Ex Parte Aram et al

Patent Trial and Appeal Board

May 14, 2018

13580254 (P.T.A.B. May. 14, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/580,254 08/21/2012 Luke J. Aram
23643 7590 05/16/2018
Barnes & Thornburg LLP (IN)
11 S. Meridian Street
Indianapolis, IN 46204
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.
265280-222415 9622
EXAMINER
MERENE, JAN CHRISTOP L
ART UNIT PAPER NUMBER
3733
NOTIFICATION DATE DELIVERY MODE
05/16/2018 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):
INDocket@btlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LUKE J. ARAM, WILLIAM BUGBEE,
CHARLES A. ENGH, JOSEPH MOSKAL, MARK P AGNANO,
MICHAEL SWANK, BRYAN ROSE, and JOSEF. GUZMAN 1
Appeal2017-004459
Application 13/580,254
Technology Center 3700
Before RICHARD J. SMITH, JOHN E. SCHNEIDER, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision under 35 U.S.C. § 134(a) involving claims on
appeal directed to a method to create a customized patient-specific
orthopaedic instrument. Claims 1-19 are on appeal as rejected under
35 U.S.C. § 101 and§ 103. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part. 2
1 Appellants identify the Real Party in Interest as "DePuy Synthes Products,
Inc., a Johnson & Johnson Company." Appeal Br. 2.
2 We refer herein to the Specification filed Aug. 21, 2012 ("Spec."); Non-
Final Office Action mailed Mar. 24, 2016 ("Non-Final Action"); Appeal
Brief filed Aug. 24, 2016 ("Appeal Br."); Examiner's Answer to Appellants'
Appeal Brief mailed Nov. 23, 2016 ("Answer"); and Reply Brief filed Jan.
23, 2017 ("Reply Br.").
Appeal2017-004459
Application 13/580,254
STATEMENT OF THE CASE
The Specification states that the invention, at least in part, relates to
an algorithm 10 for fabricating a customized patient-specific
orthopaedic surgical instrument is illustrated. What is meant
herein by the term "customized patient-specific orthopaedic
surgical instrument" is a surgical tool for use by a surgeon in
performing an orthopaedic surgical procedure that is intended,
and configured, for use on a particular patient.
Spec. ,r 37. The claims recite that a "surgical design plan compris[es] a
preoperatively planned size of at least one bone chip produced as a result of
a surgical resection of [a] bone of the patient consistent with the surgical
design plan," and the Specification, in relation thereto, states "a part of the
surgical design plan is to create a model that includes the individual sizes of
the 'bone scrap' [i.e., bone chip(s)] created by proper execution of the
surgical design plan." Spec. ,r 4 7.
Claims 1, 10, and 17 are the independent claims and are reproduced
below:
1. A method for a vendor to create a customized patient-
specific orthopaedic instrument for a patient of a healthcare
facility that is external to the vendor, comprising:
receiving, from the healthcare facility external to the
vendor, an instrument request that includes data relevant to a
bone of the patient,
creating, in response to receiving the instrument request, a
surgical design plan that has been customized for the patient per
data of the instrument request, the surgical design plan
comprising a preoperatively planned size of at least one bone
chip produced as a result of a surgical resection of the bone of
the patient consistent with the surgical design plan, and
sending the surgical design plan to the healthcare facility.
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10. A method of performing an orthopaedic surgical
procedure on a bone of a patient at a healthcare facility,
compnsmg:
making a cut in the bone of the patient at a location
indicated in a surgical design plan obtained from a vendor that is
external to the healthcare facility that has been customized for
the patient per data relevant to a bone of the patient, the surgical
design plan comprising a preoperatively planned size of a bone
chip produced as a result of the cut,
measuring the actual size of the bone chip produced as a
result of the cut, and
comparing the measured actual size of the bone chip to the
preoperatively planned size of the bone chip of the surgical
design plan.
1 7. A method of performing an orthopaedic surgical
procedure on a bone of a patient, comprising:
preoperatively planning a size of a bone chip to be
produced by resecting the bone of the patient at a
predetermined location,
making a cut in the bone of the patient at the
predetermined location thereby producing a bone chip,
measuring the actual size of the bone chip produced as a
result of the cut, and
comparing the measured actual size of the bone chip to the
preoperatively planned size of the bone chip.
Appeal Br. 33, 35, 38 (Claims App'x; emphasis added).
The following rejections are appealed:
Claims 1 and 3-9 stand rejected under 35 U.S.C. § 101 because the
claimed invention is directed to a judicial exception (i.e., an abstract idea)
without significantly more. Non-Final Action 3.
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Application 13/580,254
Claims 1-15, 17, and 18 stand rejected under 35 U.S.C. § 103(a) over
Aker3 and Haddad. 4 Id. at 4.
Claims 16 and 19 stand rejected under 35 U.S.C. § 103(a) over Aker,
Haddad, and Klein. 5 Id. at 9.
DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prim a f acie case of unpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
PATENT-ELIGIBILITY
"Phenomena of nature, though just discovered, mental processes, and
abstract intellectual concepts are not patentable, as they are the basic tools of
scientific and technological work." Mayo Collaborative Servs. v.
Prometheus Labs., Inc., 566 U.S. 66, 71 (2012) (quoting Gottschalkv.
Benson, 409 U.S. 63, 67 (1972)). Claims directed to nothing more than
abstract ideas (such as mathematical algorithms), natural phenomena, and
laws of nature are not eligible for patent protection. Diamond v. Diehr, 450
U.S. 175, 185 (1981); accord MPEP § 2106 (II) (discussing Diehr).
In analyzing patent-eligibility questions under 35 U.S.C. § 101, the
Supreme Court instructs us to "first determine whether the claims at issue
are directed to a patent-ineligible concept." Alice Corp. Pty. v. CLS Bank
Int'!, 134 S. Ct. 2347, 2355 (2014). If the initial threshold is met, we then
3 US 8,425,524 B2 (issued Apr. 23, 2013) ("Aker").
4 US 8,265,949 B2 (issued Sept. 11, 2012 ("Haddad").
5 US 8,417,544 B2 (issued Apr. 9, 2013) ("Klein").
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move to a second step and "consider the elements of each claim both
individually and 'as an ordered combination' to determine whether the
additional elements 'transform the nature of the claim' into a patent-eligible
application." Id. (quoting Mayo, 566 U.S. at 79, 78).
The Federal Circuit has "recognize[d] that defining the precise
abstract idea of patent claims in many cases is far from a 'straightforward'
exercise." Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1150
(Fed. Cir. 2016) (quoting DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d
1245, 1257 (Fed. Cir. 2014)). However, "we continue to 'treat[] analyzing
information by steps people [could] go through in their minds, or by
mathematical algorithms, without more, as essentially mental processes
within the abstract-idea category."' Synopsys, 839 F.3d at 1146-47
( emphasis added) ( quoting Electric Power Grp., LLC v. Alstom S.A., 830
F.3d 1350, 1354 (Fed. Cir. 2016) (citations omitted)); see also Electric
Power Grp., 830 F.3d at 1353 ("collecting information, analyzing it, and
displaying certain results of the collection and analysis" "fall[ s] into a
familiar class of claims 'directed to' a patent-ineligible concept," that of the
abstract idea). The Federal Circuit has recognized that "a claim for a new
abstract idea is still an abstract idea." Synopsys, 83 9 F .3 d at 1151.
The Federal Circuit, in Intellectual Ventures I LLC v. Capital One
Financial Corp., 850 F.3d 1332 (Fed. Cir. 2017), where the claims were
held to be directed to a computer programmed to edit XML documents,
"conclude[d] [the claims were] ... at their core, directed to the abstract idea
of collecting, displaying, and manipulating data." Id. at 1339-40. Even
though the patent at issue in Intellectual Ventures I indicated its invention
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provided a concrete solution to a particular problem (in computer
programming), it "at best, ... limit[ ed] the invention to a technological
environment for which to apply the underlying abstract concept," which
does "not render an otherwise abstract concept any less abstract." Id. at
1340 (citing Affinity Labs of Tex., LLC v. DIRECTV, LLC, 838 F.3d 1253,
1259 (Fed. Cir. 2016)). Under step two of the Alice analysis, the court in
Intellectual Ventures I held that claims reciting generic computer
components or elements and their functions, e.g., organizing, mapping,
identifying, defining, detecting, and modifying, "merely describe the
functions of the abstract idea itself' and are not sufficient to supply
significantly more than the abstract idea so as to confer patent-eligibility. Id.
at 1341.
The Federal Circuit has established in several other cases that
collecting, classifying, storing, analyzing, and organizing data, regardless of
whether such data manipulations are limited to a particular environment, is
an abstract idea and, without more, is not patent eligible. See, e.g., In re TL!
Communications LLC Patent Litigation, 823 F.3d 607 (Fed. Cir. 2016)
( collecting and organizing data in the form of digital images is abstract and
patent ineligible and using computer systems in their generic ways do not
add an inventive concept); Electric Power Grp., 830 F.3d at 1350 (receiving
specific data from a source, analyzing the data, displaying the data, and
manipulating the data in some useful way, even if limited to a specific
technological environment, is akin to an ordinary mental process excluded
from § 101 ); Content Extraction and Transmission LLC v. Wells Fargo
Bank, Nat'! Ass 'n, 776 F.3d 1343 (Fed. Cir. 2014) (extracting data from
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documents, recognizing information therefrom, and storing the information
is abstract).
Here, the Examiner determined, pursuant to Alice step one,
the claimed invention is directed to a judicial exception (i.e., a
law of nature, a natural phenomenon, or an abstract idea) without
significantly more. Claim(s) 1 is/are directed to an abstract idea;
the method is an idea standing alone, basically a mental process
that can be accomplished as a mental process performed by the
human mind or by a human using pencil and paper.
Non-Final Action 3; Answer 2, 9. Pursuant to Alice step two, the Examiner
determined,
The claim( s) does/ do not include additional elements that are
sufficient to amount to significantly more than the judicial
exception because the steps in claim 1 include receiving,
creating, and sending which may be performed either in one's
mind or simply with paper and pencil (sending). The information
being acted upon are similar to abstract ideas such as comparing
new information (instrument request) with stored information
(bone chip/resection) and identifying options (creating and
sending the design plan). While the claim does have additional
elements beyond a purely abstract idea, the additional elements
do not amount to significantly more than an abstract idea. That
the instrument request is received at an external facility is not
germane to the creation of the design plan and does not add a
meaningful limit to the idea. That the creation of the plan is
based on the size of a bone chip (resection) also does not add a
significant detail to the creation [abstract idea], because the chip
size is value or quantity of information [ mere data] which can be
mentally manipulated for the creation of the plan. Finally, the
sending step include[ d] does not present any additional inventive
step or details to the method.
Non-Final Action 3--4. We discern no error in the Examiner's
determinations.
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Appellants argue the facts here are analogous to those of Enfish, LLC
v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016), where the Federal
Circuit held claims to an improvement in how computers use tabular data
was patent-eligible. Appeal Br. 5.
This argument is not persuasive. The facts here are not analogous to
those of Enfish. In Enfzsh, the Federal Circuit relied on the distinction made
in Alice between computer-functionality improvements and uses of existing
computers as mere tools in processes focused on abstract ideas (e.g., the
creation and manipulation of data). See Enfzsh, 822 F.3d at 1335-36; see
Alice, 134 S. Ct. at 2358-59; see also Elec. Power Grp., 830 F.23d at 1354
( distinguishing Enfish ). Here, unlike Enfzsh, we are not presented with
claims directed to an improvement in computer technology, but with claims
directed to, essentially, a process of making a (surgery) plan based on
transmitted data. This, regardless of the specific data or technological
environment of its use, is an abstract idea.
Although not cited by Appellants, as the case was too-recently
decided, we further distinguish the facts ( and claims) here from those of
Thales Visionix Inc. v. United States, 850 F.3d 1343 (Fed. Cir. 2017). In
Thales, the Federal Circuit analogized the claims, which it found not to be
directed to an abstract idea, to those found patent-eligible in Diehr. The
Federal Circuit reasoned that the claims in Thales were directed to using
sensors and algorithms ( the application of physics to create an improved
technique) "in a non-conventional manner" to improve measuring and
orienting moving objects, as in Diehr where an algorithm and sensor were
used to improve a rubber-making process. Thales, 850 F.3d at 1348--49.
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Here, on the other hand, claim 1 is directed to mere data transmission and
analysis to create more data, which is also transmitted. Nothing other than
data (a plan) results from the process of claim 1. Compare to claim 2 (not
included in the§ 101 rejection and reciting fabricating an instrument).
Appellants argue the Examiner's determination that the claims are
directed to an abstract idea is overly generalized and not adequately tied to
the claim language. Appeal Br. 5.
This argument is not persuasive. We conclude the Examiner's
determination is not overly generalized; it is reasonably specific within the
context of the generalized language of claim 1. Claim 1 recites receiving
data, creating a plan based on that data, and sending that created plan back to
the data sender. While the claim also recites that the data is sent from a
healthcare facility, is received at a vendor outside that facility, and that the
plan is a customized plan and includes bone chip information, the Examiner
addresses these elements in determining they do not amount to significantly
more than the mere abstract idea to which the claim is directed. See Non-
Final Action 3--4.
Appellants argue the subject matter of claim 1 is not an abstract idea
because it "requires determining 'a preoperatively planned size of at least
one bone chip that would be produced as a result of a surgical resection of
the bone consistent with the surgical design plan' as part of creating the
surgical design plan." Appeal Br. 6.
This argument is not persuasive. The specific type of data does not
extricate the claimed subject matter from realm an abstract idea. As
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discussed above, the bone chip size is mere data, the sending/receiving and
analysis of which our reviewing court has held to be an abstract idea.
Appellants argue that, even if the claims are directed to an abstract
idea, as a whole, they recite significantly more and, so, are patent-eligible.
Appeal Br. 8. Appellants point to the claim element "the instrument request
[] received at an external facility," as being important to the something more.
Id. ( emphasis omitted). Appellants point to the claim element that the
surgical design plan is customized for a patient as being important. Id.
Appellants argue these are more than mere mental steps, but involve creation
of computer models or simulations. Id.
This argument is not persuasive. As discussed above, who sends and
who receives data, or that these parties are not in the same place, does not
amount to significantly more than the abstract idea. The specific type of
data, i.e., a bone chip measurement for a future-conducted surgery, also fails
to amount to significantly more than the abstract idea. The claimed
elements, individually or as a whole, do not provide an inventive concept to
distinguish the abstract idea and confer patent eligibility here.
For the reasons set forth above, we affirm the§ 101 rejection.
OBVIOUSNESS
Obviousness criteria includes: 1) scope and content of prior art;
2) differences between prior art and claims at issue; 3) level of ordinary skill
in the art at the time invention was made; and 4) objective evidence of non-
obviousness. Graham v. John Deere Co., 383 U.S. 1 (1966). "The
combination of familiar elements according to known methods is likely to be
obvious when it does no more than yield predictable results." KSR Int 'l Co.
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v. Teleflex Inc., 550 U.S. 398,416 (2007). "In determining whether the
subject matter of a patent claim is obvious, ... [ w ]hat matters is the
objective reach of the claim. If the claim extends to what is obvious, it is
invalid under§ 103." Id. at 419. When a prima facie case of obviousness
has not been established, the rejection must be reversed. In re Fine, 837
F.2d 1071, 1075 (Fed. Cir. 1988). "[D]ependent claims are nonobvious if
the independent claims from which they depend are nonobvious." In re
Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992).
The Examiner determined the Aker-Haddad combination taught or
suggested the invention of the claims, relying on Aker for much of the claim
elements and Haddad for preparing a surgical plan based on a preoperatively
planned size of a bone chip to be produced by following the surgical plan.
See Non-Final Action 5. The Examiner determined that, because Haddad
disclosed estimating amounts of bone to be resected to leave a bone ready
for an implant, that Haddad also taught or suggested planning a preoperative
size for a bone chip to be removed by such resection and basing a surgical
plan, at least in part, on that information. Id. (citing Haddad 11:5-28).
Regarding all claims, Appellants argue the Aker-Haddad combination
"fails to disclose preoperatively defining the size any bone chips produced
during the surgical procedure, the proposed combination fails to arrive at the
claimed invention." See, e.g., Appeal Br. 10. Appellants contend that Aker
and Haddad merely disclose preoperatively planning the shape of the
surgically prepared bone surface, but not the size/shape of a bone piece to be
removed (i.e., a bone chip). Id. at 10-11.
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Appellants argue that considering a bone chip is not inherent in view
of Aker's disclosure. Id. at 13. Appellants also argue Haddad does not
disclose using bone chip size information for designing a surgical plan. Id.
at 13-14. Appellants contend that Haddad teaches "a surgical plan based on
'an estimated amount of a resection of the patient[']s[] bone,' which is the
total amount of bone that needs to be removed from the patient's bone,"' but
that this only equates to "preoperatively plann[ing the] size of the patient's
remaining bone and does not disclose preoperatively planning the size and
shape of [al bone chip removed from the patient's bone." Id. at 14--15.
Appellants argue there is no articulated reasoning to modify the
references to arrive at the claimed invention. Appeal Br. 16. Appellants
argue there is an important difference between a surgeon planning for a final
shape of a bone to receive an implant and a surgeon planning for the size or
shape of a bone chip to cut away from the bone to leave such a final shape.
Id. Appellants contend Aker and Haddad teach only the former and the
Examiner has done no more than conclude that the latter would be obvious.
Id. at 17.
We are persuaded by Appellants' arguments, as identified above.
While the disclosed subject matter of Aker and Haddad is undeniably similar
to that of Appellants' Specification and claims, the distinction identified by
Appellants is an important one. Neither Aker nor Haddad suggest planning
to create a specific sized bone chip during surgery and planning a surgery
and surgical instrument to be fabricated based upon such bone chip
information. Deciding how a bone should ultimately be shaped to be paired
with an orthopedic implant is not the same as deciding what sized piece of
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scrap to cut from that bone. The Examiner presents no persuasive rationale
why a skilled artisan would have read Haddad ( or Aker) to suggest planning
for or keeping track of the bone scraps removed during resection of a bone
during orthopedic surgery.
For the reasons above, we reverse the obviousness rejections, which
rely on the Aker-Haddad combination (Klein is not cited by the Examiner as
providing the teachings identified as missing from the other prior art, as
discussed above).
SUMMARY
The rejection of claims 1 and 3-9 as directed to patent-ineligible
subject matter is affirmed.
The obviousness rejections are each reversed.
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)(l )(iv).
AFFIRMED-IN-PART
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