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 III, now claims 53-62, in the reply filed on 11/24/2025 is acknowledged.
Priority
The instant application claims foreign priority to GB2010987.2 filed 07/16/2020. The instant application is a 371 of PCT/GB2021/051807 filed 07/14/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 06/24/2025 and 01/12/2023 both comply with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the drawings are two blurry, pixelated or faint to read. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
With regards to claim 60, claim 60 recites “The oral care composition according to claim 53, wherein the composition comprises any of the following components selected from:-”, the Examiner is interpreting “any of the following” to mean any one or more of the following components.
Claim Objections
Claim 60 is objected to because of the following informalities: capitalization, there are words that have capitalization that should be lower case letters. Appropriate correction is required.
Claim 61 is objected to because of the following informalities: capitalization, there are words that have capitalization that should be lower case letters. Appropriate correction is required.
Claim 62 is objected to because of the following informalities: capitalization, there are words that have capitalization that should be lower case letters. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 53-56, 58, and 60 are rejected under 35 U.S.C. 101 because
the claimed invention is directed to a phosphopeptide which is a natural phenomenon without significantly more. The claim(s) recite(s) “an oral care composition comprising a phosphopeptide”, which is not markedly different from a phosphopeptide naturally occurring counterpart like phosphoserine or phosphothreonine which are phosphopeptides found naturally in the body. This judicial exception is not integrated into a practical application because the additional limitation of “wherein the composition does not comprise additional phosphate or an additional source of phosphate” does not meaningfully limit the naturally occurring phosphopeptide. The additional limitation of “optionally monofluorophosphate” does not meaningfully limit the phosphopeptide because it is not required by the claim. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the combined additional limitations do not amount to a composition that is more than a phosphopeptide, which is a naturally occurring compound. Casein is one of the main proteins found naturally occurring in milk. Osteopontin is a protein that is found naturally in bone. The limitations of the claims are capable of producing a composition that is just casein or just osteopontin which would be no different that the two phosphopeptides as they are found in nature.
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 60-62 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.
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 60 recites the broad recitation for amounts of phosphopeptide, fluoride, sweetener, whitening agents, and thickener and the claim also recites narrower amounts of phosphopeptide, fluoride, sweetener, whitening agents, and thickener 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.
Regarding claim 60, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 61, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 62, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claim 62 contains the trademark/trade name OPN-10 short for Lacprodan®OPN-10. Where a 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 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe osteopontin and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 55 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 55 is dependent on claim 53. Claim 53 recites “An oral care composition comprising a phosphopeptide, and optionally monofluorophosphate, wherein the composition does not comprise additional phosphate or an additional source of phosphate”. Claim 55 recites “The oral care composition according to claim 53, wherein the composition does not comprise additional phosphate or an additional source of phosphate other than the phosphopeptide and optionally monofluorophosphate”. Claims 55 therefore fails to further limit claim 53. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 53-55 and 58 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Burling et al. (US Patent Application 20090202449A1).
Burling et al recites a dental formulation containing osteopontin (Burling at claim 6). Burling et al recites wherein the composition is in the form of a toothpaste, toothpowder, tooth gel, dental mouthwash, mouth spray or chewing gum (Burling at claim 6). Burling et al recites wherein the composition comprising about 5 mg osteopontin to about 1500 mg osteopontin per kg formulation (Burling at claim 8).
Claims 53-55 and 57-59 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bannister (US Patent Application Publication 20030206939A1).
Bannister recites a formulation for the delivery of bioactive constituents to biological surfaces, wherein said formulation comprises a suspension or solution of at least one isolated and purified casein protein, or salt thereof, in water, together with at least one bioactive constituent (Bannister at claim 1). Bannister recites wherein said casein protein is in the form of casein phosphoprotein (Bannister at claim 3). Bannister recites wherein said bioactive constituents comprise ions selected from the group consisting of: calcium, phosphate, fluorophosphate, fluoride, magnesium, barium, strontium, zinc, iron, copper, aluminium, tin; and salts of said bioactive constituents selected from the group consisting of: titanium dioxide, zinc oxide, zirconia, calcium fluoride, sodium fluoride, stannous fluoride, sodium monofluorophosphate, zinc ammonium fluoride, tin ammonium fluoride, cobalt ammonium fluoride calcium phosphate, calcium fluorophosphate and calcium oxide (Bannister at claim 6). Bannister recites wherein said formulation is incorporated into a formulation selected from the group consisting of: toothpaste creams or gels, mouthwashes, lozenges, food-stuffs, and confectionary (Bannister at claim 13). Bannister recites wherein said formulation also includes a thickening agent (Bannister at claim 14). Bannister recites wherein the amount of thickening agent present in the formulation is up to about 20% by weight (Bannister at claim 18).
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 53-56, 58, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Burling et al. (US Patent Application 20090202449A1).
Burling et al recites a dental formulation containing osteopontin (Burling at claim 6). Burling et al recites wherein the composition is in the form of a toothpaste, toothpowder, tooth gel, dental mouthwash, mouth spray or chewing gum (Burling at claim 6). Burling et al recites wherein the composition comprising about 5 mg osteopontin to about 1500 mg osteopontin per kg formulation (Burling at claim 8). Burling teaches that the dental formulations can be any dentifrice or related product of relevance in oral hygiene, such as for example toothpowder, tooth gel, dental mouthwash, mouth spray or chewing gum. Osteopontin (OPN) is an acidic, highly phosphorylated, sialic acid rich, calcium binding protein. OPN binds 28 moles of phosphate and about 50 moles of Ca per mole. The isoelectric point is about 3.0. The protein exists in many tissues in the body and plays a role as a signaling and regulating protein. It is an active protein in biomineralization processes. OPN is expressed by a number of cell types including bone cells, smooth muscle cells and epithelial cells (Burling at [0019]). Burling further teaches that the amount of osteopontin is normally between about 50 mg OPN and about 1500 mg osteopontin per kg dental formulation. However, smaller amount will also have an effect. Higher amounts can be used, but the effect will not be essentially increased. A useful amount is 100-1000 mg OPN per kg, preferably 200-500 mg, and most preferred about 350 mg. Larger amounts will presumably not give better results and is therefore not recommended, because OPN is a rather expensive ingredient (Burling at [0021]). Burling teaches that preferred compositions are as already mentioned in the form of as tooth-pastes, tooth-gels and tooth powders. Components of such toothpaste and tooth-gels include one or more of the following: a dental abrasive (from about 10% to about 50%), a surfactant (from about 0.5% to about 10%), a thickening agent (from about 0.04% to about 0.5%), a humectant (from about 0.1% to about 3%), a flavoring agent (from about 0.04% to about 2%), a sweetening agent (from 0.1% to about 3%), a coloring (from about 0.01% to about 0.5%) and water (from 2% to 45%). Anticaries agents contain from 0.001% to about 1% OPN. Anti-calculus agents contain from about 0.1% to about 13% OPN (Burling at [0022]). Burling further teaches other preferred compositions are dental mouth washes, including mouth sprays. Components of such mouth washes and mouth sprays typically include one or more of the following: water (from about 45% to about 95%), ethanol (from about 0% to about 25%), a humectant (from about 0% to about 50%), a surfactant (from about 0.01% to about 7%), a flavoring agent (from about 0.04% to about 2%), a sweetening agent from (from about 0.1% to about 3%). and a coloring agent (from about 0.001% to about 0.5% anti-caries agent including OPN, from about 0.001% to 1% and an anti-calculus agent (from about 0.1% to about 13%) (Burling at [0023]).
Burling is discussed in the Anticipation Rejection supra. Burling differ from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Burling to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 53, Burling et al recites a dental formulation containing osteopontin (Burling at claim 6).
Regarding instant claim 54, Burling et al recites a dental formulation containing osteopontin (Burling at claim 6).
Regarding instant claim 55, Burling et al recites a dental formulation containing osteopontin (Burling at claim 6). Burling does not require any additional source of phosphate.
Regarding instant claim 56, Burling teaches that Osteopontin (OPN) is an acidic, highly phosphorylated, sialic acid rich, calcium binding protein. OPN binds 28 moles of phosphate and about 50 moles of Ca per mole (Burling at [0019]). Anticaries agents contain from 0.001% to about 1% OPN (Burling at [0022]). Burling further teaches that the amount of osteopontin is normally between about 50 mg OPN and about 1500 mg osteopontin per kg dental formulation (Burling at [0021]). Burling does not require any additional source of phosphate. It would be prima facie obvious to have optimized the amount of phosphate in the composition based on the teachings of Burlings. See MPEP 2144.05(II).
Regarding instant claim 58, Burling does not require a source of fluoride.
Regarding instant claim 60, Burling teaches Anticaries agents contain from 0.001% to about 1% OPN. Anti-calculus agents contain from about 0.1% to about 13% OPN (Burling at [0022]), which overlaps the instantly claimed range of about 0.5% to about 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Claims 53-62 are rejected under 35 U.S.C. 103 as being unpatentable over Bannister (US Patent Application Publication 20030206939A1).
Bannister recites a formulation for the delivery of bioactive constituents to biological surfaces, wherein said formulation comprises a suspension or solution of at least one isolated and purified casein protein, or salt thereof, in water, together with at least one bioactive constituent (Bannister at claim 1). Bannister recites wherein said casein protein is in the form of casein phosphoprotein (Bannister at claim 3). Bannister recites wherein said bioactive constituents comprise ions selected from the group consisting of: calcium, phosphate, fluorophosphate, fluoride, magnesium, barium, strontium, zinc, iron, copper, aluminium, tin; and salts of said bioactive constituents selected from the group consisting of: titanium dioxide, zinc oxide, zirconia, calcium fluoride, sodium fluoride, stannous fluoride, sodium monofluorophosphate, zinc ammonium fluoride, tin ammonium fluoride, cobalt ammonium fluoride calcium phosphate, calcium fluorophosphate and calcium oxide (Bannister at claim 6). Bannister recites wherein said formulation is incorporated into a formulation selected from the group consisting of: toothpaste creams or gels, mouthwashes, lozenges, food-stuffs, and confectionary (Bannister at claim 13). Bannister recites wherein said formulation also includes a thickening agent (Bannister at claim 14). Bannister recites wherein the amount of thickening agent present in the formulation is up to about 20% by weight (Bannister at claim 18). Bannister teaches the use of a thickening agent ,typically, the amount of thickening agent present in the formulation is between 0 and about 20% (Bannister at [0053]). Bannister teaches that the amount of casein protein, typically present as a phosphoprotein, present in the formulation in accordance with the twenty-seventh embodiment of the invention, is between 0.01 to 20% (Bannister at [0174]). Bannister teaches that fluoride ions are typically provided at a level of from about 0 ppm to 6000 ppm, more typically 0 to 3000 ppm, even more typically, 5 to 1500 ppm and still more typically, 50 to 1500 ppm (Bannister at [0042]). Bannister teaches the surfactants are present within the range of 0 to 15% (Bannister at [0044]). Bannister teaches the amount of inorganic bioactive constituents present in the formulation is between about 0.005 and about 50% (Bannister at [0045]). Bannister teaches the amount of organic constituents present in the formulation is between about 0.005 and about 30% (Bannister at [0048]). Bannister teaches the amount of ethanol present in the formulation is between about 0.05 and about 20% (Bannister at [0060]). Bannister teaches that depending on the form which the oral formulation is to take, the abrasive may be present in an amount of from 0 to about 70% by weight (Bannister at [0063]). Bannister teaches that humectants contemplated for use in the formulations of the present invention include: glycerol, polyol, sorbitol, polyethylene glycols, propylene glycol, hydrogenated partially hydrolysed polysaccharides and the like. The humectants are generally present in amounts of from 0 to about 80% (Bannister at [0064]). Bannister teaches flavouring and sweetening agents may together comprise from about 0.1% to about 10% by weight or more of the preparation (Bannister at [0066]). Bannister teaches that various other materials may be incorporated in the oral formulations of the present invention, such as whitening agents, preservatives silicones, chlorophyll compounds, other anticalculus agents, and/or ammoniated material such as urea, diammonium phosphate, and mixtures thereof. These adjuvants, where present, are incorporated in the preparations in amounts which do not substantially adversely affect the properties and characteristics desired (Bannister at [0065]). Bannister teaches the amount of bioactive constituents of the formulation as described in relation to the treatment and/or prevention of dental caries and/or tooth erosion, is between about 0.01 to about 40% of the formulation (Bannister at [0096]). Bannister teaches flavouring and sweetening agents may together comprise from about 0.1% to about 10% by weight or more of the preparation (Bannister at [0066]).
Bannister is discussed in the Anticipation Rejection supra. Bannister differ from the instant claims in this rejection insofar as it does not teach the combination of the of the instantly recited components with sufficient specificity for anticipation. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Bannister to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 53, Bannister recites a formulation for the delivery of bioactive constituents to biological surfaces, wherein said formulation comprises a suspension or solution of at least one isolated and purified casein protein, or salt thereof, in water, together with at least one bioactive constituent (Bannister at claim 1). Bannister recites wherein said casein protein is in the form of casein phosphoprotein (Bannister at claim 3). Bannister does not require the use of additional phosphates.
Regarding instant claim 54, Bannister recites a formulation for the delivery of bioactive constituents to biological surfaces, wherein said formulation comprises a suspension or solution of at least one isolated and purified casein protein, or salt thereof, in water, together with at least one bioactive constituent (Bannister at claim 1). Bannister recites wherein said casein protein is in the form of casein phosphoprotein (Bannister at claim 3). Bannister does not require the use of additional phosphates.
Regarding instant claim 55, Bannister does not require the use of additional phosphates.
Regarding instant claim 56, Bannister teaches that the amount of casein protein, typically present as a phosphoprotein, present in the formulation in accordance with the twenty-seventh embodiment of the invention, is between 0.01 to 20% (Bannister at [0174]). It would be prima facie obvious to have optimized the amount of phosphate in the composition based on the teachings of Bannister. See MPEP 2144.05(II).
Regarding instant claim 57, Bannister recites wherein said bioactive constituents comprise ions selected from the group consisting of: calcium, phosphate, fluorophosphate, fluoride, magnesium, barium, strontium, zinc, iron, copper, aluminium, tin; and salts of said bioactive constituents selected from the group consisting of: titanium dioxide, zinc oxide, zirconia, calcium fluoride, sodium fluoride, stannous fluoride, sodium monofluorophosphate, zinc ammonium fluoride, tin ammonium fluoride, cobalt ammonium fluoride calcium phosphate, calcium fluorophosphate and calcium oxide (Bannister at claim 6).
Regarding instant claim 58, Bannister does not require the use of fluoride.
Regarding instant claim 59, Bannister recites wherein said bioactive constituents comprise ions selected from the group consisting of: calcium, phosphate, fluorophosphate, fluoride, magnesium, barium, strontium, zinc, iron, copper, aluminium, tin; and salts of said bioactive constituents selected from the group consisting of: titanium dioxide, zinc oxide, zirconia, calcium fluoride, sodium fluoride, stannous fluoride, sodium monofluorophosphate, zinc ammonium fluoride, tin ammonium fluoride, cobalt ammonium fluoride calcium phosphate, calcium fluorophosphate and calcium oxide (Bannister at claim 6).
Regarding instant claim 60, Bannister teaches the use of a thickening agent, typically, the amount of thickening agent present in the formulation is between 0 and about 20% (Bannister at [0053]), which overlaps the instantly claimed range of 0.1-20%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 61,
Bannister teaches that the amount of casein protein, typically present as a phosphoprotein, present in the formulation in accordance with the twenty-seventh embodiment of the invention, is between 0.01 to 20% (Bannister at [0174]), which overlaps the instantly claimed range of about 3%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of sodium bicarbonate in partial replacement of polyols (Bannister at [0087]), Bannister also teaches the use of polyols in a range of 5% to about 70%(Bannister at [0064]), which overlaps the instantly claimed range of about 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of water in the amount of from 10% to 99.9% (Bannister at [0218]), which overlaps the instantly claimed range of about 54 to about 66%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of calcium carbonate in a range of 0% to 70% (Bannister at [0079]) which overlaps the instantly claimed range of about 3%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of sweeteners in a range of about 1% to about 50% (Bannister at [0083]), which overlaps the instantly claimed range of about 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of the phenoxy ethanol in a range of about 0.5% to about 10% (Bannister at [0109-0111]). Bannister teaches the use of saccharin in a range of up to 1% (Bannister at [0083-0084]). Bannister teaches the use of flavoring agents in an amount of about 0.02% to about 5% (Bannister at [0085]). These ranges overlap the instantly claimed rang of about 8%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 62,
Bannister teaches that the amount of casein protein, typically present as a phosphoprotein, present in the formulation in accordance with the twenty-seventh embodiment of the invention, is between 0.01 to 20% (Bannister at [0174]), which overlaps the instantly claimed range of about 3%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of sodium bicarbonate in partial replacement of polyols (Bannister at [0087]), Bannister also teaches the use of polyols in a range of 0% to about 80% (Bannister at [0064]), which overlaps the instantly claimed range of about 2%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of whitening agents (Bannister at [0065]). Bannister further teaches the use of silica in a range of about 1 to about 70% which overlaps the instantly claimed range of about 6%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of water in the amount of from 10% to 99.9% (Bannister at [0218]), which overlaps the instantly claimed range of about 23 to about 25%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of ammino acids in a range of 0.1% to about 20% (Bannister at [0173-0174]). Bannister further teaches the use of chlorides and sodium citrate in an amount of between about 0.1% and about 35%, which overlaps the instantly claimed range of about 34%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of calcium carbonate in a range of 0% to 70% (Bannister at [0079]) which overlaps the instantly claimed range of about 0.5%. Bannister further teaches the use of calcium fluoride in a range of 0 ppm to 6000ppm(Bannister at [0041-0042]), which overlaps the instantly claimed range of about 0.5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of sweeteners in a range of about 1% to about 50% (Bannister at [0083]), which overlaps the instantly claimed range of about 9%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of a thickening agent in the range of 0% to 20% (Bannister at [0049-0053]), which overlaps the instantly claimed range of about 13%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Bannister teaches the use of the phenoxy ethanol in a range of about 0.5% to about 10% (Bannister at [0109-0111]). Bannister teaches the use of saccharin in a range of up to 1% (Bannister at [0083-0084]). Bannister teaches the use of flavoring agents in an amount of about 0.02% to about 5% (Bannister at [0085]). These ranges overlap the instantly claimed rang of about 8%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
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.
Claim 53-62 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8, 14, 16, 19-20, 22-23, 27, and 30-42 of copending Application No. 18/579,107 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both teach the use of phosphopeptides in oral care compositions.
The instant application claims an oral care composition comprising a phosphopeptide, andoptionally monofluorophosphate, wherein the composition does not comprise additional phosphate or an additional source of phosphate.
The reference patent recites wherein the composition comprises:- a phosphopeptide from about 0.5% to about 15% by weight; - water from about 20% to about 99% by weight; - a buffer from about 1 % to about 20% by weight; - a flavouring, preservative and/or other ingredients from 0% to about 70% by weight; - a sweetener from about 0.1 % to about 20% by weight; - optionally a source of calcium ions from about 0.1 % to about 15% by weight; - optionally a source of phosphate ions from about 0.2% to about 32% by weight; - optionally a source of fluoride from about 0.01 % to about 3% by weight; and - optionally a thickener from about 0.1 % to about 20% by weight; or wherein the composition comprises:- a phosphopeptide in an amount of about 3% w/w;- a buffer in an amount of about 15% w/w;- water in an amount of about 54 to 66% w/w; - a source of calcium in an amount of about 3% w/w;- a flavouring and preservative agent in an amount of about 8% w/w, - optionally a source of fluoride in an amount of about 0.4% w/w; - a sweetener in an amount of about 5% w/w; and - optionally an acid in an amount of about 11 % w/w;or wherein the composition comprises:- a phosphopeptide in an amount of about 3% w/w;- a buffer in an amount of about 2% w/w; - a whitening agent in an amount of about 6% w/w;- water in an amount of about 23 to 25% w/w; - an acid in an amount of about 34% w/w;- a source of calcium in an amount of about 0.5% w/w; - a sweetener in an amount of about 9% w/w; - a thickener in an amount of about 13% w/w ;- a flavouring and preservative agent in an amount of about 8% w/w; and - optionally a source of fluoride in an amount of about 1 % w/w; or wherein the composition comprises:- a phosphopeptide in an amount of about 3% w/w;- a buffer in an amount of about 15% w/w;- water in an amount of about 30% w/w; - a source of calcium in an amount of about 3% w/w; - a source of phosphate, - a sweetener in an amount of about 5% w/w; - a flavouring and preservative agent in an amount of about 8% w/w, and - optionally, a source of fluoride (107’ at claim 37). The reference patent recites wherein:- the phosphopeptide comprises osteopontin or phosphopeptides derived therefrom, and/or casein or phosphopeptides derived therefrom; and/or - the composition comprises less than 50mM phosphate (107’ at claim 42). The reference patent recites wherein the composition comprises one or more further components selected from: alcohol(s), humectant(s), surfactant(s), preservative(s), flavouring agent(s), sweetening agent(s), colouring agent(s), anti- caries agent(s), buffer(s), acid(s), base(s), whitening agent(s), thickener(s), andanticalculus agent(s) (107’ at claim 36). The reference patent recites wherein:- the composition comprises between about 20 to about 90% by weight water; or - the composition is a liquid and wherein the composition comprises at least 50% by weight water; or - the composition is a colloid and wherein the composition comprises less than or equal to 25% by weight water (107’ at 35). The reference patent recites wherein:- the composition further comprises fluoride or a source of fluoride; or - the composition does not comprise fluoride or a source of fluoride; or - the composition further comprises calcium or a source of calcium (107’ at 34). The reference patent recites wherein:- the phosphopeptide comprises osteopontin or phosphopeptides derived therefrom, and/or casein or phosphopeptides derived therefrom; and/or - the composition comprises less than 50mM phosphate (107’ at 33). The reference patent recites wherein:- the composition does not comprise additional phosphate or an additional source of phosphate; or - the composition does not comprise a phosphate buffer (107’ at 32).
Reference claims effectively anticipate the instant claims resulting in a prima facie case of anticipatory type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are presently allowable.
Correspondence
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612