DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The examiner acknowledges receipt for IDS filed 07/10/2026 and 07/29/2024.
Claims 1-18 are pending.
Priority
The examiner acknowledges this application as a Continuation of 18/148,724 filed 12/30/2022, now US 12048854 B2, which is a Continuation of 16/512,518 filed 07/16/2019, now US 11540996 B2, which is a Continuation of 15/723,730 filed 10/03/2017, now US 10,363,210 B2, which is a Continuation of 15/293,691 filed 10/14/2016, now US 9,782,338 B2, which is a Continuation of 14/868,469 filed 09/29/2015, now US 9/498,425 B2, which is a Continuation of 13/997,430 filed 06/24/2013, now US 9,174,070 B2, which is a 371 of PCT/US201 l/038874 filed 06/02/2011 and which is a CIP of PCT /US2010/06171 filed 12/22/2010.
Information Disclosure Statement
The IDS filed 07/10/2026 and 07/29/2026 have been considered by the examiner.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zaidel et al. (US 20060045854 A1) in combination with Prencipe et al. (US 20130195942 A1) and https://en.wikipedia.org/wiki/Poloxamer_407 for teaching the units of ethylene oxide and propylene oxide in the Poloxamer 407 block copolymer.
Zaidel discloses oral care composition comprising cross-linked polyvinylpyrrolidone
hydrogen peroxide complex, ethylene oxide-propylene oxide copolymer such as
poloxamer/PLURONIC (paragraph [0063]), abrasive agents such as calcium phosphate and calcium pyrophosphate (paragraph [0078] of Zaidel), hydrophilic polymers such as polyethylene glycols and designated to have molecular weights of 200, 300, 600, 2000 (paragraphs [0049], [0050] of Zaidel), glycerin or alcohols as diluents/humectants (paragraphs [0062], [0065] of Zaidel) and optional humectant is present at from about 1 % to about 50% or about 2% to about 25% or about 5% to about 15% (paragraph [0065]; the peroxide is present in the composition at from about 0.1-50% of the oral composition (paragraphs [0038], [0073] of Zaidel); water is present at less than 5% (paragraph [0062]); the composition contains abrasives (paragraphs [0044], [0076], [0078]) and the abrasive is present in about 15% to about 30% and calcium carbonate is listed as one of the abrasives (paragraph [0078]). The peroxide-cross-linked PVP complex is present at from about 0.5 to about 40% or from about 20% to 30%; in a preferred embodiment the peroxide complex is present at about 10% by of the total composition or from about 1 % to about 6% (see at least paragraphs [0024], [0025]). 10 % or 1-6% of peroxide-cross-linked PVP represent points within the claimed range of 0.5-16.5% with 10% anticipating the claimed range of 0.5-16.5, and 1 % to 6%, anticipating the claimed range of 0.5-16.5%. Zaidel teaches that its composition can contain tartar (anticalculus) control agents such as phosphates and polyphosphates or pyrophosphates and polyaminopropanesulfonic acid (AMPS) (paragraph [0079]). Zaidel teaches composition comprising peroxide-cross-linked PVP complex, and the whitening complex is a 1: 1 molar ratio of PVP:H2O2, tartar control agent such as phosphates and polyphosphates or pyrophosphates and polyaminopropanesulfonic acid (AMPS), humectant at 1-50%, and sweeteners such as saccharin, sucralose are present at from about 0.01 % to about 1 % (paragraph [0070]). Zaidel also teaches that in one embodiment, the peroxide complex contains peroxide component at a level of from 0.1 % to about 25%, optionally from about 1 % to about 25% and optionally from about 5% to about 18% by weight of the peroxide composite (paragraph [0026]). Zaidel further teaches that commercially available peroxide-cross-linked PVP such as PEROXYDONE XL-10 and PEROXYDONE K-30 (paragraph [0026]) are used in the composition. Zaidel names sodium tripolyphosphate, tetrapolyphosphate and tetrasodium pyrophosphate (paragraph [0079]) as tarter control agents.
Principe uses poloxamer 407 in abrasive oral care composition (paragraph [0057]). Poloxamer 407 has 101 ethylene oxide units and 56 propylene oxide units according to
https://en.wikipedia.org/wiki/Poloxamer_407. Therefore, one looking to using poloxamer in the oral care of Zaidel would look to the abrasive oral care system of PRINCIPE where Poloxamer 407 has been effectively used. Poloxamer 407 is one of the ethylene oxide/propylene oxide block copolymer that fits into the recited block copolymer EO of 80-150 and PPO of 30-80) in claim 1. For molecular weight of greater than 5000 Da, it is known in the art that the molecular weight of Poloxamer 407 is greater than 5000 Da. For example, Poloxamer having 101 EO units and 56 PO units (https://en.wikipedia.org/wiki/Poloxamer_407) is 7701.73 Da which is greater than 5000 Da.
Zaidel also teaches that one or more surfactants are present in amounts of from about 0.01% to about 10% (paragraph [0063]), the 10% being an upper limit. Zaidel also teaches that the surfactants provide enhanced stability to formulation (paragraph [0063]).
Thus, for claims 1-4, Zaidel teaches oral care composition comprising whitening complex comprising polyvinylpyrrolidone complexed with hydrogen peroxide, sodium tripolyphosphate, tetrapolyphosphate and tetrasodium pyrophosphate (paragraph [0079]) as tarter control agents meeting the tarter control agents of claims 1-4, calcium phosphate and calcium pyrophosphate abrasive (paragraph [0078]), about 10% poloxamer (PLURONIC) (paragraph [0063]) or poloxamer 407 (suggested by Prencipe at paragraph [0057]).
Zaidel differs from claim 1 by not teaching the amount of the one or more polymers in the range of from about 10 to about 40 wt%.
However, while Zaidel contemplates an upper limit of 10%, Zaidel also teaches that surfactant, which meets the limitation of one or more polymers, provide enhanced stability to formulation and helps in cleaning oral cavity surfaces (paragraph [0063]).
Therefore, before the effective date of the invention, the artisan guided by the teachings of Zaidel in combination with Prencipe with respect to poloxamer 407, would be led to use surfactant/polymer poloxamer 407 in amounts that would be expected to predictably successfully enhance the stability of the composition and desired levels of oral cavity surface cleaning.
For claim 5, the tarter control agent/anticalculus agent is present typically at 0,1 to 15% (paragraph [0079]). This disclosed range overlaps the claims rant of from about 0.5 to about 5 wt%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Thus the claimed range is obvious over the disclosed range as the disclosed range allows for 0.5 to 5%, the claimed range of from about 0,5 to about 5 wt% is encompassed within the disclosed range.
For claim 6, the surfactant in Zaidel is also sodium lauryl sulfate, sodium coconut monoglyceride sulfonate, sodium lauryl sarcosinate, sodium lauryl isethionate, sodium laureth carboxylate or sodium dodecyl benzenesulfonate (paragraph [0063]) meeting the requirement of claim 6.
For claims 7 and 8, the oral composition of Zaidel contains fluoride ion source (claim 7) and acceptable fluoride ion source is sodium and ammonium fluoride and monofluorophosphates (claim 8) and are present from about 0.0025 to about 2 % (paragraphs [0080]-[0082]).
For claim 9, the oral care composition of Zaidel also contains polyvinylpyrrolidone or cross-linked polyvinylpyrrolidone (paragraphs [0030], [0031], [0033], claims 15, 22).
For claims 10 and 11, the composition of Zaidel contains humectant such as glycerin, sorbitol, xylitol and low molecular weight PEGs in amounts of about 1 % to about 50% (paragraphs [0062], [0065]). The disclosed amount overlaps the claimed amount. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the disclosed amount of 1-50% allows for 20-50%.
For claim 12, calcium carbonate, calcium pyrophosphate, tricalcium phosphate (paragraph [0078]) are named abrasives and one or more abrasives are present in amounts of about 5-70%, about 10-50% and from 15-30% (paragraph [0078]).
For claim 13, the disclosed ranges overlap the claimed amount range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the disclosed amount ranges of 5-70% and about 10-50% of allows for the claimed range of 25-45%.
For claims 14 and 15, the composition of Zaidel contains thickening agents such as carboxymethyl cellulose cellulosic polymers; natural gums such as karaya gum, xanthan gum, gum arabic; and one or more thickening agents are present in amount of about 0.01 to about 15%, from about 0.1 to 10% (paragraph [0060]). The disclosed ranges overlap the claimed amount range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the disclosed amount range of 0.01% to about 15% allows for a range of 5-15%, a point range within the claimed range of 5-35%.
For claim 16, the composition of Zaidel does not contain appreciable amount of water; specifically the composition contains less than about 5% water (paragraph [0062]). The as filed specification in paragraph [0016], section 1.6 and paragraph [0018], section 2.3 defines substantially anhydrous as compositions containing less than 3%, less than 1% and the disclosed less than 5% includes less than 2%, less than 1% and less than 3% which is substantially anhydrous.
For claim 17, the composition of Zaidel also contains butylated hydroxytoluene (BHT) as an antioxidant and other antioxidants contemplated for the composition are butylated hydroxyanisole (BHA), vitamin A, carotenoids, vitamin E, flavonoids, polyphenols, ascorbic acid, herbal antioxidants, chlorophyll, melatonin (paragraph [0083])
For claim 18, the composition of Zaildel further contains sweeteners and sucralose is named as a sweetener in paragraph [0070].
Therefore, Zaidel in combination with Prencipe and https://en.wikipedia.org/wiki/Poloxamer_407 renders claims 1-18 prima facie obvious.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 non-statutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9498425 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims teach composition comprising whitening complex, ethylene oxide propylene oxide block copolymer, (ethylene oxide)x-(propylene oxide)y, where x is an integer of 80-150 and y is an integer of 30-80, and the copolymer having molecular weight greater than 5000 Da; sodium lauryl sulfate as surfactant; calcium pyrophosphate as calcium abrasive, calcium carbonate, additional linear polyvinylpyrrolidone, stanous fluoride as fluoride source, glycerin humectant --- the composition teaches the claimed composition.
Claims 1-18 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20; 1-14; 1-15; 1-30; 1-15; 1-12; 1-19; 1-31; and 1-19 of U.S. Patent Nos. 11701312 B2; 9174070 B2; 9901521 B2; 9999585 B2; 9724280 B2; 10149804 B2; 10052270 B2; 9370472 B2; and 10507171 B2 respectively. Although the claims at issue are not identical, they
are not patentably distinct from each other because:
a. 11701312 B2: The composition comprises whitening complex, ethylene-propylene co-polymer, thickening agent, fluoride source, abrasive, surfactant, anti-calculus agent which is same as tartar control agent.
b. US 9174070 B2: The whitening composition comprising whitening complex,
calcium abrasive, anti-calculus agent, humectant (glycerin) and less than 3% water renders
claims 20-23, 29-31 and 39 prima facie obvious.
c. US 9901521 B2: The composition comprising less than 3% water meeting the
requirement for substantially anhydrous, whitening complex comprised of crosslinked
polyvinylpyrrolidone complexed with hydrogen peroxide, glycerin as the humectant,
calcium abrasive, ethylene oxide propylene oxide block copolymer renders claim 20-22,
29-31 and 39 prima facie obvious.
d. US 9999585 B2: The composition comprising less than 3% water meeting the
requirement for substantially anhydrous, crosslinked polyvinylpyrrolidone complexed to
hydrogen peroxide, polyvinylpyrrolidone thickening agent, ethylene oxide propylene
oxide block copolymer, calcium abrasive, glycerin and/or propylene glycol humectant,
and clay renders claims 20-22, 30-31 and 39 prima facie obvious. The comprising
language of the examined claims is open.
e. US 9724280 B2: The composition comprising less than 3% water meeting the
requirement for substantially anhydrous, crosslinked polyvinylpyrrolidone complexed to
hydrogen peroxide, thickening system comprising silica and crosslinked
polyvinylpyrrolidone as a second thickening agent, ethylene oxide propylene oxide block
copolymer, calcium abrasive, glycerin and/or propylene glycol humectant, and clay
renders claims 20-22, 30-31 and 39 prima facie obvious. The comprising language of
the examined claims is open.
f. US 10149804 B2: The composition comprising less than 3% water meeting the
requirement for substantially anhydrous, crosslinked polyvinylpyrrolidone complexed to
hydrogen peroxide, thickening system comprising silica as a first thickening agent and
crosslinked polyvinylpyrrolidone as a second thickening agent, ethylene oxide propylene
oxide block copolymer, calcium abrasive, glycerin and/or propylene glycol humectant,
renders claims 20-22, 30-31 and 39 prima facie obvious. The comprising language of
the examined claims is open.
g. US 10052270 B2: The composition comprising less than 3% water meeting the
requirement for substantially anhydrous, crosslinked polyvinylpyrrolidone complexed to
hydrogen peroxide, crosslinked polyvinylpyrrolidone or fumed silica thickening agent,
ethylene oxide propylene oxide block copolymer, calcium abrasive, glycerin and/or
propylene glycol humectant, renders claims 20-22, 30-31 and 39 prima facie obvious.
The comprising language of the examined claims is open.
h. US 9370472 B2: The composition comprising less than 3% water meeting the
requirement for substantially anhydrous, crosslinked polyvinylpyrrolidone complexed to
hydrogen peroxide, crosslinked polyvinylpyrrolidone thickening agent, ethylene oxide
propylene oxide block copolymer, calcium abrasive, glycerin and/or propylene glycol
humectant, renders claims 20-22, 30-31 and 39 prima facie obvious. The comprising
language of the examined claims is open.
i. US 10507171 B2: The composition comprising less than 2% water meeting the
requirement for substantially anhydrous, crosslinked polyvinylpyrrolidone complexed to
hydrogen peroxide, crosslinked polyvinylpyrrolidone or fumed silica thickening agent,
ethylene oxide propylene oxide block copolymer, calcium abrasive, glycerin and/or propylene glycol humectant, renders claims 20-22, 30-31 and 39 prima facie obvious.
The comprising language of the examined claims is open.
Claims 1-18 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-17; and 1-18 of U.S. Patent Nos. 10363210 B2; and 11540996 B2 respectively. Although the claims at issue are not identical, they are not patentably distinct from each other because:
j. US 10363210 B2: The composition comprising less than 2% water meeting the
requirement for substantially anhydrous, calcium abrasive, stannous ion source, tartar control
polyphosphate, carbomers and carrageenan and cellulose thickeners, sodium lauryl
sulfate, monofluorophosphate which is a fluoride source renders claims 1-18 prima
facie obvious.
k. US 11540996 B2: The composition comprising less than 1 % water meeting the
requirement for substantially anhydrous, stannous ion source, tartar control
polyphosphate, carbomers and carrageenan and cellulose thickeners, sodium lauryl
sulfate, monofluorophosphate which is a fluoride source and saccharin and/or sucralose sweetener, xanthan gum thickener, glycerin humectant, calcium abrasive, (ethylene oxide)x-(propylene oxide)y with x being 80 and 150 and y being 30-80, renders claims 1-18 prima facie obvious..
Claims 1-18 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-11 and 13-20 of .S. Patent No. 12053536 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the issue composition comprising whitening complex, block copolymer of ethylene oxide and propylene oxide, sorbitol or xylitol or propylene glycol as humectants,
No claim is allowed.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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