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 .
DETAILED ACTION
Claims 1-15 are pending in the application. Claims 1, 2, 4-7 and 14 are rejected. Claim 9 is objected to. Claims 3, 8, 10-13 and 15 are withdrawn from further consideration.
Election/Restrictions
Applicant's election with traverse of the species of claim 4 where M is Zn to prosecute the invention of Group I, claims 1-9 and 14, in the reply filed on December 1st, 2025 is acknowledged. The traversal is on the ground(s) that the election is “subject to the Rejoinder provisions of MPEP 821.04.” This is not found persuasive because it does not address the basis for restriction; however, the Examiner acknowledges withdrawn claims will be considered for rejoinder subject to the noted MPEP section.
The requirement is still deemed proper and is therefore made FINAL.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species appears allowable. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the scope of claim 9, which is free of the prior art, and further extended to include the species cited below under 35 USC 102 and the species of a 1:1 zinc caprylhydroxamic complex, which scope is not allowable.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 1, 2, 4, 5, 6, 7, 9 and 14 embrace the elected species and are therefore under examination. Claims 1, 2, 4, 5, 6, 7, 9 and 14 have been examined to the extent that they are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 3, 8, 10-13 and 15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected species or invention.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on June 28th, 2023.
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) 1, 2, 5, 6 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hope et al. ECS Trans, 2010, 28, 15-25.
Hope et al. teach the preparation of copper n-octanohydroxamate (Figure 4, page 20) and that it is (page 19) “a copper (II) compound with a 1:1 copper:hydroxamate stoichiometry…”. The prior art therefore anticipates instant claims 1, 2 (of about 1:1), 5 and 6. Regarding instant claim 14, MPEP 2111.02 notes: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In this situation, the claim only requires the presence of the complex itself, which is taught by the prior art, and the limitation of “personal care” is considered an intended use.
Claim(s) 1, 2, 4, 5, 6 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 108663-65-6, which entered STN on June 13th, 1987.
CAS Registry No. 108663-65-6 is drawn to N-hydroxy-octanamide copper complex having the following structure:
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The compound is embraced by formula (2) of claim 4 where M is copper and is further embraced by instant claims 1, 2 (ratio of 2:1), 5 and 6. Regarding instant claim 14, MPEP 2111.02 notes: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In this situation, the claim only requires the presence of the complec itself, which is taught by the prior art, and the limitation of “personal care” is considered an intended use.
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.
Claim(s) 1, 2, 5, 6, 7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 01/62296 A2 by Jeng et al.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Jeng et al. teach (title) “non-aqueous injectable formulations for extended release of somatotropin”. Jeng et al. further teach that the somatotropin may be in the form of a zinc salt as follows on page 7:
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As additional components, the prior art teaches the presence of bioavailability-enhancing constituents (page 14, lines 6-9) and further teach the following examples on page 14 (lines 23-27):
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Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art teaches compositions comprising zinc and suggests embodiments where caprylhydroxamic acid can additionally be present but does not explicitly teach a complex thereof.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
At least since the prior art teaches that the compositions preferably contain zinc and that caprylhydroxamic acid is one exemplary bioavailability-enhancing constituent, a person having ordinary skill in the art in seeking to optimize the prior art compositions and determine optimum components would have been motivated to prepare compositions containing both zinc and caprylhydroxamic acid. Furthermore, at least since the prior art teaches that caprylhydroxamic acid binds zinc, a person having ordinary skill in the art would expect that caprylhydroxamic acid would either bind zinc in the injectable composition itself or be a natural consequence of injecting caprylhydroxamic acid to a biological entity that also contains zinc. Accordingly, a person having ordinary skill in the art would have reasonably expected caprylhydroxamic acid to bind zinc and result in a complex embraced by instant claims 1, 5, 6 and 7. Regarding the limitation of claim 2, a person having ordinary skill in the art would expect that at least one molecule of caprylhydroxamic acid would complex first and meet the limitation of a 1:1 ratio. Regarding instant claim 14, MPEP 2111.02 notes: “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”. In this situation, the claim only requires the presence of the complex itself, which is suggested by the prior art, and the limitation of “personal care” is considered an intended use.
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626