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 .
Restriction Response
Applicant’s election with traverse of Group II (claims 11-16) in the reply filed on 06/15/26. Applicant’s arguments were persuasive. Therefore, the restriction requirement is withdrawn.
Claims 1-16 and 21-24 are included in the prosecution.
Priority
This Application is a CIP of Application No. 17/101,706 filed on 11/23/2020 which is now US Patent No. 11,911,513. Application No. 17/101,706 is a CIP of PCT/CN2019/088084 filed on 05/23/2019. This Application also claims foreign priority to the following applications:
CN 2018 105036544 filed on 05/23/2018
CN 2020 109803114 filed on 09/17/2020
CN 2023 103663509 filed on 04/04/2023
CN 2024 100656387 filed on 01/16/2024
Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119 (a)-(d) for applications (i) and (ii) listed above, which papers have been placed of record in the file.
It is noted, however, that applicant has not filed a certified copy of applications (iii) and (iv) listed above as required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) English translation(s) of the foreign application(s) must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 07/03/25 and 01/26/26 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Claim Objections
Claims 2-10, 12-16, and 21-24 are objected to because of the following informalities:
In claims 2-10, 12-16, and 21-24, the comma following the term “wherein” should be deleted.
In claim 13, line 2, the article “an” should be added before the term “embedment.”
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.
Claims 4, 7, 8, and 12 recite the term “means of” (emphasis added). These limitations invoke 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. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is 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.
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 4, 7, 8, 10, 12, 14, and 15 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 pre-AIA the applicant regards as the invention.
Claims 4, 7, 8, and 12 recite the term “means of” (emphasis added). These limitations invoke 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. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is 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; or
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the claimed function, 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 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.
Claim 10 recites that the oral stable metal comprises “dental titanium, stainless steel, nickel-chromium alloy, cobalt-chromium alloy, cobalt-chromium-molybdenum alloy or precious metal; or the thermoplastic elastomer comprises polycaprolactone, ethylene-vinyl acetate copolymer, high-density polyethylene, polypropylene, polyacrylate, polyurethane, silicon polymer, polyester, poly( styrene-ethylene-butylene-styrene), poly(styrene-butadiene-styrene), poly( styrene-isoprene-styrene) or a copolymer of any two or more of the above, or a physical combination thereof.” Although claim 10 recites the term “or” it is unclear if Applicant also intends all the listed metals to be included. It is suggested that Applicant use Markush language to clearly define the group of metals which may be selected.
Claim 14 recites the limitation “preferably cobalt-chromium alloy …” “preferably polyethylene terephthalate …” and “preferably corresponds to the length of 5-9 teeth …” (emphasis added). Claim 15 recites the limitation “preferably, polyethylene terephthalate …” (emphasis added). The term “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Notice for all US Patent Applications filed on or after March 16, 2013
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.
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 of this title, 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 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 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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 1-14, 16, and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Garay et al. (US 5,194,003 – “Garay”) in view of Goldin et al. (EP 0 389 224 B1 – “Goldin”).
Instant claim 1 is drawn to an oral retention device, comprising a tooth-matching component and a drug-loaded component, the tooth-matching component is connected to the drug-loaded component, wherein the tooth-matching component is used to bridge the teeth in the oral cavity and match with the teeth, and the drug-loaded component holds at least one medicinal tablet and is used to retain the medicinal tablet in the oral cavity.
Garay teaches a device for delivering beneficial agents such as drugs orally for sustained time periods comprising a support member that is formfit or clasped over or around the teeth and one or more reservoir members that is/are carried on an exterior surface of the support along the labial, buccal or lingual surfaces of the teeth and is adapted to hold the agent and release it to the oral cavity for achieving a local effect within the mouth (Abstract, Figures 1-5). The support member of the device is made of plastic, metal, or other material suitable for clasping teeth (FIG. 3 and Col. 5, lines 20-27).
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Garay does not expressly teach that the drugs are in a tablet form.
Goldin teaches a system to replaceably retain and protect a controlled-release intra-oral tablet such as an intra-oral fluoride device, characterized in that the system comprises: a band for attachment to a tooth; a holder attached to said band and having a plate on which the tablet is emplaceable; and retaining means connected to the holder to replaceably retain and protect the tablet while it is emplaced on the plate (claim 1, Figures 1-9C). The holder 10 is generally comprised of a band 20 which wraps around the tooth and a retaining member R which “has retaining sides 40, as best seen in FIGS. 2 and 3. The tablet 100 generally fits snugly within the retaining sides 40 and against the anterior surface of the holder 10. The posterior surface of the plate may be cusp shaped to conform to the outer surface of the tooth (Page 3, lines 36-43). The holder embodiments are preferably made of a metal (e.g., stainless steel) (Page 4, lines 54-55).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a device for delivering beneficial agents such as drugs orally for sustained time periods comprising a support member that is formfit or clasped over or around the teeth and one or more reservoir members that is/are carried on an exterior surface of the support along the labial, buccal or lingual surfaces of the teeth and is adapted to hold the agent and release it to the oral cavity for achieving a local effect within the mouth, as taught by Garay, in view of the system to replaceably retain and protect a controlled-release intra-oral tablet such as an intra-oral fluoride device, characterized in that the system comprises: a band for attachment to a tooth; a holder attached to said band and having a plate on which the tablet is emplaceable; and retaining means connected to the holder to replaceably retain and protect the tablet while it is emplaced on the plate, as taught by Goldin, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Goldin teaches the advantage of using their system, which contains a tablet that fits with the holder, for long term release of medication in the mouth (Abstract). Additionally, Goldin teaches the advantage that the intra-oral holders can be safely placed and securely retained in the mouth for an indefinite period ([0009]). One of ordinary skill in the art would have found it obvious to combine the teachings of Garay and Goldin since they are both drawn to devices that fit around the teeth and deliver drugs/medications in the mouth. According to MPEP 2141(III)(A), it is obvious to combine prior art elements according to known methods to yield predictable results.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of an oral retention device, comprising a tooth-matching component and a drug-loaded component, the tooth-matching component connected to the drug-loaded component, wherein the tooth-matching component is used to bridge the teeth in the oral cavity and match with the teeth would have been obvious over the device for delivering beneficial agents such as drugs orally for sustained time periods comprising a support member that is formfit or clasped over or around the teeth and one or more reservoir members that is/are carried on an exterior surface of the support along the labial, buccal or lingual surfaces of the teeth and is adapted to hold the agent and release it to the oral cavity for achieving a local effect within the mouth (Abstract, Figures 1-5), as taught by Garay. The limitation of the drug-loaded component that holds at least one medicinal tablet and is used to retain the medicinal tablet in the oral cavity would have been obvious over the system to replaceably retain and protect a controlled-release intra-oral tablet (claim 1, Figures 1-9C), as taught by Goldin.
Regarding instant claim 2, the limitations of the tooth-matching components would have been obvious over the support member that is formfit or clasped over or around the teeth and one or more reservoir members that is/are carried on an exterior surface of the support along the labial, buccal or lingual surfaces of the teeth and is adapted to hold the agent and release it to the oral cavity for achieving a local effect within the mouth (Abstract, Figures 1-5), as taught by Garay. The limitations of the ring body having an opening for insertion of a medicinal tablet and the retainer having a structure for limiting the medicinal tablet in the drug-loaded component would have been obvious over the band for attachment to a tooth; a holder attached to said band and having a plate on which the tablet is emplaceable; and retaining means connected to the holder to replaceably retain and protect the tablet while it is emplaced on the plate (claim 1, Figures 1-9C), as taught by Goldin.
Regarding instant claim 3, the limitation of mandibular permanent teeth would have been obvious over the device that is designed as a dental overlay to be worn on the teeth in the lower jaw (FIG. 1 and Col. 3, lines 37-40), as taught by Garay.
Regarding instant claims 4 and 5, the limitations of mandibular molars would have been obvious over the device that is designed as a dental overlay to be worn on the teeth in the lower jaw, including mandibular molars (FIG. 1 and Col. 3, lines 37-40), as taught by Garay.
Regarding instant claims 6-8 and 24, the limitations of the preparation method of the oral retention device would have been obvious over the device for delivering beneficial agents such as drugs orally for sustained time periods comprising a support member that is formfit or clasped over or around the teeth and one or more reservoir members that is/are carried on an exterior surface of the support along the labial, buccal or lingual surfaces of the teeth and is adapted to hold the agent and release it to the oral cavity for achieving a local effect within the mouth (Abstract, Figures 1-5), as taught by Garay in view of the system to replaceably retain and protect a controlled-release intra-oral tablet (claim 1, Figures 1-9C), as taught by Goldin. It is noted that the instant claims 6-8 and 24 are set forth in the form of product-by-process claims, which are considered product claims by the Office. Applicants are reminded that process limitations cannot impart patentability to a product that is not patentably distinguished over the prior art. “’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)….The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979)” (see MPEP 2113). Therefore, when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. The steps recited in instant claims 6-8 and 24 do not add any clear structure to the final product not already required by them being an oral retention device as recited in instant claim 1.
Regarding instant claims 9 and 10, the limitations of the oral stable metal and stainless steel would have been obvious over the metal (FIG. 3 and Col. 5, lines 20-27), as taught by Garay in view of the stainless steel (Page 4, lines 54-55), as taught by Goldin.
Regarding instant claim 11, the limitation of the core component comprising a molar-fitting functional area and a drug holding functional area which are integrally formed would have been obvious over the device that is designed as a dental overlay to be worn on the teeth in the lower jaw, including mandibular molars (FIGS. 1-3 and Col. 3, lines 37-40) and the reservoir element of the device (13) that is capable of receiving and holding units doses of agent (Col. 3, lines 18-29, FIG. 1 – element 13), as taught by Garay. The limitation of the drug holding functional area located in the space between the teeth and the cheek or between the teeth and the tongue would have been obvious over the reservoir members that are carried on an exterior surface of the support along the buccal or lingual surfaces of the teeth (Abstract), as taught by Garay. The limitations of the drug holding functional area comprising a first ring and a second ring arranged coaxially would have been obvious over the ligature bands (200) which can be tied around the tablet (Abstract, FIG. 1, Page 3, lines 45-48), as taught by Goldin. The limitation of the fixing component would have been obvious over the retaining posts 50 (FIG. 2 and Page 3, lines 44-46), as taught by Goldin.
Regarding instant claim 12, the limitation of the fixator and the molar-fitting functional area connected by means of mechanical assembly, mechanical connection or adhesive bonding would have been obvious over the pocket defined by an outer wall 14 and the surface of the support member (FIG. 1 and Col. 4, lines 23-26), clips, snaps, bands, adhesives or similar mechanisms (Col. 4, lines 14-17), as taught by Garay.
Regarding instant claim 13, the limitations of the mechanical assembly as an embedment and slotted holes provided in the fixator would have been obvious over the outer wall 14 which has pores 15 (FIG. 4 and Col. 4, lines 39-49), as taught by Garay. The limitation of the hollow ring and an open ring would have been obvious over the ligature bands (200) which can be tied around the tablet (Abstract, FIG. 1, Page 3, lines 45-48), as taught by Goldin.
Regarding instant claim 14, the limitation of the core component comprising one or more selected from the group that contains stainless steel would have been obvious over the stainless steel (Page 4, lines 54-55), as taught by Goldin.
Regarding instant claim 16, the limitations of the fixator connected to the molar-fitting functional area in an embedded manner, the length of the molar-fitting functional area corresponding to the length of the mandibular first and second premolars and the first and second molars would have been obvious over the device that is designed as a dental overlay to be worn on the teeth in the lower jaw, including mandibular molars (FIGS. 1-3 and Col. 3, lines 37-40), as taught by Garay. The limitation of the first ring and the second ring which are circular closed rings would have been obvious over the ligature bands (200) which can be tied around the tablet (Abstract, FIG. 1, Page 3, lines 45-48), as taught by Goldin.
Regarding instant claim 21, the limitation of the retainer located on the side of the incisors in the horizontal direction formed by the molars and incisors would have been obvious over the device that is designed as a dental overlay to be worn on the teeth including on the side of the incisors over both the upper jaw and the lower jaw (FIGS. 1-3 and Col. 3, lines 37-40 and lines 64-68) as taught by Garay.
Regarding instant claim 22, the limitation of the ring body located on the side of the molars in the horizontal direction formed by the molars and incisors would have been obvious over the device that is designed as a dental overlay to be worn on the teeth including on the side of the incisors over both the upper jaw and the lower jaw (FIGS. 1-3 and Col. 3, lines 37-40 and lines 64-68) as taught by Garay, in view of the ligature bands (200) which can be tied around the tablet (Abstract, FIG. 1, Page 3, lines 45-48), as taught by Goldin.
Regarding instant claim 23, the limitation of at least one ring body would have been obvious over the ligature bands (200) which can be tied around the tablet (Abstract, FIG. 1, Page 3, lines 45-48), as taught by Goldin. The limitation of at least one retainer would have been obvious over the device that is designed as a dental overlay to be worn on the teeth including on the side of the incisors over both the upper jaw and the lower jaw (FIGS. 1-3 and Col. 3, lines 37-40 and lines 64-68) as taught by Garay. The limitation of the ring body having an opening for insertion of a medicinal tablet would have been obvious over the band for attachment to a tooth; a holder attached to said band and having a plate on which the tablet is emplaceable; and retaining means connected to the holder to replaceably retain and protect the tablet while it is emplaced on the plate (claim 1, Figures 1-9C), as taught by Goldin. The limitation of the retainer having a structure for limiting the medicinal tablet in the drug-loaded component would have been obvious over the device that is designed as a dental overlay to be worn on the teeth in the lower jaw or upper jaw (FIGS. 1-3 and Col. 3, lines 37-40 and 64-68) and the reservoir element of the device (13) that is capable of receiving and holding units doses of agent (Col. 3, lines 18-29, FIG. 1 – element 13), as taught by Garay. The limitation of the retainer located on the side of the incisors in the horizontal direction formed by the molars and incisors would have been obvious over the device that is designed as a dental overlay to be worn on the teeth including on the side of the incisors over both the upper jaw and the lower jaw (FIGS. 1-3 and Col. 3, lines 37-40 and lines 64-68) as taught by Garay. The limitation of the ring body located on the side of the molars in the horizontal direction formed by the molars and incisors would have been obvious over the device that is designed as a dental overlay to be worn on the teeth including on the side of the incisors over both the upper jaw and the lower jaw (FIGS. 1-3 and Col. 3, lines 37-40 and lines 64-68) as taught by Garay, in view of the ligature bands (200) which can be tied around the tablet (Abstract, FIG. 1, Page 3, lines 45-48), as taught by Goldin.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Garay et al. (US 5,194,003 – “Garay”) in view of Goldin et al. (EP 0 389 224 B1 – “Goldin”), as applied to claims 1-14, 16, and 21-24 above, in view of Hakansson et al. (US 5,032,080 – “Hakansson”).
Instant claim 15 is drawn to the oral drug delivery device as defined in claim 11, wherein the material of the fixing layer is selected from a group that contains polyamide or the thickness of the fixing layer is 0.01 mm – 1 mm.
The teachings of Garay and Goldin are discussed above.
Garay and Goldin do not expressly teach the material of the fixing layer or the thickness of the fixing layer is 0.01 mm – 1 mm.
Hakansson teaches an orthodontic appliance which contains a coating of polyamide at a thickness of about 0.02 – 0.2 mm (Abstract, Col. 5, lines 13-16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a device for delivering beneficial agents such as drugs orally for sustained time periods comprising a support member that is formfit or clasped over or around the teeth and one or more reservoir members that is/are carried on an exterior surface of the support along the labial, buccal or lingual surfaces of the teeth and is adapted to hold the agent and release it to the oral cavity for achieving a local effect within the mouth, as taught by Garay, in view of the system to replaceably retain and protect a controlled-release intra-oral tablet such as an intra-oral fluoride device, characterized in that the system comprises: a band for attachment to a tooth; a holder attached to said band and having a plate on which the tablet is emplaceable; and retaining means connected to the holder to replaceably retain and protect the tablet while it is emplaced on the plate, as taught by Goldin, further in view of the orthodontic appliance which contains a coating of polyamide at a thickness of about 0.02 – 0.2 mm, as taught by Hakansson, and produce the instant invention.
One of ordinary skill in the art would have been motivated to incorporate the polyamide of Hakansson in the device of Garay because Hakansson teaches that the polyamide has a low coefficient of friction (Abstract, Col. 5, lines 16-17) which permits relative movement between the component parts of the orthodontic appliance and do not damage each other during such movement (Col. 5, lines 23-32).
Regarding instant claim 15, the limitation of polyamide and the thickness of the fixing layer of 0.01 mm – 1 mm would have been obvious over the orthodontic appliance which contains a coating of polyamide at a thickness of about 0.02 – 0.2 mm (Abstract, Col. 5, lines 13-16), as taught by Hakansson.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 20 of copending Application No. 19/215,409 (the ‘409 Application).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to an oral retention device comprising a drug-loaded component, and therefore, encompass overlapping and coextensive subject matter.
One difference is that instant claim 1 recites a tooth-matching component but claims 1 and 20 of the ‘409 Application do not recite this limitation.
However, one of ordinary skill in the art would have found it obvious to prepare the oral retention device recited in claim 20 of the ‘409 Application and include a tooth-matching component for aesthetic improvement.
Another difference is that claim 1 of the ‘409 Application recites an osmotic pump tablet whereas instant claim 1 only recites at least one medicinal tablet.
However, one of ordinary skill in the art would have found it obvious to include various types of medicinal tablets in the oral retention device recited in instant claim 1, including the osmotic pump tablet recited in claim 20 of the ‘409 Application and have a reasonable expectation of success in delivering the tablet to the oral cavity.
Therefore, instant claim 1 is obvious over claims 1 and 20 of the ‘409 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached on 571-272-6023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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