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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 08/31/2022. It is noted, however, that applicant has not filed a certified copy of the Japanese application as required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “poorly water-soluble” in claim 1 is a relative term which renders the claim indefinite. The term “poorly water soluble” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 1 is indefinite with regard to the term “10% aqueous solution of the alginate.”
Claim 2 is indefinite with regard to the term “1% aqueous solution of the alginate.”
These terms are indefinite because it is unclear on what basis the claimed percentages are calculated, e.g. mass%, volume%, etc. Clarification is required. The claims have been interpreted wherein the viscosity is of a 10% and 1% by mass aqueous solution of the alginate.
Regarding dependent claims 3-4, these claims do not remedy the deficiencies of parent claim 1 noted above, and are rejected for the same rationale.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Niizeki et al, WO 2023/053790A1 in view of Seko et al, JP 2007-105018A (Seko).
The Examiner has provided the US equivalent of WO 2023/053790A1, US 2024/0315931 A1 (Niizeki). The Examiner has provided a machine translation of Seko. The citation of the prior art in this rejection refers to the US equivalent and the machine translation.
Regarding claim 1 and 3, Niizeki teaches a dental impression material comprising a base paste and a curing paste (Niizeki; [0001] and [0044]).
The base paste comprises an alginate, water and a carboxylate (i.e., a base material paste that includes an alginate and water as claimed) (Niizeki; and [0012]). The viscosity of a 1% by mass aqueous solution of the alginate at 20oC is preferably 0.005Pa.s or higher and 0.5Pa.s or lower (i.e., 5 to 500 mPa.s) (Niizeki; [0015]). When within this viscosity range, a mixed product of the base paste and a curing-material paste has a high fluidity, and the base paste, when used in combination with an alginate impression material, can improve accuracy of impressions (Niizeki; [0017]).
Alginates may be used alone or in combination or two or more (Niizeki; [0014]).
The base paste has a lower viscosity than that of existing paste alginate impression materials. Reduction of the viscosity is inhibited while maintaining a low viscosity, and thus can be used in a combined impression method (i.e., claim 3 wherein the dental impression material is used for a combined impression) (Niizeki; [0031], [0041] and [0085]).
The curing-material paste contains a gelation reactant and a poorly water-soluble liquid compound (i.e., a curing material paste that includes a gelling reagent and a poorly water-soluble compound as claimed) (Niizeki; [0051]).
Niizeki does not explicitly teach wherein a viscosity of a 10% aqueous solution of the alginate at 20oC is 5 mPa.s or more and 90 mPa.s or less (claim 1), or wherein a viscosity of a 1% aqueous solution of the alginate at 20oC is 2 mPa.s or less (claim 2).
With respect to the difference, Seko teaches a thickener composition obtained by adding a highly viscous thickener to an aqueous solution prepared by dissolving low viscous alginate in water (Seko; Abstract). By adding a high-viscosity paste to an aqueous solution comprising a low-viscosity alginate dissolved in water, the viscosity of the paste is kept low and a liquid paste containing the high viscosity paste at a high concentration can be obtained. The resulting paste quickly disperses and develops viscosity (Seko; page 3, lines 27-32).
The “low viscosity alginate” can be adjusted to have a wide range of viscosities by adjusting the molecular weight and degree of polymerization. The low-viscosity alginate preferably has a viscosity of a 10% aqueous solution of 100mPa.s or less from the viewpoint of suppressing the viscosity of the high-viscosity polysaccharide, and improving dispersibility. 50mPa.s or less is more preferred (Seko; page 4, lines 29-44).
Alginates having a viscosity of a 10% aqueous solution of 100mPa.s or less, preferably 50mPa.s or less, overlaps in scope with the claimed alginate having a viscosity of 5 to 90mPa.s as a 10% aqueous solution at 20oC.
As set forth in MPEP 2144.05, in the case where the claimed range “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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The high viscosity paste may comprise alginates (Seko; page 4, lines 51-55). “High-viscosity” means that the viscosity is 600 mPa.s or more (Seko; page 4, lines 57-60).
Seko is analogous art as it teaches the combination of a low-viscosity alginate with a high-viscosity alginate.
Examiner note: The low-viscosity “First Alginate” as claimed is used in combination with a higher-viscosity “Second Alginate” in the base material, as exemplified in the instant specification ([0093-0096] and Examples 1-3 on pages 23-24).
In light of the motivation provided by Seko to use an aqueous solution of a low-viscosity alginate in combination with a high-viscosity alginate paste, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an alginate having a viscosity of 10% aqueous solution of 100mPa.s or less, preferably 50mPa.s or less, in combination with a higher viscosity alginate, in the aqueous dental impression base pastes of Niizeki in order to obtain maintain a lower viscosity of the base paste while improving dispersibility, and thereby arrive at the claimed invention. Further, because Niizeki teaches that a combination of alginates may be used, and also teaches the importance of maintaining low viscosity and fluidity of the base paste in order to obtain improved accuracy of impressions when used in combination with alginate impression materials, those skilled in the art would have had a reasonable expectation of success when using such a combination.
Regarding claim 2, Niizeki in view of Seko are relied upon as teaching the limitations of claim 1 as discussed above, wherein the base paste comprises a low-viscosity alginate having a viscosity of a 10% aqueous solution of 100mPa.s or less, preferably 50mPa.s or less.
Given that the alginates of Seko are substantially identical to the alginates as claimed in that they have a viscosity of a 10% aqueous solution of 90mPa.s or less, preferably 50mPa.s or less , it is clear that the alginates of Seko would inherently include those having a viscosity of a 1% aqueous solution at 20oC of 2 mPa.s or less.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01 (I).
Regarding claim 4, Niizeki in view of Seko are relied upon as teaching the limitations of claim 1 as discussed above. Niizeki teaches that the dental alginate impression material can be used in a combined impression method, wherein the dental alginate impression material is used in combination with any other alginate impression material (i.e., a combined impression material comprising an alginate impression material different from the dental impression material) (Niizeki; [0086-0088]).
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Matsushige et al, JP 2014-172891A (Matsushige) in view of Seko et al, JP 2007-105018A (Seko).
Matsushige was cited in the IDS filed 04/23/2024. The Examiner has provided machine translations of Matsushige and Seko. The citation of the prior art in this rejection refers to the machine translations.
Regarding claims 1-4, Matsushige teaches a pretreatment material for obtaining impressions with a dental alginate impression material, which enables precise impressions without the need for adjusting the hardening time of each impression material used in a combined impression (i.e., used for a combined impression of claim 3) (Matsushige; Overview and [0009]).
The pretreatment material comprises an alginate, a surfactant and water, having a viscosity in a specific range (Matsushige; [0010]). The components are mixed until a uniform paste is formed (i.e., a base material paste that includes an alginate and water) (Matsushige; [0046]).
The pretreatment material has a viscosity of 5 to 80 Pa.s at 23oC (Matsushige; [0011]). Since the pretreatment material does not cure after application, it becomes possible for the pretreatment material to flow, thus improving impression accuracy (Matsushige; [0019] and [0031]). If the viscosity is too high, the fluidity is insufficient (Matsushige; [0031]).
For adjustment of the viscosity within the appropriate range, the amount of alginate can be adjusted (Matsushige; [0027] and [0030]). The molecular weight of the alginate is not particularly limited, but from the viewpoint of gel strength and operability, is such that a 1% by mass of alginate is within the range of 30 mPa.s to 1000 mPa.s, selected as appropriate (Matsushige; [0032]).
As the alginate impression material that can be used in combination with the pretreatment material for taking an impression, a known alginate material impression material that is commercially available can be used without limitation (i.e., a combined impression material comprising an alginate impression material different from the dental impression material of claim 4) (Matsushige; [0051]). A paste-type impression material includes a curing material paste in which a gelling reaction material, a gelling regulator, a filler and an inorganic compound are formed into a paste using a hydrophobic solvent (i.e., a curing material paste comprising a gelling reagent and a poorly water-soluble liquid compound) (Matsushige; [0052]).
Matsushige does not explicitly teach wherein a viscosity of a 10% aqueous solution of the alginate at 20oC is 5 mPa.s or more and 90 mPa.s or less (claim 1), or wherein a viscosity of a 1% aqueous solution of the alginate at 20oC is 2 mPa.s or less (claim 2).
With respect to the difference, Seko teaches a thickener composition obtained by adding a highly viscous thickener to an aqueous solution prepared by dissolving low viscous alginate in water (Seko; Abstract). By adding a high-viscosity paste to an aqueous solution comprising a low-viscosity alginate dissolved in water, the viscosity of the paste is kept low and a liquid paste containing the high viscosity paste at a high concentration can be obtained. The resulting paste quickly disperses and develops viscosity (Seko; page 3, lines 27-32).
The “low viscosity alginate” can be adjusted to have a wide range of viscosities by adjusting the molecular weight and degree of polymerization. The low-viscosity alginate preferably has a viscosity of a 10% aqueous solution of 100mPa.s or less from the viewpoint of suppressing the viscosity of the high-viscosity polysaccharide, and improving dispersibility. 50mPa.s or less is more preferred (Seko; page 4, lines 29-44).
Alginates having a viscosity of a 10% aqueous solution of 100mPa.s or less, preferably 50mPa.s or less, overlaps in scope with the claimed alginate having a viscosity of 5 to 90mPa.s as a 10% aqueous solution at 20oC.
As set forth in MPEP 2144.05, in the case where the claimed range “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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The high viscosity paste may comprise alginates (Seko; page 4, lines 51-55). “High-viscosity” means that the viscosity is 600 mPa.s or more (Seko; page 4, lines 57-60).
Seko is analogous art as it teaches the combination of a low-viscosity alginate with a high-viscosity alginate.
Examiner note: The low-viscosity “First Alginate” as claimed is used in combination with a higher-viscosity “Second Alginate” in the base material, as exemplified in the instant specification ([0093-0096] and Examples 1-3 on pages 23-24).
In light of the motivation provided by Seko to use an aqueous solution of a low-viscosity alginate in combination with a high-viscosity alginate paste, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an alginate having a viscosity of 10% aqueous solution of 100mPa.s or less, preferably 50mPa.s or less, in combination with a higher viscosity alginate, in the dental impression base pastes of Matsushige in order to adjust the viscosity of the pretreatment paste while improving dispersibility, and thereby arrive at the claimed invention. Further, because Matsushige teaches that a combination of alginates may be used, and also teaches the importance of maintaining flowability of the pretreatment paste in order to obtain improved accuracy of impressions when used in combination with alginate impression materials, those skilled in the art would have had a reasonable expectation of success when using such a combination.
Regarding claim 2, Matsushige in view of Seko are relied upon as teaching the limitations of claim 1 as discussed above, wherein the pretreatment paste comprises a low-viscosity alginate having a viscosity of a 10% aqueous solution of 100mPa.s or less, preferably 50mPa.s or less.
Given that the alginates of Seko are substantially identical to the alginates as claimed in that they have a viscosity of a 10% aqueous solution of 90mPa.s or less, preferably 50mPa.s or less , it is clear that the alginates of Seko would inherently include those having a viscosity of a 1% aqueous solution at 20oC of 2 mPa.s or less.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01 (I).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/694,157 in view of Seko et al, JP 2007-105018A (Seko).
Regarding claims 1-2, copending claim 3 claims a dental impression material comprising a base paste and a curing paste. The curing paste contains a gelation reactant and a poorly water soluble liquid compound (copending claim 3). The base paste comprises an alginate, water and a carboxylate (copending claim 1). The carboxylate is not excluded by the open claim language “comprising” of instant claim 1.
Copending claim 3 does not claim wherein a viscosity of a 10% aqueous solution of the alginate at 20oC is 5 mPa.s or more and 90 mPa.s or less (claim 1), or wherein a viscosity of a 1% aqueous solution of the alginate at 20oC is 2 mPa.s or less (claim 2).
With respect to the difference, Seko teaches a thickener composition obtained by adding a highly viscous thickener to an aqueous solution prepared by dissolving low viscous alginate in water (Seko; Abstract). By adding a high-viscosity paste to an aqueous solution comprising a low-viscosity alginate dissolved in water, the viscosity of the paste is kept low and a liquid paste containing the high viscosity paste at a high concentration can be obtained. The resulting paste quickly disperses and develops viscosity (Seko; page 3, lines 27-32).
The “low viscosity alginate” can be adjusted to have a wide range of viscosities by adjusting the molecular weight and degree of polymerization. The low-viscosity alginate preferably has a viscosity of a 10% aqueous solution of 100mPa.s or less from the viewpoint of suppressing the viscosity of the high-viscosity polysaccharide, and improving dispersibility. 50mPa.s or less is more preferred (Seko; page 4, lines 29-44).
Alginates having a viscosity of a 10% aqueous solution of 100mPa.s or less, preferably 50mPa.s or less, overlaps in scope with the claimed alginate having a viscosity of 5 to 90mPa.s as a 10% aqueous solution at 20oC.
As set forth in MPEP 2144.05, in the case where the claimed range “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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The high viscosity paste may comprise alginates (Seko; page 4, lines 51-55). “High-viscosity” means that the viscosity is 600 mPa.s or more (Seko; page 4, lines 57-60).
Seko is analogous art as it teaches the combination of a low-viscosity alginate with a high-viscosity alginate.
In light of the motivation provided by Seko to use an aqueous solution of a low-viscosity alginate in combination with a high-viscosity alginate paste, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an alginate having a viscosity of 10% aqueous solution of 100mPa.s or less, preferably 50mPa.s or less, in combination with a higher viscosity alginate, in the dental impression base pastes the copending claim 3 in order to maintain a lower viscosity of the base paste while improving dispersibility, and thereby arrive at the claimed invention.
Regarding claim 3, the recitation in the claims that the dental impression material is “used for a combined impression” is merely an intended use. Applicants’ attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the copending claim 3 in view of Seko, and is therefore capable of performing the intended use.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Larsen et al, US 9597350 B2, teaches a paste which comprises at least one low viscosity alginate having a viscosity less than about 100 mPa.s in a 1% solution, at least one high viscosity alginate having a viscosity greater than about 100 mPa.s in a 1% solution. The composition is readily soluble in water such that an aqueous composition can be prepared without substantive mixing (Abstract).
Yagi et al, US 4,810,295, teaches an impression composition characterized in that it contains a combination of a low molecular weight alginate having a viscosity of about 50 to 900cps and a high molecular weight alginate having a viscosity of about 150 to 1000 cps as a 1% aqueous solution at 25oC (Abstract and col. 1, lines 54-68).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLINE D LIOTT whose telephone number is (703)756-1836. The examiner can normally be reached M-F 8:30-5.
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/CDL/Examiner, Art Unit 1732
/CORIS FUNG/Supervisory Patent Examiner, Art Unit 1732