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 .
This action is in response to the amendment filed 10/14/2025, in which claims 139, 151, 152, 196, 199, 200, 203, 208 and 211 were amended, claims 197, 201, 202, 204 and 205 were previously presented and claims 95, 198, 206, 207, 209 and 210 were cancelled. Claims 139, 151, 152, 196, 197, 199-205, 208 and 211 are currently pending.
Applicant’s arguments have been thoroughly reviewed, but are not persuasive for the
reasons that follow. Any rejection and objections not reiterated in this action have been
withdrawn.
This action is FINAL.
Information Disclosure Statement
Receipt of acknowledgment of the information disclosure statement filed on 10/14/2025 have been received and all references have been considered.
Claim Objections
Claim 211 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 199. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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.
Claim 208 is 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 the amendment filed 10/14/2025.
Claim 208 is dependent upon a canceled claim (i.e., claim 207) and is therefore “incomplete.” See MPEP § 608.01(n)(V).
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.
The following is a new rejection, necessitated by the amendment filed 10/14/2025:
Claim 200 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. Claim 139 recites “…one or more expression control sequences operably linked to the sequence encoding a protein; and a wild-type or truncated 3' inverted terminal repeat (3' ITR) derived from a second genome of a member of the viral family Parvoviridae”. Claim 200 relies upon claim 139 and recites “wherein the sequence encoding a protein is operably linked to an expression control sequence” which does not further limit claim 139. Claim 200 does not further limit but merely recites the same limitation set forth in claim 139 by establishing that the expression control sequence must be operably linked to the sequence encoding a protein. 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.
Response to Amendments - Claim Rejections - 35 USC § 112
The rejection of claims 139, 151 and 209-211 under 35 U.S.C. 112(a) has been withdrawn in view of Applicant' s amendment to the claims 139, 151 and 211 as well as Applicant’s cancellation of claims 209 and 210.
Response to Amendments - Claim Rejections - 35 USC § 102
The previous rejection of claims 95, 196 and 200-205 under 35 U.S.C. 102(a)(1) over Bieniossek et al (Current Protocols in Protein Science, 51: 5.20.1-5.20.26; 2008) as evidenced by DeBoy et al (Journal of Bacteriology, Vol. 182, No. 11, pgs. 3310- 3313; 2000) has been withdrawn in view of Applicant' s amendment to the claims 196 and 200-205 as well as Applicant’s cancellation of claim 95.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 139, 196, 197, 200-205 and 208 are rejected under 35 U.S.C. 103 as being unpatentable over Bieniossek et al (Current Protocols in Protein Science, 51: 5.20.1-5.20.26; 2008) in view of Kerr et al (WO 2020/186207 A2). This rejection was made in the Office action mailed 07/11/2025 and has been rewritten to address the amendment to the claims in the reply filed 10/14/2025.
Regarding claim 139, Bieniossek teaches a composite bacmid comprising an insert into a mini-attTn7 site located within a Lacz reporter gene, which disrupts the reading frame (Figure 5.20.2). Bieniossek teaches the insert comprises first and second heterologous sequences within multiple cloning sites (Figure 5.20.1 and Figure 5.20.2). Bieniossek teaches the composite bacmid further comprising a LoxP site for site specific recombination (Figure 5.20.2). DeBoy is cited only to provide evidence that the att-Tn7 site is duplicated upon Tn7 insertion (Figure 1). Thus, the composite bacmid of Bieniossek contains duplicated att-Tn7 sites.
Bieniossek does not teach the composite bacmid where the first heterologous gene encodes a Rep protein. Bieniossek does not teach the second heterologous gene comprises from 5' to 3': a wild-type or truncated 5' inverted terminal repeat derived from a first genome of a member of the viral family Parvoviridae; a sequence encoding a protein; one or more expression control sequences operably linked to the sequence encoding a protein; and a wild-type or truncated 3' inverted terminal repeat derived from a second genome of a member of the viral family Parvoviridae.
Kerr teaches a recombinant bacmid comprising: a reporter gene wherein the reporter gene is Lacz and a Rep protein where the Rep protein is inserted into the Lacz reporter gene disrupting the gene expression [00525]. Kerr teaches recombination between the Rep-plasmid and a baculovirus shuttle vector in the DHl0Bac cells were induced to generate recombinant bacmids [00525]. Kerr teaches the recombinant bacmids were selected by a positive selection that included-blue-white screening in E. coli (Φ80dlacZL1Ml5 marker provides a complementation of the β-galactosidase gene from the bacmid vector) on a bacterial agar plate containing X-gal and IPTG; Isolated white colonies were picked and inoculated in 10 ml of selection media (kanamycin, gentamicin, tetracycline in LB broth) [00525]. Kerr teaches CeDNA-Baculovirus can be transiently transfected to the cells, be replicated by Rep protein and produce ceDNA vectors [00339]. Kerr teaches from 5' to 3' an expression cassette comprising: a 5' ITR, the expression control sequence operably linked to a promoter, posttranscriptional regulatory element such as woodchuck hepatitis virus (WPRE) and polyadenylation signal, and a 3' ITR (Page 269, Figure 1; [00519]). Kerr teaches an "expression cassette" includes a DNA coding sequence operably linked to a promoter [0071]. Kerr teaches expression of FVIII protein, they can include a highly active virus-derived immediate early promoter [00292]. Kerr teaches the expression control sequence comprises a 5' inverted terminal repeat and a 3' invented terminal repeat wherein the 5' ITR is derived from a parvovirus AA V2 and the 3' ITR is derived from a mutated parvovirus AAV2 (Page 269, Figure 1; [00518-00519]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bieniossek to include the heterologous sequence inserted into the reporter protein in order to disrupt the reporter function as taught by Kerr because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event and Kerr teaches the use of inserting a heterologous sequence, such as a Rep protein, the disrupts the expression of the reporter protein such as the Lacz gene.
One would have been motivated to make such a modification in order to receive the expected benefit of disruption of the reporter protein allowing for transient expression as taught by Kerr.
Regarding claim 196, Bieniossek teaches the insert comprises first and second heterologous sequences within multiple cloning sites (Figure 5.20.1 and Figure 5.20.2). Bieniossek teaches two genes each inserted into a first multiple cloning site (11) and second multiple cloning site (12) (Figure 5.20.1). Therefore, Bieniossek teaches a first heterologous sequence that is a gene.
Regarding claim 197, Bieniossek does not teach an expression control sequence operably linked to a sequence encoding a protein wherein the expression control sequence comprises a baculovirus promoter.
Kerr teaches an "expression cassette" includes a DNA coding sequence operably linked to a promoter [0071]. Kerr teaches expression of FVIII protein, they can include a highly active virus-derived immediate early promoter [00292].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bieniossek to include an expression control sequence operably linked to a sequence encoding a protein wherein the expression control sequence comprises a baculovirus promoter as taught by Kerr because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site specific recombination event and Kerr teaches expression of FVIII protein, that includes a highly active virus-derived immediate early promoter.
One would have been motivated to make such a modification in order to receive the expected benefit of targeted expression of the FVIII protein as taught by Kerr.
Regarding claim 200, Kerr teaches the ceDNA bacmid may comprise a desired FVIII protein sequence operably linked to control elements capable of directing transcription of the desired FVIII protein encoded by the exogenous DNA sequence when introduced into the subject [00418].
Regarding claims 201 and 202, Bieniossek does not teach the expression control sequence comprises a tissue-specific promoter, a polyadenylation signal, and/or a post-transcriptional regulatory element and wherein the tissue-specific promoter is a tristetraprolin (TTP) or a murine transthyretin (mTTR) promoter; the polyadenylation signal is a bovine growth hormone polyadenylation signal; and/or the post-transcriptional regulatory element is a woodchuck hepatitis virus post- transcriptional regulatory element (WPRE).
Kerr teaches the expression control sequence comprises a promoter, posttranscriptional regulatory element such as woodchuck hepatitis virus (WPRE) and polyadenylation signal (Page 269, Figure 1; [00519]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bieniossek to include the expression control sequence comprises a tissue-specific promoter, a polyadenylation signal, and/or a posttranscriptional regulatory element and wherein the tissue-specific promoter is a tristetraprolin (TTP) or a murine transthyretin (mTTR) promoter; the polyadenylation signal is a bovine growth hormone polyadenylation signal; and/or the post-transcriptional regulatory element is a woodchuck hepatitis virus post- transcriptional regulatory element (WPRE) as taught by Kerr because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event and Kerr teaches the expression control sequence comprises a promoter, posttranscriptional regulatory element such as woodchuck hepatitis virus (WPRE) and polyadenylation signal.
One would have been motivated to make such a modification in order to receive the expected benefit of targeted expression of the FVIII protein as taught by Kerr.
Regarding claim 203-205, Bieniossek does not teach the protein is a therapeutic protein and the therapeutic protein is a clotting factor, such as Factor VIII (FVIII) or FVIIIXTEN.
Kerr teaches the ceDNA bacmid may comprise a desired FVIII protein sequence operably linked to control elements capable of directing transcription of the desired FVIII protein encoded by the exogenous DNA sequence when introduced into the subject [00418].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bieniossek to include the protein is a therapeutic protein and the therapeutic protein is a clotting factor, such as Factor VIII (FVIII) or FVIII-XTEN as taught by Kerr because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event and Kerr teaches the ceDNA bacmid may comprise a desired FVIII protein sequence operably linked to control elements capable of directing transcription of the desired FVIII protein encoded by the exogenous DNA sequence when introduced into the subject.
One would have been motivated to make such a modification in order to receive the expected benefit of targeted expression of the FVIII protein as taught by Kerr.
Regarding claim 208, Bieniossek does not teach the first and second genome are the same or different; the 5’ ITR and the 3’ ITR are derived from a parvovirus selected from the group consisting of B19, GPV and HBoV1; the 5’ ITR is a wild-type or truncated 5’ ITR derived from B19, GPV or HBoV1; and/or the 3’ ITR is a wild-type or truncated 3’ ITR derived from B19, GPV or HBoV1.
Kerr teaches the use of the ITR derived from a Parvovirus B19 [00232]. Kerr teaches from 5’ to 3’ an expression cassette comprising: a 5’ ITR (wherein the 5’ ITR is a wildtype or mutant), the expression control sequence operably linked to a promoter, posttranscriptional regulatory element such as woodchuck hepatitis virus (WPRE) and polyadenylation signal, and a 3’ ITR (wherein the 3’ ITR is a wildtype or mutant) (Page 269, Figure 1; [00519]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bieniossek to the first and second genome are the same or different; the 5’ ITR and the 3’ ITR are derived from a parvovirus selected from the group consisting of B19, GPV and HBoV1; the 5’ ITR is a wild-type or truncated 5’ ITR derived from B19, GPV or HBoV1; and/or the 3’ ITR is a wild-type or truncated 3’ ITR derived from B19, GPV or HBoV1 as taught by Kerr because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event and Kerr teaches the use of the ITR derived from a Parvovirus B19 wherein the expression cassette has a sequence from 5’ to 3’ comprising: a 5’ ITR (wherein the 5’ ITR is a wildtype or mutant), the expression control sequence operably linked to a promoter, posttranscriptional regulatory element such as woodchuck hepatitis virus (WPRE) and polyadenylation signal, and a 3’ ITR (wherein the 3’ ITR is a wildtype or mutant).
One would have been motivated to make such a modification in order to receive the expected benefit of targeted expression with expression control sequences such as ITRs derived from parvovirus as taught by Kerr.
Claims 199 and 211 are rejected under 35 U.S.C. 103 as being unpatentable over Bieniossek et al (Current Protocols in Protein Science, 51: 5.20.1-5.20.26; 2008) in view of Kerr et al (WO 2020/186207 A2; International Filing Date: 03/13/2020), as applied to Claims 139, 196, 197, 200-205 and 208, in further view of Smith et al (Journal of Virology, Vol.73, No.4; April 1999, pg 2930-2937). This is a NEW rejection, necessitated by the amendment filed on 10/14/2025.
The teachings of Bieniossek and Kerr are described above and applied as before.
Regarding claims 199 and 211, Bieniossek and Kerr do not teach wherein the Rep protein is selected from the group consisting of a B19 rep, a HBoV1 rep and a GPV rep and wherein the sequence encoding the Rep protein is derived from a parvovirus selected from the group consisting of B19, GPV and HBoV1.
Smith teaches the comparison of the AAV and GPV nonstructural proteins, Rep78 and Rep1, respectively (Page 2930, Abstract) Smith teaches that Rep78 and Rep1 possess several biochemical activities in common, including (i) high-affinity DNA binding for sequences that constitute the minimal DNA replication origin; (ii) nucleoside triphosphate-dependent DNA helicase activity; and (iii) origin-specific replication of double-stranded linear DNA and the comparison resulted in the indication that GPV Rep1 and AAV Rep78 support a comparable mode of replication (Page 2930, Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of the parvovirus AAV2 rep protein to include the GPV Rep1 protein as taught by Smith because Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event, Kerr teaches a recombinant bacmid comprising: a reporter gene wherein the reporter gene is LacZ and a Rep protein where the Rep protein is inserted into the LacZ reporter gene disrupting the gene expression wherein the Rep protein is derived from parvovirus and can be an AAV2 Rep and Smith teaches GPV Rep1 and AAV Rep78 support a comparable mode of replication.
Thus, substitution of the AAv2 Rep protein derived from a parvovirus of Kerr, for the GPV Rep1 protein of Smith would have been prima facie obvious to one of ordinary skill in the art, and thus the invention as claimed is unpatentable over the work of the prior art. Substitution of one known method for another known method, the methods having equivalent effect, is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See MPEP 2143(I)(B).
Response to Amendments - Claim Rejections - 35 USC § 103
The previous rejection of claims 139 and 196-211 under 35 U.S.C. 103 over Bieniossek et al (Current Protocols in Protein Science, 51: 5.20.1-5.20.26; 2008) as evidenced by DeBoy et al (Journal of Bacteriology, Vol. 182, No. 11, pgs. 3310-3313; 2000) in view of Kerr et al (WO 2020/186207 A2) has been maintained in view of Applicant' s amendments to the claims 196, 197, 199-205, 208 and 211 as well as Applicant’s cancellation of claims 198, 206, 207, 209 and 210.
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive. Applicant’s arguments are not found persuasive because Applicant argues claim 139 is amended to recite a single recombinant bacmid comprising two key features: (1) a sequence encoding a Rep protein, wherein the Rep sequence disrupts the reading frame of a reporter gene; and (2) a heterologous sequence comprising a 5' inverted terminal repeat (ITR) from Parvoviridae, a sequence encoding a protein (e.g., a therapeutic protein), a 3' ITR from Parvoviridae, and expression control sequences and one important aspect of claim 139 is that both the Rep protein sequence and the ITR-flanked therapeutic transgene cassette are present in a single bacmid.
Bieniossek teaches a single bacmid system as recited above in the 35 U.S.C. 103 rejection of claim 139.
Applicant continues to argue that Bieniossek does not teach every element of the claimed invention and Kerr does not remedy those deficiencies in combination or alone. Applicant continues to argue that Kerr teaches a two-bacmid system where the Rep coding sequence is provided separately from the ceDNA-producing vector such as the Rep coding sequence is provided either via infection or transfection with a second Rep-containing vector (e.g., Rep-baculovirus, Rep-Bacmid, or Rep-plasmid) or through cell line stably expressing Rep. Applicant continues to argue that Kerr teaches away by teaching the two-bacmid system.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Bieniossek teaches it is within the ordinary skill in the art to use a recombinant bacmid comprising: a first heterologous sequence inserted into a first reporter gene, wherein the inserted heterologous sequence disrupts the reading frame of the first reporter gene; a first preferential target site capable of mediating a site-specific recombination event; a multiple cloning site comprising a second heterologous sequence; and a second preferential target site capable of mediating a site-specific recombination event and Kerr teaches the use of inserting a heterologous sequence, such as a Rep protein, the disrupts the expression of the reporter protein such as the Lacz gene. Therefore, one would have been motivated to make such a modification in order to receive the expected benefit of disruption of the reporter protein allowing for transient expression as taught by Kerr by a single bacmid system as taught by Bieniossek.
Allowable Subject Matter
Claims 151 and 152 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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 ALEXANDRA ROSE LIPPOLIS whose telephone number is (703)756-5450. The examiner can normally be reached Monday-Friday, 8:00am to 5:00pm EST.
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/ALEXANDRA ROSE LIPPOLIS/ Examiner, Art Unit 1637
/Jennifer Dunston/ Supervisory Patent Examiner, Art Unit 1637
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