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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant's submission filed on 12/12/2025 has been entered.
Election/Restrictions
Newly submitted claim 22 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons. Claim 22 is directed to a species in which the upper fluid and the lower fluid are delivered sequentially. However, this species is mutually exclusive to the species of claim 17 which is drawn to a species in which the upper fluid and the lower fluid are delivered simultaneously. Claim 17 was already examined. Since the Applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 22 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2013/0073015 (Rozenberg).
With respect to claim 1, Rozenberg teaches a method of concentrating an upper fluid against an olfactory region of a nasal cavity of a subject, the method comprising:
a. delivering a formulation to the olfactory region of the nasal cavity, the formulation configured to form: i. the upper fluid (the water of Rozenberg; paragraph 0175 of Rozenberg); and ii. a lower fluid (the Freon of Rozenberg; paragraph 0175 of Rozenberg), immiscible with the upper fluid at intranasal environmental conditions and having a greater density than that of the upper fluid (Freon has a greater density than water), such that the upper fluid amasses on top of the lower fluid (the water in the chamber 603 amasses on top of the Freon in the balloon 605 of Rozenberg);
wherein the formulation delivered to the olfactory region of the nasal cavity forms an upper layer comprising the upper fluid (the upper layer made of the water and the balloon 602 of Rozenberg) and a separate lower layer comprising the lower fluid (the lower layer made of Freon and the balloon 605 of Rozenberg), the upper layer impacting the olfactory region and the separate lower layer supporting the upper layer, thereby concentrating the upper fluid against the olfactory region of the nasal cavity (paragraphs 0175-0177 of Rozenberg).
With respect to claim 3, Rozenberg teaches that the upper fluid comprises a therapeutic agent (the water of Rozenberg; paragraph 0175 of Rozenberg).
With respect to claim 19, Rozenberg teaches a method of delivering a therapeutic agent to an olfactory region of a nasal cavity of a subject, the method comprising:
a. delivering a formulation to the olfactory region of the nasal cavity, the formulation configured to form: i. an upper fluid comprising the therapeutic agent (the water of Rozenberg; paragraph 0175 of Rozenberg); and ii. a lower fluid (the Freon of Rozenberg; paragraph 0175 of Rozenberg), immiscible with the upper fluid at intranasal environmental conditions and having a greater density than that of the upper fluid (Freon has a greater density than water), such that the upper fluid amasses on top of the lower fluid (the water in the chamber 603 amasses on top of the Freon in the balloon 605 of Rozenberg);
wherein the formulation delivered to the olfactory region of the nasal cavity forms an upper layer comprising the upper fluid (the upper layer made of the water and the balloon 602 of Rozenberg) and a separate lower layer comprising the lower fluid (the lower layer made of Freon and the balloon 605 of Rozenberg),
the upper layer impacting the olfactory region and the separate lower layer supporting the upper layer, thereby concentrating the upper fluid against the olfactory region of the nasal cavity and delivering the therapeutic agent to the olfactory region of the nasal cavity (paragraphs 0175-0177 of Rozenberg).
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, 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.
Claims 2 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Rozenberg.
The shape of the balloon 603 in FIG. 27 of Rozenberg is similar to the balloon 652 in FIG. 28A. The balloon 652 is shown to contact the entire nasal cavity in FIG. 28B of Rozenberg. This suggests that the balloon 603 contacts the entire nasal cavity in a similar manner. Also, Rozenberg suggests that the entire nasal cavity region should be treated (paragraphs 0111 of Rozenberg). It would have been obvious for the balloon 603 to contact the entire nasal cavity surface so as to cool the entire nasal cavity region. Thus, Rozenberg teaches that “wherein the olfactory region comprises an olfactory cleft of the nasal cavity” of claim 2 and “wherein the olfactory region of the nasal cavity comprises an underside of a cribriform plate of the nasal cavity” of claim 16.
Claims 1-3, 5, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0230700 (Chandler), in view of U.S. Patent Application Publication No. 2012/0323214 (Shantha).
Chandler teaches a method of expanding a balloon 116 located at the rear of the nasal cavity which is inflated by fluid, such as air, or a liquid, such as “saline, water, etc.” (paragraph 0084 of Chandler). Additionally, the use of the term “etc.” suggests that Shantha is disclosing other liquids are contemplated. Shantha teaches that gel is a suitable fluid to inflate a balloon (paragraph 0174 of Shantha). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use gel as the inflation liquid since (1) Chandler suggests that other fluids may be used and Shantha teaches one such fluid and/or (2) it is a simple substitution of one known element for another to obtain predictable results..
With respect to claim 1, the combination teaches or suggests a method of concentrating an upper fluid against an olfactory region of a nasal cavity of a subject, the method comprising:
a. delivering a formulation to the olfactory region of the nasal cavity, the formulation configured to form: i. the upper fluid (the medication 602 of Chandler; paragraphs 0024 and 0120 of Chandler); and ii. a lower fluid (the gel of Shantha), immiscible with the upper fluid at intranasal environmental conditions and having a greater density than that of the upper fluid (the gel of Shantha has a greater density than the medication 602 of Chandler), such that the upper fluid amasses on top of the lower fluid (the medication 602 of Chandler amasses on top of the gel of Shantha; FIG. 6E of Chandler);
wherein the formulation delivered to the olfactory region of the nasal cavity forms an upper layer comprising the upper fluid (the upper layer made of the medication 602 of Chandler) and a separate lower layer comprising the lower fluid (the lower layer made of the gel of Shantha and the balloon 116 of Chandler), the upper layer impacting the olfactory region and the separate lower layer supporting the upper layer, thereby concentrating the upper fluid against the olfactory region of the nasal cavity (FIG. 6E of Chandler; paragraphs 0115-0120 of Chandler).
With respect to claim 2, the combination teaches or suggests that the olfactory region comprises an olfactory cleft of the nasal cavity (the olfactory cleft is included in FIG. 6E of Chandler).
With respect to claim 3, the combination teaches or suggests that the upper fluid comprises a therapeutic agent (the medication 602 of Chandler).
With respect to claim 5, the combination teaches or suggests that the upper fluid delivers the therapeutic agent to the olfactory region of the nasal cavity (see the location of the medication 602 of Chandler in FIG. 6E of Chandler), and the lower fluid increases a residence time of the therapeutic agent within the nasal cavity (paragraphs 0115-0120 of Chandler and FIG. 6E of Chandler).
With respect to claim 16, the combination teaches or suggests that the olfactory region of the nasal cavity comprises an underside of a cribriform plate of the nasal cavity (see the location of the medication 602 of Chandler in FIG. 6E of Chandler).
With respect to claim 19, the combination teaches or suggests that a method of delivering a therapeutic agent to an olfactory region of a nasal cavity of a subject, the method comprising:
a. delivering a formulation to the olfactory region of the nasal cavity, the formulation configured to form: i. an upper fluid comprising the therapeutic agent (the medication 602 of Chandler; paragraphs 0024 and 0120 of Chandler); and ii. a lower fluid (the gel of Shantha), immiscible with the upper fluid at intranasal environmental conditions and having a greater density than that of the upper fluid (the gel of Shantha has a greater density than the medication 602 of Chandler), such that the upper fluid amasses on top of the lower fluid (the medication 602 of Chandler amasses on top of the gel of Shantha; FIG. 6E of Chandler);
wherein the formulation delivered to the olfactory region of the nasal cavity forms an upper layer comprising the upper fluid (the upper layer made of the medication 602 of Chandler) and a separate lower layer comprising the lower fluid (the lower layer made of the gel of Shantha and balloon 116 of Chandler),
the upper layer impacting the olfactory region and the separate lower layer supporting the upper layer, thereby concentrating the upper fluid against the olfactory region of the nasal cavity and delivering the therapeutic agent to the olfactory region of the nasal cavity (FIG. 6E of Chandler; paragraphs 0115-0120 of Chandler).
Claims 1-3, 5-6, 14-16, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2012/0323214 (Shantha).
Shantha teaches a method of expanding balloons 519 and 527 (FIG. 8 of Shantha)1. The balloons 519 and 527 can be expanded using air or liquid (paragraph 0177 of Shantha). The expanding balloon 519 can also be inflated with air, liquid, or gel (paragraph 0174 of Shantha). Thus, Shantha teaches that gel is a suitable fluid to inflate a balloon. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use gel as the inflation liquid in both the balloons 519 and 527 since it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 1, Shantha teaches or suggests a method of concentrating an upper fluid against an olfactory region of a nasal cavity of a subject, the method comprising:
a. delivering a formulation to the olfactory region of the nasal cavity, the formulation configured to form: i. the upper fluid (the liquid therapeutic agent of Shantha; the abstract, paragraphs 0059-0080, 0174-0177, 0179, 0203, and 0312 of Shantha); and ii. a lower fluid (the gel of Shantha), immiscible with the upper fluid at intranasal environmental conditions and having a greater density than that of the upper fluid (the gel of Shantha has a greater density than the liquid therapeutic agent of Shantha), such that the upper fluid amasses on top of the lower fluid (the liquid therapeutic agent of Shantha amasses on top of the gel of Shantha; FIG. 7 of Shantha);
wherein the formulation delivered to the olfactory region of the nasal cavity forms an upper layer comprising the upper fluid (the upper layer made of the liquid therapeutic agent of Shantha) and a separate lower layer comprising the lower fluid (the lower layer made of the gel and the balloons 519 and 527 of Shantha), the upper layer impacting the olfactory region and the separate lower layer supporting the upper layer, thereby concentrating the upper fluid against the olfactory region of the nasal cavity (FIG. 7 and paragraphs 0174-0177 of Shantha).
With respect to claim 2, Shantha teaches or suggests that the olfactory region comprises an olfactory cleft of the nasal cavity (the olfactory cleft is included in FIG. 7 of Shantha).
With respect to claim 3, Shantha teaches or suggests that the upper fluid comprises a therapeutic agent (the liquid therapeutic agent of Shantha).
With respect to claim 5, Shantha teaches or suggests that the upper fluid delivers the therapeutic agent to the olfactory region of the nasal cavity (see the location where the liquid therapeutic agent of Shantha is dispensed in FIG. 7 of Shantha; paragraphs 0174-0177 of Shantha), and the lower fluid increases a residence time of the therapeutic agent within the nasal cavity (paragraphs 0174-0177 of Shantha; the balloons 519 and 527 increase the residence time due to their plugging properties).
With respect to claim 6, Shantha teaches or suggests that the upper fluid delivers the therapeutic agent to an olfactory cleft of the olfactory region of the nasal cavity (see the location where the liquid therapeutic agent of Shantha is dispensed in FIG. 7 of Shantha; paragraphs 0174-0177 of Shantha), and the lower fluid at least partially obstructs a lower aspect of the olfactory cleft of the olfactory region of the nasal cavity (paragraphs 0174-0177 of Shantha; the balloons 519 and 527 partially obstruct the lower aspect of the olfactory cleft in FIG. 7 of Shantha).
With respect to claim 14, Shantha teaches or suggests that the lower fluid forms a capillary bridge at a lower aspect of an olfactory cleft of the olfactory region of the nasal cavity (the gel forms a capillary bridge along with the balloons 519 and 527 and the delivery part of the device 520 at a lower aspect of an olfactory cleft in FIG. 7 of Shantha).
With respect to claim 15, Shantha teaches or suggests that the capillary bridge contacts opposing sides of the olfactory region of the subject's nasal cavity (the capillary bridge formed by the gel, the balloons 519 and 527, and the delivery part of the device 520 contacts opposing sides of the olfactory region; see FIG. 7 of Shantha), and supports a coating of the formulation about the olfactory cleft (the capillary bridge formed by the gel, the balloons 519 and 527, and the delivery part of the device 520 supports a coating of the liquid therapeutic agent of Shantha at the location when the agent is sprayed; see FIG. 7 of Shantha and paragraphs 0174-0177 of Shantha).
With respect to claim 16, Shantha teaches or suggests that the olfactory region of the nasal cavity comprises an underside of a cribriform plate of the nasal cavity (see the location where the liquid therapeutic agent of Shantha is dispensed in FIG. 7 of Shantha; paragraphs 0174-0177 of Shantha).
With respect to claim 19, Shantha teaches or suggests that a method of delivering a therapeutic agent to an olfactory region of a nasal cavity of a subject, the method comprising:
a. delivering a formulation to the olfactory region of the nasal cavity, the formulation configured to form: i. an upper fluid comprising the therapeutic agent (the liquid therapeutic agent of Shantha; the abstract, paragraphs 0059-0080, 0174-0177, 0179, 0203, and 0312 of Shantha); and ii. a lower fluid (the gel of Shantha), immiscible with the upper fluid at intranasal environmental conditions and having a greater density than that of the upper fluid (the gel of Shantha has a greater density than the liquid therapeutic agent of Shantha), such that the upper fluid amasses on top of the lower fluid (the liquid therapeutic agent of Shantha amasses on top of the gel of Shantha; FIG. 7 of Shantha);
wherein the formulation delivered to the olfactory region of the nasal cavity forms an upper layer comprising the upper fluid (the upper layer made of the liquid therapeutic agent of Shantha) and a separate lower layer comprising the lower fluid (the lower layer made of the gel and the balloons 519 and 527 of Shantha),
the upper layer impacting the olfactory region and the separate lower layer supporting the upper layer, thereby concentrating the upper fluid against the olfactory region of the nasal cavity and delivering the therapeutic agent to the olfactory region of the nasal cavity (FIG. 7 and paragraphs 0174-0177 of Shantha).
With respect to claim 21, Shantha teaches or suggests a device for delivery of a formulation to an olfactory region of a nasal cavity, the device comprising:
a. one or more fluid reservoirs (the receptacles of the syringes 521, 522, and 526 of Shantha) configured to contain a formulation, the formulation is configured such that the formulation forms: (i) an upper layer comprising an upper fluid (the liquid therapeutic agent of Shantha; the abstract, paragraphs 0059-0080, 0174-0177, 0179, 0203, and 0312 of Shantha); and (ii) a separate lower layer comprising a lower fluid (the gel of Shantha) and supporting the upper layer, at intranasal environmental conditions, wherein the lower fluid is configured to be immiscible with the upper fluid at the intranasal environmental conditions and having a greater density than that of the upper fluid (the gel of Shantha has a greater density than the liquid therapeutic agent of Shantha), such that the upper fluid amasses on top of the lower fluid (the liquid therapeutic agent of Shantha amasses on top of the gel of Shantha; FIG. 7 of Shantha);
b. a dispensing tip (the distal section of the device 220 from the balloon 519 to the balloon 527 of Shantha) for delivering the formulation to the olfactory region, wherein the dispensing tip is coupled with the one or more fluid reservoirs (FIG. 7 of Shantha and paragraphs 0174-0177 of Shantha); and
c. a dispensing mechanism (the plungers of the syringes 521, 522, and 526 of Shantha) for exerting pressure on the upper fluid and on the lower fluid such that the upper fluid and the lower fluid each flow through the dispensing tip, thereby dispensing the formulation to the olfactory region.
Claims 1-3, 5, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/069972 (Jackson), in view of U.S. Patent Application Publication No. 2012/0323214 (Shantha).
Jackson teaches a method of expanding a balloon 4701 located at the olfactory cleft (FIG. 47A-47C and paragraph 00248 of Jackson). Shantha teaches that gel is a suitable fluid to inflate a balloon (paragraph 0174 of Shantha). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use gel as the inflation liquid since it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 1, the combination teaches or suggests a method of concentrating an upper fluid against an olfactory region of a nasal cavity of a subject, the method comprising:
a. delivering a formulation to the olfactory region of the nasal cavity, the formulation configured to form: i. the upper fluid (the liquid drug of Jackson; paragraphs 00109 and 00248 of Jackson); and ii. a lower fluid (the gel of Shantha), immiscible with the upper fluid at intranasal environmental conditions and having a greater density than that of the upper fluid (the gel of Shantha has a greater density than the liquid drug of Jackson), such that the upper fluid amasses on top of the lower fluid (the liquid drug of Jackson amasses on top of the gel of Shantha; FIG. 47A-47C and paragraph 00248 of Jackson);
wherein the formulation delivered to the olfactory region of the nasal cavity forms an upper layer comprising the upper fluid (the liquid drug of Jackson) and a separate lower layer comprising the lower fluid (the lower layer made of the gel of Shantha and the balloon 4701 of Jackson), the upper layer impacting the olfactory region and the separate lower layer supporting the upper layer, thereby concentrating the upper fluid against the olfactory region of the nasal cavity (FIG. 47A-47C and paragraph 00248 of Jackson).
With respect to claim 2, the combination teaches or suggests that the olfactory region comprises an olfactory cleft of the nasal cavity (the olfactory cleft is included in FIG. 47A-47C of Jackson).
With respect to claim 3, the combination teaches or suggests that the upper fluid comprises a therapeutic agent (the liquid drug of Jackson).
With respect to claim 5, the combination teaches or suggests that the upper fluid delivers the therapeutic agent to the olfactory region of the nasal cavity (see the location where the liquid drug of Jackson is dispensed in FIG. 47A-47C of Jackson), and the lower fluid increases a residence time of the therapeutic agent within the nasal cavity (FIG. 47A-47C and paragraph 00248 of Jackson).
With respect to claim 16, the combination teaches or suggests that the olfactory region of the nasal cavity comprises an underside of a cribriform plate of the nasal cavity (see the location where the liquid drug of Jackson is dispensed in FIG. 47A-47C of Jackson).
With respect to claim 19, the combination teaches or suggests that a method of delivering a therapeutic agent to an olfactory region of a nasal cavity of a subject, the method comprising:
a. delivering a formulation to the olfactory region of the nasal cavity, the formulation configured to form: i. an upper fluid comprising the therapeutic agent (the liquid drug of Jackson; paragraphs 00109 and 00248 of Jackson); and ii. a lower fluid (the gel of Shantha), immiscible with the upper fluid at intranasal environmental conditions and having a greater density than that of the upper fluid (the gel of Shantha has a greater density than the liquid drug of Jackson), such that the upper fluid amasses on top of the lower fluid (the liquid drug of Jackson amasses on top of the gel of Shantha; FIG. 47A-47C and paragraph 00248 of Jackson);
wherein the formulation delivered to the olfactory region of the nasal cavity forms an upper layer comprising the upper fluid (the liquid drug of Jackson) and a separate lower layer comprising the lower fluid (the lower layer made of the gel of Shantha and the balloon 4701 of Jackson),
the upper layer impacting the olfactory region and the separate lower layer supporting the upper layer, thereby concentrating the upper fluid against the olfactory region of the nasal cavity and delivering the therapeutic agent to the olfactory region of the nasal cavity (FIG. 47A-47C and paragraph 00248 of Jackson).
Allowable Subject Matter
Claims 17-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter.
With respect to claim 17, the prior art does not teach or suggest “wherein the upper fluid and the lower fluid are delivered simultaneously” along with the other features of claim 17.
Claim 18 is allowable by virtue of its dependence from claim 17.
Response to Arguments
The Applicant’s arguments with respect to the rejection of claims 1-3, 5-6, 14-16, 19, and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. That is, there are new grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 Shanta refers to the distal balloon in FIG. 7-9 as the balloon 527 in FIGS. 8-9 and paragraphs 0177-0181 and refers to the same balloon as the balloon 525 in paragraph 0176. However, it is clear that the same balloon is being referred to. For simplicity, this Office Action will refer to the distal ballon of Shantha as the balloon 527.