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 .
Priority
The instant application was filed 13 September 2023 and is the national stage entry of PCT/US22/20932 filed 18 March 2022. The Applicant claims priority to provisional application 63/163,094 filed 19 March 2021. The effective filing date of the instant application is 19 March 2021.
Examiner’s Note
The Applicant's amendments and arguments filed 29 July 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 29 July 2026, it is noted that claims 1, 2, 3-6, 11, 16 have been amended, no claims have been canceled, and claims 42-47 have been newly added. Support for the amendment(s) and/or new claim(s) can be found in at least paras. 28, 55 of the specification. No new matter has been added. It is noted that although not indicated in the most recently filed claim set, claim 23 remains withdrawn.
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.
Claim(s) 1, 2, 4-7, 11, 13, 16, 43, 44, and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selaru et al. (US 2014/0249499 A1).
Selaru teaches a delivery device using microtools to deliver a drug or therapeutic agent to tissues (abs; entire teaching). The device comprises a plurality of sharp or tapered tips (para. 5) and the device is self-actuating (title). The active agent may be in a polymeric matrix and incorporated in a reservoir (para. 53) or patch (para. 46, Fig. 7), where it is interpreted that the agents and stimuli-responsive polymers, such as acrylamide-based polymers (para. 53), may be in the tip portion in some embodiments (para. 46), addressing claims 1, 2, 4-7. The tapered tip is interpreted as sloped or beveled, and the system may have a size ranging from 10 microns to about 1 mm, where it is interpreted that the tip size may therefore be in the range of 1 micron to 10 mm, addressing claims 11 and 16. A preventative or protective coating may be used (para. 56), addressing claim 13.
Regarding Applicant’s amendment to claim 1, Selaru teaches a plurality of sharp or tapered tips (para. 5). The delivery device includes a stress layer (para. 28) and a control/trigger layer, providing a trigger mechanism in response to heat or environmental stimuli (para. 29). Selaru describes the delivery site for the drug device as epithelium-lined organs or vessels (para. 69) and implies that the device is designed for delivery into the mucosa due to stiffer polymers or highly crosslinked hydrogels used (para. 34). Selaru also teaches the theragrippers opening and closing in opposite directions upon exposure to a thermal stimulus (para. 60), which is interpreted as addressing the limitation regarding the different directions. The delivery device includes multiple layers configured to allow for the structural configuration of the device to change from a first configuration to a second configuration in response to a stimulus (para. 30).
Regarding new claim 43, the claim is interpreted as a product-by-process limitation and is describing the action of the actuation instead of the final product. Additionally, the control layer of the device is described as storing torsional energy upon being constructed (para. 28). "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding new claim 44, the delivery device includes a stress layer (para. 28) and a control/trigger layer, providing a trigger mechanism in response to heat or environmental stimuli (para. 29). Selaru describes the delivery site for the drug device as epithelium-lined organs or vessels (para. 69) and implies that the device is designed for delivery into the mucosa due to stiffer polymers or highly crosslinked hydrogels used (para. 34). Additionally, the control layer of the device is described as storing torsional energy upon being constructed (para. 28). Futhermore, the limitation of “configured to move with a force sufficient to drive the active-agent-containing tips through the mucosal epithelium” is interpreted as a product-by-process limitation and is given minimal patentable weight. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding new claim 47, the change in environmental stimuli include changes in temperature (heat) and pH (paras. 60 and 70).
It would have been prima facie obvious to a person of ordinary skill in the art to arrive at the claimed invention with a reasonable expectation of success. In regards to selecting the combination of an autonomous actuator, a microinjector connected to the autonomous actuator, and an active agent, as recited in claim 1, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Selaru teaches a self-actuating delivery device using microtools to deliver a drug or therapeutic agent to tissues comprising sharp or tapered tips, whereas the claimed invention is for a microinjection device comprising an autonomous actuator, one or more microinjectors connected to the autonomous actuator, and an active agent. Since Selaru teaches the individual components of the claimed invention, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Claim(s) 1, 2, 4-7, 11, 13, 16, 42-45, and 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selaru et al. (US 2014/0249499 A1) and Ghosh et al. (Gastrointestinal-resident, shape-changing microdevices extend drug release in vivo, Sci. Ad., 2020; cited in IDS).
In regards to claim(s) 1, 2, 4-7, 11, 13, 16, 43, 44, and 47, Selaru, as applied supra, is herein applied in its entirety for its teachings of microinjector drug delivery device.
Selaru does not specifically teach using gold and chromium in a layered arrangement in claims 42 and 45.
Ghosh teaches that incorporating gold and chromium into the theragrippers allows controlled release of active agents (pg. 2).
Since Selaru does not specifically teach using gold and chromium in a layered arrangement in claims 42 and 45, one of ordinary skill in the art would have been motivated to use Ghosh’s teaching of incorporating gold and chromium into the theragrippers for more control over the release of drugs. Since Selaru teaches layers to allow for the structural configuration of the device to change from a first configuration to a second configuration in response to a stimulus (Selaru, para. 30), it is obvious to a skilled artisan to incorporate gold and/or chromium in the different layers. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Claim(s) 1, 2, 4-7, 11, 13, 16, 42-47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Selaru et al. (US 2014/0249499 A1), Ghosh et al. (Gastrointestinal-resident, shape-changing microdevices extend drug release in vivo, Sci. Ad., 2020), and Breger et al. (Self-Folding Thermo-Magnetically Responsive Soft Microgrippers, ACS Appl. Mater. Interfaces, 2015).
In regards to claim(s) 1, 2, 4-7, 11, 13, 16, 42-45, and 47, Selaru et al., as applied supra, is herein applied in its entirety for its teachings of microinjector drug delivery device.
Selaru does not specifically teach iron oxide in the microinjector layers in claim 46.
Breger teaches incorporating iron oxide into the layers of microgrippers leads to better responsiveness using magnetic fields (abs).
Since Selaru does not specifically teach iron oxide in the microinjector layers in claim 46, one of ordinary skill in the art would have been motivated to use Breger’s teaching of incorporating iron oxide into microgrippers for better responsiveness. Since Selaru teaches layers to allow for the structural configuration of the device to change from a first configuration to a second configuration in response to a stimulus (Selaru, para. 30), as well as responsiveness to a stimulus, such as an electromagnetic field (Selaru, para. 29), it is obvious to a skilled artisan to incorporate iron oxide in the device to improve the responsiveness. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Response to Arguments
Applicant's arguments filed 29 July 2026 have been fully considered but they are not persuasive.
The Applicant argues that the cited teachings do not address the amended limitations in claim 1 (Remarks, pgs. 7-8).
Applicant’s argument is not found persuasive. Regarding Applicant’s amendment to claim 1, Selaru teaches a plurality of sharp or tapered tips (para. 5). The delivery device includes a stress layer (para. 28) and a control/trigger layer, providing a trigger mechanism in response to heat or environmental stimuli (para. 29). Selaru describes the delivery site for the drug device as epithelium-lined organs or vessels (para. 69) and implies that the device is designed for delivery into the mucosa due to stiffer polymers or highly crosslinked hydrogels used (para. 34). Selaru also teaches the theragrippers opening and closing in opposite directions upon exposure to a thermal stimulus (para. 60), which is interpreted as addressing the limitation regarding the different directions. The delivery device includes multiple layers configured to allow for the structural configuration of the device to change from a first configuration to a second configuration in response to a stimulus (para. 30).
The Applicant argues against the KSR rationale (Remarks, pgs. 8-9).
Applicant’s argument is not found persuasive. The Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft.
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.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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