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.
Priority
The instant application is a 371 of PCT/JP2022/040319 filed on 10/28/2022 and claims foreign priority to JP2021-178638 filed on 11/01/2021. The certified copy of the foreign priority application filed on 04/29/2024 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
The preliminary claim amendments filed on 04/29/2024 is acknowledged. Claims 3 and 6-7 are amended.
Accordingly, claims 1-7 are pending and being examined on the merits herein.
Claim Rejections - 35 USC § 112(b)
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 2 and 5 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.
Claims 2 and 5 recite “… MATRIGEL (trade name) …”.
MPEP 2173.05(u) states that “If the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph” and “The claim scope is uncertain since the trademark or trade name cannot be used properly to describe any particular material or product”.
The recited “MATRIGEL (trade name)” is a trademark, and is used to identify a gel particle or gel material, rendering claims 2 and 5 indefinite.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-3 and 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims recite a 3D printing support material as well as a method of making thereof comprising gel particles and a gel particle stabilizer, wherein the gel particles have a number-average diameter D50, which is a particle size corresponding to a cumulative number of 50% in a number-based particle size distribution, of 1 um to 500 um, and a ratio (D90/D10) of D90, which is a particle size corresponding to a cumulative number of 90%, with respect to D10, which is a particle size corresponding to a cumulative number of 10%, is 7 or lower in the particle size distribution.
The instant claims recite a 3D printing support material comprising a genus of gel particles and a genus of gel particle stabilizers that will have the recited particle size distribution characteristics.
MPEP 2163 II.A.3.(a).ii. states that “[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention” and The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus … Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus”.
In this case, the disclosure does not provide sufficient description of a representative number of species of gel particles and gel particle stabilizers as well as no identifying characteristics for these components to show that the Applicant was in possession of a 3D printing support material comprising the recited genus of gel particles and genus of gel particle stabilizer with the recited particle size distribution characteristics.
Applicant demonstrates in Examples 1-7 (pages 19-21) the formation of 3D printing support materials. In all of these examples, a gellan gum powder was allowed to gelate by heating and dissolving the powder to a solution and maintaining the solution at room temperature for 3 hours. The gel solution was then pulverized by a 6-minute treatment using a homogenizer to obtain gellum gum particles. Furthermore, to this pulverized gellum gum particle, a specified amount of a gel particle stabilizer such as trisodium citrate (Examples 1-4), ethanol (Examples 5-6), and acetonitrile (Example 7) was added and further treated for 6 minutes using a homogenizer. Air bubbles were removed by 3-minute centrifugation at 2000 rpm to obtain the final 3D printing support material.
Applicant further demonstrates in Table 1 (paragraph 0054 page 22) that the gellum gum particles formed using 0.45M trisodium citrate and 20% / 30% ethanol as the gel particle stabilizer resulted in D50 particle size of 1 to 500 um and D90/D10 ratio of less than 7 as recited in the instant claims.
Applicant has only demonstrated in these Examples the formation of a 3D printing support material using only one type of gel particle material (gellan gum) and three species of gel particle stabilizers (trisodium citrate, ethanol, and acetonitrile). Applicant has not demonstrated or provided further guidance of using any type of gel particle material and/or any gel particle stabilizer to form a 3D printing support material that will have the recited particle size distribution characteristics.
The state of the art does not provide predictability in forming gel particles with a specific particle size distribution characteristic using any type of gel material and/or gel particle stabilizers.
For example, Isusi (Food Hydrocolloids, 2019 in PTO-892) discloses that synthesizing microgel particles requires controlling the particle size and size distribution before or after the gelation process, and that particle breakup and gelation compete during the microgel formation process (second paragraph right column page 105). For this reason, Isusi discloses that the type of particle breakup and the gelation used for microgel formation will determine the final microgel properties, including structure, size, and strength (second paragraph right column page 105).
Isusi discloses that the type of particle breakup includes grinding microgels into smaller units using devices such as high-pressure homogenizers and rotor-stator systems (first paragraph left column page 106). However, Isusi discloses that specific flow types and forces that define how droplets or particles are broken up characterize each device, making the choice of device for microgel preparation difficult (first paragraph left column page 106). Isusi discloses that the particles or droplets undergo shear, compressive, and/or tensile stress inside the dispersing/emulsifying device depending on the flow condition, and therefore the choice of the device and their specific process parameters influences resulting particle sizes (first paragraph left column page 106).
Zhang (Science, 2017 in PTO-892) discloses that gelation methods for hydrogels depend on the intrinsic properties of the polymer, and that this dependence limits the ability to fine-tune the attributes of hydrogels (second paragraph middle column page 2). Zhang discloses that during the gelation process, physical entanglement of the polymer chains occurs in response to a temperature change, and that an increase or decrease in temperature may result in thermal gelation, in which the transition temperatures are defined as lower critical solution temperature (LCST) and upper critical solution temperature (UCST) (second paragraph middle column page 2). Zhang discloses that this gelation mechanism varies with specific types of polymers (second paragraph middle column page 2). Zhang discloses some macromolecules exhibiting UCST include natural polymers such as gelatin as well as synthetic polymers such as poly-acrylic acid (PAA), which form gels as the temperature drops before the UCST. In contrast, other macromolecules such as synthetic polymer poly(N-isopropylacrylamide) gels as the temperature rises above its LCST (second paragraph middle column through first paragraph right column page 2).
The teachings of Isusi and Zhang suggest that it would not predictable to determine which gel particle material and/or gel particle stabilizers can be used to form the recited 3D support material with the recited particle size distribution characteristics because Isusi teaches that synthesizing microgels with defined particle sizes depends on the type of particle breakup method as well as the gelation to form the microgel, and that the particle size formed depends on the flow conditions and process parameters employed within a given dispersing device. Furthermore, Zhang teaches that the gelation of hydrogels depends on the intrinsic property of the polymer, in which different polymers such as the recited gelatin or poly(N-isopropylacrylamide) will exhibit different gelation behaviors.
It is not evident by the disclosure or the prior art, that the Applicant was in possession of a 3D printing support material comprising any gel particle material and any gel particle stabilizer with the recited particle size distribution characteristics. Furthermore, as described above, there is no disclosed and/or art recognized characteristics for what gel particle material and/or gel particle stabilizer is needed in order to obtain a 3D support material having the recited particle size distribution characteristics, and Applicant has only demonstrated the formation of a 3D support material using only one type of gel particle material (gellan gum) and three species of gel particle stabilizers (trisodium citrate, ethanol, and acetonitrile).
Therefore, the instant claims do not meet the written description requirement under 35 USC 112(a)
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (Science, 2019 and Supplementary Information in PTO-892).
Lee discloses the 3D bioprinting of collagen to rebuild components of the human heart (Abstract).
Lee discloses that their 3D bioprinting method involved the use of gelatin microparticles, or freeform reversible embedding of suspended hydrogels (FRESH), as support baths for 3D bioprinting collagen (Abstract and Fig. 1 page 1).
Lee discloses that the FRESH support bath was prepared using a complex coacervation method to produce gelatin microparticles with smaller and more uniform shape and size (last paragraph page 1 in Supplementary Information). Lee discloses that the coacervation method involved dissolving 2.0% (w/v) gelatin Type B, 0.25% (w/v) Pluronic F-127, and 0.1% (w/v) gum arabic in 50% (v/v) ethanol solution at 45ºC in a 1 L beaker and adjusted to 6.25 pH by addition of 1M hydrochloric acid (HCl). In order to form the slurry of gelatin microparticles, the beaker was place under an overhead stirrer, sealed with parafilm to minimize evaporation, and allowed to cool to room temperature while stirring overnight. The resulting slurry was then divided into 50 mL conical tubes and centrifuged at 300 g for 5 min to compact the gelatin microparticles.
The ethanol used in the Lee method above meets the limitation of a water-soluble organic solvent as recited in instant claim 6, and the overhead stirring as well as the centrifuging steps performed meet the limitation of applying a shear force to the mixture to obtain a gel particle dispersion as recited in instant claim 4.
Therefore, instant claims 4-6 are anticipated.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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