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 .
Acknowledgment of Papers Received: Amendment/Response dated 6/1/26.
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.
Claim(s) 1-5, 10-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Flather et al (US 2020/0121859 A1 hereafter Flather) in view of Keegan et al (US 2017/0071851 A1 hereafter Keegen).
Flather discloses a parenteral formulation comprising a therapeutically effective amount of naloxone and a parenterally acceptable adjuvant where the parenteral administration is intramuscular or subcutaneous injection [0017, 0076-0078, 0159, 0143], meeting limitation of claims 1-4. The adjuvant is present in an amount of about 0.82% [0087], meeting limitations of claims 1, 5, 13 and 15. The naloxone comprises naloxone hydrochloride [0073, 0132], meeting the limitations of 10. A kit comprising a therapeutically effective amount of naloxone and an absorption enhancing amount of an adjuvant are in solution form and stored in containers [0075, 0116-0118], meeting limitations of claims 13. The along with an injection device that is an auto injector [Figures 1, 2, 0132], the kit comprises naloxone hydrochloride [0073], meeting the limitations of claims 16 and 17. The auto-injector, comprising a syringe and needle, is pre-filled with the drug solution [Figure 3A, 268], meeting the limitations of claim 18 and 19.
As discussed above, Flather discloses a kit comprising a solution formulation comprising naloxone hydrochloride and an adjuvant that enhances the absorption of the naloxone in an auto- needle. The reference discloses the formulation provides a mean time plasma maximum plasma concentration in under 30 minutes, specifically about 18 minutes [Fig. 11-12]. The onset of the antagonist can be achieved in about 10 seconds [0111-0112]. The reference while disclosing the combination of naloxone hydrochloride and absorption enhancer, the reference does not disclose the same adjuvant of the instant claims. The use of magnesium chloride in naloxone formulation is known in the art as seen in the Keegan patent.
Keegan discloses an intramuscular injection formulation comprising naloxone hydrochloride and adjuvants [abstract, 0071]. Adjuvants include magnesium chloride as a tonicity agent [0060]. The tonicity agents are present up to 1.6-8.6 % [0113-0116]. A kit comprising a syringe for injection [04791]. The Tmax is achieved in less than 18.5 minutes with an onset of less than 20 second [00262, 0343-0345]. It would have been obvious to include the magnesium chloride of Keegan into the formulation of Flather as they solve the same problem.
With these aspects in mind, it would have been obvious to combine the prior art to achieve a stable intramuscular formulation useful in treating opioid overdoses. It would have been obvious to include the adjuvant of Keegan into the similar formulation of Flatcher as they solve the same problem with quick onset and fast relief. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a fast-acting overdose treatment.
Claim(s) 13, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Flather et al (US 2020/0121859 A1 hereafter Flather) in view of Keegan et al (US 2017/0071851 A1 hereafter Keegen) as applied above, in further view of Holroyd et al (US 2021/0023301 A1 hereafter Holroyd).
As discussed above, the combination of Flather and Keegan provides a kit comprising an effective amount of naloxone and an absorption enhancing adjuvant of magnesium chloride in an amount from 1.6-8.6%, where the kit has an onset less than 20 seconds. The kit comprises an auto-injector with a needle yet is silent to the size of the needle.
While the combination discloses the use of an auto-injector needle for the intramuscular injection of naloxone, the combination does not disclose the gauge size of the needle. The use of a specific needle size is known in the art as seen in the Holroyd patent.
Holroyd discloses an automatic injector comprising a case and needle that can be quickly deployed to the skin for subcutaneous injection [abstract]. The needle can comprise an opioid antagonist compounds like naloxone [0081]. The needle has a 19-25 G needle [0115]. It would have been obvious to use the automatic injector of Holroyd into the kit of Flather as they both disclose automatic needles for the delivery of opioid antagonist.
With these aspects in mind, it would have been obvious to combine the prior art in order to provide a kit for treating an opioid overdose. It would have been obvious to include ethe needle of Holroyd into the autoinjector kit of Fletch and Keengan as they solved the same problem of subcutaneous delivery of naloxone hydrochloride to treat an overdose. One of ordinary skill int heart would have been motivated to combine the prior art with an expected result of a stable kit useful in treating opioid overdoses quickly.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5 and 10-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. However, Flather continues to render the claims obvious when combined with supporting references. Flather discloses the same compound, combined with an adjuvant in the same concentration as the instant claims. The newly applied support reference of Keegan discloses the same adjuvant applied to a similar formulation for the same purpose in a similar concentration. It would have been an obvious substitution and optimization of ranges by those of ordinary skill in the art. The claims continue to be rendered obvious.
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 MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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