DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-20, 37 – pending, withdrawn
Claims 21-36 - pending
Election/Restrictions
Applicant’s election without traverse of Claims 21-36 in the reply filed on May 1, 2026, is acknowledged.
Claims 21-36 have been elected without traverse.
Claims 1-20 and Claim 37 have been withdrawn.
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are:
The disclosure is objected to because the instant Application’s paragraphs [0008], [0019], and [0026] clearly show the length “about 1 to about 100 mm” is greater than diameter “about 5 to about 500 microns (µm)”. While the paragraphs [0009], [0020] and [0027] state “diameter to length ratio of between about 100000:1 and about 100:1” This is definitely an error and should be corrected to “length to diameter ratio.”
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 23 and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding Claim 23:
Claim 23 recites “a diameter to length ratio of between about 100000:1 and about 100:1.” which is mathematically and logically wrong because the numbers are structured as a large number to 1, e.g., 100000:1 or 100:1, the larger dimension (length) must come first. The instant Application’s paragraphs [0008] [0019] [0026] clearly show the length is greater than diameter. Stating “diameter to length ratio” in the Claim 23 is an error and should be amended to “length to diameter ratio”.
Regarding Claim 28:
Claim 28 recites “increases a stiffness of…at least 25% to at least 100%.” This language is indefinite because the phrase “at least 25% to at least 100% “ is open to multiple conflicting interpretations.
Specifically, it is unclear whether the claim language is intended to recite:
a). a range bounded between 25% and 100% (i.e., an increase from 25% to 100%), or
b). a threshold value of at least 100% (since “at least 25%” is subsumed by “at least 100%”).
Its unclear how the term “at least” can be determined and how much it varies from the claim numerical percentages. It cannot determine the metes and bounds of the claimed invention. Because the metes and bounds of the claim cannot be reasonably determined, Claim 28 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21, 24-28 and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “A New Bioactive Bone Cement Consisting of Bis-GMA Resin and Bioactive Glass Powder” (Kawanabe et al., Journal of Applied Biomaterials, Vol. 4, 135-141, 1993), (submitted by applicant on 10/16/2023), hereafter referred as Kawanabe.
As to Claim 21:
Kawanabe discloses a material for use in a medical device (bone cement/implant), the material comprising:
a cured resin (Bis-GMA/resin matrix) “…bisphenol-a-glycidyl methacrylate (Bis-GMA” (Kawanabe, Abstract)
a reinforcement material dispersed throughout the cured resin “a bioactive bone cement consisting of silane-treated CaO-SiO2-P2O5-Na2O glass powder as the filling particles…” (Kawanabe, Abstract)
Kawanabe teaches that the bioactive glass powder dissolves in aqueous media with presence of a silane as crosslinking agent.(Kawanabe, page 135 “Introduction”)
MPEP 2112.01 (II)” COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES” “Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The claim and the prior art teach the same material composition of a cured resin Bis-GMA/resin matrix and a bioactive glass powder (fiber), therefore their solubilities are also expected to be the same.
As to Claim 24:
Kawanabe teaches that the reinforcement material comprises “A powder mixture of reagents of the nominal composition (wt%) 46.7 CaO, 35.6 SiO2, 17.0 P2O5, and 0.7 CaF2”. (Kawanabe, page 135 “Preparation of Glass Powder”), which corresponds to the instant Application’s claim “at least one of CaO and SiO2”.
As to Claim 25:
Kawanabe teaches that the reinforcement material is “a bioactive glass powder” (Kawanabe, page 135, Introduction) and “The bioactive glass powder was sifted into…” (Kawanabe, page 135, section of “Silane Treatment of Glass Powder”), which corresponds to the instant Application’s claim of “bioglass or bioglass fiber”.
As to Claim 26:
Kawanabe teaches the medical device comprises implant, bone cement “This new cement will be a potentially bioactive and load-bearing material for a variety of dental and medical applications.” (Kawanabe, page 140 “Discussion”), which corresponds to the instant Application’s claim of “medical devices comprise…”.
As to Claim 27:
Kawanabe teaches the application orthopedic surgery. “In orthopedic surgery, a silane coupling agent is used for PMMA precoating of implant materials. We used silane-treated bioactive glass powder as a filler, and the resulting new cement had compressive strength and toughness two and four times greater than PMMA cement, respectively.” (Kawanabe, page 140 “Discussion”). This corresponds to the instant Applications claim of “medical device is configurated for use as an orthodontic appliance.”
As to Claim 28
Kawanabe further teaches “The elastic modulus of the new cement with or without silane treatment was about 5 500 MPa for 1 week after soaking, whereas that of PMMA cement was 1 900 MPa.” (Kawanabe, page 137 “Mechanical Properties”). This demonstrates an increase in elastic modulus (stiffness) of approximately 289%. Claim 28 recites that the reinforcement material “increases a stiffness… by at least 25% to at least 100% relative to a stiffness of an orthodontic appliance comprising only the cured resin.” Because stiffness is an inherent property of the composition’s elastic modulus disclosed by Kawanabe, and Kawanabe demonstrates an inherent increase well exceeding 25% and capturing the open-ended lower boundary of “at least 25%”. Kawanabe inherently anticipates the physical properties recited in Claim 28. Consequentially, Kawanabe anticipates Claim 28 under 35 U.S.C. 102. MPEP 2112(V).
As to Claims 35-36:
Kawanabe discloses a methacrylate/Bis-GMA “bisphenol-a-glycidyl methacrylate (Bis-GMA)” (Kawanabe, page 135, Abstract), which precisely corresponds to the instant Application’s claim “.. one of acrylate, methacrylate…” and “…bisphenol A-glycidyl methacrylate (bis-GMA),…”
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.
3. Claims 22-23 are rejected under 35 U.S.C 103 as being unpatentable over Kawanabe, in view of EP 3,154,444 B1 (D’Agostino et al.), hereafter referred as Dagostino.
Regarding Claim 22:
Kawanabe teaches a filled bone-contacting biomaterial “a bioactive bone cement consisting of silane-treated CaO-SiO2-P2O5-CaF2 glass powder as the filling particles and bisphenol-a-glycidyl methacrylate (Bis-GMA) diluted with triethylene-glycol dimethacrylate (TEGDMA) as the organic matrix.” (Kawanabe, Abstract), but does not explicitly disclose the specific length, diameter, or aspect ratio of the reinforcement material.
D'Agostino, however, also in the same field of endeavor (medical application, bone tissue repair, fracture treatment, and bone reinforcement), explicitly teaches incorporating reinforcing fibers into polymeric resin matrix, wherein the fibers have a length-to-diameter aspect ratio ranging from 1 to 500 (D’Agostino, [0090], lines 20-21). From the aspect ratio and the particle/fiber sizing taught in D’Agostino (1nm to 100 µm) (D’Agostino, [0090], line 20), the resulting fiber length ranges from 1nm to 50mm. “with nano- and/or microparticulate with a range of sizes from 1 nm to 100 µm, and may, optionally, have a range of aspect ratios (either aligned or misaligned), from 1-500 (length/diameter).” (D’Agostino, [0090], lines 20-21)
A PHOSITA seeking to produce fiber-filled resin compositions via additive manufacturing methods or any other processing methods would have been motivated to select and substitute fibers having D’Agostino’s aspect ratio and length parameters into Kawanabe’s matrix. Specifically, a PHOSITA would recognize fiber length, diameter, and aspect ratio as result-effective variables governing filler dispersion, composite processability, viscosity, and mechanical performance. Optimizing these under competing manufacturing and material performance constraints represents routine engineering optimization involving a finite number of predictable solutions, and giving a PHOSITA a reasonable expectation of success in arriving at the claimed length range (“about 1 to about 100mm”) without much undue experimentation.
It would have been obvious for one of ordinary skill in the art at the effective date of the invention to combine the resin matrix of Kawanabe with the reinforcing fibers having the length, diameter, or aspect ratio disclosed in D’Agostino for the reasons stated above.is
Regarding Claim 23:
(Note: as stated in the section “1. Claim 23”, the Claim 23 recites the aspect ratio as “diameter to length”. The Office interprets this ratio consistent with standard art usage as “length to diameter”. The analysis and rejection are based on this interpretation.)
As set forth above with respect to Claim 22, D’Agostino expressly teaches reinforcing fibers having “aspect ratios … 1-500 (length/diameter) (D’Agostino, [0090], lines 20-21), which directly meets or overlaps the aspect ratio claimed in the instant Application Claim 23. It would have been obvious to a PHOSITA to utilize fibers within the disclosed aspect ratio range to experiment and optimize material performance and processability in Kawanabe’s composite material.
Claims 29-32 are rejected under 35 U.S.C 103 as being unpatentable over Kawanabe, in view of WO2008149221A1 (Kitching et al.), (submitted by applicant on 12/04/2023), hereafter referred as Kitching, and further in view of US 2013/0323664 A1 (Parker), hereafter referred as Parker.
Kawanabe teaches a filled bone-contacting biomaterial comprising a bioactive glass powder filler and an organic matrix (Bis-GMA/TEGDMA). (Kawanabe, Abstract), but does not explicitly disclose the “aligner” or “expander” applications.
Kitching teaches orthodontic appliances formed of polymeric materials and a treatment system using planning tools and progress scans to recalibrate/reshape aligner geometry (Kitching, [0032], [0059], Claim 1, Claim 11)
Parker discloses orthodontic appliances comprising curable resin composite materials integrated with a palatal expander to apply lateral separation pressure to widen the palatal suture (Parker, [0035], [0036])
It would have been obvious to a PHOSITA at the time of the effective filling date of the invention to modify Kawanabe’s composite material with Kitching’s progress-scan recalibrated aligners to track and position/reposition teeth during treatment, and to integrate Parker’s palatal expander structure. Combining these known orthodontic elements yields predictable results according to their established functions to optimize tooth repositioning and expansion.
5. Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over “A New Bioactive Bone Cement Consisting of Bis-GMA Resin and Bioactive Glass Powder” (Kawanabe et al., Journal of Applied Biomaterials, Vol. 4, 135-141, 1993), (submitted by applicant on 10/16/2023), hereafter referred as Kawanabe.
Kawanabe describes that the material exhibits a flexural strength (180±10 MPa) and elastic modulus (5600±500 MPa) falling with the claimed ranges. (Kawanabe, page 136 Table 1), and “with an elastic modulus and compressive strength of 17 200 MPa and 166 MPa, respectively” (Kawanabe, page 140 “Discussion”). The fact that Kawanabe’s disclosure of flexural strength (180±10 MPa; 166 MPa) and elastic modulus (5600±500 MPa, 17,200 MPa) falls within or lies substantially in the ranges claimed by the instant Application’s Claim 33 (50-600 MPa flexural strength; 5-30 GPa elastic modulus) establishes a prima facie case of obviousness.
MPEP 2144.05(I) “OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS”. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Kawanabe does not expressly disclose the instant Application’s claimed “maximum strain” but this property is an inherent property and represents standard performance parameters for structural dental methacrylates reinforced with glass fiber. It would have been obvious for a PHOSITA optimizing Kawanabe’s bone cement for a target application to routinely characterize strain alongside the flexural and stiffness properties that Kawanabe already reports. Standard mechanical testing protocols such as ASTM or DIN-ISO tensile testing would reasonably yield results within the claimed 2.5-7.5% window through expected adjustments of bioactive glass-reinforced resins. In addition, the instant Applicant has not demonstrated critically unexpected results for the specific claimed strain window.
MPEP 2112.01 (II) “COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES” “Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)
Claims 34 is rejected under 35 U.S.C 103 as being unpatentable over “A New Bioactive Bone Cement Consisting of Bis-GMA Resin and Bioactive Glass Powder” (Kawanabe et al., Journal of Applied Biomaterials, Vol. 4, 135-141, 1993), (submitted by applicant on 10/16/2023), hereafter referred as Kawanabe, in view of US 2016/0083631 A1 (Jia), hereafter referred as Jia (listed on IDS by Applicant of 12/16/2025).
Kawanabe discloses using “a filler ratio of 70% in this study” (Kawanabe, page 140 ”Discussion”), which lies just outside of the instant Application’s claimed range of “about 30 to about 60 wt% of the reinforcement material.”
Jia, however, teaches the use of “Suitable bone growth promoting substances include but are not limited to bioglass” (Jia, [0048]) and “The first Part A, the second Part B, or both, can comprise an inorganic filler in an amount of up to about ninety-five percent by weight of each component, specifically 10 to 80 wt. %, more specifically 20 to 70 wt. % in Part A and/or Part B and or both Part A and Part B.” (Jia, [0017]), and “The kit of claim 1 wherein the first Part A, the second Part B, or both, comprises an inorganic filler in an amount of up to about ninety-five percent by weight of each component.” (Jia, Claim 6)
Kawanabe and Jia are both considered to analogous to the claimed invention because they are in the same field of curable, inorganic filler-reinforced compositions for medical applications. Jia’s disclosed filler range (10-95wt%, more specifically 20-70wt%) overlaps the claimed 30-60wt% range and Kawanabe’s disclosed 70wt% giving explicit motivation for a PHOSITA to adjust Kawanabe’s filler content into the claimed range window. It is a routine experimentation in the art that inorganic filler content is an adjustable parameter to achieve desirable processability and intended mechanical performance (for example stiffness and strength) of the intended product.
It would have been obvious for one of ordinary skill in the art at the effective date of filing to select the filler content level to be in the range taught by Jia (which overlaps the claimed filler content level) and to determine the optimum filler ratio through routine experimentation, particularly absent of a showing of criticality for the claimed filler range. In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990).
Double Patenting
Claims 21 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2, respectively, of US 12,685,616 B2 (Stampfl et al.), hereafter referred as Stampfl ‘616.
Although the Claim 21 of the instant Application is not identical to the claim 1 of Stampfl ‘616, they are not patentably distinct from each other.
Stampfl ‘616’s Claim 1 claims “A method of manufacturing a finished product for a medical device” by curing “a curable resin” with a dispersed solid material, where the solid materiel has “a second solubility” “at least 102 times greater than the first solubility at 25oC and a pH of 7.” (Stampfl ‘616, Claim 1). Note that Stampfl ‘616 defines the “solid material” being a “reinforcement material” (e.g., “solid material reinforced curable resins” (in its Abstract) and “utilizing solid reinforcements” (Stampfl ‘616, col. 1, line 28). And specifically dependent claim 2 recites “the solid material is bioglass or bioglass fiber.” (Stampfl ‘616, claim 2).
Claim 21 of the instant Application recites the product resulting from the process of Stampfl ‘616’s claim 1, comprising “a cured resin having a first solubility; and a reinforcement material dispersed throughout the cured resin and having a second solubility, wherein the second solubility is at least 102 times greater than the first solubility in water at 25 °C and a pH of 7.”
And the instant Application’s Claim 25 further limits “the reinforcement material is bioglass or bioglass fiber”, corresponding directly to Stampfl ‘616’s claim 2.
Claiming a product resulting from a previously claimed process does not impart patentable distinction where the process inherently produces the identical product. The method of Stampfl ‘616’s claim 1 inherently yields the cured resin composition recited in the instant Application Claim 21, and the method of Stampfl ‘616’s claim 2 inherently yields the composition recited in the instant Claim 25.
A PHOSITA would have found it obvious to claim the physical composition produced by the method of Stampfl ‘616, as the product is the direct and expected result of performing the steps explicitly set forth in Stampfl ‘616’s claim 1 and claim 2.
Conclusion
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