Ex Parte Hermsmeyer

Patent Trial and Appeal Board

May 9, 2016

12800611 (P.T.A.B. May. 9, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/800,611 05/19/2010
29085 7590 05/10/2016
HOW ARD EISENBERG, ESQ.
1220 LIMBERLOST LANE
GLADWYNE, PA 19035
FIRST NAMED INVENTOR
R. Kent Hermsmeyer
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
796.0037 1120
EXAMINER
ARNOLD, ERNST V
ART UNIT PAPER NUMBER
1613
MAILDATE DELIVERY MODE
05/10/2016 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
Ex parte R. KENT HERMSMEYER
Appeal2013-010635
Application 12/800,611
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
TA WEN CHANG, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving a claim to a
method for increasing the accessibility of a vein for venipuncture. The
Examiner rejected the claim as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
"Venipuncture is the act of puncturing a vein for surgical or
therapeutic purposes or for the collection of blood specimens" (Spec. 1, 11.
1 Appellant identifies the Real Party in Interest as Dimera
Incorporated (see App. Br. 3).
Appeal2013-010635
Application 12/800,611
10-11 ). "With many individuals, especially children, the elderly, and people
with small veins or low blood pressure, venipuncture is difficult because the
target vein fails to fill adequately" (Spec. 1, 25-27).
The Claims
Claim 1, 5, and 31-38 are on appeal. 2 Claim 1 is representative and
reads as follows:
1. A method for increasing the accessibility of a vein for
venipuncture comprising topically applying to a subject in need
of venipuncture on the surface of skin of the subject overlying a
vein suitable for venipuncture a composition containing a salt
of a cation of an element selected from the group consisting of
copper, magnesium, and calcium, in an amount sufficient to
cause the vein to become enlarged due to filling with blood and
thereby to become more readily accessible for venipuncture.
The Issue
The Examiner rejected claims 1, 5, and 31-38 under 35 U.S.C.
§ 103(a) as obvious over White,3 Mbamalu,4 Cooper,5 Saito,6 Coleman,7 and
Ueno8 (Final Act. 14--18).
2 Claim 8 was cancelled by an amendment entered by the
Examiner in the Advisory Action mailed Aug. 20, 2013. In the
Advisory Action, the Examiner also withdrew the 35 U.S.C. § 112,
first paragraph rejection. The Examiner indicated that only claims
1, 5, and 31-38 remain rejected, while claims 2--4, 6, 7, 20, 21, 26,
28, and 30 are objected to (Adv. Act. 8/20/13).
3 White, Foundations ofNursing, 764--765 (Cengage Leaming
2005).
4 Mbamalu, D. and Banerjee, A., Methods of obtaining peripheral
venous access in difficult situations, 75 Postgrad. Med. J. 459--462
(1999).
5 Cooper et al., EMLA cream reduces the pain of venepuncture in
children, 4 Eur. J. Anaesthesiol. 441--448 (1987) Abstract only.
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Appeal2013-010635
Application 12/800,611
The issues presented are:
(i) Does the evidence of record support the Examiner's conclusion
that the prior art renders claim 1 obvious?
(ii) If so, has Appellant presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness?
Findings of Fact
1. Figure 2 of Mbamalu is reproduced below:
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tra11sH!umi11ation
"Figure 2 Algorithm for peripheral venous access in adults" includes the use
of a topical vasodilator as an adjuctive measure (Mbamulu 460).
6 Saito, S., JP 07025773 A, published Jan. 27, 1995, Derwent
Abstract only.
7 Coleman, L., US 8,071,545 B2, issued Dec. 6, 2011.
8 Ueno et al., US 5,100,879, issued Mar. 31, 1992.
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Appeal2013-010635
Application 12/800,611
2. Mbamalu teaches that "[t]opical venodilatation may be
achieved by the application of 4% nitroglycerine [sic] ointment, smeared
onto the skin and left for 2-3 minutes" (Mbamalu 460).
3. Saito teaches an analgesic that "comprises cream base,
magnesium sulphate and at least one of potassium chloride or potassium
acetate" and teaches that "[ s ]ince the cream contains potassium and
magnesium, which are very valuable to human bodies, and absorbed through
the skin into blood, it shows analgesic activity" (Saito abstract).
4. Coleman teaches "'vasodilator' drugs such as ...
nigroglycerine [sic] [and] ... MgSO[ 4]" (Coleman, col. 20, 11. 17-19).
Principles of Law
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR!nt'l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). "If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability." Id. at 417.
Analysis
Mbamalu teaches an algorithm for peripheral venous access that
comprises a series of steps culminating in topically applying a vasodilator to
the skin surface of a subject in need of improved vein access for
venipuncture (FF 1-2). Mbamalu specifically teaches applying nitroglycerin
to the skin surface as a topical vasodilator (FF 2).
Coleman teaches that MgSQ4 was known as an equivalent vasodilator
to nitroglycerin (FF 4) and Saito evidences that topical administration of
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Appeal2013-010635
Application 12/800,611
MgSQ4 resulted in absorption of MgSQ4 through the skin and into the
circulatory system (FF 3).
Applying the KSR standard of obviousness, we agree with the
Examiner's finding it "obvious to use magnesium sulphate in place of
nitroglycerin in a method of venipuncture" because "the concept of using
topical vasodilators to improve the success of venipuncture is already well
known in the art" and because "the ordinary artisan would also expect
magnesium sulphate to function as a topical vasodilator [to] relax a vein and
thus enlarge the vein with blood" (Ans. 5). We agree that this combination
was "the product not of innovation but of ordinary skill and common sense."
KSR, 550 U.S. at 421.
This result is consistent with Wrigley, where the Federal Circuit found
a "strong case of obviousness based on the prior art references of record.
[The claim] recites a combination of elements that were all known in the
prior art, and all that was required to obtain that combination was to
substitute one well-known ... agent for another." Wm. Wrigley Jr. Co. v.
Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012).
Appellant contends that "[t]here is no suggestion in Mbamalu of any
agent other than nitroglycerine [sic] for vein enlargement. ... As stated in
the specification, the use of nitroglycerin is not practical for routine
venipuncture because it is absorbed into the systemic circulation and causes
systemic effects, such as hypotension" (App. Br. 12).
We find this argument unpersuasive because Mbamalu suggests that
after unsuccessful venous access attempts in elective situations, adjunctive
measures such as the use of a topical vasodilator should be considered (FF
1 ). While Mbamalu provides a topical venodilation example that uses the
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Appeal2013-010635
Application 12/800,611
particular vasodilator nitroglycerin (FF 2), Mbamalu clearly suggests topical
use of vasodilators generally as an adjunct when venous access is otherwise
unsuccessful (FF 1 ). Coleman evidences that MgSQ4 was known as an
equivalent vasodilator to nitroglycerin (FF 4). Saito evidences that topically
administered MgSQ4 was known to penetrate skin and reach blood vessels
(FF 3), and even Appellant acknowledges that Saito evidences that MgSQ4
"is absorbed through the skin into the blood" (App. Br. 12).
Appellant contends that "Coleman is not pertinent for two reasons. (1)
The administration of vasodilator drugs in Coleman is a systemic rather than
a topical administration. (2) The effect of the vasodilator drugs in Coleman
pertains to an improvement of capillary bed perfusion" (App. Br. 13).
We are not persuaded. Coleman is relied upon to evidence that
MgSQ4 was known as an equivalent vasodilator to nitroglycerin (FF 4).
That MgSQ4 functions systemically does not teach away from its use
topically, and as already noted, Saito evidences that topically administered
MgSQ4 was known to penetrate skin and reach blood vessels (FF 3) just as
nitroglycerin was known to enlarge veins when applied topically (FF 2) but
also penetrates skin and is "absorbed into the systemic circulation" (App. Br.
12). That MgSQ4 has effects on capillary bed perfusion is irrelevant to the
issue of whether MgSQ4 was a known equivalent of nitroglycerin for
purposes of venodilation.
Appellant contends that
although Coleman may suggest that nitroglycerin and
MgSQ4 have similar systemic effects in improving perfusion
of capillary beds, there is no suggestion in the prior art that a
salt of magnesium would be effective in enlarging a
superficial vein to render the vein more suitable for
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Appeal2013-010635
Application 12/800,611
venipuncture when the magnesium salt is topically applied
to skin overlying the vein.
(App. Br. 14.)
We find this argument unpersuasive because Coleman teaches that
MgSQ4 is a vasodilator (FF 4), and even Appellant's own Specification
recognizes that "'vasodilator' refers to a compound that causes enlargement
of superficial veins" (Spec. 4, 11. 4--5). Given that Mbamalu teaches that
vasodilators may be used to make venipuncture easier (FF 1) and that
Coleman teaches MgSQ4 is a vasodilator (FF 4 ), the preponderance of the
evidence of record reasonably supports the Examiner's finding that "the
ordinary artisan would also expect magnesium sulphate to function as a
topical vasodilator [to] relax a vein and thus enlarge the vein with blood"
(Ans. 5). Appellant provides no evidence rebutting the Examiner's position,
only argument. See In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974)
("Attorney's argument in a brief cannot take the place of evidence.").
Appellant "submits that the present application and claims and solves
[sic] a problem for which a solution has long been sought and which others
have failed to solve" (App. Br. 15). Appellant contends that "the solution is
not due to a lack of interest or lack of appreciation of the potential or
marketability of any such solution because it is evident that such a solution
would have widespread applicability and would be marketable" (id.).
We are not persuaded. Establishing long-felt need requires objective
evidence that an art-recognized problem existed in the art for a long period
of time without solution. Newell Cos. v. Kenney Mfg. Co., 864 F.2d 757,
768 (Fed. Cir. 1988). "[L]ong-felt need is analyzed as of the date of an
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Application 12/800,611
articulated identified problem and evidence of efforts to solve that problem."
Texas Instruments, Inc. v. ITC, 988 F.2d 1165, 1178 (Fed. Cir. 1993).
In this case, Appellant has provided no objective evidence that
making veins more accessible for venipuncture was an art-recognized
problem that had not already been satisfied by prior art methods such as
those disclosed by Mbamalu (FF 1) including the use of topical vasodilators
such as nitroglycerin (FF 2).
Moreover, establishing long-felt need also requires objective evidence
that the invention satisfies the long-felt need. In re Cavanagh, 436 F.2d 491,
496 (CCP A 1971 ). This can be demonstrated, for example, by evidence
establishing commercial success and that the industry purchased the claimed
invention because it satisfied the long-felt need. See W.L. Gore & Assocs.,
Inc. v. Garlock, Inc., 721F.2d1540, 1555 (Fed. Cir. 1983). Appellant has
provided no objective evidence that the claimed formulation satisfied any
long-felt need.
Conclusion of Law
(i) The evidence of record supports the Examiner's conclusion that the
prior art renders claim 1 obvious.
(ii) Appellant has not presented evidence of secondary considerations,
that when weighed with the evidence of obviousness, is sufficient to support
a conclusion of non-obviousness.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over White, Mbamalu, Cooper, Saito, Coleman, and
Ueno. Claims 5 and 31-38 fall with claim 1. 37 C.F.R. § 41.37(c)(iv).
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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