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 .
Election/Restrictions
The restriction has been clarified to follow domestic restriction practice under 35 USC 121 and 37 CRF 1.141-1.142.
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to a DNA construct, vector comprising the DNA construct, and a host cell comprising the vector classified in 536/23.1.
II. Claims 20-31, drawn to an extracellular vesicle comprising sequences encoded by a host cell comprising the vector, classified in various classes/subclasses.
III. Claim 32, drawn to a method of treatment using an extracellular vesicle comprising sequences encoded by a host cell comprising the vector, classified in unknown class/subclass.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as mutually exclusive species in an intermediate-final product relationship. Distinctness is proven for claims in this relationship if the intermediate product is useful to make other than the final product, and the species are patentably distinct (MPEP § 806.05(j)). In the instant case, the intermediate product is deemed to be useful for making protein in vitro in the absence of vesicles. The inventions are deemed patentably distinct because there is nothing of record to show them to be obvious variants. Vesicles having the exact same structure/function can be obtained by putting DNA directly into microsomes and does not have to be derived from cells transformed with the vector.
Groups I and III are patentably distinct because the DNA of Group I can be used to make protein in vitro and does not have to be used for therapy in vivo as required in Group III. The protocols and reagents for DNA and vesicles comprising naturally occurring proteins and mRNA obtained from cell debris are materially distinct and separate. The burden required to search and examine the groups together would be undue.
Inventions II and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the method can be performed using microsomes comprising proteins and/or mRNA having the same structure/function as vesicles derived from debris of a cell transfected with a vector.
Applicant's election with traverse of Group I, claims 1-19, in the reply filed 12-11-25 is acknowledged. The traversal is on the ground(s) that three groups are interrelated. This is not found persuasive for reasons set forth above. A vesicle having the exact same structure/function as the one in claim 20 can be made using other methods; the vesicle of claim 20 does not have to be made using the DNA/vector/cells of claims 1, 18, 19. The burden required to search and examine vesicles and methods of using the vesicles together with the vast number of sequences encompassed by claim 1 is beyond undue. The requirement is still deemed proper and is therefore made FINAL.
Applicants elected SEQ ID NO: 1-8, 13, 14 for the species election.
Claims 12-15 do not relate to the elected invention because they are not limited to the elected species of SEQ ID NO: 1-8, 13, 14. They encompass additional sequences which require additional searches beyond SEQ ID NO: 1-8, 13, 14. Therefore, claims 12-15 have been withdrawn because they are not limited to the elected species of SEQ ID NO: 1-8, 13, 14.
Claims 20-32 have also been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12-11-25.
Claims 1-11, 16-19 are under consideration.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11, 16, 17 are rejected under 35 U.S.C. 102a1 as being anticipated by Zimin (Biol. Direct, 2014, Vol. 9, No. 20, pg 1-15).
Zimin taught a nucleic acid sequence encoding SEQ ID NO: 8. This is equivalent to the claims 1-11 because applicants argue claims 1-11 encompass SEQ ID NO: 8 in their response to the restriction requirement.
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Claim 16 has been included because GVGLSTVIGLLSCLIG (SEQ ID NO: 8) is the “amino acid of a target protein”.
Claim 17 has been included because applicants teach GVGLSTVIGLLSCLIG can be used as a “therapeutic protein”.
Claim 18 has been included because genomic DNA was cloned using standard with BACs (Materials and Methods) which inherently MUST use vectors and host cells comprising the vectors.
Conclusion
No claim is allowed.
Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638