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 .
Election/Restrictions
Applicant’s election without traverse of species A in the reply filed on 11 January 2026 is acknowledged.
Claims 2 and 6-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11 January 2026. The Examiner notes that the subject matter of claim 2, the distal balloon assembly being inserted through the mouth, is only described in the specification as originally filed as belonging to the embodiment of figure 1A, not figure 1, such that Applicant’s recitation of withdrawn claims was incomplete but as this claim clearly falls into species B it is also withdrawn.
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Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “101a/A” has been used to designate both a distal carrier disc and a “device”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "100", "101-A", and “200” have all been used to designate “the device”. If these refer to different embodiments the specification should clearly set forth how the different embodiments relate to each other. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because figure 2 includes an unclear label which does not appear to correspond to either of a dimension or an object, and additional entirely unclear marks.
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The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “attachments” which laterally support the distal balloon assembly must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 3-5 are objected to because of the following informalities:
Claim 1 does not meet the requirements of 37 CFR 1.121 for making amendments as the newly presented claims do not show all changes made to the claim; the claims filed 11 January 2026 do not include the alphabetical labels of elements of the device that are part of the originally filed claims. It is not clear what other changes may have been made to this claim and the remainder of claims that also do not comply with this requirement, as no other changes are labeled but given this clear breech it is likely other issues have also been included. Future submissions should follow all requirements of 37 1.121 or may be considered non-responsive; in the interest of expediting prosecution the claims filed 11 January 2026 will be considered this time only but future submissions will not be given this exception.
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Further, the claims appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors. These include but are not limited to
Claim 1, “lower end of nasopharynx region”, “comprising proximal carrier disc”
Claim 5, “wherein double lumen catheter further comprises”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
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 1, 3-5 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 1’s preamble refers to “the upper respiratory tract” – as no frame of reference such as a human body which would inherently have such a tract has been provided, there is no antecedent basis for this limitation in the claim; it should refer to “an upper respiratory tract”.
Claim 1 recites both “nasopharynx region” with no article and also “the soft palate”; each of these should refer to a body part when first recited, unless context is provided that the device is configured for use relating to the upper respiratory tract of a subject/user/person, where each could then refer to the soft palate of the user.
Claim 1 recites “a distal balloon mounted watertight by the distal balloon” – it is unclear how the element can be defined by itself, or if some other component has been omitted by mistake.
Claim 1 recites “the nostril” and also “one of the nostrils”; it is unclear if these refer to the same nostril or different nostrils. Further, there is no antecedent basis for the reference to “the nostril” and this should refer to a nostril unless defined as the nostril of the user, as noted above.
Claim 1 recites that a catheter “inflates the distal balloon by injecting air or water”; as the claims are directed to a device, this method step should be recited as defining the structure of the device, not an activity that is performed. For the purposes of examination the claim will be treated as though reciting “is configured to inflate the distal balloon”.
Claim 1 recites the limitation “the flexible rod”. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the liquid". There is insufficient antecedent basis for this limitation in the claim. It is unclear if this refers to the “air or water” defined earlier, though only one of these is a liquid, or some other liquid. Clarification is required.
Claim 1 recites “the confined cavity”. There is insufficient antecedent basis for this limitation in the claim. It is unclear which of the numerous structures is considered “the confined cavity”. Clarification is required.
Claim 1 calls for an agitator to be “used for agitation of the liquid into the confined cavity”; it is unclear if the intent is for the agitation to cause the liquid to be moved in to the cavity, or for the agitation to take place within the cavity, that is agitation of the liquid in the confined cavity, particularly as it is unclear what the liquid is or where the cavity is, or where the liquid might originate if it is actually being agitated into the cavity as it must inherently have some other presence prior to actively entering the cavity. Clarification is required.
Claim 3 recites “double lumen catheter”; as this appears to reference the double lumen catheter defined in claim 1 it should refer to the double lumen catheter.
Claim 4 recites that the distal balloon “is inflated” and the proximal balloon also “is inflated”; it is unclear if this is an active method step or defines how the balloons are formed into balloons when the device is made. For the purposes of examination each will be treated as though reciting “is configured to be inflated”; clarification is required.
Claim 4 defines that the proximal balloon “is inflated through one or more balloon inflation tubes (108a and 108b)”. Claim 1 already defines “a balloon inflation tube (108)” for the proximal balloon – does the device have three balloon inflation tubes? Or is balloon inflation tube 108 actually two tubes 108a and 108b? Clarification is required.
Claim 5 recites that “said distal balloon assembly (101) is supported laterally at the soft palette”; per claim 1 the distal balloon assembly is “mounted watertight by the distal balloon at the lower end of nasopharynx region above the soft palate”. The location of intended use of the distal balloon assembly is unclear, as being above the soft palate precludes the balloon from also being at the soft palate. For the purposes of examination the claim will be treated as though defining that the balloon assembly is supported laterally with one or more attachments; clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 3-5 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Numerous claims positively recite the human body; for example:
Claim 1:
“a distal balloon mounted watertight by the distal balloon at the lower end of nasopharynx region above the soft palate” should recite “a distal balloon configured to be mounted watertight by the distal balloon at the lower end of a/the nasopharynx region above the soft palate”
“a balloon inflation tube mounted watertight by the proximal balloon inside the nostril” should recite “a balloon inflation tube configured to be mounted watertight by the proximal balloon inside the nostril”
“a double lumen catheter connected to the distal balloon in one of the nostrils” should recite “a double lumen catheter configured to be connected to the distal ballon in one of the nostrils”
Claim 5: “said distal balloon assembly is supported laterally at the soft palate” should recite “said distal balloon assembly is configured to be supported laterally at the soft palate”
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.
Claim(s) 1, 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Makower (US 2008/0097295) in view of Chang (US 2008/0097516).
Regarding claim 1, Makower discloses a device for collection of one or more biological samples, scavenging and for drug delivery in the upper respiratory tract (paragraphs [0127], [0158]), the device comprising:
a distal balloon assembly (element 18) mounted watertight at the lower end of nasopharynx region above the soft palate (paragraph [0128]);
a proximal balloon assembly or nose plug assembly (element 14) comprising a balloon inflation tube (element 52) mounted watertight by the proximal balloon inside the nostril (paragraph [0128]);
a double lumen catheter (element 16) connected to the distal balloon in one of the nostrils and inflates the distal balloon (102) by injecting air or water (paragraph [0128]); and
an “agitator” mounted on a flexible rod used for agitation of a liquid in the confined cavity (paragraph [0128], “a catheter, fluid injector or other elongate device examples of which are shown in FIGS. 5A-5Y'''' and described herebelow” and “a result of the injection of matter (e.g., contrast medium, irrigation solution, medicament, etc.) into the operative field and/or suctioning or removal of matter (e.g., blood, other fluid or debris) from the operative field”; paragraph [0158], “these working devices include guide catheters, substance delivery catheters, scopes, injectors”; paragraph [0160]; paragraph [0228]; any of injecting or removing fluid from the cavity causes “agitation” of that fluid”).
Makower does not disclose each of the balloon assemblies comprising a carrier disc and a balloon; Chang teaches a device for use in an upper respiratory tract (abstract) comprising a balloon assembly used for sealing a nasal passage comprising a carrier disc and a balloon (see annotated figure 2F).
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It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Makower with the balloon assemblies each comprising carrier discs and balloons, as taught by Chang, in order to ensure the assemblies achieve their desired shapes upon inflation.
Regarding claim 3, Makower further discloses that the double lumen catheter further comprises an outer tube and an inner tube (figure 2C, one of 50, 52 is “outer” or further away relative to the other depending upon a viewer’s orientation).
Regarding claim 4, Makower further discloses that said distal balloon is inflated by water or air and the proximal balloon is inflated through one or more balloon inflation tubes (paragraph [0128]).
Regarding claim 5, Makower further discloses that said distal balloon assembly is supported laterally with one or more attachments (figure 2A, contact between the ballon and body provides “lateral” support depending upon a viewer’s orientation, where the ballon serves as “attachment”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 11103378 to Irwin, US 10016580 to Chandler, US 6394093 to Lethi, US 3766924 to Pidgeon, which disclose similar devices
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at 571-272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN E TOTH/Examiner, Art Unit 3791