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 without traverse of Group I, claims 1-7, in the reply filed on 11/04/2025 is acknowledged.
Claims 8-21 and 23-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/04/2025.
Claim Objections
Claims 2-7 are objected to because of the following informalities: In line 1, it is suggested to recite “An apparatus” as “The apparatus” for improved antecedent basis to the apparatus established in claim 1. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: In line 2, the phrase “wherein the or each droplet generator” (emphasis added) has a grammatical error . Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-7 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.
Regarding claim 1, claim 1 recites the limitation "the dispensing" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Claims 2-7 are rejected by virtue of their dependency on claim 1. It is suggested to recite “the dispensing” as “dispensing”.
Regarding claims 2-5 and 7, the phrases "preferably" and “more preferably” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the phrases of “preferably” and “more preferably” are interpreted as optional statements and are interpreted as not required by the claims. It is suggested to remove “preferably” if applicant desires to positively recite the elements.
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 as of the effective filing date of the claimed invention(s) 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 as of the effective filing date of the later invention 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 Bayley et al. (US 20160136888 A1; cited in the IDS filed 05/12/2023) in view of Murphy et al. (Murphy SV, Atala A. 3D bioprinting of tissues and organs. Nat Biotechnol. 2014 Aug;32(8):773-85. doi: 10.1038/nbt.2958. PMID: 25093879; cited in the IDS filed 05/12/2023).
Regarding claim 1, Bayley teaches an apparatus (Figs. 1-2) for producing a droplet assembly (abstract teaches an apparatus for producing a droplet assembly),
which apparatus comprises:
at least one droplet generator (Figs. 1-2a shows a droplet generator) suitable for generating droplets of a viscous droplet medium (interpreted as an intended use, see MPEP 2114; Figs. 1-2 shows the droplet generator is capable of generating droplets of droplet medium; paragraph [0055] teaches the droplet medium may be hydrogel, i.e. viscous droplet medium, therefore the generator is capable of generating droplets of viscous droplet medium);
a droplet receiving region (Figs. 1-2, interpreted as the well on the micromanipulator) which is moveable relative to the at least one droplet generator (Fig. 2a; paragraph [0088]); and
a control unit (Fig. 2a, “PC”), which control unit is adapted to control the dispensing of droplets from the at least one droplet generator and the movement of the droplet receiving region relative to the at least one droplet generator (paragraphs [0023],[0091]-[0092]),
wherein the apparatus is adapted to produce a droplet assembly in the droplet receiving region (Fig. 2a), wherein the droplet assembly comprises a plurality of droplets (Fig. 2a), wherein each of said droplets comprises a droplet medium (Fig. 2a).
While Bayley teaches a lipid may be sensitive to temperature (paragraph [0122]), a hydrocarbon medium is dependent on temperature (paragraph [0167]), and a sensor module capable of sensing a chemical, and a sensor molecule that may be sensitive to changes in temperature (paragraph [0199]), Bayley fails to teach: a temperature controller.
Murphy teaches 3D bioprinting (abstract). Murphy teaches common biological 3D printers usually consist of temperature-controlled material handling and dispensing system and stage (pages 776-777, section “Microextrusion bioprinting”, first paragraph). Murphy teaches bioreactors have an essential role in maintaining microenvironmental parameters such as temperature, where parameters will require design and engineering for each specific tissue type and developmental goal (page 782, right column, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Bayley to incorporate the teachings of temperature controlled systems of Murphy (pages 776-777, section “Microextrusion bioprinting”, first paragraph) to provide: a temperature controller. Doing so would have a reasonable expectation of successfully improving control of temperature as taught by Murphy (pages 776-777, section “Microextrusion bioprinting”, first paragraph) to ensure proper environments for desired elements of the apparatus as desired by Bayley (paragraphs [0122],[0167],[0199]).
Regarding claim 2, Bayley further teaches wherein the at least one droplet generator (Figs. 1-2a shows a droplet generator) is suitable for generating droplets of a droplet medium which has viscosity, measured at the temperature of the droplet medium in the droplet generator at the time of generating a droplet thereof, of at least 50 mPa.s (interpreted as an intended use, see MPEP 2114; Figs. 1-2 shows the droplet generator is capable of generating droplets of droplet medium; paragraph [0055] teaches the droplet medium may be hydrogel, i.e. droplet medium which has viscosity; therefore, the generator is suitable for generating a viscous droplet at a later time, such as a droplet having a viscosity of at least 50 mPa.s at a later time; note that “droplets” and “droplet medium” are not positively recited structurally and are interpreted as functional limitations of the generator).
Note that “droplets” and “droplet medium” are not positively recited structurally and is interpreted as a functional limitation of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“droplets” and “droplet medium”) worked upon by a structure (droplet generator) being claimed does not impart patentability to the claims (see MPEP 2115).
Note that the limitations of “preferably at least 75 mPa.s, more preferably 100 mPa.s, optionally from 100 mPa.s to 10 Pa.s, optionally wherein the droplet generator contains said droplet medium, preferably wherein the droplet medium has a viscosity, measured at a temperature of 5 C, of at least 50 mPa.s, preferably at least 75 mPa.s, preferably at least 100 mPa.s, optionally from 100 mPa.s to 10 Pa.s” are interpreted as optional statements and are not required by the claim.
Regarding claim 3, Bayley further teaches the droplet medium comprises a natural extracellular matrix material (paragraph [0055] teaches the droplet medium comprises matrigel), optionally wherein the natural extracellular matrix material is matrigel (paragraph [0055] teaches the droplet medium comprises matrigel).
Note that the limitations of “preferably wherein at least 80% by volume of the droplet medium is said natural extracellular matrix material, more preferably wherein at least 90% by volume of the droplet medium is said natural extracellular matrix material” are interpreted as optional statements and are not required by the claim.
Regarding claim 4, note that “droplets” and “droplet medium” are not positively recited structurally and is interpreted as a functional limitation of the claimed system. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“droplets” and “droplet medium”) worked upon by a structure (droplet generator) being claimed does not impart patentability to the claims (see MPEP 2115). Bayley teaches at least one droplet generator (Figs. 1-2a shows a droplet generator) suitable for generating droplets of a viscous droplet medium, wherein the droplet medium comprises an undiluted natural extracellular matrix material and biological cells, more preferably wherein the droplet medium consists of a natural extracellular matrix material and biological cells, preferably wherein the natural extracellular matrix material is matrigel (interpreted as an intended use, see MPEP 2114; Figs. 1-2 shows the droplet generator is capable of generating droplets of droplet medium; paragraph [0007] teaches droplet assemblies including cells within droplets; paragraph [0055] teaches the droplet medium may be matrigel, i.e. viscous droplet medium; therefore the generator is capable of generating droplets of viscous droplet medium wherein the droplet medium is an undiluted natural extracellular matrix material such as matrigel and biological cells at a later time).
Regarding claim 5, Bayley further teaches wherein the droplet generator comprises: a chamber for holding droplet medium (paragraph [0097]); an outlet (paragraph [0097]); and a component for displacing a volume of said droplet medium through said outlet and thereby dispensing said volume as a droplet (paragraph [0097]), optionally wherein the component for displacing a volume of said droplet medium through said outlet is a piezoelectric transducer (Fig. 3; paragraphs [0077],[0102]).
Note that the limitations of “preferably wherein the apparatus further comprises a piezoelectric driver which is capable of applying voltages more negative than -50 V and voltages more positive than +50 V to the piezoelectric transducer, preferably wherein the piezoelectric driver is capable of applying voltages more negative than -100 V and voltages more positive than +100 V to the piezoelectric transducer, more preferably wherein the piezoelectric driver is capable of applying voltages more negative than -120 V and voltages more positive than +120 V to the piezoelectric transducer, optionally wherein the piezoelectric driver is capable of applying voltages of -130 V and +130 V to the piezoelectric transducer” are interpreted as optional statements and are not required by the claim.
Regarding claim 6, Bayley further teaches wherein the droplet receiving region (Figs. 1-2, interpreted as the well on the micromanipulator) further comprises a bulk medium (Fig. 2a-2b; paragraph [0012], “bulk medium”), wherein the bulk medium and the droplet medium are immiscible (Fig. 2a-2b; paragraph [0012] teaches the bulk medium and the droplet medium is immiscible since one is hydrophobic while the other is aqueous). Modified Bayley fails to teach: wherein the temperature controller is for maintaining the temperature of the bulk medium.
Murphy teaches 3D bioprinting (abstract). Murphy teaches common biological 3D printers usually consist of temperature-controlled material handling and dispensing system and stage (pages 776-777, section “Microextrusion bioprinting”, first paragraph). Murphy teaches bioreactors have an essential role in maintaining microenvironmental parameters such as temperature, where parameters will require design and engineering for each specific tissue type and developmental goal (page 782, right column, first paragraph). Murphy teaches materials flow at physiologically suitable temperatures of 35-40C (page 777, left column, second full paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of Bayley to incorporate the teachings of temperature controlled systems of Murphy (pages 776-777, section “Microextrusion bioprinting”, first paragraph) to provide: wherein the temperature controller is for maintaining the temperature of the bulk medium. Doing so would have a reasonable expectation of successfully improving control of temperature as taught by Murphy (pages 776-777, section “Microextrusion bioprinting”, first paragraph) to ensure proper environments for desired elements of the apparatus as desired by Bayley (paragraphs [0122],[0167],[0199]).
Note that the limitations of “optionally wherein the temperature controller is capable of maintaining the temperature of the bulk medium at least at any temperature in the range of from -5C to +40C, optionally wherein the temperature controller is capable of maintaining temperature of the bulk medium at least at any temperature in the range of from -15 C to +80 C” are interpreted as optional statements and are not required by the claim.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bayley in view of Murphy as applied to claim 6 above, and further in view of Van Tuyl et al. (US 20060144871 A1).
Regarding claim 7, while Bayley teaches a droplet medium is an aqueous (paragraph [0012]) and a process where the tip of the droplet generator is immersed in a hydrophobic bulk medium (paragraph [0112]), Bayley fails to explicitly teach: wherein a surface of the outlet has a hydrophilic surface treatment.
Van Tuyl teaches a liquid dispensing apparatus for dispensing droplets (abstract). Van Tuyl teaches depending on the application, the inner surface of the nozzle may be coated with a hydrophilic or a hydrophobic coating; and the hydrophilic or hydrophobic coating may be utilized to modify the surface tension of the liquid free surface when the source liquid level is within the nozzle (paragraph [0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outlet of modified Bayley to incorporate the teachings of a hydrophilic coating of an inner surface of a nozzle for dispensing droplets of Van Tuyl (paragraph [0047]) to provide: wherein a surface of the outlet, preferably an inside surface of the outlet, has a hydrophilic surface treatment. Doing so would have a reasonable expectation of successfully improving and optimizing dispensing of droplets from the outlet by modifying the surface tension of the outlet as taught by Van Tuyl (paragraph [0047]).
Note that the limitations of “preferably an inside surface of the outlet…preferably wherein the hydrophilic surface treatment provides said surface of the outlet with a positive charge, more preferably wherein the hydrophilic surface treatment comprises (3- aminopropyl)trimethyoxysilane” are interpreted as optional statements and are not required by the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lewis et al. (US 20160287756 A1) teaches printing a tissue construct (abstract). Lewis teaches cell-laden inks having a viscosity that can rank from about 0.001 Pa-sec to about 10,000 Pa-sec (paragraph [0111]) and the ink can comprise cells mixed with a hydrogel (paragraph [0111]).
Shirazy et al. (US 20180320985 A1) teaches a transfer device for fluids (abstract). Shirazy teaches microchannels may be hydrophilic to promote fluid flow (paragraph [0132]). Shirazy teaches the hydrophilic coating is created by attaching chemical molecules on the surface as a self-assembled monolayer (SAM), such as APTES or other organosilanes (paragraph [0149]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758