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 .
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 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.
Election/Restrictions – Rejoinder
Upon further review, the examiner has decided to withdraw the species election. All pending claims are subject to substantive examination.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Information Disclosure Statement
Applicant must provide legible copies of foreign patent and non-patent literature references cited on an information disclosure statement (IDS), unless those references were previously provided in the file record of a parent application. See MPEP 609.04(a)(II). In the IDS submitted on 17 July 2023, there are various references for which legible copies have not provided in the file record of the instant application, and were not provided in the file record of the parent applications. As such, these references have been crossed out by the examiner.
Claim Interpretation
Claim 1 recites the term “patient.” For the purposes of all prior art rejections, the examiner will interpret the term “patient” to refer to an organism who has received single lung transplant. The organism may be an adult human, a human child, or a non-human organism such as a mouse, rat, dog or cat. This distinction is relevant regarding the determination of an appropriate dosage of active ingredient in milligrams. Also, a method in which multiple agents are being administered to a patient including but not limited to inhaled prior art in which both inhaled cyclosporine and additional agents are administered to the patient, and pulmonary chronic graft rejection is prevented or treated is understood to meet this claim limitation.
Claim 1 is drawn to a method of preventing or treating pulmonary chronic graft rejection in single lung transplanted patients. The method entails administering inhaled cyclosporine. The examiner takes the position that prior art in which both inhaled cyclosporine and additional agents are administered to the patient, and pulmonary chronic graft rejection is prevented or treated is understood to meet this claim limitation. This is the case even in the absence of evidence that it is the inhaled cyclosporine, as opposed to the additional agents, that are doing the prevention and treating.
For the purposes of examination under prior art, the examiner understands that the term “nebulization time” refers to the time it takes for the dose volume to be nebulized. A method in which a 2 mL dose is nebulized for 5 minutes, but at the end of that 5 minutes, 1.25 mL of the dose has yet to be nebulized and administered is not understood to be indicative of a 5 minute nebulization time because the full dose has not been nebulized in 5 minutes.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 1-29 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 recites the phrase “standard of care.” The instant specification discloses the following on page 21, relevant text reproduced below.
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It is unclear whether the above-reproduced text describes an example of a standard of care, or whether the phrase “standard of care” limits the claimed invention to the above-indicated triple drug therapy. As such, it is unclear if a therapy comprising different drugs that are regularly used in the treatment of single lung transplanted patients or are administered by a route other than oral administration would be within the claim scope.
For the purposes of examination under prior art, the examiner will proceed with the assumption that the phrase “standard of care” is interpreted as oral drug therapy prescribed by physicians for single lung transplanted patients.
Note Regarding Declaration in Parent Application: The examiner notes that in parent application 17/086,254, a declaration was submitted to the file record of that application on 30 November 2022. The contents of that declaration have not been taken into account in the examiner’s determination of indefiniteness. Affidavits or declarations, such as those submitted under 37 CFR 1.132, filed during the prosecution of the prior application do not automatically become a part of this application. Where it is desired to rely on an earlier-filed affidavit or declaration, the applicant should make the remarks of record in this application and include a copy of the original affidavit or declaration filed in the prior application.
Claims 1-29 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, 5th and 6th lines, recites a daily dosage, which would have been understood to have referred to a once daily dosage. However, claims 28-29 recite that the formulation may be administered twice daily. As such, it is unclear whether the formulation is to be administered once daily or twice daily.
For the purposes of examination under prior art, the examiner will examine the claims with the understanding that the formulation may be administered once or twice daily. As such, the examiner will proceed with examination with the understanding that the maximum daily dosage of cyclosporine A administered by inhalation of liposomal cyclosporine A is 60 mg, as that is double the 30 mg maximum recited by claim 1. The examiner still understands the minimum dosage to be 2 mg of cyclosporine A.
Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 further recites cyclosporine as one or more additional active ingredients. However, claim 23 depends upon claim 1, which already recites administration of the cyclosporine. As such, it is unclear how the requirement of cyclosporine further limits the claim scope because cyclosporine, in a liposomal form, is already recited by claim 1 upon which claim 23 depends.
For the purposes of examination under prior art, the examiner will proceed with the understanding that the cyclosporine recited by claim 23 is other than the liposomal cyclosporine, as required by claim 13.
Claim Rejections - 35 USC § 103 – Obviousness
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.
Claims 1-6 and 11-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groves et al. (Journal of Aerosol Medicine and Pulmonary Drug Delivery, Vol. 23 No. 10, 2010, pages 31-39) in view of Behr et al. (Journal of Aerosol Medicine and Pulmonary Drug Delivery, Vol. 22, No. 2, 2009, pages 121-129) and Corcoran (Advanced Drug Delivery Reviews, Vol. 58, 2006, pages 1119-1127).
Groves et al. (hereafter referred to as Groves) is drawn to inhaled cyclosporine in lung transplant recipients, as of Groves, page 31, title and abstract. Groves teaches administration of a liquid aerosol of cyclosporine, as of Groves, page 32, left column, bottom paragraph. Groves also teaches administration of tacrolimus, azathioprine, and prednisone in addition to cyclosporine aerosol, as of Groves, page 32, right column, section entitled “Clinical management.” Groves is drawn to prevention of bronchiolitis obliterans, as of Groves, page 38, left column, last paragraph above “acknowledgements” section, wherein prevention of bronchiolitis obliterans is understood to be indicative of prevention of chronic graft rejection. Groves appears to teach improved lung function for patients receiving the cyclosporine as opposed to the placebo in single lung transplanted patients, as of Groves, at least on page 34, Tables 2 and 3. Groves teaches 100-300 mg of cyclosporine, as of Groves, page 32, left column, bottom paragraph, relevant text reproduced below.
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Groves does not teach liposomal cyclosporine.
Behr et al. (hereafter referred to as Behr) is drawn to administration of liposomal cyclosporine A by inhalation to patients after lung transplantation, as of Behr, page 121, title and abstract. Behr teaches single lung transplanted patients, as of Behr, “Results” section of abstract on page 121. Behr teaches that inhalation of the study medications (i.e. liposomal cyclosporine) was well tolerated, and led to only minor but statistically significant changes in lung function, as of Behr, page 121, results section of abstract. Behr teaches administration of prednisone, tacrolimus, and mycophenolate mofetil, as of Behr, page 123, right column, paragraph entitled “Patient Characteristics.”
Behr is not anticipatory because there is no evidence in Behr that the inhaled cyclosporine actually prevents or treats pulmonary chronic graft rejection in single lung transplanted patients.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted liposomal cyclosporine, as of Behr, in place of non-liposomal cyclosporine, as of Groves. Both liposomal and non-liposomal cyclosporine are known to be useful for administration via aerosol to patients who have undergone single lung transplantation, as this is taught by Behr and Groves. As such, the skilled artisan would have been motivated to have substituted liposomal cyclosporine, as of Behr, in place of non-liposomal cyclosporine, as of Groves, for predictable administration to a patient who has gone through a single lung transplant for predictable prevention of bronchiolitis obliterans syndrome with a reasonable expectation of success. The simple substitution of one known element (liposomal cyclosporine for inhalation, as of Behr) in place of another (non-liposomal cyclosporine for inhalation, as of Groves) to achieve predictable results (prevention of pulmonary chronic graft rejection) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
For the purposes of this rejection, the examiner takes the skilled artisan would not have actually expected the dosage of Behr to have prevented or treated pulmonary chronic graft rejection in a single lung transplanted patient, and that the dosage of Groves exceeds the required dosage.
Corcoran is drawn to inhaled delivery of aerosolized cyclosporine, as of Corcoran, page 1119, title and abstract. Use of inhaled cyclosporine for lung transplant patients is taught as of Corcoran, paragraph 1120, right column. Corcoran suggests that the amount of cyclosporine be delivered based upon body weight, as of Corcoran, page 1122, left column, second paragraph, wherein value of 3 mg/kg and 5 mg/kg are suggested for aerosol administration. Elsewhere in the document, Corcoran suggests a 300 mg dose, as of Corcoran, page 1121, left column.
It would have been prima facie obvious for one of ordinary skill in the art to have optimized the dosage of cyclosporine based upon the body weight of the patient to whom the cyclosporine is being delivered. Groves teaches 100-300 mg of cyclosporine, as of Groves, page 32, left column, bottom paragraph. However, Corcoran suggests that the amount of cyclosporine should be optimized based upon body weight. As such, the skilled artisan would have been motivated to have optimized the dosage in order to have provided an appropriate dose to a non-human patient or to a human patient of low weight (such as a child) to have predictably maximized benefit and minimized side effects with a reasonable expectation of success.
As to claim 1, the examiner understands the claim to require between 2 mg and 60 mg cyclosporine A daily; (see the above rejection under 35 U.S.C. 112(b) in which the examiner explains why 60 mg, rather than 30 mg, is understood to be the maximum daily dosage required by instant claim 1). Behr teaches doses of 10 mg and 20 mg, as of Behr, page 121, “Methods” section of abstract. These are within the claim scope. Additionally, Groves teaches a minimum dosage of 100 mg. The range of from 10 mg, as of Behr, and 100 mg, as of Groves, overlap with the claimed amounts. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). A range can be taught by multiple prior art references; see MPEP 2144.05(I), beginning of last paragraph in section.
As to claim 2, Behr teaches a dosage of 10 mg, as of Behr, page 121, “Methods” section of abstract.
As to claim 3, Groves teaches patient with a mean age of about 50 years, as of Groves, page 33, Table 1, demographic characteristics. The examiner understands these to be human patients of higher age.
As to claim 4, Behr teaches 4.8 mg of cyclosporine A per mL, as of Behr, page 124, left column, first paragraph in results section.
As to claim 5, Behr teaches a dose of 2 mL in one embodiment, as of page 122, left column, last three lines above “Materials and Methods” section.
As to claim 6, Behr teaches an “eFlow®” nebulizer, as of Behr, page 121, “conclusions” section of abstract. This is understood to read on the required nebulizer because it is the same nebulizer as disclosed in the instant specification e.g. at page 5 line 27.
As to claim 11, Behr appears to teach a 4 mL dosage on page 122, left column, end of paragraph above section entitled “Materials and Methods.”
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As to claim 12, Behr appears to teach a 2 mL dosage on page 122, left column, end of paragraph above section entitled “Materials and Methods.”
As to claim 13, Groves also teaches administration of tacrolimus, azathioprine, and prednisone in addition to cyclosporine aerosol, as of Groves, page 32, right column, section entitled “Clinical management,” reproduced below.
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This is understood to read on the additional requirements of this claim.
As to claim 14, Groves is drawn to prevention of bronchiolitis obliterans, as of Groves, page 38, left column, last paragraph above “acknowledgements” section.
As to claim 15, Groves teaches that chronic rejection is understood to be a loss of FEV1 of 20% or greater, as of Groves, page 31, right column, and onto page 32.
As to claim 16, Groves teaches chronic obstructive pulmonary disease, emphysema, and idiopathic pulmonary fibrosis (abbreviated as “IPF”) as of page 33, Table 1, section entitled “Diagnosis.”
As to claim 17, Groves teaches idiopathic pulmonary fibrosis (abbreviated as “IPF”) as of page 33, Table 1, section entitled “Diagnosis.”
As to claim 18, Groves teaches oral prednisone; see Groves, page 32, right column, section entitled “Clinical management,” reproduced above in regard to the rejection of claim 13.
As to claims 19-20, Behr teaches the following as of table 2 on page 123, reproduced below.
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While the mean nebulization time of 11.4 minutes is higher than the about 10 minutes required by the instant claims, the standard deviation of 1.9 minutes appears to indicate some overlap in nebulization time between the teachings of Behr and the claimed invention. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I). Additionally, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of administering liposomal cyclosporine A via nebulization has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum or workable ranges of nebulization time via routine experimentation.
As to claims 21-22, Groves teaches administration of tacrolimus, azathioprine, and prednisone in addition to cyclosporine aerosol, as of Groves, page 32, right column, section entitled “Clinical management.” Tacrolimus reads on the required mTor inhibitor and calcineurin inhibitor, prednisone reads on the required corticosteroid, and azathioprine reads on the required cell cycle inhibitor.
As to claim 23, Groves’s teaching of tacrolimus, azathiropine, and tacrolimus read on the required additional elements of this claim.
As to claim 24, Groves is drawn to prevention of bronchiolitis obliterans, as of Groves, page 38, left column, last paragraph above “acknowledgements” section. The skilled artisan would not have expected said prevention to have been perfect; however, the skilled artisan would have expected that imperfect prevention of bronchiolitis obliterans would have resulted in a delay of the onset of bronchiolitis obliterans.
As to claims 25-27, Groves appears to teach administration for 6 months to 48 months, as of Groves, page 35, Table 4. This overlaps with the claimed length of time at which administration occurs. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claims 28-29, Behr teaches once or twice daily dosing as of page 121, “Conclusions” section of abstract.
Claims 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groves et al. (Journal of Aerosol Medicine and Pulmonary Drug Delivery, Vol. 23 No. 10, 2010, pages 31-39) in view of Behr et al. (Journal of Aerosol Medicine and Pulmonary Drug Delivery, Vol. 22, No. 2, 2009, pages 121-129) and Corcoran (Advanced Drug Delivery Reviews, Vol. 58, 2006, pages 1119-1127), the combination further in view of Howard et al. (Current Respiratory Medicine Reviews, Vol. 10 No. 1, March 2014, 20 printed pages).
Groves is drawn to administration of aerosol cyclosporine to patients who have undergone a single lung transplantation. Behr is drawn to administration of aerosol liposomal cyclosporine. See the rejection above over Groves in view of Behr.
None of the above references teach the required features of the inhaler.
Howard et al. (hereafter referred to as Howard) is drawn to electronic monitoring of adherence to inhaled medication, specifically for asthma as of Howard, page 1, title and abstract. Howard reviews the advantages and limitations of various devices, as of Howard, page 11, Table 1, reproduced below.
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Howard does not teach cyclosporine A or the required patient population.
It would have been prima facie obvious for one of ordinary skill in the art to have used the devices of Howard with the medications of Groves and Behr. All of Groves and Behr are drawn to formulations for administration by inhalation. The devices of Howard are drawn to detecting adherence to inhaled medication. As such, the skilled artisan would have been motivated to have used the devices of Howard in order to have predictably measured patient adherence in the methods of Groves and Behr with a reasonable expectation of success. This would have been predictably useful in predictably determining whether the patient is benefiting from the medication with a reasonable expectation of success.
The examiner notes that Howard teaches asthma in the title. This differs from the diseases of Groves and Behr, which are drawn to preventing or treating graft rejection in a single lung transplanted patient. Nevertheless, the devices and methods of Howard appear to be applicable to medications to be administered by inhalation generically, as Howard teaches inhalers or device to be used with inhalers. As such, the devices and methods of Howard appear to be useful for administration of medication by inhalation, which is applicable to both the methods of Groves and Behr, as well as the method of the claimed invention.
As to claim 7, the majority of the devices of Howard measure date and time of administration, as of Howard, Table 1, reproduced above. Howard additionally teaches measuring of duration of administration in order to detect “dose dumping” (e.g. administration of too much of the dose at once), as of Howard, page 3, top paragraph on right.
As to claims 8-9, Howard teaches an adherence rate of 77%, as of Howard, page 3, left column, first paragraph in “relevant literature section. This is understood to read on the requirement that the formulation is inhaled as intended in over 65% and over 75% of the time.
As to claim 10, these claims recite that the inhaler is to produce a signal upon insufficient patient adherence. Howard teaches an LED display that shows feedback on adherence, as of Howard, page 4, right column, second paragraph. While Howard does not teach a percentage data at which adherence feedback is displayed, the skilled artisan would have been motivated to have optimized this percentage in view of Howard, page 2, left column, first two paragraphs. In this portion of the text, Howard teaches that poor adherence results in greater symptoms and possibly death. As such, a clinician would have been motivated to have optimized the level of adherence to notify the patient to the level at which said clinician believes that the patient is at risk. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of an electronic monitoring system on an inhaler are taught by Howard, as such, the skilled artisan would have been motivated to have optimized the level of non-adherence needed to provide a notification.
Non-Statutory 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 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,744,872. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a method of preventing or treating pulmonary chronic graft rejection in a single lung transplanted patient. This method entails administration of liposomal cyclosporine A as an aerosol in an amount ranging from between 2 mg and 30 mg, along with a standard of care regimen. Instant claim 3 recites a human patient of higher age.
The conflicting claims are drawn to a method of preventing or treating pulmonary chronic graft rejection in a single lung transplanted patient in a human patient of higher age. This method entails administration of liposomal cyclosporine A as an aerosol in an amount ranging from between 1 mg/mL to 5 mg/mL of a dose range of 1 to 3 mL, along with a standard of care regimen.
The instant and conflicting claims differ because the total dose of liposomal cyclosporine A differs. The conflicting claims appears to recite a minimum dosage of 1 mg and a maximum dosage of 15 mg, which is calculated by multiplying 5 mg/mL with 3 mL. In contrast, the instant claims recite a dosage of between 2 mg and 30 mg, though the actual daily dosage recited by the instant claims may be as higher as 60 mg. Nevertheless, the amount administered by the conflicting claims overlaps with the amount administered by the instant claims. This results in a prima facie case of obviousness-type non-statutory double patenting.
Claims 1-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,857,198. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a method of preventing or treating pulmonary chronic graft rejection in a single lung transplanted patient. This method entails administration of liposomal cyclosporine A as an aerosol in an amount ranging from between 2 mg and 30 mg, along with a standard of care regimen.
The conflicting claims are drawn to a method for preventing or treating pulmonary chronic graft rejection in a single lung transplanted patient. This method entails administering liposomal cyclosporine A by aerosol at a daily dosage of 10 mg along with tacrolimus, mycophenate mofetil, and prednisone.
The instant and conflicting claims differ because the conflicting claims specifically recite a dosage of 10 mg, which as the instant claims recite a dosage range of between 2 mg and 30 mg. Additionally, the conflicting claims specify tacrolimus, mycophenate mofetil, and prednisone, whereas the instant claims specify the broader “standard of care.” As such, the subject matter of the conflicting claims appears to be within the scope of that of the instant claims. As such, the subject matter of the conflicting claims effectively anticipates that of the instant claims, thereby resulting in a prima facie case of anticipatory-type non-statutory double patenting.
Close Patent with a Common Inventor – No Double Patenting
As a relevant patent with a common inventor, the examiner cites US patent 11,454,566, which has a common inventor. The claims of the ’566 patent are drawn to a method of administering liposomal cyclosporine via inhalation. However, the patient population of the claims of the ‘566 patent differs from that of the claimed invention. This is because the patient population of the claims of the ‘566 patent is drawn to double lung transplanted patients, whereas that of the instant application is drawn to single lung transplanted patients. Single and double lung transplanted patients are understood to be distinct patient populations for at least the following reason.
The examiner’s best understanding of data in the instant specification in figures 2 and 3 appears to indicate differing effects in double lung transplanted patients as compared with single lung transplanted patients; indicating that the single lung transplanted patients and the double lung transplanted patients do not appear to be substitutable for each other. In further support of this position, the examiner notes that figure 2, drawn to single lung transplanted patients, shows a fairly significant difference between the active agent and the placebo with respect to estimated survival function. In contrast, figure 3, drawn to double long transplanted patients, shows only a small difference between the active agent and the placebo with respect to estimated survival function.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612