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: Response dated 11/26/25.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 7, 9, 10, 13, 14, 16-19 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Flather et al (US 2020/0121859 A1 hereafter Flather).
Flather discloses a parenteral formulation comprising a therapeutically effective amount of naloxone and a parenterally acceptable adjuvant that increases the systemic absorption of the naloxone upon intramuscular or subcutaneous injection [0017, 0076-0078, 0159, 0143], meeting limitation of claims 7. The adjuvant is present in an amount of about 0.82% [0087], meeting limitations of claims 9. 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. Th 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. Theses disclosures render the claims anticipated.
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) 1-20 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 Crystal et al (US 2016/0008277 A1 hereafter Crystal) and Holroyd et al (US 2021/0023301 A1 hereafter Holroyd).
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 about 10 seconds [0111-0112]. The reference while disclosing the combination of naloxone hydrochloride and absorption enhancer, the reference does not disclose the same enhancer of the instant claims. The use of magnesium chloride in naloxone formulation is known in the art as seen in the Crystal.
Crystal discloses an immediate release naloxone injection preparation [0005]. The formulation is intramuscular and is a hydrochloride salt [0025, 0048-0050]. The formulation achieves the Tmax in less than 20 minutes [0076-0077].The formulation comprises a magnesium chloride absorption enhancer [0210]. The release of the naloxone is immediate and injected via an auto-injector [0243]. The immediate release provides a Tmax and Cmax under 20 minutes [Table 9]. Given the range of the active agent present in the formulation it would have been an obvious modification to adjust the formulation to reduce the mean maximum level through routine experimentation. It would have been obvious to include the absorption enhancer of Crystal into the similar formulation of Flather as they solve the same problem.
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 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.
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/26/25, with respect to the rejection(s) of claim(s) 1-20 under 35 USC 102 (a1,2) and 103(a) 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 in view of the above recited rejections.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618