DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after July 01, 2025, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention filed on 07/01/2025 in the matter of Application N° 18/255,035. Said documents are entered on the record. The Examiner further acknowledges the following:
Thus, claims 1-6 represent all claims currently under consideration.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) because the specification, as originally filed, does not reasonably convey to one of ordinary skill in the art that the inventor was in possession of the claimed subject matter at the time of filing with respect to the negative limitation excluding phosphate ester salts or sulfate ester salts.
The claim recites, in relevant part, wherein the composition excludes phosphate ester salts and sulfate ester salts. However, the specification does not provide any description, explicit or implicit, that supports the exclusion of these particular salts. The originally filed disclosure lacks: any mention of phosphate ester salts or sulfate ester salts, any teaching suggesting these salts are undesirable, any indication that the inventor intended to omit or avoid these salts, or any listing of alternatives or preferences from which such an exclusion could be inferred. Here, the absence of phosphate ester salts or sulfate ester salts in the examples or preferred embodiments does not amount to an affirmative disclosure of their exclusion. The specification also does not contain language such as “excluding,” “free of”, “does not include,” or any teaching that would convey possession of a composition that intentionally omits these salts.
Accordingly, the negative limitation lacks written description support because a person of ordinary skill in the art would not understand from the originally filed disclosure that the inventor had possession of compositions characterized by the absence of phosphate ester salts or sulfate ester salts.
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.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka (US20150111860), in view of Fowler. (US20100234230).
Regarding claims 1-4 and 5, Tanaka teaches suspoemulsions of agrochemicals that include a liquid agrochemical active that is poorly soluble in water; a solid agrochemical active that is poorly soluble in water at room temperature, such as the claimed flumioxazin or mesotrione; a polyoxyalkylene block copolymer, specifically the claimed polyoxyethylene, polyoxypropylene, block copolymer (applicant’s first surfactant); water; hydrophobic organic solvent, etc. ligninsulfonates (the applicant’s second surfactant), water, hydrophobic organic solvent, etc., and wherein the first ingredient, a liquid agrochemical active that is poorly soluble in water, is dissolved or suspended in the hydrophobic organic solvent that is dispersed in the water, and wherein one or more of the solid agrochemical active that is poorly soluble in water at room temperature is dispersed or suspended in the water (See Abstract; claims; and paragraphs [0037-0040]; [0048-0052]; [0005-0011]; [0029]; [0032]; [0035]; and [0068]. Additionally, Tanaka do not explain how the scope of a weakly water-soluble liquid agrochemical active (ingredient 1) is especially limited as long as it is poorly water-soluble (See paragraphs 0015-0017); and (0068). Tanaka teaches how a solid agrochemical active that is weakly soluble in water at room temperature, such as the purported flumioxazin or mesotrione, is suspended in water because, for example, in production examples 2 and 3. Tanaka teaches how to suspend clothianidin, a solid agrochemical active that is poorly water soluble at room temperature, in the water/aqueous phase. Specifically, they teach how to suspend ingredient 2, the solid agrochemical active that is poorly water soluble at room temperature, into ingredient 6, which is water (See production examples 2-3, and paragraph (0032); Abstract; and (0068).
Regarding claim 6, Tanaka disclose how the claimed aromatic hydrocarbons can be used as a hydrophobic organic solvent (See paragraphs 0024); and (0078-0079).
Tanaka does not provide the applicant’s formula (I) for the weakly water-soluble liquid agrochemical active in claims 1-5. However, Fowler addresses this limitation in Tanaka.
According to Fowler it was known in the art to build the applicant’s compound of formula (I) as an emulsion. Since the compound of formula (I) is dissolved or solubilized in a hydrophobic organic solvent, it can be used as an ingredient (I) in Tanaka. (See paragraphs 0043 and 0002, example 5, and claim 14).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have chosen the applicant’s formula I as taught by Fowler for ingredient (1) in the suspoemulsions of Tanaka. since suspoemulsion are a known effective formulation type that enables the combination of poorly soluble liquids and solids to be used for herbicidal or other pesticidal applications, one of ordinary skill in the art would have been motivated to do this in order to form effective pesticidal combinations with other poorly water-soluble active agents that are solids at room temperature. Initially it is clear that combining two compositions each of which is taught by the prior art to be beneficial for the same purpose, in order to create a third composition that will be utilized for the exact same reason. Since they were taught separately in the earlier art, it makes sense to combine them. In re Kerkhoven, 626 F .2d846,850, 205, USPQ 1069, 1072, (CCPA 1980).
The examiner concludes that, in accordance with 35 U.S.C. 103(a), the subject matter specified by the aforementioned claims would have been obvious to one of ordinary skill in the art.
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 AlA. 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 |.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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 3-6 of copending Application No. 18/255,005 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims disclose a biocompatible membrane comprising a first layer having pores with a maximum pore size (MPS) less than about | micron and a first thickness less than about 10 microns; and a second layer having solid features, wherein a majority of the solid features has a solid feature spacing less than about 50 microns, wherein the solid features each comprise a representative minor axis, a representative major axis, and a solid feature depth, and wherein a majority of the solid features of the second layer has at least two of the representative minor axis, the representative major axis, and the solid feature depth are greater than about 5 microns; and a cell encapsulation device comprising said biocompatible membrane.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615