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 (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.
Claim Rejections - 35 USC § 112 –
Scope of Enablement and Prevention
Claims 67-70 and 72-75 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating pulmonary diseases [see the originally filed disclosure at ¶s 0016-0019], does not reasonably provide enablement for “preventing” diseases or disorders, generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).[1]
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to treating pulmonary diseases. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the Examiner cites the National Human Genome Research Institute, 12/27/2013 (https://www.genome.gov/Genetic-Disorders/Cystic-Fibrosis).
The National Human Genome Research Institute taught that cystic fibrosis is a genetic disease (e.g., cannot be prevented) [abstract and 1st paragraph].
The breadth of the claims
Since the instant specification provides no limiting definition of the term “prevention”, the term will be interpreted expansively. The term “prevention” may vary widely in meaning, from “preventing” a disease from occurring to “preventing” it from progressing. Nor is the term limited by any time frame.
The claims are thus very broad insofar as they suggest that one will not experience the disease when taking the claimed agent; that should one get the disease, it will not worsen; or that following its treatment, it will not recur. While such “prevention” might theoretically be possible under strictly controlled laboratory conditions, as a practical matter it is nearly impossible to achieve in the “real world” in which patients live.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful protocols for carrying out the invention as claimed, other than treating pulmonary diseases. The latter is corroborated by the working examples.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
Claim Rejections - 35 USC § 112 –
Improper Dependency and Broad Limitation followed by Narrow Limitation
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 recites surfactants present in a concentration of 0.1-5 %. Claim 11, from which claim 12 depends recites the concentration of at least 0.2 %. The claim 12 concentrations that fall between 0.1 % and 0.2 % are excluded by the “at least 0.2 %” limitation of claim 11. And, as such, claim 12 does not further limit the subject matter of claim 11. Appropriate correction of the claim scope is required.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 35 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.
Regarding broad to narrow limitations, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 35 recites the broad recitation “imidazole cholesterol ester”, and the claim also recites “(ICE)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The Applicant is encouraged to remove the parenthesis from claim 35.
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.
Claim(s) 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-70 and 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Heartlein et al (US 2018/0333457 A1), in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Heartlein taught mRNA encoding the CFTR protein, encapsulated within lipid a nanoparticle [0009; see also claims 47-49]. Heartlein generally taught delivery vehicles formulated in combination with one or more stabilizing reagents [0102, 0142], where the addition of PEGylated lipids (e.g., DMG-PEG-2K, at [0198]) provided control over particle size and stability of the nanoparticles.
Although Heartlein generally taught that PEGylated lipids provided control over particle size and stability, Heartlein was not specific an antioxidant moiety covalently linked via a linker moiety, and an amount thereof, as recited by claim 1.
Lee taught lipid nanoparticle compositions [title] encapsulating [0205, 0292] nucleic acids [abstract], and formulated with PEGylated lipids (e.g., TPGS, D-α-Tocopherol polyethylene glycol 1000 succinate), configured to promote colloidal stability and/or to prolong in vivo circulation time [0160]. As per Lee, PEGylated lipids are surfactants that form substantially uniform and stable lipid-coated nanoparticles of nucleic acids [0208].
Since Heartlein generally taught that PEGylated lipids provided control over particle size and stability, it would have been prima facie obvious to one of ordinary skill in the art to include within the teachings of Heartlein, TPGS, as taught by Lee. The ordinarily skilled artisan would have been motivated to promote colloidal stability, and/or to prolong in vivo circulation time, as taught by Lee et al [0160, 0208].
The combined teachings of Heartlein and Lee were silent the amount of surfactant.
Chen taught nanoparticle (NP) preparations [title] comprised of TPGS (e.g., [0016, 0081] at 0.47 %, where the amount of TPGS was selected to optimize NPs with the desired size and encapsulation efficiency [0088].
Since the combined teachings of Heartlein and Lee taught nanoparticles formed with TPGS, it would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of Heartlein and Lee, TPGS at 0.47 %, as taught by Chen. The ordinarily skilled artisan would have been motivated to include an amount to optimize NPs with a desired size and encapsulation efficiency, as taught by Chen [0016, 0081, 0088].
The instant claim 1 recites at least 0.1 % surfactant.
The instant claim 11 recites at least 0.2 % surfactant.
The instant claim 12 recites surfactants present at a concentration of 0.1-5 %.
Chen taught 0.47 % TPGS. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
The combined teachings of Heartlein, Lee and Chen, read on claims 1-2, 3, 5-7, 9-12, 37 and 73.
Further regarding the instant claim 3, the claim recites PEG with an average molecular weight between 1kDa and 5kDa. Chen taught PEG1000, as discussed above. A prima facie case of obviousness exists because of overlap, as discussed above.
Claim 17 is rendered prima facie obvious because Heartlein generally taught buffers [0152].
Regarding claims 18 and 20-23, Heartlein generally taught buffers, but was silent the buffers instantly recited in claim 18. Furthermore, Heartlein was silent salts, and amounts thereof, as recited in claims 20-23.
Nevertheless, Lee taught HEPES buffer, and 145 mM NaCl (to adjust the pH), in the preparation of the NPs [0229-0230, 0266, 0307, 0390].
Since Heartlein generally taught buffers, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Heartlein, HEPES buffer, as taught by Lee. The ordinarily skilled artisan would have been motivated to prepare the NPS, as taught by Lee [0229-0230, 0266, 0390]. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, it is prima facie obvious to select HEPES for incorporation into a composition, based on its recognized suitability for its intended use as a buffer, as taught by Lee.
The ordinarily skilled artisan would have been motivated to include, within Heartlein, 145 mM NaCl, motivated by the desire to adjust the pH, as taught by Lee et al.
The instant claim 21 recites a salt concentration of 50 mM to 200 mM.
The instant claim 22 recites a salt concentration of at least 10 mM.
Lee taught NaCl at 145 mM. A prima facie case of obviousness exists because of overlap, as discussed above.
Claims 24, 26-27 and 29 are rendered prima facie obvious because Heartlein taught sucrose at 1-20 % [0145].
Claims 34 and 35-38 are rendered prima facie obvious because Heartlein taught one or more cationic lipids, one or more non-cationic lipids, and one or more PEG-modified lipids [claim 19], including DOPE [claim 25], DMG-PEG-2K [previously discussed] and imidazole cholesterol ester (e.g., a cholesterol-based lipid; a cationic lipid) [claim 25].
Claim 47 is rendered prima facie obvious because Heartlein taught sizes less than about 100 nm [0009].
Claim 58 is rendered prima facie obvious because Heartlein taught pulmonary delivery of mRNA [0025]. In vivo delivery was taught at [0032, 0133, 0142].
Claim 59 is rendered prima facie obvious because Heartlein taught administering, comprising inhalation, at the abstract.
Claim 60 is rendered prima facie obvious because Heartlein taught the composition as nebulized prior to inhalation [0007].
Claim 61 is rendered prima facie obvious because Heartlein taught lyophilized or dry powder formulations, reconstituted prior to nebulization [0158].
Claims 67-70 and 72 are rendered prima facie obvious because Heartlein taught that a CFTR mRNA is delivered to a CF patient in need of treatment, at a therapeutically effective dose and an administration interval for a treatment period sufficient to improve, stabilize or reduce one or more symptoms of cystic fibrosis relative to a control [0182]. Pulmonary delivery, via nebulization, was previously discussed.
Claim(s) 74 is rejected under 35 U.S.C. 103 as being unpatentable over Heartlein et al (US 2018/0333457 A1), in view of Lee et al (US 2011/0038941 A1), further in view of Chen et al (US 2020/0197319 A1) and further in view of Karve et al (US 2020/0022921 A1).
The 35 U.S.C. 103 rejection over Heartlein, in view of Lee and Chen, was previously discussed.
Additionally, Heartlein taught that administration of a formulation comprising a CFTR mRNA results in delivery of the mRNA and encoded CFTR protein in various targets tissues, including the lung(s) [0164-0166, 0168-0178].
However, Heartlein did not teach treating primary ciliary dyskinesia, as recited in claim 74.
Karve taught administering [0048] lipid nanoparticles (LNPs) encapsulating the mRNA encoding the CFTR protein [claim 3; ¶ 0009-0010], for treating primary ciliary dyskinesia, a lung-related disease [0049, 0215].
Since Heartlein generally taught delivery of mRNA and the encoded CFTR protein to the lung(s), it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Heartlein, the treatment of primary ciliary dyskinesia, as taught by Karve. The ordinarily skilled artisan would have been motivated to treat a lung-related disease, as taught by Karve et al [0049, 0215].
Claim(s) 75 is rejected under 35 U.S.C. 103 as being unpatentable over Heartlein et al (US 2018/0333457 A1), in view of Lee et al (US 2011/0038941 A1), further in view of Chen et al (US 2020/0197319 A1), further in view of Karve et al (US 2020/0022921 A1) and further in view of Lockhart et al (US 2019/0111074 A1).
The 35 U.S.C. 103 rejection over Heartlein, in view of Lee, Chen and Karve, was previously discussed.
Although the combined teachings of the prior art taught treating primary ciliary dyskinesia with the delivery of mRNA, the combined teachings of the prior art did not teach mRNA encoding DNAI1, as recited in claim 75.
Lockhart taught DNAI1 mRNA [0244, 0261], for the treatment of primary ciliary dyskinesia [title; see also Example 9].
Since the combined teachings of the art taught the delivery of mRNA for the treatment of primary ciliary (e.g., see Heartlein and Karve, as previously discussed), it would have been prima facie obvious to one of ordinary skill in the art to include, within the combined teachings of the prior art, DNAI1-encoded mRNA, as taught by Lockhart. The ordinarily skilled artisan would have been motivated to treat primary ciliary dyskinesia, as taught by Lockhart [title; Example 9; and ¶s 0244 and 0261].
Nonstatutory Double Patenting
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 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,052,284, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,238,754, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,471,153, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11, 173,190, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,507,249, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,013,812, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,940,207, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,888,626, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,144,871, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,052,159, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,969,480, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,280117, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1).
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69 and 70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 8-24 of copending Application No. 17/522,754, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 17-18, 20, 23, 26, 28, 30-32, 35, 37, 39, 44, 47, 53-54 and 56 of copending Application No. 17/923,470, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-13, 15, 24, 31, 49-52 and 54 of copending Application No. 17/923,839, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-69, 70 and 72-75 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-10, 13-14, 18, 20, 22-23, 38-39, 46, 49-51 and 64 of copending Application No. 18/661,393, in view of Lee et al (US 2011/0038941 A1) and further in view of Chen et al (US 2020/0197319 A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require a surfactant, and an amount thereof, consisting of an antioxidant covalently linked to PEG, which is not required of the copending and issued claims.
Lee taught lipid nanoparticle compositions [title] encapsulating [0205, 0292] nucleic acids [abstract], and formulated with PEGylated lipids (e.g., TPGS, D-α-Tocopherol polyethylene glycol 1000 succinate), configured to promote colloidal stability and/or to prolong in vivo circulation time [0160]. As per Lee, PEGylated lipids are surfactants that form substantially uniform and stable lipid-coated nanoparticles of nucleic acids [0208].
Chen taught nanoparticle (NP) preparations [title] comprised of TPGS (e.g., [0016, 0081] at 0.47 %, where the amount of TPGS was selected to optimize NPs with the desired size and encapsulation efficiency [0088].
It would have been prima facie obvious to one of ordinary skill in the art to include within the copending and issued claims, TPGS, as taught by Lee. The ordinarily skilled artisan would have been motivated to promote colloidal stability and/or to prolong in vivo circulation time, as taught by Lee et al [0160, 0208].
It would have been prima facie obvious to one of ordinary skill in the art to include, within the copending and issued claims, TPGS at 0.47 %, as taught by Chen. The ordinarily skilled artisan would have been motivated to include an amount to optimize NPs with a desired size and encapsulation efficiency, as taught by Chen [0016, 0081, 0088].
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
[1] As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.