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 .
Response to Arguments
Applicant's arguments filed on 07/20/2026 have been fully considered.
With regards to applicant’s argument under Remarks, “Rejections under 35 U.S.C. § 102 and 103 – Claims 1, 3, 9, and 30”, on pages 6-7, regarding the argument that Pirfenidone and pyridine analog compounds are not chemotherapeutic agents, with respect to the rejection of claim 1 under 35 U.S.C. 103 rejection, have been fully considered but they are not persuasive. The term “chemotherapeutic agent” is not limited to agents conventionally administered as cancer chemotherapy. Rather, “chemotherapy” is broadly defined, according to Merriam-Webster, as the therapeutic use of chemical agents to treat disease. Pirfenidone is a chemical therapeutic agent and is a pyridine compound, and therefore falls within the broad scope of a “chemotherapeutic agent”. Further, Pyridone compounds have been studied and reported as potential antitumor agents. Accordingly, Pirfenidone and pyridine is reasonably encompassed by the claimed “chemotherapeutic agent”.
With regards to applicant’s argument under Remarks, “Rejections under 35 U.S.C. § 102 and 103 – Claims 1, 3, 9, and 30”, on pages 7-8, regarding Surber not disclosing administering a liquid formulation with a concentration of a chemotherapeutic agent from about 2,000 ng/mL to about 50,000 ng/mL or at any concentration within the claimed range, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 rejection have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a previously applied reference.
With regards to applicant’s argument under Remarks, “Rejections under 35 U.S.C. § 103 – Claims 4-8 and 12-20”, on page 8, “Hsia does not disclose methods comprising administering a liquid formulation of a chemotherapeutic agent to the lung tissue and only discloses general language about how to determine dosages for administering a therapeutic.” have been considered but they are not persuasive. Hsia discloses treating lung disorders, including lung cancer (Para [0018]) and further discloses that the nanoparticles may include additional chemotherapeutic active agents, including cisplatin, carboplatin, mitaplatin, oxaliplatin, and irinotecan, and derivatives or prodrugs of any thereof (Para [0081]). Hsia further discloses that the nanoparticals may be administered by aerosol for delivery to the lungs (Para [0114]) and that administration of the aerosol varies according to the subject's age, weight and the severity and response of the symptoms (Para [0057]).
Thus, Hsia provides a teaching directed to lung disorders, including lung cancer, using chemotherapeutic agents and recognizes that the amount of a therapeutic composition administered to a subject may be determined based on factors including the physical and physiological characteristics of the subject, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration (Para [0053]). Accordingly, Hsia provides a reason for a skilled artisan to adjust the amount/concentration of the therapeutic composition based on the intended therapeutic application and characteristics of the subject.
Claim Objections
Claim 1 is objected to because of the following grammatical informalities:
Claim 1, line 4, reads “concentration of a chemotherapeutic agent”, should read, “concentration of the chemotherapeutic agent”
Appropriate correction is required.
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 1, 4-9, 12-20 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Surber (US Pub No. 20150196543 A1) in view of Hsia et al. (US Pub No. 20190262376 A1, herein, Hsia).
Regarding claim 1, Surber discloses a method for treating lung cancer in a subject, comprising: administering a liquid formulation (“aqueous solution” – Para [0005]) comprising a chemotherapeutic agent directly (“pirfenidone or a pyridine” – Para [0005]) to a lung tissue in the subject (“after administration of the inhaled dose, achieves lung deposition…” – Para [0005]), wherein the concentration of a therapeutic agent in the liquid formulation is from about 0.1 mg/ml (100,000 ng/mL) to about 20 mg/mL (20,000,000 ng/mL)(Para [0005]); and
Wherein the administering comprises locally bathing the lung tissue in the liquid formulation (“each inhaled dose is administered with a liquid nebulizer” – Para [0005]).
However, Surber does not disclose wherein the concentration of the chemotherapeutic agent is from about 2000 ng/mL to about 50000 ng/mL.
Hsia teaches a method for treating lung cancer (Para [0018]) in a subject comprising a formulation comprising a chemotherapeutic agent (“cisplatin, carboplatin, mitaplatin, oxaliplatin, and irinotecan, and derivatives or prodrugs of any thereof” – Para [0081]).
Hsia further teaches that the quantity of chemotherapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia also recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration, etc. (Para [0053]). Hsia further teaches that the claimed range is within a range understood to be appropriate for the intended use.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the liquid formulation of Surber to comprise a chemotherapeutic agent as taught by Hsia since Hsia teaches that a formulation comprising a chemotherapeutic agent is a well-known method to treat lung cancer.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the concentration of the chemotherapeutic agent of Surber, as modified, to have a concentration in the range between 2000 ng/mL to about 50000 ng/mL, as suggested by Hsia to give the appropriate dose for the individual subject. Further, applicant places no criticality on the range claimed, indicating simply that the concentration of a chemotherapeutic agent in the liquid formulation is from “liquid formulation is about 2000 … or 50000 ng/mL” (Para [0054]).
Regarding claim 4, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to explicitly disclose wherein the concentration of the chemotherapeutic agent in the liquid formulation is from about 30,000 ng/mL to about 50,000 ng/mL.
Hsia teaches that the quantity of chemotherapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia further recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration, etc. (Para [0053]). Hsia further teaches that the claimed range is within a range understood to be appropriate for the intended use.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the concentration of the chemotherapeutic agent of Surber, as modified, to have a concentration in the range between 30,000 ng/mL to about 50,000 ng/mL, as suggested by Hsia to give the appropriate dose for the individual subject. Further, applicant places no criticality on the range claimed, indicating simply that the concentration of a chemotherapeutic agent in the liquid formulation is from “30,000 ng/mL to about 50,000 ng/mL” (Para [0044]).
Regarding claim 5, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to explicitly disclose wherein the concentration of the chemotherapeutic agent in the liquid formulation is from about 2,000 ng/mL to about 20,000 ng/mL.
Hsia teaches that the quantity of therapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia further recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration, etc. (Para [0053]). Hsia further teaches that the claimed range is within a range understood to be appropriate for the intended use.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the concentration of the chemotherapeutic agent of Surber, as modified, to have a concentration in the range between 2,000 ng/mL to about 20,000 ng/mL, as suggested by Hsia to give the appropriate dose for the individual subject. Further, applicant places no criticality on the range claimed, indicating simply that the concentration of a chemotherapeutic agent in the liquid formulation is from “2,000 ng/mL to about 20,000 ng/mL” (Para [0044]).
Regarding claim 6, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to explicitly disclose wherein the administration results in a plasma Cmax for the chemotherapeutic agent that is less than about 100 ng/mL.
Hsia teaches that the quantity of therapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia further recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration, etc. (Para [0053]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the administration results in a plasma Cmax for the chemotherapeutic agent of Surber, as modified, so that it is less than about 100 ng/mL, as suggested by Hsia, since the administration results of the plasma Cmax would depend on the appropriate dosage amount administered to the subject.
Regarding claim 7, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to explicitly disclose wherein the administration results in a plasma Cmax for the chemotherapeutic agent that is less than about 40 ng/mL.
Hsia teaches that the quantity of therapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia further recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration, etc. (Para [0053]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the administration results in a plasma Cmax for the chemotherapeutic agent of Surber, as modified, so that it is less than about 40 ng/mL, as suggested by Hsia, since the administration results of the plasma Cmax would depend on the appropriate dosage amount administered to the subject.
Regarding claim 8, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to explicitly disclose wherein the administration results in a plasma Cmax for the chemotherapeutic agent that is less than about 30 ng/mL.
Hsia teaches that the quantity of therapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia further recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration, etc. (Para [0053]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the administration results in a plasma Cmax for the chemotherapeutic agent of Surber, as modified, so that it is less than about 30 ng/mL, as suggested by Hsia, since the administration results of the plasma Cmax would depend on the appropriate dosage amount administered to the subject.
Regarding claim 9, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to explicitly wherein the administration results in a plasma Cmax for the chemotherapeutic agent that is less than 15% of the plasma Cmax for the chemotherapeutic agent from systemic administration.
Hsia teaches that the quantity of therapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia further recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration, etc. (Para [0053]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the administration results in a plasma Cmax for the chemotherapeutic agent of Surber, as modified, so that it is less than 15% of the plasma Cmax for the chemotherapeutic agent from systemic administration, as suggested by Hsia, since the administration results of the plasma Cmax would depend on the appropriate dosage amount administered to the subject.
Regarding claim 12, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to explicitly disclose wherein the administration results in a plasma Cmax for the chemotherapeutic agent that is less than 1% of the plasma Cmax for the chemotherapeutic agent from systemic administration.
Hsia teaches that the quantity of therapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia further recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration etc. (Para [0053]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the administration results in a plasma Cmax for the chemotherapeutic agent of Surber, as modified, so that it is less than 1% of the plasma Cmax for the chemotherapeutic agent from systemic administration, as suggested by Hsia, since the administration results of the plasma Cmax would depend on the appropriate dosage amount administered to the subject.
Regarding claim 13, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to explicitly disclose wherein the administration results in a plasma Cmax for the chemotherapeutic agent that is less than 0.1% of the plasma Cmax for the chemotherapeutic agent from systemic administration.
Hsia teaches that the quantity of therapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia further recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration etc. (Para [0053]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the administration results in a plasma Cmax for the chemotherapeutic agent of Surber, as modified, so that it is less than 0.1% of the plasma Cmax for the chemotherapeutic agent from systemic administration, as suggested by Hsia, since the administration results of the plasma Cmax would depend on the appropriate dosage amount administered to the subject.
Regarding claim 14, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to explicitly disclose wherein the administration results in a plasma Cmax for the chemotherapeutic agent that is less than 0.5% of the plasma Cmax for the chemotherapeutic agent from systemic administration.
Hsia teaches that the quantity of therapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia further recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration etc. (Para [0053]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the administration results in a plasma Cmax for the chemotherapeutic agent of Surber, as modified, so that it is less than 0.5% of the plasma Cmax for the chemotherapeutic agent from systemic administration, as suggested by Hsia, since the administration results of the plasma Cmax would depend on the appropriate dosage amount administered to the subject.
Regarding claim 15, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to explicitly disclose wherein the administration results in a plasma Cmax for the chemotherapeutic agent that is less than 0.05% of the plasma Cmax for the chemotherapeutic agent from systemic administration.
Hsia teaches that the quantity of therapeutic composition to be administered, according to unit dose, depends on effect desired. Hsia further recognizes that the actual dosage amount of the therapeutic composition administered to a subject is determined by physical and physiological factors, such as body weight, age, health, sex of the subject, previous or concurrent therapeutic interventions, idiopathy of the patient, the route of administration etc. (Para [0053]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have optimized the administration results in a plasma Cmax for the chemotherapeutic agent of Surber, as modified, so that it is less than 0.05% of the plasma Cmax for the chemotherapeutic agent from systemic administration, as suggested by Hsia, since the administration results of the plasma Cmax would depend on the appropriate dosage amount administered to the subject.
Regarding claim 16, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber, as modified, fails to expressly disclose wherein the liquid formulation further comprises dextrose, sodium chloride, potassium chloride, calcium chloride, sodium bicarbonate or combinations thereof.
Hsia teaches a liquid formulation further comprising dextrose, sodium chloride, potassium chloride, calcium chloride, sodium bicarbonate or combinations thereof (“sodium chloride” – Para [0052], “drug or therapeutic agent, may be dissolved or dispersed in a pharmaceutically acceptable carrier” – Para [0111]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the liquid formulation disclosed by Surber to further comprise sodium chloride as taught by Hsia since sodium chloride is an aqueous solvent that can be used to dissolve the therapeutic medication in, optimizing the drug's properties for a safe and effective delivery to the lungs.
Regarding claim 17, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber fails to expressly disclose wherein the liquid formulation further comprises saline solution.
Hsia teaches a liquid formulation further comprising saline solution (“saline” – Para [0052], “drug or therapeutic agent, may be dissolved or dispersed in a pharmaceutically acceptable carrier” – Para [0111]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the liquid formulation disclosed by Surber to further comprise saline as taught by Hsia since saline is an aqueous solvent that can be used to dissolve the therapeutic medication in, optimizing the drug's properties for a safe and effective delivery to the lungs.
Regarding claim 18, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber fails to expressly disclose wherein the liquid formulation further comprises Ringer’s solution.
Hsia teaches a liquid formulation further comprises Ringer's solution (“Ringer’s dextrose” – Para [0052], “drug or therapeutic agent, may be dissolved or dispersed in a pharmaceutically acceptable carrier” – Para [0111]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the liquid formulation disclosed by Surber to further comprise Ringer’s solution as taught by Hsia since Ringer’s solution is an aqueous solvent that can be used to dissolve the therapeutic medication in, optimizing the drug's properties for a safe and effective delivery to the lungs.
Regarding claim 19, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber fails to expressly disclose wherein the chemotherapeutic agent is vinblastine, vinorelbine, irinotecan, paclitaxel, docetaxel, epirubicin, doxorubicin, capecitabine, etoposide, topotecan, pemetrexed, carboplatin, fluorouracil, gemcitabine, oxaliplatin, cisplatin, trastuzumab, ramucirumab, bevacizumab or combinations thereof.
Hsia teaches a liquid formulation comprising a chemotherapeutic agent that is paclitaxel (“paclitaxel” – Para [0131]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the liquid formulation disclosed by Surber to comprise a chemotherapeutic agent that is paclitaxel as taught by Hsia since paclitaxel is a compound that is administered in the treatment of cancer to kill cancer cells (Hsia, Para [0130]).
Regarding claim 20, Surber, as modified, discloses the method for treating lung cancer set forth above, but Surber fails to expressly disclose wherein the chemotherapeutic agent is paclitaxel, cisplatin, levofloxacin or combinations thereof.
Hsia teaches a liquid formulation comprising a chemotherapeutic agent that is paclitaxel (“paclitaxel” – Para [0131]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the liquid formulation disclosed by Surber to comprise a chemotherapeutic agent that is paclitaxel as taught by Hsia since paclitaxel is a compound that is administered in the treatment of cancer to kill cancer cells (Hsia, Para [0130]).
Regarding claim 30, Surber, as modified, discloses the method for treating lung cancer set forth above, wherein the administering comprises filling all or part of the lung with the liquid formulation (Para [0012]).
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.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
