Ex Parte Schwartz

Patent Trial and Appeal Board

Jan 15, 2013

11195235 (P.T.A.B. Jan. 15, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte YITZHACK SCHWARTZ
____________

Appeal 2010-010491
Application 11/195,235
Technology Center 3700
____________

Before MICHAEL C. ASTORINO, BENJAMIN D. M. WOOD, and
JILL D. HILL, Administrative Patent Judges.

HILL, Administrative Patent Judge.

DECISION ON APPEAL
Appeal 2010-010491
Application 11/195,235

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Yitzhack Schwartz (Appellant) appeals under 35 U.S.C. § 134 from a
final rejection of claims 1-17. App. Br. 5. We have jurisdiction under 35
U.S.C. § 6(b).
We REVERSE.
REJECTIONS
Appellant seeks review of the Examiner’s rejection of claims 1-17
under 35 U.S.C. § 101 as directed to non-statutory subject matter (App. Br.
5); the Examiner’s rejection of claims 1-5, 7-14, 16, and 17 under 35 U.S.C.
§ 103(a) as unpatentable over Ciaccio (US 2004/0243012 A1, pub. Dec. 2,
2004), DiCuccio (US 2005/0202384 A1, pub. Sep. 15, 2005), and Keidar
(US 2004/0147920 A1, pub. Jul. 29, 2004) (App. Br. 8-11); and the
Examiner’s rejection of claims 6 and 15 under 35 U.S.C. § 103(a) as
unpatentable over Ciaccio, DiCuccio, Keidar, and Taylor (US 5,445,166, iss.
Aug. 29, 1995) (Id)1.
ANALYSIS
The claimed subject matter relates to a method for preventing macro-
reentrant circuits from occurring in a portion of a patient’s heart, and a
method for treating atrial fibrillation in an atrium of a heart.
Claims 1 and 10 are the independent claims on appeal. Claim 1 is
illustrative of the subject matter on appeal, and is reproduced below.

1 Although Appellant states the Grounds of Rejection to be Reviewed on
Appeal as “a) whether claims 1-17 recite statutory subject matter, and b)
whether independent Claims 1 and 10 and dependent claims 2-9 and 11-17
are patentable over Ciaccio in view of DiCuccio, Keidar, and Taylor,” we
assume the appealed grounds include the rejections more particularly set
forth by the Examiner on pages 2, 3, and 5 of the Final Rejection and on
pages 3, 5, and 6 of the Answer.
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A method for preventing macro-reentrant circuits from
occurring in a portion of a heart of a patient, comprising the
steps of:
(a) acquiring an image or map of the portion of the heart;
(b) displaying the image or map of the portion of the
heart;
(c) marking at least one feature on the image or map;
(d) calculating dimensions of the at least one feature;
(e) identifying one or more points on or within the heart
for treatment as part of a treatment plan;
(f) determining paths to the one or more points on or
within the heart for treatment based on the dimensions of the at
least one marked feature;
(g) simulating, on a computer, insertion of a sheath into
the heart through one of the paths;
(h) simulating, on the computer, insertion of a medical
device through the sheath and within the heart;
(i) verifying that the one or more points on or within the
heart can be accessed by the medical device for treatment as
part of the treatment plan;
(j) computing an overall surface area of the portion of the
heart;
(k) calculating an estimated area not treated in the portion
of the heart based on the treatment plan and in accordance with
the overall surface area of the portion of the heart;
(l) assessing whether macro-reentrant circuits can exist in
the estimated area not treated in the portion of the heart;
(m) repeating steps (e) - (l) in the event step (l) indicates
that macro-reentrant circuits can exist in the estimated area not
treated in the portion of the heart; and
(n) implementing the treatment plan of steps (g) through
(i).

Rejection of Claims 1-17 under 35 U.S.C. § 101
The Examiner finds, with respect to independent claims 1 and 10, that
the claims do not require any physical transformation and that the invention
as claimed does not produce a useful, concrete, and tangible result. The
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Examiner acknowledges that Claims 1 and 10 recite, in step (n),
"implementing the treatment plan of steps (g) through (i),” but finds that
steps (g) through (i) only involve simulation and not actual treatment. Ans.
3-4.
The Examiner additionally finds that, while Appellant has recited
performing "simulations" on a computer, a solution of the method is not
implemented by a machine and the majority of the steps claimed are not
required to be implemented by a machine, and that steps (g) and (h) amount
to insignificant extra-solution activity. Id. at 8. The Examiner states that the
object of the invention, as indicated in Claim 7, is to actually ablate the heart
of a patient, and that step (n) of "implementing the treatment plan of steps
(g) through (i)" is just a repeated step of simulating a medical procedure,
which is basically performing more computer calculations without using the
data to transform a particular article. Id. at 8-9.
Construing element (n) of claims 1 and 10 aids us in determining
whether claims 1-17 are directed to statutory subject matter. Element (n)
recites “implementing the treatment plan of steps (g) through (i).” One
skilled in the art, upon reviewing Appellant’s written description and claims,
would understand that the treatment plan of step (g) includes insertion of a
sheath into the heart and the treatment plan of step (h) includes insertion of a
medical device through the sheath and within the heart. On lines 2-5 of page
9 of the Answer, the Examiner suggests “adding the limitation of actually
inserting the sheath into a patient” to overcome the section 101 rejection.
Thus, construing the claims to include insertion of the sheath into the heart
overcomes the Examiner’s rejection under section 101.
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We therefore do not sustain the rejection of claims 1-17 under 35
U.S.C. § 101.
Rejection of Claims 1-5, 7-14, 16, and 17 over Ciaccio, DiCuccio, and
Keidar
The Examiner finds that Ciaccio discloses a method of preventing
reentrant circuits in the heart comprising the steps of constructing an image
of the heart (Paras. [0183]-[0184]), displaying the image on a screen (Para.
[0082]), marking areas on the map where adjacent areas had a difference in
electrogram duration of 15 ms or more, connecting the points to define the
estimated reentrant circuit isthmus, estimating a best ablation line based on
the estimated isthmus, and determining the surface area of the isthmus (Para.
[0187]). Ans. 5. The Examiner also finds that, in locating the isthmus,
various conduction criteria can be set for determining if a particular area is
prone to reentrant circuits (Para. [0114]). Id. The Examiner finds that
Ciaccio does not disclose simulating the procedure or assessing data post
ablation to determine if the reentrant circuit still exists and then reapplying
therapy if a determination is made that the reentrant circuit still exists. Id.
The Examiner finds, however, that DiCuccio discloses a system for mapping
out a patient's heart on a display (Para. [0025]) and simulating insertion of a
medical device, such as an ablation catheter (Para. [0027]), through a sheath
175 (Para. [0026]) for the purpose of reducing the amount of training that
occurs on an actual patient (Para. [0004]). Id. at 5-6.
The Examiner finds that Keidar teaches measuring pre-ablation tissue
characteristics 62, applying RF to ablate tissue 66, measuring post-ablation
tissue characteristics 68, comparing actual ablation to predicted ablation 70,
and repeating the steps if the characteristics do not fall within a specified
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tolerance 72 (fig. 3 and para. [0077]), and that this procedure is performed to
improve the precision and consistency of RF ablation procedures (Para.
[0005]). Id. at 6. The Examiner concludes that it would have been obvious
to one of ordinary skill in the art at the time the invention was made to
modify the method of Ciaccio to include simulating the ablation procedure,
as taught by DiCuccio, and calculating pre-ablation and post-ablation tissue
characteristics to determine if the reentrant circuit was successfully treated,
for the purpose of reducing the need to practice critical procedures on live
patients and improving the precision and consistency of RF ablation
procedures. Id.
Appellant argues that claims 1 and 10 recite, in step (m), ''repeating
steps (e) [through] (l) in the event that step (l) indicates that macro-reentrant
circuits can exist in the estimated area not treated" such that the claims recite
multiple assessments of treatment options prior to implementation of a
treatment plan in step (n). App. Br. 9.
Appellant then argues that Keidar teaches performing multiple actual
ablations, rather than at least repeatedly performing simulations of inserting
a sheath and inserting a medical device through the sheath, and therefore
does not teach or suggest each feature of the invention as recited in
independent claims 1 and 10, and their dependent claims. App. Br. 9-10.
The Examiner determines that Appellant uses the language
comprising, which is inclusive or open-ended and does not exclude
additional, unrecited method steps, and that claims 1 and 10 therefore do not
preclude performing multiple ablation steps. Ans. 9. The Examiner is
correct that a claim employing the transitional term “comprising” may not
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exclude additional, unrecited elements (i.e., steps in a method claim). In re
Baxter, 656 F.2d 679, 688-89 (CCPA 1981).
Regardless of the meaning of the term “comprising” and the effect of
such a term on the scope of Appellants’ claims, we agree with Appellant that
Keidar does not teach or suggest at least repeatedly performing simulations
of inserting a sheath and inserting a medical device through the sheath.
Rather, Keidar teaches iterative ablations based on calculating and re-
calculating an appropriate RF dosage for measured pre-ablation tissue
characteristics. Keidar, fig. 3 and para. [0077]. Such iterative estimation
and ablation is not iterative simulation as recited in the claims. Indeed, the
Examiner does not explicitly find that any of the references, alone or in
combination, teach iterative simulation and assessment prior to treatment,
regardless of whether ablation additionally occurs.
We therefore cannot sustain the rejection of claims 1-5, 7-14, 16, and
17 under 35 U.S.C. § 103(a) as unpatentable over Ciaccio, DiCuccio, and
Keidar.

Rejection of Claims 6 and 15 over Ciaccio, DiCuccio, Keidar and Taylor
With respect to the rejection of dependent claims 6 and 15 under 35
U.S.C. § 103(a), Taylor does not cure the above-stated deficiencies of
Ciaccio, DiCuccio, and Keidar. Claims 6 and 15 depend indirectly from
claims 1 and 10, respectively. We therefore cannot sustain the rejections of
claims 6 and 15 under § 103(a) as unpatentable over Ciaccio, DiCuccio,
Keidar, and Taylor.

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Application 11/195,235

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DECISION
We reverse the Examiner’s rejection of claims 1-17 under 35 U.S.C.
§ 101 as directed to non-statutory subject matter.
We reverse the Examiner’s rejection of claims 1-5, 7-14, 16, and 17
under 35 U.S.C. § 103(a) as unpatentable over Ciaccio, DiCuccio, and
Keidar.
We reverse the Examiner’s rejection of claims 6 and 15 under 35
U.S.C. § 103(a) as unpatentable over Ciaccio, DiCuccio, Keidar, and Taylor.

REVERSED

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