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 Objections
Claims 12, 21 and 22 are objected to because of the following informalities:
Examiner suggests amending claim 12 line 3 to “in addition
Examiner suggests amending claim 21 line 9 to “[[the]] mandibular teeth” and line 13 to “a source”.
Examiner suggests amending claim 23 line 9 to “[[the]] mandibular teeth” and line 13 to “a source”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The claim limitations that use the word “means” which will be interpreted under 35 U.S.C. 112(f) are:
“means” in claim 21 line 7, which uses “means”, is modified by functional language “to retain”, and is not modified by sufficient structure.
“means” in claim 21 line 11, which uses “means”, is modified by functional language “to facilitate”, and is not modified by sufficient structure, will be interpreted as referring to internal or external channels (Specification p. 10 lines 13-15).
“means” in claim 21 line 13, which uses “means”, is modified by functional language “to connect”, and is not modified by sufficient structure, will be interpreted as referring to a snap fit, a threaded fit, or a clamp fit mechanism such as a worm clamp or a spring clamp, wherein the snap fit may be of different configurations and shapes such as cylindrical, taper, spherical or other geometries as in Specification p. 10 lines 1-8 and p. 15 lines 8-13.
“means” in claim 21 line 15, which uses “means”, is modified by functional language “to pump”, and is not modified by sufficient structure, will be interpreted as referring to a manual pumping mechanism or a miniaturized electric pump as in Specification p. 10 lines 5-7.
“means” in claim 21 line 17, which uses “means”, is modified by functional language “for enabling”, and is not modified by sufficient structure, will be interpreted as referring to deflectors, valves, or combinations of the same (Specification p. 11 lines 21-p. 12 line 2).
“means” in claim 23 line 7, which uses “means”, is modified by functional language “to retain”, and is not modified by sufficient structure.
“means” in claim 23 line 11, which uses “means”, is modified by functional language “to facilitate”, and is not modified by sufficient structure, will be interpreted as referring to internal or external channels (Specification p. 10 lines 13-15).
“means” in claim 23 line 13, which uses “means”, is modified by functional language “to connect”, and is not modified by sufficient structure, will be interpreted as referring to a snap fit, a threaded fit, or a clamp fit mechanism such as a worm clamp or a spring clamp, wherein the snap fit may be of different configurations and shapes such as cylindrical, taper, spherical or other geometries as in Specification p. 10 lines 1-8 and p. 15 lines 8-13.
“means” in claim 23 line 15, which uses “means”, is modified by functional language “to pump”, and is not modified by sufficient structure, will be interpreted as referring to a manual pumping mechanism or a miniaturized electric pump as in Specification p. 10 lines 5-7.
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 22 is 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 22 recites the limitation "The system of claim 1, wherein said controlled distribution" in line 1. There is insufficient antecedent basis for this limitation in the claim as claim 1 does not recite the limitation “a controlled distribution”. In light of p. 11 section “8. Newly added Claims” of Applicant’s remarks, Examiner will interpret claim 22 as being dependent on claim 21 and suggests amending to clarify.
Claim limitation “means” in claim 1 line 5, “means” in claim 21 line 7, and “means” in claim 23 line 7, invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
For claim 1 line 7, the Specification does not describe what structures are encompassed by a means to hold and retain bite registration material or impression material. For purposes of examination, Examiner will interpret claim 1 line 7 as referring to a surface of the substrate (Fig. 1).
For claim 21 line 7, the Specification does not describe what structures are encompassed by a means to retain bite registration material or impression material. For purposes of examination, Examiner will interpret claim 21 line 7 as referring to a surface of the substrate (Fig. 1).
For claim 23 line 7, the Specification does not describe what structures are encompassed by a means to retain bite registration material or impression material. For purposes of examination, Examiner will interpret claim 23 line 7 as referring to a surface of the substrate (Fig. 1).
Therefore, the claims are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 2-12 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for their dependence on one or more rejected base and/or intervening claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 7, 10-12 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bushnell (U.S. Patent No. 5,370,533 A) in view of Choi (KR 101391038 B1, see translated PDF).
With regard to the statement of intended use and other functional statements (e.g. “for obtaining inside a person’s oral cavity a bite registration or impression… as in claim 1 lines 1-2), they do not impose any structural limitations on the claims distinguishable over the prior art which is capable of being used as claimed if one so desires to do so. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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In regard to claim 1, Bushnell discloses a system for obtaining inside a person’s oral cavity a bite registration or impression consisting of full teeth impression or full gum impression (col. 2 lines 58-62) comprising of
an impression material (M1 in Fig. 3);
a substrate (2 in Fig. 1);
a means to hold and retain said impression material on at least one or more sides or surfaces of the substrate capable of being inserted into the oral cavity (holding means in annotated Fig. 1) and held between mandibular teeth and maxillary teeth or mandibular gums and maxillary gums (col. 2 lines 58-62);
a means to facilitate flow of said impression material through the substrate (flow means in annotated Fig. 1, col. 2 lines 66-68); and
an integrated means to pump the impression material around the gums or teeth or both forming their impression (Fig. 9, col. 3 line 66- col. 4 line 22).
Bushnell does not disclose a means to connect an integrated source of said impression material to the substrate.
Choi teaches a system for obtaining bite registration (Abstract) comprising a means to hold impression material on at least one side or surface of a substrate (101 in Fig. 1) and a means to connect an integrated source of impression material (210 and 220 in Fig. 1, para. 0030) to the substrate (230, 300, 333 in Figs. 2 and 3, para. 0060, threaded fit).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Bushnell by adding the means to connect an integrated source of impression material to the substrate as taught by Choi in order to allow the connection between the impression material source and the substrate to withstand the pressure applied around where the impression material is pumped in (Choi para. 0060).
In regard to claim 7, Bushnell in view of Choi discloses the invention of claim 1. Bushnell further discloses wherein the substrate (2 in Fig. 1) has at least one internal channel (10 in Fig. 1) for conveyance of the impression material (col. 2 lines 66- col. 3 line 4) and at least one opening for the impression material (5A in Fig. 1) to eject from the opening (col. 2 lines 66- col. 3 line 4).
In regard to claim 10, Bushnell in view of Choi discloses the invention of claim 1. Bushnell does not disclose wherein impression material used with the system is a semi-solid or a liquid that may solidify after some time or a mixture of multiple liquids or a mixture of liquid and solid substances that solidify after some time.
Choi teaches wherein the impression material used with the system is a mixture of multiple liquids that solidify after some time (paras. 0043-0044).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impression material of Bushnell by specifying the impression material is a mixture of multiple liquids that solidify after some time as taught by Choi in order to allow for accurate impression taking (Choi p. 3 lines 144-147).
In regard to claim 11, Bushnell in view of Choi discloses the invention of claim 1. Bushnell does not disclose wherein the means to connect the source of the impression material to the substrate comprises a mixer to mix a plurality of constituents of the impression material.
Choi further teaches wherein the means (230, 300, 333 in Figs. 2 and 3, para. 0060) to connect the source of the impression material (210 and 220 in Fig. 1) to the substrate comprises a mixer (230 in Fig. 1) to mix a plurality of constituents of the impression material (para. 0045).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the means to connect the source of the impression material of Bushnell in view of Choi by specifying the means to connect the source comprises a mixer as taught by Choi in order to allow for uniform mixing of the impression material (Choi paras. 0044-0045).
In regard to claim 12, Bushnell in view of Choi discloses the invention of claim 1. Bushnell does not disclose wherein the means to connect the source of impression material to the substrate comprises of a snap fit or a threaded fit or a clamp fit, and in addition optionally said means may be either permanently integrated with the substrate or be detachably integrated with the substrate.
Choi further teaches wherein the means to connect the source of impression material (230, 300, 333 in Figs. 2 and 3, para. 0060) to the substrate comprises of a threaded fit (para. 0060), and in addition said means are detachably integrated with the substrate (Fig. 3, para. 0060, screw threads).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the means to connect the source of the impression material of Bushnell in view of Choi by specifying the means to connect the source comprises a threaded fit wherein the means are detachably integrated with the substrate as taught by Choi in order to allow the connection between the impression material source and the substrate to withstand the pressure applied around where the impression material is pumped in (Choi para. 0060).
In regard to claim 21, Bushnell discloses a system for obtaining inside a person's oral cavity a bite registration or impression consisting of full teeth impression or full gum impression (col. 2 lines 58-62) comprising of
an impression material (M1 in Fig. 3);
a substrate (2 in Fig. 1);
a means to retain said impression material on at least one or more sides or surfaces of the substrate capable of being inserted into the oral cavity (holding means in annotated Fig. 1) and held between the mandibular teeth and maxillary teeth or mandibular gums and maxillary gums (col. 2 lines 58-62);
a means to facilitate flow of said impression material through the substrate (flow means in annotated Fig. 1, col. 2 lines 66-68); and
a means to pump the impression material around the gums or teeth or both forming their impression (Fig. 9, col. 3 line 66- col. 4 line 22); and
a means (57, 58, 59 in Fig. 9, col. 4 lines 15-22) for enabling controlled distribution of the impression material (col. 4 lines 15-22).
Bushnell does not disclose a means to connect source of said bite registration material or said impression material to the substrate.
Choi teaches a system for obtaining bite registration (Abstract) comprising a means to retain impression material on at least one side or surface of a substrate (101 in Fig. 1) and a means to connect a source of impression material (210 and 220 in Fig. 1, para. 0030) to the substrate (230, 300, 333 in Figs. 2 and 3, para. 0060, threaded fit).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Bushnell by adding the means to connect a source of impression material to the substrate as taught by Choi in order to allow the connection between the impression material source and the substrate to withstand the pressure applied around where the impression material is pumped in (Choi para. 0060).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Bushnell in view of Choi and Spencer et al (GB 2473951 A, hereinafter “Spencer”).
In regard to claim 2, Bushnell in view of Choi discloses the invention of claim 1. Bushnell does not disclose wherein the substrate is made of plastic material such as bio-compatible Polyamides, Polyolefins, Polyesters, Fluoropolymers, Elastomers, Thermoplastics, Poly-p-xylylene, Polystyrenes, Biopolymers, or several other combinations or reinforced hybrid materials, and in addition optionally provided in several different colors.
Spencer teaches a system for obtaining an impression (Abstract) wherein the substrate is made of plastic material such as elastomers or thermoplastics (paras. 0041 and 0042, thermoplastic polyurethane elastomer).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental tray systems. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate of Bushnell in view of Choi by specifying the substrate is fabricated of an elastomer as taught by Spencer in order to allow for true alignment with the bite registration of the wearer (Spencer para. 0026).
In regard to claims 3 and 4, Bushnell in view of Choi discloses the invention of claim 1. Bushnell further discloses wherein the substrate (2 in Fig. 1) is substantially flat (Figs. 1 and 3) and is substantially horse shoe shaped (Fig. 1).
Bushnell does not disclose wherein the substrate has notches at both sides, becomes flexible when heated, and is capable of being inserted in the oral cavity of a person, and is capable of being bitten by the person for a required duration to enable appropriate registration of a bite curve, then is capable of being removed from the oral cavity and optionally further cooled for a required duration if necessary to enable the substrate to attain relatively higher rigidity for recording of said bite curve registration, and in addition optionally the substrate changes color when transforming from a flexible state to a relatively less flexible state,
wherein said registration of the bite curve is Curve of Wilson, or Curve of Spee, or Curve of Monson, or other Curves of interest, or a plurality of such curve registrations.
Choi teaches wherein the substrate (100 in Fig. 1) has notches at both sides (102 in Fig. 1, on left and right sides of substrate).
Spencer teaches wherein the substrate becomes flexible when heated (para. 0053), and is capable of being inserted in the oral cavity of a person (para. 0053), and is capable of being bitten by the person for a required duration to enable appropriate registration of a bite curve (para. 0053), then then is capable of being removed from the oral cavity (para. 0053),
wherein said registration of the bite curve is Curve of Wilson, or Curve of Spee, (para. 0053).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of dental tray systems.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate of Bushnell in view of Choi by adding notches on both sides as taught by Choi in order to allow for more effectively prevent the impression material from being separated or detached from the substrate during the process of separating the substrate from the tooth when taking an impression (Choi para. 0036).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate of Bushnell in view of Choi by specifying the substrate becomes flexible when heated, and is capable of being inserted in the oral cavity, being bitten to enable registration of a bite curve and then being removed from the oral cavity, wherein said registration of the bite curve is Curve of Wilson, or Curve of Spee as taught by Spencer in order to allow for a custom fit with the occlusal curvature of the user (Spencer para. 0053).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bushnell in view of Choi and Coscina (U.S. Patent No. 3,878,610 A) and Lee (U.S. 4,543,062 A).
In regard to claim 5, Bushnell in view of Choi discloses the invention of claim 1. Bushnell does not disclose wherein the substrate provided is one of a plurality of substrates which are a set of different widths and lengths suitable for a size of the person’s mandibular or maxillary arch and substrate thickness ranging from 0.5 millimeters to 10 millimeters suitable for verifying Vertical Dimension of Occlusion (VDO) of the person and in addition optionally verifying freeway space, and in addition optionally therapeutic oral position or a combination of these suitable for a specific oral appliance being prescribed, designed or manufactured.
Coscina teaches an apparatus wherein the substrate provided is one of a plurality of substrates which are a set of different widths and lengths suitable for a size of the person’s mandibular or maxillary arch (18, 10, 20, 22 in Fig. 3, col. 3 lines 21-32).
Lee teaches an apparatus (10 in Fig. 1) wherein substrate thickness is 0.5 millimeters (col. 4 lines 48-50) capable of verifying Vertical Dimension of Occlusion (VDO) of the person (col. 4 lines 40-50).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate of Bushnell in view of Choi by specifying the substrate provided is one of a plurality of substrates which are a set of different widths and lengths suitable for a size of the person’s mandibular or maxillary arch as taught by Coscina in order to allow for accommodation of individual patients (Coscina col. 7 lines 40-43).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate of Bushnell in view of Choi by specifying the substrate thickness is 0.5 millimeters as taught by Lee in order to allow for the material to be thin enough that teeth are almost closed together when impression are made (Lee col. 4 lines 40-46).
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bushnell in view of Choi and Coscina.
In regard to claim 6, Bushnell in view of Choi discloses the invention of claim 1. Bushnell does not disclose wherein the substrate provided is a single substrate that can be expanded according to a size of the person’s mandibular or maxillary arch and in addition optionally shortened by means of separating, clipping, or breaking one or more ends of the substrate.
Coscina teaches an apparatus wherein the substrate provided is a single substrate (10 in Fig. 1) that can be expanded according to a size of the person’s mandibular or maxillary arch and in addition optionally shortened by means of separating, clipping, or breaking one or more ends of the substrate (80 in Fig. 1, col. 7 lines 43-52).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate of Bushnell in view of Choi by specifying the substrate provided is a single substrate that can be expanded and in addition shortened by means of separating, clipping, or breaking one or more ends of the substrate as taught by Coscina in order to allow for assisting in sectionalization to accommodate individual patients (Coscina col. 7 lines 40-45).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bushnell in view of Choi and Wu et al (U.S. 7,871,269 B2, hereinafter “Wu”).
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In regard to claim 8, Bushnell in view of Choi discloses the invention of claim 1. Bushnell further discloses wherein the substrate has multiple openings (5A in Fig. 1) for the impression material (M1 in Fig. 3) to eject from the openings (col. 2 lines 63-69), and in addition at least one external channel (external channel in annotated Fig. 3) serves the purpose of retention of said material constraining it from flowing beyond the external channel (Fig. 3).
Bushnell does not disclose wherein the substrate has a plurality of internal or external channels or grooves or a combination of them for conveyance of the bite registration material or the impression material.
Wu teaches an apparatus wherein the substrate (10 in Fig. 1) has a plurality of internal channels (50, 52, 54, 56 in Fig 4) for conveyance of an impression material (col. 4 lines 52-60).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems. It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate of Bushnell in view of Choi by adding a plurality of internal channels for conveyance of the impression material as taught by Wu in order to reduce chances of interrupted flow or clogging within the tray (Wu col. 4 lines 64-67).
In regard to claim 9, Bushnell in view of Choi and Wu disclose the invention of claim 8. Bushnell further discloses wherein at least one or more valves are concurrently deployed for enabling controlled distribution of ejection of the impression material from the different openings (Fig. 9, col. 3 line 66-col. 4 line 22).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bushnell in view of Choi and Lee.
With regard to the statement of intended use and other functional statements (e.g. “useful for…” as in claim 14), they do not impose any structural limitations on the claims distinguishable over the prior art which is capable of being used as claimed if one so desires to do so. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In regard to claim 14, Bushnell in view of Choi discloses the invention of claim 1. Bushnell does not disclose wherein a bite registration obtained is directed towards bite or occlusion classification, or jaw classification, or both bite and jaw classification useful for prescribing or designing or manufacturing of a denture set such as Removable Partial Dentures or Removable Full Dentures, or useful for manufacture of oral appliances worn over the teeth such as aligners, anti-snoring devices, mandibular advancement devices, or mouth guards or a plurality of appliances.
Lee teaches wherein a bite registration obtained is directed towards bite or occlusion classification (Abstract) useful for prescribing or designing or manufacturing of a denture set such as Removable Partial Dentures or Removable Full Dentures (col. 1 lines 54-58).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Bushnell in view of Choi by specifying a bite registration obtained is directed towards bite or occlusion classification useful for prescribing or designing or manufacturing of a denture set as taught by Lee in order to allow for facilitation of the testing of dental prosthesis (Lee col. 1 lines 24-58).
Claims 22 is rejected under 35 U.S.C. 103 as being unpatentable over Bushnell in view of Choi and Bosisio et al (WO 2017/048918 A1).
In regard to claim 22, Bushnell in view of Choi discloses the invention of claim 21. Bushnell does not disclose wherein said controlled distribution of the bite registration material or the impression material is provided by feedback control using at least one sensor.
Bosisio teaches a similar apparatus (Figs. 1-20) comprising a means for enabling controlled distribution of the bite registration material or the impression material (paras. 0074-0075, controller, sensor and valves) wherein said controlled distribution of the impression material is provided by feedback control using at least one sensor (paras. 0074-0075).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the means for enabling controlled distribution of Bushnell in view of Choi by adding at least one sensor and controller wherein said controlled distribution of the impression material is provided by feedback control using the at least one sensor as taught by Bosisio in order to facilitate optimum precision and accuracy of the dental impression relative to its corresponding dental structure (Bosisio paras. 0073-0075).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Bushnell in view of Zhang et al (CN 209864113 U, see translated PDF, hereinafter “Zhang”) and Choi.
In regard to claim 23, Bushnell discloses a system for obtaining inside a person's oral cavity a bite registration or impression consisting of full teeth impression or full gum impression (col. 2 lines 58-62) comprising of
an impression material (M1 in Fig. 3);
a substrate (2 in Fig. 1);
a means to retain said bite registration material or said impression material on at least one or more sides or surfaces of the substrate capable of being inserted into the oral cavity (holding means in annotated Fig. 1) and held between the mandibular teeth and maxillary teeth or mandibular gums and maxillary gums (col. 2 lines 58-62);
a means to facilitate flow of said bite registration material or said impression material through the substrate (flow means in annotated Fig. 1, col. 2 lines 66-68); and
a means to pump the impression material around the gums or teeth or both forming their impression (Fig. 9, col. 3 line 66- col. 4 line 22).
Bushnell does not disclose that the substrate is made by an additive manufacturing process; and a means to connect a source of said bite registration material or said impression material to the substrate.
Zhang teaches a substrate made by an additive manufacturing process (paras. 0009 and 0016, 3D printing).
Choi teaches a system for obtaining bite registration (Abstract) comprising a means to retain impression material on at least one side or surface of a substrate (101 in Fig. 1) and a means to connect a source of impression material (210 and 220 in Fig. 1, para. 0030) to the substrate (230, 300, 333 in Figs. 2 and 3, para. 0060, threaded fit).
The references and the claimed invention are considered to be analogous to the claimed invention because they are in the same field of bite impression systems.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Bushnell by specifying the substrate is made by an additive manufacturing process as taught by Zhang in order to allow for the substrate to be suitably sized and integrally formed (Zhang para. 0019).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Bushnell in view of Zhang by adding the means to connect a source of impression material to the substrate as taught by Choi in order to allow the connection between the impression material source and the substrate to withstand the pressure applied around where the impression material is pumped in (Choi para. 0060).
Response to Arguments
Applicant's arguments filed 01 September 2025 have been fully considered but they are not persuasive.
Applicant argues that in claim 6 the term “expand” refers to the term “stretchable” and that “addition” of material during the 3D printing process would also expand the size of a bite fork.
Examiner notes that Applicant’s arguments are narrower than the claim limitations as claim 6 does not recite the limitations “stretchable” or recite 3D printing or addition. Examiner notes that the Merriam-Webster definition of “expand” is “to open up” (Merriam-Webster, p. 1, definition 1). In the above rejection, Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bushnell in view of Choi and Coscina. Coscina teaches an apparatus wherein the substrate provided is a single substrate (10 in Fig. 1) that can be expanded according to a size of the person’s mandibular or maxillary arch, as the tray of Coscina can be cut to open up the tray side walls to accommodate specific patients (col. 7 lines 65-col. 8 line 3). Examiner notes that one of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to have modified the substrate of Bushnell in view of Choi by the teachings of Coscina in order to allow for assisting in sectionalization to accommodate individual patients (Coscina col. 7 lines 40-45).
Applicant argues that the pumping unit and conduit of Bushnell is bulky and inconvenient to handle, and that Applicant’s invention addresses this long felt challenge and desire for improvement, by providing a lightweight integrated unit. Applicant argues that claim 1 has been amended to emphasize an integrated configuration. Applicant argues that the multiple hoses of Choi are a considerable inconvenience causing irritation to the patient undergoing the bite registration or other impression material deploying processes, and that the currently disclosed invention overcomes several of these shortcomings in the cited prior art. Applicant argues that in view of amended Claim 1 being patentable, the dependent claims 2-12, and 14 may now be allowed by reason of their dependence on amended claim 1, and in addition by reason of the further limitations that they provide. Applicant argues that a person of ordinary skill in the art would not have been reasonably motivated to combine or modify the cited prior art in such a way as to arrive at the claimed invention.
Examiner notes that Applicant’s arguments are narrower than the claims. Examiner notes that amended claim 1 does not recite limitations regarding the weight, bulk, or number of hoses of the system. Examiner notes that in the above rejection, Bushnell discloses an integrated means to pump the impression material around the gums or teeth or both forming their impression (Fig. 9, col. 3 line 66- col. 4 line 22) as the pressurized system, dispersal means 7 and tray 2 of Fig. 9 are integrated through conduit 55.
Examiner notes that in the above rejection Choi teaches a means to connect an integrated source of impression material (210 and 220 in Fig. 1, para. 0030) to the substrate (230, 300, 333 in Figs. 2 and 3, para. 0060, threaded fit). Examiner notes that in the above rejection, the impression material mixing unit 200 is integrated with the substrate through the communication unit 300 (Figs. 1 and 3). One of ordinary skill in the art would have been motivated to have modified the system of Bushnell by the teachings of Choi in order to allow the connection between the impression material source and the substrate to withstand the pressure applied around where the impression material is pumped in (Choi para. 0060).
Applicant is directed to the rejections in view of the amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/COURTNEY N HUYNH/Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772