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 without traverse of Group I and the species where the wall material is a polyolefin and the CO2 accepting active is a CO2 absorbing material selected from lithium peroxide, inorganic hydroxide compounds, and a mixture thereof in the reply filed on June 12, 2026 is acknowledged.
Claims 42-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claims 32 and 33 recite permeability of carbon dioxide and water vapor with units of “cm3 cm cm-2 Pa s-1”. These units do not appear in the specification.
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
The disclosure is objected to because of the following informalities: There are two different entries of a description of Fig. 1 as part of the description of the drawings that should be consolidated int a single description
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 27-41 and 49-52 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.
Claim 27 recites “a coated active ingredient formulation…comprising...a coating…and a core region which comprises …active ingredient”. The scope of configurations is unclear given that 1) dependent claims then recite “the coated active ingredient…is the microcapsule, wherein the microcapsule is a microspherule…wherein…the active ingredient is incorporated in solid dispersed form or in dissolved form in a polymer carrier matrix” and 2) the specification states that the CO2-permeable coating…is preferably the carrier matrix of a microspherule (see page 9 second paragraph). The instant specification on page 7 also recites that “[m]icrospherules are systems related to microcapsules, in which there is no exact separation into core and coating region” which seems to contradict the presence of a core and coating as claim 27 recites. Thus it is unclear which structural configuration and components are required to meet the instant claim limitations.
Claims 32 and 33 recite the units “cm3 cm cm-2 Pa s-1” for the permeability of carbon dioxide and water vapor. The instant specification recites different units for this property, where the pascal pressure unit is raised to the power of negative one and the recited units do not appear to be consistent with the recognized units for this parameter (see specification page 9 second full paragraph; Tock (Advances in Polymer Technology 1983 393:197-287, table 1). Further the ranges recited for these properties are recited backwards as “0.009 to 32,000 x10-13” and “0.004 to 2,500 x 10-13” which makes it unclear as to whether the numbers were intended as recited. Thus the values that are required for these parameters are not discernible. In addition, the property is also impacted by the conditions under which it is measured. A single preparation could be both inside and outside the scope of the claims, depending on how it is assessed, which also makes the scope of the claimed products unclear.
Claim 39 recites a range for the carbon dioxide acceptance capacity. However, carbon dioxide absorption capacity changes due to exposure time as well as conditions. For example Lee et al. teach the carbon dioxide absorption/acceptable capacity for a calcium hydroxide composition with polyethylene changes due to exposure time (see Food Packaging and Shelf Life 2019 21(100352):1-8; abstract, page 2 second column first full paragraph, and figure 5 left panel). A single preparation could be both inside and outside the scope of the claims, depending on how it is assessed which makes the scope of the claimed products unclear.
Claims that are rejected but are not explicitly elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity.
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.
Claims 27-31, 34, 36-41, and 49-50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. as evidenced by Tock and Cooper (US Patent No. 3,660,152).
Lee et al. disclose a polymer composite for absorbing carbon dioxide and contemplated for packaging, composed of low density polyethylene (polyolefin; LDPE) and calcium hydroxide as a carbon dioxide adsorbent (see abstract; instant claims 27, 31, and 36-38). They disclose extruding a mixture with calcium hydroxide and LDPE into a particulate (microcapsule/microspherule; round/ellipsoidal/irregular shaped) master batch that is later formed into a film (see graphical abstract and page 2 second column first full paragraph; instant claims 29-31 and 49-50). 80 wt% and 90 wt% LDPE composites are detailed (see table 1; instant claim 34). Polyethylene is permeable to CO2 and impermeable to water, thus the polyethylene has these properties (see Tock table III and Cooper column 1 lines 15-18; instant claims 27-28). Instant claims 49-50 are product-by-process recitations. “’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Here there is no structure implied by the instant process steps that the product of Lee et al. does not also provide. Lee et al. also detail combining the master batch with distilled water, a pharmaceutically acceptable aqueous carrier (see page 2 first column last partial paragraph; instant claim 40). The intended delivery of the composition via intraperitoneal or enteral administration is possible (see instant claim 41). Analysis of a calcium hydroxide loaded film with 80 wt% LDPE shows an increase of 0.4 wt% due to carbon dioxide acceptance (adsorption) over 400 minutes which corresponds to 40 mg/g of composition (see figure 5 left panel; instant claim 39). Therefore claims 27-31, 34, 36-41, and 49-50 are anticipated by Lee et al. as evidenced by Cooper and Tock.
Claims 27-31, 34, 36-39, 49-50, and 52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pi et al. (Energy and Fuels 2019 33:2381-2389) as evidenced by Cooper and Tock.
Pi et al. disclose a polymer composite for absorbing carbon dioxide composed of polyethylene (polyolefin; LDPE) and calcium hydroxide as a carbon dioxide adsorbent (see page 2382 first column first full and last full paragraphs; instant claim 27). Calcium hydroxide is combined with polyethylene (polyolefin) at 10 wt% and extruded into pellets that are spheronized into a size of 500 to 750 mm (see page 2382 first column last full paragraph; instant claims 27, 29-31, 34, 36-38, 49-50 and 52). Polyethylene is permeable to CO2 and impermeable to water, thus the polyethylene has these properties (see Tock table III and Cooper column 1 lines 15-18; instant claims 27-28). Instant claims 49-50 are product-by-process recitations. “’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Here there is no structure implied by the instant process steps that the product of Pi et al. does not also provide. Analysis of the material shows a carbon dioxide acceptance (adsorption) capacity for a 90% calcium hydroxide loaded sample (Ca9) of 550 mg/g composite (see figure 6 left panel; instant claim 39). Therefore claims 27-31, 34, 36-39, 49-50, and 52 are anticipated by Pi et al. as evidenced by Cooper and Tock.
Claims 27-29, 31, 34, and 36-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saito et al. (JP-H0751560 – English translation referenced for citations) as evidenced by Cooper and Tock.
Saito et al. disclose microcapsules that provide a polyethylene coating on an active agent core that protects and isolates the core from the outside until subjected to a sufficiently high temperature that melts the coating (see paragraphs 1 and 6). An example employs calcium hydroxide as the active agent in the core with a polyethylene coating composing about 33 wt% of the microcapsule (see paragraph 7; instant claims 27, 29, 31, 34, 36-38). Polyethylene is permeable to CO2 and impermeable to water, thus the polyethylene has these properties (see Tock table III and Cooper column 1 lines 15-18; instant claims 27-28). Applications in agriculture and pharmaceuticals as well as latent curing systems for polymers (see paragraphs 2 and 5). Polyethylene is permeable to CO2 (see Tock table III; instant claim 27). Therefore claims 27-29, 31, 34, and 36-38 are anticipated by Saito et al. as evidenced by Cooper and Tock.
Claim Rejections - 35 USC § 102/103
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.
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 27-29, 31, and 36-38 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Miller et al. (US Patent No. 4,876,296) as evidenced by Tock and Cooper.
Miller et al. disclose encapsulated thickener, where the thickener is selected from calcium oxide calcium hydroxide, magnesium oxide, magnesium hydroxide, or a combination thereof and the encapsulating material is selected from polyethylene, polystyrene, cellulose acetate butyrate, and combinations thereof (see claim 1; instant claims 27, 31, and 36-38). Amongst the small number of options of pairings of thickener compounds and encapsulating material is the polyolefins polyethylene or polystyrene with calcium hydroxide or magnesium hydroxide are combinations that meet the instant limitations of the instant CO2 accepting active ingredient and wall material. Both polyethylene and polystyrene are permeable to CO2, while polyethylene is also water impermeable (see Tock table III and Cooper column 1 lines 15-18; instant claims 27-28). The encapsulated thickener is configured as a solid core with a single layer shell/coating (see column 3 lines 20-40; instant claim 29). In the embodiment where polystyrene is the encapsulating polymer, Tock et al. teach a 1160 cm3(mil)(24hr)-1(100 in2)-1atm-1 carbon dioxide permeability which converts to 2.2 x 10-11 cm3 cm cm-2 Pa-1 s-1 for polystyrene. Alternatively, the pairing of thickener compounds and encapsulating material is the polyolefins polyethylene or polystyrene with calcium hydroxide or magnesium hydroxide would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. Therefore claims 27-29, 31, and 36-38 are anticipated by Miller et al. as evidenced by Tock et al. and Cooper.
Claims 27-31, 35-38, and 49-51 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Chu et al. (EP 0294141) as evidenced by Tock and Cooper.
Chu et al. disclose polymer pellets with a polymer core that are melt coated with an additional polymer, where the core is generated from molten polymer (see abstract). They detail polyolefins, particularly polyethylene, as the first polymer in the core and as the second polymer in the coating (see page 2 lines 4-23). The core is taught to also include additives and the coating is provided to cover objectionable characteristics of the core (see page 2 lines 9-14). Chu et al. list a set of embodiments where a polyethylene first polymer in the core is provided with an inorganic filler envisioned as magnesium hydroxide, and then coated with a polyethylene second polymer (see page 3 lines 14-20; instant claims 27, 29-31, 36-38, and 49-51). Polyethylene is permeable to CO2 and impermeable to water, thus the polyethylene coating of Chu et al. has these properties (see Tock table III and Cooper column 1 lines 15-18; instant claims 27-28). Further Chu et al. disclose the coating thickness to range from 25 to 250 mm (see page 4 lines 13-14; instant claim 35). Alternatively, the selection of magnesium hydroxide from the named inorganic fillers would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention because Chu et al. name it in a small set. Similarly, the application of the coating thickness Chu et al. also detail would have been obvious to implement because they state to do so. Instant claims 49-51 are product-by-process recitations. “’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Here there is no structure implied by the instant process steps that the product of Chu et al. does not also provide. Therefore claims 27-31, 35-38, and 49-51 are anticipated by or, alternatively are obvious over, Chu et al. as evidenced by Tock and Cooper.
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 27, 29, 31, and 34-38 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. as evidenced by Tock and Cooper.
Miller et al. disclose encapsulated thickener where the thickener is selected from calcium oxide calcium hydroxide, magnesium oxide, magnesium hydroxide, or a combination thereof and the encapsulating material is selected from polyethylene, polystyrene, cellulose acetate butyrate, and combinations thereof (see claim 1; instant claims 27, 31, and 36-38). Amongst the small number of options of pairings of thickener compounds and encapsulating material is the polyolefins polyethylene or polystyrene with calcium hydroxide or magnesium hydroxide are combinations that meet the instant limitations of the instant CO2 accepting active ingredient and wall material. Both polyethylene and polystyrene are permeable to CO2, while polyethylene is also water impermeable (see Tock table III and Cooper column 1 lines 15-18; instant claims 27-28). In the embodiment where polystyrene is the encapsulating polymer, Tock et al. teach a 1160 cm3(mil)(24hr)-1(100 in2)-1atm-1 carbon dioxide permeability which converts to 2.2 x 10-11 cm3 cm cm-2 Pa-1 s-1 for polystyrene. Miller et al. further teach that the encapsulated thickener is configured as a solid core with a single layer shell/coating sized at 5 to 30 microns (see column 3 lines 20-40 and 50-53). The thickness of the shell can be controlled by the rate of addition of non-solvent for the encapsulating polymer when made from a dispersion of the thickener in a solution of the encapsulating polymer; thereby making it a result effective variable (see column 3 line 64-column 4 line 8). Miller et al. additionally exemplify encapsulating polymer and thickener at a mass ratio of 2:3 which corresponds to the encapsulated product having about 40 wt% coating (see column 4 lines 8-22).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the encapsulated thicker particles of Miller et al. where encapsulating material polyolefin, polyethylene or polystyrene, is paired with calcium hydroxide or magnesium hydroxide thickener because they state to do so. Routine optimization would further render obvious the instantly claimed coating thickness, given the particle size between 5 and 30 microns. Application of the exemplified relative amount of encapsulating polymer and thickener (coating and core) would follow. Therefore claims 27-29, 31, and 34-38 are obvious over Miller et al. as evidenced by Tock and Cooper.
Claims 27-31, 34-38, and 49-51 are rejected under 35 U.S.C. 103 as being unpatentable over Chu et al. as evidenced by Tock and Cooper.
Chu et al. disclose polymer pellets (irregular/round/ellipsoid shaped, microspherule, microcapsule) with a polymer core that are melt coated with an additional polymer, where the core is generated from molten polymer (see abstract). They detail polyolefins, particularly polyethylene, as the first polymer in the core and as the second polymer in the coating (see page 2 lines 4-23). The core is taught to also include additives and the coating is provided to cover objectionable characteristics of the core (see page 2 lines 9-14). Chu et al. list a set of embodiments where a polyethylene first polymer in the core is provided with an inorganic filler envisioned as magnesium hydroxide and then coated with a polyethylene second polymer (see page 3 lines 14-20; instant claims 27, 29-31, 36-38, and 49-51). Polyethylene is permeable to CO2 and impermeable to water, thus the polyethylene coating of Chu et al. has these properties (see Tock table III and Cooper column 1 lines 15-18; instant claims 27-28). Further, Chu et al. disclose the coating thickness to range from 25 to 250 mm (see page 4 lines 13-14; instant claim 35). They also teach loading of the coating on the pellets such that the coating composes 5 to 30 wt% of the coated pellet (see page 4 lines 11-16; instant claim 34). A full example of each embodiment that follows from the teachings of Chu et al. is not detailed; however, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select magnesium hydroxide from the named inorganic fillers because Chu et al. name it in a small set. Similarly the application of the coating thickness and weight proportion that Chu et al. also detail would have been obvious to implement because they state to do so. Instant claims 49-50 are product-by-process recitations. “’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. Here there is no structure implied by the instant process steps that the product of Chu et al. does not also provide. Therefore claims 27-31, 34-38, and 49-51 are obvious over Chu et al. as evidenced by Tock and Cooper.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
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