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
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 28 October 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. The instant application is a national stage entry of PCT/EP2022/073003 filed 17 August 2022. Claims 1-4, 6, 8-9, 11-15, 18, 38-43, and 45 are currently pending. Claims 5, 7, 10, 16-17, 19-37, 44, and 46-47 are cancelled. Claims 1-4, 6, 8-9, 11-15, 18, 38-43, and 45 are examined on the merits within.
Claim Rejections – 35 U.S.C. 112(b)
3. 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.
4. Claims 4, 18, and 45 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.
5. Claim 4 recites “wherein the polyethylene glycol has a molecular weight of between about 500 to about 5000 Daltons.” The term “about” is not defined in the specification. Does about 500 refer to 490 Daltons, 400 Daltons, etc.? Since the term is not defined, both the upper and lower endpoints of the range cannot be determined. Claims 18 and 45 are included in this rejection for the same deficiencies regarding a molecular weight of between about 2000 to about 5000 Daltons.
Claim Rejections – 35 U.S.C. 102
6. 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.
7. Claim(s) 1-4, 6, 8-9, 11-13, 18, 38-41, 43 and 45 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henry et al. (WO2017064289).
Regarding instant claims 1 and 18, Henry et al. disclose a composition comprising a biologically active polypeptide or protein and a colloidal particle comprising an amphipathic lipid derivative with a biocompatible hydrophilic polymer. See claim 1. The colloidal particle comprises palmitoyl-oleoyl phosphatidyl choline (component i) and 1,2-distearoyl-sn-glycero-3-phosphoethanol-amine (DSPE) (component ii). See claim 10. The composition may additionally comprise a nonionic surfactant selected from polyoxyethylene sorbitans, polyhydroxyethylene stearates or polyhydroxyethylene laurylethers (component iii). See page 16. The ratio of phospholipid to surfactant may be from 30:1 to 15:1. See page 16.
Regarding instant claim 2, the biocompatible hydrophilic polymer may be a polyalkylether, polylactic acid or polyglycolic acid. See page 5.
Regarding instant claim 3, the biocompatible polymer may be polyethylene glycol. See page 6.
Regarding instant claim 4, the polyethylene glycol may have a molecular weight between 500 and 5000 Daltons. See page 6.
Regarding instant claim 6, Henry et al. disclose 1,2-distearoyl-sn-glycero-3-phosphoethanol-amine-N-[poly-(ethyleneglycol)-2000] (DSPE-PEG 2000). See page 6.
Regarding instant claim 8, the phosphatidylcholine may be 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine. See page 5.
Regarding instant claim 9, the phosphatidylcholine to 1,2-distearoyl-sn-glycero-3-phosphoethanol-amine (DSPE) is in a ratio of 90 to 99: 10 to 1. See page 5.
Regarding instant claim 11, Henry et al. disclose polysorbate 80 (Tween 80) as the surfactant. See page 16. The instant specification states that polysorbate 80 is polyoxyethylene (20) sorbitan monooleate. See page 8.
Regarding instant claim 12, Table 4 shows formulations comprising 68.7 mg/ml soy phosphotidylcholine, 7.6-9 mg/ml MPEG-2000-DSPE, and 8.5 mg/ml polysorbate 80. This equates to 68.7:7.6:8.5 which falls within the claimed range.
Regarding instant claims 13 and 39, Example 3 uses the liposomes with Factor VIII molecules. See Example 3 and claim 22.
Regarding instant claim 38, the composition is used to treat hemophilia. See page 3.
Regarding instant claims 40-41, hemophilia can be A, B or C. See page 3.
Regarding instant claims 43 and 45, Henry teach a kit comprising the components. See claim 26.
Thus the instant claims are anticipated by Henry et al.
Claim Rejections – 35 U.S.C. 103
8. 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.
9. Claim(s) 1-4, 6, 8-9, 11-15, 18, 38-43 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Henry et al. (WO2017/064289).
Regarding instant claims 1 and 18, Henry et al. teach a composition comprising a biologically active polypeptide or protein and a colloidal particle comprising an amphipathic lipid derivative with a biocompatible hydrophilic polymer. See claim 1. The colloidal particle comprises palmitoyl-oleoyl phosphatidyl choline (component i) and 1,2-distearoyl-sn-glycero-3-phosphoethanol-amine (DSPE) (component ii). See claim 10. The composition may additionally comprise a nonionic surfactant selected from polyoxyethylene sorbitans, polyhydroxyethylene stearates or polyhydroxyethylene laurylethers (component iii). See page 16. The ratio of phospholipid to surfactant may be from 30:1 to 15:1. See page 16.
Regarding instant claim 2, the biocompatible hydrophilic polymer may be a polyalkylether, polylactic acid or polyglycolic acid. See page 5.
Regarding instant claim 3, the biocompatible polymer may be polyethylene glycol. See page 6.
Regarding instant claim 4, the polyethylene glycol may have a molecular weight between 500 and 5000 Daltons. See page 6.
Regarding instant claim 6, Henry et al. teach 1,2-distearoyl-sn-glycero-3-phosphoethanol-amine-N-[poly-(ethyleneglycol)-2000] (DSPE-PEG 2000). See page 6.
Regarding instant claim 8, the phosphatidylcholine may be 1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine. See page 5.
Regarding instant claim 9, the phosphatidylcholine to 1,2-distearoyl-sn-glycero-3-phosphoethanol-amine (DSPE) is in a ratio of 90 to 99: 10 to 1. See page 5.
Regarding instant claim 11, Henry et al. teach polysorbate 80 (Tween 80) as the surfactant. See page 16. The instant specification states that polysorbate 80 is polyoxyethylene (20) sorbitan monooleate. See page 8.
Regarding instant claim 12, Table 4 shows formulations comprising 68.7 mg/ml soy phosphotidylcholine, 7.6-9 mg/ml MPEG-2000-DSPE, and 8.5 mg/ml polysorbate 80. This equates to 68.7:7.6:8.5 which falls within the claimed range.
Regarding instant claims 13 and 39, Example 3 uses the liposomes with Factor VIII molecules. See Example 3 and claim 22.
Regarding instant claim 38, the composition is used to treat hemophilia. See page 3.
Regarding instant claims 40-41, hemophilia can be A, B or C. See page 3.
Regarding instant claims 43 and 45, Henry et al. teach a kit comprising the components. See claim 26.
Henry et al. teach the disease or condition may be characterized by a loss of function of the native biologically active polypeptide or protein in a subject. Such diseases include blood factor diseases, growth disorders, growth hormone deficiency, prediabetes, diabetes, etc. See page 3.
Method E requires dissolving the compounds used for liposome preparation (lipids antioxidants, etc.) in a polar-protic water miscible solvent such as tert-butanol. This solution is then mixed with an aqueous solution or dispersion containing the blood factor. The mixing is performed at the optimum volume ratio required to maintain activity. See page 12.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the ratio of Factor VIII molecule and colloidal particle to maintain the activity of the active ingredient thereby achieving the desired therapeutic effect. Henry et al. teach administering to a subject with a condition characterized by loss of function of the native biologically active polypeptide or protein. It would have been well within the purview of the skilled artisan to administer the formulation to a pediatric patient suffering from growth disorders, diabetes, blood factor disorders, etc. since the formulation is known to be effective to treat these conditions in a subject.
Double Patenting
10. 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.
11. Claim 1-4, 6, 8-9, 11-15, 18, 38-43, and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-36 and 43-52 of copending Application No. 18/683745 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and Application No. 18/683745 are directed to colloidal particles comprising a first amphipathic lipid comprising phosphatidylcholine and a second amphipathic lipid comprising a phospholipid moiety, wherein the second amphipathic lipid comprises a phospholipid moiety derivatized with a biocompatible hydrophilic polymer. The difference lies in the fact that the instant application is directed to the composition, and additionally comprises a nonionic surfactant, while Application No. 18/683745 is directed to a method of administering the composition to treat hemophilia A and comprises a Factor VIII molecule. However, claims of the instant invention are also directed to a method of administering to treat hemophilia A and comprise a Factor VIII molecule while Application No. 18/683745 also comprises addition of a nonionic surfactant. Thus the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Claim 1-4, 6, 8-9, 11-15, 18, 38-43, and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-38 and 45-54 of copending Application No. 18/684038 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and Application No. 18/684038 are directed to colloidal particles comprising a first amphipathic lipid comprising phosphatidylcholine and a second amphipathic lipid comprising a phospholipid moiety, wherein the second amphipathic lipid comprises a phospholipid moiety derivatized with a biocompatible hydrophilic polymer. The difference lies in the fact that the instant application is directed to the composition, and additionally comprises a nonionic surfactant, while Application No. 18/684038 is directed to a method of administering the composition to treat hemophilia A and comprises a Factor VIII therapy. However, claims of the instant invention are also directed to a method of administering to treat hemophilia A and comprise a Factor VIII molecule while Application No. 18/684038 also comprises addition of a nonionic surfactant. Thus the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
13. No claims are allowed at this time.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WORSHAM/Primary Examiner, Art Unit 1615