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 filed 04/13/2026.
Claims 1, 60 and 72 are amended.
Claims 1-2, 4-14, 60-61 and 63-73 are pending.
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 canceled claims 15-59 requesting the withdrawal of the of the election of species requirement and the examination of the new claims with the elected claims because applicant argues that the new claims include the limitations of the elected claims..
The examiner agreed and based on the cancelation of claims 15-59, the restriction requirement is withdrawn.
Thus, the restriction requirement as set forth in the Office action mailed on 06/02/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1-2, 4-14, 60-61 and 63-73 are pending and under consideration.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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.
Priority
This application is a Continuation-in-part (CIP) of 17/909,480 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 points to paragraphs [0082] and [0092] as providing written description for treating the device to change surface energy of the floss. The examiner agrees that paragraph [0082]of the as filed specification describes changing the surface energy of the floss, which is the device, by coating the floss with a hydrophilic polymer to make it hydrophilic, or treating the floss with oxygen plasma or other conventional surface treatment approaches that can change the surface energy of the floss surface to better allow for the spreading of the coating liquid. The examiner also acknowledges that paragraph [0092] of the as filed specification describes micronutrient delivery to gum pocket and where in paragraph [0093] it is further described that inserting the floss coated with the micronutrient into the gum pocket and flossing delivers the micronutrient. Therefore, a rejection over written description requirement is thus not made.
Regarding the rejection under 35 USC 102: The amendment to claims 1 and 60 specifying that the device (floss) has a thickness of less than 500 microns overcomes the rejection under 35 USC 102. The rejection is being made under 35 USC 103.
On pages 11 of 14 to 12 of 14, i) applicant argues treating the surface of the floss to change the surface energy allows the device to hold onto the agent and through manipulation and insertion into the gingival crevice reaches the junctional epithelium, ii) the cited reference does not the floss as including mucoadhesive which would be understood by the skilled artisan to facilitate adhesion properties of the device, iii) the claimed device includes one or more excipients, iv) citing paragraph [0086] of the as filed specification, applicant argues that the agent is uniformly distributed over at least a portion of the device ensuring consistent delivery of nutrients and promoting adherence and that this important aspect of the configuration and controlling the amount of one or more nutrients loaded on the device is not taught in Petrus, v) the size of the device at less than 500 microns enables the device to reach the junctional epithelium.
Response: Claim 60 is a device/product. Changing the surface energy of the floss is a process of making the floss. i) A floss by its structure and mode of use/application/insertion reads of device configured to reach the junctional epithelium. Petrus does not teach that the nutrient loaded on the floss strips off and dislodges from the floss before using the floss. It is the flossing that releases the agent into the cavity that subsequently 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, Junctional epithelium – Wikipedia. For ii), Petrus teaches the floss to be coated with polymer (column 1, lines 63-67) and the polymer is namely hydroxypropyl cellulose (column 8, lines 13-25) with the hydroxypropyl cellulose meeting the limitation of mucoadhesive layer. For iii), Petrus teaches that surfactant may be loaded onto floss (column 8, lines 26-37) with the surfactant reading on excipient. For iv), Petrus does not teach that its agent loaded on the floss is not uniformly distributed over at least a portion of the device ensuring consistent delivery of nutrients and does not promote adherence; floss is configured for use between the teeth and the flossing releases active agents/nutrient on the floss that would reach the junctional epithelium because, 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 Bosshardt). For v), floss is known to have thickness ranging from 50-200 microns or 20-75 micron (paragraph [0012] of CAVALIERE US 20200121430 A1) or about 0.18 mm (180 micron) (paragraph [0055] of CAVALIERE, US 20200121430 A1), all of which are less than 500 microns.
Regarding the rejection under 35 USC 103: applicant argues that claims 6, 11-12 depend directly or indirectly from claim 1 and thus inherits every element of claim 1; claims 65, 70 and 71 depend directly or indirectly from claim 60 and thus inherits every element of claim 60; and therefore, these dependent claims are patentable over the cited art.
Response: The dependent claims are not allowable because the independent claims have not bot been fund allowable.
The comprising language of the claims is open and does not exclude components/ingredients that are not vitamins.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 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 pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 1-2, 4-14, 60-61 and 63-73 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Petrus (US 5875799) as evidenced by 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, Junctional epithelium - Wikipedia in combination with CAVALIERE (US 20200121430 A1).
Claim 1 delivers effective amount of one or more nutrients to gingival crevice of a subject. The specific amount that is sufficient to supplement the diet of the subject is not stated in claim 1. Thus, an amount sufficient to supplement diet of the subject is an any amount deemed sufficient by the artisan. Claim 1 is amended to say “wherein the one or more nutrients target a junctional epithelium within the gingival crevice.”
Claim 60 is a device configured to deliver one or more nutrients into gingival crevice. No amount is claimed for the nutrient. Floss coated or entrapping or containing nutrient meets the limitation for device of claim 60. Floss containing one or more nutrient when used to floss inherently releases the nutrient onto the teeth and the crevice of the teeth and gum. Epithelium is within the gum or is the gingival epithelium. Claim 60 is amended to say “wherein the one or more nutrients target a junctional epithelium within the gingival crevice.”
Claims 1 and 60 have been amended to recite that the device is treated to change surface energy that allows the device to become adhesive to one or more nutrients. This limitation is directed to how the device/floss is prepared. The claims are not directed to the preparation of device/floss. Claims 1 and 60 are also amended to say that the devise has a mucoadhesive layer, hydrophilic layer, hydrophobic layer or combination of mucoadhesive, hydrophilic and hydrophobic materials deposited on the device/floss. In this case, the prior art teaches a mucoadhesive coating on the floss.
For claims 1 and 60, Petrus delivers vitamin B-12 and or zinc nutrient incorporated into dental floss to a subject such as a subject over 50 years old who is need of supplementing their diet with at least 25 micrograms of vitamin B-12 daily; this amount meets the limitation of effective amount; the method entails flossing or rubbing the floss against a mouth tissue such as the gum/teeth (gingival crevice) with the dental floss having impregnated zinc salt or other therapeutic agent facilitating direct absorption of the medicaments by the periodontal tissue as the active material is wiped off the floss and onto the interdental spaces and gums thereby allowing the patient to self-administer the therapeutic agents directly to the periodontal tissues and treat gingivitis and periodontal disease as well as other systemic diseases (see the whole document with emphasis on the abstract; column 3, lines 51-63; column 7, lines 14-21; column 8, lines 9-14). Petrus teaches the floss to be coated with polymer (column 1, lines 63-67) and the polymer is namely hydroxypropyl cellulose (column 8, lines 13-25) with the hydroxypropyl cellulose meeting the limitation of mucoadhesive layer. Therefore, the mucoadhesive layer would inherently facilitate adherence of the nutrient to the device. Petrus teaches that surfactant may be loaded onto floss (column 8, lines 26-37) with the surfactant reading on excipient. During flossing with the nutrient loaded, the nutrient is released and the released nutrient would reach the junctional epithelium because as disclosed by Bosshardt, 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). Thus, the nutrient of Petrus targets junctional epithelium in the gingival crevice as the junctional epithelium is within the gingival crevice. Petrus does not teach that the coating on its floss is not uniform.
Thus, Petrus differs from claims 1 and 60 by not teaching the thickness of the nutrient coated floss. However, it is known in the art that floss is known to have thickness ranging from 50-200 micron or 20-75 micron or about 0-18 mm (180 micron) (paragraphs [0012], [0055] of CAVALIERE), all of which are less than 500 microns. Therefore, before the effective date of the invention, the artisan would expect the floss of Petrus to have thickness of less than 500 micron to be used in flossing between the teeth and gum that reaches the junctional epithelium.
For claims 2 and 61, Petrus does not teach delivering the active agents/vitamin B-12/ Zinc/nutrient to the vestibular mucosa. Claim 61 is a product claim and the recitation that the one or more nutrients are not targeted for delivery to vestibular mucosa is the process of using the device.
For claims 4 and 63, the therapeutic agents/nutrients are encapsulated (column 8, lines 9-14) and it is the encapsulation that maximizes the delivery of the one or more nutrients.
For claims 5 and 64, the active agent on the dental floss also contain sodium lauryl sulfate surfactant or sodium lauroyl sarcosinate (column 8, lines 26-36) which are penetration enhancers meeting the limitation of that the device used in claim 1 further comprises agents that increase permeability or the one or more nutrients into the epithelium. The claims and the disclosure does not name any specific permeation enhancers or agent that increase permeability of the one or more nutrients into the junctional epithelium of the gingival crevice.
For claims 6 and 65, Petrus teaches that 25 microgram of vitamin B-12, which is a nutrient, incorporated into dental floss is the amount of vitamin B-12 supplement; and 25 microgram Vitamin B-12 (column 7, lines 14-21). It is expected that 25 microgram Vitamin B-12 is required supplement daily. Petrus does not teach that between 0.001% and 100% of the Vitamin B-12 is in the depot at junctional epithelium (JE) of the gingival crevice. It would therefore by expected that 25 microgram nutrients daily represents certain percentage in the depot at the JE.
Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).
For claims 7 and 66, the flossing process involves repeated action releasing the active agents/nutrients (column 7, lines 14-21; column 8, lines 9-25) to the junctional epithelium of the gingival crevice.
For claims 8 and 67, flossing is practiced to remove food debris between the teeth and remove dental plaque to prevent and remedy gum disease (column 3, lines 41-49) such that the delivery of the nutrient, in the case vitamin B-12 or Zinc, to the junctional epithelium of the gingival crevice, is after consumption of food.
For claims 9 and 68, at least the daily use of 25 microgram vitamin B-12 (column 7, lines 14-21) meets the requirement for daily in claim 9.
For claims 10 and 69, the daily requirement of at least 25 micrograms vitamin B-12 incorporated on the dental floss is released (column 3, lines 14-21) during flossing and 25 microgram B-12 release is 100% of the daily requirement.
For claims 11-12 and 70-71, flossing is practiced to remove food debris between the teeth and remove dental plaque to prevent and remedy gum disease (column 3, lines 41-49) such that the delivery of the nutrient, in the case vitamin B-12 or Zinc, is after consumption of food and would thus be expected that the delivery could be done immediately after the food intake or sometime after the intake when flossing would be expected to effectively optimize delivery of the nutrient. There is no factual showing that the recited times produced the best times for delivery of the nutrients.
For claims 13 and 72, Vitamin B-12 is used at microgram levels (Column 7, line17) with the microgram amount being a species of the claimed range of picogram to milligram.
For claims 14 and 73, vitamin B-12 and zinc (claim 4) meet the requirement of claims 14 and 73.
Therefore, Petrus as evidenced by Bosshardt and Junctional epithelium - Wikipedia in combination with CAVALIERE renders claims 1-2, 4-14, 60-61 and 63-73 prima facie obvious.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 1-2, 4-14, 60-61 and 63-73 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 17-20, 25, 31-33 and 106-114; and claims 1, 5-9, 13-17, 19-20 of co-pending Application Nos. 17909480 and 19186888 in view of Rizzieri et al. (US 20020187100 A1) or Osman Et al. “Angioneurotic oedema secondary to oral thiamine” in BMJ 2013.
The method claims of co-pending 17909480 triggers immune response with composition comprising allergen and the device of co-pending 17909480 comprises allergen. The co-pending claims do not say of using nutrients in its composition that triggers immune response. However, iodine or thiamine, which are both recited as being nutrients have been known to have triggered allergic responses (see paragraphs [0073] and [0092] of Rizzieri and at least summary of Osman), which means that iodine and thiamine, Vitamin B1, are allergens.
The device of co-pending 18186888 comprises allergen. The device manufactured by co-pending 18186888 comprises allergen. The co-pending claims do not say of using nutrients in its devices. However, iodine or thiamine, which are both recited as being nutrients have been known to have triggered allergic responses (see paragraphs [0073] and [0092] of Rizzieri and at least summary of Osman), which means that iodine and thiamine, Vitamin B1, are allergens. Therefore, before the effective date of the invention, the ordinary skilled artisan apprised of the co-pending claims and Rizzieri and Osman would have predictably used iodine or thiamine as nutrients and allergens.
This is a provisional non-statutory double patenting rejection.
No claim is allowed.
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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