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 .
Application Status
Applicant’s amendments filed May 4, 2026, amending claims 3, 6-7 and 10-11, and adding new claims 12-16 is acknowledge. Claims 1-7 and 9-16 are pending. Claims 2, 4-5 and 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1, 3, 6-7 and 10-16 are under examination.
Withdrawn Rejections
The amendments to the claims overcome the § 112(b) rejections recited in the previous office action.
As indicated in the previous office action claim 1 is allowable. Examiner attempted to contact Applicant’s representative several times without success to propose an Examiner’s amendment to obviate the claim objections and new §112(b) rejections, necessitated by amendment, in order to proceed to allowance. The phone number for Daphne Reddy (Reg. # 53,507) provided in the Remarks led to a directory, in which an individual “Daphne Reddy” was not an option. The phone number for Daphne Reddy in the USPTO practitioner directory has been disconnected. An attempt to connect with Applicant through the general phone number for Genentech was unsuccessful.
In order to proceed to allowance, it is suggested that Applicant 1) amend the claims to overcome the objections and rejections below and 2) cancel withdrawn claims 2, 4-5 and 9, since they are not eligible for rejoinder.
Claim Objections
Claims 10 and 12 are objected to because of the following informalities:
Claim 10 recites ''in the generation of a third recombinase recognition sequence between the first promoter and the first gene following recombination ... " “the first gene” should be replaced with “the first open reading frame” for consistency.
Claim 12 recites “The double stranded DNA element of claim 1, where the first open reading frame encodes…, and where, the second open reading [] is a Rep52…; or, wherein, the second open reading [] is a Rep40…” Claim 12 is missing the term “frame” after “open reading”. Additionally, there does not need to be commas after each recitation of “wherein”.
Appropriate correction is required.
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 3, 6, 11-13 and 14-15 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. This is a new rejection necessitated by amendment.
Claim 3 recites “The double stranded DNA element of claim 1, wherein the first open reading frame encodes exclusively a Rep78 protein or exclusively a Rep68 protein, and wherein, the second open reading frame is a Rep52/Rep40 and Cap open reading frame including a polyadenylation signal operably linked to said open reading frames.” Claim 3 is indefinite because “said open reading fames” lacks clear antecedent basis. It is not clear if “the open reading frames” (plural) is referring to just the reading frame comprising Rep52/40 and Cap, or if the polyadenylation signal is to be operably linked to both the first (Rep78 or Rep68) and the second (Rep52/40/Cap) open reading frame. Additionally, claim 1 already recites a first and a second polyadenylation sequence. It is suggested to refer back to the “the first polyadenylation signal sequence” and “second polyadenylation signal sequence” or include a “third polyadenylation signal sequence” to make the structure of the claimed DNA element clear.
Claim 6 is rejected for depending from claim 3 and not remedying the indefiniteness. Additionally, claim 6 is confusing because claim 3 appears to already require a cap open reading frame with a possibly operably linked polyadenylation signal sequence. As such, the structures of the DNA elements of claim 3 and claim 6 are indefinite.
If multiple polyadenylation sequences and/or Cap are included in the DNA elements it is suggested to enumerate them: “a first polyadenylation sequence” or “a first Cap open reading frame”, and refer back to the enumeration of the polyadenylation sequences from claim 1.
Claim 12 recites “The double stranded DNA element of claim 1, where the first open reading frame encodes…, and where, the second open reading [] is a Rep52…; or, wherein, the second open reading [] is a Rep40…” Based on the position of the semicolon, it appears that the options are 1) the first open reading from is Rep78 or Rep68, and the second open reading frame is a Rep52 and Cap, or 2) no limitations for the first open reading frame and the second reading frame is a Rep40. However, the alternative, mutually exclusive interpretation is in both scenarios the first open reading frame is Rep78 or Rep68. To remedy the indefiniteness, one of the two following options is suggested:
Claim 12: “The double stranded DNA element of claim 1,
(i) wherein the first open reading frame encodes exclusively…., and wherein the second open reading frame is a Rep52 open reading frame…; or
(ii) wherein the second open reading frame is a Rep40 open reading frame.
Claim 12: “The double stranded DNA element of claim 1, wherein the first open reading frame encodes exclusively…., and wherein the second open reading frame is
(i) a Rep52 open reading frame or a Cap open reading frame…, or
(ii) a Rep40 open reading frame, optionally wherein…”
Claim 13 is rejected for depending from claim 12 and not remedying the indefiniteness. Additionally, claim 13 is confusing because claim 3 appears to already require a cap open reading frame with a possibly operably linked polyadenylation signal sequence. As such, the structures of the DNA elements of claim 3 and claim 6 are indefinite. If multiple polyadenylation sequences and/or Cap are included in the DNA elements it is suggested to enumerate them: “a first polyadenylation sequence” or “a first Cap open reading frame”, and refer back to the enumeration of the polyadenylation signal sequences from claim 1.
Claim 11 recites “a mammalian cell comprising
- one or more double stranded DNA elements according to claim 1, or
- at least one double stranded DNA element according to claim 3 or claim 12,
- one double stranded DNA element according to claim 3 and one double stranded DNA molecule according to claim 7, or
- at least one double stranded DNA element according to claim 7 and claim 14, or
- one or more double stranded DNA elements according to claim 10.
First, claim 11 is indefinite because it depends from indefinite claims 3 and 12.
Second, claim 11 is indefinite because the combinations of elements required in the mammalian cell are not clear. There is no conjunction between the 2nd and 3rd options. Additionally, the fourth option recites “at least one…according to claim 7 and claim 14”. It is not clear if the both elements from claim 7 and claim 14 are required or if “the least one” is referring to requiring one element from claim 7 or one element from claim 14.
To remedy the indefiniteness, it is suggested to enumerate with (a) or (i) all the possible options for the mammalian cell and include proper conjunctions between the enumerations. Alternatively, each of the possible combinations can be recited in separate claims.
Claims 15 and 16 are rejected for depending from claims 3 and 12, respectively, and not remedying the indefiniteness.
Allowable Subject Matter
Claims 1, 7, 10 (objected to) and 14 are allowable for the reasons recited in the previous office action.
Claims 3, 6, 11-13 and 15-16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Conclusion
Claims 1, 7 and 14 are allowed. Claims 10 and 12 are objected to. Claims 3, 6, 11-13 and 15-16 are rejected.
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 CATHERINE KONOPKA whose telephone number is (571)272-0330. The examiner can normally be reached Mon - Fri 7- 4.
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, Ram Shukla can be reached at (571)272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE KONOPKA/Primary Examiner, Art Unit 1635
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