DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election of Group I (claims 1-14 and 21) in the reply filed on 06/08/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15-20 have been cancelled by Applicant.
Specification
3. Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
4. The abstract of the disclosure is objected to because it contains legal phraseology “comprises” (line 3). Correction is required. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 1-14 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.
Claim 1 recites: “wherein the carrier is configured to deliver the medicament over a controllable period of time upon placement of the carrier within a gingival crevice of the patient to be absorbed into the patient’s system” (lines 2-4); and “such that the carrier is configured to detach from the handle and remain … until the medicament is delivered into the gingival crevice of the patient to be absorbed into the patient’s system” (lines 6-9). It is unclear whether it’s the carrier, the medicament, or another element, that is to be absorbed into the patient’s system. Furthermore, both recitations “the patient’s system” (line 4, line 9) lack sufficient antecedent basis in the claim; it is also unclear exactly what is “the patient’s system”.
The dependent claims are rejected herein based on dependency.
Claim Rejections - 35 USC § 103
7. 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.
8. Claims 1-5, 7-8, 12-14, and 21, are rejected under 35 U.S.C. 103 as being unpatentable over Warren et al. (US 3,754,332) in view of Jernberg (US 4,685,883).
Regarding claim 1, Warren et al. discloses a system comprising: a carrier (absorbent material 18 in Fig. 1; material 26 in Fig. 2; material 54 in Fig. 7) configured to carry a medicament to be delivered to a patient, wherein the carrier 18, 26, 54, is configured to deliver the medicament over a controllable period of time (Figs. 1-2, 7; column 2 lines 40-56 “absorbent material 18 or 26 carries a chemical agent which is transferred to the teeth”).
Warren et al. further discloses a handle (strip 12 in Fig. 1; strip 24 in Fig. 2; strip 52 in Fig. 7) configured to detachably secure the carrier 18, 26, 52, during delivery of the medicament, wherein the handle detachably secures the carrier 18, 26, 52, such that the carrier 18, 26, 52, is configured to detach from the handle and remain between the teeth (Figs. 1-2, column 3 lines 3-6 “detachable section 18 or 26 should remain between the teeth when the strip 12 or 24 is removed”; Fig. 7 column 3 lines 19-28 “strip 52 having a detachable section 54… when the strip 52 is removed, the detachable section 54 detaches from strip 52 and remains between the teeth…”)
Per claims 1-3, Warren et al. discloses the carrier 18, 26, 54 is inserted between the teeth where the carrier dissolves over an extended period of time and delivers medicament to an interproximal site (Figs. 3-4; abstract; column 4 lines 14-18 “the detachable section dissolves when it is wet by saliva over a moderately extended period of time”). Therefore, Warren et al. fails to disclose a junctional epithelial targeting treatment site, that the carrier is configured for placement and remaining within a gingival crevice over a controllable period of time (as claimed in claim 1). Warren et al. is also not explicit that the carrier dissolves in response to the placement within the gingival crevice, causing the medicament to be released from the carrier into the gingival crevice to be absorbed into the patient’s system, and wherein the carrier is configured to dissolve at a predetermined rate that is based on characteristics of the carrier (as claimed in claims 2-3).
Jernberg discloses a carrier 10 configured for placement and remaining within a gingival crevice, namely the junctional epithelial targeting treatment site, to deliver the medicament into the gingival crevice (epithelial junction) over a controllable period of time (Jernberg Figs. 1-5; abstract; column 3 lines 26-35 “biodegradable microspheres 10 containing chemotherapeutic agent 12”; column 3 lines 59-65 “positioning of the biodegradable microspheres 10 in a periodontal pocket or lesion 16 between a tooth 18 and gingival tissue 20… Once in position, the biodegradable microspheres 10 will begin to degrade and release the chemotherapeutic agent 12 to the localized site”).
Jernberg also discloses that the microspheres 10 may be configured to have biodegradable outer walls 14 of predetermined differing thickness to providing for predetermined time release of the medicament (see Jernberg abstract; column 3 lines 31-52).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Warren et al. by configuring the carrier for placement and remaining within a gingival crevice and to time-release the medicament at a predetermined rate by dissolvement rate of the biodegradable outer wall of the carrier as explicitly taught by Jernberg in order to effectively deliver a time-release dosage of medication at the gingival crevice treatment site.
As to claim 4, Jernberg discloses the carrier form an arm (substrate 26 retained by adhesive backing 28 as shown Figs. 6, 7A, 7B) the arm having a length and a width configured to be inserted into the gingival crevice of the patient to deliver the medicament 12, wherein the length of the arm is configured to facilitate placement of a substantial portion of the arm within the gingival crevice, and wherein the width of the arm is configured to fit into the gingival crevice without causing discomfort to the patient (see Jernberg Figs. 7A-7B).
As to claim 5, Jernberg in the embodiment discloses that the arm, i.e. a substrate material or backing 28, is coated with the medicament to form matrix 26 (see Jernberg Figs. 2A-2C; column 3 lines 40-45 “the chemotherapeutic agent 12 is mixed in with the biodegradable material 15 of the microsphere substrate”).
As to claim 7, Jernberg discloses the arm includes an internal well 10, 26, defined by a carrier frame (outer walls 14 in Figs. 1A-1C, or frame of biodegradable material 15 in Figs. 2A-2C, or frame matrix 26 in Figs. 6-7). The internal well 10, 26, configured to encapsulate a first portion of the medicament 12 within the internal well, wherein the first portion of the medicament begins to be released from the internal well upon dissolvement of at least a portion of the carrier frame sufficient to reach the internal well and allow the first portion of the medicament to escape from the internal well (column 3 lines 40-45 “The chemotherapeutic agent 12 is mixed in with the biodegradable material 15 of the microsphere substrate such that as the biodegradable material degrades, the chemotherapeutic agent is gradually released”).
As to claim 8, Jernberg discloses the internal well 10, 26, includes a plurality of sub-wells, i.e. a plurality of microsphere 10 with wall shell 14 as shown in Figs. 1A-1C, each of the plurality of sub-wells 10 (Figs. 1A-1C) configured to encapsulate (with outer wall 14) a portion of the medicament 12. See Jernberg column 3 lines 26-53 “the microsphere may have biodegradable outer walls 14 of differing thickness thereby providing for time release of the chemotherapeutic agent over differing intervals of time… the embodiments shown in FIGS. 2A, B, C might be utilized in conjunction with the embodiments shown in FIGS. 1A, B, C to provide a biodegradable microsphere having a biodegradable wall or shell of a predetermined thickness surrounding biodegradable material mixed in with chemotherapeutic agent”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Warren et al.’s carrier arm 54 having a length and a width configured to be inserted into the gingival crevice, and the carrier arm being coated or having internal well(s) defined by a carrier frame as taught by Jernberg in order to provide effectively delivery of a time-release dosage of medication at the gingival crevice being a treatment site.
As to claims 12-14 and 21, Warren in view of Jernberg discloses the JET device substantially as claimed as detailed above according to claim 1. Note that that Warren’s strip 12 has edge 16 (Fig. 1) or strip 52 has edge 50 (Fig. 7). Such edge 16, 50, is equivalent to “a stop tab” as claimed because the edge’s wide structure prevents the carrier 18, 54, from being inserted beyond the gingival crevice. Warren’s device is disintegrable, i.e. disintegrated or broken down into strip 52 and detachable section 54 (Warren Fig. 7); the whole device can be pocketed, is considered to be patterned (see Fig. 6), and/or has a reservoir, i.e. carrier mechanism.
9. Claims 6 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Warren et al. in view of Jernberg as applied to claim 1 above, and further in view of Pitucha et al. (US 2023/0069878).
Per claim 6, Warren/Jernberg fails to disclose a polymer mix including a polymer.
Per claims 9-11, Warren/Jernberg fails to disclose a multifilament mesh having a plurality of dissolvable filaments. Pitucha et al. discloses a medication carrier system comprising dissolvable filaments intertwined with each other and formed of polymer and medicament mixed together (see Pitucha Figs. 2-3, abstract’ [0023]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Warren/Jernberg by forming the arm or the carrier of dissolvable filaments intertwined with each other and formed of polymer and medicament mixed together as taught by Pitucha et al. to be a suitable alternative and effective matrix formation for such intended purpose of forming a biodegradable insert of sizes and shapes for insertion into the gingival crevice.
Conclusion
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner HAO D. MAI whose telephone number is (571)270-3002. The examiner can normally be reached on Mon-Fri 8:00-4:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAO D MAI/
Examiner, Art Unit 3772
Prosecution Insights