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
DETAILED ACTION
Claims 1-20 are pending and examined.
Election/Restrictions
Applicant's election with traverse of the species of angular velocity at which the first reduction in torque occurs and S. gordonii in the reply filed on 1/13/2026 is acknowledged. However, the prior art search included results on the non-elected species of biofilm momentum coefficient. Therefore, the requirement for election of species is withdrawn.
Claim Objections
Claims 3-7 are objected to because of the following informalities:
In claim 3, the first letter of the bacterial genus should be italicized as well as capitalized. Currently, only some of the bacterial genus names are both capitalized and italicized.
In claims 3-7, the method preamble is missing the word “of.” The claims recite ““The method claim 1” rather than “The method of claim 1.”
Appropriate correction is required.
Drawings
The drawings are objected to because Figure 5 attempts to differentiate between conditions by gray and black lines, which is difficult for the reader to interpret. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of an abstract idea without significantly more.
A flowchart has been established to determine subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 part (III) and 2106.04 part (II)(A). The flowchart comprises answering: Step 1) Is the claim to a process, machine, manufacture or composition of matter? Step 2A Prong One) Does the claim recite an abstract idea, law of nature or natural phenomenon? Step 2A Prong Two) Does the claim recite additional elements that integrate the judicial exception into a practical application? Step 2B) Does the claim recite additional elements that amount to significantly more than the judicial exception? The claims are analyzed for eligibility in accordance with their broadest reasonable interpretation.
Claim 1 is drawn to a process, which is one of the four statutory categories of invention (Step 1: Yes). However, step (d) of claim 1 recites the mental process of monitoring torque in step c) to obtain torque - angular velocity curve, which is an abstract idea. Optional step (e) recites linearizing and transforming the torque - angular velocity curve into slope (torque1/2/angular velocity) - angular velocity curve, which are mathematical transformations (also abstract ideas). Step (f) recites determining one or more parameters selected from angular velocity at which the first reduction in torque occurs, shear stress at which the first reduction in torque occurs, biofilm momentum coefficient, area under the curve of the torque – angular velocity curve, and a combination thereof, which includes a mental process (“determining”) as well as mathematical concepts, which are both abstract ideas. Thus, claim 1 recites the judicial exception of an abstract idea (Step 2A Prong One: Yes). The judicial exception is not integrated into a practical application (Step 2A Prong Two: No). The method preamble is “monitoring the detachment of a biofilm from the surface of an object or rearrangement of the structure of the biofilm in response to shear stress.” However, monitoring is not a practical application and the abstract ideas are not connected to any practical application. For example, no specific action is taken in response to the calculated parameters. The additional elements recited in the claim are providing a biofilm-coated object, immersing the biofilm-coated object in a liquid, and spinning the object with increasing angular velocity. These steps are well-understood routine, and conventional. For example, Dennington et al. (Surface Topography: Metrology and Properties 3.3 (2015): 034004) teaches immersing biofilm-coated coupons in water (page 4, left column, paragraph 1) and increasing angular velocity from standstill to 300 rad·s-1 (page 4, left column, bottom paragraph). Therefore, claim 1 as a whole does not amount to significantly more than the judicial exception of an abstract idea (Step 2B: No).
The same analysis above applies to dependent claims 2-7 (Step 1: Yes, Step 2A Prong One: Yes, Step 2A Prong Two: No).
Claim 2 recites that the object is a coupon, which is also well-understood, routine, and conventional activity. For example, Dennington teaches a biofilm-coated coupon (page 4, left column, paragraph 1).
Claims 3-4 limit the biofilm to specific bacterial strains. However, it is well-known, routine, and conventional activity that organisms such as Streptococcus gordonii form biofilms (Step 2B: No). See, for example, page 5, left column, Arginine paragraph of Kuang et al. (BioMed Research International 2018.1 (2018): 6498932).
Claim 5 requires that the object is spun from 0 to 300 rad·s-1, which is also well-understood, routine, and conventional activity. For example, Dennington spins the biofilm-coated coupon from standstill to 300 rad·s-1 (page 4, left column, bottom paragraph).
Claims 6-7 do not contain additional elements besides the judicial exception of an abstract idea (Step 2B: No).
Claim 8 is drawn to a method of identifying compositions having biofilm detachment activity or evaluating the biofilm detachment efficacy of compositions comprising providing a biofilm-coated object, treating the object with a composition, immersing the object in a liquid, spinning the object with increasing angular velocity, monitoring torque, linearizing and transforming the torque-angular velocity curve into slope-angular velocity curve, determining one or more parameters, and comparing the one or more parameters of the composition with those of a control composition.
Claim 8 is drawn to a process, which is one of the four statutory categories of invention (Step 1: Yes). However, claim 8 recites the judicial exception of an abstract idea (Step 2A Prong One: Yes): the method preamble recites “identifying,” which is a mental process, step (e) and (h) recite the mental processes of monitoring and comparing and steps (f) and (g) recite mathematical concepts (linearizing and transforming, and determining the one or more parameters selected from angular velocity, shear stress, biofilm momentum coefficient, and area under the curve). The claim is not integrated into a practical application (step 2A Prong Two: No) because the end result of performing the method is another judicial exception (“identifying” compositions, which is a mental process or abstract idea) rather than any specific application. The additional elements recited in the claim are providing a biofilm-coated object, treating the object with a composition, immersing the biofilm-coated object in a liquid, and spinning the object with increasing angular velocity. The additional elements recited in the claim are insignificant extra-solution activity (mere data-gathering). These steps are well-understood routine, and conventional. For example, Dennington et al. (Surface Topography: Metrology and Properties 3.3 (2015): 034004) teaches immersing biofilm-coated coupons in water (page 4, left column, paragraph 1) and increasing angular velocity from standstill to 300 rad·s-1 (page 4, left column, bottom paragraph). Gloag et al. (Biofilm 2 (2020): 100017) teaches treating a biofilm-coated object with a low and high concentrations of NaCl weakens the biofilm (page 7, right column, top of first full paragraph). Therefore, claim 8 as a whole does not amount to significantly more than the judicial exception of an abstract idea (Step 2B: No).
The same analysis above applies to dependent claims 9-18 (Step 1: Yes, Step 2A Prong One: Yes, Step 2A Prong Two: No).
Claim 9 recites that the object is a coupon, which is also well-understood, routine, and conventional activity. For example, Dennington teaches a biofilm-coated coupon (page 4, left column, paragraph 1).
Claims 10-11 limit the biofilm to specific bacterial strains. However, it is well-known, routine, and conventional activity that organisms such as Streptococcus gordonii form biofilms (Step 2B: No). See, for example, page 5, left column, Arginine paragraph of Kuang et al. (BioMed Research International 2018.1 (2018): 6498932).
Claims 12-14 further limit the composition requiring that the composition comprises a basic amino acid (claim 12), arginine in free form (claim 13), and zinc ion source (claim 14). However, compositions with efficacy against biofilms comprising arginine and/or zinc are well-understood, routine, and conventional. For example, Huang et al. (Archives of oral biology 82 (2017): 256-262) teaches that arginine reduces oral biofilms or plaque (Highlights, bullet point 1). Poth teaches an oral care composition comprising arginine and a zinc ion source that reduces plaque accumulation (Poth claim 1 and [0121]).
Claim 15 recites that the biofilm-coated objects are treated with the composition for 1-3 minutes or about 2 minutes. This is well-understood, routine, and conventional activity. Anderson Pediatric Dentistry (2019, website) teaches brushing teeth for two minutes (paragraph 1 on page 1), which is treating a bio-film coated object (tooth surface) with a composition (toothpaste).
Claim 16 requires that the object is spun from 0 to 300 rad·s-1, which is also well-understood, routine, and conventional activity. For example, Dennington spins the biofilm-coated coupon from standstill to 300 rad·s-1 (page 4, left column, bottom paragraph).
Claims 17-19 do not contain additional elements besides the judicial exception of an abstract idea (Step 2B: No).
Claim 20 recites a method of reducing or removing dental plaque from teeth comprising an effective amount of an oral care composition to the oral cavity of a subject in need wherein the oral care composition is identified by a method of claim 8. The additional limitations do not integrate the judicial exception into a specific practical application. The claim does not set forth how the parameters are related to the compositions efficacy in removing plaque. The claim amounts to identifying any composition and applying the composition to remove dental plaque. Thus, claim 20 does not integrate the judicial exception into a practical application (Step 2A prong Two: No). The additional element of reducing or removing dental plaque from teeth with a composition is well-understood, routine, and conventional activity. For example, Huang et al. (Archives of oral biology 82 (2017): 256-262) teaches that arginine reduces oral biofilms or plaque (Highlights, bullet point 1).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite for step (e) “slope (torque1/2/angular velocity) - angular velocity curve” because it is unclear whether the torque1/2/angular velocity in parentheses is merely exemplary or a required claim limitation.
Claim 5 recites an indefinite range. It is unclear whether angular velocity is increased from 0 to 300 rad·s-1, or at least one angular velocity during the step of increasing angular velocity is between 0 and 300 rad·s-1.
Claims 2-7 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
Claim 6 is indefinite because it is unclear whether the parameters in step (f) are limited to the angular velocity at which the first reduction in torque occurs and the shear stress at which the first reduction in torque occurs, or whether claim 6 is merely defining the significance of the parameters.
Claim 8 is indefinite because step (e) recites monitoring torque in step (c), but step (c) recites immersing the biofilm-coated object in a liquid, whereas step (d) recites spinning the biofilm-coated object. Therefore, it is unclear whether the object is also spinning in step (c) or whether step (e) actually requires monitoring torque in step (d). Claim 8 is further indefinite for the limitation “—angular velocity curve” in step (g), which appears to be missing a word.
Claim 8 recites the limitation "the one or more parameters of the composition" in step (h). There is insufficient antecedent basis for this limitation in the claim. Step (g) recites one or more parameters but they are parameters of the biofilm-coated object treated with the composition, not parameters of the composition itself.
Claims 9-20 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
Regarding claim 12, the phrase "e.g., arginine in free or salt form" renders the claim indefinite because it is unclear whether the limitation following the phrase e.g. is part of the claimed invention. See MPEP § 2173.05(d).
Claim 16 is indefinite because the claim recites wherein in step (c), the biofilm-coated object is spun at an angular velocity (ω) of from 0 to 300 rad·s-1. Step (c) of claim 8 recites immersing the biofilm-coated object in a liquid, whereas step (d) recites spinning the biofilm-coated object with increasing angular velocity. It is unclear whether step (c) further comprises spinning the object or whether it is actually step (d) that is further limited. Under the interpretation in which step (d) is further limited, it is unclear whether angular velocity is increased from 0 to 300 rad·s-1 or whether at least one angular velocity during the step of increasing angular velocity is between 0 and 300 rad·s-1.
Claim 17 is indefinite because it is unclear whether the parameters in step (g) are limited to the angular velocity at which the first reduction in torque occurs and the shear stress at which the first reduction in torque occurs, or whether claim 17 is merely defining the significance of the parameters.
Claim 18 is indefinite because it is unclear whether the method further comprises a step of determining a reduction in one or more parameters compared to a control composition.
Claim 20 is indefinite because the claim is missing a verb to describe the active method step. The claim recites “A method of reducing or removing dental plaque from teeth, comprising an effective amount of an oral care composition.” Thus, it is uncertain what operative action is required in the process. Claim 20 is further indefinite for the claim limitation “identified by a method of claim 8.” There is ambiguity in the claim scope because of the combination of the indefinite article in “a method of claim 8” and the method preamble of claim 8. It is unclear whether the scope of the claim is the oral care composition identified by the method of claim 8 (includes all of the method steps recited in claim 8) or whether the scope of the claim is any composition identified by a method comprising any one or more steps of the method of claim 8.
Claim 20 is further indefinite because of the method preamble: a method of reducing or removing dental plaque from teeth comprising an effective amount of an oral care composition to the oral cavity of a subject in need. It is unclear whether the scope of the claim is limited to subjects in need of reducing or removing dental plaque from teeth or a subject in need of anything. Applicant may consider amending to “a subject in need thereof.”
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.
Claims 6 and 17-18 are 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 6 fails to further limit the subject matter of claim 1 because claim 6 merely defines parameters that are already recited in step (f) of claim 1.
Claim 17 fails to further limit the subject matter of claim 8 because the claim merely defines parameters that are already recited in step (g) of claim 8.
Claim 18 recites “wherein reduction in the one or more parameters compared to the control composition indicates that the compound has biofilm detachment activity.” Claim 18 fails to further limit claim 8 because the claim merely recites a desired outcome of performing step (h) but does not further limit any of the active methods steps.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Dennington et al. (Surface Topography: Metrology and Properties 3.3 (2015): 034004) in view of Stoodley et al. (Journal of Industrial Microbiology and Biotechnology 29.6 (2002): 361-367).
Dennington teaches immersing biofilm-coated coupons in water (page 4, left column, paragraph 1) and increasing angular velocity from standstill to 300 rad·s-1 (page 4, left column, bottom paragraph). Dennington teaches plotting torque against ω2 for each disc condition (page 4, right column, paragraph 3), which meets the instant claim limitation “monitoring torque to obtain torque – angular velocity curve.” Dennington also teaches fitting the data to a straight line (“linearizing,” page 4, right column, paragraph 3). Dennington teaches determining the biofilm momentum coefficient (Figure 5). Dennington teaches that the momentum coefficient varies as a function of surface roughness (Figure 5).
Dennington does not teach monitoring the detachment of a biofilm from the surface of an object.
Stoodley teaches the influence of shear on biofilm detachment (page 362, left column, lines 1-2). Stoodley teaches a biofilm detachment assay in which shear stress is incrementally stepped up in 1-min intervals until either all of the cells are washed away or the maximum flow rate is achieved (page 363, right column, bottom paragraph). Stoodley teaches that this type of shear - induced detachment assay is a useful tool for determining the relative adhesion strength of biofilms formed on different surfaces or environmental conditions (Fig. 5 caption).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to monitor detachment of the biofilm in the method of Dennington by increasing the angular velocity, which induces a shear stress, until the biofilm detaches. The person of ordinary skill in the art would have been motivated by the teaching of Stoodley, who increases shear stress until the biofilm detaches.
Regarding claim 2, Dennington teaches that the biofilm-coated object is a coupon (page 4, left column, paragraph 1).
Regarding claim 5, Dennington teaches increasing angular velocity from standstill to 300 rad·s-1 (page 4, left column, bottom paragraph).
Claim 6 is rejected because it does not further limit the method of claim 1, which is rejected above. Angular velocity at which the first reduction in torque occurs and shear stress at which the first reduction in torque occurs are inherent characteristics of the biofilm-coated object.
Regarding claim 7, Dennington teaches determining a biofilm momentum coefficient over the angular velocity range between 200 and 300 rad·s-1 (page 5, left column, paragraph 1).
Claims 3-4, 8-13 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Dennington et al. (Surface Topography: Metrology and Properties 3.3 (2015): 034004) in view of Stoodley et al. (Journal of Industrial Microbiology and Biotechnology 29.6 (2002): 361-367), as applied to claims 1-2 and 5-7 above, further in view of Kuang et al. (BioMed Research International 2018.1 (2018): 6498932).
See discussion of Dennington and Stoodley above, which is incorporated into this rejection as well.
Dennington does not teach that the biofilm comprises S. gordonii.
Kuang teaches that S. gordonii, among other oral streptococci such as S. sanguinis (formerly called S. sanguis)and S. parasanguinis (formerly called S. parasanguis) are part of oral biofilms (page 5, left column, Arginine, paragraph 1). ).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the method of Dennington modified by Stoodley to a coupon coated with a biofilm comprising oral streptococci including S. gordonii in order to study the detachment of oral biofilms, which is beneficial for human health. The person of ordinary skill in the art would have had a reasonable expectation of success in applying the method of Dennington and Stoodley to Kuang’s biofilm.
Regarding claim 8, Dennington does not teach treating the biofilm-coated object with a composition prior to immersing the object in a liquid. Dennington does not teach comparing parameters of the biofilm-coated object treated with a composition to those of a biofilm-coated object treated with a control composition.
Stoodley teaches that a shear - induced detachment assay is a useful tool for determining the relative adhesion strength of biofilms formed on different surfaces or environmental conditions (Fig. 5 caption).
Kuang teaches that arginine suppresses the production of extracellular membrane glucans, thereby inhibiting the adherence activity of S. mutans to the tooth surface (page 5, left column, Arginine, paragraph 2). Kuang teaches further that L-arginine is able to reduce the biomass of polymicrobial dental biofilms, particularly by inhibiting the formation of S. mutans by reducing its water-insoluble EPS production (page 5, left column, Arginine, paragraph 2). Kuang teaches that using arginine-containing toothpaste can shift the oral bacteria composition to one similar to that of caries-free individuals (page 5, left column, Arginine paragraph 1). Kuang suggests that increasing the availability of exogenous arginine in the oral environment could be used to control biofilms (page 5, left column, Arginine paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to treat the biofilm-coated coupon with Kuang’s arginine-containing toothpaste in order to identify the impact of the arginine-containing toothpaste on biofilm detachment. It would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add a step of comparing the biofilm momentum coefficient of the biofilm-coated coupon treated with the arginine-containing toothpaste to a biofilm-coated coupon treated with toothpaste without arginine (“control composition”) in order to study the effect of arginine on biofilm detachment. The person of ordinary skill in the art would have had a reasonable expectation of success in these modifications.
Regarding claim 9, Dennington teaches that the biofilm-coated object is a coupon (page 4, left column, paragraph 1).
Regarding claims 10-11, Kuang teaches that S. gordonii, among other oral streptococci such as S. sanguinis and S. parasanguinis are part of oral biofilms (page 5, left column, Arginine, paragraph 1).
Regarding claims 12-13, Kuang teaches an arginine-containing toothpaste (page 5, left column, Arginine, paragraph 1). Kuang teaches that 1.5% L-arginine (arginine in free form) as a dietary supplement enriches S. gordonii while suppressing S. mutans (page 5, right column, paragraph 1).
Regarding claim 16, Dennington teaches increasing angular velocity from standstill to 300 rad·s-1 (page 4, left column, bottom paragraph).
Claim 17 is rejected because it does not further limit the method of claim 8, which is rejected above. Angular velocity at which the first reduction in torque occurs and shear stress at which the first reduction in torque occurs are inherent characteristics of the biofilm-coated object.
Regarding claim 18, Dennington does not teach that reduction in one or more parameters compared to the control composition indicates that the compound has biofilm detachment activity.
However, Dennington teaches that frictional resistance changes are estimated by comparing momentum coefficients (Abstract). Dennington illustrates a linear relationship between momentum coefficient and surface roughness (Fig. 5).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to compare the momentum coefficient of the biofilm treated with Kuang’s arginine-containing toothpaste to a biofilm treated with the same composition lacking arginine. The person of ordinary skill in the art would have been motivated to determine the frictional resistance changes between the two treated biofilms. The person of ordinary skill in the art would have recognized that changes in frictional resistance of the treated biofilm, corresponding to changes in momentum coefficient, would have corresponded to biofilm detachment activity of the composition.
Regarding claim 19, Dennington teaches determining a biofilm momentum coefficient over the angular velocity range between 200 and 300 rad·s-1 (page 5, left column, paragraph 1).
Regarding claim 20, Dennington does not teach a method of reducing or removing dental plaque from teeth comprising administering an effective amount of an oral care composition to the oral cavity of a subject in need.
Kuang teaches that arginine suppresses the production of extracellular membrane glucans, thereby inhibiting the adherence activity of S. mutans to the tooth surface (page 5, left column, Arginine, paragraph 2). Kuang teaches further that L-arginine is able to reduce the biomass of polymicrobial dental biofilms, particularly by inhibiting the formation of S. mutans by reducing its water-insoluble EPS production (page 5, left column, Arginine, paragraph 2). Kuang teaches that using arginine-containing toothpaste can shift the oral bacteria composition to one similar to that of caries-free individuals (page 5, left column, Arginine paragraph 1). Kuang suggests that increasing the availability of exogenous arginine in the oral environment could be used to control biofilms (page 5, left column, Arginine paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Dennington and Stoodley by administering Kuang’s arginine-containing toothpaste to the oral cavity of a subject in order to reduce dental plaque. The person of ordinary skill in the art would have had a reasonable expectation of success because plaque is an oral biofilm and Kuang suggests that arginine reduces the biomass of polymicrobial dental biofilms.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Dennington et al. (Surface Topography: Metrology and Properties 3.3 (2015): 034004) in view of Stoodley et al. (Journal of Industrial Microbiology and Biotechnology 29.6 (2002): 361-367) and Kuang et al. (BioMed Research International 2018.1 (2018): 6498932), as applied to claims 3-4, 8-13 and 16-20 above, further in view of Poth et al. (US 2018/0207073 A1).
See discussion of Dennington, Stoodley, and Kuang above, which is incorporated into this rejection as well.
Regarding claim 14, Dennington, Stoodley, and Kuang do not teach treating the biofilm-coated object with a composition comprising a zinc ion source.
Poth teaches an oral care composition comprising arginine and a zinc ion source (Poth claim 1) that inhibits microbial biofilm formation in the oral cavity and reduces plaque accumulation ([0121]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to add a zinc ion source to the arginine-containing toothpaste of Kuang in the method of Dennington modified by Stoodley and Kuang per the teaching of Poth. The person of ordinary skill in the art would have been motivated to study the effect of the zinc ion source in the plaque-removal efficiency of the toothpaste. The person of ordinary skill in the art would have had a reasonable expectation of success in adding a zinc ion source to Kuang’s toothpaste.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Dennington et al. (Surface Topography: Metrology and Properties 3.3 (2015): 034004) in view of Stoodley et al. (Journal of Industrial Microbiology and Biotechnology 29.6 (2002): 361-367) and Kuang et al. (BioMed Research International 2018.1 (2018): 6498932), as applied to claims 3-4, 8-13 and 16-20 above, further in view of Anderson Pediatric Dentistry (2019, website).
See discussion of Dennington, Stoodley, and Kuang above, which is incorporated into this rejection as well.
Dennington does not teach the biofilm-coated object is treated with the composition for about 2 minutes.
Anderson Pediatric Dentistry teaches brushing teeth for two minutes (paragraph 1 on page 1), which is treating a biofilm-coated object (tooth surface) with a composition (toothpaste).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to treat the biofilm-coated coupon with Kuang’s arginine-containing toothpaste for two minutes in order to mimic a timing similar to toothbrushing. The person of ordinary skill in the art would have had a reasonable expectation of success in applying the toothpaste to the biofilm-coated coupon for two minutes.
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.
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Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of copending Application No. 17/774,971 (‘971) in view of Dennington et al. (Surface Topography: Metrology and Properties 3.3 (2015): 034004), Stoodley et al. (Journal of Industrial Microbiology and Biotechnology 29.6 (2002): 361-367), and Kuang et al. (BioMed Research International 2018.1 (2018): 6498932).
Claim 1 of ‘971 is drawn to a method for modifying the surface topography of an oral biofilm comprising administering an oral care composition comprising an effective amount of a basic amino acid and a divalent metal ion source to the oral cavity of a subject in need thereof, wherein the basic amino acid is selected from arginine, lysine, histidine, and a combination of two or more thereof, wherein the divalent metal ion source is selected from a zinc ion source, a stannous ion source, and a combination of two or more thereof. Claims 5, 7-10, 12-15, 19, and 26-27 of ‘971 depend from claim 1 of ‘971.
Claim 5 of ‘971 recites that the arginine comprises L-arginine.
Claim 7 of ‘971 requires that the effective amount of basic amino acid or divalent metal ion is an amount required to increase the roughness of a protein of a portion of the biofilm.
Claim 13 of ‘971 recites that the oral care composition is administered to the oral cavity for from about 10 seconds to about 10 minutes. Claim 14 of ‘971 recites that the oral care composition is administered to the oral cavity for from about 30 seconds to about 2 minutes.
Claim 29 of ‘971 is drawn toa method for reducing the thickness of an oral biofilm comprising administering an oral care composition to the oral cavity of a subject in need thereof, the oral care composition comprising arginine, a zinc ion source, a stannous ion source, and an abrasive. Claims 34-35, 38, 46, 67, and 83 of ‘971 depend from claim 29 of ‘971.
Regarding instant claim 1, claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of ‘971 do not recite immersing the biofilm-coated object in a liquid, spinning the biofilm-coated object with increasing angular velocity, monitoring torque to obtain a torque-angular velocity curve, and determining biofilm momentum coefficient,.
Regarding instant claim 8, claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of ‘971 also do not recite treating a biofilm-coated object with a composition and comparing biofilm momentum coefficient of the composition-treated biofilm-coated object with the momentum coefficient of the control composition-treated biofilm-coated object.
Dennington teaches immersing biofilm-coated coupons in water (page 4, left column, paragraph 1) and increasing angular velocity from standstill to 300 rad·s-1 (page 4, left column, bottom paragraph).
Dennington teaches plotting torque against ω2 for each disc condition (page 4, right column, paragraph 3), which meets the instant claim limitation “monitoring torque to obtain torque – angular velocity curve.” Dennington also teaches fitting the data to a straight line (“linearizing,” page 4, right column, paragraph 3). Dennington teaches determining the biofilm momentum coefficient (Figure 5). Dennington teaches that the momentum coefficient varies as a function of surface roughness (Figure 5).
Dennington does not teach monitoring the detachment of a biofilm from the surface of an object.
Stoodley teaches the influence of shear on biofilm detachment (page 362, left column, lines 1-2). Stoodley teaches a biofilm detachment assay in which shear stress is incrementally stepped up in 1-min intervals until either all of the cells are washed away or the maximum flow rate is achieved (page 363, right column, bottom paragraph). Stoodley teaches that this type of shear - induced detachment assay is a useful tool for determining the relative adhesion strength of biofilms formed on different surfaces or environmental conditions (Fig. 5 caption).
Although Dennington teaches a biofilm, Dennington’s biofilm is not an oral biofilm.
Kuang teaches that S. gordonii, among other oral streptococci such as S. sanguinis and S. parasanguinis are part of oral biofilms (page 5, left column, Arginine, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the method of Dennington to a coupon coated with Kuang’s biofilm treated with the oral care composition of claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of ‘971. The person of ordinary skill in the art would have been motivated to characterize the composition’s ability to modify the surface topography of a biofilm. It would have been further obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to monitor detachment of the biofilm in the method of Dennington by increasing the angular velocity, which induces shear stress, until the biofilm detaches. The person of ordinary skill in the art would have been motivated by the teaching of Stoodley, who increases shear stress until the biofilm detaches. The person of ordinary skill in the art would have had a reasonable expectation of success in these modifications.
Regarding claim 2, Dennington teaches that the biofilm-coated object is a coupon (page 4, left column, paragraph 1).
Regarding claims 3-4 and 10-11, Kuang teaches that S. gordonii, among other oral streptococci such as S. sanguinis and S. parasanguinis are part of oral biofilms (page 5, left column, Arginine, paragraph 1).
Regarding claim 5, Dennington teaches increasing angular velocity from standstill to 300 rad·s-1 (page 4, left column, bottom paragraph).
Claim 6 is rejected because it does not further limit the method of claim 1, which is rejected above. Angular velocity at which the first reduction in torque occurs and shear stress at which the first reduction in torque occurs are inherent characteristics of the biofilm-coated object. Therefore, claim 6 is also obvious over claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of ‘971 in view of Dennington and Stoodley.
Regarding claim 7, Dennington teaches determining a biofilm momentum coefficient over the angular velocity range between 200 and 300 rad·s-1 (page 5, left column, paragraph 1).
Regarding claim 9, Dennington teaches that the biofilm-coated object is a coupon (page 4, left column, paragraph 1).
Instant claims 12-14 are obvious over claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of ‘971 because the oral care composition of claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of ‘971 includes arginine, stannous ion source, and a zinc ion source.
Regarding instant claim 15, claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of ‘971 do not recite treating a biofilm-coated object for about 2 minutes.
However, claim 14 of ‘971 recites administering the oral care composition to the oral cavity for from about 30 seconds to about 2 minutes, which overlaps with the claimed range.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply the oral care composition to the biofilm-coated coupon for the same duration as the oral care composition is administered to the oral cavity in order to mimic the surface topography changes of the biofilm induced by the composition in the oral cavity. Therefore, instant claim 15 is obvious over claim 14 of ‘971 in view of Dennington and Stoodley.
Regarding claim 16, Dennington teaches increasing angular velocity from standstill to 300 rad·s-1 (page 4, left column, bottom paragraph).
Claim 17 is rejected because it does not further limit the method of claim 8, which is rejected above. Angular velocity at which the first reduction in torque occurs and shear stress at which the first reduction in torque occurs are inherent characteristics of the biofilm-coated object. Therefore, claim 17 is also obvious over claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of ‘971 in view of Dennington and Stoodley.
Regarding claim 18, claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of ‘971 do not recite and Dennington does not teach that reduction in one or more parameters compared to the control composition indicates that the compound has biofilm detachment activity.
However, Dennington teaches that frictional resistance changes are estimated by comparing momentum coefficients (Abstract). Dennington illustrates a linear relationship between momentum coefficient and surface roughness (Fig. 5).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to compare the momentum coefficient of the biofilm-coated coupon treated with the oral care composition of claims 1, 5, 7-10, 12-15, 19, 26-27, 29, 34-35, 38, 46, 67, and 83 of ‘971 comprising arginine to a biofilm treated with the same composition lacking arginine. The person of ordinary skill in the art would have been motivated to determine the frictional resistance changes between the two treated biofilms. The person of ordinary skill in the art would have recognized that changes in frictional resistance of the treated biofilm, corresponding to changes in momentum coefficient, would have corresponded to biofilm detachment activity of the composition.
Regarding claim 19, Dennington teaches determining a biofilm momentum coefficient over the angular velocity range between 200 and 300 rad·s-1 (page 5, left column, paragraph 1).
Instant claim 20 is obvious over claims 29, 34-35, 38, 46, 67, and 83 of ‘971 in view of Dennington and Stoodley because claim 29 of ‘971 recites a method for reducing thickness of an oral biofilm comprising administering an oral care composition to the oral cavity of a subject in need thereof. Dental plaque is formed from an oral biofilm, so a method of reducing thickness of an oral biofilm is also a method of reducing plaque.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657