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 .
Claims Status
Claims 12-14, 16, 20-22, 24, 26, 27 are pending and under current examination in this application. Amendment to the Claims and Applicant Arguments/Remarks Made in an Amendment, filed 18 December 2025, are acknowledged. Claims 1-11, 15, 17-19, 23, 25, and 28-30 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 December 2025, is acknowledge and has been considered by the Examiner.
Response to Amendment
The amendment filed 18 December 2025, has been entered. The Examiner has reconsidered the application in view of the amendments and Applicant’s remarks.
The prior rejection of claims 12-14, 16, 20-22, 24, 26, and 27 under 35 U.S.C. § 103 is clarified and modified in view of the amended claims. This is a new ground of rejection because it relies on a modified rationale in view of the newly amended claim 20, specifying molar incisor hypomineralization (MIH) and a depth of at least 100 µm, and formally incorporates the general knowledge of MIH into the obviousness combination. New grounds of rejection, necessitated by amendment, under 35 USC § 112(b) and 35 U.S.C. § 103 are made for claims 12-14, 16, 20-22, 24, 26, and 27 as detailed below.
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, 20-22, 24, 26, and 27 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 that the composition is administered “in an amount able to provide deep-layer remineralization” to a specified depth. The phrase “able to provide” renders the claim indefinite because it is functional and result-oriented, without specifying any objective boundaries or measurable parameters for determining whether the limitation is met. Appropriate correction is required specifying objective boundaries or measurable parameters for the limitations.
Claim 21 further expands the scope to treating a wide array of unrelated dental conditions without specifying how the method differs when applied to each condition, thereby introducing ambiguity as to claim scope. Appropriate correction clarifying the scope of the claim.
Dependent claims 12-14, 16, 22, 24, 26, and 27 are included in this rejection because they do not cure the defect noted above.
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, 20-22, 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.
Response to Arguments
Independent claim 20 has been amended to recite a method for treating molar incisor hypomineralization (MIH), administration of a hydroxyapatite (Ca₅(PO₄)₃(OH)) composition, functional limitation requiring “deep-layer remineralization … to a depth of at least 100 µm” and dependent claims further recite fluoride-free compositions (claim 12), specific hydroxyapatite microcluster dimensions (claims 13–14), specific hydroxyapatite concentration ranges (claims 16, 26), remineralization depth of at least 200 µm (claim 24), and the presence of pharmaceutical or cosmetic excipients (claim 27). New grounds of rejection are set forth herein based on the newly emphasized functional limitations.
Enax teaches dental care compositions comprising hydroxyapatite microaggregates for remineralization of enamel and dentin, including repair of microfine defects and remineralization of carious lesions (¶[0019], [0022], [0030]). Enax further teaches that remineralization may extend beyond superficial enamel and into underlying tooth structures, including depths of 100–200 µm, as expressly referenced and incorporated by the instant specification itself (¶[0024] and [0025]). Rudin teaches dental compositions comprising ultrafine hydroxyapatite particles having dimensions that overlap and encompass the claimed microcluster length (~80 nm) and width (~30 nm), and hydroxyapatite concentrations of 0.1–50 wt.%, including preferred subranges fully corresponding to the pending instant claims.
The alleged distinctions relied upon by Applicant between the prior art and the instant claims are treatment of MIH specifically, rather than caries or general enamel defects, functional limitation of deep-layer remineralization to ≥100 µm, and alleged unpredictability of hydroxyapatite efficacy in MIH enamel.
The Applicant argues that MIH enamel differs structurally from carious enamel and that this difference would negate predictability. The Examiner disagrees. MIH is a hypomineralization disorder, characterized by reduced mineral density, increased porosity, and decreased hardness. These characteristics are precisely the conditions addressed by Enax, which targets poor tooth mineral quality, microdefects, and enamel erosion (¶[0006]-[0012]). A person of ordinary skill in the art would reasonably expect that a known remineralization agent effective in porous, mineral-deficient enamel would likewise be effective in MIH enamel, which is more porous than normal enamel. The application of a known remineralizing composition to a newly identified but structurally related pathological condition constitutes an obvious use of a known composition for its known purpose (see In re Schreiber, 128 F.3d 1473 (Fed. Cir. 1997), thus providing a motivation to combine and a reasonable expectation of success.
The limitation requiring remineralization to a depth of at least 100 µm does not confer patentability. Enax expressly teaches deep remineralization, including dentin-level repair. The instant specification acknowledges that Enax compositions are suitable to achieve 100–200 µm remineralization. The claimed depth is therefore an inherent result of practicing the prior art. Under MPEP § 2112, a limitation is inherent when it is necessarily present, even if not explicitly recognized.
While Enax does not explicitly recite numerical particle dimensions, it teaches aggregated hydroxyapatite particles formed by intermolecular forces. Rudin expressly teaches hydroxyapatite particles having dimensions that fully encompass the claimed length and width ranges. Selecting a particular particle size within a known, disclosed range to optimize performance is considered routine optimization, absent evidence of criticality (see In re Aller, 220 F.2d 454 (CCPA 1955); MPEP § 2144.05).
Rudin explicitly teaches hydroxyapatite concentrations of 0.1–50 wt.%, including the preferred subranges recited in the pending claims. Optimization of concentration for efficacy is well within the ordinary skill in the art. Enax also expressly discloses fluoride-free dental compositions and inclusion of pharmaceutical and cosmetic excipients. Accordingly, these limitations are fully taught by the primary reference.
The Applicant relies on Amaechi (2022) and Paszynska (2023), both published after the effective filing date, to allege unexpected superiority of hydroxyapatite in MIH enamel. These references are not probative of nonobviousness because post-filing evidence may only be used to corroborate, not establish, unexpected results unless a nexus is clearly demonstrated. In addition, the cited studies do not demonstrate that the claimed depth of remineralization (≥100 µm) is unexpected relative to Enax. The claims are not limited to any comparative efficacy over fluoride, nor to any specific clinical protocol disclosed in the cited studies and the evidence does not establish that the alleged results are commensurate in scope with the claims (see MPEP § 716.02(d)). Accordingly, the Examiner finds that no persuasive evidence of unexpected results sufficient to overcome the prima facie case has been provided.
The Applicant’s arguments have been fully considered but are not persuasive. The amended claims merely apply a known remineralizing composition to a known hypomineralized enamel condition, using known particle sizes, known concentration ranges, and known functional outcomes. The combination of Enax and Rudin in further view of Elhennawy would have suggested the claimed subject matter to a person of ordinary skill in the art with a reasonable expectation of success, and the results achieved are predictable. Thus, the rejection of claims 12-14, 16, 20-22, 24, 26, and 27 under 35 U.S.C. § 103 over Enax in view of Rudin have been revised on the basis of the amended claims and are now rejected under 35 U.S.C. § 103 over Enax in view of Rudin and in further view of Elhennawy.
Conclusion
No claims are allowed.
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