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 .
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 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.
DETAILED ACTION
Status of claims
The amendment filed on 07/13/2026 is acknowledged. Claims 1-50, 53, and 62-70 have been canceled and new claims 71-76 have been added. Claims 51, 52, 54-61 and 71-76 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 07/13/2026 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the claim objection of claim 53 and 35 U.S.C. 112, second paragraph (should be 112(b)) rejection of claim 53 from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Rejections maintained
The following rejections of the claims are remained for reasons of record and the following. New claims are hereby included in the rejections and the rejections are modified based on the amendments and new claims (newly underlined).
Claim Rejections - 35 USC § 112(b)
The following is a quotation of the second paragraph 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.
Claims 51, 52, 54-61, 71-74, and 76 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The recitations of "a substrate comprising at least one resilient material configured to produce and maintain an outward force for a predetermined time period between adjacent teeth” and ”wherein said substrate dissolves or disintegrates or degrades within said predetermined time period when disposed between those adjacent teeth" in claim 51 render claim 51 indefinite. It is confusing to one of ordinary skill how a material maintains an outward force while the material is dissolving or disintegrating or degrading. Claims 52-61 are rejected as dependent claims of a rejected claim.
To expedite the prosecution "a substrate comprising at least one resilient material configured to produce and maintain an outward force for a predetermined time period between adjacent teeth” and ”wherein said substrate dissolves or disintegrates or degrades within said predetermined time period when disposed between those adjacent teeth" are given their broadest reasonable interpretations by the examiner in light of the specification in the prior art rejections.
Response to Applicants’ arguments:
Applicants argue that the amendments of claim 51 have overcome the 112(b) rejection.
However, this argument is not deemed persuasive. The recitations of "a substrate comprising at least one resilient material …… (with incorporation of the limitation from cancelled claim 53 in between) configured to produce and maintain an outward force for a predetermined time period between adjacent teeth” and ”wherein said substrate dissolves or disintegrates or degrades within said predetermined time period when disposed between those adjacent teeth" are not amended.
Claim Rejections - 35 USC § 102
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 51, 52, 54-58, and 60 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jodaikin et al. (US 2005/0175959 A1).
Jodaikin et al. meet all of the limitations of claims 51-58 and 60. Jodaikin et al. disclose a single, bi or multi-layer system (the instant claim 52) to separate teeth (the claimed orthodontic separator) (paragraph 198)
for delivery of fluoridizing agents (the instant claims 51 and 52) and other agents to interproximal (approximal) sites (the claimed between adjacent teeth the instant claim 51) (abstract)
in form of a toroidal ring (the claimed concentrical in the instant claim 52) with net or fiberfilm (fluoridizing agents would be inside the polymer or on the surface of the polymer, the claimed polymer fibers having a fluoride compound incorporated therein or that coats a surface thereof in the instant claims 51 and 52) (figure 2(a-c), figure 3(c) and paragraph 66 and paragraph 183) comprising
a matrix such as polyethylene oxide which softens and swells in situ by the hydration that is self-degradable (the claimed orthodontic separator that producing and maintaining an outward force for a predetermined time period between adjacent teeth in the instant claim 51 and the claimed substrate degrades within a predetermined time period in the instant claim 51 and 52) (paragraph 29, 46, 47, and 124);
a mineralizing and/or remineralizing agent (the instant claim 57) (paragraph 232);
an anti-microbial agent in the matrix (can be in the outer portion, i.e., layer, thus an anti-microbial coating in the instant claim 60) (paragraph 24, 59, 225, and 258); and
a plasticizer (the instant claims 55 and 56) (paragraph 272);
wherein the inner portion (layer) is released after the biodegradation of the outer portion (a layer, the claimed the plurality of layers of the substrate successively degrade in the instant claim 52, and also a coating in the instant claim 58) (paragraph 59).
Although Jodaikin et al. are silent about the method of making the system; the instant claim 54 is a product-by-process claim. The determination of patentability of a product-by-process claim is based on the product itself, not its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process. The burden is shifted to the applicant to provide evidence to demonstrate that the structure of the claimed orthodontic separator resulted from the said process is different from that of system disclosed in the prior art. See MPEP 2113.
Response to Applicants’ arguments:
Applicants argue that Jodaikin et al. do not disclose a separator comprising the claimed material in claim 1 (should be claim 51).
However, this argument is not deemed persuasive. Jodaikin et al. teach a matrix such as polyethylene oxide which is the claimed material in the instant claim 51.
Applicants argue that Jodaikin et al. do not teach the system the necessity of making certain force during a determined time.
However, this argument is not deemed persuasive. The system taught by Jodaikin et al. is for separating teeth and made of the same material as claimed. Thus, the system taught by Jodaikin et al. would necessarily have the same claimed outward force during the claimed determined time.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 51, 52, 54-61, 71-74, and 76 are rejected under 35 U.S.C. 103(a) as being unpatentable over Hansen et al. (US 2003/0157454 A1) as evidenced by Mitra, et al. (US 5,876,208) in view of Jodaikin et al. (US 2005/0175959 A1).
Hansen et al. teach an orthodontic separator exerting sufficient force on the adjacent teeth to push the teeth apart (abstract) comprising
hydrophilic materials including polyvinyl alcohol (PVOH), i.e., >0% and <100% by weight of PVOH, (the same PVOH in the instant claims 51 and 71 and thus, the claimed orthodontic separator that producing and maintaining an outward force for a predetermined time period between adjacent teeth in the instant claims 51 and 61 and the claimed substrate degrades within a predetermined time period in the instant claim 51, 52, and 61) (paragraph 24 and 26); and
adjuvants including fluoride (the instant claim 51 and 52), antimicrobial (the instant claim 57), oils (plasticizers, the instant claims 55 and 56) (paragraph 32); and
a coating (as a layer, and would degrade before the inner portion upon contacting the environment, the claimed plurality of layers successively degrade in the instant in the instant claim 52) to improve slip to ease insertion and removal of the separator between the adjacent teeth (the claimed lubricating coating in the instant claims 58 and 59) and to reduce adhesion of bacteria and proteinaceous substances as described by Mitra, et al. in US 5,876,208 (paragraph 33) which includes antimicrobial (column 15, line 21- and 25) (the instant claim 60);
wherein the orthodontic separator is in form of O-ring (the claimed concentrical in the instant claims 52 and a band in the instant claim 76) (paragraph 13 and 23 and figure 1A);
wherein the separator has a diameter of 0.175” (→ 4.45 mm, within the claimed about 3-6 mm in the instant claim 76) and a thickness of 0.045” ( → 1.143 mm, within the claimed about 0.75-2.0 mm in the instant claim 76) (example 2).
Although Hansen et al. are silent about the method of making the system; the instant claim 54 is a product-by-process claim. The determination of patentability of a product-by-process claim is based on the product itself, not its method of production. If the product in the product-by-process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process. The burden is shifted to the applicant to provide evidence to demonstrate that the structure of the claimed orthodontic separator resulted from the said process is different from that of system disclosed in the prior art. See MPEP 2113.
Hansen et al. do not specify the weight percentages of PVOH in the instant claims 72-74 (>0% and <100% vs the claimed about 50-95%, about 50-75%, and about 75-90%).
A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection.
The claimed range of PVOH is about 50-95%, about 50-75%, and about 75-90% by weight and the range of PVOH taught in the prior art is >0% and <100% by weight and therefor, includes the claimed ranges.
Hansen et al. do not specify the PVOH being in form of fiber (the instant claims 51 and 52).
This deficiency is cured by Jodaikin et al. who teaches are discussed above and applied in the same manner
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Hansen et al. and Jodaikin et al. to specify PVOH being in form of fiber in the orthodontic separator taught by Hansen et al. being in form of fiber. Hydrophilic materials in a toroidal ring shaped orthodontic separator being in fiberfilm form was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Applicants argue that the separator taught by Hansen et al. increasing its size by absorption of water which is not the same as the claimed separator which reducing its size by dissolution.
However, this argument is not deemed persuasive. A separator swelling before its dissolution is not excluded as the cause for the claimed producing and maintaining an outward force for a predetermined time period between adjacent teeth and the instant specification discloses the claimed material of the separator swelling into a predetermined shape (paraph 30) while the material of the separator taught by Hansen et al. is the same as the claimed and would have the same water absorption properties as the claimed separator.
New ground of rejections necessitated by Applicant’s amendment
The amendments necessitate the following new ground of rejections.
Claims 51, 52, 54-61, 71-75, and 76 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
The recitation of "including" in claim 51 renders the claim indefinite. "Include" is used most appropriately before an incomplete list of components according to the definition from "The American Heritage Dictionary”. It is unclear what is encompassed and excluded in the list by the limitation "including”. One of ordinary skill could not ascertain and interpret the metes and bounds of the patent protection desired as to this list. Thus, it is unclear and indefinite as to how the list follows “including”, herein is encompassed. Claims 52, 54-61, 71-75, and 76 are rejected as dependent claims of a rejected claim.
Claim 75 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 75 depends on claim 64 which is a cancelled claim. One of ordinary skill could not ascertain and interpret the metes and bounds of the patent protection desired as to this claim.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HONG YU/
Primary Examiner, Art Unit 1614
