plunger head of a plunger (see Modified Fig. 2 above) of the pre-filled syringe to move the contact applicator plate or disk from a contactless position to a contact position to signal an end point (Biondi: [00131] switch key is pushed in the direction opposite the direction of injection by extension tabs which activates momentary switch on the PCBA, see fig. 2).
Biondi is silent to an electrical contact formed on a first side of the contact applicator plate or disk.
Hautaviita, in the art of medicament delivery devices with usage monitoring, teaches a contact applicator (switch tongue 152, fig. 13a/b) including a contact applicator plate or disk (flat face of switch tongue 152 as indicated in annotated fig. 13a/b below) and an electrical contact (end portion of flat face of switch tongue as shown in annotated fig. 13a/b; [0054] movement of the electrically conductive switch tongue 152 closes a switch at the end of dose delivery activation of the momentary switch triggers the sensor component to transmit a report comprising a drug dose completion signal), formed of an electrically conductive material ([0054] tongue 152 is formed of an electrically conductive material) on a first side (see Modified Fig. 13 below) of the contact applicator plate or disk (see fig. 13a/b)
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to make the contact applicator of Bondi include an electrical contact formed of an electrically conductive material on the first side of the contact applicator plate or disk closest to the PCBA/circuit as taught by Hautaviita since all both references deal with syringes. As noted above, the modification of Biondi to include an electrical contact in order to signal the end of delivery, as taught by Hautaviita, would have been an obvious alternative way to close the circuit and trigger a signal. Furthermore, Biondi discloses a proximal movement of a switch key causing a circuit to signal the end of delivery, and Hautaviita teaches a proximal movement of an electrical contact causing a circuit to signal the end of delivery. The method and structure of the signalling devices are thus similar and it would have been obvious, as previously described, to modify Biondi to have an electrical contact which closed a circuit instead of just pressing on a circuit. One would have been motivated to make the modification because switches which trigger electrical activity are often electrically conductive so that their movement can close or open a circuit. As modified, it would only be necessary for the contact applicator plate or disk to make contact with the electrical circuit to trigger recognition, because the electrical contact would be able to close the circuit without moving any element on the PCBA.
Regarding claim 33, Biondi modified by Hautaviita discloses the kit of claim 32, as described above. Biondi further discloses wherein the movable contact applicator plate or disk (cylindrical part of switch key and light pipe, see fig. 2) includes a constraint rod (light pipe, see fig. 2) projecting from the second side (see annotated fig. 2 of Biondi) of the contact applicator plate or disk and sized to be supported in a bore of the plunger (sensor housing, thumb pad, battery, and stopper rod shown in fig. 2) ( [00129] light pipe is located inside the hollow elongated rod element of the syringe stopper rod; see fig. 2) to constrain movement of the contact applicator plate or disk and the electrical contact before the plunger has reached the limit (see 112b interpretation above) of a permitted extent of a direction of injection travel of the plunger (see fig. 2 which shows that light pipe contacts the switch key; since the two elements are in contact then the rod/light-pipe restricts the movement of the contact applicator/switch key).
Regarding claim 34, Biondi modified by Hautaviita discloses the kit of claim 32, as described above, including wherein the at least one of the syringe backstop or collar includes the syringe backstop (see Biondi Fig. 3 Detail below) connectable to the prefilled syringe (Biondi: [00105] syringe is a pre-filled syringe) through the collar (see Biondi Fig. 3 Detail below) (Biondi: [00131] activation cam abuts the syringe at the end of dose delivery, thus the syringe backstop/collar/activation cam is connectable to the prefilled syringe; note also fig. 2/3 which shows that collar flange of activation cam corresponds to indentation on sensor housing, thus connecting the syringe backstop to the assembled prefilled syringe through the collar) and the displacement surface or feature (Biondi: extension tab, fig. 2) is formed on the syringe backstop (Biondi: activation cam, fig. 2 shows extension tab formed on the activation cam).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 06/02/2026
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