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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 17, both instances of “receptable” should be changed to “receptacle.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 1-4, 6-15, and 18-20 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 that the first and second chamber are on an opposite side of the first receptacle and the second receptacle “from the bottom surface.” It is unclear how the relative of the positions of the respective receptacles and chambers are related to the bottom surface.
Claim 1 also recites that “the first chamber and the second chamber are on an opposite side of the first receptable and the second receptable from the bottom surface…” However, it is unclear if the “bottom surface” is referring to the bottom surface of the base or the bottom surface of the first subassembly.
Claims 2-4, 6-15, and 18-20 are rejected by virtue of being dependent on a rejected base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 4, 6-8, 10-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2007/0038175 to Van Laar in view of U.S. Patent Publication No. 2010/0298808 to O’Dea et al. (“O’dea”).
Regarding claim 1, Van Laar teaches a wearable multi-shot injection patch (Figs. 1-3) comprising a base (Fig. 3) comprising a bottom surface (area generally designated by 120) and a top surface (area generally designated by 140), the bottom surface being capable of placement against skin of a patient (120 is an adhesive layer for attachment to the patient), a first chamber (240/220, Fig. 3 from one of the injection assemblies 80 of Figs. 1-2), a second chamber (another top assembly/disk from another of the injection assemblies 80 of Figs. 1-2), a first receptacle (210/50, Fig. 3 from one of the injection assemblies 80 of Figs. 1-2) containing a first medication (70), and a second receptacle (another injector barrel bottom 210 and diaphragm 50, from another of the injections assemblies 80 of Fig. 1-2) containing a second medication (70), the first chamber comprising a first pyrotechnic charge (10) disposed in the base between the top surface and the first receptacle, and the first chamber being aligned with the first receptacle (Fig. 3), the second chamber comprising a second pyrotechnic charge (another pyrotechnic gas generator 10, from the another injection assembly as previously defined) disposed in the base between the top surface and the second receptacle, and the second chamber being aligned with the second receptacle, wherein the first chamber and the second chamber are on an opposite side of the first receptacle and the second receptacle from the bottom surface, respectively (the first and second receptacles are inherently aligned opposite to the respective first and second chambers), and one or more electronic components (Fig. 5) configured to trigger the first pyrotechnic charge and the second pyrotechnic charge, wherein the first receptacle and the second receptacle are flexible (injector barrel 210 is understood as flexible given the broadest reasonable interpretation and at least rupture element 50, which forms part of the first and second receptacles, is flexible by virtue of being deformed and rupturable, [0040]), wherein when the first pyrotechnic charge is triggered, the first receptacle deforms, causing the first medication to be ejected externally ([0040]), and wherein when the second pyrotechnic charge is triggered, the second receptacle deforms, causing the second medication to be ejected externally ([0040]), but does not show the first subassembly and the second subassembly.
O’dea teaches a first subassembly (7, Fig. 2) comprising a first chamber (left 8) and a second chamber (right 8), and a second subassembly (7) comprising a first receptacle (left 8) containing a first medication (2) and a second receptacle (right 8) containing a second medication (2). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to yield the predictable result of providing a connection between associated chambers and receptacles. Both Van Laar and O’dea have analogous chambers with opposing receptacles having medicament being separated by a membrane/diaphragm. O’dea merely shows an alternative configuration using separate layers (Fig. 2) for stacking the analogous elements that would simply manufacturing.
Regarding claim 2, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 1 as shown above, Van Laar further teaching a first nozzle (60) disposed on an opposite side of the first receptacle from the first pyrotechnic charge (Fig. 3), and a second nozzle (another injection orifice 60 from the another injection assembly as previously defined) disposed on an opposite side of the second receptacle from the second pyrotechnic charge (Fig. 3).
Regarding claim 4, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 1 as shown above, Van Laar further teaching the base comprising an adhesive layer (12) capable of adhering the wearable multi-shot injection patch to the skin of the patient.
Regarding claim 6, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 1 as shown above, Van Laar further teaching the one or more electronic components are configured to selectively trigger the first pyrotechnic charge and the second pyrotechnic charge ([0046]).
Regarding claim 7, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 1 as shown above, Van Laar further teaching the one or more electronic components are configured to be controlled in a predetermined timed sequence ([0046]).
Regarding claim 8, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 1 as shown above, Van Laar further teaching the one or more electronic components comprising a microcontroller (100), the microcontroller being configured to store instructions to trigger at least one of the first pyrotechnic charge and the second pyrotechnic charge ([0046]).
Regarding claim 10, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 1 as shown above, Van Laar further teaching the base comprises a mask layer (230) forming the first chamber (Fig. 3) and a second chamber (230 from the another injection assembly as previously defined), wherein at least a portion of the first chamber and at least a portion of the second chamber form a barrier between the first pyrotechnic charge and the second pyrotechnic charge (at least a portion of 230 would form a barrier between an adjacent pyrotechnic charge.
Regarding claim 11, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 10 as shown above, Van Laar further teaching the base further comprises a sheet (200) disposed between the mask layer and both the first receptacle and the second receptacle, and the sheet has a first diaphragm (200) positioned to cover the first chamber and a second diaphragm (another 200 from the another injection assembly as previously defined) positioned to cover the second chamber.
Regarding claim 12, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 11 as shown above, but does not teach a dome-shaped diaphragm, although depending on the pressure within the receptable, especially when the pyrotechnic is being triggered, the flat shape would assume a dome shape at least for a moment.
In any case, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the first diaphragm and the second diaphragm of Van Laar a dome shape instead of a flat shape, since it has been held that the configuration of an object is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration claimed was significant (MPEP 2144.04(IV)(B). In instant case, simply rounding the flat diaphragm of Van Laar is a simply design variant based on user preference and does not affect the function or use of the device.
Regarding claim 13, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 12 as shown above, but do not teach a spherical-shaped receptacle.
In any case, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the first receptacle and the second receptacle of Van Laar a spherical shape instead of a dome shape, since it has been held that the configuration of an object is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration claimed was significant (MPEP 2144.04(IV)(B). In instant case, the use of a spherical shape for the receptacle of Van Laar is a simply design variant as compared to the already existing dome shape and does not affect the function or use of the device.
Regarding claim 14, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 11 as shown above, Van Laar further teaching the first diaphragm is flexible so that when the one or more electronic components trigger the first pyrotechnic charge, the first pyrotechnic charge generates a pressure spike to move the first diaphragm toward the first receptacle so that at least a portion of the first medication is ejected from the first receptacle ([0040]), and the second diaphragm is flexible so that when the one or more electronic components trigger the second pyrotechnic charge, the second pyrotechnic charge generates a pressure spike to move the second diaphragm toward the second receptacle so that at least a portion of the second medication is ejected from the second receptacle (identical functions occur in another injection assembly as previously defined).
Regarding claim 15, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 1 as shown above, Van Laar further teaching the base further comprises a clamp sheet (30) and the first receptacle and the second receptacle are disposed in the clamp sheet (Fig. 2).
Regarding claim 19, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 2 as shown above, Van Laar further teaching the base comprising an adhesive layer (120) capable of adhering the wearable multi-shot injection patch to the skin of the patient.
Claims 3, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Van Laar and O’dea as applied to claims 1 and 2 above, and further in view of U.S. Patent Publication No. 2011/0060280 to Caffey et al., herein referred to as Caffey.
Regarding claims 3 and 18, Van Laar and O’dea teach the wearable multi-shot injection patch according to claims 1 and 2, respectively, as shown above, but do not give details about the circuit board (Van Laar, gas retaining strip 20), although there is nothing teaching away from being flexible and given that the device of Van Laar is attached to a patient, flexibility would be understood as being necessary to fit the various parts of a patient body.
Caffey teaches a base (108) comprising a circuit board ([0039]) and is flexible so that a bottom surface of the circuit board is capable of conforming to a surface of a limb or torso of the patient in a similar type of patch-type drug delivery device. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the circuit board of Van Laar and O’dea to be flexible as such a trait is desirable in a patch-type drug delivery devices ([0039]) to work together with the adhesive patch in order to better conform to the patient as would be understood by skilled artisan.
Regarding claim 20, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 3 as shown above, Van Laar further teaching the base comprising an adhesive layer (120) capable of adhering the wearable multi-shot injection patch to the skin of the patient.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Van Laar and O’dea as applied to claim 1 above, and further in view of US. Patent Publication No. 2008/0015494 to Santini, JR. et al. (“Santini”).
Regarding claim 9, Van Laar and O’dea teach the wearable multi-shot injection patch according to claim 1 as shown above, but do not mention a wireless signal.
Santini teaches one or more electronic components comprising a receiver configured to receive a wireless signal ([0144]), and the one or more electronic components are capable of triggering at least one of the first pyrotechnic charge and the second pyrotechnic charge based at least in part on the wireless signal ([0065], Santini includes an embodiment using pyrotechnic means to displace multiple reservoirs). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated an electronic component for enabling wireless triggering of the device of Van Laar as taught by Santini, because the use of wireless controls is old and well-known in the art. The use of wireless control allows the patient greater convenience for control, would allow the caregiver to operate the device remotely and it also allows other types of information to be conveyed such as patient’s vital signs ([0125]).
Response to Arguments
Applicant’s arguments and amendments with respect to art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Van Laar and O’dea as shown above.
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 BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
Prosecution Insights