DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 09/24/2025, is acknowledged.
Applicant has previously elected without traverse the invention of Group I, claims 2-11, drawn to a composition comprising expanded water-soluble solid salt particles and a polymeric binder.
Claims 2-13 are pending in this action. Claim 1 has been cancelled previously. Claims 2, 11 have been amended. Claim 12 has been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 2-11, 13 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
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.
Priority
This application is a continuation of U.S. Patent Application No. 16/760,355, filed Apryl 29, 2020 and now issued as U.S. Patent No. 11,896,740, which is a 371 of PCT/US2018/062595, filed November 27, 2018, which claims benefit of provisional U.S. Application No. 62/591,336, filed November 28, 2017.
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 2-11, 13 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 pre-AIA the applicant regards as the invention.
Newly amended claim 2 recites the limitations “expanded water-soluble salt particles” and “expanded in a binder under hydration without dissolution” that are not reasonably clear. First, it is unclear what the term “expanded water-soluble” does imply. As stated previously, the instant specification does not provide a definition for said term. Therefore, clarification is required. Second, it is noted that said expanded particles are included in solid particles (i.e., “solid particles comprising expanded water-soluble salt particles”) and the binder holds the solid particles together. Therefore, it is unclear what does the limitation “extended in a binder” imply. Therefore, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Clarification is required.
Further, it is noted that claim 2 discloses compositions comprising solid particles comprising expanded water-soluble salt particles, and a polymer as a binder and defines said structural constituents by their properties, i.e., expanded water-soluble, a polymer as a binder, water solubility, expanded in a binder, soluble in a solvent other than water, expanded by a salt hydrating solution, but not by the chemical structure essential for said compositions. As stated previously, said claim attempts to define the subject-matter in terms of the result to be achieved, which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. First, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Second, it is noted that claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Third, claim 2 refers to “composition”, wherein some elements are characterized by their assumed function, e.g., “polymer acting as a binder”, and not by the structure essential for said composition. Therefore, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Similar is applied to claims 3-7. Clarification is required.
Newly amended claim 2 discloses “the extended water-soluble salt particles … that have been extended in a binder under hydration without dissolution … by the salt-hydrating solution”. To this point, it is noted that said limitation discloses a preparation of expanded particles to be used in the claimed composition. If the applicant implies that the claimed product (i.e., compositions for use in forming a porous material) can be produced by a specific process that should be clearly stated in the claims, e.g., as a product-by-process claims. Similar is applied to claims 3-6. Clarification is required.
Newly amended claim 11 (dependent on claim 2) recites the limitation “the expanded water-soluble salt particles are CuSO4” that is not reasonably clear, because the structural element (i.e., particles) is defined as a compound (i.e., CuSO4). Clarification is required.
Claims 8-10, 13 are rejected as being dependent on rejected claim 2 and failing to cure the defect.
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.
Claims 2-11, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al., CN 103,910,901A (cited in IDS; hereinafter referred to as Huang), in view of Shah et al., US 2017/0081534 (pub.date 03/23/2017; cited in IDS; hereinafter referred to as Shah), and Jakus, et al. Scientific Reports 2017, 7:44931, 1-8 pages (cited in IDS; hereinafter referred to as Jakus).
Huang teaches a method of forming a porous material, the method comprising (Claims 1-4; Abstract; Para. 0009-0019, 0069-0077 as applied to claims 2, 7-8, 10): (a) preparing a composition comprising solid salt particles, e.g., CuSO4 (identified in the instant specification as water-soluble salt particles); a polymer such as a polylactic acid (identified in the instant specification as a polymer binder), and a primary solvent such as dichloromethane, chloroform, acetone or dimethyl sulfoxide (Claims 1-4; Para. 0016, 0019-0020, 0073); (b) subject said composition to a heat treatment (Claim 1, step 5; Para.0016); (c) place said heat treated product of (b) in a polar solvent (e.g., water or alcohol), immerse and rinse for 24-72 hours to remove the porogen (Claim 1, step 6; Para. 0017, 0019); (d) freeze-dried or vacuum-dried said material of (c) at room temperature for 2-6 hours to obtain a porous material (Claim 1, step 7; Para. 0018, 0069-0073);
Huang does not specifically teach the use of polylactic-co-glycolic acid (PLGA) as a binder (claim 9); and also does not teaches the use of nickel metal, yttria-stabilized zirconia ceramic, or graphene (claim 11).
Shah teaches 3D printable compositions for forming porous objects, films and coatings (Figs. 8-9, 10-11, 13-14), wherein said compositions may include (i) dichloromethane, chloroform, or a mixture thereof; (ii) an elastic polymer binder; e.g., less than 50 vol% of PLGA; and (iii) at least 50 vol% of one or more types of solid particles, e.g., particles comprising graphene flakes, CuSO4, nickel, yttria-stabilized zirconia (Claims 1-3, 11, 16-17; Title; Abstract; Para. 0003-0005, 0049-0052, 0057-0061, 0074; Table 1). Shah teaches that said compositions can be 3D-printed into user defined architectures, i.e., in various self-supporting 3D objects (Figs. 4-19).
Jakus teaches a preparation of robust and elastic structures from 3D-printed regolith compositions and their use for preparation of porous material (Title; Abstract). To this point, Jakus teaches the use of compositions comprising: (i) 30-25 vol% of polylactic-co-glycolic acid as an elastomeric binder; (ii) 70-75 vol% of regolith powders by solids volume; and (iii) a solvent mixture including dichloromethane as a primary solvent (Page 2). Jakus further teaches that said compositions can be (iv) 3D-printed via direct extrusion through a nozzle to form a fiber; and further (v) 3D-printed into user defined architectures, e.g., comprising multiple layers (Abstract; Figs. 2-3; Pages 3-7).
Therefore, the examiner maintains the position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include/use/try PLGA as a binder polymer as well as solid particles as taught by Shah and Jakus in compositions to be used in a method as taught by Huang. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach allows providing 3D porous materials and/or objects with various/desired self-supporting architectures. Regarding the properties of the disclosed compositions (i.e., expanded particles), it is noted that the cited prior art teaches the compositions comprising the same components. Thus, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP § 2112.02.
With regard to the concentrations as instantly claimed (claims 10, 13), it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Claims 3-6 are rejected as being dependent on rejected base claim.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 7,815,826 - teaches the use of organic-solvent-soluble, water-insoluble particles and water soluble, organic-solvent-insoluble particles for 3D printing porous structures.
Response to Arguments
Applicant's arguments, filed 09/24/2025, have been fully considered, but were not found to be persuasive for the reasons set forth above. New rejections and/or arguments have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner’s comments are set forth next.
In response to the applicant’s argument that the instant claims clearly define the structure of the claimed composition/product (i.e., regarding 112(b) rejection of record), it is noted that independent claim 2 discloses a composition comprising constituents that are characterized/defined by their properties or functions (i.e., expanded, holding, etc.), but not by the structure essential for the claimed composition/product. As stated above, said claims attempt to define the subject-matter in terms of the result to be achieved, which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. Further, as stated above, claiming a result (i.e., a composition for use in forming a porous material) without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. If the applicant implies that the claimed product (i.e., a composition for use in forming a porous material) can be produced by a specific process (i.e., expanding water-soluble salt particle having a specific solubility in water; incorporating said expanded particles into solid particles; holding said solid particles together by a binder, etc.) that should be clearly stated in the claims, e.g., as a product-by-process claims.
In response to applicant’s argument that the cited prior art does not teach “expanded water-soluble salt particles held together by a binder” (i.e., regarding 103-rejection of record), it is noted that independent claim 2 teaches “the binder holding the solid particles together”, wherein “expanded water-soluble salt particles have been expanded in a binder under hydration without dissolution”. Therefore, the applicant’s argument is not persuasive, and clarification of the claim language and/or the scope of the claims is required. If the applicant implies that the claimed product (i.e., compositions for use in forming a porous material) is produced by a specific process that should be clearly stated in the claims, e.g., as a product-by-process claims, and the preparation steps should be clearly deliniated. In the present case, the examiner maintains the position that the cited prior art teaches compositions comprising the same compounds/components to be used for providing 3D porous materials and/or objects with various/desired self-supporting architectures. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP § 2112.02.
Conclusion
No claim is allowed at this time.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on (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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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615