Ex Parte Kshirsagar et al

Patent Trial and Appeal Board

Oct 24, 2017

13825676 (P.T.A.B. Oct. 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.
13/825,676 03/22/2013 Manjiri T. Kshirsagar 66209US004 3212
32692 7590 10/26/2017
3M INNOVATIVE PROPERTIES COMPANY
PO BOX 33427
ST. PAUL, MN 55133-3427
EXAMINER
GROSSMAN, ANDREA S
ART UNIT PAPER NUMBER
1678
NOTIFICATION DATE DELIVERY MODE
10/26/2017 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 MANJIRI T. KSHIRSAGAR and ANDREW W. RABINS1
Appeal 2016-008615
Application 13/825,676
Technology Center 1600
Before DONALD E. ADAMS, RICHARD J. SMITH, and
TAWEN CHANG, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a
concentration process, such as a process for concentrating microorganisms,
that includes providing a concentration device. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is 3M Company and its
affiliate 3M Innovative Properties Company. (Appeal Br. 2.)
Appeal 2016-008615
Application 13/825,676
STATEMENT OF THE CASE
Claims on Appeal
Claims 1,3, 5—17, 28, and 29 are on appeal. (Claims Appendix,
Appeal Br. 37-40.) Claim 1 is illustrative and reads as follows:
1. A concentration process comprising
(a) providing a concentration device comprising
(1) a porous fibrous non woven matrix formed by a wetlaid
process, wherein the fibers of said porous fibrous nonwoven
matrix are selected from the group consisting of polymer
fibers, inorganic fibers, and combinations thereof,
(2) a plurality of particles of at least one concentration agent
that comprises diatomaceous earth, said particles being
enmeshed in said porous fibrous nonwoven matrix, and
(3) a polymeric binder, wherein less than about 5 percent of the
total surface area of said particles is covered with polymeric
binder;
(b) providing a sample comprising at least one target cellular analyte;
(c) contacting said concentration device with said sample such that at
least a portion of said at least one target cellular analyte is bound
to or captured by said concentration device, such that the at least
one target cellular analyte remains viable; and
(d) detecting the presence of at least one target cellular analyte bound
to the concentration device.
Examiner’s Rejections
1. Claims 1, 3, 5—17, and 28 stand rejected under pre-AIA 35 U.S.C.
§ 103(a) as unpatentable over Kshirsagar,2 Carbonell,3 Koslow,4 and Young,
Sr.5 (Ans. 4—10.)
2. Claim 29 stands rejected under pre-AIA 35 U.S.C. § 103(a) as
2 Kshirsagar et al., WO 2009/046191 A2, pub. April 9, 2009 (“Kshirsagar”).
3 Carbonell, US 2006/0160064 Al, pub. July 20, 2006 (“Carbonell”).
4 Koslow, WO 03/064330 Al, pub. Aug. 7, 2003 (“Koslow”).
5 Young, Sr. et al., US 5,432,000, issued July 11, 1995 (“Young, Sr.”).
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unpatentable over Kshirsagar, Carbonell, Koslow, Young, Sr., and
Everhart.6 {Id. at 10—11.)
3. Claims 1,3, 5—17, 28, and 29 stand rejected on the ground of
nonstatutory double patenting as being unpatentable over claims 1—14 of US
Patent No. 8,546,100 B27 in view of Carbonell, Koslow, and Young, Sr. {Id.
at 12-15.)
4. Claims 1, 3, 5—17, 28, and 29 stand provisionally rejected on the
ground of nonstatutory double patenting as being unpatentable over claims
1, 3—8, 10-17, and 19 of copending Application No. 13/257,406 (“the ’406
Application”) in view of Carbonell, Koslow, and Young, Sr. {Id. at 16—19.)8
FINDINGS OF FACT
The following findings are provided for emphasis and reference
purposes. Additional findings may be found throughout this Decision and in
the Answer.
FF 1. The Examiner finds that Kshirsagar teaches
a concentration process comprising a) providing a concentration
agent that comprises particles of diatomaceous earth, b) providing
a sample comprising at least one target cellular analyte
(microorganism strain), c) contacting the concentration agent with
said sample such that at least a portion of said at least one target
cellular analyte is bound to or captured by said concentration
agent, such that the at least one target cellular analyte remains
viable, and d) detecting the presence of at least one bound target
cellular analyte.
(Ans. 4, citing Kshirsagar Abstract, 1,11. 8—11, and claims 1—3.)
6 Everhart et al., WO 98/04335, pub. Feb. 5, 1998 (“Everhart”).
7 Kshirsagar et al., US 8,546,100 B2, issued Oct. 1, 2013.
8 This double patenting rejections refers to claim 4, but claim 4 has been
cancelled. (Final Act. 2, dated July 24, 2015.)
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FF 2. The Examiner finds that Kshirsagar teaches a device for use in the
process that can be made of diatomaceous earth and a nonwoven support
matrix that can be made of polymers and inorganic solids, and that
Kshirsagar further teaches the use of binders. (Ans. 4, citing Kshirsagar 4,
11. 4—11, 6,11. 18-12 [sic, 22], 17,11. 15-20, and 19,11. 5-10.)
FF 3. The Examiner finds that Kshirsagar
does not explicitly teach that the support matrix is porous and
fibrous, does not teach that the particles are enmeshed, does not
teach that less than about 5% of the total surface area of the
particles is covered with a polymeric binder, and does not teach
that the matrix is made by a wetlaid process.
(Ans. 5.)
FF 4. The Examiner finds that Carbonell teaches a concentration device,
similar to Kshirsagar, containing particles and a porous fibrous nonwoven
matrix for binding bacteria, wherein the particles are enmeshed in the
nonwoven matrix and the nonwoven matrix may be formed by wet laying.
(Ans. 5, citing Carbonell Abstract and ^fl[ 6, 11, 22, 36, 51, 53, and 91—95.)
FF 5. Carbonell teaches that “[t]he purification and extraction techniques of
the invention offer advantages over conventional purification techniques, by
reducing the number of purification steps, improving yields, increasing
purity, and overcoming limitations associated with the traditional methods.”
(Carbonell 191.)
FF 6. The Examiner finds that Koslow teaches a nonwoven web with a
polymer binder that entraps particles. (Ans. 6, citing Koslow 15,11. 15—27,
16,11. 1-15, and 17,11. 25-30.)
FF 7. Young, Sr. teaches that “particulate materials . . . may be adhered to
the fibers by the binder material” and that “lower binder content may be
used to reduce the possibility of the binder coating the particles and
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interfering with the functionality of the particles.” (Young, Sr. col. 18,11.
20-22 and 55-58.)
FF 8. Young, Sr. teaches that “[ljower binder content may be used (for
example between 7 and 10 percent) [to] reduce the degree to which the
particles are embedded in the binder, thereby increasing the exposed surface
area of the particles and in many cases their functionality.” {Id. at col. 22,11.
64—68.)
FF 9. Young, Sr. teaches that “particles [bound to the surface of fibers by
the binder] substantially retain their medical effectiveness, with their
effectiveness being enhanced by minimizing the surface area of the particles
in contact with the binder.” {Id. at col. 23,11. 65—68.)
FF 10. The Examiner finds that
Young Sr. establishes that the amount of the binder on the surface
is a result-effective variable and therefore it would have been
routine to optimize the amount of binder. In the absence of
evidence of critical[ity] for “less than 5%,” it would be obvious
to arrive at this range out of the course of routine optimization
and one would have a reasonable expectation of success.
(Ans. 38; see also Ans. 8.)
DISCUSSION
Except as otherwise indicated, we adopt the Examiner’s findings and
conclusions as our own, including with regard to the scope and content of,
and motivation to combine, the prior art, as set forth in the Answer (Ans. 4—
19 and 29-43). We discern no error in the rejection of the claims as obvious
(Rejection Nos. 1 and 2) or as unpatentable on the grounds of nonstatutory
double patenting (Rejection Nos. 3 and 4).
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Rejection No. 1
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejection under pre-AIA 35 U.S.C. § 103(a).
Analysis
The Examiner finds that Kshirsagar teaches all of the steps of the
claimed concentration process, and only lacks teachings regarding certain
aspects of the concentration device provided in step (a) of the process. (FF
1—3.) Moreover, based on the additional teachings of Carbonell, Koslow,
and Young, Sr. (FF 4—10), the Examiner concludes that:
It would have been prima facie obvious at the time the invention
was made, for one of ordinary skill in the art to have used the
porous fibrous nonwoven matrix, made by a wetlaid process,
where particles are enmeshed in the porous fibrous non-woven
matrix, as taught by Carbonell, and include a polymeric binder,
as taught by Koslow, where less than 5% of the total surface
are [a] of the particles is covered with a polymeric binder, as
taught by Young Sr., in the method of Kshirsagar.
(Ans. 6.)
Appellants contend that the Examiner has committed at least two
errors:
First, the specific disclosure of Kshirsagar in combination with
Carbonell, Koslow, and Young, Sr. does not provide a reasonable
expectation of success in concentrating and detecting
microorganisms in the method of claim 1. Second, alleging that
the general disclosure of Young, Sr. renders obvious the explicit
recitation in claim 1 of “(3) a polymeric binder, wherein less than
about 5 percent of the total surface area of said particles is
covered with polymeric binder” is an overextension of the
teachings of Young, Sr.
(Appeal Br. 32; see also id. at 5.)
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Appellants provide the Kshirsagar Declaration9 to support their
contentions. Appellants’ arguments in support of their contentions are
addressed below.10 We limit our consideration of those arguments to claim
1 because the claims were not argued separately.
Reasonable Expectation of Success
Appellants argue that “Kshirsagar is silent regarding detecting
microorganisms captured by concentration agent particles coated on a
nonwoven material and the Kshirsagar Declaration discloses that there were
issues in preparing a nonwoven material coated with concentration agent
particles that precluded any experimental testing of the coated nonwoven
material.” (Appeal Br. 32—33.)
We are not persuaded. The reasonable expectation of success
requirement “refers to the likelihood of success in combining references to
meet the limitations of the claimed invention.” Intelligent Bio-Systems, Inc.
v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). Here,
claim 1 does not recite that the “concentration agent particles [are] coated on
a nonwoven material.” Moreover, Kshirsagar teaches “[a] process for . . .
concentrating microorganisms for detection” (Kshirsagar Abstract) and
9 37 CFR § 1.132 Declaration of Manjiri T. Kshirsagar, dated May 18, 2015.
(“Kshirsagar Declaration” or “Deck”) The Kshirsagar Declaration identifies
the declarant, Manjiri T. Kshirsagar, as one of the inventors of the present
application. (Deck 11.)
10 Appellants begin their discussion of both the first and second contentions
of error with the statement “[a]s discussed in detail above.” (Appeal Br. 32
and 34.) That statement refers to approximately 25 pages of text in which
Appellants restate prior office actions and responses, including office actions
relating to claims or rejections not on appeal. (See Ans. 20.) We address the
specific errors alleged by Appellants in response to the Final Office Action
dated July 24, 2015.
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“wherein said process further comprises detecting the presence of at least
one bound microorganism strain” (Kshirsagar 37, claim 2).
Appellants’ argument regarding “issues in preparing a non woven
material coated with concentration agent particles” is unpersuasive because
it relies on an experiment described in the Kshirsagar Declaration that uses a
specific experimental method (involving die cutting) and, as stated by the
Examiner, “[njothing in Kshirsagar limits the devices to devices produced
by the experimental method in the Declaration.” (Decl. 16; Ans. 31—32.)11
To the extent Appellants are arguing that there would be no reasonable
expectation of success in physically combining Carbonell with Kshirsagar,
that argument is unavailing because the test for obviousness is “what the
combined teachings of the references would have suggested to those of
ordinary skill in the art,” and to justify combining reference teachings “it is
not necessary that a device shown in one reference can be physically
inserted into the device shown in the other.” In re Keller, 642 F.2d 413, 425
(CCPA 1981).
Appellants further argue that “one of ordinary skill in the art would
appreciate that the presence of the fibrous porous nonwoven matrix during
detection of captured microorganisms introduces additional materials that
11 Appellants take issue with the Examiner’s statement that the experiment
reflected in paragraph 6 of the Kshirsagar Declaration was conducted before
the filing date of Kshirsagar. (Reply Br. 4 (The Reply Brief is not
numbered, but we treat the page with the heading “REMARKS” as page 2,
with subsequent pages in consecutive order).) We note Appellants’
clarification and explanation for discussing the experiment, but we remain
unpersuaded by Appellants’ “reasonable expectation of success” arguments
for the reasons stated.
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could interfere with the detection assays,” but that “surprisingly, sufficient
microorganisms were captured and detected according to the method of
claim 1 to make the method suitable for concentrating and detecting
microorganisms in a fluid sample.” (Appeal Br. 33.)
This argument that the use of a fibrous porous nonwoven matrix
during detection “could interfere with the detection assays” is also
unpersuasive. As an initial matter, claim 1 is not limited to a particular
detection method or assay, and the recited detecting step is not limited to
detection only when the concentration agent particles are enmeshed in the
matrix and the analyte is bound to or captured by those particles. (See Ans.
30—31 and 33.) Moreover, to the extent that argument is based on the
Kshirsagar Declaration, we note that the Kshirsagar Declaration states that
“[i]t was therefore unexpectedly found that microorganisms captured by the
porous fibrous nonwoven matrix could be detected using a bioluminescence
detection method without being removed from being bound to the
concentration device (having concentration agent particles enmeshed in the
porous fibrous nonwoven matrix).” (Decl. 1 5; see also Appeal Br. 18—22.)
That statement is not persuasive because it is limited to a particular detection
method (i.e. bioluminescence) and detection of microorganisms “without
being removed from being bound to the concentration device” (i.e.
enmeshed particles), and thus not commensurate in scope with the claimed
invention. See In re Dill, 604 F.2d 1356, 1361 (CCPA 1979) (“The evidence
presented to rebut a prima facie case of obviousness must be commensurate
in scope with the claims to which it pertains.”).
In further support of their “reasonable expectation of success”
contention, Appellants argue that “Carbonell would not have motivated one
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of ordinary skill in the art to enmesh the . . . concentration agent particles . . .
instead of coating them on a nonwoven material at least because Carbonell
discloses . . . entrapping resin particles, not particles similar to diatomaceous
earth.” (Appeal Br. 33.) Moreover, according to Appellants, “[t]he
advantages disclosed by Carbonell. . . relate to protein purification but are
not relevant to capturing or concentrating microorganisms.” (Id.)
We are not persuaded. Regarding Carbonell’s use of resin rather than
diatomaceous earth, the Examiner explains:
Carbonell. . . teaches that the particles are impregnated in the
nonwoven matrix and can be made of an organic or inorganic
material, which includes diatomaceous earth. Moreover,
Carbonell does not only associate wetlaid processes with resin,
but teaches . . . using a wetlaid process and does not mention
resin. Thus, since Carbonell teaches particles which include
diatomaceous earth, one would be motivated to combine
Carbonell with Kshirsagar.
(Ans. 23—24, citing Carbonell claim 1 and 42, 51, and 56; see also FF 5
and Ans. 7 regarding motivation to enmesh the particles.)12 The Examiner
further explains that the teachings of Carbonell are not limited to protein
purification and that the analyte may be a microorganism such as bacteria.
(Ans. 41, citing Carbonell Tflf 32, 36—38, 92, and claim 11.)
Appellants further argue that the method of claim 1 “provides a
surprisingly fast method of detecting the presence of microorganisms . . .
12 Appellants argue that the “conventional purification techniques” cited by
Carbonell (FF 7) “do not include a support coated with concentration agent
particles [] as disclosed by Kshirsagar.” (Reply Br. 3.) However, the
teachings of Kshirsagar are not limited to a support coated with
concentration agent particles. (See, e.g., Kshirsagar 17—19.)
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including surprisingly faster effective microorganism capture than obtained
using free concentration agent particles, including contact times as short as
about 20 seconds and without the need for a settling step.” (Appeal Br. 33;
see also Appeal Br. 22—24.) This, according to Appellants, “was unexpected
at least because the free concentration agent particles were in complete
contact with a fluid sample whereas the enmeshed concentration agent
particles were in contact with a sample only as it passed through the fibrous
porous nonwoven matrix.” (Id.)
We are unpersuaded. “[W]hen unexpected results are used as
evidence of nonobviousness, the results must be shown to be unexpected
compared with the closest prior art.” See In re Baxter Travenol Labs., 952
F.2d 388, 392 (Fed. Cir. 1991). Here, Appellants are comparing bacteria
capture by enmeshed concentration agent particles to bacteria capture by
free concentration agent particles, rather than by prior art enmeshed particles
(e.g. Carbonell). (Appeal Br. 23; Ans. 32—34.) Furthermore, Kshirsagar
teaches a similarly fast detection method, including contact times as short as
15 seconds, thereby indicating that the short assay time is not unexpected.
(Ans. 26.)
Teachings of Young
Appellants argue that Young, Sr. “fails to teach or suggest ‘not
covering the particles with binder (0%)’” and “fails to provide any guidance
regarding any amount of particle surface area to coat without interfering
with the functionality of the particles.”13 (Appeal Br. 34; see also Reply Br.
13 Because we find that the claimed range of about 5% or less is a result
effective variable, we do not rely on the Examiner’s finding that Young, Sr.
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2.) Thus, according to Appellants, Young, Sr. “cannot render obvious the
explicit recitation in the method of claim 1 of ‘less than about 5 percent of
the total surface area of said particles is covered with polymeric binder.’”
(Appeal Br. 32; see also id. at 24—27.)
We are not persuaded. It is well settled 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.” In re
Alter, 220 F.2d 454, 456 (CCPA 1955). Here, Young, Sr. discloses that the
amount of the total surface area of the particles covered with binder is a
result effective variable, including a balance between adhesion to the fibers
and functionality of the particles. (FF 7—10.) Thus, Appellants claimed
surface area coverage range of about 5% or less is prima facie obvious, and
Appellants have proffered no evidence of criticality of the claimed range.
See Alter, 220 F.2d at 456.
Accordingly, for the reasons of record and as set forth above, we
affirm the rejection of claim 1 for obviousness. Claims 3, 5—17, and 28 were
not argued separately and fall with claim 1.
Rejection No. 2
Appellants contest the rejection of claim 29 by arguing that claim 29
is patentable for at least the reasons given with respect to the rejection of
claim 1. (Appeal Br. 34.) Accordingly, because Appellants advance no
additional arguments, we affirm the rejection of claim 29 for the reasons of
record and as set forth above in connection with Rejection No. 1.
teaches “not covering the particles with the binder (0%)” (Ans. 8) for
purposes of our decision.
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Rejection No. 3
Appellants contest the nonstatutory double patenting rejection “for at
least the reasons discussed” in connection with the rejection of claim 1.
(Appeal Br. 35.) Accordingly, because Appellants advance no additional
arguments, we affirm the rejection of claims 1,3, 5—17, 28, and 29 on the
ground of nonstatutory double patenting over claims 1—14 of US Patent No.
8,546,100 B2 in view of Carbonell, Koslow, and Young, Sr., for the reasons
of record and as set forth above in connection with Rejection No. 1.
Rejection No. 4
Appellants contest the provisional rejection of claims 1, 3, 5—17, 28,
and 29 on the ground of nonstatutory double patenting over claims 1, 3—8,
10—17, and 19 of the ’406 Application in view of Carbonell, Koslow, and
Young, Sr. (Appeal Br. 35—36.) We select claim 1 for consideration of
Appellants’ arguments because the claims were not argued separately.
Claim 1 of the ’406 Application recites “a concentration device
comprising a sintered porous polymer matrix.” (See Listing of Claims
submitted with Amendment and Response under 37 CFR § 1.114, dated
Sept. 21, 2016.) Appellants cite to the ’406 Application and argue that the
Examiner “has not provided a rationale for why one of skill in the art would
develop a device that instead employs a porous fibrous nonwoven matrix
formed by a wetlaid process when the device including a sintered porous
polymer matrix works effectively, as disclosed in [the ’406 Application].”
(Appeal Br. 35.) Appellants argue further that the advantages disclosed in
Carbonell are in comparison to prior filters and other nonwoven fabrics and
“NOT in comparison to a sintered device for capturing microorganisms.”
{Id. at 35—36.) Furthermore, according to Appellants, “[n]o reason has been
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provided for why one of ordinary skill in the art would have looked towards
the fibrous webs of Carbonell when considering the sintered matrix of [the
’406 Application].” (Reply Br. 5.)
We are not persuaded. As an initial matter, we agree with the
Examiner’s position that “the advantages of Carbonell are general
advantages and not just over the prior art,” citing Carbonell’s teaching that
“fibrous webs are particularly desired because such webs provide large
surface areas, with nonwoven fibrous webs being preferred due to ease of
manufacture, low material cost, and allowance for variation in fiber texture
and fiber density.” (Ans. 42, citing Carbonell 148.) Furthermore, similar to
the teachings of Kshirsagar (FF 1, 2) and the obviousness rejection of claim
1, the cited claims of the ’406 Application recite all of the steps of the
concentration process of claim 1 except for certain aspects of the
concentration device that are recited in step (a) of the claim 1 process.
0Compare claim 1 of the ’406 Application and claim 1 at Appeal Br. 37.)
Moreover, for the same reasons that it would have been obvious to use the
claimed concentration device in the concentration process of Kshirsagar,
based on the teachings of Carbonell, Koslow, and Young, Sr., it would also
have been obvious to provide the presently claimed concentration device in
the process as claimed in the ’406 Application.
Accordingly, for the reasons set forth above in connection with
Rejection No. 1 and the reasons of record, we conclude that claim 1 is
unpatentable on the ground of nonstatutory double patenting over claims 1,
3—8, 10-17, and 19 of the ’406 Application in view of Carbonell, Koslow,
and Young, Sr. Claims 3, 5—17, 28, and 29 were not argued separately and
fall with claim 1.
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Conclusions of Law
A preponderance of evidence of record supports the Examiner’s
rejections of claims 1, 3, 5—17, 28, and 29 under pre-AIA 35 U.S.C.
§ 103(a).
A preponderance of evidence of record supports the Examiner’s
rejections of claims 1,3, 5—17, 28, and 29
(a) on the ground of nonstatutory double patenting over claims 1—
14 of US Patent No. 8,546,100 B2 in view of Carbonell, Koslow, and
Young, Sr.; and
(b) on the ground of nonstatutory double patenting over claims 1,
3—8, 10-17, and 19 of the ’406 Application in view of Carbonell, Koslow,
and Young, Sr.
SUMMARY
We affirm the rejections of all claims on appeal.
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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