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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 12/24/2025 has been entered.
Withdrawn Rejections:
Applicant's amendments and arguments filed on 12/24/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claims 26, 28-30, 33, 35-37, 40-43 are pending and under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/28/2025 is being considered by the examiner.
Response to Amendment
The supplemental reply filed on 04/01/2026 was not entered because supplemental replies are not entered as a matter of right except as provided in 37 CFR 1.111(a)(2)(ii). The supplemental reply is clearly not limited to placement of the application in condition for allowance.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 26, 28-30, 33, 35-37, 40-43 are rejected under 35 U.S.C. 103 as being unpatentable over Rabenhorst et al. (US20080008660).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Rabenhorst et al. teaches A basic problem of oral hygiene is bad breath, also known as foetor exoris or halitosis. This bad breath is formed by microorganisms by the decomposition of food residues and dead cells of the mucous membrane. The colonisation by gram-positive and gram-negative bacteria, mycobionts and/or protozoa is responsible for bad breath. In the literature anaerobic gram-negative bacteria in particular are named as the causative agent (see for example Bad Breath—A multidisciplinary Approach. Eds: D. van Steenberghe, M. Rosenberg, Leuven University Press, Leuven 1996; 111-121). Since social intercourse is often adversely affected by bad breath, there is great interest in helping those afflicted or in preventing the condition in the first place ([0006]). Rabenhorst et al. teaches a method for controlling and or preventing bad breath comprising contacting a composition in the form of toothpaste, mouthwash, mouth rinse or sucking tablet and chewing gum comprising a compound of formula I into oral cavity and one of compound of formula I is 2-(benzoylamino)-benzoic acid at concentration as low as 0.0025% (compound 27 in claim 11) which is compound of formula (A) with water, ethanol, isopropanol, propylene glycol, ethylene glycol and glycerol as solvent as well as their mixture (page 13, [0083]; page 17, [0128-0129]; claims 1, 9, 11, 15-16, 19, 21). The application concentration of the compounds of the Formula 1A to be used according to the invention to relieve itching may particularly—depending on the substance—be in the concentration range from 0.0001 to 10 weight percent, as is also already the case according to WO 2004/047833. However, it is preferred to use a low concentration of the compound or compounds of the Formula 1A. In particular a concentration range of 0.001 to 1 weight percent is preferred, and a range of 0.01 to 0.2 weight percent is particularly preferred, in each case referred to the total weight of a ready-for-use cosmetic or pharmaceutical end product ([0056]). In particular the compounds of the Formula 1 or Formula 1A used according to the invention are capable of reducing and/or preventing the growth of organisms causing bad breath, in particular of the genera Eubacterium, Fusobacterium, Haemophilus, Neisseria, Porphyromonas, Prevotella, Treponema and Veillonella, in particular Fusobacterium nucleatum, Porphyromonas endodontalis, Porphyromonas gingivalis, Prevotella intermedia, Prevotella loeschii, Treponema denticola and Veillonella parvula ([0075]). The pH of the composition is preferred in the range of 6.5 to 8.0 (page 12, [0079]). The oral hygiene preparations according to the invention may contain auxiliary substances (additives), such as are conventionally used in such preparations, in particular one or more substances of the following group such as preservatives, abrasives (smoothing agents), further antibacterial agents, inflammation-inhibiting agents, irritation-preventing agents, irritation-inhibiting agents, further antimicrobial agents, antioxidants, astringents, antistatics, binders, (mineral) fillers, buffers, carrier materials, chelating agents (chelate formers), cleaning agents, care agents ([0081-0082]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Rabenhorst et al. is that Rabenhorst et al. is not specific enough for anticipation.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Rabenhorst et al. teaches a method for controlling and or preventing bad breath comprising contacting a composition in the form of mouthwash, mouth rinse or sucking tablet and chewing gum comprising a compound of formula I into oral cavity and one of compound of formula I is 2-(benzoylamino)-benzoic acid at 0.01 to 0.2% by weight (compound 27 in claim 11) which is compound of formula (A) with water, ethanol, propylene glycol and glycerol as well as their mixture as solvent. When the composition in the form of mouthwash, mouth rinse or sucking tablet and chewing gum is administered in the mouth of individual.
Regarding the limitation of “one or more compound of formula I are dissolved in the carrier”, since 2-(benzoylamino)-benzoic acid has carboxylic acid group being neutralized at pH 6.5 to 8.0, at such small amount (0.01 to 0.2% by weight), the 2-(benzoylamino)-benzoic acid salt is expected to be dissolved in aqueous carrier. Since Prior art teaches the same 2-(benzoylamino)-benzoic acid (compound of formula I), this same compound is expected to have the same properties such as being dissolved in aqueous carrier.
Regarding the limitation of additional excipients, Rabenhorst et al. teaches additive such as preservative and antioxidant.
Rabenhorst et al. is silent about “increasing a proportion of one or more bacterial in an individual’s oral cavity”, “increasing the proportion of the one or more Neisseria in the oral cavity”, “decreasing a proportion of one or more detrimental bacteria” and “decreasing the proportion of one or more detrimental bacteria selected from Prevotella, Veillonella, Porphyomonas, Atopobium, Selenomonas and Fusobacterium” which are regarded as results of prior art procedure. In summary, although the reference is silent about all the functional properties instantly claimed, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being applied the same composition by the same mode of administration in the same amount in both the instant claims and the prior art reference, and since oral film and those bacteria are known to exist in oral cavity, the application of same oral antibacterial composition would result in “increasing a proportion of one or more bacterial in an individual’s oral cavity”, “increasing the proportion of the one or more Neisseria in the oral cavity”, “decreasing a proportion of one or more detrimental bacteria” and “decreasing the proportion of one or more detrimental bacteria selected from Prevotella, Veillonella, Porphyomonas, Atopobium, Selenomonas and Fusobacterium”. The fact that appellants may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, Rabenhorst et al. teaches, either expressly or inherently implied, each and every limitation of the instant claims. it remains the Examiner's position that the instantly claimed method is obvious.
Regarding claims 40-41, it is common practice to use mouth wash twice a day.
Regarding claims 42-43, Rabenhorst et al. teaches prevention of bad breath (halitosis). Since it is desirable to avoid the bad breath (halitosis) in the first place, it is obvious to apply the mouthwash to subject who is not suffering from bad breath (halitosis).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument
Appellants argue that the rejection should be reversed because, at the time of the invention, there was no reasonable expectation that the compound of Formula (A) would increase the proportion of Neisseria, Rothia, Corynebacterium, or Streptococcus in an oral cavity of an individual. The inventors of the instant case discovered the compound of Formula (A) surprisingly increases the number of health-promoting bacteria in oral biofilms and “decreasing a proportion of one or more detrimental bacteria”. This is the opposite of what one would expect based on the teachings of Rabenhorst. All related arguments are incorporate herein by reference.
In response to this argument: this is not persuasive. It appears that appellants argue something (increases the number of health-promoting bacteria) not recited in claim, not even in the specification, since appellant’s claim and specification only recite increasing “a proportion” or “relative abundance” one or more bacterial. It is noted that “increasing the number” is a different concept from increasing “a proportion” or “relative abundance”. As discussed in the above 103 rejections, Rabenhorst et al. is silent about “increasing a proportion of one or more bacterial in an individual’s oral cavity” and “increasing the proportion of the one or more Neisseria in the oral cavity”, and “decreasing a proportion of one or more detrimental bacteria” which is regarded as results of prior art procedure. In summary, although the reference is silent about all the functional properties instantly claimed, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being applied the same composition by the same mode of administration in the same amount in both the instant claims and the prior art reference, and since oral film and those bacteria are known to exist in oral cavity, the application of same oral antibacterial composition would result in “increasing a proportion of one or more bacterial in an individual’s oral cavity” and “increasing the proportion of Neisseria in the oral cavity”. The fact that appellants may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, Rabenhorst et al. teaches, either expressly or inherently implied, each and every limitation of the instant claims. it remains the Examiner's position that the instantly claimed method is obvious. Therefore, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 26, 28-30, 33, 35-37, 40-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 8203016 in view of Rabenhorst et al. (US20080008660). The reference patent teaches compound of formula I, in view of Rabenhorst et al. teaching compound of formula I in oral hygiene composition for reducing bad mouth smell, according to the same rational as the above 103 rejections, “increasing a proportion of one or more bacterial in an individual’s oral cavity” and “increasing the proportion of the one or more bacteria in the oral cavity wherein the one or more bacteria are chosen from Neisseria, Rothia, Corynebacterium and Streptococcus” are regarded as results of prior art procedure. In summary, although the reference is silent about all the functional properties instantly claimed, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being applied the same composition by the same mode of administration in the same amount in both the instant claims and the prior art reference, and since oral film and those bacteria are known to exist in oral cavity, the application of same oral antibacterial composition would result in “increasing a proportion of one or more bacterial in an individual’s oral cavity” and “increasing the proportion of Neisseria in the oral cavity”. The fact that appellants may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, Rabenhorst et al. teaches, either expressly or inherently implied, each and every limitation of the instant claims. it remains the Examiner's position that the instantly claimed method is obvious.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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/JIANFENG SONG/ Primary Examiner, Art Unit 1613