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 .
Detailed Action
This application is a National stage application of US application 17/127107, now abandoned, filed December 18, 2020, which is a continuation of US application 15/520452, now abandoned, filed April 20, 2017, which is a national stage application of PCT/US2015/058806, filed November 3, 2015, which claims benefit of provisional application 62/074878, filed November 4, 2014. Claims 1 and 4-20 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted May 7, 2024, is acknowledged wherein claims 1 and 4-11 are amended, claims 2 and 3 are canceled, and new claims 14-20 are introduced.
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 4 and 15 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.
These claims depend from base claims 1 and 14, which both claims methods for treating cystic fibrosis by administering a polyene macrolide to a subject. Dependent claims 4 and 15 both specify that the subject is not receiving the therapeutic agent to treat an infection. This limitation is ambiguous as to what it actually entails. For example it could be interpreted as requiring that the subject not suffer from any sort of infection that could be treated by administering a polyene macrolide. Alternately, this limitation could be taken as meaning that the polyene macrolide is not administered in a sufficient dose to produce a therapeutic effect for any infectious disease. Still further, this could be intended as a statement of intended use, which does not impose any practical limitation on the scope of the claims. Because it is not clear which of these interpretations is correct, these claims are indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 1, 4-6, 8-11, 14, 15, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stankov et al. (US patent 5880101, cited in PTO-1449)
Independent claim 1 claims a method for treating cystic fibrosis in a subject comprising administering to a subject in need thereof a pore-forming polyene macrolide. Dependent claims 5 and 6 and independent claim 14 specify that the pore-forming polyene macrolide is amphotericin B. Dependent claims 4 and 15 require that the subject not be receiving the macrolide to treat an infection. Dependent claim 8 requires that the polyene macrolide be administered systemically. Dependent claims 9, 10, and 17 claim administration as an aerosol and to an airway of a subject. Dependent claims 11 and 18 require that the subject is a human. Dependent claims 12, 13, 19, and 20 specify the age of the subject.
Stankov et al. discloses that polyene macrolides can be used to treat disease of cellular energy metabolism. (column 3 lines 46-57) Since the method described in the reference does not involve directly killing bacteria or fungi, it is not being administered to treat an infection. The active agent can be administered orally, intranasally, or topically. (column 4 lines 40-42) Cystic fibrosis is listed among the various diseases treatable in this manner. (column 32 lines 26-27) While nystatin is exemplified as a preferred embodiment other macrolide polyenes including amphotericin B can be used in the inventive method as well. (column 45 table 1) The compositions can furthermore be administered by inhalation, for example as aerosols. (column 39 lines 16-19) Therefore Stankov et al. anticipates the claimed invention.
Claims 1, 5, 6, 9-14, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Proesmans et al. (Reference included with PTO-1449)
Independent claim 1 claims a method for treating cystic fibrosis in a subject comprising administering to a subject in need thereof a pore-forming polyene macrolide. Dependent claims 5 and 6 and independent claim 14 specify that the pore-forming polyene macrolide is amphotericin B. Dependent claims 9, 10, and 17 claim administration as an aerosol and to an airway of a subject. Dependent claims 11 and 18 require that the subject is a human. Dependent claims 12, 13, 19, and 20 specify the age of the subject.
Proesmans et al. discloses that allergic pulmonary aspergillosis (APA) is a frequent complication of cystic fibrosis. (p. 1 left column first and second paragraphs) Furthermore Proesmans discloses administering inhaled amphotericin B to treat this condition. (p. 1 right column first paragraph) This therapy is therefore considered as being a method of treating cystic fibrosis comprising administering a polyene macrolide according to the present claims, thereby anticipating the claimed invention. Regarding claims 10 and 17, The amphotericin B was nebulized, which is reasonably considered as being in the form of an aerosol. (p. 1 right column last paragraph) Furthermore table I on p. 2 describes seven subjects, (see also p. 2 right column first paragraph – p. 5 right column third paragraph) who are all human beings. Some of these subjects are aged under 12 years as requires by claims 12 and 19, and some are over 12 years as requires by claims 13 and 20.
Therefore Proesmans et al. anticipates the present claims.
Claim Rejections - 35 USC § 103
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.
Claims 7, 12, 13, 16, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stankov et al. (US patent 5880101, cited in PTO-1449)
The disclosure of Stankov et al. is discussed above. Stankov et al. does not disclose the specific age of the subject being treated. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to administer the disclosed therapy to a patient who is either more than or less than 12 years old. As the reference discloses treatment of human subjects generally, choosing either of these patient populations would be merely a routine application of the disclosed invention.
Furthermore regarding instant claims 7 and 16, one of ordinary skill in the art would have found it to be obvious to adjust the dosage of the active agent to arrive at an optimum level of administration. Doing so would be within the ordinary and routine level of skill in the art.
Therefore the invention taken as a whole is prima facie obvious.
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, 4-7, and 9-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of U.S. Patent No. 12090164. (Cited in PTO-1449, herein referred to as ‘164) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘164 anticipate the present claims. Specifically, claim 1 of ‘164 claims a method of treating cystic fibrosis in a patient requiring administering to the patient a composition comprising amphotericin B to the airway of the subject, thereby anticipating present claims 1, 5, 6, 9, 14, and 16. The patient is also not described as having any infectious disease, and the amphotericin B is clearly not being administered to treat an infectious disease, anticipating claims 4 and 15. Claim 1 of ‘164 lists a number of CF mutations, which are present in humans, indicating that the subject is a human as recited in claims 11 and 18. Claim 3 of ‘164 specifies that the composition is administered as an aerosol, as recited in present claims 10 and 17.
Regarding claims 12, 13, 19, and 20, the claims of ‘164 do not specify the age of the subject. However, since every human subject has an age, and there is no indication that the age is critical, it would have been obvious to one of ordinary skill in the art at the time of the invention to administer the disclosed therapy to a patient who is either more than or less than 12 years old. As the reference claims disclose treatment of human subjects generally, choosing either of these patient populations would be merely a routine application of the disclosed invention.
Claims 1, 4-7, 9, 11-6, and 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 10, 11, 13, 14, and 16 of U.S. Patent No. 11850256. (Cited in PTO-1449, herein referred to as ‘256) Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘164 anticipate the present claims. Specifically, claims 1 and 6 of ‘256 claim a method of treating cystic fibrosis in a patient requiring administering to the patient a composition comprising amphotericin B as a dry powder, thereby anticipating present claims 1, 5, 6, 14, and 16. Dependent claims 5 and 10 further specify administration to the airway as recited in present claim 9. The patient is also not described as having any infectious disease, and the amphotericin B is clearly not being administered to treat an infectious disease, anticipating claims 4 and 15. Claims 10, 13, 14, and 16 of ‘256 list a number of CF mutations, which are present in humans, indicating that the subject is a human as recited in claims 11 and 18.
Regarding claims 12, 13, 19, and 20, the claims of ‘256 do not specify the age of the subject. However, since every human subject has an age, and there is no indication that the age is critical, it would have been obvious to one of ordinary skill in the art at the time of the invention to administer the disclosed therapy to a patient who is either more than or less than 12 years old. As the reference claims disclose treatment of human subjects generally, choosing either of these patient populations would be merely a routine application of the disclosed invention.
Claims 1, 4-7, and 9-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/886316 (reference application, pre-grant publication 2025/0000886, cited in PTO-1449, herein referred to as ‘316). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘316 anticipate the present claims. Specifically, claim 1 of ‘316 claims a method of treating cystic fibrosis in a patient requiring administering to the patient a composition comprising amphotericin B as an aerosol to the airway of a patient, thereby anticipating present claims 1, 5-7, 9, 10, 14, 16, and 17. The patient is also not described as having any infectious disease, and the amphotericin B is clearly not being administered to treat an infectious disease, anticipating claims 4 and 15. Claim 1 of ‘316 lists a number of CF mutations, which are present in humans, indicating that the subject is a human as recited in claims 11 and 18.
Regarding claims 12, 13, 19, and 20, the claims of ‘316 do not specify the age of the subject. However, since every human subject has an age, and there is no indication that the age is critical, it would have been obvious to one of ordinary skill in the art at the time of the invention to administer the disclosed therapy to a patient who is either more than or less than 12 years old. As the reference claims disclose treatment of human subjects generally, choosing either of these patient populations would be merely a routine application of the disclosed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 4-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31, 51, and 53-55 of copending Application No. 18/886318 (reference application, pre-grant publication 2025/0009775, cited in PTO-1449, herein referred to as ‘318). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘318 anticipate the present claims. Specifically, claim 13 of ‘318 claims a method of treating cystic fibrosis in a patient requiring administering to the patient a composition comprising amphotericin B, thereby anticipating present claims 1, 5-7, and 14. The patient is also not described as having any infectious disease, and the amphotericin B is clearly not being administered to treat an infectious disease, anticipating claims 4 and 15. Claim 51 specifies systemic administration anticipating present claim 8. Claims 53 and 54 specify administration to the airway as an aerosol, anticipating present claims 9, 10, and 17. Claim 55 of ‘318 lists a number of CF mutations, which are present in humans, indicating that the subject is a human as recited in claims 11 and 18.
Regarding claims 12, 13, 19, and 20, the claims of ‘316 do not specify the age of the subject. However, since every human subject has an age, and there is no indication that the age is critical, it would have been obvious to one of ordinary skill in the art at the time of the invention to administer the disclosed therapy to a patient who is either more than or less than 12 years old. As the reference claims disclose treatment of human subjects generally, choosing either of these patient populations would be merely a routine application of the disclosed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-7, and 9-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 43-45, and 52-55 of copending Application No. 19/318694 (reference application, unpublished, cited in PTO-892, herein referred to as ‘694). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘694 anticipate the present claims. Specifically, claim 1 of ‘694 claims a pharmaceutical composition comprising amphotericin B. Claims 43-45 of ‘694 further claim a method of pulmonary administration of this composition to a subject to treat a disease such as cystic fibrosis. Claims 52 and 53 specify administration to the airway as an aerosol. Claims 54 and 55 specify that the subject is a human having an age either less than 12 years or else 12 years or greater. Therefore the claims of ‘694 anticipate the present claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed in this action.
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/ERIC OLSON/ Primary Examiner, Art Unit 1693 10/31/2025