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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 13th Feb 2026 has been entered.
Status of the application
Receipt of applicant’s remarks and claim amendments filed on 19th Nov 2025 are acknowledged.
However, applicants’ arguments for the previous 103 rejection are found not persuasive. Accordingly, the previous rejection is maintained and modified to address claim amendments.
Previous nonstatutory double patenting rejection is also maintained in absence of filed terminal disclaimer and arguments.
Applicants are reminded that previous restriction requirement and elected species are still remain same.
To clarify applicants remarks, previous 103 rejection is modified.
To get clarifications on claim language, a new 112(b) rejection is made.
Examiner’s comment / suggestions
It is not clear what is the criticality of the claimed invention either from the claim language or from the specification. In case, applicants file claim amendments and declaration etc., and if such response overcomes pending 112(b) and 103 rejections, claims may be subjected to 112(a) written description, since there is no single universal method to synthesize all possible peptides, all possible proteins and all possible peptidomimetics in all possible conditions in the known art. Claims are extremely broad, and there is no description in the specification to support the broadly claimed subject matter. To avoid delay in the prosecution, a telephonic interview is highly recommended to get a better understanding on the claimed subject matter and resolve the pending issues.
Response to Arguments
Applicants argue that Takahashi and/or Albericio references disclose problems in the prior art that the present invention was designed to overcome.
However, the starting material to make peptide, other than protected amino acid, in the teachings of Takahashi reads or identical to applicants starting material. Also, building blocks of Albericio are identical to applicants claimed units. Rejection explained motivation to combine the art. Applicants fail to prove or explain why the combination does not work for or read claimed invention.
Applicants argue that protection and deprotection steps are fundamental to Takahashi, such that if they are not employed the methodology of Takahashi does not work.
If the combination of teachings of cited does not work, applicants need to prove with evidences, not simple statement, and the evidences must be in the form of declarations.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are 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 pre-AIA the applicant regards as the invention.
Claim 1 recites a first end and second end in the claim language. Do applicants intend to claim first and second end of starting compound or something else? If yes, what is the starting material? Specification is also failed to define it either explicitly or implicitly. Therefore, its metes and bounds are not clear. Accordingly, claim 1 and its dependents are rendered indefinite.
Claim 5 recites term “derivative”, it rendered its scope unclear, since it is not known to the skilled reader which structure are intended to be encompassed by this term. Such as term includes compounds from another compound by a chemical reaction (including compounds which are structurally remote from the starting material), functional derivatives (such as compounds, wherein heteroatoms are exchanged by alternative atoms), compounds with numerous different types of side groups etc. However, there is no clear definition in the application to which extent the compounds might be modified while still being regarded as derivatives. This has the effect that the person skilled in the art cannot decide clearly which compounds are to be covered by said claim and which are not.
Claim Rejections - 35 USC § 103 [Maintained and Modified]
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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi (US 2012/0059149 A1) in view of Albericio (Organic Letters, 2005, Vol.5, No.4, 597-600).
For claim 1:
Takahashi teaches a production method of peptide by using branched chain containing aromatic compound comprising the stepwise addition of protected amino acids to the aromatic compound, wherein the aromatic compound is represented by the following formula (I):
PNG
media_image1.png
172
167
media_image1.png
Greyscale
[see pages 1-2 and 17].
In the above compound of formula (I), if R1 is H, X is H, Y is OH or -NHR (R is H or alkyl or aralkyl group), Z is H, Q is bond and Ra is hydrocarbon group, see definitions in page 1, then it reads applicants starting compound comprising first end and second end, wherein second end is Y group (-NH2 or -OH group) and first end is QR8 (hydrocarbon group).
The above compound of formula (I), a starting material, which is identical to applicants starting material, as shown in page 15 of specification, provided that n is 0. The group Ra is hydrocarbon group, which can be interpreted as applicants anchoring molecule.
Takahashi further teaches the use of above compound of formula (I) in peptide synthesis, see the following scheme of peptide synthesis:
PNG
media_image2.png
158
284
media_image2.png
Greyscale
PNG
media_image3.png
131
168
media_image3.png
Greyscale
, wherein the formula (I) represents aromatic compound, P1-AA1-OH or P1-AA1-NHR protected amino acids [see page 17]. The resulted product is subjected to deprotection step,
PNG
media_image4.png
140
400
media_image4.png
Greyscale
, which is further subjected to peptide chain elongation step with the following scheme:
PNG
media_image5.png
138
291
media_image5.png
Greyscale
PNG
media_image6.png
130
216
media_image6.png
Greyscale
, which is subjected to deprotection to yield unprotected desired peptide:
PNG
media_image7.png
139
405
media_image7.png
Greyscale
[see pages 17-18].
In the above scheme, the P1-AA1-OH or P1-AA1-NHR can read or can be equivalent to applicants Qa-E-Qb, since it can be an amino acid.
Takahashi teaches suitable solvents for the above method, such as toluene, CPME, chloroform etc [0173].
Takahashi further teaches that their method is similar to general liquid phase organic synthesis [see 0155].
The differences between Takahashi and the claim are as follows:
(i) in the compound of Takahashi, there is a -CH2- group in between -OH and phenyl ring, whereas elected species do not require -CH2- group.
(ii) Takahashi silent on unprotected primary or secondary amine or hydroxyl or thiol functionality groups in the reacting compounds in the coupling reactions.
With regard to (i) of above, incorporation of -CH2- groups is common practice in the art and is obvious. For example, for a given alcohol, viz., R-OH, wherein R is methyl, ethyl, butyl, phenyl or benzyl etc., these have successive addition of same chemical groups, viz., -CH2- groups, and such compounds possess similar properties and so, are obvious variants.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c).
With regard to (ii) of above, this can be cured from the teachings of Alberico, which teaches recoverable building blocks and their utility in peptide synthesis [see abstract and Schemes 1-2], see below:
PNG
media_image8.png
182
365
media_image8.png
Greyscale
.
The above activated monomers or building blocks are stable compounds and can be prepared in multi-gram scale [see 2nd paragraph in left column in page 598].
In the above scheme, if R is a side chain of amino acid, then the ring structure [upper right] is identical to applicants claimed or shown units in the specification in page 41.
In the above scheme, H2NR’ is interpreted as applicants starting material, wherein H2N- is interpreted as second end of applicants starting material and R’ is interpreted as chemical group comprises applicants first end. The compound H2NR’ can couple with ring structure [HFA-lactone] and forms a conjugate, which comprises free N-terminal group, which can be coupled with another building block and repetition results in successive elongation to form a desired peptide.
Alberico further exemplified their methodology using bound tyrosine on solid phase and coupled it with HFA-D-Man, see below,
PNG
media_image9.png
230
384
media_image9.png
Greyscale
[see page 599].
The above schemes does not involve protecting groups for primary amine or secondary amine etc.
Alberico further teaches that their strategy also works in solution as well as solid phase [see 3rd paragraph in left column in page 599].
In light of advantages of building blocks or activated amino acids as evidenced from the teachings of Alberico, a skilled person in the art would be motivated to replace protected amino acids in the teachings of Takahashi, because the building blocks of Alberico are stable and also the methodology avoids protecting groups. There is also a reasonable expectation of success to arrive at applicants method because Alberico provided enough guidance in making building blocks and also exemplified making dipeptides etc., and it can be extrapolated to synthesize peptides.
For claims 2-5:
As explained above, Alberico teaches activated amino acids [see Scheme 1 in page 598].
For claims 6-10:
As explained under For claim 1 above, applicants elected anchoring group falls within the scope of the aromatic compound of Takahashi, which is Ra or R8 organic group, having at least one aliphatic hydrocarbon group having one or more branched chains, a total number of the branched chain of not less than 3 and total carbon number of not less than 14 and not more than 300 [see 0013].
For claim 11:
The first and second units are interpreted as N- and C-terminus of amino acid.
For claim 12:
Applicants claimed activated amino acid is identical to building block of Alberico, and so whatever the definition of first or second, which must be present in the building block of Alberico.
For claim 13:
Alberico teach coupling of amino acid bound to resin, which can be interpreted as amino acid bound to anchoring molecule, with unprotected amino acid [see Scheme 1 and 2]. However, a skilled person in the art would determine whether the protecting groups are required or not for the coupling reaction. Moreover, for the claimed method, using activated amino acids, the side chains must be protected to avoid undesirable products. Specific protected groups are not required for N- and C-terminus groups because of HFA-lactone, which default protects the end groups.
For claim 14:
Both Takahashi and Alberico teach extraction of peptide into organic layer and washing with water etc. However, these are standard and well kwon methods and a skilled person in the art would determine suitable solvents and filtration methodology etc., absent evidence to the contrary.
For claim 15:
Anchoring molecule has a reactive site which is suitable to specific group on amino acid or peptide etc., and so, the protein or amino acid can be easily detected, using known techniques, such as fluorescence emission etc., and so the claimed limitation is obvious.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components and their utility in peptide synthesis, 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 the instantly claimed method with a reasonable expectation of success.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
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.
Claims 1-3, 6-11, 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US copending application number 17/413,807.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
For claim 1:
Claim 1 of copending application teaches a method for synthesizing peptides or proteins by successively elongating the second end (Nα) of a peptide chain of which the first end is attached to an anchoring molecule that is soluble in an apolar solvent by means of the carboxylic acid function (C-terminus) thereof or the amine function (Nα) thereof, characterized in that said anchoring molecule includes a polyolefin chain with at least 10 monomer units.
The difference is that claim of instant application is further limited to the recited narrow scope of the claimed subject matter, whereas claim of copending application is broad in the nature. However, this difference does not constitute a patentable distinct, because the scope of instant claim overlaps with the scope of coopending application claim, and therefore, it is obvious.
For claims 2-3 and 11:
Claims 9-11 of copending application teaches first end of said peptide chain is a first amino acid unit AA 1, and said peptide chain is formed of n amino acid units, and the second end of said peptide chain is another amino acid unit AAn, characterized in that another amino acid unit AA(n+1) is added to said second end during said elongation.
For claims 6-10:
Claims 2-8 teach anchoring molecule, which is same or identical to applicants anchoring molecule.
For claims 13-15:
Claims 11 and 20 of copending application teach that at least one step wherein said peptide chain attached to said anchoring molecule is separated from the reaction medium by extraction in an apolar liquid.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not been patented yet.
Conclusion
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