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 .
Response to Arguments
Applicants' arguments, filed February 23, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Applicants traverse on the grounds that each independent claim has been amended with limitations from dependent claims to require the presence of lavender oil, clove oil and propylene glycol. None of the art of record, namely Benn, Hirai, Uzbelger Feldman, Nalawade et al., Illig et al. or Brown, disclose or suggest at least the independent claims 16 and 32. These claims and their dependent claims are patentably distinguished from the teachings of the cited art.
These arguments are unpersuasive. In view of the claim amendments, the rejection of independent claims 16 and 32 are now includes Nalawade et al. that teaches the inclusion of propylene glycol as part of the dispersion medium to alter the viscosity of the composition and possibly have an antimicrobial effect and Dagli et al. that teaches the use of essential oils such as lavender and clove oils for antimicrobial and reduced stress/anxiety as discussed previously and reiterated below. Applicants present no other arguments regarding the previously applied prior art for the Examiner to address herein.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 16, 18, 19, 27 – 29, 31, 32, 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Benn (WO 2012/151464) in view of Hirai (US 6,001,334), Nalawade et al. (J Int Soc Preventive Community Dentistry, 2015) and Dagli et al. (J Int Soc Preventive Community Dentistry, 2015).
Benn discloses a method of imaging dental tissue such as dental caries by the topical intraoral administration of a composition that provides enhanced radiographic imaging (whole document, e.g., abstract). The topical intra-oral compositions can comprise barium sulfate that is applied to one or more teeth of a subject in a method of imaging dental caries, diagnosing or monitoring periodontal disease and evaluating the 3D shape of dental root canals prior to root canal therapy and then producing a radiographic image of the one or more teeth in a human subject (¶ [0008]). Any concentration of contrast agent necessary to provide enhancing imaging can be present in the composition (¶ [0029]). A pharmaceutically acceptable carrier is presented in the topical intra-oral compositions (e.g., ¶ [0001]), which reads on a dispersion medium. Typical carriers may include solvents such as the alcohols n- or iso-propyl alcohol, methyl alcohol or ethyl alcohol (¶ [0034]), and these alcohols also read on an antibacterial material as these alcohols are also antibacterial. A variety of suitable inert, physiologically acceptable excipients including surfactants, flavor-modifying agents and taste masking agents may also be present in the composition (¶ [0036]). Flavor modifying agents include synthetic flavor oils and flavoring aromatics and/or natural oils, extracts from plants, leaves, flowers, fruits and combinations (¶ [0046]). Oil of wintergreen and peppermint oils are examples of flavor-modifying agents (¶ [0046]). Sugar alcohols such as sorbitol, mannitol and sylitol are disclosed as sweeteners for enhancing the palatability of the composition (¶ [0047]). Suitable dosage forms disclosed include solutions, suspensions, creams, liquids, ointments, gels, sprays, pastes and mouth rinses (¶ [0050]), that have widely ranging viscosities. Among the limited list of administration routes is brushing and swabbing (¶ [0012]) and kit with a brush, swab or tray are among another limited list of items that can be present in a kit for enhancing radiographic images (¶ [0014]). Minimal time periods are required for the topical intra-oral composition to accumulate in the oral or dental tissue (¶ [0055]), which reads on waiting a dispersion period, wherein the compositions entered the tooth during the dispersion period as required by claim 19. Typical accumulation times range from about 1 second to about 30 minutes (¶ [0055]), which encompass the range of the instant claim. The fast accumulation results in no significant delay between composition administration and imaging (¶ [0055]). Suitable radiographic imaging methods include intra- and extra-oral x-ray imaging (¶ [0057]).
Explicit application of a barium contrast agent and additional excipient containing composition to a tooth X-ray imaging as required by the instant claims is not disclosed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to apply a barium contrast agent containing composition to the tooth, waiting for the accumulation time and then acquiring a radiographic image of the teeth using X-ray. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the contrast agent solutions are used in such a manner to acquire provide enhanced radiographic images of the teeth. Additional excipients such as flavor-modifying agents can be included and would be understood by one of ordinary skill in the art to improve the taste of the composition, an important consideration for something being applied in the mouth, and can be provided by flavors or oils such as oil of wintergreen or peppermint oils that will also result in a cooling sensation when applied. Additional excipients such as alcohols can also be included as taught by Benn. One of ordinary skill in the art can select the desired form and forms such as solutions, suspensions, liquids and mouth rinses will have lower viscosities that will make it easier for the composition to reach areas in between the teeth and small areas of the tooth compared to more viscous forms such as creams, ointments, gels, or pastes. As to the accumulation time, one wants to wait long enough for sufficient image enhancement to occur but no longer than necessary, rendering the accumulation time a results effective parameter that one of ordinary skill would routinely optimize. “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the claimed time frame.
Barium sulfate as a contrast agent is disclosed but the particle size of the barium sulfate is not.
Hirai disclose barium powder preparations and application as a high density suspension and process for producing and using them in upper gastrointestinal examination (whole document, e.g., abstract). Among the problems identified is that agents composed of large particles and no small particle easily precipitate (col 2, ln 54 – 56). The barium powder of invention contains large, medium and small component particles of pure barium sulfate coated with gum tragacanth and carrageenan (col 4, ln 19 – 22). The size ranges for the large, medium and small particles are 8 µm, 2.0 – 2.5 µm and 0.8 – 1.0 µm respectively with normal size distributions for these particle size categories (col 4, ln 19 – 32). Extra small particles less than 1.0 µm increase the apparent viscosity easily when suspended while those 1.0 µm in size have a superior viscosity reducing effect when mixed with the large and medium particles (col 7, ln 16 – 29).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the barium sulfate contrast agent particle size such as to particles less than 10 µm in diameter as disclosed by Hirai. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because particle size can affect the viscosity of the formulation and settling (precipitation) of the particles, which will affect the behavior of the composition as used. Particles less than 10 µm in size can be detected in methods that involve the use of contrast agent as taught by Hirai. An additional consideration when using barium sulfate particles as contrast agents for dental applications such as cary detection, periodontal disease diagnosis/monitoring or dental fracture/crack detection on that the contrast agent particles must be able to enter into the necessary structures to result in visualization of the fracture/crack. Barium sulfate particles that are larger than the size of the crack will not be able to enter in the structure and be observed when the diagnostic image is taken which could lead to the erroneous conclusion that no fracture or crack was present because the contrast agent was unable to enter into the crack for visualization purposes. This and the effects on viscosity discussed by Hirai will lead one of ordinary skill in the art to optimize compositions characteristics including particle size and viscosity with particles less than 10 µm being suitable for imaging applications. There is no evidence of record as to the criticality of the claimed size range.
The inclusion of propylene glycol is not disclosed.
Nalawade et al. studied the bactericidal activity of various additives including propylene glycol (whole document, e.g., abstract). Intercanal medicaments are commonly used for disinfection of root canals (p 115, col 1, ¶¶ 1 and 2). Carriers or vehicles such as propylene glycol are present in the medicaments and it has been investigated to see if such vehicles have antimicrobial properties on their own (p 115, col 1, ¶¶ 2 and 3). PEG (polyethylene glycol) 1000 followed by propylene glycol were found to have better antimicrobial and bactericidal activities (p 118, col 1, ¶ 3). The materials are also viscous which can improve their handling properties and aid in sustained release of the medicaments (abstract).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use propylene glycol as part of the dispersion medium for the barium sulfate contrast agent composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the use of propylene glycol in compositions for use in the mouth is known and can be used to alter the viscosity to the desired level while also possibly having an antimicrobial effect to the composition.
While flavor modifying agents such as flavoring aromatics and/or natural oils or extracts are disclosed by Benn, a combination of lavender oil and clove oil is not disclosed.
Dagli et al. discloses that essential oils (EOs) have been used traditionally used as medicines for treating infections (p 335, col 2, ¶ 2). A systematic review of the therapeutic properties of EOs was carried out as very few reviews have published on their implications for dental treatment (p 336, col 1, ¶ 1). Lavender oil has good antimicrobial activity against most bacteria, filamentous fungi and yeasts while also reducing stress, anxiety and improving mood when inhaled or orally administered (p 336, col 2). Clove oil contains eugenol, and eugenol is well-known for its therapeutic properties and widely used in dentistry (p 337, col 2). Eugenol possesses antifungal activity and possess inhibitory activity effects on multi-resistant Staphylococcus spp. (p 337, col 2).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate both clove and lavender oils into the compositions of Benn that are then topically applied to a tooth for diagnostic imaging purposes. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the genus of flavoring aromatics and/or natural oils or extracts is disclosed by Benn, but these particular oils are not disclosed. Dagli et al. discloses that these two oils have antimicrobial effects and lavender can also reduce stress and anxiety. Those antimicrobial effects can be in the composition itself to improve storage stability and/or during use to bring about the therapeutic antimicrobial effects that clove and lavender oil are known for.
Claim(s) 16, 18, 19, 27 – 29, 31, 32, 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Benn, Hirai, Nalawade et al. and Dagli et al. as applied to claims16, 18, 19, 27 – 29, 31, 32, 34 and 35 above, and further in view of Uzbelger Feldman (US 2016/0354326).
Benn, Hirai, Nalawade et al. and Dagli et al. are discussed above.
While application to detect caries and/or periodontal disease diagnosis or monitoring is disclosed by Benn, explicit use of the applied compositions to identify the absence or presence of dental fracture is not disclosed.
Uzbelger Feldman discloses an improved local anesthetic with diminished bitter taste that may optionally include one or more additional agents such as contrast media agents (whole document, e.g., abstract). Uzbelger Feldman discloses that the use of contrast agents has been advocated to be used for the caries detection, the evaluation of cracks and tooth fracture and periodontal pocket measurement (¶ [0014]). One aspect of the invention is application of the improved anesthetic solution to tooth surfaces for caries detection or for crack and tooth fracture evaluation (¶ [0042] and claim 33). The method includes x-ray imaging after administration of the improved local anesthetic solution (¶ [0099]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the contrast agent compositions of Benn that can be used for the detection of caries or periodontal disease diagnosis and monitoring to detect the presence or absence of dental fracture. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Uzbelger Feldman discloses that the improved local anesthetic formulations that can be used for cary detection, periodontal pocket measurements (which is monitoring periodontal disease) as well as evaluation of tooth surfaces for cracks and fractures. In each instance, the presence of a contrast agent would reasonably be expected to improve the ability to observe such features after the appropriate diagnostic image, e.g., x-ray, is obtained after application to the one or more teeth and allowing sufficient time for the contrast agent to accumulate in the desired area as taught by Benn.
Claim(s) 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Benn, Hirai, Nalawade et al. and Dagli et al. and optionally Uzbelger Feldman as applied to claims 16, 18, 19, 27 – 29, 31, 32, 34 and 35 above, and further in view of Illig et al. (US 5,352,434).
Benn, Hirai, Nalawade et al. and Dagli et al. and Uzbelger Feldman are discussed above. Benn discloses any contrast agent concentration to adequately provide enhanced imaging may be included (¶ [0029]) but for barium, the concentration of barium may be about 40% w/w to about 65% w/w (¶ [0031]).
Lower barium sulfate concentrations such as 6 – 7% weight are not disclosed.
Illig et al. discloses x-ray contrast compositions for oral or retrograde examination of the gastrointestinal tract (whole document, e.g., abstract). The compositions use a barium salt; a polymeric material that is at least partially water soluble and contains polarizable or ionizable groups and Mg++, Ca++, Zn++ or Ba++ to potentiate the effect of the polymeric material as a film former (col 3, ln 1 – 8). The preferred x-ray contrast agent is barium sulfate and is commercially available with particle size range of 0.001 – 0.1 micron diameter (col 3, ln 13 – 17). The compositions contain about 5% w/w to about 95% w/w of the barium salt (col 3, ln 23 – 25). The dosage varies based on the precise nature of the ingredients used and preferably the dosage should be kept as low as it consistent with achieving contrast enhanced imaging to minimize potential toxicity (col 9, ln 28 – 35). The most preferable range is about 15% w/w to about 40% w/w (col 9, ln 51 – 52).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the lowest amount of barium in the composition required to achieve adequate contrast enhancement during imaging. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Illig et al. discloses that concentrations as low as 5% w/w barium can be sufficient in barium contrast compositions to provide enhanced contrast but the exact concentration also depends on the other ingredients in the composition. Therefore one of ordinary skill in the art would routinely optimize the barium concentration in the compositions and contemplate concentrations lower than the explicit range of about 40% w/w to about 65% w/w disclosed by Benn as Illig et al. discloses concentrations as low as 5% w/w are capable of providing adequate contrast enhancement. There is also no evidence of record as to the criticality of the claimed amounts.
Claim(s) 26, 30 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Benn, Hirai, Nalawade et al. and Dagli et al. and optionally Uzbelger Feldman are discussed above. as applied to claims 16, 18, 19, 27 – 29, 31, 32, 34 and 35 above, and further in view of Brown (US 3,236,735).
Benn, Hirai, Nalawade et al. and Dagli et al. and Uzbelger Feldman are discussed above.
Milling to reduce particle size and explicit viscosity values for oral compositions are not disclosed.
Brown discloses X-ray contrast media that can contain barium sulfate and the compositions are highly fluid at high barium sulfate concentrations (whole document, e.g., col 1 ln 1 – 24). A non-toxic fluidizing agent is added to improve the fluidity of the barium sulfate suspensions (col 1, ln 32 – 38). The barium sulfate used was obtained by purifying milled barytes and conformed to USP specifications (col 6, ln 26 – 27). The viscosities of the prepared compositions were reported for a Ford cup with a number 4 orifice (see examples beginning at col 6, ln 28) and the times in the range of 11 or 12 seconds corresponds to a viscosity of about 25 cPs (see viscosity conversion chart from cattieadhesives.com that accompanied the December 13, 2024 Office Action), which lies squarely within the claimed range.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the viscosities disclosed by Brown to aid in preparing barium contrast agent solutions of appropriate viscosity and to use milling as part of the preparation process for the barium sulfate. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Benn discloses various forms but no explicit values for the viscosities of such formulations. Brown provides explicit guidance as to suitable viscosity values for barium sulfate contrast compositions and there is no evidence of record as to the criticality of the claimed range. Based on their knowledge and the teachings of Brown, the person of ordinary skill can use milling to alter the particle size as the barium sulfate is prepared for use in the contrast agent composition that is then applied to enhance imaging such as X-ray imaging.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618 /Nissa M Westerberg/Primary Examiner, Art Unit 1618