Ex Parte Maskin

Patent Trial and Appeal Board

Feb 29, 2016

12305094 (P.T.A.B. Feb. 29, 2016)

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 03/02/2016
HERBERTL 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
03/02/2016 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@addmg.com
jlong@addmg.com
nmacdonald@addmg.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
Appeal2013-010847
Application 12/305,094
Technology Center 3700
Before LINDA E. HORNER, THOMAS F. SMEGAL, and
JASON W. MEL VIN, 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
of the Examiner's decision rejecting claims 1-31. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE and enter a NEW GROUND OF REJECTION
pursuant to our authority under 37 C.F.R. § 41.50(b).
CLAIMED SUBJECT MATTER
Appellant's claimed subject matter relates to a "device[] and method
for treating a meibomian gland of an eyelid of a patient." Spec. para. 6.
Claims 1, 26, and 31 are independent and are reproduced below.
Appeal2013-010847
Application 12/305,094
1. A method for treating a meibomian gland of an
eyelid of 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.
26. A device for treating a meibomian gland of an
eyelid of a patient comprising:
a probe having an elongated distal end with an outer
diameter of approximately 100 µm or less and a length of
approximately 6 mm or less.
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. (Claims App.).
REJECTIONS
Appellant appeals from the Final Action, dated October 3, 2012,
which contained the following rejections 1:
1. Claims 1-8, 11-15, 22-25, and 31under35 U.S.C. § 103(a) as
unpatentable over Korb (US 2007/0016256 Al, published January
18, 2007) and 2 VETERINARY OPHTHALMOLOGY, 563-617
(Frans C. Stades and Kirk N. Gelatt, Diseases and Surgery of the
Canine Eyelid), (Kirk N. Gelatt ed., 4th ed. 2007) ("Stades"). 2
1 The Final Action also included a rejection of claims 1 and 31 under
35 U.S.C. § 101 as not being supported by an asserted or well established
utility and under 35 U.S.C. § 112, first paragraph, as failing to comply with
the enablement requirement. Final Act. 2. The Examiner subsequently
withdrew these grounds of rejection. Examiner's Answer, dated July 12,
2013 ("Ans.") 4.
2 In the Final Action, the Examiner stated the rejection as being over Korb in
2
Appeal2013-010847
Application 12/305,094
2. Claims 9 and 10 under 35 U.S.C. § 103(a) as unpatentable over
Korb, Stades, and Gravely (US 2008/0081999 Al, published
April 3, 2008).
3. Claims 16-21under35 U.S.C. § 103(a) as unpatentable over Korb,
Stades, and Putz (US 2006/0058743 Al, published March 16,
2006).
4. Claims 26-30 under 35 U.S.C. § 103(a) as unpatentable over Korb
and Stades.
ANALYSIS
Method claims 1 and 31
The Examiner found that Korb discloses "[a] method for treating a
meibomian gland of an eyelid of a patient ... comprising: inserting a distal
end of an elongated probe 230 into a meibomian gland of an eyelid of a
patient via an orifice thereinto." Final Act. 3 (citing Korb, paras. 2, 51). We
find inadequate support in Korb for the Examiner's finding that probe 230 is
inserted into the orifice of a meibomian gland. 3 Korb discloses, with
view of "Stades, within Reinstein." Final Act. 3, citing footnote 1 of
S.L. Reinstein et al., "Successful treatment of distichiasis in a cat using
transconjuctival electrocautery," Veterinary Ophthalmology (2011) 14,
Supplement 1, pp. 130-134 ("Reinstein"). Appellant correctly notes that
Reinstein is not prior art to the claimed invention. Appeal Br. 17, n.2. We
understand the Examiner to cite Reinstein for its reference to the prior art
Stades publication until such time as a complete copy of the Stades
publication could be obtained. See Final Act. 3 (noting that the Stades
publication was "on back-order" and that the Examiner would provide
Appellant with a full copy of the Stades publication as soon as it became
available); see also Examiner Interview Summary, dated February 4, 2013
(providing a full copy of the Stades publication to Appellant).
3 We agree with Appellant that "via an orifice thereinto" as recited in claims
1 and 31, when read in light of the Specification, would be understood by
3
Appeal2013-010847
Application 12/305,094
reference to the apparatus shown in Figure 3a, that means 220 for applying
an external force to the gland to loosen an obstruction includes probe 230,
"which is adapted to vibrate at a preselected frequency at preselected
amplitude." Korb, para. 54. Korb further discloses that probe 230 is
"place[ d] on the eyelid" and delivers "ultrasonic vibrational energy through
the skin." Id., para. 55 (emphasis added). As such, probe 230 is a vibrating
probe used to apply external force to the gland, and Korb does not disclose
by a preponderance of the evidence that a distal end of probe 230 is inserted
into a meibomian gland of an eyelid of a patient via an orifice thereinto.
Korb further discloses that "[ t ]he means 220 for applying the
regulated external force or regulated energy to the obstruction may also
include ... needles [and] microneedles." Id., para. 55, see also id., para. 51
(describing that needles may be used for applying "an external regulated
force to the eyelid and/or directly over the obstructed orifice to loosen the
obstruction within the gland G and the orifice"). Korb further discloses that
after an obstruction has been loosened from the walls of the gland and
softened, liquefied, or fractured, a needle may be used to extract the
softened, broken apart, or fractured obstruction. Id., paras. 52, 53. As noted
by the Examiner, however, Korb does not provide further explanation as to
how these needles would be employed to either apply an external force or
regulated energy to the meibomian gland or to extract the obstruction. Final
Act. 3 ("It is unclear how the needle of Korb is used to remove the
one of ordinary skill in the art to mean via the natural orifice of the
meibomian gland, and not via a man-made opening. See Declaration of
Steven L. Maskin Under 37 C.F.R. § 1.132, dated November 21, 2011
("Second Maskin Dec."), para. 8.
4
Appeal2013-010847
Application 12/305,094
obstruction"). In other words, Korb does not disclose by a preponderance of
the evidence inserting a needle into a meibomian gland via its orifice.
Also, it is not necessarily the case that Korb's disclosure of the use of
needles is a disclosure of inserting the needles into the orifice of the
meibomian gland. 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 Declaration of Steven L. Maskin Under 37 C.F.R. § 1.132,
dated March 15, 2011 ("First Maskin Dec."), para. 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 and using needles to inject anesthetic and/or inject into persistent
oil gland blockage. Second Maskin Deel., paras. 9, 10, citing Appendix P
(S. Vasta, "Aggressive treatments developed for meibomian gland
dysfunction," PCONSuperSite, p. 3, November 18, 2011). To cure the
deficiency in Korb, the Examiner turned to Stades to teach that it was known
in the art at the time of the invention to insert a probe into the orifice of a
meibomian gland of a patient. Final Act. 3.
The Examiner found that Stades teaches "electroepilation for the
permanent treatment of distichiasis" and that this treatment involves
insertion of a probe into the hair follicle to destroy the follicle, wherein the
hair follicle is in the orifice of the meibomian gland. Final Act. 3; Ans. 5, 8-
9 (citing Stades, pp. 571-72, Figures 11.13A and 11.14). Appellant asserts
that evidence shows "in distichiasis, hair follicles are growing where
5
Appeal2013-010847
Application 12/305,094
meibomian glands should have grown, but did not (due to improper cell
differentiation)." Appeal Br. 24; see also id. at 20-25 (citing Appendices U,
V, and W attached to Declaration of Steven L. Maskin Under 37 C.F.R.
§ 1.132, dated August 29, 2012 ("Third Maskin Dec.") and Stades, p. 571,
Fig. 11.13A). Based on this asserted meaning of distichiasis, Appellant
argues that Stades does not disclose insertion of a probe into an orifice of a
meibomian gland; rather, Stades discloses insertion of an electrified wire
into a hair follicle. Id. at 25. In response, the Examiner provides evidence
to support the finding that Stades' s disclosure of insertion of a wire into a
distichiae is disclosure of insertion of a wire into the orifice of the
meibomian gland. Final Act. 6-7 (citing "[ m ]ultiple definitions [of
distichiasis] on the internet" available at Wikipedia,
http://emedicine.medscape.com/article/ 1212908-overview ("Medscape")4,
and http://www.animaleyecare.net/diseases/canine.htm ("Animal Eye
Care"))5.
4 Medscape describes that "[ d]istichiasis is a rare disorder defined as the
abnormal growth of lashes from the orifices of the meibomian glands on the
posterior lamella of the tarsal plate," distichiasis can be acquired or
congenital, "[t]his [congenital] defect may be related to the epithelial germ
cells['] failure to differentiate completely to meibomian glands, instead they
become pilosebaceous units" (Medscape, Background section,
http://emedicine.medscape.com/article/ 1212908-overview (last visited on
0212412016) ), and that acquired distichiasis can result from "metaplasia of
meibomian glands and abnormal growth of lashes from these glands [caused
by] secondary to severe chemical bum, Stevens-Johnson syndrome, OCP, or
chronic blepharoconjunctivis" (Medscape, Causes section,
http:// emedicine. medscape. com/article/ 1212 90 8-c linical#b 5 (last visited on
0212412016) ).
5 Animal Eye Care describes that distichiasis refers to abnormal hairs that
protrude from the oil gland (Meibomian gland) opening of the eyelid.
6
Appeal2013-010847
Application 12/305,094
We have reviewed the statements made in the Third Maskin Dec.
(paras. 7-11) and the accompanying Appendices U, V, and W regarding the
meaning of "distichiasis." We have also reviewed the sources describing
distichiasis cited by the Examiner. Based on our review of all the evidence,
we understand that distichiasis refers to "[a] posterior set of eyelashes
present behind the normal row." Appendix U, p. 424. One cause of
distichiasis is "meibomian gland dysfunction." Id. Other causes of
distichiasis include blepharitis6, caustic injuries, meibomianitis 7 , ocular
cicatricial pemphigoid8, and Stevens-Johnson syndrome 9. Id. Distichiasis
can be congenital or acquired. Medscape, Background. Congenital
distichiasis results in a hair follicle developing in the location on the eyelid
where normally a meibomian gland would have been present. Id.;
Appendix U, p. 424; Stades, p. 571. Appellant's declarations and evidence
are limited to discussion of congenital distichiasis, and do not address
acquired distichiasis.
Acquired distichiasis can result from "metaplasia of meibomian
glands and abnormal growth of lashes from these glands [caused by]
secondary to severe chemical bum, Stevens-Johnson syndrome, [ocular
cicatricial pemphigoid], or chronic blepharoconjunctivis." Medscape,
Causes; Appendix U, p. 424. Based on this evidence, we understand
Section 3 "Distichiasis and Ectopic Cilia".
6 "Blepharitis" refers to eyelid inflammation at the roots of the eyelashes.
7 "Meibomitis" refer to inflammation of the meibomian gland.
8 "Ocular cicatricial pemphigoid" is an auto immune disease affecting the
conjunctiva.
9 "Stevens-Johnson syndrome" is a form of toxic epidermal necrolysis that
may result in conjunctivitis of the eyes.
7
Appeal2013-010847
Application 12/305,094
"distichiasis" to encompass both hairs growing from hair follicles in the
region of the eyelid where normally a meibomian gland would be present
(congenital distichiasis) and hairs growing abnormally from meibomian
glands that have undergone metaplasia (acquired distichiasis ).
Stades discloses that electroepilation or electrocautery can be used
"[f]or permanent treatment of distichiasis." 10 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.
With regard to the proposed combination of Korb and Stades, the
Examiner determined that "it would have been obvious to a person having
ordinary skill in the art at the time the invention was made to have taken the
treatment needles of Korb ... and used them for insertion into the
10 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.
8
Appeal2013-010847
Application 12/305,094
meibomian gland via an orifice as taught by Stades for treating a gland
dysfunction." Final Act. 3 (citing Korb, para. 51); Ans. 8 (describing Korb
as providing "a solid framework that ... the probe (needle) is inserted into
[the] meibomian gland of an eyelid of a patient via an orifice thereinto" and
treating Korb as "a teaching reference in combination with Stades").
Appellant argues Korb is "directed toward meibomian gland treatment
(i.e., improving meibomian gland function)" and Stades is directed to
removal of unwanted hairs and "does not disclose that the unwanted hairs
would adversely affect meibomian gland function" such that "there is no
basis for reasonably expecting that a treatment to remove unwanted hair
would improve meibomian gland function." Appeal Br. 26.
The Examiner responds that "[t]he electroepilation of Stades
definitely treats the meibomian gland by destroying the hair follicle within
the meibomian gland, thus improving the meibomian gland function since
the unwanted hair follicle is now destroyed. It does not necessarily follow
that destroying the hair follicle destroys the meibomian gland function."
Final Act. 7; see also Ans. 9 ("even if there was destruction of meibomian
gland tissue via electroepilation, this destruction could be considered a
treatment and an improvement in meibomian gland function, i.e.[,] if the
gland had cancerous cells, the destruction of these cells would be an
improvement and a treatment").
We agree with Appellant that the Examiner has not provided adequate
reasoning based on rational underpinnings to explain why one having
ordinary skill in the art would have been led to use the treatment needles of
Korb for insertion into the meibomian gland via an orifice as taught by
Stades for treating meibomian gland dysfunction. The Examiner has not
9
Appeal2013-010847
Application 12/305,094
provided adequate evidence to show that one skilled in the art would draw a
correlation between the removal of unwanted hairs and improving
meibomian gland function. As noted by Appellant, Stades teaches the
removal of unwanted hairs from the meibomian to prevent interference with
the ocular surface from the hair itself. Appeal Br. 26; Stades, p. 571 (noting
that "hairs that rub the cornea can irritate and cause injury"). Stades does
not provide adequate evidence to support the Examiner's finding that
removal of unwanted hairs improves the functioning of the meibomian
gland. Further, as noted by Appellant, Reinstein describes that the
electroepilation technique of Stades can destroy the meibomian gland tissue.
Appeal Br. 26-27 (citing Reinstein, p. 133). In light of this knowledge of
one of ordinary skill in the art, the Examiner has not explained adequately
why the teaching of Stades to remove unwanted hair by electroepilation or
electrocautery would have suggested to one of ordinary skill in the art to
insert the treatment needle of Korb into the orifice of the meibomian gland
in order to improve meibomian gland function. Because we find the
Examiner's reasoning inadequate to support the determination of
obviousness, we need not reach Appellant's evidence of non-obviousness
that accompanied the three Maskin Declarations. For the reasons discussed
above, we do not sustain the rejection of method claims 1 and 31, and
dependent claims 2-8, 11-15, and 22-25 under 35 U.S.C. § 103(a) as
unpatentable over Korb and Stades.
The second and third grounds of rejection of dependent claims 9, 10,
and 16-21 rely on the same combination of Korb and Stades further in view
of either Gravely or Putz. Neither Gravely nor Putz cures the deficiencies in
10
Appeal2013-010847
Application 12/305,094
the combination of Korb and Stades. As such, we likewise do not sustain
the second and third grounds of rejection of claims 9, 10, and 16-21.
Device claim 26
Independent claim 26 is directed to a device for treating a meibomian
gland of an eyelid of a patient comprising a probe of a specified diameter
and length. Appeal Br. 48, Claims App. The Examiner determined that the
combination of Korb and Stades "discloses the claimed invention except for
the particular diameter and length of the distal end of the probe" and that
modification of the probe to have the claimed length and outer diameter
"would have involved a mere change in the size of a component" which is
recognized as being within the level of ordinary skill in the art. Final Act.
5-6. For the reasons discussed above in the analysis of claims 1 and 31, the
Examiner's proposed combination of Korb and Stades, which forms the
basis of the rejection of claim 26, is lacking adequate reasoning as to why
one of ordinary skill in the art would have been led to combine the teachings
of these two references. Further, the Examiner fails to explain the proposed
modification to be made to the treatment needle of Korb in light of the
teachings of Stades. For these reasons, we do not sustain the rejection of
claims 26-30 under 35 U.S.C. § 103(a) as unpatentable over Korb and
Stades.
NEW GROUND OF REJECTION
Despite concluding that the Examiner's rationale for combining the
teachings of Korb and Stades is insufficient to present a case of obviousness
of the claimed subject matter, the breadth of independent claim 1 is such that
we enter a new ground of rejection this claim under 35 U.S.C. § 102(b) as
anticipated by Stades. Based on the findings discussed above, Stades
11
Appeal2013-010847
Application 12/305,094
discloses inserting a distal end of an elongated probe (i.e., a steel wire) into a
meibomian gland 11 of an eyelid of a patient via an orifice thereinto in order
to remove an unwanted hair ( distichiae) from the meibomian gland of the
patient. Stades, pp. 571-72; Figs. 11.13A and 11.14. We find that removal
of an unwanted hair from a meibomian gland of a patient constitutes
"treating" the meibomian gland under the broadest reasonable interpretation
of the preamble of claim 112• As such Stades discloses the method of
claim 1.
DECISION
The decision of the Examiner to reject claims 1-31 is REVERSED.
We enter a NEW GROUND OF REJECTION of claim 1 under
35 U.S.C. § 102(b) as anticipated by Stades. 37 C.F.R. § 41.50(b) provides
"[a] new ground of rejection pursuant to this paragraph shall not be
considered final for judicial review."
11 At least in the case of treating acquired distichiasis.
12 The preamble of independent claim 31, by contrast, is directed to "[a]
method for improving meibomian gland function in a patient." Appeal Br.
49, Claims App. We agree with Appellant (Appeal Br. 26-27, citing
Reinstein, p. 133) that insertion of an electrocautery wire into the meibomian
gland to remove unwanted hair may result in damage to the meibomian
gland tissue, and there is insufficient evidence in Stades on which to base a
finding that eletrocautery of a hair follicle from a meibomian gland will
result in improvement of meibomian gland function, as claimed. For this
reason, we decline to enter a new ground of rejection of claim 31.
12
Appeal2013-010847
Application 12/305,094
37 C.F.R. § 41.50(b) also provides that Appellant, WlTHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground 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 [ e ]vidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the [E]xaminer, in which event the proceeding
will be remanded to the [E]xaminer ....
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record ....
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).
REVERSED; 37 C.F.R. § 41.50(b)
13