Ex Parte Faram

Patent Trial and Appeal Board

May 8, 2017

11748907 (P.T.A.B. May. 8, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/748,907 05/15/2007 Joseph Dee FARAM CADO-33589-US 7275
50639 7590 05/10/2017
HITCHCOCK EVERT LLP
P.O. BOX 131709
DALLAS, TX 75313-1709
EXAMINER
LYDDANE, KATHRYNN M
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
05/10/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
docket @ hitchcockevert. com
eevert @ hitchcockevert .com
j tower @ hitchcockevert. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH DEE FARAM
Appeal 2016-000017
Application 11/748,9071
Technology Center 3700
Before STEFAN STAICOVICI, LEE L. STEPINA, and
ARTHUR M. PESLAK, Administrative Patent Judges.
STAICOVICI, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Joseph Dee Faram (Appellant) appeals under 35 U.S.C. § 134(a) from
the Examiner’s final decision rejecting claims 1—18, 20, and 25—29.2 We
have jurisdiction over this appeal under 35 U.S.C. § 6(b).
SUMMARY OF DECISION
We REVERSE and enter a NEW GROUND of REJECTION pursuant
to our authority under 37 C.F.R. § 41.50(b).
1 According to Appellant, the inventor, Joseph Dee Faram, is the real party
in interest. Appeal Br. 4 (filed Feb. 20, 2015).
2 Claims 19 and 21—24 are canceled. Appeal Br. 41.
Appeal 2016-000017
Application 11/748,907
INVENTION
Appellant’s invention relates to “a small-volume nebulizer that is pre­
filled with medicine and hermetically sealed until use.” Spec., para. 1.
Claims 1,10, and 18 are independent. Claim 1 is illustrative of the
claimed invention and reads as follows:
1. A pre-filled, small-volume nebulizer ready for a patient
to administer for respiratory care comprising:
a small-volume nebulizer body, wherein contained within
said small-volume nebulizer body is at least one of a siphon, a
jet, and a baffle;
an outlet opening;
a first cap removably engaged with said outlet opening;
an inlet opening;
a second cap removably engaged with said inlet opening;
a unit-dose of medication contained within said small-
volume nebulizer body.
REJECTIONS3
The following rejections are before us for review:
I. The Examiner rejected claims 1, 5, and 9 under 35 U.S.C.
§ 102(b) as being anticipated by Grychowski et al. (US
5,823,179, iss. Oct. 20, 1998) (“Grychowski”).
3 Appellant presents arguments that it would not have been obvious to
modify Grychowski based on any of Zanen (US 5,429,122, iss. July 4,
1995); Edwards (US 3,774,602, iss. Nov. 27, 1973); Eicher (US 7,802,568
B2, iss. Sept. 28, 2010); Carlin (US 4,657,007, iss. Apr. 14, 1987); and
Shick (US 6,257,231 Bl, iss. July 10, 2001). See Appeal Br. 23—30; see
also Advisory Act. (mailed Dec. 4, 2014). However, because the Examiner
has not made any rejections based on these combinations of references and
as the Examiner specifically states that the additional references are not
relied upon, Appellants’ arguments are moot and will not be addressed. See
Ans. 18—19 (mailed July 17, 2015).
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II. The Examiner rejected claims 18 and 26 under 35 U.S.C.
§ 102(b) as being anticipated by Grychowski or, in the
alternative, under 35 U.S.C. § 103(a) as being unpatentable
over Grychowski and Sladek (US 4,951,661, iss. Aug. 28,
1990).4
III. The Examiner rejected claim 2 under 35 U.S.C. § 103(a) as
being unpatentable over Grychowski and Lester (US 3,762,409,
iss. Oct. 2, 1973).
IV. The Examiner rejected claims 3 and 4 under 35 U.S.C. § 103(a)
as being unpatentable over Grychowski and Denyer et al. (US
2001/0022279 Al, pub. Sept. 20, 2001) (“Denyer”).
V. The Examiner rejected claims 6 and 7 under 35 U.S.C. § 103(a)
as being unpatentable over Grychowski and Rustad et al. (US
2004/0031485 Al, pub. Feb. 19, 2004) (“Rustad”).
VI. The Examiner rejected claim 8 under 35 U.S.C. § 103(a) as
being unpatentable over Grychowski and Komendowski et al.
(US 4,036,919, iss. July 19, 1977) (“Komendowski”).
VII. The Examiner rejected claims 10, 14, 15, and 17 under
35 U.S.C. § 103(a) as being unpatentable over Grychowski and
Rustad.
VIII. The Examiner rejected claim 11 under 35 U.S.C. § 103(a) as
being unpatentable over Grychowski, Rustad, and Lester.
4 Although the heading of this rejection mentions only Sladek, as the body of
the rejection discusses both Grychowski and Sladek, we view the
Examiner’s omission of Grychowski in the heading of the rejection as a
mere typographical error.
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Application 11/748,907
IX. The Examiner rejected claims 12 and 13 under 35 U.S.C.
§ 103(a) as being unpatentable over Grychowski, Rustad, and
Denyer.
X. The Examiner rejected claim 16 under 35 U.S.C. § 103(a) as
being unpatentable over Grychowski, Rustad, and
Komendowski.
XI. The Examiner rejected claims 20 and 25 under 35 U.S.C.
§ 103(a) as being unpatentable over Grychowski and Denyer or
over Grychowski, Sladek, and Denyer.
XII. The Examiner rejected claims 27 and 28 under 35 U.S.C.
§ 103(a) as being unpatentable over Grychowski and McMahon
et al. (US 5,579,757, iss. Dec. 3, 1996) (“McMahon”).
XIII. The Examiner rejected claim 29 under 35 U.S.C. § 103(a) as
being unpatentable over Grychowski, Rustad, and McMahon.
ANALYSIS
The Anticipation Rejection Based Upon Grychowski
Claims 1, 5, 9, 18, and 26
The Examiner finds that mouthpiece 199 of Grychowski constitutes a
first cap because it is “something that serves as a cover or protection.” Final
Act. 3 (citing Grychowski, Fig. 5) (mailed July 2, 2014). Similarly, the
Examiner finds that tubing 129 of Grychowski constitutes a second cap
because it is “something that serves as a cover or protection.” Id.
Appellant argues that “the proper construction of the term ‘cap’
requires a component that provides a seal to the inlet and outlet ports or
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openings.” Appeal Br. 10. Appellant asserts that “the meaning of ‘cap’
under the Examiner’s interpretation, would be inconsistent with the
specification in direct contradiction to the requirements of MPEP 2111.” Id.
at 13.
The Examiner responds that because the Specification does not
explicitly “disclose that the inlet port cap and the outlet port cap must seal
the inlet opening and the outlet opening” “the conventional definition5 of
‘cap’ as ‘an overlaying or covering structure,’ which does not necessarily
require that the cap makes a seal, does not conflict with the disclosure.”
Ans. 5. The Examiner further states that, moreover, “Grychowski explicitly
discloses a pre-filled small-volume nebulizer in col. 7 lines 62—63, which
necessarily (inherently) must have caps over the inlet and outlet,” in order to
create a seal so that the nebulizer of Grychowski could be transported. Ans.
11—12; see also Final Act. 4 (in regards to claim 18 the Examiner states that
“Grychowski’s nebulizer must inherently have some sort of cap to seal the
inlet and outlet which must be removed in some way.”).
Appellant replies:
(1) the Examiner’s definition of the term “cap” is an
unreasonably broad construction of the claim language; and (2)
the proper interpretation by one of ordinary skill in the art in light
of the specification would require the cap to provide a seal or at
least a fitting to close an opening.
Reply Br. 3 (filed Sept. 17, 2015). Appellant argues that, moreover, “the
Grychowski reference fails to meet the requirements necessary to support
the assertion of inherency under MPEP 2112. To be inherent, a
5 The Examiner cites to Merriam-Webster Online Dictionary.
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characteristic must be ‘a necessary feature or result of a prior-art
embodiment (that is itself sufficiently described and enabled).’” Id. at 14
(citing MPEP 2112 (quoting Toro Co. v. Deere & Co., 355 F.3d 1313, 1320
(Fed. Cir. 2004))).
It is well established that during examination, “claims ... are to be
given their broadest reasonable interpretation consistent with the
specification, [ ] and . . . claim language should be read in light of the
specification as it would be interpreted by one of ordinary skill in the art.”
In re Bond, 910 F.2d 831, 833 (Fed. Cir. 1990) (alteration in original). This
means that the words of the claim must be given their plain meaning unless
the plain meaning is inconsistent with the Specification. In re Zletz, 893
F.2d 319, 321 (Fed. Cir. 1989). In this case, an ordinary customary meaning
of the term “cap” is “a protective lid or cover for an object such as a bottle,
the point of a pen, or a camera lens.” Merriam Webster’s Collegiate
Dictionary (10th ed. 2005). As such, a “‘cap’” is more than “‘an overlaying
or covering structure’” (see Ans. 5) because it provides protection for the
object that it is covering. We thus agree with Appellant’s definition of the
term “‘cap’” as “‘a fitting for closing the end of a tube,”’ so as to protect and
not just overlie the opening.6 See Reply Br. 8. Such an interpretation is
consistent with Appellant’s Specification which describes the nebulizer as
being sealed at the top with removable cap 26 and sealed at the bottom with
removable bottom cap 30. Spec., paras. 13, 29; Fig. 1. Hence, because
Grychowski’s mouthpiece 199 and tubing 129 have open ends, these
6 Appellant cites Merriam-Webster Online Dictionary, available at
http://www.merriam-webster.com/dictionary/cap (definition of “cap” 3b).
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elements do not protect the contents of the pre-filled nebulizer (see Reply
Br. 8), and, thus, do not constitute a “first cap” and a “second cap,”
respectively, as called for by independent claims 1 and 18.
In addition, we agree with Appellant that Grychowski’s disclosure of
a pre-filled nebulizer (see Grychowski, col. 7,11. 62—63) does not necessarily
mean that both the inlet opening and the outlet opening include a cap. See
Reply Br. 17—20. Grychowski’s disclosure of a pre-filled nebulizer is for the
embodiment of Figure 1, not the embodiment of Figure 5 upon which the
Examiner relies. For Grychowski’s Figure 5 embodiment, Grychowski
discloses that reservoir 123 must be filled before operation. See
Grychowski, col. 13,11. 15—17. Hence, even if the Figure 5 embodiment was
pre-filled, as discussed above, the arrangement of reservoir 123 with respect
to the inlet and outlet openings would not necessarily require caps to close
off the openings because any liquid would not readily flow out of, or spill
out of, the openings.
More specifically, because reservoir 123 of Figure 5 of Grychowski is
below the outlet of nozzle 124 (end of inlet 128), the fluid in reservoir 123
would not readily flow out of the inlet opening and, thus, the Examiner does
not adequately explain why a cap would be necessary at the inlet opening
128. Likewise, the outlet opening at 198 in Grychowski is well above
reservoir 123 and is separated from the reservoir by wall 171 having gap 186
for aerosolized liquid, and the Examiner does not adequately explain why
such a configuration would necessarily require a cap at outlet opening 198
for transport. See Ans. 12. Thus, Grychowski does not necessarily include
caps for closing off inlet and outlet openings.
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Application 11/748,907
In conclusion, for the foregoing reasons, we do not sustain the
rejection under 35 U.S.C. § 102(b) of claims 1,5,9, 18, and 26 as
anticipated by Grychowski.
The Obviousness Rejection Based Upon Grychowski and Sladek
The Examiner finds that Grychowski discloses most of the limitations
of independent claim 18, but “does not explicitly disclose the method steps
of removing an outlet cap and replacing said outlet cap with the mouthpiece
199, or removing an inlet cap.” Final Act. 4. Nonetheless, the Examiner
relies on Sladek as teaching “a snap-on cap 12 (removably engaged cap) to
cover an opening of a valve connected to a nebulizer.” Id. (citing Sladek,
Fig. 2). The Examiner concludes that it would have been obvious “to
modify Grychowski’s method to provide a removably engaged cap, as taught
by Sladek, to the outlet and the inlet of Grychowski’s nebulizer, which
would . . . protect the pre-filled medicine within the nebulizer from being
contaminated prior to use.” Id. at 5.
Appellant asserts that Sladek discloses an adapter valve 1 having one
end that connects to a nebulizer 25 and when the nebulizer is disconnected
from the adapter valve, “a snap-on cap” 12 attached to the port of the adapter
valve is used to close the adapter valve to prevent contamination. Appeal
Br. 33; see also Sladek, Fig. 6. Thus, according to Appellant, “the snap-on
cap does not affect the nebulizer in any manner—let alone prevent
contamination of the nebulizer—and . . . the snap-on cap in Sladek is
associated solely with the second port of the adaptor valve.” Id.
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Application 11/748,907
The Examiner reiterates that the pre-filled nebulizer of Grychowski
“would have to be sealed for transporting the nebulizer to a point of patient
administration (e.g. a hospital).” Ans. 22 (citing Grychowski, col. 7,11. 62—
63). The Examiner notes that, moreover, because “Sladek teaches a snap-on
cap 12 specifically adapted to cover and seal an inlet 5 of an adapter valve 1
of a ventilator” (Sladek, col. 3,11. 39—41), any details lacking in Grychowski
are addressed by Sladek because “Sladek teaches the importance] of
positioning a snap-on cap on an inlet and outlet opening to prevent bacteria
from building up.” Id. (citing Sladek, col. 4,11. 28—32).
Appellant replies that adapter valve 1 of Sladek is a distinct
component from nebulizer 25 and that “Sladek does not teach the nebulizer
ever connecting to the snap-on cap.” Reply Br. 16. Appellant asserts that
“Sladek does not teach ‘positioning a snap-on cap on an inlet and outlet
opening’ as asserted by the Examiner,” and rather, “Sladek teaches ‘a snap-
on cap’ attached to a single port of the adapter valve.” Id. Appellant argues
that
Because the disclosure of Sladek does not teach a cap for a
nebulizer or any means to prevent contamination of a nebulizer
and Grychowski does not teach a cap—as properly interpreted—
for a nebulizer or any means to prevent contamination of a
nebulizer, there is no support for the assertion of obviousness.
Id. at 17.
We agree with Appellant that Sladek does not disclose removing an
outlet cap and an inlet cap engaged with the nebulizer as recited. Sladek
removes a single cap, i.e., cap 12 from adapter valve 1 to connect the
nebulizer 25 to adapter valve 1. See Sladek, col. 4,11. 3—8. The Examiner
does not adequately explain why a person of ordinary skill in the art would
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provide a cap on both the inlet opening and the outlet opening of the
nebulizer of Grychowski, when Sladek only discloses a single cap and that
cap is on the inlet opening of adapter valve 1, not on a nebulizer. As such,
the Examiner has failed to provide an adequate reason with rational
underpinnings explaining why, based on the teachings of Sladek, a person of
ordinary skill in the art would provide an outlet cap and an inlet cap
removably engaged with Grychowski’s nebulizer.
Accordingly, for the foregoing reasons, we do not sustain the rejection
of independent claim 18, and of claim 26 depending therefrom, as
unpatentable over Grychowski and Sladek.
The Obviousness Rejections Based Upon Grychowski, Lester, Denyer,
Rustad, Komendowski, and McMahon
The Examiner does not rely on the disclosures of Lester, Denyer,
Rustad, Komendowski, and McMahon in any manner that would remedy the
deficiency of the anticipation rejection based on Grychowski discussed
supra. See Final Act. 5—8, 14, and 15.
Therefore, for the same reasons, we do not sustain the rejections under
35 U.S.C. § 103(a) of claim 2 as unpatentable over Grychowski and Lester;
of claims 3 and 4 as unpatentable over Grychowski and Denyer; of claims 6
and 7 as unpatentable over Grychowski and Rustad; of claim 8 as
unpatentable over Grychowski and Komendowski; and of claims 27 and 28
as unpatentable over Grychowski and McMahon.
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The Obviousness Rejection Based Upon Grychowski and Rustad
Independent claim 10 recites, in relevant part, “a first cap removably
engaged with said outlet opening” and “a second cap removably engaged
with said inlet opening.” Appeal Br. 40, Claims App.
As with claim 1, the Examiner finds that Grychowski discloses a first
cap 199 and a second cap 129, because elements 199 and 129 are
“something that serves as a cover or protection.” Final Act. 9.
For the reasons discussed supra with respect to the rejection of claim
1 as anticipated by Grychowski, the Examiner’s characterization of the term
“cap” is unreasonably broad. Therefore, for the same reasons, Grychowski’s
mouthpiece 199 and tubing 129 do not constitute a “first cap” and a “second
cap,” respectively, as called for by independent claim 10. The Examiner’s
use of Rustad’s disclosure does not remedy the deficiency of Grychowski.
See Final Act. 9.
Accordingly, we do not sustain the rejection under 35 U.S.C. § 103(a)
of independent claim 10, and claims 14, 15, and 17, depending therefrom, as
unpatentable over Grychowski and Rustad.
The Obviousness Rejections Based Upon Grychowski, Rustad, Lester,
Denyer, Komendowski, and McMahon
The Examiner does not rely on the disclosures of Lester, Denyer,
Komendowski, and McMahon in any manner that would remedy the
deficiencies of Grychowski and Rustad discussed supra. See Final Act. 10-
13, 15, and 16.
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Therefore, for the same reasons, we do not sustain the rejections under
35 U.S.C. § 103(a) of claim 11 as unpatentable over Grychowski, Rustad,
and Lester; of claims 12 and 13 as unpatentable over Grychowski, Rustad,
and Denyer; of claim 16 as unpatentable over Grychowski, Rustad, and
Komendowski; and of claim 29 as unpatentable over Grychowski, Rustad
and McMahon.
The Obviousness Rejections Based Upon Grychowski, Sladek, and Denyer
The Examiner does not rely on the disclosures of Denyer in any
manner that would remedy the deficiencies of Grychowski and Sladek
discussed supra. See Final Act. 13—14.
Therefore, for the same reasons, we do not sustain the rejections under
35 U.S.C. § 103(a) of claims 20 and 25 as unpatentable over Grychowski
and Denyer, or Grychowski, Sladek, and Denyer.
NEW GROUND OF REJECTION
We make the following new ground of rejection pursuant to 37 C.F.R.
§ 41.50(b).
Claim 1 is rejected under 35 U.S.C. § 103 as being unpatentable over
Grychowski.
We adopt the Examiner’s findings regarding the nebulizer of
Grychowski, except that mouthpiece 199 of Grychowski does not constitute
a first cap and tubing 129 does not constitute a second cap. See Final Act. 3.
Nonetheless, Grychowski discloses that, “the nebulizer may be provided pre-
filled with the appropriate amount of medicine from the manufacturer.”
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Grychowski, col. 7,11. 62—63. Therefore, because Grychowski’s nebulizer
may be pre-filled, it would have been obvious for a person of ordinary skill
in the art to modify the Grychowski nebulizer to include a first cap that is
removably engaged with the outlet opening and a second cap that is
removably engaged with the inlet opening. Such a modification would have
been made to ensure the hygiene of the medicine during transport from the
manufacturer to the point of usage. Furthermore, although we appreciate
that Grychowski’s nebulizer has a tortuous flow path design that may
impede liquid flow, nonetheless, providing caps would have the additional
advantage of protecting the inlet and outlet openings from damage or
contamination prior to assembly to appropriate connectors for usage.
With respect to claims 2—18, 20, and 25—29, although we decline to
reject every claim under our discretionary authority under 37 C.F.R.
§ 41.50(b), we emphasize that our decision does not mean the remaining
claims are patentable. Rather, we merely leave the patentability
determination of these claims to the Examiner. See MPEP § 1213.02.
SUMMARY
The Examiner’s decision to reject claims 1—18, 20, and 25—29 is
reversed.
We enter a new ground of rejection of claim 1 under 35 U.S.C. § 103
as being unpatentable over Grychowski.
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
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37 C.F.R. § 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the Examiner, in which event the prosecution will be
remanded to the Examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
REVERSED: 37 C.F.R, § 41.500?)
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