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 .
Status of the Application
The amendment and remarks of 3 September are entered.
Claim 1 has been canceled. Claims 2-23 are pending. Claims 2-12 and 14 are withdrawn as being directed to claims non-elected by original presentation. Claims 13 and 15-23 are being examined on the merits.
The objection to claims 14, 22, and 23 is withdrawn in light of the amendment filed 3 September.
The rejection of claims 4-9, 12, 14, 15, 21, and 22 under 35 U.S.C. 112(b) is withdrawn in light of the amendment filed 3 September 2025.
The rejection of claims 1-23 under 35 U.S.C. 101 is withdrawn in light of the amendment filed 3 September 2025.
The rejection of claims 1-12 under 35 U.S.C. 102(a)(1) as being anticipated by UniProt is withdrawn in light of the amendment filed 3 September 2025.
The remaining rejections under 35 U.S.C. 102(a)(1) and 103 are maintained, with the Examiner’s response to Applicants’ arguments found below.
Election/Restrictions
Newly submitted claims 1-12 and 14 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the original claims were all directed to a peptidylglycine alpha-amidated monooxygenase (PAM) expressing intended uses or pharmaceutical formulations therefore. Newly amended claims 1-12 and 14 are now directed to methods of treatment that would have been restricted from the pharmaceutical formulation claims if presented in the previous amendment prior to the start of examination.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 1-12 and 14 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
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.
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.
Claims 13, 15-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gilligan et al. (EP0308067A2, published 26 July 1986, hereafter referred to as ‘067).
The specification defines a pharmaceutical formulation as one that “is in such a form as to permit the biological activity of an active ingredient contained therein to be effective, and which contains no additional components which are unacceptably toxic to a subject to which the formulation would be administered”. ‘067 discloses a purified enzyme composition containing a peptidylglycine alpha-amidating monooxygenase (see e.g. claim 2). The PAM is claimed as capable of catalyzing conversion of a C-terminal glycine residue in a peptide to a C-terminal amino group, i.e. it permits biological activities (see e.g. claim 2). The PAM is described as being purified into 50 mM Tris pH 8.0 and salt of 190 mM and 200 mM NaCl (see e.g. Example 1). This anticipates a pharmaceutical formulation comprising a PAM as in claim 13.
With respect to claim 15, the PAM is in solution.
With respect to claim 16, a lyophilized PAM is also disclosed (see e.g. p.16. lines 14-15).
With respect to claims 17-20, each of these claims utilize a form of claim language of “wherein said pharmaceutical formulation is to be administered…” Per MPEP 2111.04, a “wherein”-type clause that merely expresses an intended result of a process step positively recited is not given weight. Therefore, ‘067 anticipates each claim since the claims express an intended result.
With respect to claim 21, Tris and NaCl are pharmaceutically acceptable ingredients.
Response to Arguments:
The Applicants argue ‘067 discloses purified PAM for production of amidated peptides and that the administration of amidated peptides was a therapy. The Applicants argue the instant claims require direct administration in vivo and not amidated peptides. The Applicants argue ‘067 does not disclose the claims.
The Examiner agrees that ‘067 purifies PAM and uses that composition to produce amidated peptides for therapy. However, nothing in the examined claims requires that the PAM be administered, only that a PAM formulation be produced. As discussed above, the claims drawn to methods of administering the PAM formulation are all withdrawn as being directed to inventions non-elected by original presentation. Accordingly, the arguments concerning administration are not relevant to the instant claims that are drawn to a pharmaceutical formulation comprising a PAM.
The Applicants’ arguments have been considered but are not persuasive.
The rejection is modified and maintained.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Gilligan et al. (EP0308067A2, published 26 July 1986) as applied to claim 13 above, and further in view of Mains et al. (J. Biol. Chem. 261:11938-11941, published 1986, hereafter referred to as Mains).
The relevance of ‘067 is set forth above. The difference between ‘067 and the claimed invention is that ‘067 does not discuss addition of ascorbate and/or copper.
The Mains art discusses that PAM is dependent on the presence of copper and ascorbate for enzymatic activity (see e.g. Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘067 by including ascorbate and copper as indicated by Main as necessary for enzymatic activity of PAM. The rationale comes from the Main disclosure that enzymatic activity of PAM relies upon these two elements such that one of ordinary skill in the art would include both to ensure amidation of a target peptide. There would have been a reasonable expectation of success because the art established the necessity of both elements to enzymatic activity and addition of both would be within the level of ordinary skill in the art. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments:
The Applicants reiterate the arguments concerning ‘067 as found above with reference to the rejection under 35 U.S.C. 102(a)(1).
The Examiner has addressed those arguments and not found them persuasive as concerning a pharmaceutical formulation claim.
The Applicants argue Mains discloses administration of a copper chelator to rats and show that a certain peptide in the pituitary gland is no longer amidated. The Applicants argue PAM is not administered. The Applicants argue in combination the ‘067 and Mains art fail to render claims 22 and 23 obvious.
As note above, the claims do not actually require administration since they are merely drawn to a pharmaceutical formulation. The Mains art provides an incentive for one of ordinary skill in the art to include copper because the PAM no longer amidates a target peptide when copper is removed via the chelation of Mains. Furthermore Mains directly states that PAM “…is a copper- and ascorbate-dependent enzyme…” which provides a rationale for one of ordinary skill to include copper and ascorbate in any PAM formulation to ensure enzyme activity.
The Applicants’ arguments have been considered but are not persuasive. The rejection is maintained.
Conclusion
No claims are allowed.
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 ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Z.J.M/Patent Examiner, Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658