Ex Parte 7955614 et al

Patent Trials and Appeals Board

Jul 1, 2019

95002099 - (R) (P.T.A.B. Jul. 1, 2019)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
95/002,099 08/24/2012 7955614 091505-0022/8002.US 1171
108547 7590 07/01/2019
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001
EXAMINER
JASTRZAB, KRISANNE MARIE
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
07/01/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

NANO PRECISION MEDICAL
Requester and Appellant

v.

DELPOR, INC.
Patent Owner and Respondent
____________

Appeal 2018-003281
Reexamination Control 95/002,099
Patent 7,955,614 B2
Technology Center 3900
____________

Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
RAE LYNN P. GUEST, Administrative Patent Judges.

Opinion for the Board filed by GUEST, Administrative Patent Judge.

Opinion Dissenting-in-part filed by FREDMAN, Administrative Patent
Judge.

DECISION ON REHEARING

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STATEMENT OF THE CASE
United States Patent 7,955,614 B2 (hereinafter the “’614 Patent”),
which is the subject of the current inter partes reexamination, issued to
Francis J. Martin and Anthony A. Boiarski on June 7, 2011.
On September 27, 2018, the Patent Trial and Appeal Board issued a
Final Decision on Appeal (“Final Decision”). The Decision incorporated the
First Decision on Appeal (“First Decision”), mailed August 9, 2016, and
maintained the following new grounds rejecting claims 1, 4-6, 8-16, 19, and
30 of the ’614 patent (Final Decision 43-44) that were first set forth in the
First Decision:
Claims 1, 10-16, 19, and 30 under 35 U.S.C. § 102(b) as anticipated
by Desai;1
Claims 1, 9, 10-16, 19 and 30 under 35 U.S.C. § 103(a) as being
unpatentable over Desai alone or further in view of Wong;2
Claims 4-6, and 8 under 35 U.S.C. § 103(a) as being unpatentable
over Desai in view of Atkinson.3
On October 26, 2018, Patent Owner, Nano Precision Medical,
requested rehearing of the rejections of claims 1, 4-6, 8-16, 19 and 30.
Patent Owner’s Request for Rehearing (“Rh’g Req.”) 1. Third-Party

1 Tejal A. Desai et al., “Characterization of micromachined silicon membranes
for immunoisolation and bioseparation applications,” J. Membrane Sci.,
Vol. 159, pp. 221-231 (1999) (“Desai”).
2 WO 01/30323 A2, published May 3, 2001, and naming Vernon G. Wong,
et al. as inventors (“Wong”).
3 U.S. Patent 5,443,461, issued August 22, 1995, to Linda E. Atkinson et al.
(“Atkinson”).
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Requester, Delpor, Inc. (“Requester”), filed Comments in accordance with
37 C.F.R. § 41.79(c) (“Req. Comments”) on November 21, 2018.
In accordance with § 41.79(b)(1), the party requesting rehearing must
“state with particularity the points believed to have been misapprehended or
overlooked in rendering the Board’s decision” and that new arguments are
not permitted.
Patent Owner contends the following items were misapprehended or
overlooked:
1. the case law cited by Petitioner and/or the Board in the First
Decision does not support a finding that the drug recited in the
claim is either the material worked upon or an intended use of the
drug delivery device (Rh’g Req. 8, 20-21);
2. in the First Decision, the Board inconsistently found the drug is a
structural limitation on the size of the capsule reservoir but does
not further limit the pore size of the nanopore membrane (Rh’g
Req. 10);
3. Desai does not show or suggest a device with a drug in an amount
sufficient for therapy because the only drug taught for use with the
device of Figure 5 is IgG which requires a fairly large dosage for
human therapy (Rh’g Req. 12-13);
4. the Board improperly relied on inherency to show that the drug is
necessarily met by reference to “any drug having a size between
0.4-100 nm” (Rh’g Req. 14);
5. the Board ignored, and thus did not give proper weight to, the
functional limitation “that the pores control the rate of diffusion of
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said drug to achieve zero-order release of the drug from said
reservoir for the period,” which is not a statement of intended use
(Rh’g Req. 14-18); and
6. Desai lacks a membrane that separates the reservoir from an
environment external to the device (Rh’g Req. 19-20).
Requester submits a Response on November 21, 2018 (“Req.
Response”) contending that:
1. the Board is correct to construe the claim language as not being
limited by the specifics of the drug upon which the claimed device
acts (Req. Response 3);
2. the drug limitation is not a structural limitation, but a material
being worked upon, because it is released and then exhausted (Req.
Response 3, 5-6);
3. the Patent Owner is attempting to predicate patentability upon the
use of the device to provide therapy for a period of time and using
a given process (Req. Response 4-5, 12-13);
4. the Board was correct in finding that the device of Fig. 5 was
capable of achieving a zero-order release of a so dimensioned drug
(Req. Response 5-10); and
5. the Board was correct in finding that the reservoir of Fig. 5 was
consistent in size to that recited in the Specification as being
capable of containing enough drug to provide therapy for several
weeks (Req. Response 11).
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Case law regarding device claim and the material upon which the device
works
We disagree with Patent Owner that we misinterpreted the law
regarding intended use and/or the patentable weight of claiming the material
upon which a device works. Patent Owner, in relying on the specific facts of
the cases cited,4 argues a new legal standard, namely that a material can only
be consider worked on by a device if it is “introduced to the device upon its
operation” or is “created during operation of the device.” Rh’g Req. 8.
Initially, we note that claim interpretation is a matter of law, and, in
any determination of controlling case law, the interpretation and the weight
given to recited elements of the claims at issue are to be decided based on
the particular claim language and the facts of the case at issue. In re Hiniker
Co., 150 F.3d 1362, 1369 (Fed. Cir. 1998) (“[T]he name of the game is the
claim.”); In re Stencel, 828 F.2d 751, 754-55 (Fed. Cir. 1987) (“Whether a
[statement in a claim] constitutes a limitation to the claims is, as has long

4 Patent Owner particularly analyzes the facts of In re Otto, 312 F.2d 937
(CCPA 1963). See Rh’g Req. 5-6. Patent Owner further analyzes in detail
Ex parte Woodson, Appeal No. 95-1827, 1998 WL 1699231 (BPAI
December 11, 1998), distinguishing the recited line of cases because “the
material being claimed [an electrically conductive material] was necessary
element of the claimed apparatus [a sterilizer].” Rh’g Req. 6-8. Yet, unlike
the conductive material in Woodson without which the sterilizer would not
operate to sterilize, Patent Owner has not shown that the presence of a
“drug” is necessary to the operation of the drug delivery device, which
would operate to deliver anything small enough to migrate through the
membrane’s pores, including materials that are not drugs at all. See e.g.,
Desai 224, ¶ spanning col. 1-2 and 227, ¶ spanning col. 1-2 (describing the
diffusion of polystyrene beads of various dimensions through the same
membrane’s pores).
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been established, a matter to be determined on the facts of each case in view
of the claimed invention as a whole.”); Manual of Patent Examining
Procedure § 2115 (“Claim analysis is highly fact-dependent.”); Ex parte
Bruck, Appeal 2017-010719 (slip op. 8), 2018 WL 3951618, *5 (PTAB
August 1, 2018) (“We recognize that whether a claim recites material
worked upon, like the analysis of preambles discussed in the Otto and Casey
decisions, requires a fact-based case by case analysis that, in some cases,
present close questions.”). We note that no case law cited on this record is
exactly on point with the facts of this case.
Further, this new legal standard argued by Patent Owner is not
expressly articulated by our reviewing Court and is not consistent with
additional case law discussed below. We do not find that the doctrine has
been so narrowly limited as indicated by Patent Owner. Indeed, such a
determination runs contrary to historical applications of this doctrine. For
example, in In re Hughes, 49 F.2d 478, 479 (CCPA 1931), the court found
that a mechanism for printing trade-marks on carbon paper to be an
“attempted combination . . . of the machine and the material or dye solvent
use therewith,” despite the fact that the dye solvent recited in the claims was
further used to print on paper. The court found that
a person may not patent a combination of a device and the
material upon which the device works, nor limit other persons
from the use of similar material by claiming a device patent. If
the material which appellant uses here for printing is new to the
art, then such material may be patentable; but he may not take
advantage of this in applying for a patent upon a mechanism to
apply it. Any feature of the mechanism which is particularly
constructed for the use of such a fluid might be patentable in
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combination or otherwise. Appellant cannot, however, properly
claim a combination of device and material worked upon.
Id. Hughes distinguishes where the material to be worked upon is new to the
art and thus where a feature of the device might be particularly constructed
(i.e., structurally different) to accommodate the new material.
In this case before us, however, no particular drug is recited in the
claims, so it reads on any known drug in the art that satisfies the drug-release
characteristics, but requires no change in the device’s structure whatsoever,
and thus the recited device has no specific features that are designed for any
particular new drug. Following Hughes, the material worked upon is the dye
solvent subsequently delivered to paper using the printing device, just as, in
the present invention, the material to be worked on is the drug subsequently
delivered to an “exterior environment” (i.e., a body) using the delivery
device. Both the dye solvent and the drug are exhausted during operation of
the device. Similarly, in In re Smith, 36 F.2d 302, 303 (CCPA 1929), the
Court notes the impropriety of patenting an old device by asserting a new
function for that device or by reciting a specific material upon which the
device works. In the case of Smith, the applicant attempted to patent a
known printing machine by reciting specific carbon sheets used in the
printing machine, which again delivers the text to paper. Id.
Patent Owner contends that In re Schreiber, 128 F.3d 1473 (Fed. Cir.
1997), and In re Ludtke, 441 F.2d 660 (CCPA 1971), are distinguishable
because the claims in those cases specifically recited functional language.
Similarly, Patent Owner contends that In re Yanush, 477 F.2d 958 (CCPA
1973) is distinguishable because it particularly recites how a structural
element of the claim is used. However, the reasoning in all these cases
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stems from the same principle -- that it is improper to allow an applicant to
obtain a claim to a device that is structurally identical to a prior art device,
merely by claiming that it is used for a new purpose, whether the form of
reciting the new purpose is via functional language, intended use language,
or by reciting the material to be worked upon, where the language imparts
no structural distinction between the claimed and prior art devices.
In Schreiber, the claims were directed to a “dispensing top for passing
only several kernels of a popped popcorn at a time from an open-ended
container filled with popped popcorn.” Id. at 1475. The Board found that
the claim was anticipated by the prior art’s (Harz’s) description of a conical
top for dispensing oil because it was inherently capable of performing the
claimed function for dispensing popcorn from a popcorn container, even if it
had not been used in that way. Id. at 1476. The court agreed, holding that
“Schreiber is correct that Harz does not address the use of the disclosed
structure to dispense popcorn, [but] the absence of a disclosure relating to
function does not defeat the Board’s finding of anticipation.” Id. at 1477.
Would Schreiber had been decided any differently if there were a
kernel of popped popcorn expressly recited along with the dispenser top, and
would doing so require Harz’s oil can to hold a popcorn to anticipate? We,
the majority, doubt that would be so because the oil/popcorn creates no
structural distinction between the devices otherwise sought to be patented.
In other words, as put in Parker v. Flook, 437 U.S. 584, 593 (1978) in the
context of 35 U.S.C § 101, should the determination of patentability “depend
simply on the draftsman’s art,” which in this case is the addition of a
different drug to a device otherwise described by Desai. 35 U.S.C. § 102
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reflects an important principle of patent law that an invention available to
the public before the effective date of a claimed invention is not entitled to a
patent. In this case, the drug delivery device itself was available to the
public prior to the date on which the application in this appeal was filed.
Patent Owner is attempting to avoid the prior public disclosure of the device,
not by changing the structure of the claimed device to make it different from
Desai, but by adding a drug of no particular structure to it with the restriction
that the drug has to have a certain dimension to fit through the pores to
achieve zero-order release. In our view, this is little different than the
functional limitation in Schreiber “that the claimed top ‘allows several
kernels of popped popcorn to pass through at the same time,’ and that the
taper of the top is such ‘as to by itself jam up the popped popcorn before the
end of the cone and permit the dispensing of only a few kernels at a shake of
a package when the top is mounted on the container.’” Schreiber, 128 F.3d
at 1478. The only difference is that, in this case, Patent Owner drafted the
claim to include the popped popcorn – namely a drug – to avoid by artful
claim drafting the public disclosure by Desai.5

5 Cf. Ex parte Bruck, Appeal 2017-010719 (slip op. 7-8), 2018 WL 3951618,
*5 (PTAB August 1, 2018) (after determining that “[n]either Otto nor Casey
actually positively recited the feature identified in these decisions as the
material worked upon, i.e., the hair in Otto and the tape in Casey” finding
that “[u]nlike Otto, Young, and Casey, the claims here positively recite, as a
structural element of the claim, a fluidized bed of powdered material” in
addition to finding that “processing depends on a number of inter-related
parameters including, among others, the size and density of the powdered
materials. Thus, the powdered materials are necessary parameters of the
fluidized bed, which itself is a structural element of the apparatus.”) (internal
citations omitted). We find the fluidized bed of powdered materials of Bruck
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Interpreting the claim so as to not give patentable weight to the drug
limitation is proper because the presence of the drug does not affect the pore
size, which is specifically recited in the claim, and taught by the prior art.
We are not ignoring the “drug” limitation in the claim, but simply not
giving it patentable weight. This treatment of an expressly recited claim
limitation is not new. In the so-called “printed matter” cases, printed matter
is not given patentable weight, despite an express recitation of the subject
matter in the claim, unless the printed matter and substrate functionally
relate to each other. See In re Gulack, 703 F.2d 1381, 1385 (Fed. Cir. 1983).
We do not intend to apply the printed matters to the claimed invention set
forth here. However, in this case, where the drug is only recited generically
in the claim, and does not modify the structure of the claimed device, it is
consistent with the principles of claim interpretation and the purpose of
35 U.S.C. § 102, to not give the presence of the drug in the device patentable
weight.
While we recognize the discovery made by the Patent Owner
regarding the flow of materials through pores based on their size is of value
to drug delivery devices, the attempt to claim a drug delivery device, which
structurally does not distinguish over what was known in the art, for delivery
of a specific drug, is nonetheless improper. Nonetheless, we recognize the
propriety of claims directed to a method of using a known device in a new
and non-obvious way in the form of a method claim, rather than an
apparatus claim, as with claim 20. See 35 U.S.C. § 100(b) (“The term

similar to the electrically conductive material of Woodson, which we
distinguish above. See note 4.
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‘process’ means process, art, or method, and includes a new use of a known
process, machine, manufacture, composition of matter, or material.”)
(emphasis added).

Alleged inconsistency of finding the drug is a structural limitation
We disagree with the Patent Owner that our decision finds the drug to
be a structural limitation, even in interpreting that a structural feature of the
capsule is a reservoir of sufficient size, i.e., “[t]he capsule reservoir must be
structured (i.e., sized) to be capable of comprising a drug in an amount to
provide therapy for several weeks to about six months.” First Decision 9.
While we note that our claim interpretation further states that the
“capsule reservoir must be capable of holding at least a several week supply
of a drug having a size of between 0.4 and 100 nm (i.e., where the drug is 1-
5 times smaller than a pore size of 2-100 nm)” (Id.), this portion of the claim
interpretation is not necessary to our conclusion that an appropriate reservoir
sized is taught by Desai. Therefore, we expressly disclaim this portion of
the claim interpretation, and the portion of our analysis and further reference
to holding a drug having a size of between 0.4 and 100nm. See Decision 13.
However, even without reference to any particular drug or particular
drug size, we found that the capsule taught by Desai has a 2 mL reservoir
volume, which is “of an identical size or larger than that described in the
’614 Patent” because the ’614 Patent “describes a preferred drug delivery
device having ‘an internal volume of approximately 250 µL to several
millimeters.’” Decision 13 (quoting ’614 Patent, col. 5, 11. 35-38). The
Decision then shifted the burden to show that the reservoir of Desai, which is
identical to that of the size preferred in the ’614 patent, is not of sufficient size
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to contain a therapeutic amount of at least one drug for several weeks. Id.
Thus, we decline to further amend our decision on appeal.

None of the drug taught by Desai, insulin, glucose, and immune globulin
(IgG), are either the correct size or have a therapeutic amount to anticipate
the claim
Patent Owner disagrees with our claim interpretation finding that the
recited drug does not structurally distinguish the device from that taught by
Desai. First Decision 6-8; Final Decision 7-8. As explained above, the
teaching in Desai of particular drugs does not negate Desai’s description of a
drug delivery device structurally identical to that recited in the claims.
Patent Owner does not point to any arguments or evidence that was
misunderstood or overlooked.

Functional language not give proper weight
We disagree with Patent Owner that the Decision did not give
sufficient weight to the functional language that “the pores control the rate
of diffusion of said drug to achieve zero-order release of the drug from said
reservoir for the period.” Rh’g Req. 14-18. The Decision considered this
functional language to reflect an intended use of drug delivery device having
the recited pore size and found that
the membrane pore size makes the device capable of achieving
zero-order release when a drug of the recited dimensions is
included in the drug delivery device. In our view, the presence of
a drug which is outside the dimensions recited in claim 1 should
not patentably distinguish the claim from a device that otherwise
meets all the structural limitations of the claim.
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First Decision 8. The Decision further found that
the membrane and capsule of Desai are capable of achieving
zero-order release for a drug having dimensions which are 1-5
times smaller than the pore sizes of 18, 66 and 78 nm, which
includes overlapping ranges of 3.6-18 nm (drug dimension 1-5
times an 18 nm pore size), 13.2-66 nm (drug dimension 1-5 times
a 66 nm pore size), and 15.6 to 78 nm (drug dimension 1-5 times
a 78 nm pore size).
First Decision 13-14. Thus, Patent Owner does not point to any arguments
or evidence that was misunderstood or overlooked in this analysis.

“an environment external to the device”
Patent Owner disagrees with our findings and determinations
regarding the additional claim language “an environment external to the
device” and further present arguments based on the premise that the drug
recited in the claims is a structural limitation, a determination with which we
disagree. Rh’g Req. 19-21. Thus, Patent Owner does not point to any
arguments or evidence that was misunderstood or overlooked, but merely
presents arguments substantially similar to those addressed in the Decision
and Final Decision. See Decision 6-9 and Final Decision 8-11.
The subject Request has been granted to the extent that the First
Decision and Final Decision have been reconsidered, but is denied with
respect to making any changes to our ultimate determinations herein.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).
Pursuant to 37 C.F.R. § 41.79(d), this decision is final for the purpose
of judicial review. A party seeking judicial review must timely serve notice
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on the Director of the United States Patent and Trademark Office. See
37 C.F.R. §§ 90.1 and 1.983.

DENIED

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FREDMAN, Administrative Patent Judge, dissenting-in-part.
While I continue to concur with the Majority’s decision to not sustain
any of the new grounds of rejections of claims 20–22 and 31–38 under
35 U.S.C. § 103(a), I again respectfully dissent from the Majority’s decision
to sustain the rejection of claims 1, 9, 10–16, 19, and 30 under 35 U.S.C.
§ 102(b) as anticipated by Desai and to sustain the rejections of claims 1, 4–
6, 8, 9, 10–16, 19 and 30 under 35 U.S.C. § 103(a) as obvious over Desai
alone or combined with Wong or Atkinson. I rely upon the same claim
interpretation as discussed in my previous dissent. I also fully agree with
Patent Owner’s position.
“nanopore membrane”
In particular, I interpret the “nanopore membrane” in claim 1 that
separates the “reservoir from an environment external to the device” as
requiring that the membrane must function to release the drug into the
environment, not into another chamber within the device itself. Figure 5 of
Desai depicts a device that consists of “two compartments A and B with
fixed volumes of 2 ml, separated by the biocapsule membrane, sealed with
a-rings, and finally screwed together” (Desai 224, col. 2). At best, Desai
teaches a device that releases a drug from one internal volume to another,
not into an external environment. Desai does not teach a device with a
membrane that functions “to separate the reservoir from an environment
external to the device” as required by claim 1.
Thus in order for Desai to anticipate, the device of Desai would
require restructuring in order to allow release of the drug into the
environment. “It is not sufficient to constitute an anticipation that the device
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relied upon might, by modification, be made to accomplish the function
performed by the patent in question, if it were not designed by its maker, nor
adapted, nor actually used, for the performance of such functions.” Topliff v.
Topliff, 145 U.S. 156, 161 (1892). Here, Desai must be modified or adapted
to a different structure in order to release the drug and therefore Desai does
not anticipate the instant claims.
“a drug contained in the reservoir”
The Majority reasons that interpreting claims 1 and 20 so as to not
give patentable weight to the drug limitation is proper because the presence
of the drug does not affect the pore size, which is specifically recited in the
claim, and taught by the prior art. I disagree. The comparison of the instant
claims that require a drug of particular size dimensions in a capsule to the
dye solvent in Hughes is inapposite because the claim in Hughes does not
require any particular solvent, and indeed, does not expressly require
anything other than “a receptacle for the liquid.” See Hughes, 49 F.2d at
478. The instant claims are limited to a capsule with a reservoir that
contains a membrane with a particular relationship between a drug and the
membrane pore size that result in zero order release to the external
environment and expressly recite the presence of a drug in structure and
amount satisfying these requirements.
A simple analogy is to a drug formulation and a placebo formulation,
where the formulations comprise many identical components but differ in
the presence or absence of the drug. As in the instant claims, a drug is
released from the formulation into the body after administration, while the
placebo releases no drug. This significant difference between treatment with
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a placebo and an active drug compound cannot be elided by characterizing
the drug as “material worked upon.” Similarly, in the instant claims, the
required presence of the drug in the reservoir is a claim limitation that
cannot be ignored for purposes of anticipation, but rather must be met, or the
claim is not anticipated. There is no real dispute that Desai fails to meet this
limitation and therefore fails to anticipate the claims.
The Majority asks “Would Schreiber had been decided any differently
if there were a kernel of popped popcorn expressly recited along with the
dispenser top, and would doing so require Harz’s oil can to hold a popcorn
to anticipate?” My answer is yes. A dispenser filled with popcorn is not
simply a “new intended use” of a dispenser filled with oil, but is a different
device. The average cinema buff would be dismayed to find motor oil in
their snack or popcorn in the oil dispenser used to fill their car’s engine.
“[C]laims are interpreted with an eye toward giving effect to all terms in the
claim.” Bicon, Inc. v. Straumann Co., 441 F.3d 945, 950 (Fed. Cir. 2006).
I also disagree with the Majority’s policy argument that Patent Owner
is “attempting to avoid the prior public disclosure of the device, not by
changing the structure of the claimed device to make it different from Desai,
but by adding a drug of no particular structure to it with the restriction that
the drug has to have a certain dimension to fit through the pores to achieve
zero-order release.”
In my view, this is the essence of invention. In the original Wright
brothers patent for an airplane, the claims required lateral margin portions
capable of movement to positions above and below the plane body, because
this change in structure was the insight that allowed for controlled flight.
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Similarly, the presence of a membrane of a particular pore size and a drug is
the structure that allows for zero order release. From a policy position,
every required structural element must be considered in order for a claim to
anticipate. A required element is not an “intended use.”6 It is that structure,
drug and membrane, that must be present in the prior art to anticipate. Desai
lacks that structure and therefore does not anticipate.
This situation is very different than that in the printed matter cases
such as the instructions in Gulack and In re Ngai, 367 F.3d 1336 (Fed, Cir.
2004). In Ngai, the only difference between the prior art and the claim was
“the content of the instructions.” Id. at 1338. The prior art taught the
presence of a piece of paper with writing on it, the instruction sheet, but
simply had different words on the paper. Thus, Ngai and Gulack stand for
the proposition that printed information not functionally related to the
substrate do not distinguish the prior art. In the current case, the drug is
neither printed information nor unrelated to the capsule and membrane
substrate. The drug is a physical element and must have a particular
functional relationship with the membrane to obtain zero order release.
I therefore respectfully dissent from the decision of the Majority.
For these reasons, I would not sustain the rejection of claims 1, 9, 10–
16, 19, and 30 under 35 U.S.C. § 103(a) as obvious over Desai alone or
combined with Wong and Atkinson.

6 I recognize that in some instances, the structural element may be an
obvious addition. Here, for the reasons given above regarding the
modifications to Desai necessary to obtain a membrane that functions “to
separate the reservoir from an environment external to the device,” I find the
claims would not have been obvious over the cited prior art.
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I do concur with the Majority’s decision to not sustain any of the new
grounds of rejections of claims 20–22 and 31–38 under 35 U.S.C. § 103(a).

PATENT OWNER:
McDermott Will & Emery LLP
500 North Capitol Street NW
Washington, DC 20001

THIRD-PARTY REQUESTER:
ALEXANDER R. TRIMBLE
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