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 amendment filed on 10/27/2025 has been entered.
Amended claims 1 and 4-14 are pending in the present application.
Applicant elected previously without traverse the Invention of Group I.
Applicant also elected previously the species of SEQ ID NO: 17.
Claims 6 and 10-14 were withdrawn previously from further considerations because they are directed to non-elected inventions. Additionally, claims 8-9 were also withdrawn from further considerations because they are directed to non-elected species.
Therefore, amended claims 1, 4-5 and 7 are examined on the merits herein with the elected SEQ ID NO: 17.
Response to Amendment
The rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for Scope of Enablement was withdrawn in light of currently amended independent claim 1, particularly with the new limitation “wherein the ribonucleic acid encodes an immunogenic polypeptide comprising the sequence of SEQ ID NO: 14”, and in favor of the New Matter rejection below.
Claim Rejections - 35 USC § 112 (New Matter)
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Amended claims 1 and 4-5 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new ground of rejection necessitated by Applicant’s amendment.
Amended independent claim 1 recites the new limitation “A human codon optimized ribonucleic acid transcribed from the complementary human codon optimized template nucleic acid selected from the group consisting of SEQ ID NO: 17, SEQ ID NO: 18 and SEQ ID NO: 19”. The claims encompass a human codon optimized ribonucleic acid transcribed from the complementary human codon optimized nucleic acid with SEQ ID NO: 17, SEQ ID NO: 18, or SEQ ID NO: 19, wherein the ribonucleic acid encodes an immunogenic polypeptide comprising the sequence of SEQ ID NO: 14, and wherein the ribonucleic acid will express the immunogenic polypeptide when transfected into mammalian cancer cells. The as-filed specification does not have a written support for the above new limitation.
As an initial matter, amended claims 1 and 4-5 have been introduced in the Amendment filed on 10/27/2025, so the claim itself is not part of the original disclosure. 37 CFR § 1.115(a)(2). “New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. . . . While there is no in haec verba requirement, newly added claims or claim limitations must be supported in the specification through express, implicit, or inherent disclosure. . . . The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed.” MPEP § 2163, part (I)(B); see also MPEP § 2163.02. In this case, the original specification does not convey the particular invention recited in claims 1 and 4-5 with reasonable clarity to skilled artisans. “The trouble is that there is no such disclosure, easy though it is to imagine it.” MPEP § 2163.05, part (II) (quoting In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967)).
In the Amendment filed on 10/27/2025 (at page 6, first paragraph), Applicant simply stated that no new matter has been introduced by the amendments and support for the amendments can be found throughout the subject specification and original claims. Upon careful examination of the as-filed specification, nowhere in the specification indicates or suggests that the template nucleic acid with SEQ ID NO: 17 (elected species), SEQ ID NO: 18, or SEQ ID NO: 19 is the complementary human codon optimized template nucleic acid as encompassed by currently amended claims. Original claim 1 recites specifically “A human codon optimized ribonucleic acid transcribed from a template nucleic acid selected from the group consisting of SEQ ID NO: 17, SEQ ID NO: 18 and SEQ ID NO: 19, wherein the ribonucleic acid expressed an immunogenic polypeptide in transfected cells”. Paragraph [00241] of the as-filed specification also stated “Codons in the emm55 gene encoding an immunogenic polypeptide were optimized to improve expression in transfected human cells. Three synthetic human codon optimized DNAs (SEQ ID NO:17, SEQ ID NO:18, SEQ ID NO:19) were used as templates to transcribe human codon optimized RNAs) which expressed the EmmL polypeptide (SEQ ID NO: 14) in transfected human and mouse cancer cells”. Thus, the as-filed specification does not have a written support for any one of SEQ ID NO: 17, 18 or 19 to be the complementary human codon optimized template nucleic acid that is used to transcribe a human codon optimized ribonucleic acid of the instant claims. In contrast, an ordinary skill in the art would readily recognize that each of the SEQ ID NOs. 17, 18 and 19 is the sense or coding strand template nucleic acid because each encodes the immunogenic polypeptide of SEQ ID NO: 14; and not the complementary human codon optimized template nucleic acid as recited by currently amended claims. Moreover, a human codon optimized template DNA (e.g., SEQ ID NO: 17, 18, or 19) has a coding strand and a complementary strand, and the RNA transcribed from a DNA template strand is a complementary RNA molecule (transcript), synthesized by RNA polymerase that reads the DNA’s template strand (antisense strand), creating an RNA sequence with complementary bases (A-U, G-C) but with Uracil (U) instead of Thymine (T); and the transcription process is depicted diagrammatically below:
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The fact that the person of ordinary skill in the art could have carried out the claimed invention without undue experimentation based on applicants’ disclosure is inadequate to meet this requirement. “The Federal Circuit has pointed out that, under United States law, a description that merely renders a claimed invention obvious may not sufficiently describe the invention for the purposes of the written description requirement of 35 U.S.C. 112.” MPEP § 2163, part (I)(A).
Therefore, given the lack of sufficient guidance provided by the originally filed specification, it would appear that Applicants did not contemplate or have possession of invention as now claimed at the time the application was filed.
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.
Claim 7 is 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.
In claim 7, it is unclear what is encompassed by the limitation “The human codon optimized ribonucleic acid of claim 1 transcribed from the human codon optimized template nucleic acid SEQ ID NO:17”. This is because independent claim 1 from which claim 7 is dependent upon already recites “A human codon optimized ribonucleic acid transcribed from the complementary human codon optimized template nucleic acid selected from the group consisting of SEQ ID NO:17, SEQ ID NO:18 and SEQ ID NO:19”. Clarification is requested because the metes and bounds of the claim are not clearly determined.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This is because dependent claim 7 recites the limitation “The human codon optimized ribonucleic acid of claim 1 transcribed from the human codon optimized template nucleic acid SEQ ID NO: 17”, and yet independent claim 1 from which claim 7 is dependent on already recites the limitation “A human codon optimized ribonucleic acid transcribed from the complementary human codon optimized template nucleic acid selected from the group consisting of SEQ ID NO:17, SEQ ID NO:18 and SEQ ID NO:19”. The scope of dependent claim 17 no longer requires a human codon optimized ribonucleic acid transcribed from the complementary human codon optimized template nucleic acid SEQ ID NO: 17. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusions
No claim is 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 Quang Nguyen, Ph.D., whose telephone number is (571) 272-0776.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s SPE, James Douglas (Doug) Schultz, Ph.D., may be reached at (571) 272-0763.
To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Group Art Unit 1631; Central Fax No. (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/QUANG NGUYEN/Primary Examiner, Art Unit 1631
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