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 .
Priority
This application claims benefit to foreign application CHINA 202310830730.3 (filed on 07/07/2023).
Specification
The use of the term Phanta® Max Super Fidelity DNA Polymerase (Vazyme), 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.
Claims Status
Claims 1-6 are pending and have been examined on the merits.
Claim Interpretation
Regarding claims 1-4, the claim recites a product-by-process limitation. Products-by process limitations are considered only insofar as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed is the same or obvious over a product of the prior art (i.e. is not structurally or chemically distinct), the claim is considered unpatentable over prior art, even though the prior art product is made by a different process (See, MPEP 2113).
In the instant case, claim 1 is directed to an expression vector. The expression vector is required to contain a circRNA-expressing frame sequence with 25 bp homology arms at two ends of the frame sequence separately, an EcoR I restriction site at the junction between the upstream and downstream frame sequence, all within a pcDNA 3.1 (+) expression vector. The claim states that the expression vector is constructed by designing primers, amplifying synthesized circRNA-expression frame sequence as template with PCR, adding homology arm sequence (25bp) to two ends of the frame sequence separately, ligating the resulting expression framework sequence to pcDNA3.1(+) expression vector, such that EcoR I restriction site is at the junction between the up and down stream frame sequence, derived from SEQ ID NO: 2 and 3. The result is an expression vector pcDNA3.1(+) with circRNA framework sequence with an EcoR I restriction site (SEQ ID NO:1). Therefore, any expression vector comprising a pcDNA3.1(+) expression vector with circRNA framework with SEQ ID NO:1 would read on the claim.
Regarding claim 5, the claim recites a product-by-process limitation. Products-by process limitations are considered only insofar as the method of production imparts distinct structural or chemical characteristics or properties to the product. Therefore, if the product, as claimed is the same or obvious over a product of the prior art (i.e. is not structurally or chemically distinct), the claim is considered unpatentable over prior art, even though the prior art product is made by a different process (See, MPEP 2113).
Claim 5 provides further details of the process of claim 1 but overall does not change the resulting product or expression vector of claim 1. Claim 5 only provides specific details on the PCR amplification, the reaction composition and the settings/ program for the thermocycler. Therefore, any expression vector comprising that reads on claim 1, will also read on the limitations of claim 5.
Claim Rejections - 35 USC § 112 (b)
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 1-6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, recites “high-efficiency expression vector” in line 1, contains a relative term which renders the claim indefinite. It is unclear what the phrase, specifically what the term ‘high-efficiency’ encompasses in the context of the claims. The term, ‘high-efficiency’ is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is also not clear what the metes and bounds of ‘high-efficiency’ is and any interpretation leads to the claims being indefinite. It is unclear what the term ‘high-efficiency’ is in reference to in the context of the vector (i.e. the vector, the circRNA framework, homology arms, etc.).
Claims 2-5 depend directly from claim 1, therefore, inherit the deficiencies, and thus are rejected on the same basis.
Claim 5 contains the trademark/trade name Phanta® Max Super Fidelity DNA Polymerase. 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 DNA polymerase for DNA amplification and, accordingly, the identification/description is indefinite.
Regarding claim 6, recites “a method for efficiently expressing” in line 1, renders the claim indefinite, because it is unclear what the phrase, specifically what the term ‘efficiently’ encompasses in the context of the claims. It is not clear what the metes and bounds of ‘efficiently’ are and any interpretation leads to the claim being indefinite. It is unclear what the term ‘efficient is in reference to in the context of the method.
Regarding claim 6, recites “exogenous target gene/a” in line 1, renders the claim indefinite, because it is unclear what the phrase, specifically what the term ‘gene/a’ encompasses in the context of the claims. It is not clear what the metes and bounds of ‘gene/a’ are and any interpretation leads to the claim being indefinite. The claim is being interpreted as reciting, “a method for expressing an exogenous target gene in a circRNA”.
Appropriate correction or clarification is required.
Claim Rejections - 35 USC § 112 (d)
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.
Claims 2-4 are 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 2 recites “an expression vector of a circRNA according to claim 1, comprising the upstream frame sequence, the downstream frame sequence, and the restriction site for inserting an exogenous circRNA linear sequence”. As claim 1 is a product by process, the product of claim 1 recites and requires the components outlined in claim 2. Therefore, claim 2 does not further limit the product of claim 1, which it is dependent on.
Claim 3 recites “an expression vector of a circRNA according to claim 2, wherein the restriction site for inserting the exogenous circRNA linear sequence is EcoR I”. As claim 1 is a product by process, the product of claim 1 recites and requires the components outlined in claims 2 and 3. Therefore, claim 3 does not further limit the product of claim 1 or 2, which it is dependent on.
Applicants may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
Relevant Prior Art
While none of the claims are currently allowable, SEQ ID NO: 1 is free of the art. Prior to the effective filing date of the instant application, the art did not teach an expression vector of a circRNA comprising SEQ ID NO: 1, pcDNA3.1(+) vector, and an
EcoR I restriction site, as Applicant demonstrated in the instant disclosure ¶0030, ¶0038-0049 and Figure 3.
The closest prior art is Liu et al (Methods in Molecular Biology, 2018) teaches a method for cloning circRNAs for high-efficiency overexpression in mammalian cell lines (See, Abstract).
Liu et al teaches a method of constructing by cloning circRNA into vector, pcDNA3.1 and the transfection of the vector into mammalian cells (See, p98-99). Liu et al teaches a circRNA sequence with upstream intron fragment, downstream intron fragment (See, p98). This is shown in Figure 1, the circRNA in pcDNA3.1 His C vector shows that insertion of the circRNA between the upstream and downstream fragments with an EcoRV restriction site (See, p99). Liu et al also teaches the method includes inserting particular gene in the circRNA vector, Figure 2 shows the circRNA vector overexpressing of circMLLT1, circMLLT2, and circMLLT3 (See, p 100 figure 2). Liu et al teaches that the construct with the circRNA inserted between the intron fragments achieves higher circRNA expression than traditional cloning and 400-5000 times higher than endogenous levels with high conversion efficiency with minimal by-products (See, p 98 paragraph 2 and Figure 2).
While Liu et al does teach a vector with circRNA sequence with two fragments with a restriction site between, it does not teach that the inclusion of SEQ ID NO: 1 as the circRNA expression frame.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Caroline M Lara whose telephone number is (571)272-4262. The examiner can normally be reached 7:00 to 4:30pm M-Th.
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/CAROLINE M LARA/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
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