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 .
According to paper filed on Nov. 19, 2025, the applicants have elected group IV, claims 41-44 and 50-54.
Claims 1, 6, 14, 25, 29, 34-36, 38-39, 41-44 and 50-54 are pending in the application. Claims 1, 6, 14, 25, 29, 34-36 and 38-39 are withdrawn from further consideration as being drawn to non-elected inventions.
Response to Arguments
Applicant's arguments filed on Nov. 19, 2025 regarding restriction requirement have been fully considered but they are not persuasive. The examiner does not agree with the applicant’s arguments that all groups have a common core and therefore, have unity. As stated clearly in the restriction requirement, groups I through IV relate to unrelated inventions, do not share a common core and therefore, do lack unity. Therefore, restriction requirement is proper and thereby made final.
Claim Rejections - 35 USC § 102
(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 50 is rejected under 35 U.S.C. 102(a) (1) as being anticipated by McCarthy (WO 2016/005923 A1, cited on applicant’s form 1449).
McCarthy discloses reduction of alpha, beta-unsaturated ketone levels in morphinan derivative compositions. Pure noroxymorphone disclosed on pages 133-134 by McCarthy anticipates the instant claim. It is of note that the instant claim is product by process claim. Therefore, the process is irrelevant
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.
7. 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.
8. Claims 41, 42, 44 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Buehler (US 2018/0008596 A1, cited on applicant’s form 1449).
Buehler discloses a process for preparing morphinan-6one products with low levels of impurity. The process of preparing pure noroxymorphone (see scheme 5 on page 5) via formation of bisulfite adduct using sulfurous acid (see scheme 12 A and 12 B on page 10, lines 6-18 in left column on page 10 as well as examples 2A and 2B on page 16) meets all the limitations of instant claims except that the instant process mentions colored impurities instead of alpha, beta unsaturated ketones as impurity. However, the instant specification does not define colored impurities. Since all the steps in the instant process and the cited reference are identical, it would have been obvious to one skilled in the art to remove colored impurities also in order to prepare pure noroxymorphone with reasonable expectations of success. Regarding claim 50, an improved colorimetric profile will be inherently present in the pure noroxymorphone.
9. Claims 41, 43 and 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over McCarthy (WO 2016/ 005923 A1, cited on applicant’s form 1449) in view of Buehler (US 2018/0008596 A1, cited on applicant’s form 1449).
McCarthy discloses preparing noroxymorphone from oxymorphone by demethylation and further teaches preparing naloxone and naltrexone form noroxymorphone (see schemes 1 and 2 on page 2). McCarthy meets all the limitations of instant claims except that it does not teach preparing pure noroxymorphone. However, Buehler discloses a process for preparing morphinan-6one products with low levels of impurity. The process of preparing pure noroxymorphone (see scheme 5 on page 5) via formation of bisulfite adduct using sulfurous acid (see scheme 12 A and 12 B on page 10, lines 6-18 in left column on page 10 as well as examples 2A and 2B on page 16) meets all the limitations of instant claims except that the instant process mentions colored impurities instead of alpha, beta unsaturated ketones as impurity. However, the instant specification does not define colored impurities. Since all the steps in the instant process and the cited reference are identical, it would have been obvious to one skilled in the art to remove colored impurities also in order to prepare pure noroxymorphone and then use it to prepare naloxone and naltrexone with reasonable expectations of success.
10. Claims 41 and 51-54 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell (WO 2017/ 207519 A1) in view of Buehler (US 2018/0008596 A1, cited on applicant’s form 1449).
Mitchell discloses preparing naloxone, naltrexone, nalmefene and nalbuphine from noroxymorphone (see examples 29-31 on pages 48-50 and claim 15, last line). Mitchell meets all the limitations of instant claims except that it does not teach preparing pure noroxymorphone. However, Buehler discloses a process for preparing morphinan-6one products with low levels of impurity. The process of preparing pure noroxymorphone (see scheme 5 on page 5) via formation of bisulfite adduct using sulfurous acid (see scheme 12 A and 12 B on page 10, lines 6-18 in left column on page 10 as well as examples 2A and 2B on page 16) meets all the limitations of instant claims except that the instant process mentions colored impurities instead of alpha, beta unsaturated ketones as impurity. However, the instant specification does not define colored impurities. Since all the steps in the instant process and the cited reference are identical, it would have been obvious to one skilled in the art to remove colored impurities also in order to prepare pure noroxymorphone and then use it to prepare naloxone, naltrexone, nalmefene and nalbuphine with reasonable expectations of success.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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