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 .
Status of Claims
Preliminary amendment filed on 12/17/2024 is acknowledged.
Claims 3-8, 10-13 and 15-18 are amended. Claims 19-53 are cancelled.
Claims 1-18 are pending and being examined on the merits herein.
Priority
The instant application 18984413, filed on 12/17/2024, is a CON of 18049095, filed on 10/24/2022 (now patent US12213993, 02/04/2025), which claims benefit of 63/262999, filed on 10/25/2021 and claims benefit of 63/364657, filed on 05/13/2022.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 01/06/2025 (3 files), 05/19/2025 (1 file), 08/12/2025 (1 file), 05/18/2026 (1 file), is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Specification-Objection to Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. The instant abstract uses word “disclosed”.
Correction is required.
Claim Objections
Claims 1, 3-4, 8, 10, 13-14 objected to because of the following informalities:
Claim 1 shows left side indent for most of the lines except three of the lines, e.g., 2nd line, in the middle line containing “at least one coating agent …”, and the last line of the end of claim. If there are no specific reasons, the format, e.g., without left indent, should keep consistent within the claim. Further, the space between the words “EO-PO” and “copolymer” leaves the line half empty, wherein the copolymer needs to be right behind EO-PO.
Claim 1 recites “EO-PO” without full definition of the acronym.
Claim 1 recites “A medicinal clay composition comprising” in line 1 and “a medicinal clay composition comprising” in line 2. It appears to be repetitive and one of these shall be removed.
Claim 1 recites “clay minerals” in line 2, and also recites “clay mineral” in line 3. Using either singular or plural format of the word mineral should be consistent within the claim.
Claim 1 recites “…; and at least one coating agent …; wherein the medicinal clay composition comprises at least 20 wt-% of the composition”. If the semicolon herein is used to indicate the parallel limitations, a word “and” is recommended to be added in front of the word “wherein” as “…; and wherein …”.
Claim 3 recites “Smectite”, “Illite” and “Illite-Smectite”. The uppercases of these words should be revised to lowercases for consistency through the entire claim set.
Claim 4 recites “…a Cation Exchange Capacity (CEC)”, wherein the acronym should present at the location the word first time appears, for this instance, “CEC” needs to be in claim 1.
Claim 4 recites “ a Cation Exchange …”, “an Oxidation …”, “a pH”, “a clay crystalline …”. Since they are further defining the specific limitations in claim 1, the indefinite article word “a” or “an” should be revised to the definite article “the”.
Claim 4 recites “ at least about wt-% pyrite” without a number value. A specific value is required for the percentage.
Claim 8 recites triblock polymer (PEOa-PPOb-PEOa) without full definition of the acronym.
Claim 10 recites “at least two, at least three, or at least four, or at least five”, wherein the second “or” should be removed.
Claim 13 recites “a medicinal clay composition according to claim 1”. This “a” should be revised to “the” identifier as depending on claim 1.
Claim 14 recites “…enema, transdermal therapeutic system or dressing or other …”, additional word “or” should be added in front of “transdermal” to appear as “… enema, or transdermal …” so that the systems impregnated with the medicinal clay composition would read as an equal alternative as other composition forms.
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 1-18 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 1 recites “a medicinal clay composition comprising” in lines 1 and 2 twice, resulting in “a medicinal clay composition comprising a medicinal clay composition comprising …”, which is indefinite because a composition cannot comprise a composition itself. At meantime, based on “at least one coating agent comprising … surrounding the medicinal clay composition”, it suggests that second “medicinal clay composition” does not include the coating, while the first “medicinal clay composition” comprises the coating in addition to the second “medicinal clay composition”. Thus the first and second “a medicinal clay composition” seem to include different ingredients, while the same phrase “a medicinal clay composition” cannot represent two different compositions. For these discussed reasons, the claim’s metes and bounds is unclear, and that renders the claim indefinite.
Claim 1 recites “wherein the clay composition” in line 3, because previously there are two “medicinal clay composition” appearing in the claim and these two compositions may comprise different contents, it is unclear which clay composition here refers to, and it renders the claim indefinite.
Claim 1 recites “at least about 40 wt-% of the clay” in line 6. Because there are multiple appearances of the word “clay” previously in the claim, e.g., “a medicinal clay composition” (twice), nature clay or clay minerals, synthetic clay or clay mineral, etc. , it is unclear which clay this refers to; and it is also unclear whether it refers to the entire clay composition weight regarding to the first “medicinal clay composition”.
Claim 1 recites “a crystalline composition” in lines 6 and 7 twice comprising different ingredients. It is confusing how two crystalline compositions with different ingredients can coexist in a composition as two different crystalline compositions while being defined as “product specifications”. If it is meant to be alternatives of ingredients for one or the other, it is recommended to rephrase and combine the two options like “a crystalline composition comprising … (ingredients option 1) or … (ingredients option 2)”. However, a crystalline composition, as a subject matter itself, cannot be a specification, e.g., property, or feature, of the medicinal clay composition.
Claim 1 recites “at least 1 wt-% pyrite”. It is unclear what calculation basis is calculated upon, whether it is based on the total weight of the final product composition, or it is based on the crystalline composition, or something else. It is also unclear whether this specification belongs to a component of the second “a crystalline composition”, or it is a specification itself for the medicinal clay composition.
Claim 1 recites “and/or at less than 40 ppm heavy metal contaminant”. It is unclear whether this is one of the product specifications for the medicinal clay composition, or it belongs to the component of the second “a crystalline composition”. It is also unclear what calculation basis it is calculated based upon, whether it is out of the total medicinal clay composition, or it is the crystalline composition, or it is something else.
Claim 1 recites “the medicinal clay composition comprises at least about 20 wt-% of the composition”. It is unclear what exact compositions of “the medicinal clay composition” and “the composition” refer to. It is unclear whether “the medicinal clay composition” refers to the medicinal clay composition appeared in 1st line or 2nd line of the claim, and whether “the composition” is supposed to mean the final product composition.
Claim 2 recites “the clay composition”, because in claim 1 there are multiple “medicinal clay composition” in addition to “the clay composition”, it is unclear which specific one it refers to, whether it is meant to be the intermediate composition, or the final composition is unclear.
Claims 2-12 reach recite “[T]he composition of claim 1”, due to the different medicinal clay compositions in claim 1 being described using the same identifier “a medicinal clay composition”, while they may include different ingredients, it is unclear which composition exactly in claim 1 each claim refers to, all these claims are indefinite.
Claims 3-4 each recites “wherein the medicinal clay composition”. It is unclear which medicinal clay composition it refers to due to the multiple available “medicinal clay composition” appeared in claim 1.
Claim 3 recites ingredient percentages without defining the calculation basis, e.g., about 10 to about 40 wt-% smecitite. It is unclear whether the percentage is based upon total weight of the final composition product, or the intermediate product.
Claim 4 recites “at least 40 wt-% of the clay”, “at least about wt-% pyrite”, and “40 ppm” without defining the calculation basis, and it is unclear whether the calculation is based on the total weight of the medicinal clay composition or the total weight of the crystalline composition, or something else. Further, the pyrite percentage does not appear to have a value. Moreover, it is unclear “the clay” in “at least 40 wt-% of the clay” refers to which clay because there are multiple clays including natural clay or clay minerals, synthetic clay or clay minerals, or combinations thereof, appear in claim 1, which claim 4 depends upon, in addition to the instantly mentioned clay components, e.g., smecitite, illite, and/or illite-smectite, in the clay crystalline composition. Moreover, claim 4 recites “at least about >10 mEq/100 g”, it is unclear whether it is meant to be at least about 10 mEq/100g, or it is meant to be more than 10 mEq/100g. “At least” cannot be used to define “about >10 mEq/100g”, since at least indicates a starting point of value, while “>” indicates a value above a point, not the point per se. The claim is indefinite for the issues addressed above.
Claim 5 recites “particle size of the clay”. It is unclear which clay it refers to because there are multiple clay words previously present in claim 1 as discussed above.
Claim 11 recites “wherein the composition is shelf-stable”, it is unclear which composition it refers to, because there are multiple medicinal clay compositions and crystalline compositions in claim 1, and it is unclear whether it refers to the final product or intermediate compositions.
Claim 13 recites “a medicinal clay composition according to claim 1”. It is unclear which specific one it refers to because there are multiple such compositions mentioned in claim 1.
Claim 14 recites “film, … hydrogel, gel, alginate gel, gel sheet, …enema, transdermal therapeutic system or dressing or other delivery system impregnated …”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitation “hydrogel gel”, “gel”, “gel sheet”, “transdermal therapeutic system …”, and the claim also recites “alginate gel”, “film” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 14 recites “…enema, transdermal therapeutic system or dressing or other delivery system impregnated …”. The claim is unclear whether all the alternative forms are all belong to the “transdermal therapeutic system or dressing or other delivery system impregnated with the medicinal clay composition”. If the “transdermal therapeutic system …” is an equal alternative as other forms, a word “or” in front of word “transdermal” is required to read as “ enema, or transdermal therapeutic system or …” to clarify the limitation scope.
Claim 14 recites “the medicinal clay composition”. It is unclear which medicinal clay composition it refers to because of the multiple appearances of medicinal clay compositions in claim 1 as discussed above.
Claims 15-18 are rejected accordingly because they are directly depending on claim 13 and indirectly depending on claim 1, while they do not further clarify the issues as addressed above in claims 1 and 13.
Claim Interpretation
Some claims are interpreted as following:
Claim 1 in light of instant specification (e.g., [0061],[0068]) using broadest reasonable interpretation (BRI) is interpreted as following:
A medicinal composition comprising:
a medicinal clay composition comprising natural clay or clay minerals, synthetic clay or clay minerals, or combinations thereof, wherein the medicinal clay composition has at least two specifications selected from following:
a Cation Exchange Capacity of at least about greater than about 10 mEq/100 g,
an Oxidation-Reduction Potential greater than about 250 mV,
a pH less than about 5.0,
clay crystalline structure of smectite, illite, and/or illite-smectite present at least about 40 wt-% of the total weight of the clay in the medicinal clay composition,
2:1 tetrahedral/octahedral phyllosilicate with reduced iron octahedral and exchangeable cations,
at least 1 wt-% pyrite of the total weight of the medicinal clay composition, and/or
less than 40 ppm heavy metal contaminants;
at least one coating agent comprising a nonionic block ethylene oxide-propylene oxide (EO-PO) copolymer, mineral salts, polysaccharide, water soluble or hydrocolloid polymer, or combination thereof, surrounding the medicinal clay composition having a thickness of at least about 1 micron, or from about 1 to about 100 microns;
wherein the medicinal clay composition is at least about 20 wt-% of the total weight of the final medicinal composition.
Claims 2-12, the phrase “[T]he composition of claim 1” is interpreted as “the medicinal composition of claim 1” as interpreted above in claim 1. In claim 11, “wherein the composition …” is interpreted as “the medicinal composition” as interpreted in claim 1.
Claim 4 is interpreted as the medicinal composition according to claim 1 has specifications i), ii), iii), iv), vi) and vii) as interpreted above in claim 1 with i), ii), iii) further defined in claim 4. The phrase “at least about wt-% pyrite” is interpreted as “at least about 1 wt-% pyrite of the total weight of the medicinal clay composition”. The phrase “at least about >10 mEq/100 g” is interpreted as “at least about 10 mEq/100 g”.
Claim 13 phrase “a medicinal clay composition according to claim 1” is interpreted as “the medicinal composition according to claim 1” as interpreted in claim 1 above.
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.
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over McCord (US20210046186, 02/18/2021, IDS of 01/06/2025) in view of Marcussen et al. (DK/EP2160950, 03/10/2010, PTO-892).
McCord throughout the reference teaches antimicrobial compositions comprising clay antimicrobial composition, comprising suspending agents, poloxamer and one or more nonionic EO-PO block copolymers in a water-based delivery system for treatment (e.g., Abstract).
For Claims 1 and 4:
McCord teaches the a) antimicrobial clay composition in exemplary embodiments having the corresponding specifications (in Roman numerals) as in interpreted claims, that the clay is a naturally mined antimicrobial clay known as Blue clay (e.g., [0070]; Claims 16, 17 and 39), which is dominated by iv) illite-smectite (a group of clay minerals having an expandable interlayer structure), quartz (having crystalline structure) (e.g., [0070]), while McCord also teaches clays include a variety of natural mineral made up of crystalline material such as bentonites, smectite, illite,-smectite, pyrite, silicates (e.g., [0069]), vi) pyrite ranging from about 3 wt-% to about 10 wt-% and/or from about 1 wt-% to about 5 wt-% (overlapping with at least 1 wt-% pyrite in instant claims), and Ca-plagioclase; the expandable smectite interlayer region functions like a reservoir from which metals, which may have antibacterial effects, are slowly released via i) cation exchange in interpreted claims) (e.g., [0070]).
McCord teaches to use pH adjusters (e.g., [0114]; Claim 21) while teaching compositions have pH neutral (e.g., Claims 1 and 17), specifying that beneficially the natural minerals can release soluble transition metals at iii) low pH which are effective in killing bacteria due to the generation of reactive oxygen species and damage to bacterial membranes (e.g., [0070]), and by reducing neutral pH of bodily fluids like exudate and saliva clay makes the tissues a less friendly environment for pathogens, thereby providing at least one mechanism for the efficacy of the clay delivery systems described herein (e.g., [0131]). McCord further teaches the antimicrobial clay may be modified with various substituents to alter the properties of the clay, include modification by treatment with a strong acid (e.g., [0071]), which provides motivation for artisans in the field to lower pH to acidic for the benefit and advantages.
McCord emphasizes that the compositions are produced using a ceramic ball instead of conventional use of a metal ball milling to ensure vii) no metal contaminants (or 0 ppm) are included in the clay delivery systems (e.g., [0075]) (overlapping with less than 40 ppm heavy metal contaminants in instant claims 1 and 4).
McCord teaches the clay portion (corresponding to c) medicinal clay composition percentage) is included in the clay delivery system in an amount of at least about 10 wt-% to about 50 wt-%, about 15 wt-% to about 40 wt-%, or about 20 wt-% to about 35 wt-% (e.g., [0077]) (overlapping with at least about 20 wt-% of the medicinal clay composition of the total medicinal composition in instant claim 1 c). McCord exemplifies in a clay/hydrogel mixture including Oregon Millard Blue Clay mixture, containing clay minerals iv) smectite, illite, and kaolinite and soluble Fe2+ and Al3+, present at 30 wt-% of the total weight clay portion, and c) the medicinal clay composition is 90 wt-% of the total weight of the clay/hydrogel mixture as final medicinal composition (e.g., [0158], Table 6). McCord also teaches products containing 10 wt-% to 60 wt-% of the clay (e.g., [0175-0176]; Table 7) (overlapping with at least about 40 wt-% of the clay in instant claims 1 iv) and 4 iv)).
McCord teaches that the clay can deliver toxins to the targeted bacteria and also absorb toxins (e.g., [0005-0006]; [0120]; [0133]), through feature ii) oxidation-reduction potential: when the clay is hydrated, or once the clay comes in contact with a water source (such as the second part of the delivery system), the clay releases metals, such as iron (particularly reduced Fe2+) and aluminum (particularly Al3 +), where both elements cause toxicity to bacteria through damaging bacterial membranes. The damaging of the membranes then allows for the excess iron to cause intracellular protein damage through oxidation. Hydroxyl radicals are generated as Fe2+ is oxidized by H2O2 through the Fenton reaction. The proximity of .OH generation to target to be treated (i.e. tissue or organ) is important for toxicity of the pathogen as the radical .OH has a short half-life ( estimated at between 10-9 second half life and also diffuses only nanometers before reacting (e.g., [0119]).
MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty."). MPEP 2145 II. also states that “prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art”, see In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991). For this instance, the i) Cation Exchange Capacity at least about greater than about 10 mEq/100 g in instant claim 1, or about >10 mEq/100g to about 100 mEq/100 g in instant claim 4, and ii) Oxidation-Reduction Potential greater than about 250 mV in instant claim 1, or greater than about 400 mV in instant claim 4 are properties of the clay materials, e.g., illite-smectite, natural clay, which are already taught by prior art, therefore, the properties would necessarily present in prior art, or would be capable of being achieved in prior art.
McCord teaches the medicinal composition comprises ingredients b) nonionic block EO-PO copolymer in the first part comprising clay as well as in the second part of hydrogel to prevent premature activation of the clay from hydration by the water-based system in the second part of the two-part delivery system (suggesting that the copolymer functions as protection coating), and also beneficially to facilitate and enhance release acceleration of clay into the water system (e.g., [0132]), and the nonionic block EO-PO copolymer can be poloxamer 407, poloxamer 85, poloxamer 105 and/or poloxamer 188 (e.g., Claims 1, 6, 9 and 12), gellants b) polysaccharides and gums (e.g., [0063]; Claim 13). MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. For this instance, being coating agent is property of EO-PO copolymer, which has been taught by prior art, therefore, such property would necessarily present in prior art.
For Claim 2, McCord teaches that the clay particle size is reduced, e.g., down to about 10 microns, about 10-100 microns, through processes such as milling (e.g., [0074]; [0075]), which would inevitably generate clay bead particles. Claim 2 is interpreted as product-by-process claim, the patentability is based on the product itself. If the product is the same as a product from the prior art, the claim is unpatentable. The MPEP indicates that the process of making is only relevant “if the process by which a product is made imparts ‘structural and functional differences’ distinguishing the claimed produce from the prior art”. See MPEP 2113:"[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). "In determining validity of a product-by-process claim, the focus is on the product and not the process of making it." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1369 (Fed.Cir.2009). The process of making is only relevant "if the process by which a product is made imparts 'structural and functional differences' distinguishing the claimed product from the prior art" Greenliant Systems, Inc. v. XicorLLC, 692 F.3d 1261, 1268 (Fed. Cir. 2012).
For Claim 3 as interpreted, McCord teaches medicinal clay composition products contain 10 wt-% to 60 wt-% of the clay (e.g., [0175-0176]; Table 7), such as Oregon Millard Blue Clay, containing clay minerals smectite, illite, and kaolinite and soluble Fe2+ and Al3 (e.g., [0158], Table 6), overlapping with from about 20 to about 50 wt-% of illite-smectite in instant claim 3.
For Claim 5, McCord teaches the average particle size of the clay is between about 10-100 microns, 10-50 microns, or 10-25 microns in diameter (e.g., Claims 14 and 39), overlapping with less than about 250 microns in diameter in instant claim 5.
For Claim 7, as discussed above regarding claim 1b), McCord teaches the medicinal composition comprises ingredients b) nonionic block EO-PO copolymer (e.g., [0132]), and the nonionic block EO-PO copolymer can be poloxamer 407, poloxamer 85, poloxamer 105 and/or poloxamer 188 (e.g., Claims 1, 6, 9 and 12), gellants b) polysaccharides and gums including pectin, lignin, algin, gums and agar-agar, carrageenan (e.g., [0063]; Claim 13). MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. For this instance, being non-cytotoxic is property of EO-PO copolymer or polysaccharides, which have been taught by prior art, therefore, such property would necessarily present in prior art. Further, poloxamers and pectin, which are taught in prior art [0063], are non-cytotoxic as evidenced by instant specification [0107].
For Claim 8, McCord teaches that the non-ionic block EO-PO copolymer has the formula PEOaPPOb-PEOa (same formula as instant claim 8), where the sum of a=70-120 and b=40-65 [0054] (same as instantly claimed), with the same structure [0051] shown as instantly claimed.
For Claim 9, McCord teaches suitable nonionic EO-PO copolymer as poloxamers including, e.g., poloxamer 124, 188, 237, 338, 407, 401 and 184, for the composition (e.g., Claim 31; [0051]; Table 2).
For Claim 11, McCord teaches that the clay delivery system and compositions provide shelf stable compositions for various applications of use, and they are shelf stable for a period of at least about 1 year, at least about 1 year and 6 months, longer than 1.5 years, or 2 years prior to administration (e.g., [0078]), since the non-ionic polymers help prevent premature activation of the clay from hydration by the water-based system in the second part of the two-part delivery system [0132].
For Claim 13, McCord teaches that the pharmaceutical compositions comprising clay (e.g., [0103] can include therapeutic agents, such as an antibiotic, a steroid, an antifungal, an antiviral, an antihistamine, or combinations thereof (e.g., Claim 22; Claim 48), additional amino acids, other functional ingredients such as oleuropein, N-acetyl cysteine, antioxidants, vitamins (e.g. Vitamins A, B, D, C and/or E, in all forms), and/or minerals, L-sulforphane, and curcumin can be included in the antimicrobial clay composition (e.g., [0093]).
For Claim 14, McCord teaches the pharmaceutical compositions incorporating the clay delivery systems can include additional additives for the intended preparations for the composition to be in the forms of powders, emulsions, suspensions, aerosols, oils, ointments, fatty ointments, creams, pastes, gels and gel sheets, syrups, foams or solutions, and transdermal therapeutic systems (e.g., Claim 20, [0103]).
For Claim 15, McCord teaches the clay antimicrobial composition as clay delivery system can be administered via a syrup (corresponding to an aqueous dosage form) prophylactically or at the time of diagnosis through the course of treatment to reduce the risk of C. Difficile infection (e.g., [0127]).
For Claim 16, McCord teaches the pharmaceutical composition comprising clay can be in the form of an ointment, cream, lotion, solution, suspension, emulsion, paste, gel or gel sheet, or syrup (e.g., Claim 20), and powders and transdermal therapeutic systems (e.g., [0103]), among which paste, gel sheet, powders, and transdermal systems can be dry dosage forms or semi-solid dosage forms.
For Claim 17, McCord teaches that the clay delivery systems are effective against gastrointestinal pathogens and bacteria, preferably C. Difficile; without being limited to a particular mechanism of action, the clay delivery systems coat a treated surface (such as a tissue or organ of the body) and effectively kill the gastrointestinal bacteria, such as C Difficile, wherein the coating provides a local effect on the gastric mucosa, coating it and protecting it from the corrosive effects of acid and pepsin while providing the local antimicrobial properties (e.g., [0127]), corresponding to the biofilm-inhibiting coating.
For Claim 18, McCord teaches the antimicrobial clay may be modified with various substituents to alter the properties of the clay, with non-limiting examples of modifications include modification with organic material, polymers, reducing agents, and various elements such as sodium, iron, silver, or bromide, or by treatment with a strong acid (e.g., [0071]).
McCord does not explicitly teach the agents, e.g., nonionic block EO-PO copolymer, polysaccharide, generate a coating surrounding the medicinal clay composition in a thickness of at least one 1 micron, or from about 1 to about 100 microns as recited in instant claim 1, or a thickness at least 5 microns as recited in instant claim 6. McCord also does not teach the coating agent can comprise multiple mineral salts selected from the group sodium chloride, magnesium chloride, sodium sulfate, calcium chloride, and potassium chloride as recited in instant claim 10, or the coating agent is a combination at mass ratio of about 1: 1 to about 20: 1 of nonionic block EO-PO copolymers to mineral salts mixture as recited in instant claim 12.
Marcussen throughout the reference teaches salt coated granules for steam-treated pelletized feed compositions [0001]. Marcussen teaches the composition core [0028] can be a homogenous blend of an active compound and materials which act as binders which is coated with an active compound (e.g., enzymes [0008]), and suitable inert particle materials can include minerals such as clays or silicates or a combination of two or more of these (e.g., [0030]), which can be produced by variety of granulation techniques including crystallization, prilling, etc. (e.g., [0031]), indicating that the composition core can be medicinal clay compositions as instantly claimed.
Marcussen teaches that the salt coating is a layer surrounding the core of the granule composition (e.g., [0083]). The coating thickness is at least 2 um (same as microns), at least 4 um, at least 8 um, below 40 um, below 60 um, or below 100 um (e.g., [0090]), overlapping with a thickness of at least one 1 micron, or from about 1 to about 100 microns as recited in instant claim 1, or a thickness at least 5 microns as recited in instant claim 6.
Marcussen teaches that materials suitable as binders (corresponding to coating agents) can be synthetic polymers, salts [0042], including water soluble or water dispersible waxes, such as polymers of ethylene oxide, propylene oxide, or copolymers (corresponding to nonionic block EO-PO copolymers) thereof, such as block polymers, e.g., Pluronic PE6800 from BASF [0052], for providing a quick release and dissolution of the active incorporated in the particles to the aqueous solution [0046], polysaccharides including cellulose, pectin, dextrin and starch [0060], inorganic salts in particular with alkali or earth alkali metal ions, such as sodium, potassium, magnesium, calcium, zinc, in salt forms of chloride, sulfate and others (e.g., [0066]), resulting in salts like sodium chloride, magnesium chloride, sodium sulfate, calcium chloride, and potassium chloride, and many others (corresponding to instant claim 10). Marcussen specifies that the salt in the salt coating can either be one particular salt or a mixture of salts (e.g., [0098]). Therefore, artisans in the field would be able to select multiple salt species and incorporate into the composition since they are all suitable for intended use.
Marcussen teaches that in a particular embodiment the amount of salt in the coating of the granules constitute at least 60% w/w of the coating (e.g., [0085-0087]). As discussed above, since the coating can use polyethylene oxide and propylene oxide copolymers (or nonionic block EO-PO copolymers) with salts, the coating materials other than salt therefore can be 40%, which can be non-ionic EO-PO copolymers, resulting in EO-PO copolymer to salt mass ratio at 40:60, or 2:3 (corresponding to mass ratio in instant claim 12).
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate the teaching from Marcussen into the clay medicinal or pharmaceutical composition of McCord to arrive at current invention. Because McCord already uses EO-PO polymers to prevent premature activation of the clay from hydration by the water-based system in the second part of the two-part delivery system and also beneficially to facilitate and enhance release acceleration of clay into the water system, while Marcussen teaches the medicinal granule composition which can comprise clay in the core with a coating of salt and/or polymer materials, and specifies that the salt coating makes it possible to keep more than 50% of activity of the active compound present in the core, more than 60%, such as more than 70%, and even more than 75% of activity after steam pelleting at 100°C at 60 seconds (e.g., [0033]), strongly suggesting that the coating protects the activity of the active compound. This would have motivated artisans in the field to modify the McCord two-part delivery system using the convenient coating system taught by Marcussen, especially it is convenient because the coating materials, e.g., EO-PO polymer, polysaccharides like pectin, already present in McCord clay delivery system to provide some protection of the active in the composition. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Moreover, It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Moreover, It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the ingredient percentage ranges and coating thickness overlap with those taught by prior art. Although the pH, Cation Exchange Capacity, Oxidation-Reduction Potential, or mass ratio of the EO-PO copolymer to salts in the coating are not overlapping or not explicitly indicated in prior art, there is no evidence that these values are critical. Moreover, as discussed above, prior art teaches to lower pH for the specific benefits for releasing toxins from clay to kill bacteria; Cation Exchange Capacity and Oxidation-Reduction Potential are properties that would be capable of being achieved since prior art teach the same chemical compounds. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 10-11 and 18-21 of U.S. Patent No. US12213993 (hereafter Pn’993) in view of McCord (US20210046186, 02/18/2021, IDS of 01/06/2025) and Marcussen et al. (DK/EP2160950, 03/10/2010, PTO-892).
Pn’993 recites a method of treatment of a subject with a composition comprising a medicinal clay composition comprising a cation source and has a Cation Exchange Capacity of at least about greater than about 10 mEq/100g, an Oxidation-Reduction Potential greater than about 250 mV, pH less than about 5.0, a crystalline comprising smectite, illite, and/or illite-smectite that is at least about 40 wt-% of the medicinal clay composition, and less than 40 ppm heavy metal contaminants; and at least one coating agent comprising nonionic block EO-PO copolymer with an average molecular weight of from about 5,000 to about 20,000, while the coating prevents the premature activation of the medicinal clay composition by surrounding the medicinal clay composition (Claims 1 and 20), the coating thickness of at least about 5 microns and average particle size of the clay is less than about 250 microns in diameter (Claim 18), the crystalline comprising a 2:1 tetrahedral/octahedral phyllosilicate with reduced iron octahedral and exchangeable cations, and/or at least 1 wt-% pyrite (Claims 19 and 21), corresponding to instant claims 1, 2, 4, and 5-8). Pn’993 indicates that the medicinal clay composition further comprises a therapeutic agent that can be silver (Claims 10-11), corresponding to instant claims 13 and 18.
Pn’993 does not recite the amounts of smectite, illite or illite-smecitite in the medicinal clay composition as recited in instant claim 3, the EO-PO copolymer as poloxamer 407 and/or poloxamer 188 in instant claim 9, composition comprising multiple mineral salts and their species as recited in instant claim 10, shelf life of the composition as recited in instant claim 11, the mass ratio of EO-PO copolymer to mineral salts in the coating as recited in instant claim 12, composition forms as recites in instant claims 14-16, or a biofilm-inhibiting coating in instant claim 17.
As discussed above in detail and incorporated herein, McCord and Marcussen combined teaching teaches these features of the medicinal clay composition, including illite-smecitite amount, poloxamer 4-7 or 188, mass ratio of EO-PO to salt in the coating, and salt species in the coating, shelf life of the composition, as well as the biofilm-inhibiting coating, and composition forms.
It would have been prima facie obvious for a person to incorporate the teachings of McCord and Marcussen into the medicinal clay composition recited in Pn’993 to arrive at current invention. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the ingredient percentage ranges, pH, Cation Exchange Capacity, Oxidation-Reduction Potential, coating thickness overlap with those taught by prior art or the same as recited in Pn’993. Although the mass ratio of the EO-PO copolymer to salts in the coating are not overlapping or not explicitly indicated in prior art, there is no evidence that these values are critical. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Conclusion
No claim is allowed.
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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