DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Declaration pursuant to 37 CFR 1.132, Amendments to the Claims and Arguments/Remarks filed 26 April 2026, in response to the Office Correspondence dated 09 January 2026, are acknowledged.
The listing of Claims filed 26 April 2026, have been examined. Claims 12-14, 16, 20, 24, 26, 27, 31, and 32 are pending. Claim 20 has been amended, claims 21 and 22 are canceled, and new claims 31 and 32 have been added.
Response to Amendment
New claims 31 and 32 have been added and claim 20 has been amended to recite brushing for at least two minutes followed by rinsing, and that administration provides deep-layer remineralization to a depth of at least 100 µm.
The prior rejection of claim 20 under 35 U.S.C. § 112(b) based on the phrase “able to provide” is withdrawn. The applicant has amended claim 20 to recite that administration “provides deep-layer remineralization … to a depth of at least 100 µm.” The amendment supplies objective claim scope sufficient to apprise a person of ordinary skill in the art of the metes and bounds of the claimed subject matter. Former claim 21 has been cancelled. Accordingly, the prior rejection directed thereto is withdrawn.
The Examiner has fully considered Applicant’s Remarks and the Declaration of Dr. Enax submitted under 37 CFR 1.132. The arguments are found unpersuasive for the reasons set forth below in the Response to Arguments. The rejection of claims 12-14, 16, 20, 24, and 26-27 under 35 U.S.C. § 103 are maintained.
A new ground of rejection for claims 31 and 32 under 35 U.S.C. § 103 is made because the claims are newly added and were not present in prior claims. New grounds of rejection for amended claim 20 (including dependent claims 12, 13, 14, 16, 24, 26, 27, and 31) and claim 32 under 35 U.S.C. § 112(b) are necessitated by amendmend.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 09 January 2026, since the art which was previously cited continues to read on the amended/newly cited limitations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 12-14, 16, 20, 24, 26, and 27 are rejected under 35 U.S.C. § 103 as being unpatentable over Enax et al. (DE102016114189A1; publication date 01 February 2018, hereinafter referred to as “Enax”) in view of Rudin et al. (EP1023035B1; publication date 05 June 2022, hereinafter referred to as “Rudin”) and in further view of Elhennawy et al. (Structural, mechanical and chemical evaluation of molar-incisor hypomineralization-affected enamel: A systematic review. Arch Oral Biol. 2017 Nov;83:272-281, published electronically 19 August 2017, hereinafter referred to as “Elhennawy”).
Enax teaches a method of tooth remineralization by administering a composition comprising hydroxyapatite to the tooth surface (use as a dentifrice). Enax explicitly discloses oral care compositions comprising hydroxyapatite, including in toothpaste and other dental formulations suitable for enamel and dental surface treatments that are "free of fluoride" (claim 11) and contains "one or more pharmaceutical or cosmetic excipients" (claim 8) for use in caries prophylaxis and remineralization of enamel (¶[0001], claim 12 and ¶[0019]). While Enax does not explicitly teach the species of caries as ICDAS code 3 and 4, these specific species of caries are necessarily encompassed within the genus of all caries specified by Enax.
Enax teaches remineralization to repair "microfine defects in the enamel" and even to the dentin layer, indicating a capability for remineralization beyond the superficial enamel repair to the underlying dentin (“deep remineralization”) (¶[0019], ¶[0022]). The reference explicitly discloses remineralizing "smaller carious lesions" and repairing "microfine defects in the enamel," which encompasses treating conditions that involve enamel defects and demineralization such as molar incisor hypomineralization (MIH).
MIH is a specific type of enamel hypomineralization that was a well-known clinical condition identified in the art prior to the effective filing date as established by Elhennawy. MIH as a condition characterized by enamel defects and demineralization, falling squarely within the category of diseases the cited art is disclosed to treat. Elhennawy teaches that MIH is characterized by porous, defective enamel with reduced mineral content. The fundamental pathology is hypomineralization – a lack of minerals (i.e., Ca and P; Abstract). The fundamental mechanism of hydroxyapatite, as taught by Enax, is effective remineralization, the deposition of minerals, to demineralized, porous enamel defects. Applying a known enamel-repairing biomimetic agent such as hydroxyapatite to a newly identified subclass of the same condition such as MIH is an obvious use of a known composition for its intended purpose.
Thus, a person of ordinary skill in the art prior to the instant effective filing date, would have had a reasonable expectation of success in having some beneficial effect in applying a known, effective remineralizing agent to a known, mineralization-deficient condition. A composition that deposits mineral into one type of porous enamel is a logical candidate to try for another type of porous enamel. The legal test for obviousness requires a "reasonable expectation of success," not a guarantee (see In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988)).
It would have then been obvious to use the invention of Enax for treating MIH because it addresses the core pathological features of hypomineralization, hypersensitivity and higher caries risk. It is logical to use an invention for tooth remineralization to remineralize hypomineralized molar and incisor enamel and help prevent further demineralization. In particular, Enax teaches, “Both these organic acids produced by bacteria and the dietary acids, such as fruit acids, can cause erosion of the hard tooth substance. Among other things, calcium phosphates are dissolved out of the enamel. If this process is not halted, or even vice versa, demineralization of the enamel and possibly also of the dentin may occur after some time. Such a defect in the hard tooth substance is called a carious lesion, whereby, for example, carious lesions on the dentin layer can be recognized as having a yellow to brown coloration of the corresponding site of the tooth. So while carious lesions on the enamel alone often can be reduced or eliminated by re-mineralizing the enamel, is carious lesions that affect in addition to the enamel also other layers, usually the damaged part of the tooth removed and the resulting hole with a filling material closed. In summary, it can be said that caries formation can be promoted by the interaction of the following factors:
-Specific bacteria that adhere to the pellicle
– Poor tooth quality or mineral quality of the tooth
– Plaque
– Food containing low-molecular-weight carbohydrates
– Time” (¶[0006]-[0012]), wherein, “In particular, it was unexpectedly found that the composition according to the invention advantageously remineralises smaller carious lesions and / or repairs microfine defects in the enamel, especially in patients with dry mouth / low salivary. Furthermore, the composition according to the invention can be used to apply a protective layer to the tooth and, furthermore, it has been found that the enamel has advantageous solubility and resistance to acid after use of the composition according to the invention.”(¶[0022]).
In addition, the instant Specification teaches, “A Ca5(PO4)3(OH) suitable according to the invention is described, for example, in DE102016114189.5 [Enax (DE102016114189A1)]. The Ca5(PO4)3(OH) used according to the invention is used for the remineralization of teeth to a depth of 200 μm” (¶[0024] and ¶[0025]), thus the general crystal shape microaggregates taught by Enax are sufficient and suitable, according to the instant invention, to be used to produce the very specific size of microaggregates to achieve the functional result having the tooth mineralization depth of the instant claim 24. Reciting a depth of "at least 200 µm" merely sets a greater depth goal (e.g., 200 µm vs. 100 µm) within the same functional capability taught by Enax for treating deep lesions. This is an obvious optimization to a person of ordinary skill seeking an effective treatment regimen to achieve a greater depth through routine experimentation (e.g., longer treatment time, adjusting application frequency, or more concentrated formulation).
Enax also teaches wherein the preferred embodiment is microaggregated form as, “In a preferred embodiment, the Ca5(PO4)3(OH) is present in aggregated form. In this case, an aggregation is understood to mean an aggregation of molecules or particles into a larger dressing, the aggregate. This assembly or aggregate is caused and held together by various forces and / or modes of attachment such as ionic bonding, van der Waals forces, intermolecular forces or other chemical bonding modes.” (¶[0030]). The teaching of Enax1 of microaggregates in general terms, can broadly be interpreted as aggregates of any size and shape as long as they do not break down into nanoparticles (<100nm) under stress, while included, Enax does not explicitly teach microaggregates with the specific length of between 60-100 nm and a width of between 20-40 nm.
Rudin teaches stomatic compositions comprising hydroxyapatite particles for the same intended use as Enax and the instant invention, having an average size by length from 0.2-0.01 µm [10-200 nm] and width from 0.1-0.001 µm [1-100 nm] (Claim 1), thus encompasses the "approximately 80 nm" length and "approximately 30 nm" width recited in instant claims 13 and 14 as, “The composition comprises hydroxyapatite in the form of particles of ultra finely divided hydroxyapatite with an average size by length (l), width (d) and thickness (h) of about l x d x h = 0,06 µm x 0,015 µm; x 0,005 µm (i.e., 60 nm x 15 nm x 5 nm) is capable to stimulate reparative osteogenesis processes and possessing a high bioactivity and specific pharmacological activity.” (Abstract). A person of ordinary skill in the art, seeking to optimize the Enax remineralization composition for efficacy, would have been motivated to look to Rudin for specific, effective hydroxyapatite particle sizes.
Rudin teaches that ultra-finely divided hydroxyapatite possesses "high adhesive-sorption activity to the dental enamel and to microdefects on its surface" and is useful for "preventive measures preventing the spread of caries disease" (¶[0019]). The reference further teaches that the HA crystals are "adapted to the maximum to the dental enamel structure" and act as a "building material" in the "osteoreparative process," which one of ordinary skill would understand includes deep integration and repair within the enamel structure (¶[0018]). To optimize the depth and efficacy of this remineralization for a hypomineralization condition, it would have been obvious to combine this with the teaching of Rudin, which specifically discloses that ultra-finely divided hydroxyapatite adhesively integrates into the enamel structure to act as a building material for repair. The combined teachings reasonably encompass achieving "deep-layer remineralization" as a natural result of applying a biomimetic repair agent, hydroxyapatite, designed to integrate into the enamel substrate.
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to adopt the specific primary particle size scale described by Rudin for the microaggregate size in the invention of Enax, given that this size is considered acceptable for stomatic compositions comprising hydroxyapatite particles, while also achieving high bioactivity and being capable of stimulating reparative osteogenesis to preserve tooth structure. One would be motivated to use the species of the Enax hydroxyapatite microaggregate particles at the size scale taught by Rudin to achieve high bioactivity for optimal formulations as a matter of routine optimization to Enax’s spherical crystalline structure microaggregates, while avoiding any potential safety risk associated with acicular crystals of Rudin. Combining these known elements (using particles within the size range disclosed by Rudin to enhance bioactivity and remineralization potential in the Enax composition) would be obvious combination of known elements for their known purpose to achieve a predictable result of enhanced remineralization depth.
Rudin also teaches hydroxyapatite concentrations of "0.1 to 50.0 wt.%" (claim 6, ¶[0017]), and further teaches, “The amount of HA present in the oral composition of the present invention is in the range of 0,1% to 50%, preferably from 0,1% to 25%, and most preferably from about 0,2% to 20% by weight of the oral composition.” (¶[0017]), thus encompassing the ranges in instant claims 16 and 26.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 09 January 2026, as the Applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
Claim Rejections - 35 USC § 112(b)
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 Applicant regards as his invention.
Claims 12-14, 16, 20, 24, 26, 27, 31 and 32 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, regards as the invention.
Claim 20 recites a method for treating molar incisor hypomineralization (MIH) comprising administering a composition by brushing for at least two minutes followed by rinsing, "wherein administration of the composition is administered in an amount able to provide deep-layer remineralization to the one or more teeth affected by MIH to a depth of at least 100 um". The phrase "able to provide deep-layer remineralization ... to a depth of at least 100 µm" sets forth a desired result of the method rather than a positively recited step or a measurable structural limitation. The "amount" is defined only by reference to the very result it is supposed to produce. No separate limitation on dosage, concentration, frequency, or duration (beyond the two-minute brushing step) is provided. Thus, any amount that happens to work falls within the claim, but the claim provides no guidance on what that amount is. This renders the claim indefinite (see In re Borkowski, 505 F.2d 713, 718 (CCPA 1974), wherein claims that define a limitation solely by reference to the result to be achieved are indefinite).
In addition, the claim does not specify how one determines whether the method has achieved remineralization to 100 µm depth. A person of ordinary skill in the art would not know, with reasonable certainty, whether a given administration of the composition meets the claim limitation without an objective measurement standard being recited (see Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 913 (2014). The specification discloses that remineralization depth can be measured by transverse microradiography, however, claim 20 does not incorporate any such measurement technique. Without recitation of an objective measurement protocol (e.g., "as measured by transverse microradiography," "as determined by lesion depth reduction percentage," or "as assessed by polarized light microscopy"), what evidence would establish compliance with the depth limitation is ambiguous.
To overcome this rejection, the applicant may consider replacing "is administered in an amount able to provide" with "wherein the composition is administered in an amount sufficient to provide" and recite the method by which the remineralization depth is measured. Dependent claims 12, 13, 14, 16, 24, 26, 27, and 31 are rejected under 35 U.S.C. § 112(b) for the same reason, as they depend from claim 20 and do not cure the underlying indefiniteness.
Claim 32 is rejected as indefinite. Claim 32 recites a method for treating MIH wherein “the subject is suffering from MIH present at a depth of at least 100 μm in the one or more teeth.” The phrase “MIH present at a depth of at least 100 μm” is ambiguous. It is unclear whether this refers to the depth of the MIH lesion (i.e., the vertical extent of hypomineralized tissue from the enamel surface inward) or the depth of remineralization achieved after treatment. Moreover, no objective measurement standard is provided.
The specification defines MIH as an enamel formation disorder but does not define "depth of MIH" as a clinical parameter. Elhennawy et al., cited in the applicant’s Remarks, discusses lesion depth in the context of enamel defects, but claim 32 does not incorporate any objective measurement standard. A person of ordinary skill in the art would not know, with reasonable certainty, how to determine whether a subject "is suffering from MIH present at a depth of at least 100 µm" without a recited measurement technique (e.g., "as determined by transverse microradiography," "as measured by optical coherence tomography," or "as assessed by microhardness testing").
Because the claim fails to provide objective boundaries for this patient selection limitation, the scope of the claim is ambiguous. To overcome this rejection, the applicant may amend claim 32 to clarify the meaning of "depth" or delete the depth limitation and provide an recite an objective measurement methodology for determining MIH depth.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. § 102 and 103 (or as subject to pre-AIA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 20, 31 and 32 are rejected under 35 U.S.C. § 103 as being unpatentable over Enax et al. (DE102016114189A1; publication date 01 February 2018, hereinafter referred to as “Enax”) in view of Rudin et al. (EP1023035B1; publication date 05 June 2022, hereinafter referred to as “Rudin”) and in further view of Elhennawy et al. (Structural, mechanical and chemical evaluation of molar-incisor hypomineralization-affected enamel: A systematic review. Arch Oral Biol. 2017 Nov;83:272-281, published electronically 19 August 2017, hereinafter referred to as “Elhennawy”).
Enax, Rudin and Elhennawy teach the limitations of instant claim 20, from which instant claim 31 depends, as described above. Claim 31 recites that the composition is in the form of a toothpaste. Enax expressly teaches toothpaste formulations comprising hydroxyapatite (claim 6; ¶[0001] and ¶[0019])). Accordingly, claim 31 is unpatentable for the same reasons set forth above.
Claim 32 recites treatment of a subject suffering from MIH present at a depth of at least 100 µm. This is a patient-selection limitation based on the condition being treated. Selecting subjects exhibiting known manifestations of the target pathology does not impart patentable weight absent a new treatment step or materially different method (see In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990)). Further, Elhennawy teaches that MIH lesions extend into subsurface enamel and teaches that MIH lesions vary in depth and severity, as stated above. Enax teaches remineralization of porous, mineral-deficient enamel. Selecting a patient subpopulation having deeper lesions (≥100 μm) is a routine and obvious patient selection criterion. There is no unexpected result in treating patients with deeper lesions versus shallower lesions using the same composition and method. Accordingly, as claim 20 is obvious, claim 32 is also obvious.
Response to Arguments
Applicant Arguments/Remarks of the reply and the Declaration of Dr. Enax submitted under 37 CFR 1.132, filed 26 April 2026, have been fully considered.
Regarding the rejection under 35 U.S.C. § 112(b), the applicant’s reliance on the Declaration of Dr. Enax is noted, but does not cure the indefiniteness rejections, as indefiniteness is determined from the face of the claim as understood by a person of ordinary skill in light of the specification, not from post-hoc expert testimony regarding operability.
Regarding the rejection under 35 U.S.C. § 103, the applicant argues that MIH differs from caries because MIH is developmental rather than acid-mediated and the MIH-affected enamel is structurally and compositionally distinct from caries-affected enamel (increased protein content, altered microstructure, developmental origin). The argument has been considered but is not persuasive. The relevant obviousness inquiry is not whether MIH and caries are identical in etiology, but whether a person of ordinary skill would have had reason to apply a known remineralizing agent to another known mineral-deficient porous enamel substrate. Elhennawy expressly characterizes MIH enamel as mineral deficient, porous, and structurally weakened. Those are the very substrate characteristics to which Enax directs hydroxyapatite-mediated remineralization. Enax teaches the use of hydroxyapatite compositions for remineralizing “smaller carious lesions” and repairing “microfine defects in the enamel” precisely by depositing minerals into demineralized, porous enamel.
The prior art therefore provides a rational basis for applying hydroxyapatite to MIH enamel. The core pathological feature addressed by both Enax and the claimed invention is the same, a lack of mineral content in enamel. A person of ordinary skill would reasonably expect that an agent effective at depositing mineral into one type of porous, mineral-deficient enamel (caries) would be effective at depositing mineral into another type of porous, mineral-deficient enamel (MIH). A known composition used for the same purpose on a structurally related substrate constitutes an obvious application of known technology (see In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997)).
The Declaration of Dr. Enax has been fully considered. However, the Declaration constitutes subjective opinion testimony from an interested party, not objective evidence of nonobviousness. The declaration primarily expresses scientific opinion regarding reduced predictability. The declaration does not provide contemporaneous comparative experimental data demonstrating that hydroxyapatite fails to remineralize MIH enamel or that the results obtained are unexpected over the closest prior art. In particular, the declaration does not provide side-by-side comparison with Enax compositions, quantitative comparative data, statistical analysis, and evidence that ≥100 µm remineralization is unexpected relative to prior art hydroxyapatite treatment. Instead, it provides theoretical reasons why one might doubt success.
Obviousness does not require certainty or the absence of any doubt, it requires a reasonable expectation of success, not a guarantee (see In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988)). The fact that MIH enamel has increased protein content does not render it non-remineralizable, to the contrary, the porous structure provides a scaffold for hydroxyapatite deposition. Moreover, the applicant’s own specification demonstrates successful remineralization, confirming that the alleged structural obstacles were not insurmountable.
A declaration that merely states that success would not have been expected is insufficient, without objective comparative evidence, to rebut a prima facie case of obviousness (see MPEP § 716.01(c)). Further, the declaration acknowledges that experiments were conducted “under my direction and control,” but no underlying experimental protocol, raw data, reproducibility analysis, controls, or quantitative methodology is provided. Accordingly, the declaration is accorded limited evidentiary weight. The declaration does not overcome the prima facie case of obviousness.
The applicant also argues that Enax does not teach deep remineralization of MIH specifically. However, the instant specification itself acknowledges that the Enax reference is suitable for remineralization to a depth of 200 μm (¶[0024]-[0025]). Enax expressly teaches remineralization extending to “the dentin layer,” which necessarily exceeds 100 μm because human enamel thickness ranges from approximately 500 μm to 2,500 μm.
Thus, a person of ordinary skill would have expected that the known hydroxyapatite compositions of Enax, when applied under appropriate conditions (e.g., including brushing for at least two minutes), would achieve remineralization depths of at least 100 μm in any porous, mineral-deficient enamel, including MIH. The claimed depth is therefore an inherent or predictable result of practicing the Enax method on hypomineralized tissue. Where the prior art teaches the same composition applied to the same substrate for the same purpose, discovery of an inherent property or result does not render the claim patentable (see MPEP § 2112). In addition, achieving greater penetration depth through treatment duration, formulation optimization, particle selection, and routine parameter adjustment would have been obvious to a person of ordinary skill.
The applicant further argues that prior MIH treatment relied on leave-on products (i.e., fluoride varnishes, CPP-ACP crèmes) and that a rinse-off treatment (e.g., toothpaste applied by brushing for two minutes followed by rinsing) would not have been expected to be effective for MIH because the art teaches leave-on products. This argument is not persuasive.
Enax discloses oral care compositions comprising hydroxyapatite “in the form of a toothpaste” and “for use in caries prophylaxis” (¶[0001], [0019], claim 12). The ordinary and customary use of toothpaste involves brushing followed by rinsing and is routine oral-care administration practice. Thus, Enax already teaches the identical administration regimen, brushing and rinsing, for remineralization of enamel defects. Claim 20 merely recites a known method of administration of a known oral-care composition.
The applicant has not provided any evidence that MIH enamel requires prolonged contact of hydroxyapatite, nor that rinsing negates the remineralization effect. The Declaration is silent on this point. To the contrary, the instant claims demonstrate that brushing for two minutes followed by rinsing is effective, confirming that the prior art regimen was suitable. The prior art need not disclose the preferred embodiment to render the claimed embodiment obvious (see Merck & Co. v. Biocraft Labs, 874 F.2d 804 (Fed. Cir. 1989)). Selecting a routine brushing duration of “at least two minutes” represents no more than optimization of a result-effective variable (see In re Aller, 220 F.2d 454 (CCPA 1955)).
The fact that some prior MIH products may be leave-on formulations does not teach away from conventional toothpaste-based administration. “Teaching away” requires clear criticism, discredit, or discouragement of the claimed approach (see DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)). The applicant has not identified any reference that states or implies that hydroxyapatite cannot be used in a rinse-off toothpaste for MIH, or that leave-on products are the only effective approach. A person of ordinary skill would have recognized that a rinse-off toothpaste is a matter of formulation choice and patient convenience, not a critical parameter affecting efficacy.
Regarding the dependent claims, Enax expressly discloses fluoride-free compositions (claim 11). Rudin teaches hydroxyapatite particles having dimensions of 60 nm × 15 nm × 5 nm (Abstract), which fully encompasses and provides a clear motivation for the claimed dimensions as a matter of routine optimization. The applicant has provided no evidence of criticality or unexpected results associated with these specific dimensions (see In re Aller, 220 F.2d 454 (CCPA 1955)). Rudin teaches HAP concentration ranges of 0.1-20.0 wt.% and 0.1-50.0 wt.% (claim 6, ¶[0017]) and selecting a concentration within those ranges is a matter of routine optimization. The instant Specification cites Enax as teaching remineralization to 200 μm (¶[0024]-[0025]). This is a mere recitation of a known capability. Enax discloses “one or more pharmaceutical or cosmetic excipients” (claim 8). Enax explicitly teaches toothpaste formulations (claim 6, ¶[0001], and, ¶[0019]).
The applicant cites Somani et al. and Pramanik et al. but does not clearly argue unexpected results from those references. To the extent the applicant intends to rely on any post-filing comparative data, no such data has been submitted. A declaration attesting to opinions of nonobviousness, without comparative data showing superiority over the closest prior art, is insufficient to overcome a prima facie case of obviousness (see In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).
In summary, Enax teaches oral care compositions comprising hydroxyapatite for remineralization of tooth surfaces, including dentifrices, toothpaste formulations, fluoride-free embodiments, and compositions containing pharmaceutical or cosmetic excipients. Enax further teaches repair of enamel microdefects, small carious lesions, subsurface mineral loss, and remineralization extending toward deeper tooth structures.
Rudin teaches ultrafine hydroxyapatite particles, dimensions encompassing approximately 80 nm length and approximately 30 nm width, hydroxyapatite concentration ranges of 0.1-50 wt.%, toothpaste and oral hygiene formulations, adhesive integration of hydroxyapatite into enamel microdefects. Elhennawy teaches that MIH enamel is hypomineralized, porous, reduced in calcium/phosphate content, mechanically weakened, and structurally defective. Elhennawy therefore establishes that MIH is a known enamel mineral-deficiency pathology. Thus, all pending claim are prima facie obvious over Enax, Rudin and Elhennawy.
Conclusion
No claims are allowed.
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 (87 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 REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights