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 .
Applicant’s response of 04/21/2026, including replacement drawings and a substitute specification, has been received and entered into the application file.
Claims 31-35 were amended in the claim set filed 04/21/2026.
Claims 1-30 (previously withdrawn) were canceled in the claim set filed 04/21/2026.
Claims 36-62 were added in the claim set filed 04/21/2026.
Accordingly, claims 31-62 are pending and under consideration.
Election/Restrictions
Applicant's previous election with traverse of Group III in the reply filed on 10/09/2025 is acknowledged. The traversal was on the grounds that both groups are directed to a single inventive concept-namely, the development of an integrated system and process for generating hairpin loop-ended, self-complementary, covalently closed linear DNA vectors, and the resulting DNA molecules produced thereby. Applicant asserted that Group III is directed to process/system claims, while Group IV is directed to product claims stemming therefrom. Applicant did not present any arguments traversing the restriction of Groups I or II.
In response, the traversal of the restriction between Groups III and IV was found persuasive. Groups III and IV were previously rejoined and will be examined together as a single invention.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement between Groups I and II, and Groups III and IV (hereby rejoined), the election has been treated as an election without traverse (MPEP § 818.01(a)).
Upon rejoining of Groups III and IV, claims 31-35 were pending and under consideration. Claims 36-62 were added in the amended claim set filed 04/21/2026. Previously withdrawn claims 1-30 were cancelled in the amended claim set filed 04/21/2026. Accordingly, claims 36-62 are pending and under consideration.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The earliest effective filing date to which the instant application is entitled is 08/06/2021.
Status of Prior Objections/Rejections
RE: Drawings
►The drawings were previously objected to for various informalities.
The replacement drawings filed 04/21/2026 have obviated the basis of the objections of record. The objections of record are hereby withdrawn.
RE: Specification
►The disclosure was previously objected to for various informalities.
The substitute specification filed 04/21/2026 has obviated the basis of the objections of record. The objections of record are hereby withdrawn.
RE: Claim Objections
►Claims 31-35 were previously objected to for various informalities.
The amendments to the instant claim set have obviated the basis of the objections of record. The objections of record are hereby withdrawn.
RE: Claim Rejections - 35 USC § 101
►Claim 31 was previously rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
The amendments to the instant claim set have obviated the basis of the rejection of record. The rejection of record is hereby withdrawn.
RE: Claim Rejections - 35 USC § 112(a)
►Claims 31-35 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The amendments to the instant claim set have obviated the basis of the rejection of record. The rejection of record is hereby withdrawn.
►Claim 35 was previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
The amendments to the instant claim set have obviated the basis of the rejection of record. The rejection of record is hereby withdrawn.
RE: Claim Rejections - 35 USC § 112(b)
►Claim 32 was previously 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.
The amendments to the instant claim set have obviated the basis of the rejection of record. The rejection of record is hereby withdrawn.
The amendments to the instant claim set have necessitated new grounds of rejection, which are set forth below.
New/Maintained Grounds of Objection/Rejection
Drawings
The drawings are objected to because:
37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."” In the current case, the view numbers are preceded by the word "Figure" instead of the abbreviation "FIG.". It would be remedial to amend the instant drawings such that the view numbers are preceded by the abbreviation “FIG.” in place of “Figure.”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 31, 32, 43, 44, 46, 49, 51, 58, 59, 60, and 62 are objected to because of the following informalities:
Claim 31 recites “a hairpin loop ended, self-complementary, double-stranded, linear, covalently closed DNA vector production system comprising:…(ii)…a second recombinase under a third inducible promoter…” (bolded emphasis added), which does not comport with standard grammatical and/or linguistic conventions. It would be remedial to amend the instant claim language to be consistent with earlier recitations within the same claim (i.e. “a second recombinase under the control of a third inducible promoter” bolded emphasis added). This is merely an example set forth by the Examiner and is not intended to be limiting.
Claim 32 recites “a hairpin loop ended, self-complementary, double-stranded, linear, covalently closed DNA vector production process using the system of claim 31 comprising the stages of:…(b) obtaining a cointegrate plasmid pDNAv_ABc by subjecting both parental plasmids pDNAv_Ac and pDNAv_Bc to a method selected from:…(iii) a recombination including PCR amplification of each plasmid…” (bolded emphasis added), which is not consistent with earlier claim language. Both (i) and (ii) of (b) recite “a first in vitro recombination” (bolded emphasis added). For purposes of internal consistency, it would be remedial to amend the instant claim to recite “a first in vitro recombination including PCR amplification of each plasmid…” as it is recited elsewhere within the same claim. This is merely an example set forth by the Examiner and is not intended to be limiting.
Claim 43 recites “the production system of claim 31, wherein the recombinase recognition sequence of the engineered parental circular covalently closed synthetic plasmids is selected from the group consisting of PhiC31 attP recombinase recognition sequence, phiC31 attP recombinase recognition site…”. Absent a showing to the contrary, these claim terms appear to invoke the same PhiC31 attP site. It would be remedial to amend the instant claim such that this site is recited only once. Furthermore, the instant claim is drawn to “the recombinase recognition sequence” (bolded emphasis added). Therefore, the recitations of “phiC31 attP recombinase recognition site” and “the FRT site” do not comport with standard linguistic conventions, as they do not recite recombinase recognition sequences but rather recombinase recognition sites. It would be remedial to amend the instant claim language such that recombination recognition sequences are recited, as stated in the preamble.
Claim 44 recites “the endonuclease recognition sequence of the engineered parental circular covalently closed synthetic plasmids is selected from the group consisting of I- SceI endonuclease…F-SuvI…I-DirI…I-TevIII, and combinations thereof” (underlined emphasis added). First, it would be remedial to remove the extra spaces when reciting “I-SceI.” Furthermore, all endonuclease recognition sequences are recited as the enzyme name followed by “endonuclease,” with the exception of F-Suv1, I-DirI, and I-TevIII, as noted above. For purposes of internal consistency, it would be remedial to recite all endonuclease recognition sequences consistently, for example by reciting “F-SuvI endonuclease.” This is merely an example set forth by the Examiner and is not intended to be limiting.
Claim 46 recites “the bacterial selection system of the engineered parental circular covalently closed synthetic plasmids is selected from the group consisting of antibiotics resistance selection…” (bolded emphasis added), which does not comport with standard grammatical and/or linguistic conventions. It would be remedial to amend the instant claim language such that it comports with said conventions, for example by reciting “the bacterial selection system of the engineered parental circular covalently closed synthetic plasmids is selected from the group consisting of antibiotic resistance selection…”. This is merely an example set forth by the Examiner and is not intended to be limiting.
Claim 49 recites “the nuclear matrix-association sequence of the engineered parental circular covalently closed synthetic plasmids is selected from the group consisting of…Epstein-Barr virus (EBV) elements oriP…” (bolded and underlined emphasis added), which does not comport with standard grammatical and/or linguistic conventions. It would be remedial to amend the instant claim language to recite “the nuclear matrix-association sequence of the engineered parental circular covalently closed synthetic plasmids is selected from the group consisting of…Epstein-Barr virus (EBV) element oriP…” (bolded and underlined emphasis added). This is merely an example set forth by the Examiner and is not intended to be limiting.
Claim 51 recites “the eukaryotic origin of replication is selected from the group consisting of Homo sapiens xxx ORI…” (bolded emphasis added), which appears to be a simple typographical error. Looking to the instant specification, paragraph [0071] discloses that the eukaryotic origin of replication may be selected from the group consisting of Homo sapiens LOC107198088 ORI or Homo sapiens LOC107133510 ORI. It would be remedial to amend the instant claim language to correct this simple typographical error such that it properly recites Homo sapiens LOC107198088 ORI or Homo sapiens LOC107133510 ORI, as at paragraph [0071] of the instant specification.
Claim 58 recites “the synthetic or wild-type IRES sequence is selected from the group consisting of encephalomyocarditis virus (ECMV) IRES…Triatoma Virus (TV), Human mastadenovirus C (HAdV-B)…” (bolded emphasis added), followed by multiple virus recitations that do not recite the bolded IRES. Given that instant claim 58 is drawn to IRES sequences, it would be remedial to ensure that all claimed virus IRES sequences are clearly denoted as such by reciting, for example, “Triatoma Virus (TV) IRES” as with “encephalomyocarditis virus (ECMV) IRES.”
With regard to claim 59, which recites “the MIRES sequence comprises a RRACH consensus motif…” (bolded emphasis added), the article “a” is grammatically improper when preceding words articulated with an initial vowel sound. While “RRACH” is spelled such that it recites a consonant letter “R”, the pronunciation of the “R” in “RRACH” nonetheless begins with a vowel sound. It would be remedial to update the instant claim language to be grammatically proper.
Claim 60 recites “the sequence for non-coding RNAs is selected from the group consisting of non-coding RNA…guideRNA (gRNA), single-guideRNA(sgRNA)…” (bolded emphasis added), which omits proper spaces between “guide” and “RNA” as well as incorporates improper spacing between the recited term and its associated acronym. It would be remedial to amend the instant claim language such that spaces are proper, for example by reciting “the sequence for non-coding RNAs is selected from the group consisting of non-coding RNA…guide RNA (gRNA), single-guide RNA (sgRNA)…”.
Claim 62 recites “the permuted Intron-Exon sequence is selected from the group consisting of self-splicing group I intron fragment, group II intron fragment introns, and combinations thereof” (bolded emphasis added), which does not comport with standard grammatical and/or linguistic conventions. It appears that the phrase “group II intron fragment introns” unintentionally incorporated a simple typographical error meant to recite “group II intron fragment.” It would be remedial to amend the instant claim language to correct this typographical error.
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 43, 51, and 53 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.
Claim 43 recites the limitation "the FRT site" (bolded emphasis added) in line 6. There is insufficient antecedent basis for this limitation in the claim. It would be remedial to amend the instant claim language such that there is sufficient antecedent basis for each and every claim term.
As set forth above, claim 51 recites “the eukaryotic origin of replication is selected from the group consisting of Homo sapiens xxx ORI…” (bolded emphasis added), which appears to be a simple typographical error. While the instant specification discloses that the eukaryotic origin of replication may be selected from the group consisting of Homo sapiens LOC107198088 ORI or Homo sapiens LOC107133510 ORI (paragraph [0071]), it is improper to read limitations from the specification into the instant claim set. Therefore, it is unclear and indefinite which Homo sapiens ORI sequence is being claimed. It would be remedial to amend the instant claim language to correct this simple typographical error such that it properly recites a Homo sapiens ORI sequence.
Claim 53 contains the trademark/trade name TALENs. 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 gene editing system and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 33-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang et al., 2016 (hereinafter Jiang).
Regarding claims 33-35, the Examiner notes that per MPEP § 2113, product-by-process claims are not limited to the manipulations of the recited steps-only the structure implied by the steps. Claim 33 is a product-by-process claim, as it recites “a hairpin loop ended, self-complementary, double-stranded, linear, covalently closed DNA vector obtainable by the process of claim 32.” Accordingly, any art that reads on the structure of the claimed product must be applied, as product-by-process claims are not limited to the manipulations of the recited steps. In the instant case and as set forth above, claim 33 is drawn to “a hairpin loop ended, self-complementary, double-stranded, linear, covalently closed DNA vector,” such as those disclosed in Jiang.
Jiang discloses dumbbell-shaped DNA minimal vectors (depicted in Figure 1c), wherein said dumbbell-shaped DNA minimal vectors are hairpin loop ended, self-complementary, double-stranded, linear, covalently closed DNA vectors, as instantly claimed. Thus, Jiang anticipates each and every product limitation of instant claim 33.
With regard to claim 34, which depends from claim 33 and recites “the hairpin loop ended, self-complementary, double-stranded, linear, covalently closed DNA vector of claim 33, wherein the genetic elements of the DNA vector are operably linked in the following order: a single-stranded DNA loop…a promoter…a coding sequence or sequence of interest…a transcriptional terminator sequence…and a single-stranded DNA loop,” as set forth above, Jiang anticipates each and every limitation of instant claim 33. Jiang further discloses that the dumbbell vectors taught therein comprise a single-stranded DNA loop, a promoter, a coding sequence (i.e. luciferase), a transcriptional terminator sequence, and a single-stranded DNA loop, as instantly claimed (Figure 4a; abstract; page 1582, column 2, paragraph 1). Thus, Jiang anticipates each and every product limitation of instant claim 34.
With regard to claim 35, which depends from claim 33 and recites “the hairpin loop ended, self-complementary, double-stranded, linear, covalently closed DNA vector of claim 33, wherein the vector is applicable to gene therapies,” as set forth above, Jiang anticipates each and every product limitation of instant claim 35. Jiang further discloses that the dumbbell vectors taught therein are suitable for therapeutic applications that require profound transient expression in primary cells ex vivo or in vivo but in which vector integration is neither required nor desirable (page 1588, column 2, paragraph 2). Thus, Jiang anticipates each and every product limitation of instant claim 35.
Conclusion
No claims are allowed.
Claims 33-35, 43, 51, and 53 are rejected.
Claims 31-62 are objected to, either for the reasons set above (see section Claim Objections) or by virtue of their dependency from another objected claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sarah E Allen whose telephone number is (571)272-0408. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at 571-272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH E ALLEN/ Examiner, Art Unit 1637
/J. E. ANGELL/ Primary Examiner, Art Unit 1637
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