Ex Parte Maskin

Patent Trial and Appeal Board

Sep 12, 2018

12305094 (P.T.A.B. Sep. 12, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/305,094 12/16/2008 Steven L. Maskin
45191 7590 09/14/2018
HERBERT L. ALLEN
ALLEN, DYER, DOPPELT, MILBRATH & GILCHRIST, P.A.
255 SOUTH ORANGE A VENUE, SUITE 1401
P. 0. BOX 3791
ORLANDO, FL 32802-3791
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.
43101 1961
EXAMINER
HALL, DEANNA K
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
09/14/2018 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):
skemraj@allendyer.com
jlong@allendyer.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN L. MASK.IN
Appeal2017-010980
Application 12/305,094 1
Technology Center 3700
Before LINDA E. HORNER, JEFFREY A. STEPHENS, and
JASON W. MELVIN, Administrative Patent Judges.
HORNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Steven L. Maskin (Appellant) seeks our review under 35 U.S.C.
§ 134(a) of the Examiner's decision rejecting claims 2-25 and 31.
Non-Final Action (February 6, 2017) (hereinafter "Non-Final Act."). 2 We
have jurisdiction under 35 U.S.C. § 6(b).
The subject matter at issue relates to a "method for treating a
meibomian gland of an eyelid of a patient." Spec. ,r 6. In one aspect of the
1 Appellant identifies MGD Innovations, LLC as the real party in interest.
Appeal Brief (May 8, 2017) (hereinafter "Appeal Br."), at 2.
2 Claims 1 and 26-30 are canceled. Non-Final Act. 2.
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invention, an obstruction in a meibomian gland and the orifice thereof can be
alleviated by inserting an elongated probe into a meibomian gland via its
orifice. Id. ,r,r 6-7. Such obstructions can include fibrotic bands and
vascular structures within the meibomian gland duct. Id. ,r 35. The probe
can be inserted into the meibomian gland duct to break through these
obstructions. Id.
The Examiner rejected the claims as indefinite. The Examiner also
determined that the claimed subject matter is anticipated by and obvious
over the prior art. For the reasons explained below, we REVERSE.
CLAIMED SUBJECT MATTER
Claim 31 is the sole independent claim on appeal and is reproduced
below.
31. A method for improving meibomian gland function
in a patient comprising:
inserting a distal end of an elongated probe into a
meibomian gland of an eyelid of a patient via an orifice thereinto.
Appeal Br. 68 (Claims App.).
EVIDENCE
The Examiner relies upon the following evidence in the rejections on
appeal:
Block
Karlin et al. ("Karlin")
MacKeen et al. ("MacKeen")
Stewart
Christiano
Korb et al. ("Korb")
us 3,834,391
us 4,583,539
us 4,915,684
US 6,235,016 Bl
US 2006/0270621 Al
US 2007/0016256 Al
Sept. 10, 1974
Apr. 22, 1986
Apr. 10, 1990
May 22, 2001
Nov. 30, 2006
Jan. 18,2007
H.W. Cowper, M.D., F.A.C.S., Meibomian Seborrhea, Am. J.
Ophthalmology, Vol. 5, Iss. 1 (Jan. 1922), pp. 25-30 ("Cowper")
2
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Application 12/305,094
Frans C. Stades and Kirk N. Gelatt, Diseases and Surgery of the Canine
Eyelid, Veterinary Ophthalmology, Fourth Ed., Vol. 2, pp. 563-617 (2007)
("Stades")
Appellant presents the following evidence in rebuttal:
Declaration of Steven L. Maskin Under 37 C.F.R. § 1.132 (March 15,
2011), including Appendices A through I ("First Maskin Dec.")
Declaration of Steven L. Maskin Under 37 C.F.R. § 1.132 (November 21,
2011 ), including Appendices J through P ("Second Maskin Dec.")
Declaration of Steven L. Maskin Under 37 C.F.R. § 1.132 (August 29,
2012) ("Third Maskin Dec.")
Declaration of Steven L. Maskin Under 37 C.F.R. § 1.132 (November 2,
2016), including Appendices Q through AT ("Fourth Maskin Dec.")
REJECTIONS
The Non-Final Office Action includes the following rejections:
1. Claims 2-25 and 31 under 35 U.S.C. § 112, second paragraph, as
being indefinite. 3
2. Claim 31 under 35 U.S.C. § 102(b) as anticipated by Stades.
3. Claims 22-25 and 31 under 35 U.S.C. § 103(a) as unpatentable
over Stewart and Cowper.
4. Claims 2-8 and 12 under 35 U.S.C. § 103(a) as unpatentable over
Stewart, Cowper, and Christiano.
5. Claims 13-15 under 35 U.S.C. § 103(a) as unpatentable over
Stewart, Cowper, Christiano, and Korb.
3 The Non-Final Office Action contains an internal inconsistency. The
Examiner indicates that dependent claims 11 and 18 are objected to as being
dependent upon a rejected base claim, but would be allowable if rewritten in
independent form. Non-Final Act. 1, 4. Yet, the Examiner also rejects these
claims as indefinite based on their dependence on claim 31. Id. at 3. We
treat these claims as rejected.
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6. Claims 16, 17, and 19 under 35 U.S.C. § 103(a) as unpatentable
over Stewart, Cowper, Christiano, and Block.
7. Claims 20 and 21 under 35 U.S.C. § 103(a) as unpatentable over
Stewart, Cowper, Christiano, Block, and MacKeen.
8. Claims 9 and 10 under 35 U.S.C. § 103(a) as unpatentable over
Stewart, Cowper, and Karlin.
PROCEDURAL HISTORY
This application came before the Board in prior Appeal 2013-010847.
In the Board's Decision in this prior appeal, the Board reversed rejections
under 35 U.S.C. § 103(a) of then-pending claims 1-31 as unpatentable over
Korb and Stades, either alone or in combination with other prior art
references. PTAB Decision in Appeal 2013-010847 (March 2, 2016)
(hereinafter "Prior Dec."), at 1-11. The Board also entered a new ground of
rejection ofclaim 1 under 35 U.S.C. § 102(b) as anticipated by Stades. Id. at
11-12. The Board expressly declined to enter a new ground of rejection of
claim 31 as anticipated by Stades because the Board found that "insertion of
an electrocautery wire into the meibomian gland to remove unwanted hair
may result in damage to the meibomian gland tissue." Id. at 12 n.12 ( citing
S.L. Reinstein et al., "Successful treatment of distichiasis in a cat using
transconjuctival electrocautery," Veterinary Ophthalmology (2011) 14,
Supplement 1, pp. 130-134, n.1) (hereinafter "Reinstein"). The Board, thus,
found that Stades contained insufficient evidence to support a finding that
electrocautery of a hair follicle from a meibomian gland will result in
improvement of meibomian gland function, as claimed. Id.
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ANALYSIS
First Ground of Rejection: Indefiniteness
The Examiner provided several explanations as to why claim 31, and
its dependent claims 2-25, are indefinite. First, the Examiner explained that
claim 31 "fails to correspond in scope with that which the [Appellant]
regard[s] as the invention." Non-Final Act. 2-3. In support of this finding,
the Examiner cited to Appellant's reply of November 2, 2016 (hereinafter
"Sixth Resp."), filed in response to the sixth Office Action. See Appeal
Br. 5-6 (listing Office Actions and Responses). The Examiner stated that in
this reply, Appellant equates "treating" a meibomian gland with "improving
the function" of the meibomian gland, yet the Specification does not
reference "improving" meibomian gland function. Id. at 3. Second, in a
similar vein, the Examiner explained that claim 31 is indefinite because
"'[i]mproving meibomian gland function' is not disclosed by [Appellant's]
[S]pecification." Id. Third, the Examiner determined that claim 31 is
indefinite for failing to include essential steps because "[ o ]nee the distal end
of the probe is inserted into the meibomian gland[,] the steps that lead to an
improvement of the gland function are omitted." Id. at 4. The Examiner
explained that additional steps are essential "because the insertion of the
probe is not readily known or defined in the disclosure to be an improvement
to the gland function" and "'improving' is not even provided for in
[Appellant's] disclosure." Id.
The Examiner's explanations are insufficient to support a
determination of indefiniteness when claim 3 1 is read in light of the
Specification. As noted by Appellant (Appeal Br. 11 ), in the reply to the
sixth Office Action, Appellant provided a summary of Appellant's past
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position and noted that the Board expressly declined to adopt this position.
Sixth Resp. 10. As is clear from this Sixth Response and Appellant's brief,
Appellant no longer seeks a claim that broadly recites "treating" a
meibomian gland, and Appellant has confined the claim scope to a method
for "improving gland function." Sixth Resp. 12 (noting that Appellant
canceled the method of "treating" claim); Appeal Br. 11-12 (distinguishing
"treating" from the claimed method of "improving meibomian gland
function"). 4
Also, as aptly noted by Appellant (id. at 12), failure to disclose the
exact claim language in the Specification is not an adequate basis, by itself,
to support an indefiniteness determination absent some explanation of how
the allegedly unsupported claim language lacks clarity or precision. Here,
the Examiner failed to explain adequately why the claim language
"improving meibomian gland function" renders the claim scope unclear.
Further, we find adequate disclosure in the Specification explaining
how the use of a probe inserted into the orifice of a meibomian gland
improves meibomian gland function. See, e.g., Spec. ,r 3 (noting that "'[d]ry
eye syndrome' can be caused by ... obstructions in the meibomian gland,
preventing lipid secretions from reaching the surface of the eye"); id. ,r 31
( describing that a probe can be used to alleviate an obstruction in the
meibomian gland), id. ,r 35 (describing that a probe can be used to break
through fibrotic bands or vascular structures blocking the orifice to the
meibomian gland).
4 Because the Examiner and Appellant treat the preamble of claim 31 as
limiting, we likewise treat it as such.
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The Specification implies that such obstructions, once alleviated,
might eventually re-form. Id. Nonetheless, the Specification provides
adequate support for a finding that the simple act of inserting the probe into
the meibomian gland via its orifice is sufficient to improve gland function, at
least temporarily. In other words, we understand from the Specification that
in order to pass the probe into the gland via the orifice, the probe must pass
through obstructions blocking the orifice, and that by breaking through such
obstructions to reach the gland, secretions of the gland will thereafter, at
least temporarily, be able to exude from the orifice of the gland. No further
step, apart from the recited step, is required to achieve this improvement to
meibomian gland function. Although the Specification describes further
steps that may be taken to improve gland function, these steps are employed
in addition to passing the probe into the gland via the orifice. See, e.g.,
Spec. ,r 35 (describing introducing medicines into the meibomian gland via
the probe after insertion to present the re-formation of obstructions); id. ,r 36
( describing the application of additional energy after insertion of the probe
through the orifice); id. ,r 42 ( describing applying suction through a lumen in
the probe to remove contents from the gland or pumping fluid through a
lumen in the probe to inject a substance into the gland after insertion of the
probe into the gland); id. ,r,r 49-50 ( describing various probe tips to assist
with removal of obstructions and/or prevention of re-formation of
obstructions).
As such, we find adequate description in Appellant's Specification to
support and render clear the claimed method for improving meibomian
gland function by inserting a distal end of an elongated probe into a
meibomian gland of an eyelid of a patient via an orifice thereinto. For these
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reasons, we do not sustain the rejection of claims 2-25 and 31 under
35 U.S.C. § 112, second paragraph, as being indefinite.
Second Ground of Rejection: Anticipation
The Examiner found that Stades discloses "a method for improving
meibomian gland function in a patient comprising inserting a distal end of an
elongated probe ( steel wire) into a meibomian gland of an eyelid of a patient
via an orifice thereinto." Non-Final Act. 5 (citing Stades, pp. 571-72,
Figs. 11.13A, 11.14). The Examiner's finding is premised on Appellant's
equating "treatment" of the meibomian gland with "improving gland
function." Id. at 12 (stating that Stades's removal of the hair follicle within
the meibomian gland can be considered an improvement to the gland
function despite any damage to the gland tissue from the application of the
additional energy used in the electroepilation treatment of Stades ).
In its prior decision, the Board expressly distinguished the broader
recitation of "treating" the meibomian gland, which encompasses treatments
that might damage the meibomian gland function, from the narrower
recitation of "improving meibomian gland function," as recited in claim 31.
Prior Dec. 12 n.12. Thus, the Board expressly declined to adopt Appellant's
position, as asserted in the prior appeal, that equated "treating" the
meibomian gland with "improving meibomian gland function." The
Examiner's reliance on Appellant's denounced position is insufficient as a
basis for anticipation of the claimed subject matter by Stades.
As explained in detail in the Board's prior decision on appeal, Stades
discloses insertion of a steel wire into the orifice of the meibomian gland for
treatment of distichiasis:
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Stades discloses that electroepilation or electrocautery can
be used "[f]or permanent treatment of distichiasis."5 Stades,
p. 571. Stades describes that "[i]n electrocautery, the hair follicle
is destroyed by coagulation" by introduction of a thin, stiff steel
wire into the opening of the hair follicle about 3 to 5 mm deep
into the lid margin. Id., p. 572, Fig. 11.14. Thus, Stades teaches
treating distichiasis by inserting a steel wire into the opening in
the eyelid from which the hair emanates to destroy the hair
follicle. Stades, pp. 571-72; Fig. 11.14. Stades does not
differentiate between using this procedure for treatment of
congenital versus acquired distichiasis. Rather, we understand
Stades to teach that this treatment is effective in treating either
type of distichiasis. In the case of treatment of acquired
distichiasis, we find that insertion of the steel wire "via the
opening of the gland," as shown in Figure 11.14 of Stades, would
result in insertion of the wire into the orifice of the meibomian
gland.
Prior Dec. 8. Further, as explained in the prior appeal, although removal of
an unwanted hair from a meibomian gland of a patient constitutes "treating"
the meibomian gland, Stades does not provide adequate evidence to support
a finding that removal of unwanted hairs improves the functioning of the
meibomian gland. Id. at 10. As the Board noted previously, Reinstein
describes that such treatment can destroy the meibomian gland tissue. Id.;
see also id. at 12 n.12.
As such, Stades does not provide adequate evidence to support a
finding that it discloses a method for improving meibomian gland function,
5 Stades describes distichiasis as referring to "single or multiple hairs arising
from the free lid margin" and that "[ t ]hey usually arise singly or with two or
more hairs from the meibomian duct openings." Stades, p. 571,
Fig. 11.13A). Stades discloses that "[t]he meibomian glands are modified
hair follicles, and distichia develop from undifferentiated gland tissue." Id.
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as recited in claim 31. For this reason, we do not sustain the rejection of
claim 31 under 35 U.S.C. § 102(b) as anticipated by Stades.
Third through Eighth Grounds of Rejection: Obviousness
In the rejection of claim 31, the Examiner found that Stewart discloses
a method of improving sebaceous gland function by reducing sebum
production by inserting a distal end of a probe 20 into a sebaceous
gland/follicle 15 via an orifice thereinto. Non-Final Act. 6; see also id. at
12-13 (citing Stewart's intrafollicular approach described in column 8, lines
4-8). The Examiner determined that Stewart does not disclose inserting the
probe into a meibomian gland to improve meibomian gland function. Id.
The Examiner turned to Cowper to teach that the meibomian gland "is a
specific type of sebaceous gland and is also known to suffer from
Meibomian seborrhea." Id. Based on this teaching, the Examiner
determined that it would have been obvious to one having ordinary skill in
the art at the time of Appellant's invention "to insert Stewart's probe into a
Meibomian gland of an eyelid of a patient via an orifice thereinto" to treat a
meibomian gland suffering from seborrhea. Id. The Examiner found that
"[t]his alleviation of the abnormal function of the gland (altered secretion,
excessive sebum production) thereby improves gland function in a patient."
Id. at 6-7.
Appellant argues that the Examiner's rejection should not be sustained
because: (1) the combined teachings of Stewart and Cowper would not have
led one of ordinary skill in the art at the time of Appellant's invention to use
Stewart's intrafollicular approach to improve meibomian gland function; and
(2) objective evidence of non-obviousness outweighs the Examiner's
evidence of obviousness. Appeal Br. 19-59. We are persuaded by
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Appellant's argument and evidence that the Examiner has not demonstrated
that the claimed method would have been obvious to one having ordinary
skill in the art at the time of Appellant's invention in light of Stewart and
Cowper.
For instance, Appellant demonstrates that at the time of Appellant's
invention, the disclosure of Cowper would not have led a person having
ordinary skill in the art to treat meibomian seborrhea by Stewart's method
because Cowper's understanding of meibomian glands and the cause of
meibomian seborrhea were no longer accepted as accurate in the art. See
Appeal Br. 25 (citing Fourth Maskin Dec. ,r,r 5, 14) (arguing that at the time
of Appellant's invention, a skilled artisan would have understood that
"meibomian glands are neither identical to common sebaceous glands in
structure ... nor character of secretion" and that a person of ordinary skill in
the art at the time of Appellant's invention "would see Cowper as badly out
of date"). Id.
Appellant also provides evidence rebutting the Examiner's hypothesis
that meibomian seborrhea is caused by overproduction of meibum, and thus,
the condition would be amenable to treatment by Stewart's method. Id. at
26 (emphasis omitted) (citing Fourth Maskin Dec. ,r 4); see also id. (citing
First Maskin Dec, App. D, for description of how understanding of
meibomian gland dysfunction has progressed in the past several decades);
and Fourth Maskin Dec. ,r 6, App. AA ( describing that in July, 2003 there
was no evidence to support overproduction of the meibomian gland as the
cause of meibomian seborrhea).
Appellant further proffered persuasive reasoning, supported by
evidence, rebutting the Examiner's proposition that a person having ordinary
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skill in the art seeking to employ Stewart's technique to treat meibomian
seborrhea would have been led to use Stewart's intrafollicular approach.
Appeal Br. 30 (citing Fourth Maskin Dec. ,r,r 12-14). For instance, we agree
with Appellant that Stewart discloses using an intrafollicular approach only
when performing photothermolysis of sebaceous glands using visible light to
target squalene, which is a component of sebum having an absorption peak
around 480 nm. Stewart, col. 7, 11. 40--43. Stewart teaches that using an
intrafollicular approach with visible light minimizes absorption of the light
by melanin and blood in non-targeted tissue. Id. at col. 7, 11. 43--47 and
col. 9, 11. 4-10. Appellant demonstrates, however, that meibum, unlike
sebum, does not contain an appreciable amount of squalene. Appeal Br. 30
(citing Fourth Maskin Dec. ,r 14, discussing Appendix AC, which discloses
the concentration of squalene in sebum is much higher than in meibum).
Based on this evidence, the Examiner has not explained adequately what
would have prompted a person having ordinary skill in the art to use
Stewart's intrafollicular approach to suppress meibum production. As such,
we are persuaded by Appellant's argument and evidence that a person
having ordinary skill in the art would not have been led to use Stewart's
intrafollicular approach if attempting photothermolysis of the meibomian
gland.
We also find persuasive Appellant's proffered evidence that
practitioners in the art that employ intense pulsed light (IPL) therapy to treat
meibomian gland dysfunction seek to target blood components, which
undercuts the Examiner's proposed use of Stewart's intrafollicular approach,
which seeks to avoid absorption of light by blood components. Appeal
Br. 34 (citing Fourth Maskin Dec. ,r 17 and App. AD). Further, Appellant's
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proffered evidence that, despite mutual awareness of intraductal probing and
IPL therapy to treat meibomian gland dysfunction, practitioners in the art
apply the IPL therapy transcutaneously, and not intraductally, weighs against
the Examiner's proposed rationale for obviousness. Appeal Br. 31-34
( citing Apps. X, AB, AD, AG, AP).
Finally, Appellant's proffered evidence of recognition by others in the
art of the inventor's "novel" probing method and the demonstrated efficacy
of this method even with patients that do not respond to existing therapies,
tips the scales in favor of non-obviousness of the claimed method. For
instance, in an article co-authored by Korb that was published after the time
of Appellant's invention, the Appellant's claimed probing method was
referred to as a "novel" treatment of obstructive meibomian gland
dysfunction. See First Maskin Dec. ,r 8, citing Appendix D (C.A. Blackie et
al., "Nonobvious Obstructive Meibomian Gland Dysfunction," Cornea,
Vol. 29, No. 12, December 2010), p. 1341. Further, Appellant provides
evidence showing that prior to use of Appellant's intraductal probe, a
traditional treatment consisted of lancing the meibomian gland open, getting
it to drain, and injecting anesthetic and/or injecting with a needle into the
persistent oil gland blockage. Second Maskin Deel. ,r,r 9, 10, citing
Appendix P (S. Vasta, "Aggressive treatments developed for meibomian
gland dysfunction," PCONSuperSite, p. 3, November 18, 2011). See also
Appeal Br. 37-59 (discussing various Appendices submitted with the First
Maskin Dec., the Second Maskin Dec., and the Fourth Maskin Dec.) In one
example, Appendix AB demonstrates that "[i]ntraductal meibomian gland
probing (MGP) is a procedure that may be of benefit in patients who are
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recalcitrant to traditional therapies."6 Fourth Maskin Dec. ,r 19, App. AB, p.
8; see also Apps. AE through AT (discussed in Fourth Maskin Dec. ,r 19).
Upon review of the totality of the evidence and argument proffered by
the Examiner and Appellant as to obviousness of the claimed method, we
find that the evidence and argument proffered by Appellant in favor of
non-obviousness outweighs the evidence and argument of obviousness
proffered by the Examiner. Accordingly, we do not sustain the rejection of
independent claim 31 and its dependent claims 22-25 under 35 U.S.C.
§ 103(a) as unpatentable over Stewart and Cowper.
The Examiner does not rely on any of Christiano, Korb, Block,
MacKeen, and Karlin, to cure the above-noted deficiencies in the base
combination of Stewart and Cowper. Accordingly, we likewise do not
sustain the rejections under 35 U.S.C. § 103(a) of dependent claims 2-10,
12-17, or 19-21.
DECISION
The decision of the Examiner to reject claims 2-25 and 31 is
REVERSED.
REVERSED
6 Appendix AB attributes intraductal meibomian gland probing to Maskin.
App. AB, p. 8, p. 9 n.18.
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