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 .
Claims 1-3 are pending after amendment.
Applicant’s amendments (and arguments thereto) have overcome the rejections of record, but necessitated new rejections, that may be overcome by amendment(s).
Claim Rejections - 35 USC § 102-Modified, Necessitated by Amendment
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gautvik et al. (U.S. Patent No.5,420,242).
After amendment, the claims are now drawn to requiring at least an integer of 2 amino acids of Formula I, where when such is ‘an’ amino acid sequence of two amino acids therein (e.g. Glu-Ala could be repeated twice). The claim(s) recite(s) a peptide consisting of ‘an’ amino acid sequence of the tripeptide Formula I, which according to the definition in specification paragraph [0030] may be a peptide consisting of two or more amino acids. Such is found in the prior art (naturally occurring) per Gautvik et al. (U.S. Patent 5,420,242) at col. 8, line 54, teaching “Glu Ala Glu Ala” as the naturally occurring “recognition sequence of the yeast STE13 aminopeptidease”.
PNG
media_image1.png
71
260
media_image1.png
Greyscale
NOTE: The rejection may be overcome by replacing the term “an” with --the--in claim 1, line 1 and also incorporating claim 2, which is rejected as depending therefrom, into claim 1, forming the intended protected amino acid sequence options (for administration).
Claim Rejections - 35 USC § 103-Modified, Necessitated by Amendment
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) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gautvik et al. (U.S. Patent No.5,420,242).
After amendment, the claims are now drawn to requiring at least an integer of 2 amino acids of Formula I, where when such is ‘an’ amino acid sequence of two amino acids therein (e.g. Glu-Ala could be repeated twice). The claim(s) recite(s) a peptide consisting of ‘an’ amino acid sequence of the tripeptide Formula I, which according to the definition in specification paragraph [0030] may be a peptide consisting of two or more amino acids. Such is found in the prior art (naturally occurring) per Gautvik et al. (U.S. Patent 5,420,242) at col. 8, line 54, teaching “Glu Ala Glu Ala” as the naturally occurring “recognition sequence of the yeast STE13 aminopeptidease”.
PNG
media_image1.png
71
260
media_image1.png
Greyscale
Gautvik et al. does not expressly teach adding a protecting group to the above said peptide to e.g. N or C-terminus. However, protecting group addition to the N or C-terminus of peptides is art-recognized, standard practice and the addition thereof would have been merely a matter of routine optimization to the skilled artisan when putting the peptide above in protected state prior to active use. Thus, claims 1-2 are deemed prima facie obvious, based on Gautvik et al. in view of the state of the art (MPEP 2144.03).
NOTE: The rejection may be overcome by replacing the term “an” with --the--in claim 1, line 1 and also incorporating claim 2, which is rejected as depending therefrom, into claim 1, forming the intended protected amino acid sequence options (for administration).
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description – Modified,
Necessitated by Amendment
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In this case, while applicant has amended the claims to treating rheumatoid arthritis; however, based on the definition of peptide (scope) being as small as two amino acids, in duplicate (e.g. Glu-Ala-Glu-Ala, per Gautvik et al., U.S. Patent No. 5,420,242), such was not in possession at the time of filing as being able to treat rheumatoid arthritis; as opposed to e.g. Lys-Glu-Ala (tripeptide).
NOTE: The rejection may be overcome by replacing the term “an” with --the--in claim 1, line 1 and also incorporating claim 2, which is rejected as depending therefrom, into claim 1, forming the intended protected amino acid sequence options (for administration).
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111; clearly states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry,whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Therefore, the full breadth of the claims are not presently deemed to have been in Applicant’s ‘possession’ and found to meet the written description provision of 35 U.S.C. §112.
Claim Rejections - 35 USC § 101 – Necessitated by Amendment
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. After amendment, the claims are now drawn to requiring at least an integer of 2 amino acids of Formula I, where when such is ‘an’ amino acid sequence of two amino acids therein (e.g. Glu-Ala could be repeated twice). The claim(s) recite(s) a peptide consisting of ‘an’ amino acid sequence of the tripeptide Formula I, which according to the definition in specification paragraph [0030] may be a peptide consisting of two or more amino acids. Such is found in the prior art (naturally occurring) per Gautvik et al. (U.S. Patent 5,420,242) at col. 8, line 54, teaching “Glu Ala Glu Ala” as the naturally occurring “recognition sequence of the yeast STE13 aminopeptidease”.
PNG
media_image1.png
71
260
media_image1.png
Greyscale
This judicial exception is not integrated into a practical application. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no further modifications are claimed therein.
NOTE: The rejection may be overcome by replacing the term “an” with --the--in claim 1, line 1 and also incorporating claim 2, which is rejected as depending therefrom, into claim 1, forming the intended protected amino acid sequence.
Election/Restrictions – Withdrawn
Claims 1 and 6 (Group I, originally withdrawn but rejoined by examiner) are directed to an allowable product. All claims including elected Group II, claim 7, directed to the process of making or using an allowable product, are hereby allowed.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 1/6/22 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Conclusion
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 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
Prosecution Insights