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 .
The examiner acknowledges receipt of request for extension of time, request for continued examination under 37 CFR 1.114, amendment and remarks all filed 04/13/2026.
Claims 1, 5-7, 9, 17 and 20 are amended.
Claims 2-4, 10-12 and 18 are canceled.
Claims 1, 5-9, 13-17 and 19-20 are pending.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/13/2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14, in the reply filed on 07/23/2025 was acknowledged.
Applicant also elected antigen species with traverse because as per applicant, allergen, immunogen and antigen have significant overlap in meaning and that there would not be significant burden on the examiner to search for dental floss having immunogen, allergen and antigen. It appears that applicant is intimating that immunogen and allergens are antigens since antigens encompass immunogen and allergens which trigger immune system to react. Therefore, with applicant’s suggestion, art teaching antigen would be sufficient to imply allergen and immunogen. No specific antigen, immunogen, allergen is taught is claim 1 as distinguishing immunogen and allergen from the antigen. Therefore, the requirement for the specie election is withdrawn based on applicant’s statement of overlap between antigen, immunogen and allergen. Claims 15-16 depend on claim 9 and are examined with claim 9.
Claims 1, 5-9 and 13-15 are under examination after the current amendment.
Claims 17 and 19-20, after the current amendment, stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/23/2025.
Priority
This application is a continuation of 17/909,490 filed 09/06/2022, which is a 371 of PCT/US2022/039536 filed 08/05/2022 and which claims benefit of 63/229,784 filed 08/05/2021.
Response to Arguments
Applicant's arguments filed 04/13/2026 have been fully and carefully considered but they are not persuasive. Applicant argues: a) that claimed floss is treated by changing the surface energy of the floss so that the floss becomes adhesive to the agents allowing the floss to hold onto the when the agent is loaded onto the floss, that through manipulation and insertion the loaded agent reaches the junctional epithelium; that the surface treatment is significant because the treatment helps to ensure adherence of the agent while the floss is being inserted through the tight space of the gingival crevice. b) The cited references do not teach the claimed floss that includes mucoadhesive layer or hydrophilic layer or hydrophobic layer and that those skilled in the art would understand that the floss having mucoadhesive layer or hydrophilic layer or hydrophobic layer helps with adhesion properties of the floss and facilitates the release of the agents once the floss reaches the junctional epithelium. c) The claimed floss also includes agent composition that comprises one or more excipients that enable the controlled release of the agents. d) The claimed floss is configured such that the agent is uniformly distributed over at least over a portion of the floss where it is loaded. Paragraph [0086] of the specification as filed teaches coating on the floss is uniform or consistent promoting adherence and ensuring consistent delivery of the agent. e) The claimed floss is sized to be able to reach the apical aspect of the gingival crevice where the junctional epithelium is located and the thickness of the floss is less than 500 micron (this limited is found in paragraph [0056] of the specification as filed where it is said that “thin instruments measuring less than 1 mm and preferably less than 500 mm to enter the cavity ….” f) With respect to the rejection under 35 USC 103, applicant states that the arguments presented above are also applicable under 35 USC 103 requesting reconsideration and withdrawal of the rejection.
Response: For a), changing the surface area is how the floss is treated for production or is a step in the making of the floss. Further surface area of the floss has not been claimed. In Francois, the floss is impregnated or coated thereon with allergen (see the whole document with emphasis on column 20, lines 18-24; column 22, lines 28-66; column 23, lines 1-2, 35-42), which is release when the floss is used during flossing. Allergen is an antigen (see paragraph [0030] of JEONG). For b), Francois Francois teaches dental floss or dental pick having allergen encapsulated or impregnated or coated thereon into the coating layer or distributed as an outer layer of a coating layer (see the whole document with emphasis on column 20, lines 18-24; column 22, lines 28-66; column 23, lines 1-2, 35-42) and comprises polymeric delivery vehicles (column 24, lines 62-63) such as chitosan (column 25, line 25) with layer comprising the chitosan meeting the limitation of mucoadhesive layer. Therefore, Francois teaches mucoadhesive and because gingival crevice which is also known as the gingival sulcus is the space between the tooth and the surrounding gum, the allergen on the floss is released into the crevice during flossing. Therefore, mucoadhesive chitosan would inherently help with adhesion properties of the floss to facilitate the release of the agents once the floss reaches the junctional epithelium. The junctional epithelium lies immediately apical to the sulcular epithelium which lines the gingival sulcus from the base to the free gingival margin where it interfaces with the epithelium of the oral cavity (see the whole document with emphasis on the abstract and concluding remarks of Bosshardt et al. “The Junctional Epithelium: from Health to Disease” in Critical Review in Oral Biology & Medicine, J Dent Res 84(1):9-20, 2005;
https://en.wikipedia.org › wiki › Junctional_epithelium
For c), the floss of Francois comprises excipient (column 5, line 51; column 6, line 4; column 6, lines 4, 5, 8). For d), Francois teaches floss which has the structure of the floss of the examined claims. The floss is used between the tooth and surrounding gum and thus it could be said that the floss is configured to be used between the tooth and the surrounding gum. Francois does not teach that its floss is not uniform or consistent and does not promote adherence and does not ensure consistent delivery of the agent. It would be expected that the floss of Francois having coating of allergen agent would release the agent during flossing into the junctional epithelium. For e), Francois does not teach the new limitation of thickness of the floss. However, it is known that floss is known to have thickness ranging from 50-200 mm or 20-75 mm (paragraph [0012]) or about 0.18 mm (180 mm) (paragraph [0055] of CAVALIERE, US 20200121430 A1), all of which are less than the 500 microns claimed. Therefore, before the effective date of the invention the artisan would expect the floss of Francois to be less than 500 micron in thickness. For f), the examiner incorporates the response in a) through e) here.
The examiner has reconsidered the claims and the closest prior art Francois which is also cited in the as filed specification in paragraph [0008], page 3. The comparative data on page 11 of the presentation presented during the interview of March 02, 2026 uses liquid drop method for Francois and not floss disclosed in Francois. The claims have not recited any specific surface area. There is no factual showing that the allergen of Francois is not uniformly distributed.
The proper terminal disclaimer filed 03/12/2026 overcomes the provisional obviousness type double patenting rejection.
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.
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.
Claim(s) 1, 5-9 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Francois (US 9271899 B2), as evidenced by JEONG et al., (US 20190091292 A1) that allergen is antigen, in combination with CAVALIERE (US 20200121430 A1).
Claim 1 is a floss device comprising an effective amount of one or more antigens, immunogens, allergens or combination. “The device for triggering immune response in a subject” is the intended outcome when the floss is used in a subject. The recitation that the one or more antigens, immunogens, allergens or combination is deposited into a gingival crevice of the subject represents the application of the floss in the gingival crevice. A prior art dental floss having one or more antigens, immunogens, allergens or combination would deposit the one or more antigens, immunogens, allergens or combination when used for flossing. Effective amount is any amount deemed effective by the artisan. Maximizing delivery is a process of delivery of the one or more antigens, immunogens, allergens or combination on the floss; providing the one or more antigens, immunogens, allergens or combination to the junctional epithelium of the gingival crevice is a process of using the composition of claim 1; applying once or more than once with frequency on a daily or weekly basis the one or more antigens, immunogens, allergens or combination is a process of using the dental floss of claim 1, and … gingival crevice required by claim 5. Effective amount is any amount deemed effective by the artisan. The claims have not defined what an effective amount is. Triggering immune response in the subject is the effect of the one or more antigens, immunogens, allergens or combination when the floss is used. Triggering immune response is the effect of the one or more antigens, immunogens, allergens or combination when the floss is used and triggering immune response within the gingival crevice is the effect of the one or more antigens, immunogens, allergens or combination when the floss is used. Treating the floss to change the surface area is the process of making the floss. Claim 1 is directed to a floss device comprising one or more antigens, immunogens, allergens or combination, one or more mucoadhesive and one or more excipients. A prior art floss having allergens agent coated on to the layer of the floss is capable of releasing the agent and because junctional epithelium lies immediately apical to the sulcular epithelium which lines the gingival sulcus from the base to the free gingival margin where it interfaces with the epithelium of the oral cavity to reach the junction epithelium, the agent released during flossing would be expected to reach the junction epithelium. Claims 1 and 5-8 are directed to a floss and not to the process of delivering agents to the junction epithelium. Applicant elected antigen and JEONG teaches that Allergen is an antigen (paragraph [0030] of JEONG).
Thus, for claims 1 and 5-8, Francois teaches dental floss or dental pick having allergen encapsulated or impregnated or coated thereon into the coating layer or distributed as an outer layer of a coating layer (see the whole document with emphasis on column 20, lines 18-24; column 22, lines 28-66; column 23, lines 1-2, 35-42) and comprises polymeric delivery vehicles (column 24, lines 62-63) such as chitosan (column 25, line 25) with layer comprising the chitosan meeting the limitation of mucoadhesive layer. Therefore, Francois teaches mucoadhesive and because gingival crevice which is also known as the gingival sulcus is the space between the tooth and the surrounding gum, the allergen on the floss is released into the crevice during flossing. Therefore, mucoadhesive chitosan would inherently help with adhesion properties of the floss to facilitate the release of the agents once the floss reaches the junctional epithelium. The junctional epithelium lies immediately apical to the sulcular epithelium which lines the gingival sulcus from the base to the free gingival margin where it interfaces with the epithelium of the oral cavity (see the whole document with emphasis on the abstract and concluding remarks;
https://en.wikipedia.org › wiki › Junctional_epithelium.
The floss of Francois comprises excipient (column 5, line 51; column 6, line 4; column 6, lines 4, 5, 8). Francois teaches floss which has the structure of the floss of the examined claims. The floss is used between the tooth and surrounding gum and thus it could be said that the floss is configured to be used between the tooth and the surrounding gum. Francois does not teach that its floss is not uniform or consistent and does not promote adherence and does not ensure consistent delivery of the agent. It would be expected that the floss of Francois having coating of allergen agent would release the agent during flossing into the junctional epithelium.
Francois differs from claim 1 by not teaching the new limitation of thickness of the floss. However, it is known in the art that floss is known to have thickness ranging from 50-200 mm or 20-75 mm (paragraph [0012]) or about 0.18 mm (180 mm) (paragraph [0055] of CAVALIERE), all of which are less than the 500 microns claimed. Therefore, before the effective date of the invention the artisan would expect the floss of Francois to be less than 500 micron in thickness.
In another embodiment, Francois teaches dental floss and dental pick comprising allergen that is used to slide between teeth to remove plaque and food particles to promote contact of the composition with gingival mucosa and the allergen diffuses through the gingival mucosa (column 22, line 28 to column 23, line 2; column 3, line 6; column 4, lines 45-48 and 55-67; column 16, lines 35-37; column 18, lines 1-55). Francois teaches that allergen triggers immune response (column 6, lines 55-67). The dental floss or dental pick has allergen encapsulated or impregnated or coated therein (see the whole document with emphasis on column 20, lines 18-24; column 22, lines 28-66; column 23, lines 1-2 and 35-42).
For claims 9 and 13, it is the agent deposited in the gingival crevice during flossing that triggers immune response. Francois teaches that allergen triggers immune response (column 6, lines 55-67) and the it is inherent that the triggering results in activating the immune response. Floss is a device that has been configured for insertion between the gum and tooth. But, Francois teaches dental floss and dental pick is used to slide between teeth to remove plaque and food particles and promotes contact of the composition with gingival mucosa and the allergen/antigen diffuses through the gingival mucosa. The gingiva has crevices or small groove or space around each tooth such that the artisan would reasonably expect that diffusion of the allergen/antigen through the gingival mucosa predictably depositing the allergen/antigen into the spaces/groove/crevice of the gingiva. The composition coating the floss comprises excipient, chitosan polymer meeting the limitation of mucoadhesive.
For claim 14, Francois teaches dental floss or dental pick having allergen encapsulated or impregnated or coated therein (see the whole document with emphasis on column 20, lines 18-24; column 22, lines 28-66; column 23, lines 1-2, 35-42).
For claim 15, the dental floss and dental pick are used to slide between teeth to remove plaque and food particles and promotes contact of the composition with gingival mucosa and the allergen/antigen diffuses through the gingival mucosa. Effective amount is amount determined effective by the artisan
For claim 16, Francois teaches that allergen triggers immune response (column 6, lines 55-67) and the it is inherent that the triggering results in activating the immune response.
Therefore, Francois, as evidenced by JEONG, in combination with CAVALIERE renders claims 1, 5-9 and 13-16 prima facie obvious.
The attorney is encouraged to reach out to the examiner to explore amendments that may move the claims closer to allowability.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Yong Kwon can be reached at 5712720581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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