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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/11/25 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-35 are rejected under 35 U.S.C. 103 as being unpatentable over McCuiston et al. (US 2,987,261) (“McCuiston”) in view of Montgomery (US 2008/0197097) further in view of Ko-Wen (US 6,241,705).
McCuiston discloses: (Fig. 1) A nasal irrigation device comprising: a) a container 1 comprising a top end, a bottom end, a bottom surface, an upper portion and a lower portion, the top end defining a neck portion comprising an inner surface and an outer surface; c) a nozzle 2 comprising an opening, a top portion, a middle portion and a bottom portion, the nozzle defining a passageway therethrough, the top portion of the nozzle defining a tip, the nozzle engaging with a thermoplastic elastomer sealing ring (see claim 1) (claim 29) of the inner cap and (claim 11) tip of the nozzle is capable of fitting within a nostril of a patient; and d) a tube 6 having a top end and a bottom end, the top end of the tube engaging with the bottom portion of the nozzle and the bottom end of the tube extending within the container from the top end of the container toward the bottom end of the container.
The b) an inner cap area of McCuiston is not modular. However, Montgomery, in the analogous art, teaches a typical modular bottle system (Fig. 1). Taken from this system is the inner cap 19 to modify the inner cap as shown in McCuiston Fig. 1, below. The inner cap of Montgomery comprises an inner surface, an outer surface, a top end and a bottom end, the inner cap comprising a sealing ring proximal to the top end of the inner cap; (claim 28) the inner cap comprises ABS—design choice
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The middle portion of the nozzle of McCuiston does not directly define a ball joint, wherein the angle of the nozzle is adjustable relative to the container when the nasal irrigation device is assembled. The nasal irrigator having an adjustable tip via a ball joint is taught by Ko-Wen, see Figs. 2-3.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of McCuiston with the modular parts of Montgomery as well known in the art and with the adjustable tip as taught by Ko-Wen to easily use the device. (see also US 2016/0114096 providing for adjustable irrigation).
(claim 2) Montgomery further teaches: the outer surface of the neck portion comprises a first fitting and the inner surface of the inner cap comprises a second fitting, wherein the first fitting and the second fitting are designed to releasably engage with each other. (Fig. 1, [0035]). Further, (claim 3) the fittings being reversed, as in claim 3 would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167. (claims 30-33) Threaded engagement versus a snap fit engagement are obvious substitutions well known in the art.
(claim 6) Montgomery further teaches an outer cap 18 capable of engaging with the outer surface of the inner cap 19, Fig. 1.
(claim 7) a time management strip attached to the bottom surface of the container [0014-0015]
Ko-Wen further teaches: (claim 4) the nozzle is adjustable relative to the container when the nasal irrigation device is assembled based on a rotational position of the ball joint relative to the sealing ring of the inner cap. (see Figs. 1-3)
(claims 34-35) upon engagement of the ball joint with the sealing ring the nozzle comprises multidirectional positioning capabilities; the nozzle is positioned to irrigate in at least one of a superior or inferior arrangement. See Figs. 1-3
McCuiston further discloses:
(claims 5, 24) the opening (tip of the nozzle) has a stellate shape; (claim 12) semicircular shape; (claim 13) comprised of rubber or a thermoplastic elastomer. Design choice. (claims 14-16) tip is in the shape of a reverse taper and has a safe and comfortable nasal fit, see Fig. 3.
(claims 8-10) the container 1 is comprised of a flexible polymer (low density polyethylene LDPE) C1L11-16; polymer comprises zinc or silver—design choice
(claims 17-18) the middle portion of the nozzle is comprised of plastic (acrylonitrile butadiene styrene ABS)—threads, design choice, Fig. 1
(claims 19-23) the container further comprises a liquid 5, and wherein the nozzle is capable of varying the amount of the liquid passing through the nozzle.
the liquid is a saline solution; the container further comprises a flexible sidewall;
the container further comprises a liquid, and wherein the nozzle is configured to create a turbulent stream of liquid exiting the nozzle when the sidewall is squeezed;
the container further comprises a liquid, and wherein the nozzle is configured to create a level of turbulence in a stream of liquid exiting the nozzle when the sidewall is squeezed, such that the turbulent stream of liquid is directed toward and sufficient to enter and flush at least a substantial portion of a sinus passage. C1L9-C2L42
(claims 25-26) the tip of the nozzle defines an opening that increases surface area dispersion and intranasal turbulence; the surface area dispersion and intranasal turbulence are sufficient to generate a flooding mechanism for irrigation of a sinus cavity. C1L9-C2L42
(claim 27) the upper portion of the container is angled relative to the lower portion of the container. Fig. 1
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 9:00am-5:30pm est.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783