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 .
Specification
The amendment to the specification filed on 5/28/26 has been entered.
The use of the term pSilencer, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 5/28/26, with respect to the rejection(s) of claims 1-20 under 112 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn because the deletion of claims 1-20. However, upon further consideration, a new ground(s) of rejection is made in view of the addition of new claims 21-25.
Claim Interpretation
The instant claims appear to be wordy, redundant, and consists of run-on sentences. The Office will do their best to provide an interpretation of what the claimed invention embraces.
A skilled artisan would understand that RBD stands for a receptor binding domain. See page 2 of the specification. SEQ ID NO: 59 limits the RBD to a coronavirus RBD.
Instant claim 21 embraces a method of making a novel coronavirus shRNA-2RBD having the chemical structure RBD-shRNA-RBD, the method comprising making two siRNA, wherein a sequence of one of the siRNA is SEQ ID NO: 20 and the other sequence is complementary to SEQ ID NO: 20; or a sequence of the one of the siRNA is SEQ ID NO; 22 and a sequence that is complementary thereto; making an shRNA from the two siRNA, making an RBD comprising SEQ ID NO: 59 and connecting the ends of the shRNA to the RBD.
Claim Rejections - 35 USC § 112
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.
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for connecting each end of the shRNA with one RBD comprising coupling the ends of the shRNA to the RBD, wherein the coupling between the RBD and shRNA and is an oxime bond, amide bond, sulfur ether bond, disulfide bond, phosphoryl bond, acylurete bond, phosphodiester bond, or maleidyl-sulfhydryl bond, does not reasonably provide enablement for using the coupling steps starting on lines 11-26 of the instant claim. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Claim 25 is directed to using different coupling steps to attach the RBD to the ends of the shRNA. The method steps appear to be directed to well-known methods for coupling an oligonucleotide (shRNA) to a protein (RBD) to form a shRNA-RBD conjugate, however, the method steps are confusing and the wording of the method steps are redundant or directed to products and methods steps with no nexus between them and the pre-amble.
The limitation ‘coupling the mercapto group with another oligomer containing a mercarpto group such that the RBD-shRNA-RND conjugate is obtained’ has no nexus between conjugating the mercapto group with another oligomer and RBD-shRNA-RBD. The claimed limitation does not complete or indicate how the RBD-shRNA-RBD is formed using these method steps.
There is no nexus between using the limitation ‘bifunctional oligonucleotides and peptides’ and obtaining RBD-shRNA-RBD. In addition, the claimed method appears to be limited to one RBD connected to the ends of the shRNA, however, the limitation ‘two RBSs are simultaneously connected to the 5’ and 3’ end of the shRNA’ indicates that two RBD are connected to the 5’ and 3’ ends of the shRNA without indicating how this method is carried out or adding another RBD to the shRNA, which would result in 2RBD-shRNA.
The amide bond coupling step does not include method steps to make the RBD-shRNA-RBD because the limitation reacting a polymer substance containing activated carboxylic acid or thioester with another polymer with amino groups has no products that would make the RBD-shRNA-RBD. The polymers are broader than RBD or shRNA and do not require either to make the claimed product.
Suggest removing all of the method steps after the ‘wherein’ clause on lines 11-26 of claim 25 because even though the steps are well-known in the prior art the wording for each step that corresponds to the well-known method steps adds confusion to the claimed method.
Thus, claim 25 is not fully enabled.
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 23 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.
Claim 23 contains the trademark/trade name pSilencer. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a vector comprising a nCOV shRNA and, accordingly, the identification/description is indefinite.
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 25 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. Claim 25 depends on claim 21 that is limited to one RDB attached to the each end of the shRNA, however, the oxime bond coupling step requires two RBDs that are simultaneously attached at a 5’ end and a 3’ end of the shRNA The pre-amble of claim 25 is directed to attaching one RBD to the two ends of the shRNA. 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.
Allowable Subject Matter
Claims 21-22 and 24 are in condition for allowance. A sequence search of the prior art for SEQ ID NO: 59 indicates that sequence is free of the prior art. The closest prior art is SEQ ID NO: 10 in WO 2021198963. SEQ ID NO: 10 is 99.2% identical to SEQ ID NO: 59, but the prior art does not teach or suggest modifying SEQ ID NO: 10 to arrive at the claimed SEQ ID NO: 59 and then conjugating it to the ends of a shRNA comprising SEQ ID NO: 20 or 22.
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.
See attached PTO-326 for disposition of claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian Whiteman whose telephone number is (571)272-0764. The examiner can normally be reached on Monday thru Friday; 6:00 AM to 3:00PM.
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/BRIAN WHITEMAN/ Primary Examiner, Art Unit 1636
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