Ex Parte Greene

Patent Trial and Appeal Board

Aug 29, 2018

14635021 (P.T.A.B. Aug. 29, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO.
14/635,021
12779 7590
Lathrop Gage LLP
28 State Street
7th Floor
Boston, MA 02109
FILING DATE FIRST NAMED INVENTOR
03/02/2015 Donald J. Greene
08/31/2018
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.
579637: GDMC-OOlCON 9387
EXAMINER
WESTERBERG, NISSA M
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
08/31/2018 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):
bostonpatent@lathropgage.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DONALD J. GREENE 1
Appeal2017-007374
Application 14/635,021
Technology Center 1600
Before TA WEN CHANG, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims an oral
formulation for treating migraine headaches, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Migraine headache is a well studied disease [sic] in
which neurogenic inflammation has been implicated.
Neurogenic inflammation has been postulated to be involved in
1 Appellant identifies the Real Party in Interest as Donald J. Greene. Br. 3.
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Application 14/635,021
a variety of human disease states and conditions, including but
not limited to, migraine headache, arthritis, and fibromyalgia.
The basis of these conditions may be an acquired neuronal
pathway that shunts neurogenic inflammatory stimuli to the
cerebral vasculature, joints or muscles, respectively.
Spec. 1. The Specification discloses an oral formulation that effectively
treats migraine headaches. Id.
Claims 44--62 are on appeal. Claim 44 is illustrative and reads as
follows:
44. An orally ingestible formulation consisting essentially of
50-1000 mg of a riboflavin compound;
125- 1000 mg magnesium; and
120-2500 mg of fish oil comprising an unsaturated fatty
acid that is eicosapentaenoic acid (EPA), docosahexaenoic acid
(DHA), or a combination of EPA and DHA, wherein the
combination is provided in a unit dosage form and the
combination of riboflavin, heavy metal, and fatty acid is
effective to prevent or treat a migraine headache when said
formulation is ingested by a human subject, and wherein said
formulation is provided as a capsule, powder, effervescent
formulation, tablet, solution, suspension, emulsion or aerosol
spray.
The claims stand rejected2 as follows:
Claims 44--47, 50-54, and 57---60 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Crawford. 3
2 Claim 63 was rejected under 35 U.S.C. §§ 103(a) and 112, first paragraph.
Final Act. 2--4. Claim 63 has been cancelled by Appellants rendering those
rejections moot. Appeal Br. 9.
3 Crawford and Simmons, What dietary modifications are indicated for
migraines?, 55 J. Family Pract. 62 (2006) ("Crawford").
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Claims 48, 49, 55, and 56 have been rejected under 35 U.S.C.
§ 103(a) as unpatentable over Crawford in view of Piper. 4
DISCUSSION
Crawford
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that the subject matter of
the rejected claims would have been obvious over Crawford.
The Examiner finds that Crawford teaches 600 mg of magnesium,
1.5 g of fish oil, and 400 mg of riboflavin when administered individually,
reduce either the frequency or intensity of migraines or both. Ans. 2. The
Examiner finds that Crawford teaches that "[ a ]n empiric trial of magnesium
and riboflavin is worth considering, as is a low-fat diet high in omega-3 fatty
acids and olive oil (clinical commentary)." Ans. 2, citing Crawford at 63
and 66. The Examiner concludes:
It would have been obvious to the person of ordinary
skill in the art at the time the invention was made to prepare a
composition for treatment of migraine comprising riboflavin,
magnesium, and fish oil and to optimize the amount of each
ingredient in the composition. The amount of a specific
ingredient in a composition is clearly a result effective
parameter that a person of ordinary skill in the art would
routinely optimize. Optimization of parameters is a routine
practice that would be obvious for a person of ordinary skill in
the art to employ and reasonably would expect success. It
would have been customary for an artisan of ordinary skill to
determine the optimal amount of each ingredient to add in order
4 Piper, US 6,159,505, issued Dec. 12, 2000 ("Piper").
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to best achieve the desired results based on factors such as the
age and weight of the patient and severity of the condition to be
treated. The composition can either be provided as individual
components in a kit to readily allow for variation in the dosage
of each ingredient or already combined in a kit for ease of
administration in a single unit dosage form, although with less
ability to vary the dosages in a kit format. The person of
ordinary skill can readily provide the formulation in an
appropriate dosage form such as a capsule or tablet.
Ans. 3.
Appellant contends that Crawford does not teach or suggest the three-
component composition recited in the claims. Appeal Br. 9. Appellant also
argues that Crawford teaches that fish oil has the same effect as olive oil and
that this would have diminished the motivation to use fish oil in the
composition. Id. at 9--10. Appellant contends that Crawford is silent about
the dosages recited in the claims. Id. at 10. Appellant contends that there is
no teaching in Crawford which would lead one skilled in the art to
reasonably expect that the combination recited in the claims would be
effective against migraines, especially when the table 2 of Crawford shows
that fish oil has no effect on migraines. Id. Appellant contends that the
Examiner engaged in impermissible hindsight in making the rejection. Id.
Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
case ofunpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
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record, by a preponderance of evidence with due consideration
to persuasiveness of argument
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). "[W]hen the
question is whether a patent claiming the combination of elements of prior
art is obvious," the answer depends on "whether the improvement is more
than the predictable use of prior art elements according to their established
functions." Id. at 417.
"[W]here the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation." In re Aller, 220 F.2d 454, 456 (CCPA 1955).
"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).
Analysis
We adopt the Examiner's findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding this rejection. We find the Examiner has established that
the subject matter of the claims would have been obvious over Crawford to
one of ordinary skill in the art at the time the invention was made. Appellant
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has not produced evidence showing, or persuasively argued, that the
Examiner's determinations on obviousness are incorrect. Only those
arguments made by Appellant in the Briefs have been considered in this
Decision. Argument not presented in the Briefs are waived. See 37 C.F.R.
§ 41.3 7 ( c )( 1 )(iv) (2015). We have identified claim 44 as representative;
therefore, all claims fall with claim 44. We address Appellant's arguments
below.
Appellant contends that Crawford does not teach or suggest the three-
component composition recited in the claims. We find this argument
unpersuasive.
While we agree with Appellant that Crawford does not describe the
specific composition recited in the claims, Crawford does teach that each of
the components, riboflavin, magnesium and fish oil, are effective in
relieving migraines. Crawford 63. In addition, Crawford teaches combining
different compositions to create an effective composition to relieve
migraines. See, Crawford 63---64 ( describing a trial using riboflavin,
magnesium and feverfew and recommending a trial using magnesium and
riboflavin).
The claimed composition comprises known elements in a known
manner to produce an expected result. Absent any evidence of unexpected
properties, the combination is deemed obvious. KSR, 550 U.S. at 416-417;
see also In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) ("It is prima facie
obvious to combine two compositions each of which is taught by the prior
art to be useful for the same purpose, in order to form a third composition
which is to be used for the very same purpose .... [T]he idea of combining
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them flows logically from their having been individually taught in the prior
art."). Appellant has not advanced any credible evidence that the results
achieved by the claimed composition are unexpected.
Appellant next argues that since Crawford teaches that olive oil has
the same effect as fish oil, that this would diminish the motivation to used
fish oil in the composition. Appeal Br. 9--10. Again, we find this argument
unpersuasive.
While Crawford suggests that fish oil and olive oil have the same
effect, this does not rise to a teaching away from using fish oil. "The prior
art's mere disclosure of more than one alternative does not constitute a
teaching away from ... alternatives because such disclosure does not
criticize, discredit, or otherwise discourage the solution claimed." In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Indeed, substituting known
functional equivalents is prima facie obvious. In re Fout, 675 F.2d 297, 301
(CCPA 1982).
Appellant contends that the Examiner engaged in impermissible
hindsight in making the rejection. Appeal br. 10. In support of this
contention, Appellant argues that Crawford does not tech or suggest the
dosages recited in the claims and that Crawford teaches against the use of
fish oil. Id.
We have considered Appellant's arguments and are not persuaded.
It is well established that some hindsight is permissible as long as the
Examiner only takes into account the teachings of the prior art and does not
use information taken solely from Appellant's disclosure. In re McLaughlin,
443 F.2d at 1395. As shown below, the present rejection is based on
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information recited in the prior art. Appellant has not pointed to any
teaching in the present specification that forms the basis of the present
rejection.
Crawford discloses the use of 1.5 g fish oil (1500 mg), 600 mg
magnesium, and 400 mg riboflavin. Crawford 63. These values fall within
the ranges recited in claim 1 - 50-1000 mg riboflavin, 125-1000 mg
magnesium and 120-2500 mg fish oil. We agree with the Examiner that,
using the teachings of Crawford, it would have been a matter of routine
optimization to discover the effective ranges for each component. Ans. 3.
With respect to fish oil, we do not agree with Appellant that Crawford
teaches away from its use. While table 2 of Crawford may suggest that fish
oil is ineffective, a careful reading of the section of Crawford discussing
omega-3 fatty acids (fish oil) reveals that fish oil and olive oil both reduced
the severity and frequency of migraines. Crawford 63; cf In re Mouttet, 686
F.3d 1322, 1334 (Fed. Cir. 2012) ("[J]ust because better alternatives exist in
the prior art does not mean that an inferior combination is inapt for
obviousness purposes."). In addition, Crawford specifically recommends
studying diets high in omega-3 fatty acids and olive oil. Crawford 64. Thus,
when Crawford is considered as a whole, Crawford does not teach that fish
oil would be ineffective.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner's conclusion that the subject matter of claim 44 would have been
obvious over Crawford.
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Claims 45--47, 50-54, 57-60, and 63 have not been argued separately
and therefore fall with claim 44. 37 C.F.R. § 4I.37(c)(l)(iv).
Crawford Combined with Piper
Appellant's only argument with respect to this rejection is that Piper
does not cure the deficiencies of Crawford. As we have concludes above,
the teachings of Crawford are not deficient. We therefore affirm this
rejection.
SUMMARY
We affirm the rejections under 35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
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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