KONINKLIJKE PHILIPS N.V.

Patent Trials and Appeals Board

Mar 26, 2021

2020004467 (P.T.A.B. Mar. 26, 2021)

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.
15/111,328 07/13/2016 DAVID HALTER 2013P01183WOUS 3344
24737 7590 03/26/2021
PHILIPS INTELLECTUAL PROPERTY & STANDARDS
465 Columbus Avenue
Suite 340
Valhalla, NY 10595
EXAMINER
COOK, LISA V
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
03/26/2021 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):
katelyn.mulroy@philips.com
marianne.fox@philips.com
patti.demichele@Philips.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DAVID HALTER, REINHOLD WIMBERGER-FRIEDL,
ANJA VAN DE STOLPE, FREEK VAN HEMERT,
and GEESKE CHRISTINA DAM-DE VEEN

Appeal 2020-004467
Application 15/111,328
Technology Center 1600
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and
RYAN H. FLAX, Administrative Patent Judges.

FLAX, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims to a method for stratification of a patient for assessing suitability of a
therapy for the patient. Appellant appeals the rejection of claims 1–7 under
35 U.S.C. § 101, § 112(a) and § 112(b).1,2 We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 “Appellant” herein refers to the “applicant” as defined by 37 C.F.R. § 1.42.
Appellant identifies “Koninklijke Philips N.V.” as the real party-in-interest.
Appeal Br. 3.
2 Claims 8–13 stand withdrawn from consideration. Appeal Br. 25–26.
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STATEMENT OF THE CASE
Claim 1 is the sole independent claim on appeal and is reproduced
below:
1. A method for stratification of a patient for assessing
suitability of a therapy for the patient suffering from an ER
(estrogen receptor) and/or PR (progesterone receptor) positive
and HER2 (human epidermal growth factor receptor 2) negative
cancer, the therapy being directed towards a signaling pathway,
comprising:
(i) determining an activation status of an ER and/or PR
signaling pathway by applying a Proximity Ligation Assay to
detect in a tissue sample of the patient a presence of at least one
member of the ER family, said at least one member being part of
a transcription factor complex, and at least one protein selected
from a group consisting of TAFs (TATA-binding protein
associated factor), TBP (TATA-box binding protein), POLII
(RNA polymerase Ii), TFII (transcription factor II), p300, CREB
(cyclic-AMP response element-binding protein), and CBP
(CREB binding protein), wherein the at least one protein is part
of the same transcription factor complex,
wherein the stratification is based on the activation status
determined in (i) and the suitability of the therapy is assessed
based on the stratification,
wherein a signaling pathway of (i) is determined to be
active, if the at least one ER family member is located in the
nucleus in the Proximity Ligation Assay close proximity to the
at least one protein selected from the group consisting of either
TAFs, TBP, POLII, TFII, p300, CREB, and CBP.
Appeal Br. 23 (Claims Appendix).
The Specification states “[t]he method according to the present
invention (as described herein) is particularly suitable for stratification of a
cancer patient, in particular for stratification of a breast cancer or prostate
cancer patient, especially of an ER (estrogen receptor) and/or PR
(progesterone receptor) positive and HER2 negative breast cancer patient”
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and “[i]n particular, the method according to the present invention can be
advantageously used for assessing the suitability of a hormonal therapy for
the patient.” Spec. 4:21–25. In such an assessment, according to the
Specification,
a patient is [initially] stratified as belonging into one of the four
following breast cancer classes:
(1) Positive for either ER or PR (or both) AND negative
for HER2
➔ hormone receptor positive breast cancer
(2) Negative for both ER AND PR, BUT positive for
HER2
➔ HER2 positive breast cancer
(3) Positive for either ER or PR (or both) AND positive
for HER2
➔ hormone receptor and HER2 positive breast cancer
(4) Negative for all receptors
➔ so called triple negative breast cancer
(Side remark: if either ER or PR are positive, then it can
be called hormone receptor positive (without mentioning
whether ER or PR is meant), as it has (currently) the same
implications for treatment).
Id. at 5:28–6:7. According to the Specification, the treatment choices for
this initial stratification break down as follows: (1) a patient classified as ER
or PR positive is prescribed endocrine treatment; (2) a patient classified as
HER2 positive is prescribed HER2-specific antibody treatment; (3) a patient
classified as ER/PR and HER2 positive would be prescribed a combination
of endocrine and antibody treatment; and (4) a patient classified as ER/PR
and HER2 negative would be prescribed an alternative treatment such as
chemotherapy. Id. at 6:16–7:10, 18:24–19:8.
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Per claim 1, reproduced above, the invention is directed to category 1
of this initial stratification list, which may be further “stratified” in terms of
potential resistance to therapy. See, e.g., id. at 13:16–32. The Specification
states that, “[d]epending on for which marker a patient is tested positive, i.e.
depending on which of the aforementioned breast cancer classes a patient
belongs to, a different treatment is the therapy of choice.” Id. at 6:13–15.
Again, per claim 1, above, the invention is directed to the first of these
treatment choices (ER/PR+, HER2-) and, thus, endocrine treatment.
The Specification further describes that “the step of determining the
activation status of [for example,] the PI3K pathway, the Wnt pathway,
and/or the HH pathway,” e.g., pAkt positive or negative, is important
because “[t]hose pathways may also have influence on potential resistance
or, respectively, may be indicative of such resistance” to the endocrine
treatment. Id. at 11:22–26; see also, e.g., id. at 13:25–31 (listing signaling
pathways or relevance).
The Specification states, “[b]y applying the methods of the present
invention, especially methods according to the preferred embodiments
described herein, it is possible to make a reliable prediction of the likelihood
that (cancer) patients will develop a resistance to a certain therapeutic, or to
determine if such a resistance already exists.” Id. at 14:21–24. The further
stratification of the invention is described as follows:
By employing such methods, basically four different test
results are possible with four different treatment choices in an
adjuvant setting (in all cases additional chemotherapy and
radiation therapy are decided separately):
1. ER containing transcription factor complex (step (i)):
positive[;] pAkt (step (v)): negative
➔ treatment choice: “endocrine treatment”.
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2. ER containing transcription factor complex (step (i)):
positive[;] pAkt (step ( v)): positive
➔ treatment choice: “endocrine treatment” and (potential
new) inhibitors of the PBK pathway.
3. ER containing transcription factor complex (step (i)):
negative[;] pAkt (step (v)): negative
➔ no endocrine treatment, no PBK pathway drugs
(potentially with exception of PBK pathway inhibitors
downstream of pAkt, such as TORCl and/or TORC2
inhibitors).
4. ER containing transcription factor complex (step (i)):
negative[;] pAkt (step (v)): positive
➔ (potential new) inhibitors of the PBK pathway.
Id. at 18:24–19:8. The Specification states that this additional stratification
“allows for an improved choice of suitable treatment for the respective
(cancer) patient.” Id. at 19:12.
Claim 1 recites “transcription factor complex” and several proteins as
detected via a Proximity Ligation Assay (PLA), and that the two analytes
may be in “close proximity.” The Specification states:
In the canonical ER pathway for example, ER enters the nucleus
as a dimer, which can be detected using PLA. After entering the
nucleus, a transcription factor complex is formed involving many
factors (cf. Fig. 1), any two of which may serve as the basis
(targets) for a PLA assay. The mere presence of ER or for
example the general cofactor p300 in the nucleus may be
meaningless while their close proximity is indicative of the
formation of a fully functional transcription factor complex and
thus active transcription of a set of genes.
Id. at 7:18–24. The Specification further states that “[t]he Proximity
Ligation Assay . . . is a method that is capable of reporting on the co-
location of two protein epitopes . . . us[ing] two antibodies labeled with a
DNA oligo,” where the oligos “form a closed circle” probe that is amplified
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by RCA, which can be labeled by a complementary probe with a fluorophore
“yielding a very bright spot in the place where the two proteins are co-
located.” Id. at 7:33–8:9; see also Figs. 3–6 (showing results of IHC and
PLA assays against ER and p300).
The following rejections are on appeal:
Claims 1–7 stand rejected under 35 U.S.C. § 101 as directed to a
judicial exception to patentability, i.e., a natural product and an abstract idea,
without significantly more. Answer 7–18.
Claims 1–7 stand rejected under 35 U.S.C. § 112(a) as failing under
the enablement requirement. Answer 18–25.
Claims 1–7 stand rejected under 35 U.S.C. § 112(b) as indefinite.
Answer 3–7.
DISCUSSION
“[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting a prima facie 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).
Arguments made by Appellant in the Appeal Brief and properly presented in
the Reply Brief have been considered. See 37 C.F.R. § 41.37(c)(1)(iv)
(2015); see also Ex parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010)
(informative) (“Any bases for asserting error, whether factual or legal, that
are not raised in the principal brief are waived.”).
I. PATENT ELIGIBILITY
LEGAL STANDARDS
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the U.S. Supreme Court has interpreted 35 U.S.C. § 101 to include
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implicit exceptions: “[l]aws of nature, natural phenomena, and abstract
ideas” are not patent-eligible. See, e.g., Alice Corp. v. CLS Bank Int’l, 573
U.S. 208, 216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Court’s two-part framework, described in Mayo and Alice.
Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc.,
566 U.S. 66, 75–77 (2012)). In accordance with that framework, we first
determine to what concept the claim is “directed.” See Alice, 573 U.S. at
219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
If the claim is “directed to” an abstract idea or law of nature or natural
phenomenon, we turn to the next step of the Alice and Mayo framework,
where “we must examine the elements of the claim to determine whether it
contains an ‘inventive concept’ sufficient to ‘transform’ the claimed abstract
idea [or law of nature or natural phenomenon] into a patent-eligible
application.” Alice, 573 U.S. at 221 (internal quotation marks omitted). For
example, “[a] claim that recites an abstract idea must include ‘additional
features’ to ensure ‘that the [claim] is more than a drafting effort designed to
monopolize the [patent-ineligible concept].’” Id. (alterations in original)
(quoting Mayo, 566 U.S. at 77).
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101. See 2019 Revised
Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
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(“Revised Guidance”).3 “All USPTO personnel are, as a matter of internal
agency management, expected to follow the guidance.” Id. at 51; see also
October 2019 Update at 1. Under the Revised Guidance and the October
2019 Update, (as “Step 2A”) we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts, certain methods of
organizing human activity such as a fundamental economic
practice, or mental processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP §§ 2106.05(a)–(c), (e)–(h)
(9th ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).4
Revised Guidance, 84 Fed. Reg. at 52–55.
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look, under
Step 2B, to whether the claim:
(3) adds a specific limitation beyond the judicial exception that
is not “well-understood, routine, conventional” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional
activities previously known to the industry, specified at a high
level of generality, to the judicial exception.
Revised Guidance, 84 Fed. Reg. at 52–56.

3 The Office issued further guidance on October 17, 2019, clarifying the
Revised Guidance. USPTO, October 2019 Update: Subject Matter
Eligibility (the “October 2019 Update”) (available at https://www.uspto.gov/
sites/default/files/documents/peg_oct_2019_update.pdf).
4 This includes (a) identifying whether there are any additional elements
recited in the claim beyond the judicial exception, and (b) evaluating those
additional elements individually and in combination to determine whether
the claim as a whole integrates the exception into a practical application.
See Revised Guidance — Section III(A)(2), 84 Fed. Reg. at 54–55.
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With these standards in mind, we address the Examiner’s rejection
and Appellant’s arguments thereover.
ANALYSIS
The Examiner determines that claims 1–7 are directed to an abstract
idea and to a natural phenomenon and, so, are patent-ineligible. Answer 7–
18. Regarding the natural phenomenon aspect of the claims, the Examiner
asserts that
the instant claims are directed to the natural binding in protein
interactions with biological materials. All of the compositions
listed in the method are found in nature and the complex formed
between substances such as protein-peptides is a natural event.
The claims are further directed to natural signally pathways that
are found in nature without significantly more.
Id. at 8. The Examiner elaborates:
the claims are directed to a naturally occurring correlation,
namely the naturally occurring measurement of protein
interactions within natural signally pathways. Although the
claims recite the utility of a proximity ligation assay to measure
the natural components (proteins, peptides, composition), the use
of a PLA assay is deemed routine and conventional.
Id. at 9. The Examiner also asserts that the claim’s recitation of comparing
information (i.e., determining activation status and stratification) is an
abstract idea because it reads on a mental process. Id. at 11–12.
The Examiner asserts that the claims do not recite anything
significantly more than the ineligible subject matter so as to confer patent-
eligibility under Step 2B, identifying the recited Proximity Ligation Assay
(PLA) as something in addition to the recited natural phenomenon and
mental process, and cites Treviño as evidencing that the recited PLA was
used routinely and conventionally to measure ER phosphorylation, which
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was known as a biomarker for breast cancer.5 Id. at 9–10, 15, 17 (citing
Treviño at 515, 519, 522).
In response, Appellant argues that the subject matter of claim 1, “as a
whole is integrated into a practical application” because the determining of
activation status by PLA, which detects the ER family proteins, allows for
stratification and is a technological improvement. Appeal Br. 15–16.
Appellant also argues that claim 1 recites significantly more (Step 2B) in
reciting the use of PLA in the claimed stratification method and that the
Examiner has failed to establish that this use of PLA was routine or
commonplace in the relevant field. Id. at 17–18. To this end, Appellant
argues that, although Treviño may identify that PLA was a known technique,
the Examiner failed to show it was “widely prevalent or in common use” for
the purposes claimed. Id. at 18; see also Reply Br. 15–17.
We are persuaded by Appellant’s second argument addressing
Step 2B of the Office’s patent-eligibility analysis. See supra Section I,
Legal Standards section. The Examiner’s evidence in support of the claimed
PLA technique being merely routine and conventional and not amounting to
“significantly more” under Step 2B, whether considered individually or in
combination with the remainder of the claimed steps, is Treviño. See Final
Action 8–10, 13; Answer 8–11, 15–17. We conclude this evidence is
insufficient to support the Examiner’s position.
The entirety of Treviño’s disclosure regarding PLA use is the
following: “[t]echniques such as proximity ligation assays (PLAs), which
give a positive signal only when two antibodies (e.g., SHR and phospho-

5 Lindsey S. Treviño, Phosphorylation: a Fundamental Regulator of Steroid
Receptor Action, 24(10) TRENDS ENDOCRINOL METAB. 515–524 (2013)
(“Treviño”).
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specific) are in close proximity may overcome these limitations for
immunohistochemical studies.” Treviño, 522 (referring to limitations in
measuring gene regulation and receptor binding using microarrays and
phosphorylation-specific antibodies). Although this identifies that the PLA
technique existed as of Treviño’s publication and that it was likely capable
of identifying ER and related proteins, it does not evidence that such a
proximity assay was routinely or conventionally used for this purpose or for
methods as claimed. “The mere fact that something is disclosed in a piece of
prior art . . . does not mean it was well-understood, routine, and
conventional.” Berkheimer v. HP Inc., 881 F.3d 1360 (Fed. Cir. 2018).
Even if Treviño could be considered to teach assaying for ER and
transcription factors in relation to cancer treatment considerations, it merely
suggests PLA might be useful to overcome shortcomings in other
techniques; it does not indicate PLA was routinely or conventionally used.
On this record, because the Examiner did not persuasively address the
inquiries under Step 2B, we conclude that the Examiner failed to make a
threshold showing sufficient to support the rejection. Reversal of the
rejection is, therefore, warranted.
II. ENABLEMENT
LEGAL STANDARDS
“Section 112 requires that the patent specification enable those skilled
in the art to make and use the full scope of the claimed invention without
undue experimentation. . . . [S]ee also In re Goodman, 11 F.3d 1046, 1050
(Fed. Cir. 1993) (‘[T]he specification must teach those of skill in the art how
to make and how to use the invention as broadly as it is claimed.’).”
Invitrogen Corp. v. Clontech Labs. Inc., 429 F.3d 1052, 1070–71 (Fed. Cir.
2005) (internal quotes omitted).
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Regarding any required experimentation to practice a claimed
invention based on a specification’s description, some experimentation, even
a considerable amount, is not “undue” if, e.g., it is merely routine, or if the
specification provides a reasonable amount of guidance as to the direction in
which the experimentation should proceed.
Factors to be considered in determining whether a disclosure
would require undue experimentation . . . include (1) the quantity
of experimentation necessary, (2) the amount of direction or
guidance presented, (3) the presence or absence of working
examples, (4) the nature of the invention, (5) the state of the prior
art, (6) the relative skill of those in the art, (7) the predictability
or unpredictability of the art, and (8) the breadth of the claims.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
With such standards of law in mind, we analyze the Examiner’s
rejection and Appellant’s arguments regarding enablement below.
ANALYSIS
The Examiner determines that claims 1–7 are not enabled by the
Specification because “the actual determination of activation status and
subsequent stratification are not exemplified” in that “the actual relevant
peptide/protein interaction necessary for activation and stratification has not
been identified.” Answer 18–19. The Examiner also determines that “the
intended patient population is not certain,” asserting that ER/PR+ and
HER2- cancer patients is not sufficient clarity. Id. at 19.
Appellant argues that there are express examples in the Specification
where claimed proteins, i.e., ER and p300, are assayed as complexed to
indicate activation status. Appeal Br. 19. Appellant argues that such
activation status is useful in assessment for therapy as indicated by this
proximity assay and that the stratification for disclosed cancer therapies is
described. Id. at 19–21.
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Based on our review of the Specification, we find the record supports
Appellant. We conclude that the Wands factors weigh in favor of
Appellant’s position because the amount of direction or guidance presented
in the Specification is adequate, there are working examples provided in the
Specification, the nature of the invention, although superficially complex, is
straight forward, the state of the prior art appears to be mature, and the
relative skill of those in the art (those engaged in cancer research and/or
treatment) is undoubtedly high. These factors indicate that any amount of
experimentation necessary would not be unduly burdensome, as further
explained below.
Although the claims are directed to somewhat complex cellular
processes and, generally, to the unpredictable field of cancer treatment, no
actual cancer treatment or results thereof are required by the claims. The
claims are, ultimately, directed to the much simpler subject matter of
detecting analytes and classifying a patient based thereon. According to
claim 1, addressing a population of ER and/or PR positive and HER2
negative cancer patients, generally, the claim requires identifying the
presence in cell nuclei of ER in close proximity to one of several proteins
that associate with ER to form an active complex. Thus, the claimed
invention boils down to identifying whether two known components are
present in the nuclei of sampled cells from a particular patient and then
classifying that patient into one of just a few categories for potential
treatment. “Section 112 does not require that a specification convince
persons skilled in the art that the assertions therein are correct.” In re
Armbruster, 512 F.2d 676, 678 (CCPA 1975). No treatment is required, nor
is it required that the results of the aforementioned protein detection and
patient categorization be reliable in terms of actual treatment success.
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The Specification explains that if such proteins are found to be in
close proximity to one another, which PLA can identify, it can be
determined that the ER transcription complex is active (because it requires
the two components for activation). Spec. 7:15–8:9. The Specification
further explains that if a patent is ER/PR positive, this indicates prescribing
endocrine treatment (and also that the HER2 negative status would foreclose
antibody treatment). Id. at 6:13–7:10. This is a first level of therapy
stratification. The Specification also explains that, depending on the
activation status determination, one can further stratify such patients as
potentially reacting well or not to endocrine treatment, individually or in
combination with another treatment. Id. 18:24–19:12; see also id. at 20:1–
21:7, Fig. 2 (identifying treatment options that might be selected based on
the activation status results). Finally, the Specification provides examples
where the necessary steps to make an activation status determination, upon
which such described stratification is based, are explained and demonstrated
to work. Id. at 24:25–25:33, Figs. 4–6.
We conclude such disclosure in the Specification is sufficient to
enable a person of ordinary skill in the art to practice the claimed analyte
detection and patient categorization invention.
III. INDEFINITENESS
LEGAL STANDARDS
A patent specification “shall conclude with one or more claims
particularly pointing out and distinctly claiming the subject matter which the
inventor . . . regards as the invention.” 35 U.S.C. § 112(b) (2019). For
claims under examination, “a claim is indefinite when it contains words or
phrases whose meaning is unclear,” i.e., “ambiguous, vague, incoherent,
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opaque, or otherwise unclear in describing and defining the claimed
invention.” In re Packard, 751 F.3d 1307, 1310–13 (Fed. Cir. 2014).
With such standards of law in mind, we analyze the Examiner’s
rejection and Appellant’s arguments regarding indefiniteness below.
ANALYSIS
The Examiner determines that the claim terms “stratification,”
“activation status,” and “suitability,” are vague and indefinite. Answer 3–7.
The Examiner determines that “stratification” is indefinite because it is not
clear what the limitation encompasses; its meets and bounds cannot be
determined. Id. at 3. The Examiner questions “what will be considered an
active level of detection (activation)” and “[h]ow will the activation level
correlate to therapy” for stratification based on activation status? Id.
Appellant argues that the term “stratification” and its scope is clear in
the context of the remainder of the claim because the claim requires that
stratification is based on the determined activation status and directly relates
to assessing therapy suitability. Appeal Br. 8. Appellant argues that its
Specification describes stratification based on determining activation status
at pages 18–19 and 24, for example. Id. at 9. Appellant argues that the
terms “activation status” and “suitability” (of a therapy) are not mere relative
terms, but activation status and suitability are each, essentially, binary
variables and depend on whether detected analytes are in close proximity or
not, and, based thereon, if the patent falls within a category for a specific
treatment. Id. at 9–11.
We conclude the claims are not indefinite. “The purpose of claims is
not to explain the technology or how it works, but to state the legal
boundaries of the patent grant. A claim is not ‘indefinite’ simply because it
is hard to understand when viewed without benefit of the specification.” S3
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Incorporated v. NVidia Corp., 259 F.3d 1364, 1369 (Fed. Cir. 2001). We
find that the claims, including the language at issue under this rejection, are
clear and unambiguous when read as a whole and in view of the
Specification.
Based on the Specification, which has been discussed at length above,
we find the term stratification clear as referring to the classifying of patients
(ER/PR+, HER2-) into one of four categories for treatment based on whether
or not ER transcription factor complexes are found in sample nuclei, i.e., ER
is in close proximity (which means a PLA test shows, via a bright spot, two
components to be complexed) with a protein related to the complex (as
otherwise claimed, phosphorylation can also be assayed to support this
classification). Moreover, if this is found (or if it is not), the activation
status of the tested tissue/patient can be determined. Once these
determinations are made, the patient is identified as suitable for certain
treatments or not, e.g., endocrine treatment, with or without inhibitors of
other pathways.
For the reasons above, we find the record supports Appellant’s
position and we reverse the indefiniteness rejection.
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CONCLUSION
In summary, each of the patent-eligibility, enablement, and
indefiniteness rejections are reversed.

Claims
Rejected 35 U.S.C. § Basis Affirmed Reversed
1–7 101 Eligibility 1–7
1–7 112(a) Enablement 1–7
1–7 112(b) Indefiniteness 1–7
Overall
Outcome 1–7

REVERSED