Ex Parte Duan et al

Patent Trial and Appeal Board

Feb 27, 2019

13989194 (P.T.A.B. Feb. 27, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/989, 194 05/23/2013
32692 7590 03/01/2019
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
FIRST NAMED INVENTOR
Daniel C. Duan
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.
65318US004 3600
EXAMINER
ORTMAN JR, KEVIN C
ART UNIT PAPER NUMBER
1782
NOTIFICATION DATE DELIVERY MODE
03/01/2019 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):
LegalUSDocketing@mmm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DANIEL C. DUAN and STANLEY RENDON
Appeal2018-001086
Application 13/989, 194 1
Technology Center 1700
Before ADRIENE LEPIANE HANLON, MARK NAGUMO, and
JANEE. INGLESE, Administrative Patent Judges.
HANLON, Administrative Patent Judge.
DECISION ON APPEAL
A. STATEMENT OF THE CASE
The Appellants filed an appeal under 35 U.S.C. § 134(a) from an Examiner's
decision finally rejecting claims 1-5 and 7-16, which are all of the pending
claims. 2 We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to the Appellants, the real party in interest is 3M Innovative Properties
Company. Appeal Brief dated July 10, 2017 ("App. Br."), at 2.
2 Claim 17 was cancelled in an amendment after the Notice of Appeal was filed.
The Examiner entered the amendment. See Advisory Action dated May 19, 2017.
Appeal2018-001086
Application 13/989,194
The subject matter on appeal is directed to thermotropic liquid crystalline
polymer (TLCP) microneedles. The Appellants disclose that "[i]n commercially
relevant TLCPs, mesogens constitute the most fundamental unit of the liquid
crystal polymer." Id. at 2, 11. 4--5. As used in the Appellants' Specification, the
term "'molten TLCP"' is said to refer
not only to all of a TLCP being in a molten state (i.e., where its
mesogens can flow tumble) but also to a TLCP having its mesogens in
the form of solid oriented crystalline regions ( e.g., where the
mesogens are flow aligned) with the remainder of the TLCP being
molten ( e.g., being in the form of one or a plurality of fluid
amorphous regions).
Id. at 2, 11. 12-16.
According to the Appellants,
[i]t can be desirable for a maximum of about 25% of the TLCP
mesogens across the microneedle to be flow tumbled (i.e., for a
maximum of about 25% of the minor dimension of the corresponding
portion of the device or molded article to be isotropic). For other
applications, higher amounts of flow tumbled TLCP mesogens in each
microneedle may be tolerable. For other applications, even a lower
maximum of flow tumbled TLCP mesogens microneedle may be
desirable.
Id. at 3, 11. 1---6.
In one embodiment of the Appellants' invention,
the device ... comprises a microneedle that itself comprises a tip and
a base. To illustrate the stiffness of the needle, it may be observed in
certain embodiments that the microneedle has a bending moment as
measured at 15% of the distance from the tip to the base of from
30,000 to 60,000 mN-µm. In yet other embodiments, the microneedle
has a bending moment as measured at 60% of the distance from the
tip to the base of from 85,000 to 105,000 mN-µm.
Id. at 10, 11. 14--19 (emphasis added).
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Application 13/989,194
The Appellants disclose that the microneedles are typically less than 1000
microns in height and may be more than 50 microns in height. Id. at 8, 11. 10-13.
The Appellants disclose that the microneedles may be inserted into skin. For
example, the Appellants disclose that "hollow microneedles or microneedle arrays
may be used to deliver a formulation of active agent into the intradermal space."
Id. at 12, 11. 21-22. Alternatively, the Appellants disclose that solid microneedles
or microneedle arrays may be used "to penetrate the stratum comeum, providing
channels into the intradermal space, which may be followed by a post treatment
such as application of a transdermal patch." Id. at 12, 11. 28-30.
Representative claim 1 is reproduced below from the Claims Appendix to
the Appeal Brief.
1. A device comprising a thermotropic liquid crystalline polymer
microneedle comprising a tip and a base and having a bending
moment as measured at 15% of the distance from the tip to the base of
from 30,000 to 60,000 mN-µm.
The Examiner maintains the following rejections on appeal:
(1) claims 1-3, 7, 8, and 12-14 under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Ferguson et al. 3 in view of Peeters et al. 4 and Shetty; 5
(2) claims 4, 5, and 9-11 under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Ferguson in view of Peeters and Shetty, and as evidenced by
Manas; 6 and
3 WO 2010/117602 A2, published October 14, 2010 ("Ferguson").
4 WO 90/07348, published July 12, 1990 ("Peeters").
5 Smitha Shetty, Investigation of geometrical effects on microneedle reliability for
transdermal applications (2005) (graduate thesis, University of South Florida),
available at http://scholarcommons.usf.edu/etd/860 (last visited Feb. 6, 2019)
("Shetty").
6 Manas Chanda & Salil K. Roy, Industrial Polymers, Specialty Polymers, and
Their Applications (2009) ("Manas").
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Application 13/989,194
(3) claims 15 and 16 under pre-AIA 35 U.S.C. § I03(a) as unpatentable
over Ferguson in view of Peeters and Sheety, and further in view of Delmore et al. 7
B. DISCUSSION
1. Rejection (1)
The Examiner finds Ferguson discloses a microneedle array made of a liquid
crystalline polymer (LCP). Final Act. 4. 8 Ferguson discloses that the
microneedles are used for delivering therapeutic agents through the skin. Ferguson
,r 3. The microneedles are said to pierce the stratum comeum and form a plurality
of microscopic slits or holes in the outermost layer of skin to facilitate the
transdermal delivery of therapeutic agents through the skin. Ferguson ,r 3. The
Examiner finds Ferguson does not expressly disclose that the LCP is a
thermotropic LCP. Final Act. 5.
Peeters discloses that known, commercially available LCPs are suitable
materials for needles in the medical and health care field. Peeters 2, 11. 19-20. The
Examiner finds Peeters discloses that both thermotropic and lyotropic LCPs are
known LCPs. Final Act. 5 ( citing Peeters 2, 11. 28-29).
Peeters discloses that LCPs are polymers, wherein "mesogenic or 'rigid'
groups are present in the main chain or in the side chain." Peeters 2, 11. 21-22.
The Examiner finds that needles according to the invention disclosed in Peeters
have a high bending stiffness (self-reinforcement) because rigid molecular chains
of the LCP are uniaxially directed during the forming process. Final Act. 5 ( citing
Peeters 1, 11. 29-31 ). The Examiner finds Peeters teaches that "thermotropic
LCP's are preferred because the [sic] can be processed conveniently through the
7 US 2003/0045837 Al, published March 6, 2003 ("Delmore").
8 Final Office Action dated February 9, 2017.
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Application 13/989,194
melt[], allowing the needle to be shaped as desired in any convenient way known,
whereby the required uniaxial orientation is obtained (elongation flow) (i.e.[,] flow
aligned)." Final Act. 5 (citing Peeters 2, 11. 30-32; id. at 3, 11. 11-15).
The Examiner concludes that it would have been obvious to one of ordinary
skill in the art "to modify the LCP material of Ferguson to be a thermotropic LCP
for the purpose of conveniently melt processing the LCP material [], thus
producing needles with high bending stiffness (self-reinforcement) .... " Final
Act. 5-6 ( citations omitted).
The Examiner finds Ferguson, as modified by Peeters, does not expressly
disclose that the microneedle has a bending moment at 15% of the distance from
the tip to the base of from 30,000 to 60,000 mN-µm, as recited in claim 1. Final
Act. 6. The Examiner, however, finds Peeters discloses that it is well known, in
the health care field, that needles require high bending strength. Final Act. 6
( citing Peeters 1, 11. 22-25). The Examiner finds Peeters teaches that "the stiffness
of the LCP' s can be varied in a known way by changing the relation between
mesogenic (rigid) groups and flexible groups, by incorporating angle forming
groups such as meta substituted aromatic groups and the like." Final Act. 6 ( citing
Peeters 2, 11. 32-36). If a particularly high stiffness is required, Peeters discloses
that "the LCP can be blended with reinforcement fibres, such as glass fibres,
carbon fibres etc." Peeters 3, 11. 5-7; Final Act. 6.
The Examiner concludes that
[ a ]bsent a showing of criticality with respect to the bending moment,
it would have been obvious to a person of ordinary skill in the art ...
to optimize the LCP structure ... through routine experimentation as
taught by modified Ferguson [i.e., Ferguson as modified by Peeters]
in order to achieve a needle with sufficient bending strength based on
its end use application.
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Final Act. 7. The Examiner notes that "where 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." Final Act. 7 (citing MPEP § 2144.05 (II)).
Moreover, the Examiner finds Shetty exemplifies bending moments that
overlap the range recited in claim 1, and teaches that design parameters, such as
width, length, and geometry of a microneedle, directly affect the bending moment
of a microneedle. Final Act. 8. Shetty, like Ferguson, discloses microneedles for
transdermal applications. Final Act. 7. Thus, we understand Shetty to teach that
bending moments within the claimed range would have been desirable in a
microneedle having transdermal applications. See Final Act. 18 (finding that "the
use of needles having bending moments overlapping with the recited range are
known for reliable transdermal applications").
The Appellants do not direct us to any error in the Examiner's reason for
modifying the LCP of Ferguson's microneedle with the TLCP disclosed in Peeters
(i.e., "for the purpose of conveniently melt processing the LCP material [ of
Ferguson]" (Final Act. 5)). Rather, the Appellants' arguments on appeal focus on
the claimed bending moment.
The Appellants argue:
Ferguson fails to establish even the possibility of achieving the
bending moment recited in claim 1 in a microneedle made from a
thermotropic liquid crystalline polymer [TLCP]. Without such as
[sic] suggestion, it is impossible for the skilled person to use routine
experimentation to achieve the thermotropic liquid crystalline
polymer [TLCP] microneedle exhibiting the bending moment recited
in claim 1.
App. Br. 6 (emphasis omitted); see also App. Br. 6 (arguing that "it is not
predictable that the bending moment recited in claim 1 was achievable for
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Application 13/989,194
thermotropic liquid crystalline polymer [TLCP] microneedles based on Ferguson"
( emphasis omitted)).
Significantly, the obviousness rejection on appeal is not based solely on
Ferguson but rather is based on the combination of Ferguson, Peeters, and Shetty.
See In re Keller, 642 F.2d 413,425 (CCPA 1981) (the test for obviousness is what
the combined teachings of the prior art would have suggested to one of ordinary
skill in the art). Thus, the Appellants' arguments summarily contending that the
claimed bending moment could not have been predicted or achieved using routine
experimentation based on the teachings of Ferguson alone are not persuasive of
reversible error.
On this record, the Examiner has presented a prima facie case of
obviousness based on the combined teachings of the prior art of record. In
particular, Ferguson, as modified by Peeters, discloses a microneedle array used
for the same purpose as the Appellants' microneedles (i.e., for insertion into skin)
wherein the microneedles have a height that overlaps the height of the Appellants'
microneedles (Spec. 8, 11. 10-13; Ferguson ,r 109) and are composed of the same
material (i.e., TLCP). There is no dispute on this record that Peeters discloses that
the stiffness of a TLCP can be varied in a known way. See Peeters 2, 11. 31-36
(disclosing that "[t]he stiffness and melt behaviour of the LCP's can be varied in a
known way"); see also Reply Br. 2 ("Appellants do not dispute that the stiffness of
a liquid crystalline polymer microneedle can be controlled by manipulating the
ratio of mesogenic and flexible groups [] or processing methods []" ( citations
omitted).). 9 Moreover, Shetty teaches that a bending moment within the range
9 Reply Brief dated November 10, 2017.
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Application 13/989,194
recited in claim 1 would have been desirable in a microneedle having transdermal
applications. Final Act. 7-8, 18.
The Appellants recognize that Peeters describes a hypodermic needle having
a strength "high enough to avoid any risk of bending or breaking during use."
App. Br. 7 (citing Peeters 2, 11. 7-9). Nonetheless, the Appellants argue that
Peeters teaches that "'exerting a greater force in the transversal direction than
occurring in normal use, the needle can be broken, cracked or crushed, readily
rendering it unfit for further use.'" App. Br. 7-8 ( quoting Peeters 2, 11. 9-11 ). The
Appellants argue that "[i]t is not at all clear that this needle would have the high
bending moment recited in claim 1 since it is designed to be broken after use."
App. Br. 8.
Contrary to the Appellants' argument, Peeters does not disclose that force
alone breaks the needle. Peeters discloses that the needle can be "broken, cracked
or crushed" in the following manner:
A very simple and effective way of making the needle unusable is the
use of a flame (match, lighter, gas flame). This is preferably effected
at a temperature around or above the melting temperature or the
degradation temperature of the liquid crystal polymer [LCP]. As a
result of the melting and/or degrading, the molecules loose [sic] their
unidirectional orientation causing the material to deform, the needle
point to loose [sic] its sharpness permanently and the hollow space in
the needle to be lost.
Peeters 2, 11. 11-18 ( emphasis added). The unidirectional orientation described in
Peeters is responsible for imparting a high bending stiffness to the needle. See
Peeters 1, 1. 29-2, 1. 1 (disclosing that "[b]ecause the rigid molecular chains of the
liquid crystal polymer [LCP] have been uniaxially directed during the forming
process, the needle according to the invention has a high bending stiffness ( self-
reinforcement )"). Thus, the mere fact that Peeters' needle can be broken when the
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Application 13/989,194
molecules lose their unidirectional orientation after being heated does not establish
that the needle does not have, or could not be made to have, a bending moment
within the range recited in claim 1 prior to heating.
The Appellants also argue that the microneedles disclosed in Sheety are
prepared from silicon materials and not the claimed TLCP material. App. Br. 8.
For that reason alone, the Appellants argue that "nothing in Shetty helps to
establish that [the claimed] bending moment was known in the prior art with
respect to the thermotropic liquid crystalline polymer [TLCP] microneedles recited
in claim 1." App. Br. 8 (emphasis omitted).
As discussed above, there is no dispute that Peeters discloses that the
stiffness of a TLCP can be varied in a known way. See Peeters 2, 11. 32-36
(disclosing that "[t]he stiffness and melt behaviour of the LCP's can be varied in a
known way"); see also Reply Br. 2 ("Appellants do not dispute that the stiffness of
a liquid crystalline polymer microneedle can be controlled by manipulating the
ratio of mesogenic and flexible groups [] or processing methods []" ( citations
omitted).). The Appellants do not direct us to any evidence or provide any
technical reasoning establishing that it would have been outside the level of
ordinary skill in the art to make a TLCP microneedle having a bending moment as
disclosed in Shetty using the methods described in Peeters. In that regard, the
Appellants do not contend that a TLCP microneedle having the claimed bending
moment would have been unexpected to one of ordinary skill in the art at the time
of the Appellants' invention. Moreover, the Appellants do not expressly disclose
the conditions necessary to achieve the claimed bending moment in a TLCP
microneedle. See Spec. 10, 11. 14--19 ( disclosing one bending moment for "certain
embodiments" and a second, different bending moment for "other embodiments").
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Thus, on this record, it appears that nothing more than ordinary skill in the art
would have been required to make the claimed invention.
Finally, the Appellants argue that "the microneedles described in Ferguson
possess orifices 561 near the tip of the needle (see, e.g., Ferguson, Figure 5C)
[that] would interrupt alignment of polymer that is the result of manipulating
certain processing parameters." App. Br. 7. As a result, the Appellants argue that
the microneedles "would be expected to lack the orientation necessary to achieve
the bending moment recited in claim 1." App. Br. 7.
The Appellants do not direct us to any evidence to support their argument.
See In re Schulze, 346 F .2d 600, 602 (CCP A 1965) ("Argument in the brief does
not take the place of evidence in the record."). In that regard, the Appellants
disclose that their inventive microneedles "may comprise any of a variety of
configurations," such as "tapered structures that include at least one channel
formed in the outside surface of each microneedle" which "extend from one of the
ends of the elongated bases towards the tips of the microneedles." Spec. 8, 11. 22-
31. The Appellants do not disclose that those microneedles have a bending
moment outside the range recited in claim 1.
For the reasons discussed above, a preponderance of the evidence of record
supports the Examiner's obviousness conclusion. Therefore, the rejection of
claims 1-3, 7, 8, and 12-14 is sustained. 10
2. Rejection (2)
Claim 4 depends from claim 3, which depends from claim 1, and recites that
"at least about 30% of the mesogens are flow aligned." App. Br., Claims
10 The Appellants do not present arguments in support of the separate patentability
of any of claims 2, 3, 7, 8, and 12-14.
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Appendix. Claim 5 depends from claim 2, which depends from claim 1, and
recites that "at least about 10% of the mesogens are flow aligned." Id.
The Examiner finds Ferguson does not expressly disclose the percentage of
mesogens that are flow aligned. Final Act. 12. Nonetheless, the Examiner finds:
Ferguson teaches the microneedle part to be created by thermoplastic
injection molding[] (Ferguson, [0094-0095], and as Manas evidences
that injection molding of LCP's creates parts with 15% - 30% of
highly oriented, self-reinforcing skin, which is due to the rigid
molecular chains (i.e.[,] mesogens) (see Peeters, p. 1, lines 29-31, and
p. 2, line 1), the microneedle device of Ferguson would be expected to
have at least about 10% and at least about 30% of the mesogens being
flow aligned, absent an objective showing to the contrary.
Final Act. 13; see also Ans. 20. 11
The Appellants argue:
Ferguson discloses needles that would not be capable of
achieving the bending moment as recited in claim 1 even if formed as
described in Manas. Figure 5C of Ferguson shows orifices 561 near
the tip of the needle. The orifices would interrupt the alignment of
polymer at the tip of the needle. Thus, the needles of Ferguson, even
if formed using the injection mold filling process taught in Manas,
would be expected to lack the orientation necessary to achieve
bending moment recited in claim 1.
App. Br. 9.
For the reasons discussed above, the Appellants' reliance on Ferguson
Figure 5C alone is not persuasive of reversible error. See Ans. 20 (noting that
"Appellant has not provided any evidence to support this position"). Therefore,
the obviousness rejection of claims 4, 5, and 9-11 is sustained.
3. Rejection (3)
11 Examiner's Answer dated September 12, 2017.
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The Appellants argue that "[ n ]othing in Delmore cures the deficiencies of
the combination of Ferguson, Peeters, and Shetty with respect to liquid crystalline
polymer [LCP] microneedles having the bending moment recited in claim 1."
App. Br. 9. For the reasons discussed above, there are no deficiencies in Ferguson,
Peeters, or Shetty that require curing by Delmore in the rejection of claim 1.
Therefore, the obviousness rejection of claims 15 and 16 is sustained.
C. DECISION
The Examiner's decision is affirmed.
No time period for taking any subsequent action in connection with this
appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
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