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.
DETAILED ACTION
Claims 18-34 are pending, claims 1-17 are canceled in this application. This application is a national stage entry of PCT/EP23/50010, filled on 01/02/2023, which claims foreign priority to EP 22150365.9, filed on 01/05/2022 in Europe.
Election/Restrictions
During a telephone conversation with Kari Moyer-Henry on restriction on 03/30/2026 a provisional election was made to prosecute the invention of I, claims 18-31, 33, and 34. Affirmation of this election must be made by applicant in replying to this office action. Claim 32 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to non-elected inventions and species.
Claims 18-31, 33, and 34 will presently be examined to the extent they read on the elected subject matter of record.
Election/Restrictions
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 18-31, 33, and 34, drawn to an aqueous composition comprising: 0.1-10% by total weight of at least one water-soluble or water-dispersible natural or synthetic polymer selected from the group of polymers consisting of cellulose derivatives, etc.; 0.1-7.5% by total weight of at least one 1st surfactant selected from polysorbate esters, etc.; 0.1-7.5% by total weight of at least one 2nd surfactant selected from sodium glycocholate, etc.; 2-15% by total weight of at least one avermectin, having a mean particle size of 0.01-20 μm obtained by laser diffraction; and 60-97.7% by total weight of water;
Group II, claim(s) 33, drawn to a discharging device, in particular a blow-fill-seal device or a syringe or a spray device, filled with said aqueous composition.
As set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), the international application shall relate to one invention only or to a group of inventions. Moreover, as stated in PCT Rule 13.2, the requirement of unity of invention referred to in PCT Rule 13.2 shall be fulfilled where a group of inventions is claimed in one and the same international application only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression special technical features shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art, so linked, as to form a single general inventive concept.
The inventions listed as Groups I-II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: the special technical feature in all groups is an aqueous composition comprising: 0.1-10% by total weight of at least one water-soluble or water-dispersible natural or synthetic polymer selected from the group of polymers consisting of cellulose derivatives, etc.; 0.1-7.5% by total weight of at least one 1st surfactant selected from polysorbate esters, etc.; 0.1-7.5% by total weight of at least one 2nd surfactant selected from sodium glycocholate, etc.; 2-15% by total weight of at least one avermectins, having a mean particle size of 0.01-20 μm obtained by laser diffraction; and 60-97.7% by total weight of water. The element cannot be a special technical feature under PCT Rule 13.2 because the element is shown in prior art. Patel et al. (US 6,294,192 B1) teach 10x by weight aqueous solution to carrier ratio dilution (column 20, line 6-43 and column 26, line 25-45) of a composition comprising a plurality of particles each comprising a composition of (a) a hydrophobic therapeutic agent including ivermectin (claims 1, 41, and 73), and (b) a carrier comprised of (i) at least one hydrophilic surfactant selected from hydrophilic ionic surfactants such as Sodium glycocholate (the claimed 2nd surfactant) (claim 73 and table 18), (ii) 100% by weight relative to hydrophilic surfactant of at least one hydrophobic surfactant selected from polyoxyethylene sorbitan fatty acid esters such as PEG-6 sorbitan monooleate (the claimed 2nd surfactant) (claim 73 and table 11), and 50% by weight relative to surfactant of solubilizers such as hydroxypropyl methylcellulose (HPMC) (the claimed polymer) (column 25, line 14 and 58); and exemplified 21.84% by weight of hydrophobic therapeutic agent in a preconcentrate (example 75) → 2.184% upon 10X dilution; wherein the carrier forms a clear aqueous dispersion having a particle size of <50 nm (claims, 1, 31, and 73). The weight ration among a hydrophilic surfactant, a hydrophobic surfactant, and HPMC is 1:1:1 (100%:100%: (100%+100%)x50% =1:1:1) and the weight ration among a hydrophilic surfactant, a hydrophobic surfactant, HPMC, and hydrophobic therapeutic agent is 26.05:26.05:26.05:21.84 (100%-21.84%)/(1+1+1)=26.05%) → 2.605% by total diluted weight of hydrophilic surfactant, 2.605% by total diluted weight of hydrophobic surfactant, 2.605% by total diluted weight of HPMC, and 2.184% by total diluted weight of hydrophobic therapeutic agent, and 90% by weight of water. Consequently, groups I and II are not linked by the same or a corresponding special feature as to form a single general inventive concept. Therefore, Unity of Invention is lacking and restriction is deemed proper.
Multiple inventors
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Rejoinder
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
In the event of rejoinder, the requirement for restriction between the subcombination claims and the rejoined combination claims will be withdrawn, and the rejoined combination claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected subcombination are found allowable, an otherwise proper restriction requirement between the subcombination claims and the rejoined combination claims may be maintained. Withdrawn combination claims that are not commensurate in scope with an allowable subcombination claim will not be rejoined. See MPEP § 821.04(b). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the combination claims should be amended during prosecution to require the limitations of the subcombination claims. Failure to do so may result in a loss of the right to rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention. Should applicant traverse on the ground that the inventions or species are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions or species to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C.103(a) of the other invention.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Objections
Claim 18 is objected to because of the following informalities: “,” in “7,5%”. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: “,” in “0,14%”. Appropriate correction is required.
Claim Rejections - 35 USC 112(b)
The following is a quotation of the second paragraph 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.
Claims 19, 21, 23, 25, 26-28, 31, and 33 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP 2173.05(c). See the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In the present instance, each of claims 19, 21, 23, 25, 26-28, 31, and 33 recites a broad recitation followed by the narrower statement of the range/limitation after “preferably” or “preferred” or “in particular”.
Claim 25 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The recitation of "in particular according to claim 7" renders the claim indefinite. Claim 7 is a cancelled claim. Thus, it is unclear and indefinite as to how the "in particular according to claim 7" herein is encompassed.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 18-24, 26-29, 31, 33, and 34 are rejected under 35 U.S.C. 103(a) as being unpatentable over Patel et al. (US 6,294,192 B1).
Patel et al. teach 10x by weight aqueous solution to carrier ratio dilution (column 20, line 6-43 and column 26, line 25-45) of a composition comprising a plurality of particles each comprising a composition of
(a) a hydrophobic therapeutic agent including ivermectin (the instant claims 18, 24, and 29) (claims 1, 41, and 73), and
(b) a carrier comprised of
(i) at least one hydrophilic surfactant selected from hydrophilic ionic surfactants such as sodium glycocholate (the claimed 2nd surfactant in the instant claims 18 and 29) (claim 73 and table 18),
(ii) 100% by weight relative to hydrophilic surfactant of at least one hydrophobic surfactant selected from polyoxyethylene sorbitan fatty acid esters such as PEG-6 sorbitan monooleate (the claimed 1st surfactant in the instant claims 18, 22 and 29) (claim 73 and table 11), and
50% by weight relative to surfactant of solubilizers such as hydroxypropyl methylcellulose (HPMC) (the claimed polymer in the instant claims 18, 20, and 29) (column 25, line 14 and 58);
chelating agent (the instant claims 26 and 27) and preservatives (column 26, line 16-23); and
exemplified 21.84% by weight of hydrophobic therapeutic agent in a preconcentrate in example 75 → 2.184% upon 10X dilution;
wherein the carrier forms a clear aqueous dispersion having a particle size of < about 100 nm (→ all particles including ivermectin particles < about 100 nm, the instant claim 28) using Nicomp particle size analyzer → dynamic light scattering (DLS) (claims, 1, 31, and 73 and column 20, lime 46-50).
The weight ratio among a hydrophilic surfactant, a hydrophobic surfactant, and HPMC is 1:1:1 (100%:100%: (100%+100%)x50% =1:1:1) and the weight ratio among a hydrophilic surfactant, a hydrophobic surfactant, HPMC, and hydrophobic therapeutic agent is 26.05:26.05:26.05:21.84 (100%-21.84%)/(1+1+1)=26.05%) → 2.605% by total diluted weight of hydrophilic surfactant, 2.605% by total diluted weight of hydrophobic surfactant, 2.605% by total diluted weight of HPMC, and 2.184% by total diluted weight of hydrophobic therapeutic agent, and 90% by total diluted weight of water (the instant claims 18, 19, 21, 23, and 29).
The limitations in the instant claims 31, 33, and 34 are intended use limitation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The method of measuring particle size taught by Patel et al. is different from the method recited (dynamic light scattering vs laser diffraction in the instant claim 18); please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether the particle size of the same particles measured by laser diffraction (suitable for particle size range 10 nm to 3500 µm) differs and that of the particles measure by dynamic light scattering (suitable for particle size range 0.3 nm to 10 µm), if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Patel et al. do not specify the same particle size (< about 100 nm vs 0.01-20 µm and 0.1-0.5 µm in the instant claims 18 and 29.
This deficiency is cured by the rationale that a prima facie case of obviousness typically exists when the range of a claimed composition overlaps with the range disclosed in the prior art, such as in the instant rejection and a prima facie case of obviousness exists where the claimed ranges.
The claimed ranges of particle size are 0.01-20 µm and 0.1-0.5 µm and the range of particle size taught in the prior art is < about 100 nm and therefor, overlaps with the claimed range.
Claims 18-24, 26-31, 33, and 34 are rejected under 35 U.S.C. 103(a) as being unpatentable over Patel et al. (US 6,294,192 B1) in view of Spring et al. (US 2008/0275107 A1).
The teachings of Patel et al. are discussed above and applied in the same manner.
Patel et al. do not specify the preservatives including 0.14-6% by weight of sodium citrate in the instant claim 30.
This deficiency is cured by Spring et al. who teach preservatives in a composition comprising an avermectin including about 1.0-1.25% by weight of sodium citrate (paragraph 39 and 106).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Patel et al. and Spring et al. to specify the preservatives in the composition taught by Patel et al. including about 1.0-1.25% by weight of sodium citrate. Preservatives in a composition comprising an avermectin including about 1.0-1.25% by weight of sodium citrate was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Patel et al. do not specify the same particle size (< about 100 nm vs 1-4 µm in the instant claim 30).
This deficiency is cured by the rationale that prior art range does not overlap but is close enough that one skilled in the art would have expected them to have the same properties.
The claimed range of particle size is 1-4 µm and the range of particle size taught in the prior art is < about 100 nm, although they do not overlap but are close enough that one skilled in the art would have expected them to have the same properties while 0.01-20 µm is claimed being suitable and thus the criticality of the claimed 1-4 µm over < about 100 nm is not established.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614
Prosecution Insights