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 elected species (i) of group (a), (i) of group (b), (i) of group (c), and (i) of group (d).
Claims 4, 5, 9-12 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 1/15/2026.
Claims 1-3, 6-8, and 13-15 are currently examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “the first zone will separate from the center such fluid can flow” in line 8. This should be corrected to -- such that--.
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 13-15 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 13 recites “the second zone being between the first zone and the second zone”, which would not be possible. In an effort to promote compact prosecution, this limitation is interpreted as the second zone being between the first zone and the third zone.
Claims 14-15 are rejected via their dependency on claim 13.
Claim Rejections - 35 USC § 102
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 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, 6, and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being by anticipated by Gerber et al (US 2003/0173380 A1).
Regarding claim 1, Gerber discloses a nozzle for an eye dropper (Figs. 1-2; Abstract) comprising:
a center (seat 104 beneath seal 108) configured to affix to a reservoir at a proximal end of the center (container 102; ¶ 23) and having a distal end opposite the proximal end (at exit port 106 and at the top of the seat 104 near cap 112);
a sleeve extending around the center (seal 108) and having a first zone, second zone, and third zone, the first zone being positioned closer to the proximal end than the second zone and the third zone being positioned closer to the distal end than the second zone (see annotated Fig. 2 below).
Further, the limitations of: wherein at least a portion of the first zone has a first expansion pressure at which the at least portion of the first zone will separate from the center such that fluid can flow between the at least the portion of the first zone and the center; wherein at least a portion of the second zone has a second expansion pressure at which the at least the portion of the second zone will separate from the center such that the fluid can flow between the at least the portion of the second zone and the center; wherein at least a portion of the third zone has a third expansion pressure which the at least the portion of the third zone will separate from the center such that the fluid can flow between the at least portion of the third zone and the center; and wherein the second expansion pressure is less than the first expansion pressure; are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Gerber. As such, it is capable of performing the functions as claimed (i.e. the zones of the seal would be configured to be overcome by fluid pressure, causing them to expand, thus comprising expansion pressures, and expanding such that fluid flows from the first zone, to the second zone, and then to the third zone, and said zones collapse after the fluid has been delivered (¶ 23 describes how the seat 104 is engaged with elastomeric seal 108; ¶s 41-43 describe how the seal 108 is moved off the seat 104 by pressure from the fluid, thus comprising an expansion pressure where the zones will separate from the center such that fluid can flow; ¶s 11-12 and 39-41 describes a progressive seal configuration to force fluid distally away from the exit port, i.e. from the first zone towards the second zone and third zone, upon closure and restricts backflow, thus having progressively lower expansion pressures).
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Regarding claim 2, Gerber discloses the sleeve is made of a more flexible material than the center (¶s 23 and 28-29 describes the seal 108 as elastomeric while ¶ 27 indicates the seat is a hard plastic; ¶ 33 also describes how the retainer 110 compresses the seal 108 against the seat 104 to form a seal with the seat functioning as a rigid backing).
Regarding claim 3, Gerber discloses the center is cylindrical (Figs. 2 and 4A-B show the center 104 having a cylindrical portion, e.g. at the first zone as marked in annotated Fig. 2 above).
Regarding claim 6, Gerber discloses the third expansion pressure is less than the second expansion pressure (¶s 11-12 and 39-41 describes a progressive seal configuration to force fluid distally away from the exit port, i.e. from the first zone towards the second zone and subsequently the third zone, upon closure and restricts backflow).
Regarding claim 13, Gerber discloses a nozzle for an eye dropper (Figs. 1-2; Abstract) comprising:
a first zone, second zone, and third zone, the second zone being between the first zone and the third zone (see annotated Fig. 2 below) and the first zone configured to receive fluid from a reservoir (via exit port 106; ¶ 23).
Further, the limitations of:
the first zone, the second zone, and third zone configured such that:
in response to pressurization of the fluid from the reservoir:
the fluid overcomes a first expansion pressure of the first zone and the fluid flows through the first zone;
the fluid overcomes a second expansion pressure of the second zone such that the fluid flows into the second zone and expands the second zone to form a chamber; and
the fluid overcomes a third expansion pressure of the third zone in combination with expansion of the third zone induced by expansion of the second zone and causes the fluid to flow through the third zone; and
in response to depressurization of the fluid from the reservoir:
the first zone collapses; and
following (iv), the fluid reservoir continues to flow out of the second zone and the third zone such that backflow into the reservoir is reduced.
are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Gerber. As such, it is capable of performing the functions as claimed (i.e. the zones of the seal would be configured to be overcome by fluid pressure, causing them to expand such that fluid flows between zones, and said zones collapse after the fluid has been delivered; ¶s 11-12 and 39-41).
Regarding claim 14, the limitations of wherein the nozzle is configured such that “(ii) occurs after (i) and (iii) occurs after (ii) are considered functional language. While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does. See MPEP 2112.02. Thus, if a prior art structure is capable of performing the intended use as recited the claim, then it meets the claim. In the instant case, the device of Gerber. As such, it is capable of performing the functions as claimed (i.e. the zones of the seal would be configured to be overcome by fluid pressure, causing them to expand such that fluid flows from the first zone, to the second, and then third zones; ¶s 11-12 and 39-41).
Regarding claim 15, Gerber further discloses the first expansion pressure is greater than the second expansion pressure (¶s 11-12 and 39-41 describes a progressive seal configuration to force fluid distally away from the exit port, i.e. from the first zone towards the second zone and third zone, upon closure and restricts backflow, indicating a progressive expansion pressure gradient).
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gerber, as applied to claim 1 above, and further in view of Pardes (US 2009/0152306 A1).
Regarding claim 7, Gerber teaches at least a portion of the first zone has a first thickness extending outwardly from the center, at least portion of the second zone having a second thickness extending outwardly from the center, and the at least the portion of the third zone having a third thickness (Figs. 1-2 show the entire seal 8 having a thickness) and the seal below the exit port being thicker than the seal above the exit port in order to direct fluid upward (¶s 14 and 30-31), but does not explicitly teach the first thickness being less than the third thickness.
However, Pardes teaches a one-way valve nozzle system (Figs. 1 and 4A), thus being in the same field of endeavor, where a membrane (flexible membrane 13) is disposed around a center (core 10) and where the thickness of the membrane is used to control cracking pressure in the direction of flow (¶ 10).
Thus, Pardes shows that a variable thickness membrane is an equivalent structure known in the art. Therefore, because these membrane valve means were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the different thickness membrane configuration of Pardes for the original membrane configuration of Gerber. Doing so with thus comprise the second thickness being less than the first thickness (i.e. in order to maintain the distally directed flow originally disclosed by Gerber).
Regarding claim 8, the combination of Gerber and Pardes substantially discloses the invention of claim 7.
As previously stated, Pardes shows that a variable thickness membrane is an equivalent structure known in the art. Therefore, because these membrane valve means were art-recognized equivalents before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to substitute the different thickness membrane configuration of Pardes for the original membrane configuration of Gerber. Doing so with thus comprise the third thickness being less than the first thickness (i.e. in order to maintain the distally directed flow originally disclosed by Gerber).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781
/GUY K TOWNSEND/ Primary Examiner, Art Unit 3781