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 17, 20, 33, 106, 109 and 113 are amended.
Claims 17-20, 25, 31-33, 36, 106-114 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 17-20, 25, 31-33 and 36 in the reply filed on 07/23/2025 was acknowledged.
Applicant also elected influenza as specific antigen and the device of claim 20 with traverse without indicating which of the alternative delivery devices of claim 20 is elected with traverse. Because applicant has not specifically articulated the reasons for traversal, the election of species was considered to be made without traverse.
Further, because claims 1-5, 13, 15-16, 38-43, 45-46, 48-52, 55, 61, 73-76, 78, 82-83, 91, 94, 97, 103 and 105 were canceled, the restriction requirement as set forth in the Office action mailed on 05/27/2025 was withdrawn.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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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 17-20, 25, 31-33, 36 and 106-114 are under examination.
Priority
This application is a is a 371 of PCT/US2022/039536 filed 08/05/2022 and which claims benefit of 63/229,784 filed 08/05/2021.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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.
Response to Arguments
With respect to the rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, the rejection is withdrawn in light of applicant’s persuasive argument.
With respect to the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), the rejection with respect to claim 20 and the repetitive “less than” is withdrawn in light of the amendment to claim 20.
The rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph based on claims 17 and 106 reciting that the delivery device is “sized to deposit the one or more …within the gingival crevice …” is withdrawn in light of the amendment to claims 17 and 106.
The amendment to claim 17 necessitates rejection under 35 USC 112, second for citing a device in line 7 of the claims as though device has been previously recited in the claim --- “device” in line 7 is the first occurrence.
With respect to the rejection of claim(s) 106-108 and 111-114 under 35 U.S.C. 102(a)(1) and 102(a)(2), applicant argues that: a) The floss is treated by changing the surface energy of the floss so that it becomes adhesive to the agents allowing the floss to hold onto the loaded agent; and that through manipulation and insertion into the gingival crevice, the agent reaches the junction epithelium. Applicant further states that the surface energy treatment is significant because the treatment helps ensure adherence of the agent on the floss while the floss is being inserted through tight space of the gingival crevice, and that without the treatment, the agent “could easily strip off” dislodging the agents from the floss. b) That the cited references do not teach the floss to include mucoadhesive and that the skilled artisan would understand that such a layer facilitates at least two things, one, altering the surface properties and second, facilitating agent release thereby helping to ensure that the agent adheres to the floss without being dislodged while being inserted. c) The claimed floss also includes one or more excipients added to the agent to enable controlled release of the agents onto the apical aspect of the gingival crevice. d) The claimed floss is configured in such a way to allow uniform distribution of the agent over at least a portion of the floss and it is disclosed in paragraph [0086] of the as filed specification that uniform and consistent coating ensures consistent delivery, controlled amounts of the loaded agent and promoting adherence. e) The claimed floss is also sized at less than 500 microns to reach the apical aspect of the gingival crevice where the junction epithelium is located and that without this size limitation, the floss could not reach the junction epithelium and without causing damage or pain and dislodging of the agent during insertion.
Claims 107,108, 110-114 depend directly or indirectly from claim 106. Thus, applicant requests withdrawal of the rejections of these dependent claims 107, 108 and 110-114 because they are allowable over the cited art for the reasons presented above.
Response: At the outset, claim 106 is a device/product. Claim 106 is not directed to how the floss is made or treated. Thus for a), treating the floss by changing the surface area is how the floss is made. No specific surface energy for the floss is 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 released when the floss is used during flossing. There is no evidence and applicant has not provided one that the agent does not adhere to the floss and/or dislodges from the floss when the floss is inserted in the crevice between the teeth and/or the agent on the floss does not reach the junction epithelium and/or the agent strips off during insertion. For b), The examiner disagrees with applicant that cited references do not teach the floss to include mucoadhesive because 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; Junctional epithelium - Wikipedia). For c), The floss of Francois comprises excipients (column 5, line 51; 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, 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 Al), 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. The dependent claims are not allowable because the independent claim is not allowable. The claims are being rejected below addressing the size of the floss at less than 500 micron and based on the less than 500 micron size for the floss, the rejection will be made under 35 USC 103.
For the rejections under 35 USC 103: Citing KSR Int’l Co. v. Teleflex Inc., 82 U.S.P.Q. 2d 1385, 1391 (2007), and In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), applicant argues that claim 109 is patentable over the cited art for reasons a) through e) above.
Response: The examiner also incorporates the response to applicant’s argument presented above for )a through e) above. The findings in KSR Int’l Co. v. Teleflex Inc., 82 U.S.P.Q. 2d 1385, 1391 (2007), and In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) are not violated.
For the rejections under 35 USC 103 and claims 17-19, 25, 31-33 and 36, applicant argues that for reasons a) through e) presented above and incorporated here, the rejections of these claims under 35 USC 103 falls and because the deficiencies detailed above in a) through e) are sufficient to traverse the rejection and thus requests withdrawal of the rejection. Claims 18, 19, 25, 31-33 and 36 depend directly or indirectly from claim 17.
Response: The examiner incorporates the response to arguments a) through e) here. Therefore for those responses, the rejections will be maintained below.
For the rejection of claim 20 under 35 USC 103, applicant argues that claim 20 depends on claim 17 and is allowable over the cited art for the reasons set forth above reasons a) through e) above and because the cited prior art does not teach each and every elements of claim 20 and because the deficiencies detailed above in a) through e) are sufficient to traverse the rejection and thus requests withdrawal of the rejection.
Response: The examiner disagrees and incorporates the response to arguments a) through e) above here; claim 20 is prima facie obvious over the cited art for the response/reasons presented above.
Double Patenting Rejections: Applicant is requesting that the obviousness type double patenting rejections over 19/186,888 and 17/956,270 be held in abeyance until claims are found allowable.
Response: The rejections are being maintained below because the rejections have not been overcome.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17-20, 25, 31-33, 36 and 106-114 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is new matter rejection.
Claim 17 recite “configuration of the device” in line 5 and claim 106 recite “delivery device configured” in line 2. The as filed disclosure of the invention does not envision configuring the device. Correction is respectfully requested.
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 17-20, 25, 31-33, 36 and 106-114 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites “the configuration” and “the device” in line 5 and “the gingival crevice” in line 14 and “junctional epithelium” in line 15. Claim 106 recites “the gingival crevice” in line 14 and “the junctional epithelium” in line 15.
Claim 17 recites the limitation "the configuration" and “the device” in line 5 and “the gingival crevice” in line 14 and “junctional epithelium” in line 15. Also, claim 106 recites “the gingival crevice” in line 14 and “the junctional epithelium” in line 15. There is insufficient antecedent basis for these limitations in these claims. “Device” and “configuration” and “gingival crevice” and “junctional epithelium” are the first occurrence in these claims. Correction is respectfully requested.
Claim 19 recites “a junctional epithelium” in line 2. Claim 19 depends on claim 17 which already recites junctional epithelium. It is thus unclear if the “junctional epithelium” in line 2 of claim 19 is the same as that in claim 17. Clarification and amendment is requested.
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) 17, 19, 20, 25, 31-33, 36, 106-108, 109 and 110-114 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francois (US 9271899 B2) 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; and Junctional epithelium - Wikipedia, in combination with CAVALIERE (US 20200121430 A1).
In one 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) which reads on claims 19 and 108. 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).
Dental floss or dental pick reads on device of claims 17 and 106 and the dental floss of claims 33 and 113.
Francois does not specifically state that effective amount of the allergen/antigen is deposited by the floss into gingival crevice of a subject. But, Francois teaches dental floss and dental pick 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 deposits the allergen/antigen into the spaces/groove/crevice of the gingiva. The floss deposits antigens between the teeth and gum, which is the gingival crevice and the junctional epithelium is within the gingival crevice, which is supported by claim 17.
For claims 17, 19, 20, 25, 33, 106-108, 109 and 111-114, 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 62-063) such as chitosan (column 25, line 25) with a layer comprising the chitosan meeting the limitation of mucoadhesive layer.
Therefore, Francois teaches mucoadhesive layer 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 reading on claim 25. 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 evidentiary reference 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).
The dental floss of Francois comprises excipient (column 5, line 51; column 6, line, 5 and 8). The dental floss of Francois has the structure of the floss of the examined claims.
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 and it can be said that the floss is configured to be used between the tooth and the surrounding gum. Effective amount is amount determined effective by the artisan. Francois does not teach that the coating on its floss is not uniform or consistent or does not promote adherence and does not ensure consistent delivery of the agent. It would be reasonably expected that the floss of Francois having a coating of allergen agent would predictably release agent during flossing into the junctional epithelium.
Francois teaches that allergen triggers immune response (column 6, lines 55-67) and it is inherent and predictably expected that the triggering results in activating the immune response which reads on claims 19 and 33. The floss deposits antigens between the teeth and gum, which is the gingival crevice and the junctional epithelium is within the gingival crevice, which is supported by claims 17 and 108.
Treating the floss to change the surface energy is the process of making the floss/device. Claims 17 and 106 are not directed to how the floss/device is made. There is nothing in Francois that indicates that the agent does not adhere to the floss.
Francois differs from claims 17 and 106 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.
For claims 25 and 110, the allergen is present at pg to mg (column 17, lines 27-28)
Claim 107 depends on claim 106 and claims 106 is a device and not to method of delivering allergens.
For claims 31 and 111, one of the allergens of Francois is a toxin (column 7, line 8).
For claims 32 and 112, an embodiment of Francois comprises DNA or RNA viruses as allergens/antigens (column 14, lines 20-21).
For claims 36 and 114, the dental floss/device of Francois also contains cytokine (column 16, line 63).
For claim 113, food allergens/antigen in Francois include peanuts, shellfish, eggs, milk (column 16, line 63. See also column 18, column 19, lines 13-27.
For claims 20 and 109, the claims are in the alternative, “…natural or synthetic polymers, mucoadhesive layer or hydrophilic layer, … or the delivery of antigens, … drinks water or both.” 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 62-063) such as chitosan (column 25, line 25) with a layer comprising the chitosan meeting the limitation of mucoadhesive layer. In this embodiment, the coating layer of Francois comprises polymeric delivery vehicles (column 24, lines 62-063) such as chitosan (column 25, line 25) with a layer comprising the chitosan meeting the limitation of mucoadhesive layer which thus reads on claims 20 and 109.
Therefore, Francois as evidenced by Bosshardt and Junctional epithelium - Wikipedia, in combination with CAVALIERE renders claims 17, 19, 25, 31-33, 36, 106-108 and 110-114 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 17-19, 25, 31-33, 36, 106-108 and 110-114 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 19186888 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the device of co-pending claims is used in method of triggering immune response of the examined claims 17-19, 25, 31-33, 36 and device of the co-pending claims teaches the device of the examined claims 106-108 and 110-114.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 20 and 109 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 19186888 in view of Clark, Jr. (US 20060110709 A1). The difference between claims 20 and 109, and the co-pending claims is that the co-pending claims do not teach the diameter or thickness of the dental floss or dental pick. However, it is known in the art that dental floss has average diameter of about 0.28 mm to 1.0 mmm or 0.5 mm to 3 mm (see abstract, claims 7 and 15 of Clark, Jr.). The range of 0.5 mm to 3 mm and 0.28 mm to 1.00 mm are all less than 5 mm of claim 20.
Therefore, before the effective date of the invention, the artisan would look to Clark, Jr. for a dental floss having less than 5 mm that when used for flossing would be effective to clean the crevices of the gingiva and deposit the allergen/antigen in the gingiva.
Therefore, co-pending claims in combination with Clark Jr. renders claims 20 and 109 prima facie obvious.
This is a provisional non-statutory double patenting rejection.
Claims 17-19, 25, 31-33, 36 and 106-108 and 110-114 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-14 and 60-73 of co-pending Application No. 17956270 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims of 17956270 delivers the device composition used in method of triggering immune response of the examined claims 17-19, 25, 31-33, 36 and composition device of the co-pending claims teaches the device of the examined claims 106-108 and 110-114.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 20 and 109 are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-14 and 60-73 of co-pending Application No. 17956270 in view of Clark, Jr. (US 20060110709 A1). The difference between claims 20 and 109, and the co-pending claims is that the co-pending claims do not teach the diameter or thickness of the dental floss or dental pick. However, it is known in the art that dental floss has average diameter of about 0.28 mm to 1.0 mmm or 0.5 mm to 3 mm (see abstract, claims 7 and 15 of Clark, Jr.). The range of 0.5 mm to 3 mm and 0.28 mm to 1.00 mm are all less than 5 mm of claim 20.
Therefore, before the effective date of the invention, the artisan would look to Clark, Jr. for a dental floss having less than 5 mm that when used for flossing would be effective to clean the crevices of the gingiva and deposit the allergen/antigen in the gingiva.
Therefore, co-pending claims in combination with Clark Jr. renders claims 20 and 109 prima facie obvious.
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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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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