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 .
Status of Claims
Claims 1, 7, 10-12, 14-15, 19, 21, 24, 26-27, 29-30, 33-34, 36, and 42-43 are present for examination.
Priority
Acknowledgment is made for this Application filed on 04/12/2024 which claims priority to provisional application 63/256,416 filed on 10/15/2021 and PCT/US2022/078165, filed on Oct 14th, 2022.
Objection – Specification
The disclosure is objected to for referring to color (blue, green, light blue) in either the figures themselves or the figure legends within the Specification. Note: references to black, white, and/or grey/gray are acceptable.
Objection – Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. See MPEP Patent Rules: 1.438 The abstract.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps. Extensive mechanical and design details of an apparatus should not be included in the abstract.
In addition, Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In the instant case:
The invention is drawn to electrotransfer of a therapeutic gene. The abstract does not state any of this.
The abstract is less than 50 words.
See MPEP 714 “Amendments, Applicant’s Action” for guidelines for the submission of amended patent abstracts. Briefly, a corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text, in accordance with 37 CFR 1.21(h).
Objection – Title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. See MPEP 606.01 “Examiner May Require Change in Title”.
The only agent in the claims and description including background, embodiments and working examples, that is described is a nucleic acid. Therefore, the following title is suggested: RESPIRATORY DELIVERY OF THERAPEUTIC NUCLEIC ACIDS.
Claim Objections
Claim 21 is objected to because of the following informalities: Claim 21 recites the limitation "has been" in line 2.
The recitation of limitations in past tense is unnecessary. Applicants may consider amending to: wherein the individual has a monogenic respiratory disease.
Appropriate correction is required.
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.
Claims 10 and 24 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 10 recites agent. The BRI of the term encompasses an entity that can perform an action or results in an output. With respect to a therapeutic agent this encompasses: small molecule, nucleic acid inhibitors, antibodies, aptamers,.. etc., However, the specification does not disclose any one of these agents with respect to therapeutic activity that may be introduced in to a cell by electroporation. The specification only discloses nucleic acid vectors as therapeutic agents. Further, claim 1, that recites a method of expressing a therapeutic sequence that the method of claim 10 depends from, is directed to a therapeutic sequence. Thus, the method is designed to electrotransfer a therapeutic sequence only. Thus the recitation of “agent” in instant claim controverts the design of the method it depends on.
Claim 24 recites the limitation "has been" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 that this claim depends from requires a step of “exposing the target airway cell to a synthetic circular DNA vector” (line 2). Claim 24 reads on such a step already having been carried out. Such a step is not recited in claim 1.
Claim Interpretation
The synthetic DNA of instant claims is being interpreted as per pg. 22: III. Synthetic Circular DNA Vectors of the instant specification; i.e., vectors persist intracellularly and feature one or more therapeutic sequences; all other limitations in this paragraph are interpreted as exemplary and not limiting the definition of synthetic. Thus, the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 7, 10-12, 14-15, 19, 21, 24, 26-27, and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malone (WO 03/013615 A1, IDS) and evidenced by CD Genomics website at <Plasmid Fact Sheet: Definition, Structure and Application | CD Genomics Blog> published September 25, 2019, 2 pgs. [retrieved on 5th Oct 2026].
Regarding claims 1 and 36, Malone teaches a method of introducing a molecule of interest into a cell of an intact organ, or part thereof, comprising: (a) administering said molecule via an epithelially-lined or endothelially-lined lumen connected to said organ and (b) applying a plurality of electrical pulses to said organ, wherein said pulses are sufficient to electroporate at least some cells of said organ (Claim 1); wherein the cell is an airway cell (claim 35; pg. 12, In 1-4, Exemplary of epithelially-lined lumens is an airway lumen, such as the trachea or bronchial tract)...; wherein said molecule is a polynucleotide encoding a therapeutic protein (Claim 11, polynucleotide encoding a protein or a peptide comprises a polynucleotide sequence selected from ..... CFTR gene.); wherein the polynucleotide can be any plasmid, RNA, or vector
containing a protein-encoding polynucleotide (pg. 13, In 16-17). As evidenced by CD Genomics, plasmids are synthetic (usually artificial, see pg. 1, The structure of a plasmid), circular (see Figure 2) and persist intracellularly (can autonomously replicate independently, see pg. 1, What is a plasmid?). thus, Malone’s plasmid reads on instant synthetic circular DNA.
Regarding claim 7, Malone teaches the therapeutic sequence can be cystic fibrosis transmembrane receptor (CFTR) (pg. 13, In 27; Claim 11).
Regarding claim 10, Malone teaches the method of claim 1, wherein said electrical pulse comprises a voltage between 200-500 V/cm of variable frequency and duration (Claim 38); i.e., less than 2,400 V.
Regarding claim 11, Malone teaches the method of claim 1 wherein 1 or about 2 to 10 pulses is administered (pg. 9, In 3-12, Preferably the number of pulses administered to an organ is between from about 2 to about 10 pulses. In a more preferred embodiment, the number of pulses administered to an organ of the instant invention is four pulses. ); i.e., 1-6 pulses of electrical energy are transmitted.
Regarding claims 12 and 14-15, Malone teaches the method of claim 1 wherein a duration of about 10 ms to about 20 ms is used, amplitude sufficient to generate a filed strength of 200 V/cm to about 500 V/cm (pg. 33, In 10-25, between from about 10 ms to about 20 ms….The frequency and the duration may be varied so long as the voltage applied to the tissue is from about 200 V/cm to about 500 V/cm.; (pg. 9, In 3-5, preferred embodiment, the electrical pulse comprises a voltage with electrical field strength of between about 200 to about 500 V/cm of variable frequency and duration.).
Regarding claim 19, Malone teaches the method of claim 1, wherein the electrical pulses are transmitted in situ in an individual by inserting a catheter comprising the electrode into an airway lumen of the individual (pg. 28, In 21-25, A cardioversion paddle may then be used in conjunction with the internalized electrode to generate an electrical field between the catheter electrode and the cardioversion paddle and to deliver a pulse or number of pulses to the chest cavity, specifically the lung.; pg. 11, In 21-24, an organ need not be exposed surgically, but instead is electroporated internally, through the use of catheter electrodes fed through vessels connected to the organ such that electrical pulses may be delivered inside the organ.).
Regarding claim 21, Malone teaches the method of claim 19 is particularly useful for treating cystic fibrosis (pg. 13, In 23-24).
Regarding claim 24, Malone teaches the method of claim 1 with local methods of administering the polynucleotide encoding the therapeutic protein (pg. 11, In 21-24, an organ need not be exposed surgically, but instead is electroporated internally, through the use of catheter electrodes fed through vessels connected to the organ such that electrical pulses may be delivered inside the organ.; pg. 21, In 1-8, plasmid DNA is injected through a catheter using an infusion pump ..... a wide variety of organs may be similarly targeted with a catheter, including, but not limited to the bladder, heart, lung, kidney, brain and liver.; pg. 35, In 8-9, In larger animals, the agent may be administered using a wide range of methods including bronchoscopic administration.).
Regarding claim 26, Malone teaches the method of claim 24 by administering via inhalation (pg. 19, In 6-8, delivered in the form of an aerosol spray from a pressurized pack or a nebulizer).
Regarding claim 27, Malone teaches the method of claim 1 by administering systemically (pg. 19, In 4-5, administering solution containing a molecule of interest is introduced into a vascular lumen).
Claim(s) 33 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Malone (WO 03/013615 A1, IDS).
Regarding claim 33, Malone teaches a method of delivering a therapeutic agent to a target airway cell in an individual (Claim 1, A method of introducing a molecule of interest into a cell of an intact organ, or part thereof, comprising: (a) administering said molecule via an epithelially-lined or endothelially lined lumen connected to said organ, and (b) applying a plurality of electrical pulses to said organ, wherein said pulses are sufficient to electroporate at least some cells of said organ.; pg. 13, In 16-18, any plasmid, RNA, or vector containing a protein-encoding polynucleotide can be introduced into a cell of an intact organ.);
the method comprising:
(i) inserting a catheter comprising an electrode into an airway lumen of the individual (pg. 11, In 21-24, an organ need not be exposed surgically, but instead is electroporated internally, through the use of catheter electrodes fed through vessels connected to the organ such that electrical pulses may be delivered inside the organ.; pg. 12, In 1-4, Exemplary of epithelially-lined lumens is an airway lumen, such as the trachea or bronchial tract.);
(ii) positioning the electrode in electrical communication with target airway cells of the individual (pg. 24, In 9-15, A catheter may comprise an electrode or a plurality of electrodes fixed to its outer surface so as to deliver electrical pulses to the internal areas of the organ.); and
(iii) transmitting one to ten pulses of electrical energy through the electrode for a field strength between 200-500 V/cm (pg. 8, In 3-12, the electrical pulse further comprises (a) a field strength between 200-500 V/cm, (b) a frequency of 1 Hz, and (c) a duration of between about 5 ms and 20 ms ..... Preferably the number of pulses administered to an organ is between from about 2 to about 1 0 pulses.; pg. 29, In 18-21, Results obtained via this latter approach indicate that electroporation of the lung, after instilling a plasmid through the bronchial airway, causes near a 100-fold increase in transfection activity of DNA into lung cells, compared to when electroporation is not used.).
Thus, Malone clearly anticipates instant claim 33.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The rejections below are directed to Applicants preferred embodiment of the cDNA being a cccDNA.
Claim(s) 1, 7, 10-12, 14-15, 19, 21, 24, 26-27, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malone (WO 03/013615 A1, IDS) in view of Schnepp (US 20210002667 A1, IDS).
Regarding claims 1 and 36, Malone teaches a method of introducing a molecule of interest into a cell of an intact organ, or part thereof, comprising: (a) administering said molecule via an epithelially-lined or endothelially-lined lumen connected to said organ and (b) applying a plurality of electrical pulses to said organ, wherein said pulses are sufficient to electroporate at least some cells of said organ (Claim 1); wherein the cell is an airway cell (claim 35; pg. 12, In 1-4, Exemplary of epithelially-lined lumens is an airway lumen, such as the trachea or bronchial tract)...; wherein said molecule is a polynucleotide encoding a therapeutic protein (Claim 11, polynucleotide encoding a protein or a peptide comprises a polynucleotide sequence selected from ..... CFTR gene.); wherein the polynucleotide can be any plasmid, RNA, or vector
containing a protein-encoding polynucleotide (pg. 13, In 16-17).
Regarding claim 7, Malone teaches the therapeutic sequence can be cystic fibrosis transmembrane receptor (CFTR) (pg. 13, In 27; Claim 11).
Regarding claim 10, Malone teaches the method of claim 1, wherein said electrical pulse comprises a voltage between 200-500 V/cm of variable frequency and duration (Claim 38); i.e., less than 2,400 V.
Regarding claim 11, Malone teaches the method of claim 1 wherein 1 or about 2 to 10 pulses is administered (pg. 9, In 3-12, Preferably the number of pulses administered to an organ is between from about 2 to about 10 pulses. In a more preferred embodiment, the number of pulses administered to an organ of the instant invention is four pulses. ); i.e., 1-6 pulses of electrical energy are transmitted.
Regarding claims 12 and 14-15, Malone teaches the method of claim 1 wherein a duration of about 10 ms to about 20 ms is used, amplitude sufficient to generate a filed strength of 200 V/cm to about 500 V/cm (pg. 33, In 10-25, between from about 10 ms to about 20 ms….The frequency and the duration may be varied so long as the voltage applied to the tissue is from about 200 V/cm to about 500 V/cm.; (pg. 9, In 3-5, preferred embodiment, the electrical pulse comprises a voltage with electrical field strength of between about 200 to about 500 V/cm of variable frequency and duration.).
Regarding claim 19, Malone teaches the method of claim 1, wherein the electrical pulses are transmitted in situ in an individual by inserting a catheter comprising the electrode into an airway lumen of the individual (pg. 28, In 21-25, A cardioversion paddle may then be used in conjunction with the internalized electrode to generate an electrical field between the catheter electrode and the cardioversion paddle and to deliver a pulse or number of pulses to the chest cavity, specifically the lung.; pg. 11, In 21-24, an organ need not be exposed surgically, but instead is electroporated internally, through the use of catheter electrodes fed through vessels connected to the organ such that electrical pulses may be delivered inside the organ.).
Regarding claim 21, Malone teaches the method of claim 19 is particularly useful for treating cystic fibrosis (pg. 13, In 23-24).
Regarding claim 24, Malone teaches the method of claim 1 with local methods of administering the polynucleotide encoding the therapeutic protein (pg. 11, In 21-24, an organ need not be exposed surgically, but instead is electroporated internally, through the use of catheter electrodes fed through vessels connected to the organ such that electrical pulses may be delivered inside the organ.; pg. 21, In 1-8, plasmid DNA is injected through a catheter using an infusion pump ..... a wide variety of organs may be similarly targeted with a catheter, including, but not limited to the bladder, heart, lung, kidney, brain and liver.; pg. 35, In 8-9, In larger animals, the agent may be administered using a wide range of methods including bronchoscopic administration.).
Regarding claim 26, Malone teaches the method of claim 24 by administering via inhalation (pg. 19, In 6-8, delivered in the form of an aerosol spray from a pressurized pack or a nebulizer).
Regarding claim 27, Malone teaches the method of claim 1 by administering systemically (pg. 19, In 4-5, administering solution containing a molecule of interest is introduced into a vascular lumen).
Malone does not teach a synthetic circular vector.
However, before the effective filing date of instant invention, Schnepp had taught pharmaceutical compositions that contain synthetic circular DNA vectors in monomeric form. Said synthetic vectors comprise a heterologous gene and a double D (DD) element. Synthetic DNA vectors having DD elements can persist intracellularly (e.g., in quiescent cells, such as post-mitotic cells) as episomes, e.g., in a manner similar to AAV vectors. Vectors provided in Schnepp can be naked DNA vectors, devoid of components inherent to viral vectors (e.g., viral proteins) and bacterial plasmid DNA, such as immunogenic components (e.g., immunogenic bacterial signatures (e.g., CpG islands or CpG motifs)) or components additionally or otherwise associated with reduced persistence (e.g., CpG islands or CpG motifs) (e.g. [0101] - [0103]). By eliminating the presence of immunogenic components (e.g., bacterial endotoxin, DNA, or RNA, or bacterial signatures, such as CpG motifs), the risk of stimulating the host immune system is reduced [0071]. Further advantages of synthetic circular vectors are in recitation from [0165]:
Monomeric DNA vectors were produced in which the vectors contain no bacterial plasmid DNA sequences and are synthesized entirely in a test tube (no replication in bacteria required). Therefore, the synthetic DNA vectors can endow a given target cell with transgene DNA that behaves like AAV viral DNA—without needing the virus itself. This strategy offers several advantages over viral vectors. First, it allows delivery of genes that are too large for packaging into common viral vectors. Furthermore, it enables repeat dosing, since there are no viral proteins that would trigger an immune response to prevent repeat dosing of another viral vector. In addition, the in vitro synthesis process has a greater potential for more efficient manufacturing relative to other viral vectors.
Schnepp taught an embodiment wherein the synthetic vector is an isolated circular DNA vector including one or more heterologous genes [0007] wherein the heterologous genes encode a therapeutic protein configured to treat a monogenic disease [0008].
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to have acted upon the various advantages disclosed by Schnepp and designed the synthetic circular DNA vectors for use in the method taught by Malone, and arrive at synthetic circular DNA vectors encoding a therapeutic gene for electroporation into an airway epithelial cell of claims 1, 7, 10-12, 14-15, 19, 21, 24, 26-27, and 36. One of ordinary skill in the art would be motivated to do so to obtain a superior vector to carry out a method with a therapeutic intent. One of ordinary skill in the art would have reasonable expectation of success in carrying out the substitution of Malone’s polynucleotides encoding a therapeutic sequence with a synthetic circular DNA vector encoding a therapeutic sequence because both Malone and Schnepp provide detailed methodology to carrying out the method and producing the synthetic circular DNA vectors, respectively. See MPEP 2144 II and MPEP 2143 B.
Claim(s) 29-30 and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Malone (WO 03/013615 A1, IDS) in view of Schnepp (US 20210002667 A1, IDS) as applied to claims 1, 7, 10-12, 14-15, 19, 21, 24, 26-27, and 36 above, and further in view of Waldstreicher (US 10702337 B2, IDS 04/12/2024).
Regarding claims, neither Malone nor Schnepp teach ablation using a pulsed electric field.
However, before the effective filing date of instant invention, Waldstreicher had taught a method for treating pulmonary tissues via delivery of energy, generally characterized by high voltage pulses, to target tissue using a pulmonary tissue modification system (e.g., an energy delivery catheter system) (Abstract). The method treats a portion of a wall of a lung passageway of a patient, the method comprising: positioning an electrode within a lumen of the lung passageway so that the electrode is able to transmit energy to the portion of the wall of the lung passageway; and providing an electrical signal to energize the electrode so as to transmit the energy up to and at least partially including a target layer within a mucosa of the portion of the wall of the lung passageway for a duration of treatment, wherein the target layer is an epithelial layer. (claims 21 and 23). The method results in partial ablation of the epithelial layer because Waldstreicher state in (115): Each energy dose delivered to the airway wall (W) maintains the temperature at or in the wall (W) below a threshold for thermal ablation, particularly thermal ablation of the basement membrane (BM).
It would have been obvious to one of ordinary skill in the art before the instant invention to modify the method of Malone nor Schnepp comprising electroporation of a synthetic circular DNA vector encoding a therapeutic gene into an airway epithelial cell by addition of an ablation step known to be a way of treating pulmonary tissues because it is prima facie obvious to combine two known methods into a single method for the same end-goal. The MPEP states:
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)
There would have been a reasonable expectation of success in making this modification because both the methods were disclosed in the prior art in detail and both methods required the same devices to carry out thus enabling easy combination. One of ordinary skill in the art would be motivated to make the combination to obtain a superior method to carry out a therapeutic method with greater success. See MPEP 2144 II and MPEP 2143 A.
Thus, Malone and Schnepp in view of Waldstreicher make obvious instant claims 29-30 and 42-43.
Claim(s) 34 is rejected under 35 U.S.C. 103 as being unpatentable over Malone (WO 03/013615 A1, IDS) in view of Waldstreicher (US 10702337 B2, IDS 04/12/2024).
The teachings of Malone with respect to claim 33 were discussed in the §102 rejection above. Claim 34 depends from claim 33.
Malone did not teach ablation using a pulsed electric field.
However, before the effective filing date of instant invention, Waldstreicher had taught a method for treating pulmonary tissues via delivery of energy, generally characterized by high voltage pulses, to target tissue using a pulmonary tissue modification system (e.g., an energy delivery catheter system) (Abstract). Further teachings of Waldstreicher with respect to ablation were taught in the §103 rejection above and similarly apply. Thus, Waldstreicher’s method results in partial ablation.
As discussed for instant claims 29-30 and 42-43, it would be obvious to combine Malone and Waldstreicher to arrive at instant claim 34. See MPEP 2144 II and MPEP 2143 A.
Thus, Malone in view of Waldstreicher make obvious instant claim 34.
Therefore the invention as a whole would have been prima facie obvious to one ordinary skill in the art before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 7, 10-12, 14-15, 19, 21, 24, 26-27, 29-30, 33-34, 36, and 42-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 67 and 69-70 of copending Application No. 18721403 (reference) in view of Schnepp (US 20210002667 A1, IDS) and Waldstreicher (US 10702337 B2, IDS 04/12/2024). The reference has common inventors and applicant.
Particularly, ref app claims 67, 69, and 70 read on instant claim 1. See below:
Present Application claim 1
‘403 application claims
A method of expressing a therapeutic sequence in a target airway cell, the method comprising: (i) exposing the target airway cell to a synthetic circular DNA vector comprising the therapeutic sequence, wherein the target airway cell is in electrical communication with an electrode;
and (ii) transmitting one or more pulses of electrical energy through the electrode at conditions suitable for electrotransfer of the synthetic circular DNA vector into the target airway cell, thereby expressing the therapeutic sequence.
67: A method of delivering an agent to a target cell in a hollow tissue, the method comprising: (a) providing a device comprising: (i) a catheter comprising: a proximal end and a distal end; a delivery lumen that runs from the proximal end of the catheter to a delivery port proximal to the distal end of the catheter; an elongate conductor that runs from the proximal end of the catheter to a lead proximal to the distal end of the catheter; and one or more inflation lumens that run from the proximal end of the catheter to a proximal inflation port proximal to the delivery port and a distal inflation port distal to the delivery port, wherein the distal inflation port is proximal to the distal end of the catheter; (ii) a proximal balloon disposed about the catheter over the proximal inflation port; (iii) a distal balloon disposed about the catheter over the distal inflation port; and (iv) an electrode disposed about the catheter proximal to the balloon, wherein the electrode is connected to the lead; (b) positioning the electrode within the hollow tissue, wherein the region of the hollow tissue radially adjacent to the electrode comprises the target cell; (c) flowing an inflation medium distally through the one or more inflation lumens to inflate the proximal balloon and the distal balloon such that each of the proximal balloon and distal balloon contacts the hollow tissue; (d) introducing the agent through the delivery lumen and the delivery port such that the agent contacts the region of the hollow tissue radially adjacent to the electrode; and (e) while the proximal and distal balloons are inflated, transmitting electrical energy through the electrode at conditions suitable for electrotransfer of the agent into the target cell.
69. The method of claim 67, wherein the agent is a nucleic acid vector.
70. The method of claim 69, wherein the nucleic acid vector is expressed in the hollow tissue.
The specification of the reference application describes “hollow tissue” to be lung. Specifically, in pg. 7, the ref application states: In some embodiments, the target cell is an airway epithelial cell.
The reference application does not recite the instant applicant’s “synthetic vector” in the claims. However, given the teachings of Schnepp in the §103 rejection above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized a synthetic circular DNA vector encoding a therapeutic protein as taught by Schnepp in place of the nucleic acid vector of the ref app, and utilized the same in the method recited in the reference application. Such substitution would have arrived at least at instant independent claim 1.
The reference application does not recite recitations of instant dependent claims namely, ablation using a pulsed electric field. However, given the teachings of Waldstreicher in the §103 rejection above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have performed a partial ablation taught by Waldstreicher, and included the same in the method recited in the reference application. Such substitution would have arrived at least at instant dependent claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Relevant Prior Art Not relied Upon
The following art is made note of and not currently relied on, but is relevant to applicants invention. Rodriguez et al., (US 20190336757 A1, IDS 04/12/2024) like the art of Malone applied in instant office action, have taught method of treating lungs by administering an effective dose of at least one plasmid coding for a therapeutic protein, administering electric pulse to allow transfer of a DNA plasmid in to the target area, for example. Also, like the primary reference, Rodriguez et al., do not teach a synthetic vector or partial ablation. The closest prior art is applied above.
Conclusion
No claims are allowed.
Correspondence
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SHABANA S. MEYERING, Ph.D.
Examiner
Art Unit 1635
/SHABANA S MEYERING/Examiner, Art Unit 1635
/CATHERINE KONOPKA/Primary Examiner, Art Unit 1635
