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 claims 1-10 in the reply filed on 08/25/2025 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)).
Claims 11-18, 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/25/2025.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim, line 3: “and/” which should recite “and”. 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.
Claim 2 is 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 2 recites the limitation "significantly longer" in line 2. It is unclear to the examiner what the scope of “significantly longer” is in the claim. The specification fails to provide any further description or special definition of “significantly longer”. Under broadest reasonable interpretation, “significant” means “of noticeably or measurably large amount” (see attached Merriam-Webster dictionary definition). For examination purposes, the limitation is interpreted as “noticeably or measurably longer”.
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.
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) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bendory et al. (US 20200288962) [hereinafter Bendory] in view of Chan et al. (US 20170119414) [hereinafter Chan].
Regarding claim 1, Bendory discloses a device 10 for dilating a structure in an ear, nose or throat of a patient (Fig. 1A, para. 0065, 0067), the device comprising:
a handle 16 (Fig. 1A, para. 0067);
a shaft 20 extending from the handle 16 (Fig. 1A, para. 0067);
an elastic distal portion 18, 22 extending from the shaft 20 (Fig. 1A, para. 0067);
a balloon 34 disposed over at least part of the elastic distal portion (Fig. 1A, para. 0067); and
an inflation tube 102 extending from the handle 16 and coupled with the balloon 34 via an inflation lumen (Fig. 1A, para. 0067), wherein the inflation tube is bendable to form a kink in the tube (see Figs. 11A-E which illustrates that the inflation tube is bendable, and therefore capable of forming a kink in the tube; see note below in regards to functional language). However, the inflation tube of Bendory utilizes a spring-loaded inflation device (such as syringe 26, 28) (Fig. 1A, para. 0067-0068) and thereby fails to disclose wherein forming a kink in the tube would thus push inflation fluid out of the inflation tube and through the inflation lumen to inflate the balloon.
Chan in the same field of endeavor of balloon dilation devices 500 (Figs. 15A-B, para. 0102) teaches an inflation tube (interpreted bladder member 513 which is a tube having a bulbous end) extending from a handle 515 and coupled with a balloon 504 via. an inflation lumen 532 (Figs. 15A-B, para. 0101-0102), wherein the inflation tube 513 is bendable to form a kink in the tube (Figs. 15A-B, para. 0102; see note below in regards to functional language) and thus push inflation fluid out of the inflation tube 513 via. a two-way valve 516 and through the inflation lumen 532 to inflate the balloon 504 (Figs. 15A-B, para. 0102-0104). Chan further teaches that the bladder member is a known alternative to a syringe (see Figs. 14A-B, para. 0092) in the inflation device art.
The substitution of one known inflation device (bladder member and two-way valve as shown in Chan) for another (syringe as shown in Bendory) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the bladder member and two-way valve shown in Chan would have yielded predictable results, namely, an alternative way to inflate the balloon (para. 0102 of Chan).
Note: The limitation wherein the inflation tube is bendable to form a kink in the tube and thus push inflation fluid out of the inflation tube and through the inflation lumen to inflate the balloon” is interpreted as functional language that describes the intended use of the inflation tube. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Chan discloses the structural component i.e. bendable inflation tube (Figs. 15A-B, para. 0102 of Chan) to necessitate the functional language of claim 1. Since the bladder member 513 uses compression to actuate inflation fluid flow, the bladder is capable of being bent into a kink to push inflation fluid out of the inflation tube and through the inflation lumen to inflate the balloon. The examiner notes that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 2, modified Bendory discloses wherein the shaft 20 comprises a first material (para. 0075 of Bendory), wherein the elastic distal portion 18, 22 comprises a second material (para. 0067, 0075), and wherein the shaft 20 is significantly longer than the elastic distal portion 18, 22 (see 112(b) rejection above, Fig. 1A, para. 0071 of Bendory).
Regarding claim 3, modified Bendory discloses wherein the elastic distal portion 18, 22 comprises an atraumatic, ball-shaped tip 18 (Fig. 1A, para. 0067).
Regarding claim 4, modified Bendory discloses wherein the elastic distal portion comprises at least one preformed curve (Figs. 8A-E, para. 0066, 0068 of Bendory).
Regarding claim 5, modified Bendory discloses wherein the at least one preformed curve of the elastic distal portion comprises:
a first curve in a first plane (Figs. 8A-E, para. 0066, 0068 of Bendory); and
a second curve in a second plane (Figs. 8A-E, para. 0066, 0068 of Bendory).
Regarding claim 6, modified Bendory discloses wherein the balloon comprises a non-compliant balloon (para. 0019 of Bendory).
Regarding claim 7, modified Bendory discloses wherein the handle and the inflation tube are configured to be held in a single hand of a user (para. 0017, 0033, 0077 of Bendory; para. 0105 of Chan), and wherein the inflation tube is configured to be bent by one or more fingers of the single hand of the user (para. 0102, 0105 of Chan).
Regarding claim 8, modified Bendory discloses wherein the inflation tube is configured to at least partially unbend when released, thus deflating the balloon by allowing inflation fluid from the balloon to flow back into the inflation lumen and the inflation tube (para. 0104 of Chan).
Regarding claim 9, modified Bendory discloses wherein the inflation tube comprises a filling port (interpreted as opening of bladder member 513 integral with the most proximal end of shaft 502, Fig. 15A, para. 0102 if Chan).
Regarding claim 10, modified Bendory discloses wherein the shaft 20 forms the inflation lumen (Fig. 1G, para. 0079 of Bendory).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Thursday 7:30am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAUREN DUBOSE/Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771