Ex Parte Olson et al

Patent Trial and Appeal Board

Mar 27, 2018

13622637 (P.T.A.B. Mar. 27, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/622,637 09/19/2012
49106 7590
IP GROUP
C/O MOSS & BARNETT
150 South Fifth Street
Suite 1200
MINNEAPOLIS, MN 55402
03/29/2018
FIRST NAMED INVENTOR
Curtis E. Olson
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.
55724.103102 1877
EXAMINER
HAWTHORNE, OPHELIA AL THEA
ART UNIT PAPER NUMBER
3772
NOTIFICATION DATE DELIVERY MODE
03/29/2018 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):
PatentGroup@lawmoss.com
PTOL-90A (Rev. 04/07)
1 UNITED STATES PATENT AND TRADEMARK OFFICE
2
3
4 BEFORE THE PATENT TRIAL AND APPEAL BOARD
5
6
7 Ex parte CURTIS E. OLSON and PHILIP A. MESSINA
8
9
10 Appeal 2017-000666
11 Application 13/622,637
12 Technology Center 3700
13
14
15 Before: STEVEN D. A. MCCARTHY, THOMAS F. SMEGAL, and
16 ERIC C. JESCHKE, Administrative Patent Judges.
17
18
19 Opinion for the Board filed by Administrative Patent Judge SMEGAL.
20
21 Opinion dissenting filed by Administrative Patent Judge MCCARTHY.
22
23
24 SMEGAL, Administrative Patent Judge.
25
26 DECISION ON APPEAL
27
28
29 STATEMENT OF THE CASE
30 Appellant 1 seeks our review under 35 U.S.C. § 134 of the Examiner's
31 Final rejections, 2 under 35 U.S.C. § 102(b) of claims 19, 26-29, 31-33 and
1 Appellant is the Applicant, St. Teresa Medical, Inc., which, according to
the Appeal Brief, is the real party in interest. Appeal Br. 3.
2 Appeal is taken from the adverse decision of the Examiner, set forth in the
Final Office Action, mailed April 8, 2015 (hereinafter "Final Act"), as
modified in the Answer, mailed August 10, 2016 (hereinafter "Ans."). In
the Examiner's Answer, the Examiner withdrew the rejection of claims 12,
1 35 as anticipated by Bowlin (US 2011/0150973 Al, pub. June 23, 2011);
2 and under 35 U.S.C. § 103(a) of claims 10-14, 16, 17, and 20-22 as
3 unpatentable over Bowlin, Landoll (US 5,667,864, iss. Sept. 16, 1997), Cao
4 (US 2011/0171281, pub. July 14, 2011) and Larsen (US 2011/0021964 Al,
5 pub. Jan. 27, 2011); of claim 15 as unpatentable over Bowlin, Landoll, Cao,
6 and Cederholm-Williams (US 5,795,571, iss. Aug. 18, 1998); of claim 30 as
7 unpatentable over Bowlin and Cederholm-Williams; and of claim 34 as
8 unpatentable over Bowlin. 3 We have jurisdiction under 35 U.S.C. § 6(b ).
9 We AFFIRM.
10
11 CLAIMED SUBJECT MATTER 4
12 Claims 10 and 19 are independent claims. Claim 19 is reproduced
13 below and illustrates the claimed subject matter, with disputed limitations
14 emphasized.
15 19. A method of preparing a hemostatic product comprising:
16 fabricating a plurality of hemostatic layers that each
17 compnse:
18 forming a first electrospun dextran support; and
19 dispensing at least one hemostatic agent on the first
19 and 26-35 under 35 U.S.C. § 112, first paragraph, as failing to comply
with the written description requirement and the rejection of claim 12 under
35 § U.S.C. 112, second paragraph, as being indefinite for failing to
particularly point out and distinctly claim the subject matter which the joint
inventors regard as the invention. Ans. 2--4.
3 Claims 1-9, 18, and 23-25 are cancelled by an Amendment filed
December 18, 2014.
4A revised copy of the CLAIMS APPENDIX, including a correct copy of
the claims on appeal, is included with a "Response to Notification of Non-
Compliant Appeal Brief," (hereinafter "Second Br.," filed January 25,
2016).
2
1 electrospun dextran support, wherein the at least one
2 hemostatic agent is selected from the group consisting of
3 thrombin and fibrinogen;
4 arranging the hemostatic layers in a stacked
5 configuration; and
6 packaging the hemostatic product in a compressed
7 configuration to cause the hemostatic layers to resist
8 separation after being removed from the packaging.
9
10 ANALYSIS
11 Anticipation of Claims 19, 26-29, 31-33 and 35 by Bowlin
12 Appellant argues claims 19, 26-29, 31-33 and 35 as a group. See
13 Appeal Br. 8-10; Reply Br. 2-3. We select claim 19 as the representative
14 claim for this group, and the remaining claims stand or fall with claim 19.
15 See 37 C.F.R. § 41.37(c)(l)(iv).
16 While acknowledging that "Bowlin discloses forming a hemostatic
17 product having multiple layers of electrospun dextran fibers (such as in
18 Paragraph [0053]) and discloses compression of the electrospun dextran
19 fibers (such as in Paragraph [0054])," Appellant first contends that "Bowlin
20 does not teach or suggest: ... compressing the hemostatic product after the
21 hemostatic agent has been applied to the electrospun dextran fiber mat [and]
22 compressing the hemostatic product having multiple layers so that the layers
23 resist separation." Appeal Br. 8-9.
24 However, we agree with the Examiner that the "features upon which
25 [Appellant] relies (i.e., compressing the hemostatic product after the
26 hemostatic agent has been applied to the electrospun dextran fiber mat and
27 compressing the hemostatic product having multiple layers so that the layers
28 resist separation) are not recited in the rejected claim(s)." Ans. 12
29 (emphasis added). As we are instructed by our reviewing court, "limitations
30 are not to be read into the claims from the [S]pecification." In re Van
3
1 Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (citing In re Zietz, 893 F.2d
2 319, 321 (Fed. Cir. 1989)). For example, Appellant's claim is further
3 limited to the separation being resisted "after being removed from the
4 packaging." See Second Br. 4, Claims App.
5 Appellant also contends that Bowlin does not teach or suggest
6 "placing the hemostatic product having multiple layers in a package in a
7 compressed configuration so that the layers resist separation after the
8 hemostatic product is removed from the package."5 Appeal Br. 9; Reply Br.
9 2. However, we disagree.
10 We find that at paragraph 21, Bowlin discloses an electrospun dextran
11 fiber device including "support material [that] may also be formed from ...
12 compressed electrospun dextran," while at paragraph 58, Bowlin discloses
13 storing such a compressed device "within a protective covering or packaging
14 or tube. "6 Spec. i-f 116; see also Ans. 13. Thus, we agree with the Examiner
15 that "the plurality of hemostatic layers [taught by Bowlin] each comprising
16 [compressed] electrospun dextran support consisting of thrombin and
1 7 fibrinogen as a laminate structure would inherently resist separation after
18 being removed from the packaging."7 Ans. 13 (emphasis added). Appellant
19 has not disputed this finding. See Reply Br. 2-3.
5 It is well established that "[a Jn intended use or purpose usually will not
limit the scope of the claim because such statements usually do no more than
define a context in which the invention operates." Boehringer Ingelheim
Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir.
2003).
6 At paragraph 53, Bowlin discloses devices of "even several hundred"
layers of electrospun dextran fibers.
7 It is well settled that a prior art reference may anticipate when the claim
limitations not expressly found in that reference are nonetheless inherent in
it. ... Under the principles of inherency, if the prior art necessarily functions
4
1 The Examiner also points out that "the claimed and prior art products .
2 .. are produced by identical or substantially identical processes."8 Id.
3 Although "[a] patent applicant is free to recite features of an apparatus either
4 structurally or functionally [], choosing to define an element functionally ...
5 carries with it a risk." In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir.
6 1997). This risk is that, once the Examiner has shown a sound basis for
7 believing the claimed structure to be the same as the prior art structure,
8 Appellant bears the burden to prove that the prior art does not possess the
9 functional characteristic. See In re Spada, 911 F.2d 705, 708 (Fed. Cir.
10 1990). Again, Appellant has not disputed this finding. See Reply Br. 2-3.
11 For the foregoing reasons, we discern no error in the Examiner's
12 findings and sustain the Examiner's rejection of claims 19, 26-29, 31-33
13 and 35 as anticipated by Bowlin.
14 Obviousness of Claims 10-14, 16, 17, and 20-22 over Bowlin,
15 Landoll, Cao, and Larsen
16 Appellant argues claims 10-14, 16, 17, and 20-22 as a group. See
1 7 Appeal Br. 11-13; Reply Br. 4--5. We select claim 10 as the representative
18 claim for this group, and the remaining claims stand or fall with claim 10.
19 See 37 C.F.R. § 41.37(c)(l)(iv).
20 The Examiner determines that Bowlin discloses a method of preparing
21 a hemostatic product with substantially all the limitations of claim 10,
in accordance with, or includes, the claimed limitations, it anticipates. In re
Cruciferous Sprout Litig., 301F.3d1343, 1349 (Fed. Cir. 2002) (citations
omitted).
8 While Appellant discloses vacuum packaging of the hermostatic product
(see Spec. i-fi-1232-233), the claims are not so limited.
5
1 including fabricating electro spun dextran supports. 9 Final Act. 7. Although
2 observing Bowlin does not disclose that "the hemostatic product is cut into
3 at least two pieces using a cutter, wherein the cutter causes the hemostatic
4 layers adjacent to the cutter to be compressed so that the hemostatic layers
5 stay together," the Examiner reasons that "[ d]extran is a known adhesive
6 agent as evidenced by Larsen," so that "when the layers are cut they will
7 automatically adhere to themselves." 10 Id. at 8.
8 Appellant acknowledges that Larsen contains paragraphs listing
9 "various compositions that can be adhesive agents," but contends that "the
10 list does not include dextran." Appeal Br. 9. Even assuming Appellant's
11 contention to be correct, it is not persuasive of Examiner error, as claim 10
12 does not require that dextran be the adhesive agent, as the claim merely
13 recites that "the cutter causes the hemostatic layers adjacent to the cutter to
14 be compressed." See Appeal Br., Claim App 3. As we previously
15 explained, "limitations are not to be read into the claims from the
16 [S]pecification." In re Van Geuns, 988 F.2d at 1184.
1 7 The Examiner continues by explaining that Landoll "teaches an
18 adhesive laminate bandage ([Col. 1 ], lines 5-9) wherein the laminate can be
19 cut and bonded selectively along the edges to fuse together the laminate at
20 the edges by a rotary die-cutting or hot die-stamping operation to provide, in
21 an economical and uncomplicated process, completed articles with sealed
22 edges." 11 Final Act. 8 (citing Landoll, col. 5, 11. 65---67). The Examiner
9 Bowlin describes electrospun dextran fibers, as well as bandages made
from such fibers. (See Bowlin, paras. 34 & 35).
10 We determine the correct citation to Larsen is of paragraphs 663---664, not
631.
11 The Examiner also observes that "Cao teaches a method of producing a
film solution to be used to [form] two halves of a soft capsule [] that will
6
1 reasons that "it would have been obvious ... to modify the method of
2 preparing a hemostatic product of Bowlin ... by incorporating a cutter [such
3 as used in Landoll, for] rotary die-cutting to cause the hemostatic layers to
4 be compressed when subjected to sufficient pressure." Id.
5 After republishing, verbatim, the Examiner's findings and conclusions
6 regarding claim 10, Appellant acknowledges that "Landoll describes the use
7 of a cutter to cause the layers in the adhesive bandage to fuse together," but
8 contends that "Landoll does not include any references to the use of
9 dextran." Appeal Br. 11-12 (citing Landoll, col. 7, 11. 50-59; col. 8, 11. 28-
10 38). However, Appellant is simply attacking Landoll in isolation for lacking
11 support for teachings for which it was not cited. Nonobviousness cannot be
12 established by attacking references individually when the rejection is
13 predicated upon a combination of prior art disclosures. See In re Merck &
14 Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
15 Having determined that Bowlin discloses fabricating electrospun
16 dextran supports, 12 the Examiner explains that "Landoll ... teaches the
17 concept of fusing or compressing together a laminate structure when cut
18 using a cutter." Ans. 16. Thus, we agree with the Examiner that "the
19 plurality of hemostatic layers of Bowlin [] each comprises electrospun
20 dextran support consisting of thrombin and fibrinogen as a laminate
21 structure, [that] when cut using a cutter would inherently [be] compressed so
22 that the hemostatic layers stay together." Id.
fuse together during the filling and cutting process when subjected to
sufficient pressure [0005]. "' Final 8.
12 See, supra, n. 9.
7
1 Based on the foregoing, we sustain the Examiner's rejection of claims
2 10-14, 16, 17, and 20-22 over Bowlin, Landoll, Cao, and Larsen. 13
3 Obviousness of Claim 15 over Bowlin, Landoll, Cao, and Cederholm-
4 Williams
5 Regarding claim 15 dependent from claim 10, Appellant contends that
6 "Cederholm-Williams does not overcome the deficiencies in Bowlin,
7 Landoll and Cao that are discussed above." Appeal Br. 13-14. However,
8 we are not persuaded that Appellant's arguments are demonstrative of error
9 in the Examiner's rejection of claim 10, as set forth supra. As such, for the
10 same reasons, we sustain the rejection of claim 15 under 35 U.S.C. § 103(a)
11 as unpatentable over Bowlin, Landoll, Cao, and Cederholm-Williams.
12 Obviousness of Claim 30 over Bowlin and Cederholm-Williams
13 Regarding claim 3 0 dependent from claim 19, Appellant contends that
14 "Cederholm-Williams does not overcome the deficiencies in Bowlin that are
15 discussed above." Appeal Br. 14. However, we are not persuaded that
16 Appellant's arguments are demonstrative of error in the Examiner's rejection
17 of claim 19, as set forth supra. As such, for the same reasons, we sustain the
18 rejection of claim 30 under 35 U.S.C. § 103(a) as unpatentable over Bowlin
19 and Cederholm-Williams.
20 Obviousness of Claim 34 over Bowlin
13
. We consider the remaining reference to Cao cumulative to the teachings
of Bowlin, Landoll, and Larsen. The Board may rely on less than all of the
references applied by an Examiner in an obviousness rationale without
designating it as a new ground of rejection. In re Bush, 296 F .2d 491, 496,
131USPQ263, 266-67 (CCPA 1961); In re Boyer, 363 F.2d 455, 458, n.2,
150 USPQ 441, 444, n.2 (CCPA 1966); See, e.g., In re Kronig, 539 F.2d
1300, 1302 (CCPA 1976).
8
1 Regarding claim 34 dependent from claim 19, Appellant contends that
2 "Cederholm-Williams does not overcome the deficiencies in Bowlin that are
3 discussed above." Appeal Br. 15. However, the rejection is over Bowlin
4 alone. See Final Act. 13; Ans. 10-11, and 16. Thus, Appellant does not
5 present an argument responsive to the Examiner's rejection of claim 34 over
6 Bowlin. 14
7 For the foregoing reason, we sustain the Examiner's rejection of claim
8 34 as obvious over Bowlin.
9 DECISION
10 We affirm the Examiner's rejections.
11 No time period for taking any subsequent action in connection with
12 this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
13 § 1.136(a)(l)(iv).
14 AFFIRMED
14 In an appeal under 35 U.S.C. § 134(a), it is the Examiner's Final rejection
that we review. See in re Webb, 916 F. 2d 1553, 1556 (Fed. Cir. 1990).
9
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CURTIS E. OLSON and PHILIP A. MESSINA
(Applicant: St. Teresa Medical, Inc)
Appeal2017-000666
Application 13/622,637
Technology Center 3700
Before: STEVEN D.A. McCARTHY, THOMAS F. SMEGAL, and
ERIC C. JESCHKE, Administrative Patent Judges.
McCARTHY, Administrative Patent Judge, dissenting.
1 My colleagues find that Bowlin (US 2011/0150973 Al, publ. June 23,
2 2011) anticipates appealed claims 19, 26-29, 31-33 and 35. My colleagues
3 also conclude that the subject matter of claims 10-14, 16, 17 and 20-22
4 would have been obvious from the combined teachings of Bowlin, Landoll
5 (US 5,667,864, issued Sept. 16, 1997), Cao (US 2011/0171281 Al, publ.
6 July 14, 2011) and Larsen US 2011/0021964 Al, publ. Jan. 27,2011). I
7 disagree and, disagreeing, dissent.
8 The claims at issue in this appeal are most easily understood against
9 the backdrop of the teachings of Bowlin.
10
1 THE TEACHINGS OF BOWLIN
2 Bowlin describes electrospun dextran fibers, 15 as well as bandages
3 made from such fibers. (See Bowlin, paras. 34 & 35). Dextran is a water-
4 soluble polysaccharide composed of branched organic macromolecules.
5 (See Bowlin, para. 40). In general terms, Bowlin teaches fabricating
6 electrospun dextran fibers by extruding dextran material through
7 electrically-charged dies to form electrically-charged jets; and then
8 depositing the electrically-charged jets onto a grounded mandrel. The
9 dextran material solidifies to form continuous, non-woven mats of dextran
10 fibers. (See Bowlin, paras. 36 & 37; see also id., Fig. 1).
11 Bowlin also describes fabricating hemostatic bandages, that is,
12 bandages that promote the stoppage of bleeding, using electrospun dextran
13 fiber mats. (See Bowlin, para. 35 & 62; see also id., para. 4). For example,
14 Bowlin teaches adding dry thrombin or fibrinogen in particulate or granular
15 form to an electrospun dextran fiber mat to promote the coagulation of
16 blood. (See Bowlin, para. 51 & 62; see also id, para. 45). In particular,
1 7 Bowlin teaches that the thrombin or fibrinogen powder may be sprinkled,
18 shaken, blown or otherwise applied to the surface of the electrospun dextran
19 fiber mat. The thrombin or fibrinogen applied in such manner may be
20 evenly distributed through the electrospun dextran fiber mat; or may
21 concentrate near the topmost section of the mat. (See Bowlin, para. 52).
22 When the mat is applied to a bleeding wound, blood or other fluid
23 dissolves at least a portion of the electrospun dextran fibers so as to release
24 the thrombin or fibrinogen. The thrombin or fibrinogen promotes clotting.
15 Bowlin uses the abbreviation "EDFs" for electrospun dextran fibers.
(See, e.g., Bowlin, para. 34). I will not use the abbreviation in this opinion.
11
1 (See Bowlin, para. 3 5 & 62). Bowlin teaches that "[ c ]ompression of an
2 electrospun dextran mat may be used to modulate the rate of dissolution,
3 with greater levels of compression inversely impacting the rate, i.e.
4 generally, the greater the degree of compression, the slower the rate of
5 dissolution." (Bowlin, para. 43).
6 Bowlin describes combining the electrospun dextran fiber mat with a
7 supportive backing. The backing sheet may consist of compressed
8 electrospun dextran fibers. (See Bowlin, para. 54). The electrospun dextran
9 fiber mat bearing the thrombin or fibrinogen may be deposited onto the
10 compressed electro spun fiber backing; or the mat bearing the thrombin or
11 fibrinogen may be joined to the backing after being spun. (See id.)
12 Bowlin describes one particular embodiment in which a first
13 electrospun dextran fiber layer is formed. One or more substances such as
14 thrombin or fibrinogen are associated with the first layer. A second
15 electro spun dextran fiber layer is then formed on top of the substance; and
16 the same substance, or a different substance, is associated with the second
17 layer. Additional electrospun dextran fiber layers may be added in a similar
18 fashion. An outermost layer, not associated with any additional substance,
19 may help retain the substance or substances within the layered material.
20 (See Bowlin, para. 53).
21 Bowlin also describes fabricating a "cigar-shaped" bandage for use in
22 treating wounds bleeding primarily at a location below the surface of the
23 skin. As depicted in Figures 4D and 4E, such bandages include cigar-shaped
24 electrospun dextran fiber bodies with which a substance such as thrombin or
25 fibrinogen has been associated. The device is stored within a package in the
26 shape of a cylindrical tube. In order to position the electrospun dextran fiber
27 body near the source of the bleeding, one opens an end of the tube, presses
12
1 the tube into the wound and forces a plunger through the other end of the
2 tube to eject the bandage into the wound. (See Bowlin, para. 58).
3
4 THE CLAIMED SUBJECT MATTER
5 The application underlying this appeal is directed to a hemostatic
6 product including a plurality of layers of hemostatic material arranged in a
7 stacked configuration. (See Spec., paras. 22, 23, 35 & 225-27). The
8 application teaches that one drawback to such hemostatic products is the
9 problem of maintaining the layers in position relative to one another. (See
10 Spec., para. 36). The application addresses this problem in two ways.
11 First, the application teaches fabricating an electrospun dextran fiber
12 mat; associating thrombin and fibrinogen with the mat; and then cutting the
13 product into generally square pieces sized based on the desired medical
14 application. (See Spec., para. 230). The Application teaches that, "[i]n
15 addition to cutting the hemostatic product into pieces, the cutter may cause
16 the layers of the dextran sheets that are adjacent to the cutter to be
17 compressed together. This compression causes the dextran layers to stay
18 together." (Spec., para. 231 ).
19 Second, the application teaches vacuum packaging the cut pieces of
20 the hemostatic product. "In addition to maintaining the hemostatic product
21 sterile, the vacuum packaging also compresses the layers in the hemostatic
22 product, which enhances the ability of the layers to resist separation after the
23 hemostatic product is removed from the package prior to use." (Spec., para.
24 232). The application teaches that a method combining the cutting of the
25 hemostatic product into pieces and the vacuum packaging of the pieces
26 "enhances the ability to use the hemostatic product because the layers in the
27 hemostatic product resist coming apart. An advantage of using this process
13
1 is that no additional steps are necessary to retain the layers together."
2 (Spec., para. 233).
3 Claims 10 and 19 are independent:
4 10. A method of preparing a hemostatic product comprising:
5 fabricating a plurality of hemostatic layers that each
6 comprise:
7
8
9
10
11
12
13
14
15
16
17
18
19
forming electrospun dextran support; and
dispensing at least one hemostatic agent on the
electrospun dextran support, wherein the at
least one hemostatic agent is selected from
the group consisting of thrombin and
fibrinogen;
arranging the hemostatic layers in a stacked configuration;
and
cutting the hemostatic product is cut into at least two
pieces using a cutter, wherein the cutter causes the
hemostatic layers adjacent to the cutter to be
compressed so that the hemostatic layers stay
together.
20 19. A method of preparing a hemostatic product comprising:
21 fabricating a plurality of hemostatic layers that each
22 comprise:
23
24
25
26
27
28
29
30
31
32
33
forming a dextran support; and
dispensing at least one hemostatic agent on the
dextran support, wherein the at least one
hemostatic agent is selected from the group
consisting of thrombin and fibrinogen;
arranging the hemostatic layers in a stacked configuration;
and
packaging the hemostatic product in a compressed
configuration to cause the hemostatic layers to resist
separation after being removed from the packaging.
14
1 BOWLIN DOES NOT ANTICIPATE CLAIM 19
2 As indicated by the discussion above, paragraph 53 of Bowlin, read in
3 the context of Bowlin's description as a whole, describes a method that
4 satisfies each limitation of claim 19 except "packaging the hemostatic
5 product in a compressed configuration to cause the hemostatic layers to
6 resist separation after being removed from the packaging." The Examiner
7 finds that, "[i]n [paragraph 21 ], Bowlin et al. discusses the support material
8 may also be formed from electrospun material, such as compressed
9 electrospun dextran, or other electrospun fibers and in [paragraph 58]
10 Bowlin et al. discloses packaging for the hemostatic product." (Final Office
11 Action, mailed April 8, 2015 ("Final Act."), at 5).
12 The broadest reasonable interpretation of the phrase "packaging the
13 hemostatic product in a compressed configuration" might encompass
14 packaging a hemostatic product, where the product is in a compressed
15 configuration due to compression prior to the packaging step; or packaging a
16 hemostatic product, where the packaging itself has a configuration that
17 compresses the hemostatic product. I need not resolve the ambiguity for
18 purposes of this appeal. Bowlin describes neither alternative.
19 The Examiner correctly finds that paragraph 21 of Bowlin teaches
20 forming a backing for an electrospun dextran fiber mat from compressed
21 electro spun dextran fibers. (See Final Act. 5). Paragraph 43 of Bowlin
22 teaches compressing an electrospun dextran fiber mat to extend the time
23 required for the mat to dissolve in blood or other fluids to release agents
24 such as thrombin or fibrinogen at a bleeding site. The Examiner also
25 correctly finds that paragraph 58 of Bowlin describes packaging a
26 hemostatic product including a cigar-shaped electrospun dextran fiber body
15
1 in a cylindrical tube for insertion into a relatively deep wound. (See Final
2 Act. 5).
3 That said, the Examiner does not cite to any description in Bowlin
4 indicating that the electrospun dextran fibers in the cigar-shaped body
5 described in paragraph 58 necessarily were compressed before the body was
6 packaged in the cylindrical tube. (See, e.g., "Appeal Brief under 37 C.F.R.
7 § 41.37," dated July 8, 2015 ("App. Br."), at 9). Likewise, Bowlin does not
8 teach that it would have been desirable to slow down the dissolution of the
9 fibers in the cigar-shaped body, with sufficient clarity to permit one to
10 deduce that the fibers necessarily were compressed before being packaged in
11 the cylindrical tube. Neither does Bowlin teach that each layer includes a
12 support backing, much less a support backing of compressed electrospun
13 dextran fibers.
14 The Examiner does not cite any description in Bowlin indicating that
15 the cylindrical tube described in paragraph 5 8 necessarily compressed the
16 cigar-shaped electrospun dextran fiber body when the body was packaged in
17 the tube. (See "Appellant's Reply Brief," dated Oct. 10, 2016, at 3). Neither
18 does the Examiner provide persuasive technical reasoning demonstrating the
19 cylindrical tube depicted schematically in Figures 4D and 4E necessarily
20 was configured to effect such compression. Although not itself decisive, I
21 note that Bowling does not include the teaching of paragraph 232 of the
22 underlying application to vacuum package pieces of an electrospun dextran
23 fiber hemostatic product.
24 Therefore, the Examiner has not shown that Bowlin teaches the step
25 of "packaging the hemostatic product in a compressed configuration to cause
26 the hemostatic layers to resist separation after being removed from the
27 packaging." For this reason, I would not sustain the rejection of independent
16
1 claim 19, or of dependent claims 26-29, 31-33 and 35, under pre-AIA 35
2 U.S.C. § 102( e) as being anticipated by Bowlin. Neither would I sustain the
3 rejection of claim 34 under§ 103(a) as being unpatentable over Bowlin
4 alone.
5
6 THE SUBJECT MATTER OF CLAIM 10 WOULD NOT HA VE BEEN
7 OBVIOUS FROM THE COMBINED TEACHINGS OF BOWLIN,
8 LANDOLL, CAO AND LARSEN
9 Paragraph 53 of Bowlin, read in the context of Bowlin's description as
10 a whole, describes a method that satisfies each limitation of claim 10 except
11 "cutting the hemostatic product ... into at least two pieces using a cutter,
12 wherein the cutter causes the hemostatic layers adjacent to the cutter to be
13 compressed so that the hemostatic layers stay together." The Examiner finds
14 that:
15 Dextran is a known adhesive agent as evidenced by Larsen
16 et al. in [paragraphs 631 and 791] as such, when the layers are
1 7 cut they will automatically adhere to themselves ....
18 Landoll however, teaches an adhesive laminate bandage
19 ([Col. I], lines 5-9) wherein the laminate can be cut and bonded
20 selectively along the edges to fuse together the laminate at the
21 edges by a rotary die-cutting or hot die-stamping operation to
22 provide, in an economical and uncomplicated process, completed
23 articles with sealed edges ([Col.5], lines 65---67).
24 Furthermore, Cao teaches a method of producing a film
25 solution to be used to [form] two halves of a soft capsule and that
26 will fuse together during the filling and cutting process when
27 subjected to sufficient pressure [0005].
28 In view of the teachings of Landoll/Cao, it would have
29 been obvious ... to modify the method of preparing a hemostatic
30 product of Bowlin et al. in like manner, by incorporating a cutter,
31 as for example, a rotary die-cutting to cause the hemostatic layers
32 to be compressed when subjected to sufficient pressure.
17
1 (Final Act. 8).
2 Implicit in the Examiner's reasoning is a finding that one of ordinary
3 skill in the art would have recognized the problem of maintaining the layers
4 of a multi-layer hemostatic product in position relative to one another prior
5 to the Appellants' disclosure of the problem in the application. The nature
6 of the problem supports such a finding. Bowlin teaches fabricating
7 hemostatic products from multiple layers or mats of electrospun dextran
8 fibers. (See Bowlin, para. 53). One of ordinary skill in the art inevitably
9 would have recognized the problem of layer separation when attempts were
10 made to apply such hemostatic products to patients. The Appellants have
11 not presented evidence suggesting that they alone discovered the problem
12 prior to the filing of their application,
13 That said the Examiner has not shown that the step of "cutting the
14 hemostatic product ... into at least two pieces using a cutter, wherein the
15 cutter causes the hemostatic layers adjacent to the cutter to be compressed"
16 was a known solution to the problem of causing electrospun dextran fiber
17 layers of a hemostatic product to stay together.
18 Landoll taught fabricating laminated products including non-woven
19 absorbent members sandwiched between plastic substrates. The non-woven
20 absorbent members included bi-component fibers having skins or sheaths
21 with melting points lower than the softening points of the plastic substrates.
22 (See Landoll, col. 5, 1. 45 - col. 6, 1. 3). Landoll taught "cut[ ting] and
23 bond[ing the laminate] selectively along the edges to fuse together the
24 laminate at the edges by a rotary die-cutting or hot die-stamping operation to
25 provide, in an economical and uncomplicated process, completed articles
26 with sealed edges." (Landoll, col. 5, 1. 65 - col. 6, 1. 3).
18
1 Cao taught fabricating vegetarian dosage capsules having properties
2 as favorable as those of mammalian gelatin. Cao taught fabricating the
3 capsule from a biphasic network system including a first phase comprising
4 polysaccharide, seaweed extract, a rheology modifier and water; and a
5 second phase comprising a polysaccharide, a buffer, a plasticizer and water.
6 (See Cao, paras. 7-9). In particular, Cao taught forming a first and second
7 films from a mixture of the two phases and using a rotary die process to
8 form recesses within the film. The recesses were filled with an active agent;
9 and the second film was extruded or overlaid over the first film. (See Cao,
10 paras. 10-13). Cao taught sealing the two film together under pressure at
11 elevated temperature to form a sheet of capsule that might be cut out to
12 provide individual dosages. (See Cao, para. 13).
13 The Examiner has not shown that one of ordinary skill in the art
14 would have understood that electrospun dextran fiber layers could be joined
15 by means of the pressure, or the combination of heat and pressure, imposed
16 on the layers by a cutter. Landoll teaches fusing softenable plastic substrates
17 to a nonwoven absorbent member including bi-component fibers by means
18 of a rotary die-cutter. (See Landoll, col. 5, 1. 45 - col. 6, 1. 3). As the
19 Appellants point out, Landoll's bi-component fibers include a fusible skin
20 that the electro spun dextran fibers recited in claim 10 do not inherently
21 possess. (See App. Br. 12). Likewise, Landoll's films, although fabricated
22 from mixtures including one or more polysaccharides, are continuous rather
23 than fibrous in nature. Although the issue is a close one, I am not persuaded
24 that Landoll and Cao would have provided one of ordinary skill in the art
25 sufficient reason even to try cutting Bowlin's stack of electrospun dextran
26 fibrous layers as a means to cause the layers to stay together.
19
1 The Examiner's finding that Larsen teaches dextran is an adhesive
2 does not persuade me otherwise. Paragraphs 209-14 of Larsen teach the use
3 of "animated" dextran, a genus that includes diethyleneaminoethyl-dextran,
4 may be used as a tackifier in a mixture used to fabricate a biocompatible,
5 celluler matrix that serves as a substrate for a hemostatic agent such as
6 thrombin in a hemostatic product. Assuming for present purposes only that
7 Larsen actually teaches dextran is an adhesive, a point that the Appellants
8 contest (see App. Br. 9 & 10), the Examiner has not shown that one of
9 ordinary skill in the art would have understood an electrospun dextran fiber
10 mat to act as either a pressure-activated adhesive or a temperature-activated
11 adhesive. Absent such proof, the Examiner has not shown that Larsen's
12 teachings would have bridged the gap between the combined teachings of
13 Bowlin and Landoll, on the one hand, and the claimed subject matter, on the
14 other. I would not sustain the rejection of independent claim 10, or of
15 dependent claims 11-14, 16, 17 and 20-22, under§ 103(a) as being
16 unpatentable over Bowlin, Landoll, Cao and Larsen.
17 With regard to claim 15, the Examiner cites Cedarholm-Williams (US
18 5,795,571, issued Aug. 18, 1998) as "teach[ing] the use ofthrombin in a
19 medical procedure in an animal." (Final Act. 11 ). This teaching does not
20 remedy the deficiencies in the combined teachings of Bowlin, Landoll, Cao
21 and Larsen as applied to parent claim 10. I would not sustain the rejection
22 of claim 15 under § 103 (a) as being unpatentable over Bowlin, Landoll, Cao,
23 Larsen and Cedarholm-Williams.
20