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 filed 07/08/2026 has been received and considered entered. This is a response to amendments and arguments filed 07/08/2026.
Election/Restrictions
All species election requirements have been withdrawn. As such, claim 3 is no longer withdrawn.
Claims 32-35 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/25/2025.
Claims Status
Claims 40-49 are newly added. Claims 1-49 is/are currently pending with claims 32-35 withdrawn. Claims 1-31, and 36-49 is/are under examination.
Claim Objections
The amendment to the claims filed on 07/08/2026 does not comply with the requirements of 37 CFR 1.121(c) because applicant failed to indicate all new claim limitations appropriately. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).
(1) Claim listing. All of the claims presented in a claim listing shall be presented in ascending numerical order. Consecutive claims having the same status of “canceled” or “not entered” may be aggregated into one statement (e.g., Claims 1–5 (canceled)). The claim listing shall commence on a separate sheet of the amendment document and the sheet(s) that contain the text of any part of the claims shall not contain any other part of the amendment.
(2) When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended,” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn—currently amended.”
(3) When claim text in clean version is required. The text of all pending claims not being currently amended shall be presented in the claim listing in clean version, i.e., without any markings in the presentation of text. The presentation of a clean version of any claim having the status of “original,” “withdrawn” or “previously presented” will constitute an assertion that it has not been changed relative to the immediate prior version, except to omit markings that may have been present in the immediate prior version of the claims of the status of “withdrawn” or “previously presented.” Any claim added by amendment must be indicated with the status of “new” and presented in clean version, i.e., without any underlining.
(4) When claim text shall not be presented; canceling a claim.
(i) No claim text shall be presented for any claim in the claim listing with the status of “canceled” or “not entered.”
(ii) Cancellation of a claim shall be effected by an instruction to cancel a particular claim number. Identifying the status of a claim in the claim listing as “canceled” will constitute an instruction to cancel the claim.
(5) Reinstatement of previously canceled claim. A claim which was previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
Currently amended claim 17 contains limitations not previously presented which are not underlined to indicate the limitations were added (lines 4-11).
Claim Rejections - 35 USC § 112
112(a):
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.
Claims 1-16, 19-27, 30-31, 41-49 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 rejection has been amended to reflect that it is claim 30 which is drawn to a vaccine, and not claim 29, and has been amended in consideration of newly added claims.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V, v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Eiees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641,1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F. 2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it”).
According to the MPEP § 2163, "The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutsch land GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.")."
Claim 30 is drawn to a vaccine comprising the RNA of claim 1; however, the claim does not specify what disease or condition said vaccine prevents. The common definition of “vaccine” is “any preventive preparation used to stimulate the body’s immune response against a specific disease, using either messenger RNA or killed or weakened bacteria or viruses to prepare the body to recognize a disease and produce antibodies” (see Dictionary.com “vaccine”, provided herein). Claim 31 recites that the RNA can be used “as a medicament”, with no specification as to what specific diseases or conditions said RNA can be used as a medicament for. On pages 14-15, the specification states that the “vaccines according to the invention are suitable for the treatment of cancers and tumors” and “may be furthermore employed against infectious diseases”, including but not limited to HIV, hepatitis A, B, or C, herpes, herpes zoster, rubella, yellow fever, “dengue etc.”, flaviviruses, influenza viruses, coronaviruses, hemorrhagic infectious diseases, bacterial infectious diseases, protozoan diseases, or fungal infections. However, the specification does not provide specific structures, in particular specific coding sequences of the claimed RNA, which can be used to vaccinate against or treat specific cancers, tumors, viruses, bacteria, protozoa, or fungi. An artisan would need to perform further experimentation in order to determine a suitable RNA structure (e.g., a suitable coding sequence of the claimed RNA) for a vaccine targeting any of the cancers, tumors, viruses, bacteria, protozoa, or fungi taught in the specification or broadly encompassed by the pending claims, and such an artisan would recognize that each specific disease would require a different RNA structure or different combination of RNA structures. As the disclosure does not provide a number of species of peptides encoded by the coding sequence of the claimed RNA which is representative of the entire genus of RNA-encoded peptides which could be used in methods of treating or preventing the broad genus of cancers, tumors, viral infections, bacterial infections, protozoan infections, and fungal infections, an artisan would not be able to conclude that the applicants were in possession of the full scope of the genus of RNA molecules for use as vaccines or medicaments for any condition or agent, or for use in the treatment of any cancers or tumors, or for the treatment or prevention of any infectious diseases. Thus claims 30-31 lack sufficient written description. As claim 31 is drawn to the RNA of claim 1, reciting intended uses of the RNA of claim 1 with no further structural limitations, claim 1 is considered to encompass the RNA structures of claim 31 which have the recited intended uses which lack sufficient written description. As a result, claim 1 is also rejected for lacking sufficient written description. Claims 2-16, 19-27, 41-49 depend on claim 1 and do not further limit the RNA such that the intended uses of claims 30-31 are sufficiently described, and thus claims 2-16, 19-27, 41-49 are also rejected for lacking sufficient written description of the RNA structures required for the claimed intended uses.
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive. Applicant did not address the rejection of claims 30-31 for lack of written description of broad recitations of medicaments and vaccines comprising the RNA of claim 1. Furthermore, as claim 31 does not provide additional structural limitations which would enable the use as a medicament (additional relative to the structure recited in claim 1), claim 1 is interpreted as reciting a structure which could be “used as a medicament”. As the disclosure does not provide a written description of RNA structures useful as medicaments or vaccines in a number of diseases or conditions representative of the broad scope of diseases or conditions, claims 30-31 and all claims which require the same broadly-recited structures are not sufficiently described.
Allowable Subject Matter and Subject Matter Not Found In the Prior Art
Claims 17-18, 28-29, 36-40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 1 requires that the RNA be fully chemically synthesized and comprise a free 5’-triphosphate, 5’-diphosphate, 5’-monophosphate, or 5’-OH group. The art found in a search of the art teaches against uncapped mRNA molecules (such as Schlake and Schnee, previously cited in rejections under 35 USC 102 and 103). Further review of the art did not yield art which teaches that mRNA should be uncapped. Furthermore, the prior art did not teach or suggest uncapped RNA molecules encoding SEQ ID NOs: 1-21 or other polypeptides recited in claims 17 and 28.
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 AFRICA M MCLEOD whose telephone number is (703)756-1907. The examiner can normally be reached Mon-Fri 9:00AM-6:00PM EST.
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/AFRICA M MCLEOD/ Examiner, Art Unit 1635
/KIMBERLY CHONG/ Primary Examiner, Art Unit 1636
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