Ex Parte McKinnon et al

Patent Trial and Appeal Board

Jun 23, 2017

13232847 (P.T.A.B. Jun. 23, 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.
13/232,847 09/14/2011 Robert J. McKinnon 3170-62 7814
22442 7590
Sheridan Ross PC
1560 Broadway
Suite 1200
Denver, CO 80202
06/27/2017 EXAMINER
STUART, COLIN W
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
06/27/2017 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):
e-docket @ sheridanross. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ROBERT J. MCKINNON and
JAMES DALE BICKLEY
Appeal 2015-004696
Application 13/232,847
Technology Center 3700
Before MICHAEL L. HOELTER, THOMAS F. SMEGAL, and
GORDON D. KINDER, Administrative Patent Judges.
KINDER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants1 appeal under 35 U.S.C. § 134 from a rejection of claims
1—9, 11—17, 19 and 20. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm and enter NEW GROUNDS OF REJECTION pursuant to
37 C.F.R. § 41.50(b).
1 We are informed that the real party in interest is Westmed Inc. Appeal
Br. 3.
Appeal 2015-004696
Application 13/232,847
CLAIMED SUBJECT MATTER
The claims are directed to a compliant nasal cannula. Claims 1 and 12
are independent. Appeal Br. 32, 33 (Claims App.). Claim 1, reproduced
below, illustrates the claimed subject matter:
1. A nasal cannula assembly designed for contact with the
nasalabidial area of a patient’s nose and comprising:
a hollow tubular member having an oxygen supply
opening at each end and having a pair of spaced tubular
extensions projecting therefrom that terminate in gas-directing
orifices;
a first tube interconnected at a first end to one end of said
hollow tubular member, said first tube is made of a material that
stretches about 1 inch per foot of length when between about 0.5
lbs to about 1.5 lbs of force is applied thereto; and
a second tube interconnected at a first end to one end of
said hollow tubular member, said second tube is made at least
partially of said material that stretches about 1 inch per foot of
length when between about 0.5 lbs to about 1.5 lbs of force is
applied thereto.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Marshall US 4,699,139 Oct. 13, 1987
Winthrop US 5,682,881 Nov. 4, 1997
Thompson US 2005/0033247 A1 Feb. 10, 2005
Jaffe US 2008/0190436 A1 Aug. 14, 2008
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Appellants’ Admitted Prior Art as set forth on pages 9—10 of the
Specification (AAPA).
REJECTIONS
I. Claims 8, 11, 13, 17, and 19 are rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which the applicant regards as the
invention.
II. Claims 1—2, 4, 7—9, 11—15, 17, and 19-20 are rejected under pre-
AIA 35 U.S.C. § 103(a) as being unpatentable over Thompson and AAPA.
III. Claim 3 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Thompson, AAPA, and Winthrop.
IV. Claim 5 is rejected under pre-AIA 35 U.S.C. § 103(a) as being
unpatentable over Thompson, AAPA, and Marshall.
V. Claims 6 and 16 are rejected under pre-AIA 35 U.S.C. § 103(a) as
being unpatentable over Thompson, AAPA, and Jaffe.
OPINION
New Ground: New Matter
Claims 1—9, 11—17, and 19-20 are rejected under 35 U.S.C. §112, first
paragraph, as failing to comply with the written description requirement.
These claims contain subject matter which was not described in the
specification in such a way as reasonably to convey to one skilled in the art
that the inventors had possession of the claimed invention. Specifically, we
find that new matter has been introduced by amendment into claims 1
and 12.
As originally filed, claim 1 twice recited use of “a material that
stretches about 1 inch per foot of length when less than about 0.5 lbs of
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tension is applied thereto.” Spec. 11. Claim 1 was amended so that in the
same two places the claim uses the phrase “a material that stretches about 1
inch per foot of length when between about 0.5 lbs to about 1.5 lbs of force
is applied thereto.” Appeal Br. 32, Claim 1,11. 7—8, 10—12. The quoted
phrase from amended claim 1 introduces new matter.
The Specification discloses:
Further, it is believed that any elastomer that would exert less
than 3.0 psi, preferably less than about 1.5 psi, and most
preferably less than 0.5 psi under the test conditions described
above would help reduce or eliminate patient discomfort and
injury.
Specification 8:30-9:2.
The abbreviation “psi” is universally recognized as meaning “pounds
per square inch.”2 This unit is used to measure pressure or stress with
respect to an area, inter alia, and is a different measure from simply “pounds
of force” (regardless of area), commonly abbreviated “lbf.”3 These two
units of measure, psi (in the Specification) and lbs of force (in claim 1),
measure different quantities. The disclosure of a range of pressures
(representing force distributed over area) does not support a claim to a range
of forces. Accordingly, claim 1 and claims 2—9 and 11, which depend from
claim 1, contain new matter.
2 See http://www.dictionary.com/browse/psi?s=t (“psi or p.s.i. 1. Pounds per
square inch”) last viewed June 15, 2017.
3 See http://www.dictionary.com/browse/pound-force (“pound-force: noun,
Physics. 1. a foot-pound-second unit of force, equal to the force that
produces an acceleration equal to the acceleration of gravity when acting on
a mass of one pound. Abbreviation: lbf.”) last viewed June 15, 2017.
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Claim 12 as originally filed included the limitation that a portion of
the tubing “experienc[es] less than about 1.5 psi of tensile force when
elongated 10% of its original length.”4 Spec. 13. As amended, claim 12
recites that that portion “experienc[es] between about 0.5 lbs to about 1.5 lbs
of tensile force when elongated 10% of its original length.” Appeal Br. 33—
34. As discussed above in connection with claim 1, there is no support in
the specification for the claimed range of pounds of force.
In the Final Action the Examiner rejected claims 1—11 for claiming a
range which was not disclosed in the specification. Final Act. 2—3.5 In the
course of overcoming that rejection, the Appellants wrote:
The Specification at page 8, line 30 to page 9, line 2 states that
the tubing of one embodiment of the present invention is adapted
to elongate when less than about 1.5 pounds of force is applied.
Thus the claimed range between 0.5 pounds and 1.5 pounds of
force is inherently supported.
Response After Final, Sept. 3, 2014, p. 2. The above quoted statement by
Appellants misstates the Specification which clearly uses the units “psi” and
not “pounds of force.” Inasmuch as Appellants’ argument concerning the
Examiner’s new matter rejection focused on whether the recitation of the
sub-range within a disclosed range constitutes new matter, it appears
possible but unlikely that the Appellants’ mistaken paraphrasing of the
specification influenced the Examiner’s decision. Nevertheless, as discussed
4 Independent claim 12 uses the term “lbs of tensile force”, and other claims
use the term “lbs of tension.” See Appeal Br. 33—34. We perceive no
difference in the resulting claim scope arising from the use of “lbs of force”
as compared to “lbs of tension” or “lbs of tensile force.’ '’ In all cases the
applied tension and applied force result in stretching a tubular member.
5 The new matter rejections of claims 1, 7, and 12 are withdrawn. Advisory
Act. 9/12/2014, p. 2.
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above, the assertion that a range of pounds of force is disclosed in the cited
passage from the Specification is incorrect. Further, we have reviewed the
Specification in detail and find no other part of the specification to support
the recited range of pounds of force.
Accordingly, claims 1—9, 11—17, and 19—20 are rejected under 35
U.S.C. § 112, first paragraph, as indefinite.
New Ground: Indefiniteness Claims 1—11
Claims 1—11 are rejected under 35 U.S.C. § 112, second paragraph, as
being indefinite for failing to particularly point out and distinctly claim the
subject matter which Appellants regard as the invention.
The problem to which Appellants have directed their inventive efforts
is eliminating the discomfort and injury to a patient’s skin caused when
tubing rubs against it. See Spec. 1—2. Appellants conducted tests which
showed that the problem was alleviated when “[t]he elongation of the left
tube 18L and/or the right tube in response to head tilting and turning are
such that elongations of up to 10% of the tubing length,” for “[tjhis
simulated the amount of tube stretch needed to accommodate a patient
turning his or her head, which allowed assessment of the amount of tube
stretch needed to reduce or eliminate the application of force by left and
right tubing onto a patient’s head due to head turning,” and “[a]s one of skill
in the art will appreciate, the amount of tensile force applied to the tubing is
directly proportional to the force felt by the patient and the associated injury
and/or discomfort.” Id. at 7—8; emphasis added. “[T]he amount of tensile
force on the tube 18 is directly proportional to the amount of frictional force
felt by the patient 2. That is, a cannula made in accordance with
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embodiments of the present invention will exert a decreased level of normal
force onto a patient’s face and/or ear.” Id. at 9. Thus, it
appears to be clear from these passages in the Specification that it is the
degree to which the tube can stretch that is the key to solving the stated
problem.
However, the Specification does not describe the properties of the
tube, but rather of the material from which the tube is made, to wit:
For example, the clear medical grade flexible PVC
APEX©3200-50NT manufactured by Teknor Apex may be used
[]. Further, it is believed that any elastomer that would exert less
than 3.0 psi, preferably less than about 1.5 psi, and most
preferably less than 0.5 psi, under the test conditions described
above would help reduce or eliminate patient discomfort and
injury.
Id. at 8—9. Nowhere in the Specification is the material from which the tube
is made directly related to the tension required to be present in the tubing in
order to solve the stated problem, except for a mention on page 8 that the
tests were conducted with a three inch section of “standard tubing.” The
Specification does not include details of the construction of this “standard
tubing,” or any other tubing, for that matter, such as diameter and wall
thickness.
Independent claim 1 recites a nasal cannula comprising first and
second tubes “made of a material that stretches about 1 inch per foot of
length when between about 0.5 lbs to about 1.5 lbs of force” is applied,
however, no details are provided of the construction of the tubing, nor is
there a definite relationship set forth between the cannula tube and the
material from which it is made. Appellants’ Specification establishes that
the cited problem is solved by providing cannula tubes that can be stretched
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1 inch per foot when about 0.5 pounds of tension is applied, but this is not
reflected in the claims, which require only that in some form the material
from which the tubes are made meet this test, and not that it be met by the
tubes themselves. By way of example, a narrow strand of the selected
material, having a small cross-sectional area, could meet this claim provision
when tested, whereas a cannula tube constructed of that same material,
which has a significant cross-sectional area of material compared to a
narrow strand, would not. This being the case, the cited recitation renders
independent claim 1 indefinite for, in our view, the metes and bounds of the
claim cannot be determined.
New Ground: Indefiniteness Claim 20
Claim 20 is rejected on grounds a similar to the new matter rejection.
Claim 20 recites generally that stretching the first and second tube “will
generate a tensile force of less than 1.5 psi in said first tube and said second
tube.” Appeal Br. 34 (Claims App.). This claim is indefinite because force
is not measured in units of pounds per square inch. Accordingly, it is not
possible to know the metes and bounds of claim 20, and claim 20 is rejected
for indefmiteness.
Rejection I
Claims 8, 11, 13, 17, and 19 use the phrases “less than about” and
“about [*]% or more.” The Examiner finds these phrases indefinite because
referring to the latter the Examiner “cannot ascertain where the upper bound
of this limitation is” and referring to the former, “cannot ascertain where the
lower bound of this limitation is set.” Final Act. 4, Ans. 2—A. The
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Appellants argue that one of ordinary skill in the art would understand the
limits, but points to no evidence to support this assertion, either intrinsic or
extrinsic. Appeal Br. 10.
The challenged phrases are terms of degree. See, e.g., Interval
Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370 (Fed. Cir. 2014)
(identifying “unobtrusive manner” as a term of degree); Star Scientific, Inc.
v. R.J. Reynolds Tobacco Co., 537 F.3d 1357, 1372 (Fed. Cir. 2008) (“Here,
the term ‘anaerobic condition’ is in effect a term of degree because its
bounds depend on the degree of oxygen deficiency.”). Our reviewing court
has reaffirmed that terms of degree are not “inherently indefinite” and that
“[cjlaim language employing terms of degree has long been found definite
where it provided enough certainty to one of skill in the art when read in the
context of the invention.” Interval Licensing, 766 F.3d at 1370 (citations
omitted). However, Appellants have made no showing that the context in
which the phrases are used gives them meaning. In light of the record, we
agree with the Examiner that claims 8, 11, 13, 17, and 19 are indefinite.6
6 The Examiner's proposed amendment to claims 8, 11, 13, 17, and 19
deleted the word “about” to resolve the indefmiteness issue. It is not clear
why the Examiner did not find that the use of the word “about” leads to
indefmiteness in claims 1,7, and 12. In the event of further prosecution of
this application, the Examiner may wish to consider whether claims 1,7, 12
are indefinite for the same reasons that the claims subject to Rejection I are
indefinite.
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Rejection II
Claims 1, 2, 4, 7—9, 11—15, 17, 19, and 20
Obviousness - Thompson and Appellants’ Admitted Prior Art
Appellants argue claims 1, 2, 4, 7—9, 11—15, 17, 19, and 20 as a group.
Appeal Br. 10-29. We select claim 1 as representative, and 2, 4, 7—9, 11—
15, 17, 19, and 20 stand or fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner’s Position
The Examiner finds that Thompson discloses all of the subject matter
recited in independent claim 1, except that:
Thompson is silent as to explicitly disclosing that the first and
second tubes are made of a material that stretches about 1 inch
per foot of length when between about 0.5 lbs to about 1.5 lbs of
force is applied thereto. However, as evidenced by Applicant’s
[sic] admitted prior art, Applicant [sic] discloses a previously
provided material APEX 3200-50NT manufactured by Teknor
Apex as being used as a material which provides the various
properties found in the claimed invention.
Final Act. 5. The Examiner notes that Thompson also “discusses material
choice for providing a cannula assembly that bends freely with head
movements as well as elongates under tensile stress and discloses that
Teknor Apex series 3300 is prior art knowledge within the field of [the]
invention.” Final Act. 5—6, citing Thompson H 52—54. The Examiner goes
on to state:
Thompson para. 0050 highlights the same problem of pressure
sores/ulcers due to cannula tubing rubbing against the patient’s
face as Applicant’s [sic] claims address (see pages 3—5 of
specification for example). Para. 0050 and 0052-0054 also
attempt to solve this problem in the same fashion as Appellant’s
[sic] claimed invention, for example by providing flexible tubing
made of a material which elongates easier or to a greater degree
than current prior art tubing material. In addition, Thompson's
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device has the same structure as claimed. The only difference is
the choice of the tubing material.
Final Act. 13. Based on these teachings, the Examiner concludes that
providing first and second tubes made of a material that stretches to about 1
inch per foot of length when between about 0.5 pounds to about 1.5 pounds
of force is applied would have been an obvious matter of material design
choice. Final Act. 6. The Examiner also concludes that one of ordinary
skill would have found it obvious to optimize the material selected to
include the claimed range. Id. In addition, the Examiner finds that “one of
ordinary skill in the art would have expected the Thompson device to
perform equally well with the material that stretches about 1 inch per foot of
length when between about 0.5 lbs to about 1.5 lbs of force is applied
(Teknor Apex 3200-50NT).”7 Final Act. 6.
In response to Appellants’ arguments in the Appeal Brief, the
Examiner points out that Thompson recognizes in paragraph 50 the same
problem to which Appellants’ invention is directed and, as set forth in
paragraphs 52—54, seeks to solve the problem in the same manner as
Appellants, that is, “by providing flexible tubing made of a material which
elongates easier or to a greater degree than [the] current prior art tubing
material.” Ans. 12. The Examiner goes on to state that
Thompson’s device has the same structure as claimed. The only
difference is the choice of the tubing material. While Thompson
in para. 0054 discloses that the use of Teknor-Apex 3300-82 is
well-known, and also discloses an improvement upon the 3 3GO-
82 material in paragraph 0052, there is no structure in Thompson
that would prevent one of ordinary skill in the art from choosing
7 Teknor Apex 3200-50NT is, in the rejection, the “admitted prior art”
material disclosed by Appellants on page 8 of their Specification.
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another well-known material, such as the material disclosed in
Appellant’s specification, Teknor-Apex 3200-50NT, to further
reduce or eliminate patient skin irritation or injury.
Id. at 13—14.
The Examiner further explains the rejection in the following manner
Regardless of the interpretation of the exact meaning of the 10%
tensile modulus, or any equations or force values derived
therefrom, one of ordinary skill in the art, reading para. 0050
and 0052-0054 of Thompson would appreciate that
Thompson’s [sic] was attempting to solve the problem of
pressure sores by providing tubing capable of elongation at
lower forces as compared to the prior art. This is shown through
Thompson’s [sic] explanation of the tensile test performed:
suspending weights from a 13 inch length of tubing and adding
weight until the length increased to 14.3 inches (see para. 0053).
In light of this explanation of the tensile test used, one of
ordinary skill in the art would appreciate that the Thompson
tubing material, having the 10% tensile modulus of 200 psi or
less (para. 0052), provides elongation at lower forces than the
prior art tubing.
Id. at 14.
The modification to the Thompson reference in view of
Applicant’s admitted prior art of the material Teknor Apex
3200-50NT, which exhibits] properties claimed such as the
ability to stretch about 1 inch per foot of length when less than
about 0.5 lbs of force is applied (see specification page 8 line 13
through page 9 line 2 for example), is based on the following
KSR rationale: Substitution of one know[n] element (Teknor
Apex 3200-50NT) for another (Thompson’s tubing material of
para. 0052) to obtain predictable results, further reducing
occurrence of pressure sores by providing tubing material
capable of elongation at even lower forces; obvious to
try/choose a material from a finite number of choices with a
reasonable expectation of success as one of ordinary skill would
have found it obvious to try Teknor Apex 3200-50NT, made by
the same company as the prior art of para. 0054 of Thompson,
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which provides greater elongation and would therefore provide
even less pressure sores; and one of ordinary skill in the art
would have found motivation to choose a well-known material
such as Teknor Apex 3200-50NT based on the fact that
Thompson addresses the problem of pressure sores/ulcers via a
tubing material which exhibits elongation at lower forces than
the prior art of Thompson.
Id. at 14—15.
With regard to the evidence of secondary considerations, the
Examiner takes the position that:
[t]here does not appear to be a nexus between the evidence of
secondary considerations and the claimed invention which would
overcome the obviousness rejections. MPEP section 716.03(a) 1
states that affidavits or declarations attributing commercial
success to a product according to the claims does not establish a
nexus between the invention as claimed and the commercial
success as it is not known that the product sold corresponds to
the claims or that whatever commercial success may have
occurred is attributable to the claims.
Id. at 18.
Appellants’ Arguments
Appellants’ initial argument is that the Examiner failed to present “a
convincing line of reasoning” as to why the claimed features in claim 1
would have been obvious on the basis that it was a matter of design choice.
Appeal Br. 11—12. Appellants continue with a comparison of the differences
between the information disclosed in Thompson’s paragraphs 52—54 and
Appellants’ invention, focusing on Young’s Modulus and Hooke’s law. In
the course of this discussion, Appellants assert that the Examiner’s position
as to what one of ordinary skill in the art would have been taught by the
cited portion of Thompson is refuted by the explanations in the declaration
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of Dr. Braun. See id. at 11—20. Appellants assert that Thompson is a non­
enabling reference, for it “omits information that would allow identification
of a material that can be used to satisfy Thompson’s cannula requirements”
or meet the limitations in the independent claims in their application, and
because paragraphs 50-55 “are scientifically inaccurate, incomplete, and
contain numerous and significant errors.” Id. at 21.
Appellants also argue that “the direction provided by Thompson
would discourage rather than encourage one of ordinary skill in the art from
using, testing, experimenting, and selecting a material having the properties
identified by Thompson, especially when that material is to be used for low
margin, disposable medical cannula,” and, thus, “would be left to conduct
extensive experimentation, using Thompson’s inaccurate, incomplete, and
questionable disclosure as a guide.” See id. at 22—23. Arguments also are
presented that the Examiner has utilized impermissible hindsight in
formulating the rejection and that there is no reasonable likelihood of
successfully finding a suitable material by following Thompson’s guidance.
Id. at 22—24.
Appellants quote the Examiner as having said that Appellants’
cannula results in “great improvement and utility over the art.” Appeal Br.
24. This quotation, which appears in the Final Action at 15, is taken out of
context and was not made with reference to Appellants’ invention, but rather
as a statement of law in general. The argument based on the alleged
quotation from the Examiner is therefore without merit.
Appellants contend that the Examiner has improperly “deemed the
affidavits submitted in support of non-obviousness insufficient to overcome
rejection of the pending claims.” Id. at 24. Appellants rely on evidence of
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secondary considerations in the form of declarations asserting long-felt need,
commercial success, the failure of others and opinions as to the success of
Appellants’ invention in solving the stated problem, as well as extensive
discussions thereof. See id. at 24—29.
In the Reply Brief, Appellants also argue the Examiner did not give
weight to evidence of a long felt need or to Appellants’ commercial success.
Reply 1—2. Appellant’s point to the Bickley Declaration as establishing the
required nexus between the claimed subject matter and the commercial
product. Id. at 2. Turning to the obviousness rejection, Appellants contend
that the Examiner relied on hindsight by using Appellants’ admission that
pre-existing Teknor Apex 3200-50 NT was a suitable material. Id. at 2—3.
Appellants renew their contention that Thompson is not an enabling
reference because its description of a 10% modulus is confused and would
not be understood as the Examiner asserted by one of ordinary skill in the
art. Id. at 3^4.
Finally in their Reply Appellants attack the Examiner’s comment (at
Ans. 15) that the pending “claims do not include information regarding the
inner diameter, strain-rate, and temperature in describing the material
property claim limitations.” Reply 5. Appellants contend that any
comparison of the adequacy of the Thompson disclosure to the adequacy of
their own disclosure is irrelevant because if Thompson’s disclosure is
inadequate, Thompson is removed as a reference, while Appellants’
disclosure is adequate if the claims are enabled, and this does not necessarily
require the same information as is missing (allegedly) from Thompson. Id.
at 5—6.
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Analysis
It is clear that the problem to which Appellants and Thompson have
directed their inventive efforts is the same. Appellants state that one aspect
of the invention is to provide a nasal cannula:
made at least partially of a flexible material that readily
elongates without restricting air flow\,] capable of stretching
approximately 1 inch per foot of length when less than about 0.5
pounds of force is applied. The length increase reduces tube
tension and associated pressure, thereby reducing or eliminating
patient irritation. One embodiment of the present invention is
made of an elastomer, such as flexible polyvinyl chloride (PVC),
silicone, polyurethane, or similar material which elongates when
tensioned without reducing the internal diameter to such a
degree that would constrict the gas flow.
Spec. 4 (emphasis added). Appellants explain that they conducted tests
using “a three inch section of standard tubing” that “yielded an average tube
length increase of 10% associated with a full head rotation” of the patient
{id. at 8; emphasis added).
Thompson is directed not only to nasal cannula tubing, but also to an
entire nasal cannula assembly, and explains that “[t]he combination of
flexible tubing and the form fitting shape and light weight of the cannula
keeps it in place with almost no tubing tension that, all at once, reduces
sores on the ears, nose and neck and eliminates grooves across the cheeks.'1'’
Id. at [0050] (emphasis added). Thompson teaches that the problem is
solved by the use of “/e/xlremely flexible support tubing that reliably orients
and positions the cannula with little or no tension on the face” {id. at
[0019]), “with specific properties that work in concert with the shape of the
cannula to reduce tubing tension to a bare minimum yet secure the
placement,” and is made of an “ultra-high molecular weight PVC resin that
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gives it rubber-like qualities such as resilience, [and] extreme flexibility'1'’ (id.
at [0022]) (emphasis added in all).
Thompson also states that “[t]he special support tubing used with the
cannula of the present invention was chosen after extensive experimentation
with a number of different materials and variations of materials. The
considerations included flexibility, manufacturability, service life,
packaging, smell, skin compatibility, medical compatibility, toxicity, cost
and availability” (id. at [0051] emphasis added), that the tubing material may
have one or more properties from a list of desirable properties, one of which
is “10% tensile modulus of200 psi or less,” as established by a tensile test in
which a 13 inch length of tubing was suspended and subjected to weights
until the length increased to 14.3 inches. Id. at [0052],
Thompson contrasts this value with one exhibited by a typical prior
art tubing, stating that “[t]ypical values for prior art tubing extruded from
Teknor-Apex 3300-82 PVC compound are [sic] a 10% tensile strength
modulus of 450 psi.” Id. at [0054], We take note here that the term “tensile
modulus” is synonymous with “modulus of elasticity,” “elastic modulus,”
and “Young’s modulus”, and is “a number that measures an object or
substance’s resistance to being deformed elastically (i.e. non-permanently)
when a force is applied to it, and that a stiffer material will have a higher
elastic modulus.”8
The Supreme Court in KSR Int’l v. Teleflex, Inc., 550 U.S. 398 (2007),
reiterated that the framework for the objective analysis for determining
8 See www.wikipedia.org/Elastic_modulus See also
www.thefreedictionary.com/Tensile+Modulus, and www.engineering
toolbox.com/young-modulus-d_417 .html.
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obviousness under 35 U.S.C. § 103 is stated in Graham v. John Deere Co,,
383 U.S. L 86 (1966). Obviousness is a question of law based on
underlying factual inquiries which, as enunciated by the Court are:
determining the scope and content of the prior art; ascertaining the
differences between the claimed invention and the prior art; and resolving
the level of ordinary' skill in the pertinent art. In the present ease, Thompson
provides evidence that a known problem in the prior art to which the
invention is directed is preventing nasal cannula support tubing from causing
pain and tissue irritation and damage to a patient’s face and ears, and
represents that the present state of the art is exemplified by utilization of
Teknor-Apex 3300-82 PVC compound or the improvement outlined in
Thompson |52.
Thompson states: “Perhaps the most important feature of the cannula
[i.e. the part of that projects into the patient’s nostrils] of the present
invention is that it can be used with extremely flexible support tubing that
bends freely with head movements without disturbing the position of the
cannula on the face.” Id. at [0050]. This statement focuses on the same
result as Appellants’ cannula assembly. Significantly, Thompson also
teaches that the amount of extension under tension required in order to
provide for this movement is the same as that set forth in Appellants’ claims,
that is, “about 1 inch per foot of length,” which is supported by Thompson’s
recitation of “suspending weights from a 13” length of tubing and adding
weights until the length increased to 14.3”.” Id. at [0053].
Thompson also teaches that the composition of cannula support tubing
that solves the stated problem is a thermoplastic material such as PVC,
which is quite pliable and extremely flexible so that it bends freely with the
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patient’s head movements, and has a 10% tensile modulus of 200 psi or less.
The terms used by Thompson to describe the desired cannula tubing are
“bends freely,” “extremely flexible,” and “almost no tubing tension.”
Thompson |50. Thompson does not explicitly disclose that the desired
amount of stretching of the tubes is accomplished “when between about 0.5
lbs to about 1.5 lbs of force is applied thereto,” as is set forth in Appellants’
claim 1.
However, it is our view that in the paragraphs cited by the Examiner,
Thompson’s teaching that a 10% extension of the cannula under tension
solves the problem, along with the adjectives used to describe the required
PVC material, provide sufficient information to direct the attention of one of
ordinary skill in the art to a finite number of tubing materials from which to
choose ones that perform in such a manner as to solve the problem, thus
supporting the conclusion that it would have been a matter of design choice
to select one in which the claimed degree of extension is accomplished by
applying “between about 0.5 lbs to about 1.5 lbs of force.” We regard the
clear medical grade flexible PVC APEX 3200-50NT manufactured by
Teknor Apex as being an example of the type of material that would come to
the attention of one of ordinary skill in the art.
We also note here that, as explained supra, in the new indefiniteness
rejection, Appellants’ independent claim 1 can be interpreted as being very
broad, requiring only that, in some form, the material from which the
cannula tubing is made be capable of stretching about 1 inch per foot when
between about 0.5 lbs. and about 1.5 lbs. of force is applied, and not that the
tubing made from the material meet this limitation. We find that, in view of
the teachings of Thompson and, in particular, the adjectives used by
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Thompson to describe the characteristics of the tubing, that it would have
been obvious to one of ordinary skill in the art to utilize a material which, in
some form, meets the requirements of the claims. We further find, in light
of Thompson’s paragraph 53, that it would have been obvious to use a tube
in a cannula assembly that stretches about 1 inch per foot when a force of
between about 0.5 lbs. to 1.5 lbs. is applied.
Therefore, although we have carefully considered all of the arguments
presented by Appellants, it is our view that the Examiner has established a
prima case of obviousness on the basis of the cited prior art with regard to
independent claims 1 and 12, and dependent claims 2, 3, 5, 7—9, 11—17, 19
and 20.
The Secondary Considerations
The Appellants bear the burden of proving commercial success. In re
Huang, 100 F.3d 135, 139-40 (Fed. Cir. 1996). Objective evidence of
nonobviousness including commercial success must be commensurate in
scope with the claims. In re Tiffin, 448 F.2d 791 (CCPA 1971) (evidence
showing commercial success of thermoplastic foam “cups” used in vending
machines was not commensurate in scope with claims directed to
thermoplastic foam “containers” broadly). “[The] inventor’s statement that
his commercial [product] is ‘constructed according to the disclosure and
claims of my patent application’ does not constitute probative evidence that
the [product] which has been sold corresponds to the [product] defined by
the appealed claims or that whatever commercial success may have occurred
is attributable to the construction defined by the appealed claims.” Ex Parte
Standish, 10 USPQ2d 1454 (Bd. Pat. App. & Inter. July 26, 1988).
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The declaration of co-inventor McKinnon states that the “claimed
nasal cannula embodied by the Comfort Soft Plus cannula” reduces pressure
sores. McKinnon Dec. |14. Further the Comfort Soft Plus cannula
“elongates in the manner articulated in independent Claims 1 and 12”(id.)
and “meets [the] limitations of at least Claims 1—5, 7—17, and 19-20.” Id. at
|15. The declaration states that sales of cannula have risen from 3 million
units per year before the introduction in January 2010 of Comfort Soft Plus
to approximately 30 million units per year since “without any increase in
sales or marketing effort.” McKinnon Dec. ^fl[ 8, 16.
The statements of Mr. McKinnon are the kind that this Board’s
predecessor and reviewing court have found not probative of commercial
success. They offer broad conclusory claims that the commercial product,
“Comfort Soft Plus” conforms to the claims of the pending application9 and
allege that growth occurred without any change in marketing. But no
specifics are provided. Thus, we have no evidence that the increase in sales
was not generated by a drop in price, or by an increase in price by
competitors. For example, we have no evidence that the market conditions
had not changed, such as a competitor changing its product line, or dropping
out altogether, in a manner that favored Appellants. In addition, the
McKinnon Declaration, paragraph 13, identifies five properties of a suitable
cannula material, but none appears in claim 1. Thus the McKinnon
Declaration lends support to the proposition that properties other than those
9 The McKinnon declaration alludes to the claims in Application
13/413,941, not the application involved in the instant appeal which is
13/232,847. This is an additional reason to give little weight to this
Declaration.
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claimed are responsible for the asserted sales increase rather than the
opposite.
Although the declaration of Mr. Bickley identifies the proper patent
application serial number, it is no more specific, stating that the Comfort
Plus “is covered by pending Claim 1—5, 7—17, 19, and 20.” Bickley
Declaration, |6. After describing test procedures, and without reporting any
data, Bickley states:
11. The results of the tests show the following:
a. Westmed’s Comfort Soft Plus cannula tubing, which are [sic]
adapted to fit over patient’s ears, stretches about 1.0 inches per
foot of length when less than 0.5 lbf of tension is applied.
Bickley Dec. |11. Although Bickley reports additional test results, the
above quotation is as close as any of the reported results come to being
limitations recited in claim 1. Claim 1 requires “a material that stretches
about 1 inch per foot of length when between about 0.5 lbs to about 1.5 lbs
of force is applied.” Appeal Br. 32 (Claims App.). The reported less than
0.5 lbf is not between 0.5 lbs. and 1.5 lbs. of force. Because the Bickley
declaration reaches a conclusion that is outside the claimed range, the
Bickley declaration cannot support the Appellants’ position that “the
declaration of Mr. Bickley establishes that Appellant’s [sic] Comfort Soft
Plus cannula practices the invention of the present claims.” Reply 2.
In sum, the declarations of the inventors, Bickley and McKinnon,
contain generic assertions that Westmed’s commercial product is covered by
the appealed claims, but even the reported test conclusions fail to support
this assertion. Accordingly, we give little weight to these Declarations or
those that depend on them, like the declarations of health care professionals,
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for a connection between the commercial product and the invention of
claim 1.
Appellants also present declarations from three nursing professionals
who attest to the utility of the Comfort Soft Plus cannula. We do not
consider these declarations probative of non-obviousness because they are
not tied in any way to the language of the appealed claims. We note that
discovery of the problem preceded the Appellants’ application, as evidenced
by Thompson, and the material Appellants used was readily available, per
Appellants’ admission. There is no evidence that despite knowledge of the
problem and the material, one of ordinary skill in the art still would not have
found the invention obvious. To hold otherwise would reward those taking
advantage of disparate knowledge rather than meeting the statutory standard
of non-obviousness.
Appellants argue in their Reply that the Examiner is relying on
hindsight in combining Thompson with AAPA. Reply 2—3. Appellants
assert that the Examiner relied on “Appellant’s identification of an
acceptable material as a road map to support an obvious contention.” Id.
While the Examiner relied on AAP A to establish two facts, first, that Teknor
Apex 3200-50NT was a preexisting material and, second, that it had
properties corresponding to the material limitation in claim 1, the “roadmap”
is supplied by Thompson. Thus the Examiner cites Thompson paragraph 50
(“Perhaps the most important feature of the cannula of the present invention
is that it can be used with extremely flexible support tubing that bends freely
with head movements without disturbing the position of the cannula on the
face.”) and paragraphs 52—54 which describe the properties of a preferred
material.
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“Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it takes into
account only knowledge which was within the level of ordinary skill at the
time the claimed invention was made and does not include knowledge
gleaned only from applicant’s disclosure, such a reconstruction is proper.”
In re McLaughlin, 443 F.2d 1392, 1395, (CCPA 1971). Here, the Examiner
followed the instructions of Thompson finding one known material to
substitute for another that meets Thompson’s extreme flexibility requirement
and that achieves Thompson’s goals of reducing sores on the ears, nose, and
neck and eliminating grooves across the cheeks. Thompson |50. See Ans.
13.
“In United States v. Adams [, 383 U.S. 39 (1966)], . . . [t]he
[Supreme] Court recognized that when a patent claims a structure already
known in the prior art that is altered by the mere substitution of one element
for another known in the field, the combination must do more than yield a
predictable result.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
“[I]n Sakraida v. Ag Pro, Inc., 425 U.S. 273 (1976), the Court derived from
the precedents the conclusion that when a patent ‘simply arranges old
elements with each performing the same function it had been known to
perform’ and yields no more than one would expect from such an
arrangement, the combination is obvious. Id. at 282.” KSR at 417. We find
no impermissible hindsight, and instead find that substituting one known
element for another with results that were entirely predictable would have
been obvious at the time the application was filed.
Finally, Appellants offer the declaration of Dr. Braun. Dr. Braun is of
the view that Thompson is misleading and incomplete. We have reviewed
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Dr. Braun’s Declaration, particularly paragraphs 14—18. There Dr. Braun
calculates that Thompson’s 10% tensile modulus and a 200 PSI tensile stress
would result in a tube requiring 1.84 pounds to achieve a 10% stretch. Dr.
Braun’s argument is highly dependent on his assumptions. For example, by
increasing the assumed inside diameter of the tube from 1/8 inch to 3/16
inch, the required force drops to 1.07 pounds, at the very middle of the
claimed range of from 0.5 to 1.5 pounds. Dr. Braun’s conclusion that by his
calculation Thompson suggests more than three times the claimed force
appears based on claim 1 as filed rather than as amended. See Braun
Declaration || 18, 21. For these reasons, even were we to find the questions
raised by Dr. Braun relevant, the declaration would not persuade us that the
Examiner erred.
Appellants’ arguments concerning the mathematical and engineering
errors made by the Examiner are free of citations to the record. See Appeal
Br. 12—13. Such arguments are not persuasive. As noted above, the
Examiner relied on Thompson for its recognition of the problem and its
qualitative statements of the requirements for a material useful in solving the
problem. Dr. Braun’s statements are not persuasive because they challenge
portions of Thompson on matters that are irrelevant insofar as our decision is
concerned.
In view of the foregoing and after a review of all of the arguments and
evidence, we affirm the Examiner’s rejection of claim 1 and with it the
rejection of claims 2, 4, 7—9, 11—15, 17, 19, and 20.
Rejections III, IV and V
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Appellants argue that claims 3, 5, 6, and 16 are patentable for the
same reasons that claims 1 and 12 are patentable. Appeal Br. 29-31. We
have affirmed the rejection of claims 1 and 12 from which claims 3, 5, 6,
and 16 depend. Accordingly we affirm the Rejections of claims 3, 5, 6, and
16.
DECISION
The Examiner’s rejections of claims 1—9, 11—17, 19, and 20 are
affirmed.
Claims 1—9, 11—17, 19, and 20 are newly rejected under 35 U.S.C. §
112, first paragraph, for failing to comply with the written description
requirement.
Claims 1—11 are newly rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite for failing to particularly point out and
distinctly claim the subject matter which appellants regard as the invention.
Claim 20 is newly rejected under 35 U.S.C. § 112, second paragraph,
as being indefinite for failing to particularly point out and distinctly claim
the subject matter which appellants regard as the invention.
Regarding the affirmed rejections, 37 C.F.R. § 41.52(a)(1) provides
“Appellants may file a single request for rehearing within two months from
the date of the original decision of the Board.”
This decision contains new grounds of rejection pursuant to 37 C.F.R.
§ 41.50(b). Section 41.50(b) provides that “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section41.50(b) also provides:
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When the Board enters such a non—final decision Appellants,
WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must
exercise one of the following two options with respect to the new grounds 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 proceeding will be remanded to
the Examiner. . . .
(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same record. . . .
Should Appellants elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure§ 1214.01.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED: 37 C.F.R, $ 41.50(b).
27