Rong-Xiang Ni

Patent Trials and Appeals Board

Jul 31, 2019

14091800 - (D) (P.T.A.B. Jul. 31, 2019)

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.
14/091,800 11/27/2013 Rong-Xiang Ni 4965.001US1 8237
21186 7590 07/31/2019
SCHWEGMAN LUNDBERG & WOESSNER, P.A.
P.O. BOX 2938
MINNEAPOLIS, MN 55402
EXAMINER
MOSS, NATALIE M
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
07/31/2019 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):
SLW@blackhillsip.com
uspto@slwip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte RONG-XIANG NI
__________

Appeal 2019-0036411
Application 14/091,800
Technology Center 1600
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
RICHARD J. SMITH, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
The application involved in this appeal under 35 U.S.C. § 134(a) has
been before us previously, in Appeal 2016-003298 (decision entered March
31, 2016). In the present appeal, some of the claims recite methods of
culturing lung cancer cells by placing the cells in a device free of
electromagnetic fields, and also free of the earth’s magnetic field. Another
appealed claim recites a method of treating a lung cancer patient by placing
the patient in a device free of electromagnetic fields and the earth’s magnetic
field.

1 The inventor, Rong-Xiang Ni, is the real party in interest. Appeal Br. 2
(Appeal Brief entered October 22, 2018).
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All of the appealed claims stand rejected under 35 U.S.C. § 112(a) for
failure to comply with the written description requirement, and for lack of
enablement. Some of the appealed claims have also been rejected under 35
U.S.C. § 112(b) for indefiniteness.2
We have jurisdiction under 35 U.S.C. § 6(b)(1). We affirm.
STATEMENT OF THE CASE
Appellant’s invention “relates to the use of Earth’s Magnetic Field
Free plus Electromagnetic Fields Free environment in a method for treating
cancer. The invention also provides a device for producing an Earth’s
Magnetic Field Free plus Electromagnetic Fields Free environment for
therapy and treatment of cancer.” Spec. ¶ 5. That is, Appellant proposes to
treat cancer cells by creating an environment free of the earth’s magnetic
field, and free of electromagnetic fields, and placing cultured cancer cells
and/or cancer patients in that environment. See id. ¶ 24.
The Specification describes a device that is asserted to produce an
environment free of the earth’s magnetic field, and free of electromagnetic
fields, as follows:
The device of the present invention features a cylinder
with four concentric layers and provides a GMF-Free
[(geomagnetic field-free)] + EMFs-free [(electromagnetic fields-
free)] environment. The inner layer and outer layer consist of a
superconducting material that repels magnetic fields. The two
middle layers are a ferromagnetic material that attracts magnetic
fields. Such device has a natural ventilation system design

2 This Application was filed on November, 27, 2013. Accordingly, the
version of § 112 enacted by the Leahy-Smith America Invents Act (“AIA”)
applies to the claims on appeal. See AIA, Public Law No. 112-29, § 4(e),
125 Stat. 297.
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between the overlapping side walls which allows air or 5% CO2
air in and out of the device freely, while at the same time
preventing any magnetic external fields from leaking inside
through this ventilation system.

Id. ¶ 12. The Specification explains more specifically that the “the side wall
of the device has four layers when the top cover and the bottom part are put
together; the inner layer and outer layer consist of copper; the two middle
layers are carbon steel and there is a 2.0mm space between the two middle
layers for ventilation.” Id. ¶ 47.
Appellant’s Figure 7 shows a schematic diagram of the device, and
indicates that the device is made of “typical” carbon steel with a copper
lined interior and exterior. Fig. 7. Figure 6 is a photograph of the device,
showing the device to be similar in shape and configuration to two metal
cylindrical cooking pans with handles removed, with one cylinder smaller
than the other, allowing the smaller metal cylinder to be placed
concentrically inside the larger metal cylinder. Fig. 6.
The device shown in Figure 7 has an inner cylinder, which is 188
millimeters in diameter and 80 millimeters in height, and an outer cylinder
which is 190 millimeters in diameter and 68 millimeters in height. Spec.
¶ 46. The Specification explains that the “size of the present device is
enough for studies in a variety of cancer in cell culture or small animals.
The big size devices, like a tank, a room or a house (same shape, structure
and component) will be used for the treatment of cancer patients.” Id. ¶ 49.
The Specification presents a single working example in which
“human non-small cell lung cancer cells (NCI-H358) were seeded in a soft
agar Assay Mix and incubated in a 100% humidified, 5% CO2 cell culture
incubator at the 37ºC for 5 days to form colonies (small tumors).” Spec.
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¶ 28.3 After establishing colonies, on day 5, the cells were put inside either
(a) the device discussed above, or (b) a control device “made from
polymethylmethacrylate (PMMA).” Id. Once inside the devices, the cells
were cultured in the incubator “for 24 hour[s], 72 hours, 120 hours and 168
hours separately. The NCI-H358 cell colonies were stained with 0.1%
p-iodonitrotetrazolium violet in PBS” and the “colonies that are 200 micron
and larger were counted (FIG. 3) and the representative images were
obtained (FIG. 4).” Id. (emphasis omitted).
The Specification discloses that, as compared to the cell culture in the
control device, the number of colonies in the culture in the metal device of
the invention showed a “75.86% inhibition ratio at 24 hours, 51.52%
inhibition ratio at 72 hours, 51.96% inhibition ratio at 120 hours and 54.55%
inhibition ratio at 168 hours.” Id. ¶ 29. The Specification discloses also that
the “colony size, the numbers of cells in a colony, the color of stain and the
cells combined together in a colony of the treated group are smaller, less,
lighter and loose as compared with the control group at the same time point
(FIG. 4).” Id. The Specification states that these results “suggested that
earth’s magnetic field free plus electromagnetic fields free environment
effectively inhibited NCI-H358 cell proliferation in cell culture.” Id. ¶ 30.
Based on the experiment, the Specification concludes as follows:
The lung cancer cell proliferation was disrupted because the
earth’s magnetic field lost control of the cells. That means these
cells are unable to detect the direction of the earth’s magnetic
field and use it for their division, combination, and movement.
It looks like a lung cancer cell has a magnetic pole. Applicant
will investigate the earth’s magnetic field free plus

3 Specification as amended by amendment entered November 14, 2014.
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electromagnetic fields free environment in a variety of cancer
cells to develop a new method for the cancer treatment.

Id. ¶ 32. The Specification further asserts that it has
demonstrated that earth’s magnetic field free plus
electromagnetic fields free environment itself effectively
inhibited human non-small lung cancer proliferation in cell
culture. This method will be developing to a new method for
treating a variety of cancer in humans and animals. Such cancer
includes but is not limited to cancer, malignant or benign tumor.

Id. ¶ 24.
Claims 1 and 8 are the independent claims on appeal and read as
follows (Appeal Br. 24) (Claims App’x):
l. A method comprising:
providing an Earth’s Magnetic Field Free plus
Electromagnetic Fields Free condition having a magnetic flux of
0.00 gauss using an Earth’s Magnetic Field Free plus
Electromagnetic Fields Free device that is made from copper and
carbon steel, the Earth’s Magnetic Field Free plus
Electromagnetic Fields Free condition being provided within the
Earth’s Magnetic Field Free plus Electromagnetic Fields Free
device;
seeding human non-small cell lung cancer cells of a cell
culture in a soft agar assay mix;
incubating the seeded human non-small cell lung cancer
cells in a cell culture incubator to form colonies that are tumors;
dividing the colonies of cancer cells into a treated group
and a non-treated group; and
placing the treated group of colonies in the Earth’s
Magnetic Field Free plus Electromagnetic Fields Free device,
and then placing the Earth’s Magnetic Field Free plus
Electromagnetic Fields Free device with the treated group in the
cell culture incubator on to continue to culture.

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8. A method comprising:
providing an Earth’s Magnetic Field Free plus
Electromagnetic Fields Free condition having a magnetic flux of
0.00 gauss using an Earth’s Magnetic Field Free plus
Electromagnetic Fields Free device that is made from copper and
carbon steel, the Earth’s Magnetic Field Free plus
Electromagnetic Fields Free condition being provided within the
Earth’s Magnetic Field Free plus Electromagnetic Fields Free
device; and
placing a non-small cell lung cancer patient in the Earth’s
Magnetic Field Free plus Electromagnetic Fields Free device.

The claims stand rejected as follows:
(1) Claims 1, 8, and 11–15, under 35 U.S.C. § 112(a), for failure to
comply with the written description requirement (Final Act. 3–54; Ans.
3–45);
(2) Claims 1 and 11–15, under 35 U.S.C. § 112(a), for failure to
comply with the enablement requirement (Final Act. 5–9; Ans. 4–8);
(3) Claim 8, under 35 U.S.C. § 112(a), for failure to comply with the
enablement requirement (Final Act. 10–13; Ans. 8–11); and
(4) Claims 1 and 11–15, under 35 U.S.C. § 112(b), for indefiniteness
(Final Act. 14–15; Ans. 11–12).
STANDARD OF REVIEW
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992)
(citations omitted):
[T]he examiner bears the initial burden . . . of presenting a prima
facie case of unpatentability. . . .

4 Final Office Action entered March 22, 2018.
5 Examiner’s Answer entered February 8, 2019.
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After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the record,
by a preponderance of evidence with due consideration to
persuasiveness of argument.
WRITTEN DESCRIPTION
“a magnetic flux of 0.0 gauss”
The Examiner finds that the recitation in claims 1 and 8 of using a
device to provide “an Earth’s Magnetic Field Free plus Electromagnetic
Fields Free condition having a magnetic flux of 0.00 gauss” does not have
adequate descriptive support in the originally filed Specification. Ans. 3
(citing Spec. ¶ 18)).
Appellant contends that, because the Specification repeatedly
describes the disclosed device as providing an environment “free” of the
earth’s magnetic field as well as being free of electromagnetic fields, and
because the Specification provides substantial details as to the construction
of the device, the Specification provides descriptive support for a device that
provides the claimed condition having a magnetic flux of 0.00 gauss.
Appeal Br. 9–11 (citing Spec. ¶¶ 5–7, 12, 13, 15, 46, and 48; also citing
Merriam Webster’s Online Dictionary (definition of “free”)); see also Reply
Br. 5–9.
The Examiner responds that a skilled artisan would not have
understood the Specification’s use of the term “free” of the earth’s magnetic
field and “free” of electromagnetic fields, inherently to mean “0.0 gauss” as
now recited in claims 1 and 8, because “‘Zero Gauss’ devices are recognized
in the art as having ‘low level’ or ‘near zero’ magnetic flux (i.e. .00002
gauss), but not absolute 0.00 gauss.” Ans. 15. Therefore, the Examiner
reasons, “the use of the term ‘free’ in the instant specification cannot
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necessarily be interpreted to mean the claimed device has absolute 0.00
gauss since the state of the art clearly demonstrates that making a device
with a magnetic flux of 0.00 gauss is not known or possible.” Id.
Appellant replies that the Examiner’s interpretation of claims 1 and 8
as requiring an environment of absolute is unreasonable because “0.00 gauss
is a measured reading number that indicates how low residual magnetic field
is in the inside of magnetic shield device or room. It does not mean
‘absolute zero gauss’ as phrased by Examiner.” Reply Br. 4. Appellant
contends further:
Additionally, Appellant tested the claimed device with
more a magnetometer (μMAG-01 HANDHELD FLUXGATE
MAGNETOMETER WITH LONGITUDINAL PROBE sn 7296
(MEDA, Inc.)) and found the total field magnitude of the GMF-
free + EMFs-free Device is 0.00032 gauss, the total field
magnitude of the Control Device is 0.479 gauss, and the total
field magnitude of Earth’s magnetic field (Background field - No
shield) is 0.479 gauss, thereby proving that the claimed device
achieves a magnetic flux of 0.00 gauss.
Id. at 9.
We find that the preponderance of the evidence supports the
Examiner’s position.
As stated in TurboCare Div. of Demag Delaval Turbomachinery
Corp. v. General Elec. Co., 264 F.3d 1111, 1118 (Fed. Cir. 2001):
The written description requirement and its corollary, the new
matter prohibition of 35 U.S.C. § 132, both serve to ensure that
the patent applicant was in full possession of the claimed subject
matter on the application filing date. When the applicant adds a
claim or otherwise amends his specification after the original
filing date . . . , the new claims or other added material must find
support in the original specification.
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It is well settled that, “[i]n order to satisfy the written description
requirement, the disclosure as originally filed does not have to provide in
haec verba support for the claimed subject matter at issue.” Purdue Pharma
L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000).
Nonetheless, although the originally filed disclosure need not provide
word-for-word support for claimed subject matter, “the written description
must include all of the limitations . . . , or the applicant must show that any
absent text is necessarily comprehended in the description provided and
would have been so understood at the time the patent application was filed.”
Hyatt v. Boone, 146 F.3d 1348, 1354–55 (Fed. Cir. 1998) (emphasis added).
In the present case, it is undisputed that the Specification as originally
filed does not provide literal word-for-word support for the claimed device
that provides an environment with a “magnetic flux of 0.0 gauss” recited in
claims 1 and 8. Appellant does not persuade us, moreover, that a skilled
artisan would have comprehended the Specification as necessarily or
inherently describing such a device.
We acknowledge the Specification’s repeated statement that the
disclosed devices provide an environment “free” of the earth’s magnetic
field and free of electromagnetic fields. See, e.g., Spec. ¶¶ 12, 13, 33, 48.
As Appellant concedes, however, “0.00 gauss is a measured reading
number that indicates how low residual magnetic field is in the inside of
magnetic shield device or room.” Reply Br. 4. Appellant does not identify
in the originally filed Specification any specific disclosure of measuring the
magnetic flux inside of any of the disclosed devices, much less a
measurement that provides a value of 0.00 gauss.
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The Examiner, moreover, cites several publications as evidence that
known devices constructed similarly to the device disclosed in Appellant’s
Specification do not inherently produce environments with magnetic fluxes
of 0.00 gauss as recited in Appellant’s claims, but instead have small
magnetic fluxes. See Ans. 7–8 (citing Ad-Vance Magnetics, Inc.6 (p. 1,
magnetic flux of 0.00002 gauss)); the Magnetic Shield Corporation7 (p. 2,
“ZERO GAUSS CHAMBERS” with internal magnetic flux as high as 10
milligauss); AlphaLab8 (p. 1, “Zero Gauss Chamber” with internal field
less than 0.01 gauss).
Because the Specification does not include any specific disclosure in
which the magnetic fields of the disclosed devices were actually measured
and determined to be 0.00 gauss, and because devices similar to the
disclosed device were known to have magnetic fluxes as high as 0.01 gauss,
Appellant does not persuade us that the Specification provides inherent
support for a device that produces an internal field of 0.00 gauss as presently
recited in claims 1 and 8. It might be true that, by rounding the internal field
values generated by devices not discussed or described in Appellant’s
Specification to a smaller number of significant figures, a skilled artisan
would have been able to arrive at the claimed value of 0.00 gauss. See
Reply Br. 4. That fact, however, does not persuade us that the Specification

6 http://www.advancemag.com/mic.html (retrieved by Examiner February 2,
2018).
7 The Magnetic Shield Corporation, Zero Gauss Chambers, 2007
(publication date provided by Examiner).
8 https://www.alphalabinc.com/content/zero-gauss-chamber (2009
(publication date provided by Examiner); retrieved by Examiner February 2,
2018).
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provides inherent support for a device that produces an internal field of 0.00
gauss, given the absence on this record of any specific evidence
demonstrating that the devices actually disclosed by Appellant inherently
provide the condition required by the claims.
We acknowledge Appellant’s assertion, noted above, that the
magnetic field generated by the claimed device was actually measured and
determined to be 0.00032 gauss. Reply Br. 9. While that measurement
might provide inherent support for a device that generates an internal field of
0.00032 gauss, the measurement does not provide inherent support for a
value of 0.00 gauss, because the rounded value is not the value that
Appellant asserts was actually measured. Simply put, the actually measured
value and the rounded value are not the same. The actually measured value,
therefore, does not provide either inherent or express support for the rounded
value, i.e., the value Appellant asserts is present in claims 1 and 8.
In addition, Appellant’s assertions regarding the measured value of
the internal field generated by the claimed device have not been presented in
the form of a declaration or affidavit, and do not include the averments
required by the relevant rules, and technically, therefore, cannot constitute
evidence in this proceeding. See 37 C.F.R. § 1.132 (“[A]ny evidence
submitted to traverse the rejection or objection on a basis not otherwise
provided for must be by way of an oath or declaration under this section.”);
see also 37 C.F.R. § 1.68 (explaining requirements for written declaration,
including (1) warning against willful false statements and (2) requirement of
positively stating that “all statements made of the declarant’s own
knowledge are true and that all statements made on information and belief
are believed to be true”).
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We note, moreover, that Appellant’s argument—that the measured
magnetic field generated by the claimed device is actually 0.00032
gauss—is presented for the first time in Appellant’s Reply Brief. As
explained in 37 C.F.R. § 41.37(c)(1)(iv), except in certain circumstances not
applicable here, “any arguments or authorities not included in the appeal
brief will be refused consideration by the Board for purposes of the present
appeal.”
We are not persuaded, therefore, that this new argument is properly
presented for the first time in the Reply Brief, such that we should consider
it. See also 37 C.F.R. § 41.41(b)(2) (“Any argument raised in the reply brief
which was not raised in the appeal brief, or is not responsive to an argument
raised in the examiner’s answer, including any designated new ground of
rejection, will not be considered by the Board for purposes of the present
appeal, unless good cause is shown.”); Ex parte Borden, 93 USPQ2d 1473,
1474 (BPAI 2010) (The reply brief is not “an opportunity to make
arguments that could have been made in the principal brief on appeal to
rebut the Examiner’s rejections, but were not.”) (“Informative”).
In sum, for the reasons discussed, Appellant does not persuade us that
preponderant evidence does not support the Examiner’s finding of lack of
written description as to the device in claims 1 and 8 that provides a
condition of 0.00 gauss. We, therefore, affirm the Examiner’s rejection of
those claims, and their dependent claims, on that ground.
“placing a non-small cell lung cancer patient in the
Earth’s Magnetic Field Free plus Electromagnetic Fields Free device”
(Claim 8)
As to claim 8, the Examiner additionally finds that, although the
Specification includes a prophetic disclosure of putting a patient in “‘big size
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devices’ like a tank, a room or a house . . . , Appellant does not appear to be
in possession of a device with 0.00 gauss that is large enough for a patient.”
Ans. 3 (citing Spec. ¶ 49).
Appellant contends that because the Specification provides a detailed
description of a small prototype which has been built and tested by culturing
lung cancer cells therein, and because the Specification explains that a larger
device may be used for treating cancer patients, the Specification provides
sufficient descriptive support for the larger device recited in claim 8. Appeal
Br. 11–12; see Reply Br. 4 (citing prior art publication allegedly “discussing
magnetically-shielded walk-in shields or rooms that are roughly spherical in
shape, with 26 sides, inner and outer diameters of 2.5 meters and 4.0 meters,
three layers of high-µ sheets and two layers of pure aluminium, and a
residual field of l x 10-8 gauss at the room center”).
We again find that the Examiner has the better position.
The written description requirement “serves a teaching function, as a
quid pro quo in which the public is given meaningful disclosure in exchange
for being excluded from practicing the invention for a limited period of
time.” Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed.
Cir. 2004) (internal quotation marks and citation omitted).
Thus, while there is some flexibility in how applicants may comply
with the written description requirement, “the patent specification [must] set
forth enough detail to allow a person of ordinary skill in the art to
understand what is claimed and to recognize that the inventor invented what
is claimed.” Id. at 928.
In the present case, as noted above in our summary of Appellant’s
disclosure, Appellant’s Figure 7 shows a schematic diagram of a device
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according to Appellant’s invention, and indicates that the device is made of
“typical” carbon steel with a copper lined interior and exterior. Fig. 7. The
Specification explains that the device shown in Figure 7 has an inner
cylinder which is 188 millimeters in diameter and 80 millimeters in height,
and an outer cylinder is 190 millimeters in diameter and 68 millimeters in
height. Spec. ¶ 46. The Specification explains that the “size of the present
device is enough for studies in a variety of cancer in cell culture or small
animals.” Id. ¶ 49.
As to the larger device recited in Appellant’s claim 8, however, the
only details provided in the Specification state that “[t]he big size devices,
like a tank, a room or a house (same shape, structure and component) will be
used for the treatment of cancer patients.” Id.
Thus, as is evident, Appellant’s Specification provides essentially no
specific details as to any actual dimensions of the larger device recited in
Appellant’s claim 8, nor does the Specification include any specific details
as to how the device of claim 8 is to be constructed and practicably
implemented to perform the claimed cancer treatment. Because of the near
total lack of any concrete detail as to the larger device of claim 8, a
practitioner seeking to perform the process of Appellant’s claim 8 must
figure out the specifics of essentially all of the practical considerations that
go into preparing and implementing the claimed device. We, therefore,
agree with the Examiner that Appellant’s Specification does not provide the
public with a sufficiently meaningful disclosure of the claimed device that
merits allowing Appellant to exclude the public from practicing the
invention for a limited period. See Univ. of Rochester v. G.D. Searle, 358
F.3d at 922.
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Accordingly, we also agree with the Examiner that, in reciting the step
of placing a non-small cell lung cancer patient in the Earth’s Magnetic Field
Free plus Electromagnetic Fields Free device, Appellant’s claim 8 does not
comply with the written description requirement. Indeed, even if we were to
agree with Appellant (which we do not) that based on the limited disclosure
in the Specification, a skilled artisan would have considered constructing a
larger device encompassed by claim 8 to be obvious, that would not satisfy
the written description requirement. See Ariad Pharms., Inc. v. Eli Lilly and
Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010) (“[A] description that merely
renders the invention obvious does not satisfy the requirement.”).
In sum, for the reasons discussed, we affirm the Examiner’s rejection
of claim 8 as failing to comply with the written description requirement.
Written Description—Claim 11
The Examiner finds that claim 11 recites several distinct devices, none
of which have descriptive support in the Specification as originally filed.
Ans. 4.
Appellant contends that the Specification provides support for the
control device recited in claim 11. See Appeal Br. 12–13 (citing Spec. ¶ 28).
As to the additional devices recited in claim 11, however, Appellant
concedes that the claim includes a typographical error in the terminology
used in the claim, which is correctable by amendment. See id. at 13–14.
We again find that the preponderance of the evidence supports the
Examiner’s rejection.

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Appellant’s claim 11 recites three distinct devices:
(1) “a control device that is made from polymethylmethacrylate” that
“provid[es] an Earth’s Magnetic Field plus Electromagnetic Fields condition
that does not have a magnetic flux of 0.00 gauss”;
(2) an “Earth’s Magnetic Field Free plus Electromagnetic Fields
device”; and
(3) an “Earth’s Magnetic Field plus Electromagnetic Fields device.”
Appeal Br. 24–25.
Although perhaps not drafted as straightforwardly as it might be, as
we understand it, claim 11 is intended to capture the comparative step of
culturing lung cancer cells in the polymethylmethacrylate control device that
does not exclude the cultured cells from the earth’s magnetic field or other
magnetic fields. See Spec. ¶ 28. Nonetheless, because claim 11 refers to the
control device in three inconsistent ways, and because Appellant concedes
that claim 11 is inconsistent in that regard (see Appeal Br. 13–14), we affirm
the Examiner’s rejection of claim 11 for failure to comply with the written
description requirement.
ENABLEMENT—CLAIMS 1 AND 11–15
The Examiner’s rejection of claims 1 and 11–15 for lack of
enablement applies a similar rationale to that discussed above in relation to
the written description requirement. In particular, applying the factors set
out in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988), the Examiner finds
that Appellant’s Specification does not provide a single working example of
a device that provides an internal magnetic flux of 0.00 gauss as recited in
claim 1. Ans. 6.
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In addition, the Examiner cites several publications as evidence that
known devices constructed similarly to the device disclosed in Appellant’s
Specification do not provide environments with magnetic fluxes of 0.00
gauss as recited in Appellant’s claim 1, but instead have small magnetic
fluxes. See id. at 7–8 (citing Ad-Vance Magnetics, Inc. (p. 1, magnetic flux
of 0.00002 gauss)); the Magnetic Shield Corporation (p. 2, “Zero Gauss
Chambers” with internal magnetic flux as high as 10 milligauss); AlphaLab
(p. 1, “Zero Gauss Chamber” with internal field less than 0.01 gauss).
Based on an overall consideration of the Wands factors, including the
absence of working examples within the scope of the invention recited in
Appellant’s claim 1, and the uncontroverted evidence supporting a
recognition in the art that magnetic field-excluding devices similar to that
disclosed in the Specification all have a small magnetic field, the Examiner
concludes that the Specification does not enable a device that provides the
internal magnetic flux of 0.00 gauss recited in claim 1. See Ans. 8.
Appellant contends that the absence in the prior art of devices
achieving the claimed internal magnetic field is not an adequate basis for an
enablement rejection. Appeal Br. 15. Appellant contends that the
Specification provides a detailed disclosure of how to prepare the claimed
device, and that a skilled artisan therefore would be able to make the device
without undue experimentation. Id. at 16–18.
We find that the preponderance of the evidence supports the
Examiner’s determination that the Specification does not provide an
enabling disclosure of a device that provides an internal magnetic flux of
0.00 gauss as recited in claim 1.
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We agree with Appellant that the Specification provides a detailed
disclosure of how to make a device for culturing cells, as seen in our
introductory summary of Appellant’s disclosure above. See Spec. ¶¶ 41–48;
Fig. 7. As Appellant concedes, however, the device disclosed in the
Specification does not produce an internal magnetic flux having 0.00 gauss
as recited in claim 1. See Reply Br. 9.
Specifically, as Appellant concedes, the device disclosed in the
Specification, at best, has an internal magnetic flux of 0.00032 gauss, even if
Appellant had met the procedural requirements for submission of evidence.
See id. Appellant, moreover, does not explain specifically why, given the
express language in claim 1, it is unreasonable for the Examiner to interpret
claim 1 as encompassing a device that has an internal magnetic field of zero.
See Reply Br. 10.
Thus, on the current record, claim 1, by its express language,
encompasses a device that has an internal magnetic field of zero, and
Appellant effectively concedes that the device described in the Specification
does not achieve the internal magnetic field required by claim 1. And the
Examiner has advanced uncontroverted evidence that similar devices do not
have an internal magnetic flux of zero, supporting the assertion that such
devices generally have a small internal magnetic field, rather than the
internal magnetic field of zero required by claim 1.
Appellant does not persuade us, therefore, that the preponderance of
the evidence fails to support Examiner’s determination of non-enablement as
to claim 1. Accordingly, we affirm the Examiner’s rejection of claim 1, and
its dependent claims 11–15, for failure to comply with the enablement
requirement.
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ENABLEMENT—CLAIM 8
The Examiner, again applying the Wands factors, determines that
Appellant’s Specification does not provide disclosure sufficient to enable the
treatment of a cancer patient as recited in Appellant’s claim 8. Ans. 8–11.
In particular, the Examiner notes that while the Specification describes
culturing cancer cells in vitro, the Specification does not provide a working
example in which cancer is treated in the manner recited in claim 8. Id. at 9.
The Examiner also contends that the nature of the disclosures in the
Specification relating to cancer treatment is merely prophetic, and that the
Specification provides essentially no specific guidance explaining how to
build a structure able to accommodate and treat a cancer patient. Id. at 10.
Appellant contends that the Specification enables the method of
treating cancer recited in claim 8 because the Specification provides a
detailed description of a device capable of accommodating cultured cells in
vitro, and because the Specification explains expressly that a larger device of
the same construction, such as a room or a house, may be used to treat
cancer in a living patient. Appeal Br. 18–20 (citing Spec. ¶ 49).
We find that the preponderance of the evidence supports the
Examiner’s determination that the Specification does not provide disclosure
sufficient to enable the treatment of a cancer patient as recited in Appellant’s
claim 8.
As an initial matter, we note that claim 8, like claim 1 discussed
above, recites the use of a device that produces an internal magnetic flux of
0.00 gauss. For essentially the same reasons discussed above as to claim 1,
Appellant does not persuade us that the Specification enables a device that
provides an internal magnetic flux of 0.00 gauss, as recited in claim 8.
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As to the cancer treatment also recited in claim 8, even assuming for
argument’s sake that, based on the in vitro test results in the Specification,
Appellant’s contentions regarding the treatability of cancer might be
plausible, our reviewing court has instructed that mere plausibility of a
proposed theory of operability is insufficient to establish enablement:
“If mere plausibility were the test for enablement under section
112, applicants could obtain patent rights to ‘inventions’
consisting of little more than respectable guesses as to the
likelihood of their success. When one of the guesses later proved
true, the ‘inventor’ would be rewarded the spoils instead of the
party who demonstrated that the method actually worked. That
scenario is not consistent with the statutory requirement that the
inventor enable an invention rather than merely proposing an
unproved hypothesis.”
In re ‘318 Patent Infringement Litigation, 583 F.3d 1317, 1327 (Fed. Cir.
2009) (quoting Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318,
1325 (Fed. Cir. 2005)).
Thus, “[t]ossing out the mere germ of an idea does not constitute
enabling disclosure.” Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361,
1366 (Fed. Cir. 1997). Instead, “[w]hile every aspect of a generic claim
certainly need not have been carried out by an inventor, or exemplified in
the specification, reasonable detail must be provided in order to enable
members of the public to understand and carry out the invention.” Id.
In the present case, as discussed above, we agree with Appellant that
the Specification provides a detailed disclosure of how to make a device for
culturing cells, as seen above in our introductory summary of Appellant’s
disclosure. See Spec. ¶¶ 41–48; Fig. 7.
As discussed above, however, as to the larger device required for the
treatment of lung cancer recited in claim 8, the only details provided in the
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Specification are that “[t]he big size devices, like a tank, a room or a house
(same shape, structure and component) will be used for the treatment of
cancer patients.” Spec. ¶ 49.
Because Appellant’s Specification, thus, provides essentially no
concrete details as to the device to be used in the cancer treatment recited in
claim 8, a practitioner seeking to perform the claimed process must figure
out the specifics of essentially all of the practical considerations that go into
preparing and implementing the claimed device. Appellant does not
persuade us, therefore, that the Specification provides sufficiently reasonable
detail that explains how to carry out the cancer treatment process recited in
claim 8.
In sum, because the Specification, at best, shows that the cancer
treatment method recited in Appellant’s claim 8 might be plausible, and
because the Specification does not include any essential practical details
explaining how to make and implement the patient-accommodating device
which is critical to the claimed treatment method, we find that the
preponderance of the evidence supports the Examiner’s determination that
the Specification does not enable the treatment of a cancer patient recited in
Appellant’s claim 8. We, therefore, affirm the Examiner’s rejection of claim
8 for lack of enablement.
INDEFINITENESS
In rejecting claims 1 and 11–15 for indefiniteness, the Examiner
determines that the recitation in claims 1 and 11 of placing cultured cells in a
device “on to continue to culture” is indefinite. Ans. 12. In particular, the
Examiner contends that “[i]t is unclear what ‘on to continue to culture’
means.” Id.
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Appellant does not assert error in the Examiner’s determination of
indefiniteness. See Appeal Br. 21–22. Rather, Appellant contends that the
indefiniteness issue in claims 1 and 11 raised by the Examiner relates to a
typographical error that is correctable by amendment. See id.
Because Appellant does not assert error in the Examiner’s
determination of indefiniteness as to claims 1 and 11, we affirm the
Examiner’s rejection of claims 1 and 11, and their dependent claims 12–15,
under 35 U.S.C. § 112(b).

SUMMARY
For the reasons discussed, we affirm each of the Examiner’s
rejections.
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