Ex Parte Frederickson et al

Patent Trial and Appeal Board

Mar 24, 2017

11917300 (P.T.A.B. Mar. 24, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/917,300 12/12/2007 Franklyn L. Frederickson 60873US005 4931
32692 7590 03/28/2017
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
EXAMINER
BOSWORTH, KAMI A
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
03/28/2017 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 FRANKLYN L. FREDERICKSON, MICHAEL D. JOHNSON,
and DAVID J. WIRTANEN
Appeal 2014-009762
Application 11/917,300
Technology Center 3700
Before JOHN C. KERINS, DANIEL S. SONG, and SEAN P. O’HANLON,
Administrative Patent Judges.
O’HANLON, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Franklyn L. Frederickson et al. (Appellants)1 appeal under 35 U.S.C.
§ 134 from the Examiner’s April 23, 2013, non-final decision (“Non-Final
Act.”) rejecting claims 1, 3—10, 12—20, and 27—29.2 We have jurisdiction
over this appeal under 35 U.S.C. § 6(b).
1 According to Appellants, the real party in interest is 3M Company. App.
Br. 3.
2 Claims 2, 11, and 21—26 are canceled. App. Br., Claims App’x.
Appeal 2014-009762
Application 11/917,300
SUMMARY OF THE DECISION
We AFFIRM.
SUMMARY OF THE INVENTION
Appellants’ claimed invention relates to “collapsible microneedle
patches and patch assemblies for carrying and delivering microneedle
arrays.” Spec. 1:9—10. Claim 1, reproduced below from page 18 (Claims
Appendix) of the Appeal Brief, is illustrative of the claimed subject matter:
1. A microneedle patch comprising:
a base having at least one collapsible side wall extending
therefrom, the collapsible side wall being foldable upon itself;
a lip disposed along the at least one collapsible side wall
and opposite the base;
an adhesive disposed along the base; and
a microneedle array affixed to the base by the adhesive,
wherein the adhesive extends beyond and surrounds the
microneedle array, such that the adhesive surrounding the
microneedle array can be adhered to a target site.
REJECTIONS
Claims 1, 3—5, 7, 8, 12—16, 19, 20, and 29 stand rejected under 35
U.S.C. § 103(a) as being unpatentable over Carpenter (GB 2 064 329 A,
pub. June 17, 1981) and Maganias (US 4,473,083, iss. Sept. 25, 1984).
Claim 6 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Carpenter, Maganias, and Trautman (US 6,322,808 Bl,
iss. Nov. 27, 2001).
Claims 9 and 10 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Carpenter, Maganias, and Rosenthal (US 3,221,740,
iss. Dec. 7, 1965).
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Application 11/917,300
Claims 17, 18, 27, and 28 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Carpenter, Maganias, and Palmer (US
6,537,242 Bl, iss. Mar. 25, 2003).
ANALYSIS
Rejection Based on Carpenter and Maganias
Appellants argue claims 1, 3—5, 7, 8, 12—16, 19, 20, and 29 together.
App. Br. 10-16. We select claim 1 as representative, treating claims 3—5, 7,
8, 12—16, 19, 20, and 29 as standing or falling with representative claim 1.
See 37 C.F.R. § 41.37(c)(l)(iv).
The Examiner finds that Carpenter discloses a microneedle patch
substantially as defined in claim 1, but “does not disclose that [the
microneedle array] is affixed [to the base] by adhesive that extends beyond
and surrounds the microneedle array such that the adhesive surrounding the
microneedle array can be adhered to a target site.” Non-Final Act. 2—3. The
Examiner finds that Maganias discloses a microneedle array that is affixed to
a base by an adhesive, and reasons that it would have been obvious to a
skilled artisan “to modify [Carpenter] to include an adhesive, as taught by
Maganias, for the purpose of holding the microneedle patch in place so that
it maintains constant contact with the skin until it is removed.” Id. at 3
(citing Maganias 3:41—43, 47^49).
Appellants traverse, first arguing that “reference to Barber [(UK
1,080,986, pub. Aug. 31, 1967)] is required to understand the function of
Carpenter because Barber was used by Carpenter to make an enabling
disclosure.” App. Br. 12. Appellants note that
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Application 11/917,300
the device disclosed in Barber includes a spring that is
compressed when the plunger is displaced downward so that the
needle plate contacts the skin and the skin of the patient is
punctured. When the device is “removed from the patient. . .
the parts return to their original positions under the action of the
spring 6.”
Id. at 12—13 (citation omitted). Continuing, Appellants assert that
“[bjecause Carpenter teaches using the device of Barber, the needle plate of
Carpenter would also be retracted when the device was removed from the
patient. Carpenter, therefore, teaches only transient contact between the
needles and the target site.” Id. at 13. Appellants also assert that
“modifying Carpenter to include adhesive that [would] cause [] the needle
plate to adhere to the target site would frustrate the retractive operation of
the device taught by Barber and used by Carpenter.” Id. Appellants further
posit that “the devices disclosed [by Barber and Carpenter] were likely
intended to be used for large scale vaccinations,” which, Appellants argue,
“require^ only transient contact with the needles.” Id. at 13—14; see also
Reply Br. 2-A.
Appellants’ reliance on Barber to limit the scope of Carpenter’s
disclosure is misplaced. Carpenter discloses that its “invention relates to
surgical multiple puncture devices,” and that Barber discloses “/o]ne such
apparatus.” Carpenter 1:5—12 (emphasis added). Carpenter further
discloses that “a flexible barrier is provided between the needle plate and the
plunger,” and that “this barrier may be used in a multiple puncture device
constructed as described in [Barber] except that it does not include a skin
plate.” Id. at 1:35—37, 88—91 (emphasis added). Carpenter thus discloses
that its barrier may be used in a device such as that disclosed by Barber, but
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there is no requirement that Barber’s device must be used. Appellants’
allegations to the contrary are unpersuasive. Moreover, even if Carpenter’s
barrier is used with Barber’s device, Carpenter instructs the user to modify
Barber’s device to remove the skin plate. Id. at 1:88—91. As correctly noted
by the Examiner, Carpenter discloses that Barber’s “needle plate is
removable from the plunger as desired.” Id. at 1:18—19; see also Ans. 12.
These modifications further refute the restrictive understanding of Carpenter
as argued by Appellants.
We further note that the Examiner relied on Maganias to provide the
reasoning to leave the microneedle array in extended contact with the
patient’s skin. Non-Final Act. 3. Maganias teaches maintaining a
microneedle array in contact with a patient’s skin for 15—20 minutes to
ensure proper transmittal of its allergen to observe a patient reaction. See
Maganias 3:47—52. Thus, although Carpenter does not expressly disclose
operating its device in a manner that leaves the barrier and needle plate in
place on the patient’s skin, Maganias provides a reason why such operation
would be desirable.
Furthermore, we do not disagree with Appellants’ assertion that “[t]he
addition of adhesive to the needle plate of Carpenter would . . . have
impeded removal of the needle plate along with the device, frustrating the
device’s ability of return the parts to their original position as the device was
withdrawn.” Reply Br. 4. We are not persuaded of error, however, because
such modification provides the benefits taught by Maganias as discussed
above. Moreover, Appellants’ argument is essentially an ineffective attack
on Carpenter (as informed by Barber) individually, whereas the rejection is
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based on the combined teachings of Carpenter and Maganias. See In re
Keller, 642 F.2d 413 (CCPA 1981); In re Merck & Co., 800 F.2d 1091 (Fed.
Cir. 1986) (nonobviousness cannot be established by attacking references
individually where rejections are based on combinations of references). A
person of ordinary skill in the art would have found it obvious to modify
Carpenter to include adhering the needle plate to the flexible barrier therein,
in order to provide a device that will allow, as desired by Maganias, the
microneedle patch to be maintained in contact with the skin until later
removed. See Non-Final Act. 3; see also Carpenter 1:18—19 (disclosing that
in Barber, “needle plate is removable from the plunger as desired”). This
modification is not a result of employing hindsight bias in view of
Appellants’ disclosure. Instead, the reason for the modification is found in
Maganias itself.
Next, Appellants argue that “in the method taught by Maganias, the
adhesive strip is used to adhere the allergy testing device before the lances
are inserted into the skin. After the lances are inserted into the skin, nothing
in Maganias suggests that the adhesive is needed to hold the strip in place.”
App. Br. 14. Appellants acknowledge that “Maganias teaches maintaining
contact between the allergy test and the skin for 15-20 minutes,” but argue
that “Maganias does not teach that adhesive is required to maintain this
contact.” Id. at 14—15.
We find these arguments to be unpersuasive. As correctly noted by
the Examiner, Maganias discloses that the practitioner can cause the lances
of the microneedle array to penetrate the patient’s skin “[simultaneously or
subsequently” to the test strip being adhered to the patient. Maganias 3:42—
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46; see also Ans. 13—14. As the Examiner also correctly notes, this
discussion in Maganias further discloses that “[t]he liquid allergen [delivered
by the lances] is thus carried partly into the skin and is maintained in
constant contact with the traumatized skin cells until the strip is removed,”
suggesting “[a] contact time of 15-20 minutes.” Maganias 3:47—52; see also
Ans. 14. A fair reading of this disclosure reveals that Maganias’s adhesive
is used to maintain the lance array in place for a length of time to deliver
allergen to the patient. Appellants’ arguments to the contrary are
unpersuasive.
Next, Appellants argue that a skilled artisan “would not have looked
to the teachings of Maganias because Maganias teaches that the practitioner
applies the allergy test by touching the adhesive strip,” and “[a] person
having skill in the art of microneedle arrays . . . would have recognized that
it is advantageous if neither the microneedle patch or microneedle array is
‘touched before application to a target site.’” App. Br. 15 (citing Spec.
2:7-8).
This argument is unpersuasive because the Examiner’s rejection does
not purport to apply the microneedle array as Appellants suggest. Rather,
the rejection modifies Carpenter’s microneedle array to include adhesive as
taught by Maganias. Non-Final Act. 2—3. The modified microneedle patch
would still be applied in the manner disclosed by Carpenter, but would be
maintained in constant contact with the patient as taught by Maganias. A
person of ordinary skill, being a person of ordinary creativity, would choose
the adhesive and/or modify the strength of Carpenter’s magnet to allow the
modified microneedle array to remain in contact with the patient. See KSR
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Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007); see also Carpenter 1:18—
19 (disclosing that in Barber, “needle plate is removable from the plunger as
desired”). Furthermore, Appellants’ argument is inconsistent with their
Specification, which states, in a manner similar to that of Maganias, “[i]t
should be understood that after the patch is adhered to the target surface it
may simply be pressed manually to engage the microneedle array with the
application surface.” Spec. 13:12—14.
Finally, Appellants argue that “[t]he Examiner’s rationale for
combining Carpenter and Maganias is unsupported by the documents and by
common sense,” setting forth four rationales to support their contention.
App. Br. 15—16.
Each of Appellant’s four asserted reasons is unpersuasive for the
reasons set forth above. We further agree with and adopt the Examiner’s
responses as set forth in the Examiner’s Answer. See Ans. 15—17.
Accordingly, for the foregoing reasons, we sustain the Examiner’s
rejection of claim 1, as well as claims 3—5, 7, 8, 12—16, 19, 20, and 29 that
fall with claim 1, as being unpatentable over Carpenter and Maganias.
Rejections Based on Carpenter, Maganias, and one of Trautman,
Rosenthal, and Palmer
With respect to the rejection of dependent claims 6, 9, 10, 17, 18, 27,
and 28, Appellants explicitly rely only on the arguments presented above in
regard to the rejection of claim 1. App. Br. 16. Accordingly, for the same
reasons as discussed above, we also sustain the rejection: of claim 6 as
being obvious over Carpenter, Maganias, and Trautman; of claims 9 and 10
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as being obvious over Carpenter, Maganias, and Rosenthal; and of claims
17, 18, 27, and 28 as being obvious over Carpenter, Maganias, and Palmer.
DECISION
The Examiner’s decision to reject claims 1, 3—10, 12—20, and 27—29 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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