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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
This Action is responsive to the Reply filed 19 December 2025 (“Reply”). As directed in the Reply:
Claims 2, 3, 7, 10, 13, 16, 17, 19, and 20 have been amended;
Claims 1, 8, and 18 have been and/or remain cancelled; and
Claims 21 and 22 have been added.
Thus, Claims 2-7, 9-17, and 19-22 are presently pending in this application. Applicant’s amendments to Claims 7, 16, and 17 are sufficient to overcome the objections thereto.
The Reply is not fully responsive (see 37 C.F.R. § 1.111(b), (c)) to the prior Action because of the following omission(s) or matter(s): the Reply does not address the patentability of new Claims 21 and 22 with respect to the prior art.
As a courtesy to Applicant, the Reply has been treated on the merits without requiring a supplemental reply to remedy the foregoing deficiency; this treatment does not, however, relieve Applicant of this or any other requirement of Title 37, C.F.R., for any future papers filed in this application.
Response to Arguments
Applicant’s arguments with respect to Claims 2-7, 9-17, 19, and 20 have been considered but not persuasive.
Applicant argues (Reply, pg. 10, last full paragraph) that modification of Tremblay’s device to include a release mechanism would interfere with the operation of trigger 98 and actuation assembly 28, and require reconfiguration of the device. While the Examiner understands this argument, given the high level of abstraction in which the “release component” is claimed, the further inclusion into Tremblay’s device of some sort of release component would not necessarily interfere with the function of trigger 98 (which is now identified below as being part of the cartridge) or the safety (now read on by the broader ‘safety’ of the claims). Given that Tremblay expressly states that its outer housing is held together with “clips . . . or screws” ([0006]), and not a more permanent connection (overmolding, gluing, or melting), a person of ordinary skill in the art would understand that Tremblay’s device is designed so that it can be taken apart, for which a release, activated by Marlin’s electronics, would be important for reuse of the device. Notably, Applicant has only concluded that modification of Tremblay’s device would require ‘too much’ modification, were it modified in view of Marlin’s disclosure, without pointing out any particular record evidence that supports that conclusion - that is, what technical aspects of Tremblay’s device would necessarily be inhibited by inclusion of a very broadly recited “release component.” Accordingly, the record evidence still supports a prima facie case of obviousness of the claimed combinations.
The balance of Applicant’s arguments rely expressly on the foregoing, and are therefore also unpersuasive.
Terminal Disclaimer
The terminal disclaimer filed with the Reply, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,890,456, has been reviewed and is accepted. The terminal disclaimer has been recorded.
Priority
This application, which discloses and claims only subject matter disclosed in prior Application No. 15/815,026, filed 16 November 2017, appears to claim only subject matter directed to an invention that is independent and distinct from that claimed in the prior application, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a divisional application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Claim Objections
Claim 13 is objected to because of the following informalities: at line 1, “the” is missing.
Claim Rejections - 35 USC § 112
Claims 21 and 22 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 21 and 22 depend from cancelled Claim 1, rendering their scopes completely indefinite; they have been treated as if they depend from Claim 2.
Claim Rejections - 35 USC § 103
Claims 2-7, 9, 21, and 22 are rejected under 35 U.S.C. 103 as being obvious, and therefore unpatentable, over U.S. Patent App. Pub. No. 2016/0287788, by Tremblay et al. (“Tremblay”), in view of U.S. Patent App. Pub. No. 2017/0281877, by Marlin et al. (“Marlin”).
Tremblay discloses a device substantially as claimed by Applicant, as follows.
Claim 2: An injection device for self-administering an injection of a fluid (Fig. 1), the device comprising:
a cartridge (Fig. 1: 98, 74, 64, 66; [0046]) comprising a needle (66) and a chamber (interior of 74) for holding the fluid;
a body portion configured to engage the cartridge (84), the body portion comprising:
an injection component for effecting the injection of the fluid (60); and
a safety arranged at least in part on the body portion wherein the injection component cannot function until the safety mechanism is released (28, 30); and
wherein the safety is configured to be released when a tip of the cartridge is pressed against a target surface for injection ([0046]).
Tremblay does not, however, include a release component configured to disengage the cartridge from the body portion upon application of force to the release component.
Marlin relates to hand-held medication injectors with replaceable medication cartridges and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Marlin teaches (Figs. 2, 4, [0139]) that such injectors can be constructed to include a release component (182) which is configured to disengage the cartridge from the body portion upon application of force to the release component ([0139]), and which ejects the cartridge (id.), which a person of ordinary skill in the art understands would: permit the device to be reloaded and reused with another cartridge, which a person of ordinary skill in the art would immediately understand would greatly reduce the cost per injection, because the expensive injection pen, including its electronics, can be reused; make the device simpler to use for those with limited dexterity; inhibits or prevents the cartridge from falling out of the device when being replaced; and, allow the user to destroy or dispose of the spent needle in a secure sharps container once separated from the rest of the device.
It 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, to include, in Tremblay’s injector, a release component configured to disengage the cartridge from the body portion upon application of force to the release component, because Marlin teaches doing so in a closely related device “to removably lock and eject the cartridge 54 during and after operation, respectively”, which a person of ordinary skill in the art understands would: permit the device to be reloaded and reused with another cartridge, which a person of ordinary skill in the art would immediately understand would greatly reduce the cost per injection, because the expensive injection pen, including its electronics, can be reused; make the device simpler to use for those with limited dexterity; inhibits or prevents the cartridge from falling out of the device when being replaced; and, allow the user to destroy or dispose of the spent needle in a secure sharps container once separated from the rest of the device.
Claim 3: (The injection device of claim 2,) wherein the injection component is configured to fully insert he needle first followed by depressing of a plunger within the cartridge to inject the fluid (Tremblay Abstract; pressing 98, then 22).
Claim 4: (The injection device of claim 3,) wherein the injection component includes a hammer (Tremblay 48) and a plunger (Tremblay 60).
Claim 5: (The injection device of claim 4,) wherein the cartridge includes a needle shroud secluding the needle (Tremblay 114) until the cartridge is pressed against a surface and wherein insertion of the needle cannot be done until the needle shroud reveals the needle (compare Tremblay Figs. 5 and 6).
Claim 6: (The injection device of claim 2,) wherein the body portion includes an opening configured to engage the cartridge (interior of 84).
Claim 7: (The injection device of claim 2,) wherein the release component is configured to eject the cartridge from the body portion (Marlin, [0139]).
Claim 9: (The injection device of claim 2,) wherein, when the body portion has engaged the cartridge, a gap remains between the body portion and the cartridge (Tremblay’s Fig. 2, the radial gap between the distal end of the needle cover 112 and the radially adjacent portion of body 84), and wherein the injection component is prevented from functioning until the body portion and the cartridge come in contact (triggers 22, 98, prevent functioning as claimed; distalmost tip of body 84 is pressed proximally by the portion 98 of the cartridge).
Claim 21: (The injection device of claim 1 [sic: 2],) wherein the injection component comprises a two stage system that comprises a hammer for inserting the needle (Tremblay 48) and a plunger within the cartridge to inject the fluid after insertion of the needle (Tremblay 60), wherein the plunger is configured to be released upon completion of a stroke of the hammer ([0046], describing the claimed order of operation),
wherein the cartridge comprises a fluid pod (74) comprising the chamber configured for holding the fluid (78), the fluid pod further comprising a plug at a trailing end thereof (76), the plug configured for moving through the chamber when engaged by the plunger so as to cause the fluid in the chamber to be ejected through the needle ([0046]), and
wherein, when the body portion has engaged the cartridge, a gap remains between a tip of the body portion and the cartridge (Tremblay’s Fig. 2, the radial gap between the distal end of the needle cover 112 and the radially adjacent portion of body 84), and wherein the safety is configured to be released when the tip of the cartridge is pressed against a target surface and the tip of the body and the cartridge come in contact (Tremblay’s triggers 22, 98, prevent functioning as claimed; distalmost tip of body 84 is pressed proximally by the portion 98 of the cartridge).
Claim 22: (The injection device of claim 1 [sic: 2],) wherein the injection component and the release component are configured to be effectuated by a common trigger motion (Marlin, [0139]: “Cartridge ejector assembly 182 may be controlled by the main control unit 605 upon being coupled to the drive unit 610 . . . ,” indicating that the same actuation button is used to “effectuate” injection, e.g., step 809 and 811 in Fig. 8, as will eventually result in the release component being actuated).
Claims 10-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tremblay and Marlin as applied to Claim 1 et sqq. above, and further in view of U.S. Patent App. Pub. No. 2008/0119958, by Bear et al. (“Bear”).
Tremblay and Marlin together describe a device substantially as claimed by Applicant; see above. They do not, however, describe a series of its cartridges, or a tray for holding those cartridges.
Bear relates to medication injection systems and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Bear teaches that, in order to ease the administration of multiple medications to a patient over the course of multiple days, the medication injection system can include a series of cartridges (Fig. 2, 222) held in a tray (238), which better enables the caregiver or patient to correctly manage the patient’s medication administration schedule.
It 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, to include, with Tremblay/Marlin’s injection device, a series of its cartridges, and a tray for holding those cartridges, because Bear teaches doing so in a closely related system, in order to better manage a patient’s multiple injection protocol.
Claim 11: (The system of claim 10,) wherein the cartridges are preloaded with a predetermined quantity of fluid (Tremblay’s and Bear’s cartridges are preloaded), wherein at least two of the cartridges contain differing quantities of fluid (Bear at [0003], [0023] describes multiple medications, which will be in different volumes).
Claim 12: (The system of claim 11,) wherein the cartridges are arranged in the tray in an order reflecting injection order based upon the quantity of fluid in each cartridge (when considering any two of Bear’s different medications, one will have a different volume from the other and thus be arranged as claimed).
Claim 13: (The injection device of claim 10,) wherein [sic: “the”] injection component includes a hammer (Tremblay 48) and a plunger (Tremblay 60).
Claim 14: (The injection device of claim 10,) wherein the injection component is configured to fully insert the needle first followed by depressing of a plunger within the cartridge to inject the fluid (Tremblay [0046]).
Claim 15: (The injection device of claim 14,) wherein the cartridge includes a needle shroud secluding the needle (Tremblay’s 114) until the cartridge is pressed against a surface and wherein insertion of the needle cannot be done until the needle shroud reveals the needle (compare Tremblay’s Figs. 5 and 6).
Claim 16: (The injection device of claim 10,) wherein the body portion includes an opening configured to engage the cartridge (Tremblay interior of 84).
Claim 17: (The injection device of claim 10,) wherein the release component is configured to eject the cartridge from the body portion (Marlin [0139]).
Claim 19: (The injection device of claim 10,) wherein, when the body portion has engaged the cartridge, a gap remains between a tip of the body portion and the cartridge (Tremblay’s Fig. 2, the radial gap between the distal end of the needle cover 112 and the radially adjacent portion of body 84), and wherein the safety is configured to be released when the tip of the cartridge is pressed against the target surface (Tremblay [0046]) and the tip of the body and the cartridge come in contact (Tremblay’s triggers 22, 98, prevent functioning as claimed; distalmost tip of body 84 is pressed proximally by the portion 98 of the cartridge).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tremblay, Marlin, and Bear as applied to Claim 10 above, and further in view of U.S. Patent App. Pub. No. 2014/0324021, by Ulrich et al. (previously of record; “Ulrich”).
Tremblay, Marlin, and Bear together describe a device substantially as claimed by Applicant; see above. They do not, however, describe the further inclusion of an injection patch having a numbing agent arranged on at least a portion of a surface thereof.
Ulrich relates to pen injectors and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Ulrich teaches that an injection patch (22) can be provided with an injection pen (such as those of Tremblay and Marlin), and that the patch can have a numbing agent arranged on at least a portion of a surface of the patch ([0036]), so that the patch can both present a target receptable for the pen ([0031]) and reduce injection pain ([0036]).
It 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, to further include, with a Tremblay-Marlin-Bear device, an injection patch having a numbing agent arranged on at least a portion of a surface thereof, because Ulrich teaches doing so in a related device, so that the patch can both present a target receptable for the pen and reduce injection pain.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783