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 .
Claim 21 has been cancelled.
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.
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.
Claims 1 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Pierce et al. (U.S. Patent Application Publication 2018/0318393 (and equivalent documents WO 2016/154473 and U.S. Patent No. 10,426,847) in view of Chen et al. (U.S. Patent Application Publication 2012/0121634), Jaroszeski et al. (U.S. Patent Application Publication 2018/0036529), and Donate et al. (2016).
U.S. Patent Application Publication 2018/0318393; WO 2016/154473; and U.S. Patent No. 10,426,847 are equivalent documents. U.S. Patent Application Publication 2018/0318393 will be referenced.
Pierce et al. discloses that systemic and local expression of a gene or cDNA encoded by a plasmid can be obtained with administration by in vivo electroporation. Use of in vivo electroporation enhances plasmid DNA uptake in tumor tissue, resulting in expression within the tumor, and delivers plasmids to muscle tissue, resulting in systemic expression of certain immunomodulatory molecules, such as cytokines. Pierce et al. discloses administering a plasmid coding for an immunostimulatory cytokine into the tumor by electroporation and administering a checkpoint inhibitor as a plasmid by electroporation. See at least claims 29 and 33. Table 1 discloses PD-1 as a checkpoint target. Table 2 discloses the immunostimulatory cytokine IL-12. See also claims 37-38. Treatment of melanoma is disclosed. See at least claim 39. See also at least abstract; claims; paragraphs [0006-0009, 0014-0017, 0033-0040].
Pierce et al. does not disclose administering to a non-tumor tissue or the use of heat in electroporation.
Chen et al. discloses electroporation of polynucleotides encoding checkpoint molecule PD-1 fragments as a DNA vaccine. Intramuscular electroporation is disclosed. Administration results in the production of anti-PD1 antibodies that are checkpoint inhibitors. See at least abstract; paragraphs [0113 and 0139]; and claims 2, 10-13, and 17-18.
Jaroszeski et al. discloses electroporation using impedance measurements that have been reduced by 80-95% compared to the pre-pulsed mean norm. Using impedance feedback control is disclosed. (See instant claim 1.) Impedance measurements in the 1 kHz to 3 kHz range are disclosed. (See instant claims 11 and 17.) Using electric field strengths of 100 V/cm, 150 V/cm, and 200 V/cm are disclosed. (See instant claims 18-19.) Pulse durations of 25 ms and 150 ms are disclosed. (See instant claim 20.) See at least abstract, claims, figures, and paragraphs [0020, 0026-0029, 0031].
Donate et al. discloses that plasmid electroporation by applying heat with gene electrotransfer increases expression with reduced voltage. The tissue was heated by infrared radiation. Heating to 43 degrees Celsius is disclosed. This would implicitly require monitoring temperature. (See instant claims 12 and 14-16.) Temperature was monitored using a thermocouple temperature probe. (See instant claim 13.) See at least abstract; sections 2.3, 2.4, and 2.5 on page 84; and page 84, left column, first full paragraph.
It would have been obvious to administer a first polynucleotide encoding IL-12, an immunostimulatory cytokine, to tumor tissue and administer a second polynucleotide encoding a PD-1 fragment (i.e. a DNA vaccine that would produce anti-PD-1 antibodies that are checkpoint inhibitors) to non-tumor tissue. Pierce et al. suggests administering at least two different plasmids by electroporation and Chen et al. makes clear that a polynucleotide encoding a PD-1 fragment (i.e. a DNA vaccine that would produce anti-PD-1 antibodies that are checkpoint inhibitors) could be administered to non-tumor tissue such as muscle. Pierce et al., Chen et al., Jaroszeski et al., and Donate et al. make clear that electroporation techniques within the claims would have been well known to those of ordinary skill in the art at the time of the effective filing date. In particular, Donate et al. discloses the advantages of using heat during electroporation. One would have been motivated to administer a first polynucleotide encoding IL-12, an immunostimulatory cytokine, to tumor tissue and administer a second polynucleotide encoding a PD-1 fragment (i.e. a DNA vaccine that would produce anti-PD-1 antibodies that are checkpoint inhibitors) to non-tumor tissue by electroporation with the use of heat as suggested by the combination of the prior art in order to treat cancers such as melanoma. The IL-12 encoded by the first polynucleotide would activate or maintain an immune response in the tumor tissue (e.g. an anti-tumor response) and the PD-1 fragment encoded by the second polynucleotide would activate an adaptive immune response (e.g. an antibody response).
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 1-20 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 1 is indefinite in reciting “an effective amount to activate or maintain an immune response in the tumor tissue” and “an effective amount to activate an adaptive immune response.” The specification does not provide a limiting definition of what is encompassed by the required immune responses, including what level or degree of activation is required and length of time (with respect to the maintenance limitation). Paragraphs [0050-0052] provide examples; however, the claims are not so limited. The metes and bounds of the claims cannot be determined.
Claim 1 recites “desired impedance.” While the specification provides an example of a desired impedance being at least a 10% reduction in impedance as compared to pre-pulse impedance (see claim 11), claim 1 is are not limited to this. See at least paragraph 0069]. It is unknown what criteria must be met for the “desired impedance.” The metes and bounds of the claim cannot be determined.
Claims 2 and 3 are confusing in reciting “combination thereof.” Each of first and second polynucleotides must encode a checkpoint molecule. It is unclear what the “combination” refers to.
Claim 6 is confusing in reciting “combination thereof.” Each of first and second polynucleotides must encode a cytokine or a chemokine. It is unclear what the “combination” refers to. If applicant intended that the first polynucleotide encoded a cytokine and the second polynucleotide encoded a chemokine (or vice versa) this is unclear.
Claim 10 is confusing in reciting that step (a) and/or step (b) in claim 1 is repeated on a different day. Steps (a) and (b) in claim 1 are not required to occur in any particular order. As claim 1 sets forth no particular timing, it is unclear if step (a) can be repeated before step (b) occurs. As claim 1 sets forth no particular timing, it is unclear if step (b) can be repeated before step (a) occurs. In the case where both steps (a) and (b) are repeated, must they both be repeated on the same “different day.” Clarification is requested.
Claim 12 is confusing in reciting “further comprising monitoring temperature.” This appears to be implicit to the method of claim 1 as both the tumor tissue and non-tumor tissue are being heated to a preset temperature. Clarification is requested.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are 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 claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 1 is directed to:
A method for bimodal immunotherapy in a subject, comprising
(a) delivering a first polynucleotide to a tumor tissue of the subject by a method that comprises:
(1) applying heat to the tumor tissue to heat the tumor tissue to a preset temperature; applying at least one electroporation pulse to deliver the first polynucleotide into the tumor tissue,
(2) measuring impedance of the tumor tissue as a feedback control mechanism after each pulse, and
(3) adjusting pulse parameters based on the measured impedance of the tumor tissue until desired impedance is reached indicating delivery of the first polynucleotide to the tumor tissue; and
(b) delivering a second polynucleotide to a non-tumor tissue of the subject by a method that comprises:
(1) applying heat to the non-tumor tissue to a preset temperature; applying at least one electroporation pulse to deliver the second polynucleotide into the tumor tissue,
(2) measuring impedance of the non-tumor tissue as a feedback control mechanism after each pulse, and
(3) adjusting pulse parameters based on the measured impedance of the tumor tissue until desired impedance is reached indicating delivery of the second polynucleotide to the non-tumor tissue,
wherein the first polynucleotide is delivered to the tumor tissue in an effective amount to activate or maintain an immune response in the tumor tissue, and
wherein the second polynucleotide is delivered to the non-tumor tissue in an effective amount to activate an adaptive immune response in the subject.
None of the examples deliver a first nucleotide to a tumor tissue as recited in claim 1 wherein the first polynucleotide is delivered to the tumor tissue in an effective amount to activate or maintain an immune response in the tumor tissue, followed by delivering a second nucleotide to a non-tumor tissue as recited in claim 1 wherein the second polynucleotide is delivered to the non-tumor tissue in an effective amount to activate an adaptive immune response in the subject.
Example 1 discloses IM electroporation of a single PD1ex plasmid (i.e. there is no second polynucleotide as required by claim 1). No heat appears to have been used. No plasmid appears to have been delivered to tumor tissue. See at least paragraphs [0025, 0076] and Figure 2. This plasmid does not encode the entirety of the checkpoint molecule PD1. It only encodes the murine PD1 extracellular region which is a soluble protein. See at least paragraphs [0074-0075]. Note that the claims are not directed to polynucleotides encoding fragments of checkpoint proteins or soluble forms of the checkpoint proteins that function as vaccines to generate anti-checkpoint protein antibodies. The antibodies produced after administering the plasmid encoding the soluble protein are checkpoint inhibitors. The claims are not directed to producing checkpoint inhibitors.
Example 2 discloses intratumoral delivery of plasmids encoding PD1 peptides alone or in combination with a plasmid encoding IL-12 using gene electrotransfer. No plasmids were delivered to non-tumor tissue. No heat was used except in the experiment shown in Figure 4. See at least paragraphs [0026-0027, 0078-0080] and Figures 3-4. The plasmid pPD1N encodes SEQ ID NO: 1 which is 10 amino acids. The plasmid pPD1P encodes SEQ ID NO: 3 is 26 amino acids. See at least paragraphs [0074 and 0078]. Again, these plasmids do not encode the entirety of the checkpoint molecule murine PD1 but rather fragments. The claims are not directed to polynucleotides encoding fragments of checkpoint proteins or soluble forms of the checkpoint proteins that function as vaccines to generate anti-checkpoint protein antibodies. The antibodies produced after administering the plasmid encoding the soluble protein are checkpoint inhibitors. The claims are not directed to producing checkpoint inhibitors.
The examples do not demonstrate or disclose the variety of immune responses encompassed by the limitations “wherein the first polynucleotide is delivered to the tumor tissue in an effective amount to activate or maintain an immune response in the tumor tissue, and wherein the second polynucleotide is delivered to the non-tumor tissue in an effective amount to activate an adaptive immune response in the subject.” See the examples of immune responses set forth in paragraphs [0050-0052]. The examples do not evaluate all adaptive immune responses in non-tumor tissue. The examples do not evaluate activation and maintenance of all immune response in the tumor tissue.
None of the examples have both the first and second polynucleotide encoding a checkpoint molecules. See claims 2-3.
None of the examples have both the first and second polynucleotide encoding a cytokine or chemokine. See claims 6-7.
None of the examples follow the dosing protocols of claim 8.
None of the examples appear to meet the temperature and electroporation limitations of claims 11 and 13-16. The examples do not provide any of these parameters, particularly temperature and manner with which heat was applied as well as impedance. None of the examples measure impedance and adjust the pulse parameters as in claim 1.
In particular, claims 1 and 8-20 are not limited to any particular first and second polynucleotides. The specification does not disclose sufficient first and second polynucleotides that will achieve the recited functions. The examples and disclosure do not provide adequate guidance and direction.
Claim 2 recites that the first and second polynucleotides encode any checkpoint molecule. Claim 3 recites some particular checkpoint molecules. The claims are not limited to the checkpoint molecules disclosed in paragraph [0056]. Note that a checkpoint molecule is not limited to molecules expressed on the cell surface of a tumor cell. Note that a checkpoint molecule is not the same thing as a checkpoint inhibitor.
Claim 6 recites that the first and second polynucleotides encode any cytokine or chemokine. Claim 7 recites some particular checkpoint molecules. The claims are not limited to the chemokines or cytokines disclosed in paragraph [0057].
The claims are not limited to any particular tumor tissue for applying heat and electroporating the first polynucleotide. As such, the claims include tumors that would be difficult to access such as tumors deep in the brain or internal organs. The examples use tumors established by injecting tumor cells into the flank of mice. The specification does not disclose how to perform the claimed method with respect to these inaccessible tumors. See in particular the temperatures and types of heat permitted by claims 14-16.
The claims are not limited to any particular non-tumor tissue for applying heat and electroporating the second polynucleotide. As such, the claims include non-tumor tissues that would be difficult to access such as structures deep in the brain or internal organs. The tumor and non-tumor tissues of the claims do not need to be near each other. Again, the specification does not disclose how to perform the claimed method with respect to these inaccessible non-tumor tissues. See in particular the temperatures and types of heat permitted by claims 14-16.
The examples do not perform the method recited in the claims and the breadth of what is encompassed by the claimed method is large and highly variable. It is not considered to be so predictable that all of the biological functions required by the claims would be achieved with the highly variant combinations of first and second polynucleotides and the highly variant combination of tumor and non-tumor tissues. Undue experimentation would be required.
The claims are not enabled.
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 and 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,814,129 (of record) in view of Pierce et al. (U.S. Patent Application Publication 2018/0318393 and Chen et al. (U.S. Patent Application Publication 2012/0121634).
The issued claims are directed to a method of delivering a molecule by electroporation by heating the biological structure as in instant claim 1 and having the limitations of instant claims 12-19 (see issued claims 3-9, respectively). The limitations of instant claim 20 are found in issued claims 11-12. The 10% impedance limitation in instant claim 11 is found in issued claims 1 and 14. Issued claim 13 indicates that the molecule delivered can be a therapeutic drug, gene, nucleic acid sequence, or plasmid DNA.
The issued claims do not specify that the method is repeated twice or identify the specific function of the delivered molecule.
Pierce et al. and Chen et al. are applied as above.
It would have been obvious to administer a first polynucleotide encoding IL-12, an immunostimulatory cytokine, to tumor tissue and administer a second polynucleotide encoding a PD-1 fragment (i.e. a DNA vaccine that would produce anti-PD-1 antibodies that are checkpoint inhibitors) to non-tumor tissue by using the electroporation method of the issued claims. Pierce et al. suggests administering at least two different plasmids by electroporation and Chen et al. makes clear that a polynucleotide encoding a PD-1 fragment (i.e. a DNA vaccine that would produce anti-PD-1 antibodies that are checkpoint inhibitors) could be administered to non-tumor tissue such as muscle. Pierce et al. and Chen et al. make clear that electroporation techniques would have been well known to those of ordinary skill in the art at the time of the effective filing date for administering these DNA vaccines and therapeutics. One would have been motivated to administer a first polynucleotide encoding IL-12, an immunostimulatory cytokine, to tumor tissue and administer a second polynucleotide encoding a PD-1 fragment (i.e. a DNA vaccine that would produce anti-PD-1 antibodies that are checkpoint inhibitors) to non-tumor tissue by electroporation with the use of heat according to the method of the issued claims in order to treat cancers such as melanoma. The IL-12 encoded by the first polynucleotide would activate or maintain an immune response in the tumor tissue (e.g. an anti-tumor response) and the PD-1 fragment encoded by the second polynucleotide would activate an adaptive immune response (e.g. an antibody response).
The instant claims are not patentably distinct from the issued claims in view of Pierce et al. and Chen et al.
Claims 1, 11-12, 14, and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-11, 13-18 of U.S. Patent No. 11,123,554 in view of Pierce et al. (U.S. Patent Application Publication 2018/0318393 and Chen et al. (U.S. Patent Application Publication 2012/0121634).
The issued claims are directed to a method of delivering an agent that can be a vaccine or a therapeutic by electroporation by heating the biological structure as in instant claim 1 and having the limitations of instant claims 12, 14, 17-20 (see at least issued claims 2 and 4-8, respectively). See also issued claims 13-18. The 10% impedance limitation in instant claim 11 is found in issued claims 1 and 10.
The issued claims do not specify that the method is repeated twice or identify the specific structure of the agent.
Pierce et al. and Chen et al. are applied as above.
It would have been obvious to administer a first polynucleotide encoding IL-12, an immunostimulatory cytokine, to tumor tissue and administer a second polynucleotide encoding a PD-1 fragment (i.e. a DNA vaccine that would produce anti-PD-1 antibodies that are checkpoint inhibitors) to non-tumor tissue by using the electroporation method of the issued claims. Pierce et al. suggests administering at least two different plasmids by electroporation and Chen et al. makes clear that a polynucleotide encoding a PD-1 fragment (i.e. a DNA vaccine that would produce anti-PD-1 antibodies that are checkpoint inhibitors) could be administered to non-tumor tissue such as muscle. Pierce et al. and Chen et al. make clear that electroporation techniques would have been well known to those of ordinary skill in the art at the time of the effective filing date for administering these DNA vaccines and therapeutics. One would have been motivated to administer a first polynucleotide encoding IL-12, an immunostimulatory cytokine, to tumor tissue and administer a second polynucleotide encoding a PD-1 fragment (i.e. a DNA vaccine that would produce anti-PD-1 antibodies that are checkpoint inhibitors) to non-tumor tissue by electroporation with the use of heat according to the method of the issued claims in order to treat cancers such as melanoma. The IL-12 encoded by the first polynucleotide would activate or maintain an immune response in the tumor tissue (e.g. an anti-tumor response) and the PD-1 fragment encoded by the second polynucleotide would activate an adaptive immune response (e.g. an antibody response).
The instant claims are not patentably distinct from the issued claims in view of Pierce et al. and Chen et al.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jaroszeski et al. (U.S. Patent No. 10,814,128, of record, and sited on search report) was published 27 October 2020 and filed 9 March 2020). It has a common applicant and common inventors (R. Heller and Jaroszeski) to the instant application. It is not by other and is not valid prior art against the instant claims under 35 USC 102(a)(2). It is not valid prior art under 35 USC 102(a)(1) in view of the exception under 35 USC 102(b)(1)(A). U.S. Patent No. 10,974,045 has claims directed to a system. It issued from a CON application of Jaroszeski et al., above. U.S. Patent No. 11,123,554 is a CIP application. The ‘045 and ‘554 patents are not by other and are also not valid prior art against the instant claims.
Tao et al. (U.S. Patent Application Publication 2003/0018006) discloses electroporating immunocytokine genes in an expression plasmid into muscle or cancer calls or at a site near an active cancer site. Immunocytokines such as IL-12, interferon-γ, and GM-CSF are disclosed. See at least paragraphs [0007-0010] and claims.
Conclusion
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/Marianne P Allen/Primary Examiner, Art Unit 1647
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