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.
Election/Restrictions
Applicant’s election without traverse of group II in the reply filed on 26 January 2026 is acknowledged.
Response to Amendment
This Office action is responsive to the amendment filed 26 January 2026. Claims 1, 3-9, 15, 17 and 21-31 are pending. Claims 1, 3-9 and 15-17 are withdrawn. Claims 21-31 are examined.
Claim Objections
Claim 26 objected to because of the following informalities: It appears claim 26 should depend from claim 27 as the housing is not mentioned in claim 21 and in claim 27 a housing is first recited as well as a naloxone medication reservoir. Else, “the housing further defines” should be “a housing defines.” Appropriate correction is required.
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.
Claims 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Hillis (US 2007/0088334) and Thayumanavan (US 2011/0200675).
Regarding claims 21, 24, 28 and 29, Hillis teaches a method of intranasal delivery to an individual (Fig. 1 and 2, Fig. 56), the method comprising applying an intranasal clip to the nose of the individual (¶153).
Hillis teaches a delivery of a drug via the intranasal clip (¶118). Further, Hillis teaches the drug can be encapsulated in a hydrogel (¶118, In FIG. 37A, deliverable material 1024 is stored in carrier material 1026. Carrier material 1026 may be, for example, a polymeric material such as a hydrogel, and deliverable material is dispersed or dissolved within carrier material 1026.). In addition, Hillis teaches the delivery device is positioned adjacent to the intranasal mucosa to deliver a material to the mucosa (¶131, Controllable release nasal device may be
positioned on nasal septum 40, with delivery portion 1306 located against the nasal mucosa 32).
Hillis doesn’t teach the intranasal clip is configured to release a dosage of naloxone, the hydrogel encapsulates naloxone, the intranasal clip comprises a hydrogel configured to release naloxone and the hydrogel is configured to release naloxone to the intranasal mucosa.
Thayumanavan teaches delivery of Naloxone to block the effects of Opioids (¶5). In ¶100, it is taught the drug can be intranasally. In ¶38, the drug delivery vehicle for the opioid antagonist is a hydrogel. In ¶41, it is taught the opioid antagonist is naloxone.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the intranasal clip of Hillis be configured to release a dosage of naloxone, the hydrogel encapsulates naloxone, the intranasal clip comprises a hydrogel configured to release naloxone and the hydrogel is configured to release naloxone to the intranasal mucosa, as taught by Thayumanavan, in order to allow the naloxone to be delivered intranasally as taught by Thayumanavan.
Regarding claims 26 and 27, Hillis in view of Thayumanavan teaches the invention as discussed above and Hillis further teaches a housing comprising a naloxone medication reservoir and the housing further defines a second internal medication chamber for containing naloxone. (¶116, two reservoirs 804, are used to store the drug. As modified, the intranasal clip of Hillis is delivering naloxone).
Regarding claims 30, Hillis in view of Thayumanavan teaches the invention as discussed above and Hillis further teaches the applying the intranasal clip to the nose is performed by the individual (¶153, In some cases, the device may be mounted manually, by the subject, or by someone acting on behalf of the subject, for example a medical care provider.).
Regarding claims 22, 23 and 25, Hillis in view of Thayumanavan teaches the invention as discussed above and Hillis further teaches the use of a biosensor to affect drug delivery. In particular, a biosensor to detect a gas composition (¶133, a biosensor may detect a gas).
Hillis in view of Thayumanavan, as discussed so far, doesn’t teach the hydrogel is a hydrogel biosensor configured to release naloxone in response to opioid overdose-associated respiratory distress and the hydrogel biosensor is responsive to increasing CO2 concentrations exhibited during opioid overdose-associated respiratory distress and the method a prophylactic technique.
Thayumanavan teaches the drug delivery vehicle comprises an opioid and a hydrogel, wherein the release of the opioid is CO2-responsive. In this case, the CO2-responsive
release of the opioid means that the hydrogel ceases or decreases release of the opioid in response to an increase in partial pressure of CO2 in the environment of the hydrogel (¶39). The systems release an antidote to opioid overdose ( e.g., an opioid antagonist such as naloxone, naltrexone, nalmefene, or nalorphine) in response to elevated levels of CO2 in blood plasma. Thus, patients receiving an accidental opioid overdose would automatically have an opioid overdose antidote released into the bloodstream so that the dangerous effects of the overdose would be reversed without further human intervention (¶41). In particular, as illustrated schematically in FIG. 1, an increase in the partial pressure of CO2 (e.g., under a condition
of opioid overdose, or hypoventilation) results in an increase in the release of the opioid antagonist from the first hydrogel (¶42). The release of the opioid antagonist in response to CO2 can prevent overdose with an opioid is administered in a battlefield or trauma situation (¶41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the intranasal clip of Hillis in view of Thayumanavan have a hydrogel biosensor configured to release naloxone in response to opioid overdose-associated respiratory distress and the hydrogel biosensor is responsive to increasing CO2 concentrations exhibited during opioid overdose-associated respiratory distress and the method of using the intranasal clip being prophylactic, as taught by Thayumanavan, in order to prevent accidental overdose in a trauma situation.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Hillis in view of Thayumanavan as applied to claim 21 above, and further in view of MacDonald (US 2018/0228969).
Regarding claim 31, Hillis in view of Thayumanavan teaches the invention of claim 21 as discussed above. Hillis in view of Thayumanavan doesn’t teach the applying the intranasal clip to the nose of the individual is performed prior to use of an opioid.
MacDonald teaches a wearable device that injects an opioid antagonist in response to detecting a drug overdose (Abstract, Fig. 2). The device is implantable and implanted prior to taking an opioid. It monitors breathing rate and automatically can inject an overdose reversal agent to prevent an accidental overdose(¶7-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to operate the intranasal clip of Hillis in view of Thayumanavan such that the intranasal clip is applied to the nose of the individual prior to use of an opioid, as taught by MacDonald, in order to automatically prevent an accidental overdose.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID OLYNICK whose telephone number is (571)272-2355. The examiner can normally be reached M-F: 7:30 am-5 pm (ET).
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, Phuttiwat Wongwian can be reached at (571) 270-5426. 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.
/DAVID P. OLYNICK/Primary Examiner, Art Unit 3741