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 .
Election/Restrictions
Applicant's election with traverse of group I, claims 1-15 in the reply filed on 10/13/2025 is acknowledged. The traversal is on the ground(s) that the prior art does not teach two or more channels. This is not found persuasive because this technical feature is not a special technical feature as it does not make a contribution over the prior art. See new unity of invention analysis and art rejection below in light of applicant amendment.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-21 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/13/2025.
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled 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.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
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) 1-15, drawn to a method for generating capsules.
Group II, claim(s) 16-17, drawn to an assembly of capsules.
Group III, claim(s) 18-21, drawn to a device for generating capsules.
The groups of inventions listed above 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:
I and II lack unity of invention because even though the inventions of these groups require the technical feature of claim 1, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Saragnese in view of Nakajima. See art rejection below.
I and III lack unity of invention because even though the inventions of these groups require the technical feature of a first chamber, a second chamber, wherein the first chamber and the second chamber are fluidic connected by two or more channels, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Saragnese in view of Nakajima. See art rejection below.
II and III lack unity of invention because even though the inventions of these groups require the technical feature of a first chamber, a second chamber, wherein the first chamber and the second chamber are fluidic connected by two or more channels, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Saragnese in view of Nakajima. See art rejection below.
Response to Amendment
Applicant amendment filed 10/13/2025 has been entered and is currently under consideration. Claims 1-21 remain pending in the application.
Specification
The disclosure is objected to because of the following informalities:
In page 19, ln 13-14, “h min” is not a standard unit of time.
Appropriate correction is required.
Claim Objections
Claim 1 objected to because of the following informalities:
In claim 1, ln 10, “fluidic connected” should read -- fluidically connected --
Appropriate correction is required.
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 13 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 13 recites wherein the pressure applied to the first chamber is smaller than the pressure applied to the second chamber. While this step is simple enough for one of ordinary skill in the art to apply on a facial examination of the claim, there is a question of enablement when viewed in light of claim 1 on which claim 13 indirectly depends and the application as a whole. Claim 1 recites guiding the dispersed phase from the first chamber through the two or more channels into the second chamber. It is well understood in the art that barring any outside factors, fluids flow from high pressure to low pressure environments. This principle appears to be supported by applicant specification. Page 8, ln 5-10, discloses that “the pressure at an immiscible liquid interface is higher at the channel outlets than in the second chamber. Thus a pressure gradient along the direction of the flow is generated”. Page 21, ln 10-14, discloses that pressure applied to the dispersed phase through the channels generates droplets into the continuous phase.
Page 19, ln 8-12, recites the subject mater of claim 13. However, the examiner notes that applicant disclosure provides no explanation of how to guide the dispersed phase from the first chamber through the two or more channels into the second chamber as recited in claim 1 when the negative pressure difference of claim 13 is applied. Claim 13 therefore appears to operate contrary to what is implied in other parts of applicant disclosure and contrary to a principle that is well known in the art.
For at least the above reasons, the claim lacks enablement.
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 8 and 14 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.
Claim 8 is rendered indefinite because it is not clear which emulsion is being referenced.
Claim 14 recites “h min”, which the examiner notes is not a standard unit of time, and therefore it unclear what the scope of the claimed range encompass. Applicant specification similarly recites the unit of “h min” with no further explanation.
Claim Rejections - 35 USC § 103
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.
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) 1-6, 8-11 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saragnese et al. (US2021/0085607 of record) hereinafter Saragnese in view of Nakajima et al. (US2008/0061459) hereinafter Nakajima.
Regarding claim 1, Saragnese teaches:
A method for generating capsules (Fig 1a; [0080]) the method comprising the steps:
a. providing in first chamber a dispersed phase (Fig 1a, d: mixer 300; [0099]), the dispersed phase comprising a solution comprising a first solvent and a matrix-forming agent ([0099]), wherein the matrix-forming agent is a solid in its pure state and wherein the first solvent and the matrix-forming agent are configured such that the matrix-forming agent is soluble in the first solvent ([0080-0089, 0099, 0260-0288]; the polymer solidifies into microparticles once the solvent is removed);
b. providing in a chamber a continuous phase (Fig 1a, d: mixer 300; [0099]), the continuous phase comprising a second solvent ([0099, 0290-0291]);
wherein the first chamber and the second chamber are fluidically connected by a channel (Fig 1a, d: conduit 211; [0099]); and wherein the method further comprises:
c. guiding the dispersed phase to form an emulsion or a dispersion comprising a plurality of droplets of the dispersed phase, in the continuous phase (Fig 1a; [0080-0089, 0099-0100]);
d. removing the first solvent from the droplets of the dispersed phase and solidifying the matrix-forming agent to form a capsule (Fig 1a; [0080-0089]).
Saragnese does not teach providing in a first chamber a dispersed phase and providing in a second chamber a continuous phase, wherein the first chamber and the second chamber are fluidically connected by two or more channels, and guiding the dispersed phase from the first chamber through the two or more channels into the second chamber.
In the same field of endeavor regarding forming of microparticles, Nakajima teaches providing in a first chamber a dispersed phase and providing in a second chamber a continuous phase, wherein the first chamber and the second chamber are fluidic connected by one or more channels and guiding the dispersed phase from the first chamber through the one or more channels into the second chamber for the motivation of realizing high fine patterning accuracy, low production costs, and high durability (Fig 11: first channel 101, second channel 102, plate 12, through holes 7; [001, 0202]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the chamber for forming microcapsules as taught by Saragnese with the device for forming microspheres as taught by in order realize to high fine patterning accuracy, low production costs, and high durability.
Regarding claim 2, Saragnese in view of Nakajima teaches the method of claim 1.
Saragnese further teaches wherein the dispersed phase in step a. further comprises at least one first compound of interest ([0099]).
Regarding claim 3, Saragnese in view of Nakajima teaches the method of claim 1.
Saragnese further teaches wherein step a. comprises dissolving the matrix-forming agent in the first solvent to provide the dispersed phase ([0099]).
Regarding claim 4, Saragnese in view of Nakajima teaches the method of claim 1.
Saragnese in view of Nakajima does not explicitly recite wherein step d. comprises the extraction of the first solvent from the droplets of the dispersed phase into the continuous phase. However, Saragnese teaches solvent of the dispersed phase that is soluble in the continuous phase ([0290-0292]), and that microparticles are formed upon mixing of the dispersed and continuous phase ([0100]). Therefore one of ordinary skill in the art would reasonably expect extraction of the first solvent from the droplets of the dispersed phase into the continuous phase to occur in the prior art process as well.
Regarding claim 5, Saragnese in view of Nakajima teaches the method of claim 4.
Saragnese in view of Nakajima does not explicitly recite wherein the first solvent of the dispersed phase has a solubility of 0.1 wt.% to 40 wt.% at 25 °C and 1 atm., in the second solvent of the continuous phase. However, applicant specification discloses that a suitable solvent combination fulfilling the above limitations may be dichloromethane as the first solvent and water as the second solvent. Saragnese teaches the same first and second solvent combination ([0290-0292]). Therefore Saragnese teaches the limitations of the claim.
Regarding claim 6, Saragnese in view of Nakajima teaches the method of claim 4.
Saragnese further teaches wherein a third solvent is added to the emulsion or dispersion formed in step c. (Fig 1a; [0085]).
Saragnese in view of Nakajima does not explicitly recite wherein the third solvent has a higher solubility or a lower solubility for the first solvent of the dispersed phase as compared to the solubility of a second solvent of the continuous phase for the first solvent.
Saragnese further teaches the third solvent can be water ([0085]), the first solvent can be dichloromethane ([00290]), and the second solvent can be methanol ([0291]).
Applicant specification discloses that dichloromethane has a solubility of 0.1 wt.% to 40 wt.% at 25 °C and 1 atm in water. It is well known in the art that dichloromethane is completely miscible in methanol. Therefore Saragnese further teaches wherein the third solvent has a higher solubility or a lower solubility for the first solvent of the dispersed phase as compared to the solubility of a second solvent of the continuous phase for the first solvent.
Regarding claim 8, Saragnese in view of Nakajima teaches the method of claim 1.
Saragnese further teaches wherein the dispersed phase in step a. is an emulsion of the first solvent and a fourth solvent ([0099, 0290]), wherein the emulsion comprises at least one second surfactant ([0290, 0292]; Saragnese teaches alcohols are surfactants and that alcohols can be used in the dispersed phase).
Regarding claim 9, Saragnese in view of Nakajima teaches the method of claim 1.
Saragnese further teaches wherein the matrix-forming agent is a polymer ([0099]).
Regarding claim 10, Saragnese in view of Nakajima teaches the method of claim 1.
Saragnese further teaches wherein step d. is at least partially performed under continuous flow of the emulsion or dispersion formed in step c ([0015]).
Regarding claim 11, Saragnese in view of Nakajima teaches the method of claim 1.
Saragnese further teaches wherein prior to step d. the emulsion or dispersion formed in step c. is removed from the second chamber ([0099-0101]).
Regarding claim 14, Saragnese in view of Nakajima teaches the method of claim 1.
Saragnese does not explicitly recite wherein step d. is performed for 0.01 min to 48 h.
However, Saragnese teaches a range of values for the residence time for extraction that overlaps with the claimed range ([0085]).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.
Since overlapping ranges are evidence of prima facie obviousness, it would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have chosen the portion of the residence time as taught by Saragnese that overlaps with the claimed range.
Regarding claim 15, Saragnese in view of Nakajima teaches the method of claim 1.
Saragnese further teaches wherein after step d. the formed capsules are isolated, dried, cured and/or preserved (Fig 1a; [0089]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saragnese in view of Nakajima as applied to claim 4 above, and further in view of Shekunov et al. (US2006/0008531) hereinafter Shekunov.
Regarding claim 7, Saragnese in view of Nakajima teaches the method of claim 4.
Saragnese in view of Nakajima does not teach wherein the extraction is performed in an extraction column.
In the same field of endeavor regarding forming of microparticles, Shekunov teaches performing solvent extraction of an emulsion using an extraction column for the motivation of reducing processing time (Fig 1: extractor 110; [0007, 0021-0022, 0029]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the extraction as taught by Saragnese in view of Nakajima with the extraction column as taught by Shekunov in order to reduce processing time.
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saragnese in view of Nakajima as applied to claim 1 above, and further in view of Ma (US2022/0331769).
Regarding claim 12, Saragnese in view of Nakajima teaches the method of claim 1.
Nakajima further teaches supplying a disperse phase to the first chamber at a predetermined pressure and supplying the continuous phase at a predetermined pressure ([0202]).
Saragnese in view of Nakajima does not explicitly recite wherein a pressure of 1.01 bar to 2.0 bar is applied to the first chamber and/or wherein a pressure of 1.02 bar to 1.2 bar is applied to the second chamber.
Saragnese in view of Nakajima is silent as to the pressures to pump the dispersed or continuous phases. Therefore one of ordinary skill in the art would be motivated to look to other methods of forming microparticles for the pressures at which supply the disperse and continuous phases.
In the same field of endeavor regarding forming of microparticles Ma teaches using precision pressure pumps to supply disperse and continuous phases at a pressure with a range of values that overlaps with the claimed range ([0153]; 0-4 bar).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have tried the precision pressure pumps as taught by Ma to supply the disperse and continuous phases as taught by Saragnese in view of Nakajima and there would be a reasonable expectation of success since Ma teaches using said pumps to supply disperse and continuous phases.
Furthermore, since overlapping ranges are evidence of prima facie obviousness, it would have been obvious to one of ordinary skill prior to the effective filing date of the claimed invention to have chosen the portion of the pump pressure as taught by Ma that overlaps with the claimed range.
Regarding claim 13, Saragnese in view of Nakajima and Ma teaches the method of claim 12.
Saragnese in view of Nakajima and Ma does not teach wherein the pressure applied to the first chamber is smaller than the pressure applied to the second chamber.
However, Nakajima teaches that the first chamber is generally set higher than that of the second chamber ([0202]). This implies that in some instances pressure of the first chamber can be set to not be higher than that of the second chamber. Logically, in these instances, the pressure applied to the first chamber must naturally be either smaller or equal to the pressure applied to the second chamber. Therefore one of ordinary skill in the art would recognize that there are a finite number of identified, predictable solutions for how to pressurize the first and second chambers.
Therefore it would have been obvious to one of ordinary skill in the art to apply a lower pressure to the first chamber as compared to the second chamber and there would be a reasonable expectation of success since Nakajima implies application of pressure to the first chamber can be set to not be higher than that of the second chamber.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER A WANG whose telephone number is (571)272-5361. The examiner can normally be reached M-Th 8 am-4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alison Hindenlang can be reached at 571-270-7001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER A WANG/Examiner, Art Unit 1741
/ALISON L HINDENLANG/Supervisory Patent Examiner, Art Unit 1741
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