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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/02/2025 has been entered.
Response to Amendment
Claims 16, 17, 21, 26, and 35 have been amended, and new claims 36-37 have been added.
Claim 20 has been cancelled. Claims 16-19 and 21-37 remain pending, with claims 22-25 withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 36-37 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
New claims 36 and 37 require a needle cover that is arranged to cover the needle and an additional second information feature thereon. Independent claim 16, which claim 36 depends on, requires a movable trigger member. The trigger member as recited in claim 16 is the needle cover of Applicant as called out in Applicant’s Response to Election/Restriction filed 10/11/2024, (“Applicant respectfully notes that the “trigger member” of Species 4 is illustrated in the application disclosure as the ”needle cover 6”.”). Thus, it is considered new matter to require a trigger member which is a needle cover and, separately, a needle cover, as Applicant does not disclose multiple needle covers.
Claim 37 further requires an additional second information feature on a needle cover; it is not made clear how this would be arranged as Applicant’s disclosure only shows a single needle cover which is a trigger member, and Applicant’s Drawings only show a single second information feature on the single needle cover, and thus this is also considered new matter.
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 36-37 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.
Claims 36-37 are rejected as being indefinite where the claims first require a movable trigger member (required in claim 16 which claim 36 depends on) which Applicant has previously specified to be a needle cover (see Applicant’s Response to Election/Restriction filed 10/11/2024, “Applicant respectfully notes that the “trigger member” of Species 4 is illustrated in the application disclosure as the ”needle cover 6”.”.), and additionally requires a separate needle cover in new claim 36. It is unclear how this needle cover is meant to be different from the needle cover which is the movable trigger member which renders the claim indefinite.
For the purposes of compact prosecution, Examiner has understood the needle cover of claim 36 to be the movable trigger member of claim 16 as the elements appear to be the same. Further, Applicant has required an additional second information feature on the unclear needle cover; the Specification does not make clear how there is to be two second information features on the needle cover, particularly as this feature is not shown in the Drawings, and thus this is also considered to be the same second information feature already required in the independent claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 26 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 26 fails to further limit claim 21 which it depends upon where claim 26 requires a functional limitation that “the movable trigger button, when actuated, triggers the dispensing operation”, while claim 16 (which claim 26 depends on) already requires a functional limitation that “a movable trigger button that initiates the dispensing operation when pressed by a user”. These limitations are the same as a pressing by a user as in claim 16 is an actuation as in claim 26, the trigger button is the same, and the pressing by the user for the actuation is already required in claim 16 to initiate the dispensing operation, and thus the triggering of the dispensing operation in claim 26 is not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 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.
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) 16, 18, 21, 26-31, 33-34, and 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wozencroft (US 20130310758, henceforth Wozencroft) in view of Sundquist et al. (US 20160030677, henceforth Sundquist), Hickle et al. (US 20020188259, henceforth Hickle), Gardner (US 20190355463), and Saussaye et al. (US 20160303323, henceforth Saussaye).
Regarding claim 16, Wozencroft discloses an assembly for a drug delivery device (see fig. 1), the assembly comprising: a housing unit (rear assembly 10 and front assembly 12, fig. 1) comprising a housing (rear assembly 10, fig. 1) for receiving a reservoir (syringe 13, fig. 2) and a dispensing mechanism (firing button 18, body housing 20, shroud 24, syringe carrier 34, springe guide 46, shroud springs 44, fig. 3) configured to dispense a liquid drug content from the reservoir in a dispensing operation (see [0029]-[0032] and [0037]); a cap (removable front cap 14, fig. 3) that is releasably connected to the housing unit (see [0028]), the cap, when connected to the housing unit, at least partially covering a distal dispensing end of the assembly (see [0028] and fig. 2, the distal dispensing end of the assembly is the end of the assembly closer to rigid needle shield 15 as in fig. 2) that is uncovered when the cap is disconnected from the housing unit (see at least [0039] and fig. 1); and a movable trigger button (needle shroud 24, fig. 3) that initiates the dispensing operation when pressed by a user (see [0037] and see [0042], needle shroud 24 is a trigger button where it must be pressed against the skin to allow the injection to occur, thus it is a part actuated for triggering of the injection sequence; the pressing against the skin is the claimed actuation, and is part of what triggers the dispensing as in [0042]), wherein the movable trigger button is in a first position (proximally retracted position prior to backward extension, see [0037], also referred to as the pre-use position) when the dispensing mechanism is in a first state in which the dispensing mechanism is in a ready-to-dispense condition (see at least [0037] regarding the pre use positioning state; the pre use condition is further described in [0039] and [0040]), and wherein the movable trigger button is in a second position (distally, or forwardly, displaced position after use in [0037]) when the dispensing mechanism is in a second state in which the dispensing mechanism is in a dispensed condition (see at least [0037], [0042], and fig. 15(b)).
Wozencroft does not disclose a first information feature having a coded first content and being machine-readable for retrieval of the coded first content from the first information feature, wherein the first information feature is visible and/or machine-readable when the cap is connected to the housing unit, or wherein the first information feature is removable together with the cap from the housing unit or rendered unreadable when the cap is disconnected from the housing unit. Sundquist teaches an injection device (injection system 100, fig. 4) including an information carrier (second tamper evident band 115, fig. 4) including a first information feature (printed design of [0052] which is present on second tamper evident band 115) which is visible when it is connected to a cap (hub cap housing 119, fig. 4) and a housing unit (housing 110, fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the tamper evident seal of Sundquist onto the assembly of Wozencroft to prevent the assembly from being tampered with as this could render it unsafe for use ([0012], see [0044] which details that the sealing is used to prevent inadvertent movement and protection from tampering).
Wozencroft as modified discloses that the tamper-evident seal which comprises the first information feature is perforated (see Sundquist [0051] and note that this is the perforation of tamper evident seal 115).
Wozencroft as modified discloses that the tamper-evident seal which comprises the first information feature is perforated (see Sundquist [0051] and note that this is the perforation of tamper evident seal 115).
Wozencroft as modified does not explicitly disclose that the first information feature is rendered unreadable when the cap is disconnected from the housing unit. Hickle teaches that computer readable information features (EEPROMS, [0059]) can be arranged on frangible tamper-evident seals (tamper-evident seals of [0059]) such as to make the information feature unreadable after the seal is removed ([0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the information on the tamper evident seal such that the information feature becomes unreadable after the seal has been broken as in Hickle ([0059]) for the benefit of preventing fraudulent or unwanted use (see at least Hickle [0010] and [0045]). In the modified device of Wozencroft, since the tamper-evident seal is perforated (and thus is understood to tear at this perforation), this would include arranging the information feature such that the information feature becomes unreadable after the seal has been broken at the perforation.
Additionally, there is a limited number of options for the arrangement of the information feature, with these options being (1) that the first information feature is rendered unreadable when the cap is disconnected from the housing unit due to the information stretching across the perforation (note that this is the perforation of tamper evident seal 115 as in Sundquist [0051]) and (2) the first information feature not being rendered unreadable when the cap is disconnected from the housing unit due to the information feature only being arranged on one side of the perforation. Either of these arrangements would have yielded an assembly which has an information feature which is at one point readably arranged on a tamper evident seal.
Thus, it would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tried arranging the first information feature across the disclosed perforation such that the first information feature is rendered unreadable when the cap is disconnected from the housing unit as claimed since this is one of a very limited options and since such an arrangement would have yielded a reasonable expectation of success (where success is considered to be the information feature being readable). Further, such an arrangement would mean that the size of the information feature could be maximized on the tamper-evident seal such as to maximize the readability of the information feature as compared to the alternative arrangement where the information feature would have to be wholly comprised on one side of the perforation.
Wozencroft as modified by Sundquist and Hickle does not disclose that the first information feature has a coded first content or is machine-readable for retrieval of the coded first content from the first information feature. Gardner teaches the use of information features such as bar codes (2-D bar code 22, fig. 2B) on injection devices (see syringe 2 of fig. 1A) with these bar codes having coded contents (large amount of information, [0007]) which are machine-readable for retrieval of the coded content from the information features (see [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a 2-D bar code as in Gardner for the printed design of Sundquist on the assembly of Wozencroft as 2-D bar codes can contain large amounts of information (Gardner [0007]) and because 2-D barcodes can be used to create unique identifiers for each syringe (Gardner [0029]).
Wozencroft as modified by Sundquist, Hickle, and Gardner does not disclose a second information feature which indicates the second state of the dispensing mechanism, and wherein the second information feature is located on the movable trigger button such that the second information feature is not visible in the first state and is visible in the second state to indicate the dispensed condition of the dispensing mechanism in the second state. Saussaye teaches the use of a second information feature (visual indicator 15, fig. 2) on an axially extensible movable trigger button (actuator sleeve 10, fig. 2, which is a trigger button as it is used to press against the skin to release the piston, see at least [0029]) which is not visible in a first, pre-use state (see fig. 1) and is visible in a second, post-use state (see fig. 2) and indicates a second state of the dispensing mechanism ([0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the second information feature of Saussaye to the axially extensible movable member of Wozencroft for informing the user that the autoinjector has already been used (Saussaye [0026]). Since the location of the information feature in Saussaye is what allows it to perform this indication to the user as it is hidden before an axial extension movement of its movable member and then is visible after the extension of its movable member, it would have been further obvious to have placed the information feature in the same place on the movable member of Wozencroft as it undergoes the same extension and would allow the feature to achieve its same purpose.
{Examiner notes that all subsequent references are to Wozencroft unless otherwise specified.}
Regarding claim 18, Wozencroft as modified discloses the assembly of claim 16 wherein the second information feature indicates the second state of the dispensing mechanism (see Saussaye [0026], indicator 15 is present to inform the user that the device has been used, which is the second state). Wozencroft as modified also discloses that the second information feature can include symbols (Saussaye [0026]).
Wozencroft as modified does not disclose the assembly wherein the second information feature has a coded second content, or wherein the second information feature is machine-readable for retrieval of the coded second content from the second information feature. Gardner teaches the use of information features comprising symbols such as bar codes (2-D bar code 22, fig. 2B) on injection devices (see syringe 2 of fig. 1A) with these bar codes having coded contents (large amount of information, [0007]) which are machine-readable for retrieval of the coded content from the information features (see [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a 2-D bar code as in Gardner for the symbol of the indicator of Saussaye on the assembly of Wozencroft as 2-D bar codes can contain large amounts of information (Gardner [0007]) and because 2-D barcodes can be used to create unique identifiers for each syringe (Gardner [0029]).
Regarding claim 21, Wozencroft as modified discloses the assembly of claim 16 wherein the movable trigger button is configured to move from the first position to the second position during the dispensing operation and/or after completion of the dispensing operation ([0037]).
Regarding claim 26, Wozencroft as modified discloses the assembly of claim 21 wherein the movable trigger button, when actuated, triggers the dispensing operation (see [0037] and see [0042], needle shroud 24 is a trigger member where it must be pressed against the skin to allow the injection to occur, thus it is a part actuated for triggering of the injection sequence; the pressing against the skin is the claimed actuation, and is part of what triggers the dispensing as in [0042]).
{See the rejection of claim 26 above under 35 U.S.C. 112(d) as well, this is the same explanation as in claim 16.}
Regarding claim 27, Wozencroft as modified discloses the assembly of claim 21 wherein the first information feature is permanently modified when removing the cap (see Sundquist [0049], the tamper-evident seal which has been added in the modified device and comprises the first information feature is modified where the seal is ripped when the cap of the device of Wozencroft is removed).
Regarding claim 28, Wozencroft as modified discloses the assembly of claim 27 wherein after having removed the cap, the coded first content is no longer retrievable from the modified first information feature.
{In the modified device of Wozencroft, the first information feature is a 2-D barcode which is present on a tamper-evident perforated seal. It is well known to those of ordinary skill in the art that in order to scan a 2-D barcode, the whole barcode must be present. Since the seal of Sundquist rips during use as in Sundquist [0049], the 2-D barcode which is the first information feature present on said seal would also be ripped and thus no longer be readable. Since it would no longer be readable, it would no longer be retrievable since the retrieving action must come after the reading action in regards to scanning information from a 2-D barcode as is known to those of ordinary skill in the art.}
Regarding claim 29, Wozencroft as modified discloses the assembly of claim 16 further comprising an information carrier (tamper evident seal 115 of Sundquist added into the assembly of Wozencroft in claim 16 above) connected to the cap and/or to the housing unit (see Sundquist fig. 4; the tamper evident seal 115 is connected a cap 119 and the housing 110 as in the modified device of Wozencroft; see rejection of claim 16 above), wherein the first information feature is located on the information carrier (see rejection of claim 16 above).
Regarding claim 30, Wozencroft as modified discloses the assembly of claim 29 wherein the information carrier comprises a sealing (see Sundquist fig. 4, a sealing element which is tamper evident seal 115 is added to Wozencroft).
Regarding claim 31, Wozencroft as modified discloses the assembly of claim 16 wherein at least one of the first information feature and the second information feature comprises a two-dimensional barcode (see modification to Wozencroft in view of Gardner in claim 16 above, the first information feature is a 2-D barcode).
Regarding claim 33, Wozencroft as modified discloses the assembly of claim 16 wherein the assembly comprises an auto-injector (see Wozencroft fig. 1 and Abstract).
Regarding claim 34, Wozencroft as modified discloses the assembly of claim 16 further comprising the reservoir (syringe 13, fig. 2), that comprises a liquid drug (medicament of [0028] is understood to be liquid as it is medicament to be injected via a needle as shown in fig. 15(a)).
Regarding claim 36, Wozencroft as modified discloses the assembly of claim 16 further comprising a needle (see the needle shown in fig. 15(a)) and a needle cover that is arranged to cover the needle (this is the same as the movable trigger element, see the rejection above with respect to 35 U.S.C. 112(b)).
Regarding claim 37, Wozencroft as modified discloses the assembly of claim 36 further comprising an additional second information feature located on the needle cover (see the rejection above with regards to 35 U.S.C. 112(b)).
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wozencroft (US 20130310758, henceforth Wozencroft) in view of Sundquist et al. (US 20160030677, henceforth Sundquist), Hickle et al. (US 20020188259, henceforth Hickle), Gardner (US 20190355463), and Saussaye et al. (US 20160303323, henceforth Saussaye) as applied to claims 16 and 18 above, respectively, and further in view of Eilersen (US 20020020654).
Regarding claim 17, Wozencroft as modified discloses the assembly wherein the second information feature indicates the second state of the dispensing mechanism (see Saussaye [0026], indicator 15 is present to inform the user that the device has been used, which is the second state).
Wozencroft as modified does not disclose the assembly wherein the coded first content of the first information feature indicates the first state of the dispensing mechanism. Eilersen teaches a coded content of an information feature indicating a first state of a dispensing mechanism where the state is that the mechanism is unused ([0006], the taught electronically readable code is the information feature, the coded content that it contains includes drug administration history, and drug administration history and the monitoring of delivery of medication to the user as taught is understood to include whether or not the device has been operated since this is what constitutes drug administration history and monitoring of delivery; whether or not the device has been operated or not indicates that the dispensing mechanism is in the first state as that is an unused state).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included an indication as to the state of the dispensing mechanism in the coded first content of the first information feature of Wozencroft as modified as Eilersen teaches inclusion of drug administration history in coded contents from machine readable codes as a way of avoiding errors in drug administration ([0006]).
Regarding claim 19, Wozencroft as modified does not disclose the assembly wherein the coded first content of the first information feature indicates the first state of the dispensing mechanism. Wozencroft as modified also does not disclose the coded second content of the second information feature indicating the second state of the dispensing mechanism. Eilersen teaches coded content of an information feature indicating a state of a dispensing mechanism where the state is that the mechanism is either unused, equivalent to the first state, or is already used, equivalent to the second state ([0006], the taught electronically readable code is the information feature, the coded content that it contains includes drug administration history, and drug administration history and the monitoring of delivery of medication to the user as taught is understood to include whether or not the device has been operated since this is what constitutes drug administration history and monitoring of delivery; whether or not the device has been operated or not indicates that the dispensing mechanism is in the first state as that is an unused state, or that the dispensing mechanism is in the second state as that is a used state).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included an indication as to the state of the dispensing mechanism in the coded content of each of the information features of Wozencroft as modified as Eilersen teaches inclusion of drug administration history in coded contents from machine readable codes as a way of avoiding errors in drug administration ([0006]).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Wozencroft (US 20130310758, henceforth Wozencroft) in view of Sundquist et al. (US 20160030677, henceforth Sundquist), Hickle et al. (US 20020188259, henceforth Hickle), Gardner (US 20190355463), and Saussaye et al. (US 20160303323, henceforth Saussaye) as applied to claim 16 above, and further in view of Hopper et al. (US 20190341136, henceforth Hopper).
Regarding claim 32, Wozencroft as modified discloses the assembly of claim 16 wherein the first information feature comprises a 2-D bar code (see modification to Wozencroft in view of Gardner in claim 16 above, the first information feature is a 2-D barcode).
Wozencroft as modified does not disclose the assembly wherein the first information feature comprises a QR code. Hopper teaches an autoinjector assembly (drug delivery device 100, fig. 1A) comprising a first information feature (machine readable code 110, fig. 1A) which can be a 2-D bar code (see [0025]) or equivalently can be a QR code (see [0025]).
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 a QR code for the 2-D barcode of Wozencroft as modified as Hopper teaches that a QR code is an art effective equivalent of a 2-D barcode (Hopper [0025] teaches that 2-D barcodes and QR codes are equivalent optically readable codes) and further because such a substitution would yield the same, equivalent result of an assembly for a drug delivery device comprising a first information feature with a coded first content where the information feature is machine readable for retrieval of the coded first content when scanned by a computer.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Wozencroft (US 20130310758, henceforth Wozencroft) in view of Sundquist et al. (US 20160030677, henceforth Sundquist), Hickle et al. (US 20020188259, henceforth Hickle), Gardner (US 20190355463), Saussaye et al. (US 20160303323, henceforth Saussaye), and Eilersen (US 20020020654).
Regarding claim 35, Wozencroft discloses an assembly for a drug delivery device (see fig. 1), the assembly comprising: a housing unit (rear assembly 10 and front assembly 12, fig. 1) comprising a housing (rear assembly 10 and front assembly 12, fig. 1) for receiving a reservoir (rear assembly 10 and front assembly 12, fig. 1) and a dispensing mechanism (rear assembly 10 and front assembly 12, fig. 1) configured to dispense a liquid drug content from the reservoir in a dispensing operation (see [0029]-[0032] and [0037]); a cap (see [0029]-[0032] and [0037]) that is releasably connected to the housing unit (see [0028]), the cap, when connected to the housing unit, at least partially covering a distal dispensing end of the assembly (see [0028] and fig. 2, the distal dispensing end of the assembly is the end of the assembly closer to rigid needle shield 15 as in fig. 2) that is uncovered when the cap is disconnected from the housing unit ([0039]); and a movable trigger button (needle shroud 24, fig. 3) that initiates the dispensing operation when pressed by a user (see [0037] and see [0042], needle shroud 24 is a trigger button where it must be pressed against the skin to allow the injection to occur, thus it is a part actuated for triggering of the injection sequence; the pressing against the skin is the claimed actuation, and is part of what triggers the dispensing as in [0042]), wherein the movable trigger button is in a first position (proximally retracted position prior to backward extension, see [0037], also referred to as the pre-use position) when the dispensing mechanism is in a first state in which the dispensing mechanism is in a ready-to-dispense condition (see at least [0037] regarding the pre use positioning state; the pre use condition is further described in [0039] and [0040]), and wherein the movable trigger button is in a second position (distally, or forwardly, displaced position after use in [0037]) when the dispensing mechanism is in a second state in which the dispensing mechanism is in a dispensed condition (see at least [0037], [0042], and fig. 15(b)).
Wozencroft does not disclose a first information feature having a coded first content and being machine-readable for retrieval of the coded first content from the first information feature, wherein the first information feature is visible and/or machine-readable when the cap is connected to the housing unit, or wherein the first information feature is removable together with the cap from the housing unit or rendered unreadable when the cap is disconnected from the housing unit. Sundquist teaches an injection device (injection system 100, fig. 4) including an information carrier (second tamper evident band 115, fig. 4) including a first information feature (printed design of [0052] which is present on second tamper evident band 115) which is visible when it is connected to a cap (hub cap housing 119, fig. 4) and a housing unit (housing 110, fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the tamper evident seal of Sundquist onto the assembly of Wozencroft to prevent the assembly from being tampered with as this could render it unsafe for use ([0012], see [0044] which details that the sealing is used to prevent inadvertent movement and protection from tampering).
Wozencroft as modified discloses that the tamper-evident seal which comprises the first information feature is perforated (see Sundquist [0051] and note that this is the perforation of tamper evident seal 115).
Wozencroft as modified does not explicitly disclose that the first information feature is rendered unreadable when the cap is disconnected from the housing unit. Hickle teaches that computer readable information features (EEPROMS, [0059]) can be arranged on frangible tamper-evident seals (tamper-evident seals of [0059]) such as to make the information feature unreadable after the seal is removed ([0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arranged the information on the tamper evident seal such that the information feature becomes unreadable after the seal has been broken as in Hickle ([0059]) for the benefit of preventing fraudulent or unwanted use (see at least Hickle [0010] and [0045]). In the modified device of Wozencroft, since the tamper-evident seal is perforated (and thus is understood to tear at this perforation), this would include arranging the information feature such that the information feature becomes unreadable after the seal has been broken at the perforation.
Additionally, there is a limited number of options for the arrangement of the information feature, with these options being (1) that the first information feature is rendered unreadable when the cap is disconnected from the housing unit due to the information stretching across the perforation (note that this is the perforation of tamper evident seal 115 as in Sundquist [0051]) and (2) the first information feature not being rendered unreadable when the cap is disconnected from the housing unit due to the information feature only being arranged on one side of the perforation. Either of these arrangements would have yielded an assembly which has an information feature which is at one point readably arranged on a tamper evident seal.
Thus, it would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have tried arranging the first information feature across the disclosed perforation such that the first information feature is rendered unreadable when the cap is disconnected from the housing unit as claimed since this is one of a very limited options and since such an arrangement would have yielded a reasonable expectation of success (where success is considered to be the information feature being readable). Further, such an arrangement would mean that the size of the information feature could be maximized on the tamper-evident seal such as to maximize the readability of the information feature as compared to the alternative arrangement where the information feature would have to be wholly comprised on one side of the perforation.
Wozencroft as modified by Sundquist and Hickle does not disclose that the first information feature has a coded first content or is machine-readable for retrieval of the coded first content from the first information feature. Gardner teaches the use of information features such as bar codes (2-D bar code 22, fig. 2B) on injection devices (see syringe 2 of fig. 1A) with these bar codes having coded contents (large amount of information, [0007]) which are machine-readable for retrieval of the coded content from the information features (see [0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used a 2-D bar code as in Gardner for the printed design of Sundquist on the assembly of Wozencroft as 2-D bar codes can contain large amounts of information (Gardner [0007]) and because 2-D barcodes can be used to create unique identifiers for each syringe (Gardner [0029]).
Wozencroft as modified by Sundquist, Hickle, and Gardner does not disclose a second information feature which indicates the second state of the dispensing mechanism, and wherein the second information feature is located on the movable trigger button such that the second information feature is not visible in the first state and is visible in the second state to indicate the dispensed condition of the dispensing mechanism in the second state. Saussaye teaches the use of a second information feature (visual indicator 15, fig. 2) on an axially extensible movable trigger button (actuator sleeve 10, fig. 2, which is a trigger button as it is used to press against the skin to release the piston, see at least [0029]) which is not visible in a first, pre-use state (see fig. 1) and is visible in a second, post-use state (see fig. 2) and indicates a second state of the dispensing mechanism ([0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the second information feature of Saussaye to the axially extensible movable member of Wozencroft for informing the user that the autoinjector has already been used (Saussaye [0026]). Since the location of the information feature in Saussaye is what allows it to perform this indication to the user as it is hidden before an axial extension movement of its movable member and then is visible after the extension of its movable member, it would have been further obvious to have placed the information feature in the same place on the movable member of Wozencroft as it undergoes the same extension and would allow the feature to achieve its same purpose.
Wozencroft as modified does not disclose the assembly wherein the coded first content of the first information feature indicates the first state of the dispensing mechanism. Wozencroft as modified also does not disclose the coded second content of the second information feature indicating the second state of the dispensing mechanism. Eilersen teaches coded content of an information feature indicating a state of a dispensing mechanism where the state is that the mechanism is either unused, equivalent to the first state, or is already used, equivalent to the second state ([0006], the taught electronically readable code is the information feature, the coded content that it contains includes drug administration history, and drug administration history and the monitoring of delivery of medication to the user as taught is understood to include whether or not the device has been operated since this is what constitutes drug administration history and monitoring of delivery; whether or not the device has been operated or not indicates that the dispensing mechanism is in the first state as that is an unused state, or that the dispensing mechanism is in the second state as that is a used state).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included an indication as to the state of the dispensing mechanism in the coded content of each of the information features of Wozencroft as modified as Eilersen teaches inclusion of drug administration history in coded contents from machine readable codes as a way of avoiding errors in drug administration ([0006]).
Response to Arguments
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive.
Applicant has argued that Wozencroft does not disclose a movable trigger member as claimed because the needle shroud 24 of Wozencroft is not configured to initiate dispensing when pressed by a user as claimed. Examiner respectfully disagrees. Wozencroft requires its needle shroud to be pressed against the skin to allow for initiation of dispensing to occur. While there is an additional structure in Wozencroft required to be pressed to further initiate drug delivery, the claim does not prohibit additional structures from being pressed or moved to initiate the delivery so long as the pressing of the trigger member is also used to initiate dispensing.
Additionally, the claim does not define any structures that move as part of the dispensing operation (plunger moving through a reservoir to force fluid into the patient, for example), and thus the pressing of the trigger member against the skin could be considered the first step of the dispensing operation since it is required for drug delivery, and thus the trigger button of Wozencroft (shroud 24) could also be said to directly initiate the dispensing operation if the dispensing operation is considered to include the pressing of the device of Wozencroft against the skin.
Regarding Applicant’s arguments towards the previously relied upon Walker, the arguments have been considered but are rendered moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument since it relies upon Hickle and not Walker.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Schrul et al. (US 20190151564) is considered relevant prior art where it is an autoinjector device similar to Wozencroft as relied upon above which has a movable trigger member (needle protection sleeve 3) which is the only element used for triggering, and has a removable cap (cap 20) covering a needle (needle 11) at its distal end.
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/SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783