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
Receipt of applicant’s remarks and claim amendments filed on 08/17/2026 are acknowledged.
In light of claim amendments previous 112(b) rejection is withdrawn.
However, applicants’ arguments for the previous 103 and nonstatutory double patenting rejection are found not persuasive. Accordingly, the previous rejections are maintained and modified to address claim amendments.
Response to Arguments
(i) Applicants’ argue that CRLLIF is used in TAVASSOLI to demonstrate the modification of sequences with non- natural amino acids. No reason is given as to why CRLLIF was chosen, and the skilled person would not associate any particular advantage with this peptide over any other peptide disclosed in TAVASSOLI (see TAVASSOLI page 5 lines 10-16 and Table 3). In fact, page 12 lines 10-13 state that CRVIIF (SEQ ID NO: 4) was the most potent in the initial screening, and CRVIIF is used in the majority of the Examples. Clearly, TAVASSOLI describes a large number of different peptide sequences, specifically refers to 27 different peptide sequences one of which issued in the majority of the Examples and one of which is used to demonstrate the effects of using non-natural derivatives.
The reason for citing CRLLIF in the rejection is that it is the closest species to the elected or cited SEQ ID NO:6. As explained in the rejection, applicants elected species or SEQ ID NO:6 is obvious over the CRLLIF at least based on established case laws.
The cited page 5 and Table in TAVASSOLI described various substitutions on Phe ring, and it appears that it is not relevant to the rejection.
TAVASSOLI exemplified species which are closely related to elected applicants peptide, and the rejection is based on these species.
(ii) Applicants argue that CKLIIF had the greatest affinity for both la and 2a PAS-B domains (2uM); CRLLIF had a poorer affinity (10-14uM) and CRVIIF had the worst affinity and a preference for la. Inventors also identified an issue with the lysine residue of CKLIIF that was previously unrecognized.
Rejection is not based on CKLIIF and so the arguments related to this peptide are not relevant. With regard to affinity, it depends on what kind of test is being conducted. Regardless, there is no direct comparison of claimed SEQ ID NO:6 with examiner cited CRLLIF in applicants response.
(iii) With regard to nonstatutory double patenting rejection. applicants argue that the arguments set out above regarding the absence of any direction or motivation, as well as the non-obvious nature of the specific sequence now claimed, apply with equal effect to these rejections and are thus incorporated here by reference. Accordingly, reconsideration and withdrawal of these rejections are also respectfully requested.
As explained in the rejection and provided reasoning above, applicants elected species or SEQ ID NO:6 is obvious over the CRLLIF at least based on established case laws.
Claim Rejections - 35 USC § 103
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1, 20-22, 27, 29, 34, 39 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Tavassoli (WO2017/129997A1).
Claims are examined in light of elected species.
For claim 1:
Tavassoli teaches the following cyclic peptide:
PNG
media_image1.png
188
287
media_image1.png
Greyscale
, wherein R1 is H, X is S, R2 is replacement of the LLI motif with any combination of aliphatic amino acids, e.g., valine, leucine homoleucine, isoleucine, R3 is any substituted phenyl, for example 4-Me-Phe [see Fig.4].
The above cyclic peptide reads applicants claimed compound, when in the applicants compound, if X1 is Arg, X2 and X3 are Ile, and X4 is 4-Me-Phe.
Difference is that Tavassoli silent on exemplifying applicants elected species, wherein (i) X2 and X3 are Ile and (ii) X4 is Phe.
With regard to (i) of above, Tavassoli suggests that LLI motif with any combination of aliphatic amino acids, and limited to small number of species, such as valine, leucine homoleucine, isoleucine, which are interpreted as equivalents or exchangeable. Established case law holds that the mere substitution of an equivalent (something equal in value or meaning, as taught by analogous prior art) is not an act of invention; where equivalency is known to the prior art, the substitution of one equivalent for another is not patentable. See In re Ruff 118 USPQ 343 (CCPA 1958). In this case, art teaches that both Lue and Ile are interchangeable and are equivalent.
With regard to (ii) of above, Tavassoli teaches 4-Me-Phe. So the difference is that additional methyl group on Phe. This differences is interpreted as H vs Methyl group on Phe ring. The MPEP 2144.09 states “Compounds which are….homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by –CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA).
Alternatively, the issue of patentability over the replacement of alkyl groups for hydrogen or vice versa has arisen many times. For instance, the replacement of a methylene group with a dialkyl-substituted methylene group was determined to be prima facie obvious on the ground that "one skilled in the art would have been, prima facie, motivated to make the claimed compounds in the expectation that they, too, would possess antimicrobial activity." (In re Wood 199 USPQ 137) See also In re Doebel 174 USPQ 158 (where replacement of methyl for hydrogen on an amino nitrogen was considered prima facie obvious - at page 159); In re Druey 138 USPQ 39 (where replacement of methyl for hydrogen on a known compound was considered prima face obvious based on the homologous and close structural relationship to the known compound - at page 41); In re Lohr 137 USPQ 548 (where the replacement of a methyl group for a hydrogen on two positions of a tetrahydropyran ring on a known compound was not considered a patentable modification given the close structural relationship to the known compounds - at page 550); Ex parte Bluestone 135 USPQ 199 (where fungicidal compounds differing by hydrogen versus methyl on the nitrogen of a thiazolidine-2-thione ring were considered homologs and were not found to be patentable over each other without a showing of unexpected results - at page 200); Ex parte Weston 121 USPQ 429 (where the replacement of methyl for hydrogen on the nitrogen of a piperazine ring was not found to be a patentable modification).
So, the motivation to make the claimed compound derives from the fact that the expectation that structurally similar compounds would possess similar properties.
For claims 20-21:
Tavassoli teaches that amino acids in the cyclic peptides may be L or D amino acids [see Figure 4].
For claims 22, 27 and 29:
Recited limitations are nothing but properties of the cyclic peptides and these are expected to present in applicants elected species since these are structurally similar to the cyclic peptides of Tavassoli, absent evidence to the contrary. Moreover Tavassoli also teaches similar properties for their cyclic peptides [see abstract and Table 3].
For claim 34:
Tavassoli also teaches pharmaceutical compositions of their cyclic peptides [see page 5, lines 21-25].
For claim 39:
Tavassoli also teaches that the polypeptide may be formulated for simultaneous or subsequent administration with another drug or chemotherapeutic agent. This agent may be any known drug or chemotherapeutic agent. [See page 8, lines 6-9].
For claim 47:
Tavassoli teaches pharmaceutical composition [see page 5, lines 21-25], which can be interpreted as a kit.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants cyclic peptide and possible modifications in it, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make applicants elected speices with a reasonable expectation of success.
Nonstatutory Double Patenting Rejection
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
(i) Claims 1, 20-22, 27, 29, 34, 39 and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 10,962,549 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
For claim 1:
Claims 1-2 of US patent teaches a cyclic peptide, represented by sequences, CXZZZF (SEQ ID NO:7), CRLLIF (SEQ ID NO:3 and CRVIIF (SEQ ID NO:4), wherein X is arginine, lysine, or a non-natural derivative of arginine or lysine and Z is leucine, valine, isoleucine.
The above cyclic peptide reads applicants claimed compound, when in the applicants compound, if X1 is Arg, X2 and X3 are Ile, and X4 is Phe.
Difference is that claims of US patent silent on exemplifying applicants elected species, wherein X2 and X3 are Ile.
However, US patent suggests that ZZZ is any combination of aliphatic amino acids, and limited to small number of species, such as valine, leucine homoleucine, isoleucine, which are interpreted as equivalents or exchangeable. Established case law holds that the mere substitution of an equivalent (something equal in value or meaning, as taught by analogous prior art) is not an act of invention; where equivalency is known to the prior art, the substitution of one equivalent for another is not patentable. See In re Ruff 118 USPQ 343 (CCPA 1958). In this case, art teaches that both Lue and Ile are interchangeable and are equivalent.
So, the motivation to make the claimed compound derives from the fact that the expectation that structurally similar compounds would possess similar properties.
For claims 20-21:
Claims 5 of US patent teaches that wherein one or more of the amino acids is replaced with a D amino acid, and so remaining must be L-amino acids.
For claims 22, 27 and 29:
Claim 1 of US paten teaches similar properties for their cyclic peptides [see abstract and Table 3]. Recited limitations are nothing but properties of the cyclic peptides and these are expected to present in applicants elected species since these are structurally similar to the cyclic peptides of US patent.
For claim 34:
Claim 7 of US patent teaches pharmaceutical compositions of their cyclic peptides.
For claim 39:
Claim 8 of US patent teaches a pharmaceutical composition further comprises a chemotherapeutic agent.
For claim 47:
Pharmaceutical composition of US patent [see claim 8] can be interpreted as a kit.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants cyclic peptide and possible modifications in it, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make applicants elected speices with a reasonable expectation of success.
(ii) Claims 1, 20-22, 27, 29, 34, 39 and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US 11,644,469 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
For claim 1:
Claims 1-2 of US patent teaches a cyclic peptide, represented by sequences, CXZZZF (SEQ ID NO:7), CRLLIF (SEQ ID NO:3 and CRVIIF (SEQ ID NO:4), wherein X is arginine, lysine, or a non-natural derivative of arginine or lysine and Z is leucine, valine, isoleucine.
The above cyclic peptide reads applicants claimed compound, when in the applicants compound, if X1 is Arg, X2 and X3 are Ile, and X4 is Phe.
Difference is that claims of US patent silent on exemplifying applicants elected species, wherein X2 and X3 are Ile.
However, US patent suggests that ZZZ is any combination of aliphatic amino acids, and limited to small number of species, such as valine, leucine homoleucine, isoleucine, which are interpreted as equivalents or exchangeable. Established case law holds that the mere substitution of an equivalent (something equal in value or meaning, as taught by analogous prior art) is not an act of invention; where equivalency is known to the prior art, the substitution of one equivalent for another is not patentable. See In re Ruff 118 USPQ 343 (CCPA 1958). In this case, art teaches that both Lue and Ile are interchangeable and are equivalent.
So, the motivation to make the claimed compound derives from the fact that the expectation that structurally similar compounds would possess similar properties.
For claims 20-21:
Claims 5 of US patent teaches that wherein non-natural amino acid is D amino acid, and so remaining must be L-amino acids.
For claims 22, 27 and 29:
Claim 1 of US paten teaches similar properties for their cyclic peptides [see abstract and Table 3]. Recited limitations are nothing but properties of the cyclic peptides and these are expected to present in applicants elected species since these are structurally similar to the cyclic peptides of US patent.
For claim 34:
Claim 8 of US patent teaches pharmaceutical compositions of their cyclic peptides.
For claim 39:
Claim 9 of US patent teaches a pharmaceutical composition further comprises a chemotherapeutic agent.
For claim 47:
Pharmaceutical composition of US patent [see claim 8] can be interpreted as a kit.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants cyclic peptide and possible modifications in it, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make applicants elected speices with a reasonable expectation of success.
Conclusion
THIS ACTION IS MADE FINAL. 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 SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
Prosecution Insights