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 .
Applicant’s response (amendments, arguments) filed with the RCE are acknowledged.
Claims 17-30 (28-30 new) are pending and examined on the merits.
Any claim rejections no longer of record have been overcome by amendment and/or arguments thereto.
Applicant’s amendments have been fully weighed but there remains certain critical/essential elements relevant to the monitoring of progress claimed that appear missing (namely, optional[ly] claimed limitations that cannot be determined as required or not; intended claim scope indefinite).
The examiner remains open to interview to advance prosecution on the merits.
Backdrop: originally filed claims 1-16 were cancelled without prejudice - the subject matter class directed to a method of making rather than a system). Previous original claims 1-13 were indicated as mirroring the subject matter of claims 35-41 that were searched, examined and found lacking inventive step by the International Authority in the related PCT Search Report & Written Opinion thereof. The latter findings had been equally found here and the prior art and equivalent (obviousness) disposition applied here in the U.S. National Stage.
Claim Rejections - 35 USC § 112(b) – Indefiniteness, Modified, Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 17-30 remain rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17, after amendment to address the previous 112(b) rejection below, has been amended to include “optional[ly]” limitations that render the claim indefinite as not being required even when the activated ester has not been added or is added in the wrong place and is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim. In order for the claim to be definite, absent further evidence, the actual invention must be positively claimed, which does not appear as such following the amendments inclusion of the “optionally” in these stanzas. Until addressed (truly optional and not required or required, a reasonable updated search of the intended claim scope cannot be carried out until addressed on the record by amendment and/or argument).
Previously the rejection stated:
The claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, elements, and/or structural cooperative relationships of elements, such omission amounting to a gap between the steps, elements, and/or necessary structural connections. See MPEP § 2172.01. The omitted steps are:
Here, para 10 defines/describes that the amino acid activated ester is critical/essential element and/or step to the structural cooperative relationship of the stepwise addition of amino acids for which the method of making claimed is asserted to be monitoring:
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However, new claim 17 makes no mention of the activated ester of the amino acid (as a step, element and/or structural cooperative relationship between elements and/or steps) relevant to determining whether the stepwise addition of amino acids is proceeding properly OR if not, why not, in the context of the activated ester. Even if the skilled artisan might/will appreciate such, all critical/essential elements of a claim scope must be claimed in order that the metes and bounds of the intended claimed invention may be reasonably searched/examined on the merits.
Here, the method claimed still does not guide in any way – where even if an amino acid is found to have not been added – is this an activated ester binding issue or some other binding issue that may be addressed. In other words, something is missing in the way of standard methods may employ ways of determining if amino acids are added or not, but without a method that guides as to why and claim scope commensurate therewith relevant to the metes and bounds, such a method is confirming or not confirming without more. Thus, there remains missing steps, elements, and/or structural cooperation of the steps and/or elements which are necessary to provide the foundation that is the metes and bounds of any intended claim scope.
Claim Rejections - 35 USC § 103 – Obviousness; Modified as Necessitated by Amendment - New Subject Matter Class (Method of Making Now, Rather than System for Making); Disposition Held in Abeyance, Pending Resolution of the 35 USC 112(b) Rejection Above;
So That the Intended Claim Scope is Searched/Examined v. the Prior Art of Record
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 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.
Claim(s) 17-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over:
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(Claims 10-15); in view of
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(Claims 1-18, Example 1)
Claims 17-27 (method of making now; rather than system for making) are deemed to to overlap the subject matter of claims 35-41 searched, examined and found lacking inventive step by the International Authority in the related PCT Search Report & Written Opinion thereof. The latter findings have been equally found here and the prior art and equivalent (obviousness) disposition applied here in the U.S. National Stage.
Independent Claim 35 in related PCT:
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Independent Claim 1 here:
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As such, equivalently here, claims 17-27 (method of making now, rather than system for making) are found obvious over this same prior art combination absent evidence to the contrary of secondary considerations of unexpected results employing one or more critical/essential elements now present or later amended into the claims for which the evidence supports something more and not expected, which is not presently found here as by the international authority examined the same subject matter.
Prior Art Disposition Made of Record But Not Relied Upon
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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 17-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,485,402 (parent application hereto in which a provisional double patenting rejection was applied hereon). Although the claims at issue are not identical, they are not patentably distinct from each other because parent ‘402 patent is drawn to a method for coupling an amino acid to a protected N-group attached to a peptide synthesis resin comprising the steps claimed therein, the method comprising a reactor and an LCMS device, wherein the method also (under BRI) automatically samples slurry from the reactor, and cleaves the peptide from resin and deprotects the functional groups. The independent claim of the reference application includes additional limitations, including dilution of the cleaved peptide. While the claims set are not mirrors of each other, the invention claim scope here is encompassed within the BRI of parent patent ‘402, including dependent claims, and substantially overlap the invention recited by the instant claims. Therefore, the instant claims are prima facie obvious in view of the claims of the parent patent ‘402.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MAURY A AUDET/Primary Examiner, Art Unit 1654
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