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 of Species iii (fig. 19-23) in the reply filed on 2/2/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Specification
The disclosure is objected to because of the following informalities: on paragraph [001] the parent application number and its corresponding patent number must be added.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
On lines 15-16, “the cross-sectional area of the balloon” should be -- a cross-sectional area of the balloon--. Appropriate correction is required.
On lines 16-17, “the relatively smaller cross-sectional area at the lateral end” should be -- a relatively smaller cross-sectional area at the lateral end—
On line 18, “the relatively larger cross-sectional area at the medial end” should be -- a relatively larger cross-sectional area at the medial end —
Claim 4 is objected to because of the following informalities: on line 2 “a lateral wall of a nasopharynx” should be –the lateral wall of the nasopharynx--. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: on line 2 “a lateral wall of a nasopharynx” should be –the lateral wall of the nasopharynx--. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: on line 2 “a lateral wall of a nasopharynx” should be –the lateral wall of the nasopharynx--. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: on line 2 “a Eustachian tube” should be –the Eustachian tube --. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-10 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 recites the limitation "the distal end" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Furthermore, it is unclear to the examiner if applicant is referring to the lateral end which is seen in the original disclosure as component 236 in Fig. 21 which appears to be the distal end of the device.
It appears to the examiner that applicant is referring to the lateral end in view of the specification therefor the limitation will be interpreted as “the lateral end” for purposes of this office action.
Note that claim 10 also recites “the distal end of the balloon” in line 2 and it will be interpreted as –the lateral end of the balloon—for purposes of this office action.
Claim 10 recites the limitation "the proximal end" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Furthermore, it is unclear to the examiner if applicant is referring to the medial end which is seen in the original disclosure as component 232 in Fig. 21 which appears to be the proximal end of the device.
It appears to the examiner that applicant is referring to the medial end in view of the specification therefor the limitation will be interpreted as “the medial end” for purposes of this office action.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Muvhar (2006/0030920) in view of Nagasrinivasa et al. (2017/0304595).
Claim 1:
Ben-Muvhar discloses a balloon comprising a high-pressure balloon (200) (Fig. 2 and [0040-41]) having a body (Fig. 2) that includes a medial end (220) (Fig. 2 and [0040]) configured for being positioned in and/or next to the medial portion of the eustachian tube (where it is capable of performing this function), and a lateral end (210) (Fig. 2 and [0040]) configured to be positioned in and/or next to the lateral portion of the eustachian tube (where it is capable of performing this function), the balloon including a longitudinal axis (see figure below) extending from the medial end to the lateral end (see figure below), an exterior surface (see figure below), an interior surface (surface inside that is connected to the channel portion of the catheter ([0040]) and receives the fluid to inflate) defining an air receiving interior ([0040]), a lateral cross-sectional profile (Fig. 2 where it has a lateral cross-section profile), and a longitudinal cross-sectional profile (Fig. 2 where it has a longitudinal cross-section profile), wherein the balloon is inflatable between a deflated configuration and an inflated configuration ([0040]), the body being capable of retaining its desired size and shape when in the inflated configuration (Fig. 2 and [0040-41]), and wherein the cross-sectional area of the balloon increases along the longitudinal axis from the relatively smaller cross-sectional area at the lateral end (Fig. 2 and [0040]), to the relatively larger cross-sectional area at the medial end (Fig. 2 and [0040]), wherein the balloon is configured to uniformly expand the eustachian tube when in the inflated configuration (where it is capable of performing this function).
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
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Ben-Muvhar discloses all the claimed limitations discussed above, however Ben-Muvhar is silent with regards to the body having an ovaloid lateral cross-section.
Nagasrinivasa discloses another well-known balloon catheter having an expandable balloon (20) which can include any suitable cross-sectional shape or combination of cross-sectional shapes in a plane that is transverse to the longitudinal axis , e.g., round, oval, rectangular, triangular, etc. ([0055]). Thus, Nagasrinivasa discloses that these arrangements for the lateral cross-section of the body is well known equivalents in the art.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the body of Ben-Muvhar to have an ovaloid lateral cross-section, as taught by Nagasrinivasa, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim 2: Ben-Muvhar discloses that the balloon includes a first height dimension (see figure above) and a first width dimension (see figure above), and wherein the first height dimension is larger than the first width dimension (see figure above).
Claims 3 and 5: Ben-Muvhar discloses that the balloon includes a bell-shaped medial end (see figure above).
Claims 4, 6, and 7: Ben-Muvhar discloses that the bell-shaped medial end comprises a trumpet-bell-shaped medial end (see figure above) configured for engaging a lateral wall of a nasopharynx (where it is capable of performing this function).
Claim 8: Ben-Muvhar discloses that the medial end of the balloon is sized and configured for engaging a lateral wall of a nasopharynx (where it is capable of performing this function).
Claim 9: Ben-Muvhar discloses that the balloon is configured to expand a cross sectional area of a Eustachian tube (where it is capable of performing this function).
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gianotti et al. (2013/0237950) in view of Nagasrinivasa et al. (2017/0304595).
Claim 1:
Gianotti discloses a balloon comprising a high-pressure balloon (140) (Fig. 4-5a and [0154]) having a body (Fig. 5a) that includes a medial end (see figure below) configured for being positioned in and/or next to the medial portion of the eustachian tube (where it is capable of performing this function), and a lateral end (see figure below) configured to be positioned in and/or next to the lateral portion of the eustachian tube (where it is capable of performing this function), the balloon including a longitudinal axis (see figure below) extending from the medial end to the lateral end (see figure below), an exterior surface (outer surface of the balloon seen in Fig. 4), an interior surface (inner surface of the balloon seen in Fig. 4) defining an air receiving interior (35) (Fig. 4 and [0069]), a lateral cross-sectional profile (Fig. 5a where it has a lateral cross-section profile), and a longitudinal cross-sectional profile (Fig. 5a where it has a longitudinal cross-section profile), wherein the balloon is inflatable between a deflated configuration and an inflated configuration ([0070]), the body being capable of retaining its desired size and shape when in the inflated configuration (Fig. 5a where it is capable of retaining the size), and wherein the cross-sectional area of the balloon increases along the longitudinal axis from the relatively smaller cross-sectional area at the lateral end (see figure below), to the relatively larger cross-sectional area at the medial end (see figure below), wherein the balloon is configured to uniformly expand the eustachian tube when in the inflated configuration (where it is capable of performing this function).
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
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Gianotti discloses all the claimed limitations discussed above, however Gianotti is silent with regards to the body having an ovaloid lateral cross-section.
Nagasrinivasa discloses another well-known balloon catheter having an expandable balloon (20) which can include any suitable cross-sectional shape or combination of cross-sectional shapes in a plane that is transverse to the longitudinal axis , e.g., round, oval, rectangular, triangular, etc. ([0055]). Thus, Nagasrinivasa discloses that these arrangements for the lateral cross-section of the body is well known equivalents in the art.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the body of Gianotti to have an ovaloid lateral cross-section, as taught by Nagasrinivasa, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim 2: Gianotti discloses that the balloon includes a first height dimension (see figure above) and a first width dimension (see figure above), and wherein the first height dimension is larger than the first width dimension (see figure above).
Claims 3 and 5: Gianotti discloses that the balloon includes a bell-shaped medial end (see figure above).
Claims 4, 6, and 7: Gianotti discloses that the bell-shaped medial end comprises a trumpet-bell-shaped medial end (see figure above) configured for engaging a lateral wall of a nasopharynx (where it is capable of performing this function).
Claim 8: Gianotti discloses that the medial end of the balloon is sized and configured for engaging a lateral wall of a nasopharynx (where it is capable of performing this function).
Claim 9: Gianotti discloses that the balloon is configured to expand a cross sectional area of a Eustachian tube (where it is capable of performing this function).
Claim 10: Gianotti further discloses a longitudinally extending guide member (110) having a distal end (see figure below) disposed adjacent to the lateral end of the balloon (see figure below), a balloon engaging portion (see figure below) that extends through the balloon (see figure below) and out of the medial end of the balloon (see figure below), and a proximal portion (see figure below which extends to the handle 103 seen in Fig. 1a) having a length (Fig. 1a) sufficient to include a proximal end (end at 103 in Fig. 1a) that can be positioned exteriorly of a patient’s nasal cavity when the balloon is positioned in the Eustacian tube (where it is positioned outside the patient and it is capable of performing this function).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art appears to teach the claimed limitations when considered in combination.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/ Primary Examiner, Art Unit 3771