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.
Election/Restrictions
Claims 18-20, 22, 23, 25, 28-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 January 2026.
Applicant’s election without traverse of Group I (claims 1, 2, 4-7, 11, 13, 16) in the reply filed on 29 January 2026 is acknowledged.
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.
Claim 16 is 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 16 recites “the device is less than about 1 cm.” The metes and bounds of the limitation cannot be determined because the length is not defined in terms of height, width, length, etc.
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, and 16 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 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.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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, Brian-Yong Kwon can be reached at (571)272-0581. 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.
/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
Prosecution Insights