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
1. Applicant's election with traverse of the invention of Group I and the species of -1-2-3 order and luminescent enzyme in the reply filed on 01/14/2026 is acknowledged. The traversal is on the ground(s) that searching all invention together would not be a burden for the examiner.
This is not found persuasive because searches for the elected invention did not render results relevant for the inventions of Groups II and IV-IX. The requirement is still deemed proper and is therefore made FINAL.
However, since searches for the elected invention rendered results relevant for the invention of Group III, the restriction requirement between the inventions of Groups I and III is withdrawn.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 55, 58, 71-90, and 92 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions and species, there being no allowable generic or linking claim.
Claims 46-54, 56, 57, 59-70, 91, and 92 are under examination.
Claim Objections
2. Claim 46 is objected to because of the recitation “a cleavage site mentioned below” in line 3. Correction to “the cleavage site mentioned below” is required.
3. The following amendment to claim 46 is suggested:
“(2) a mutant gene sequence encoding a protein containing a cleavage site in the protein coding region”.
4. Claim 49 is objected to because of the recitation that the sequence of (3) is “a continuous partial sequence”. It is clear that this recitation refers to the sequence of (3)(i). The following amendment is suggested:
The pharmaceutical or reagent according to claim 47, wherein the sequence of (3)(i) contains a stop codon.
Claim Rejections - 35 USC § 112(d)
5. 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.
6. Claim 49 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.
Specifically, claim 47 recites that the sequence of (2) contains a stop codon. Thus, the recitation “the stop codon” in the dependent claim 49 refers to the stop codon recited in the parent claim 47. By reciting that the stop codon is located in the sequence of (3), claim 49 fails to further limit the subject matter of the parent claim 47, which requires the stop codon to be located in the sequence of (2).
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.
Claim Rejections - 35 USC § 103
7. 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
8. Claims 46-51, 53, 54, 56, 57, 59, 61-70, and 91 are rejected under 35 U.S.C. 103 as being unpatentable over Czochor et al. (Mol. Cancer Res., 2016, 14: 363-373), in view of Pierce et al. (Genes & Development, 1999, 13: 2633-2638; IDS), as evidenced by the attached NEB Data Sheet.
Czochor et al. teach a plasmid comprising in 5’ to 3’ order: a promoter, operably linked to a luciferase cDNA mutated to comprise the I-SceI site within the luciferase coding region, and a promoterless copy of the luciferase cDNA in reverse orientation; the promoterless luciferase cDNA copy serves as a donor template for homologous recombination (HR). Czochor et al. teach linearizing the plasmid by cleaving it with I-SceI and introducing the linearized plasmid into test cells to determine HR activity in the test cells; determining HR activity takes place by measuring and comparing the luciferase levels in the test cells and HR-proficient control cells; a lower luciferase expression in the test cells compared to the control cells indicates that the test cells have lower HR activity (claims 46, 53, 54, 56, 57, 59, 61, 70, and 91) (see p. 365, column 2, second full paragraph; p. 368, column 2, last paragraph; p. 369).
Czochor et al. teach a full copy and not a continuous partial sequence of the luciferase cDNA (claims 46, 48, and 50). Pierce et al. teach similar a construct which comprises a continuous partial sequence as the donor template, where the construct is used to measure HR activity in cells; the partial donor template sequence has upstream and downstream regions adjacent to the I-SceI site (see p. 2634, paragraph bridging columns 1 and 2 and Fig. 1). Modifying Czochor et al. by using a continuous partial luciferase cDNA sequence overlapping with the I-SceI site would have been obvious to one of skill in the art to achieve the predictable result of obtaining a linearized construct suitable for determining HR activity in the test cells.
With respect to claim 47, Pierce et al. disclose that the I-SceI site has the sequence:
PNG
media_image1.png
20
206
media_image1.png
Greyscale
, where the underlined nucleotides represent termination codons (see Fig. 1). As evidenced by the NEB Data Sheet, I-SceI cleaves at the sites indicated by the arrowheads:
PNG
media_image2.png
58
290
media_image2.png
Greyscale
(see p. 1).
Thus, the mutated luciferase cDNA comprises a stop codon upstream of the cleavage site.
With respect to claim 49, the cited prior art does not teach that the continuous partial luciferase sequence comprises a stop codon. However, since the continuous partial luciferase sequence taught by Czochor et al. and Pierce et al. is promoterless and cannot be expressed unless HR takes place; thus, there is no need for a stop codon. Importantly, there is no evidence of record indicating that the stop codon provides unexpected properties over the cited prior art. The specification discloses that adding a stop codon to the continuous partial sequence is not necessary because this sequence is not expressed before HR occurs (see [0034]). Adding a stop codon is not significant if it does not provide a novel feature.
With respect to claim 51, since it is a fragment of the luciferase cDNA, the continuous partial luciferase sequence necessarily has homologous sequences having a length of at least 20 nucleotides.
The limitations recited on claims 62-69 only represent an intended use which does not state any distinct limitation differentiating the claimed composition from the composition taught by the prior art. The intended use is of no significance to the composition structure and therefore, it is of no significance to claim construction.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
9. Claims 46-54, 56, 57, 59, 61-70, and 91 are rejected under 35 U.S.C. 103 as being unpatentable over Czochor et al. taken with Pierce et al., as evidenced by the attached NEB Data Sheet, in further view of Klauer et al. (Wiley Interdiscip. Rev. RNA, 2012, 3: 1-16).
The teachings of Czochor et al. and Pierce et al. are applied as above for claims 46-51, 53, 54, 56, 57, 59, 61-70, and 91. Czochor et al. and Pierce et al. do not specifically teach a polyA downstream of the mutated luciferase gene (claim 52). Klauer et al. teach that the absence of a polyA tail leads to mRNA degradation (see p. 2, first paragraph). Thus, including a polyA tail downstream of the mutated luciferase gene to achieve the predictable result of expressing the luciferase reconstituted upon HR.
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
10. Claims 46-48, 50, 53, 54, 56, 57, 59-70, and 91 are rejected under 35 U.S.C. 103 as being unpatentable over Czochor et al. taken with Pierce et al., as evidenced by the attached NEB Data Sheet, in further view of Ahren (The Scientist, 1995).
The teachings of Czochor et al. and Pierce et al. are applied as above for claims 46-48, 50, 53, 54, 56, 57, 59, 61-70, and 91. Czochor et al. and Pierce et al. do not teach a kit (claim 60). However, the limitation of a kit is not innovative over the prior art; kits containing nucleic acid constructs and instructions for introducing them into cells have been used before the invention was made. One of skill in the art would have been motivated to assemble a kit, i.e., put the reagents in a box containing instructions how to use the reagents, because they are convenient to use and save time (see Ahren, p. 20, the paragraph entitled “The Kit Concept”).
Thus, the claimed invention was prima facie obvious at the time of its effective filing date.
11. No claim is allowed. No claim is free of prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILEANA POPA whose telephone number is (571)272-5546. The examiner can normally be reached 8:00 am to 4:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ILEANA POPA/Primary Examiner, Art Unit 1633
Prosecution Insights