DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election in the reply filed on 1/15/2026 is acknowledged:
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Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Based on the election, claims 1-9 cover the elected invention and are treated on the merits, below. Consequently, claims 10-20 are withdrawn from consideration as exclusively covering a non-elected invention.
Specification
The use of a trade name or a mark used in commerce has been noted in this application. See, for example, Sepaflash, in the examples.
The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to methods of identifying or selecting a patient having an elevated erythropoietin-producing hepatocellular receptor A2 (EphA2) level in a tumor tissue without significantly more.
The claims recite "judicial exception" as a limiting element or step without reciting additional elements/steps that integrate the judicial exceptions into the claimed inventions such that the judicial exceptions are practically applied, and are sufficient to ensure that the claims amount to significantly more than the judicial exceptions themselves.
In the instant case, the "judicial exceptions" include the mental processes of: selecting patients having an elevated EphA2 level in a tumor tissue.
A claim that focuses on use of judicial exceptions must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas).
The Mayo framework provides that the claims at issue are directed to a patent-ineligible concept is determined. If the answer is yes, then the elements of each claim both individually and "as an ordered combination" are considered to determine whether additional elements "transform the nature of the claim" into a patent eligible application. The second step known as the "inventive concept"-requires that claims include elements which would render the method both new and useful.
The PTO' s revised guidance on the application of§ 101. (USPTO's January 7, 2019, Memorandum, 2019 Revised Patent Subject Matter Eligibility Guidance indicates that 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); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look 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.
The rejected claims are directed to selecting patients having an elevated EphA2 level in a tumor tissue.
The question then becomes are there other limitations in the claim that show a patent-eligible application of the mental steps, i.e., more than a mere instruction to apply these mental steps. If there are no meaningful limitations in the claim that transform the exception into a patent eligible application such that the claim amounts to significantly more than the exception itself, the claim should be rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter. To expand on this concept, the Court in Diehr, Flook and Alice Corporation have pointed out that the basic mathematical equation, like a law of nature, was not patentable. The Court in Diehr, found that there were other steps added to the formula that in terms of patent law's objectives had significance-they transformed the process into an inventive application of the formula. However, in the present claims, there are no active method steps that transform the measuring and comparing steps into a practical application.
The next step is to determine whether the claim as a whole adds a specific limitation beyond the judicial exception that is not "well-understood, routine, conventional" in the field. Here, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the measuring and comparing steps represent routine data gathering. Such steps would be routinely used by those of ordinary skill in the art to identify and apply a correlation.
As discussed above, the active method steps of measuring and comparing set forth well-understood, routine and conventional activity engaged in by scientists at the time the application was filed and are the activities that a scientist would have relied upon to achieve the goals of the invention.
In sum, when the relevant factors are analyzed, they weigh against the present claims amounting to significantly more than the judicial exceptions themselves.
Accordingly, the rejected claims do not qualify as patent-eligible subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejected claim covers an EphA2 immunohistochemistry (IHC) IHC staining assay that uses a human EphA2 antibody selectively binding to an extracellular domain (ECD) or a cytoplasm domain of EphA2.
Here, a genus of antibodies that selectively bind to an ECD or a cytoplasm domain of EphA2 lack written description because:
1) The specification lacks a representative number of species that satisfies the entirety of the genus; and
2) The recited functional definition of EphA2 binding does not describe the claimed invention.
Firstly, to satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”).
1) The specification lacks a representative number of species that satisfies the entirety of the genus.
Specifically, with regard to a genus of anti-EphA2 antibodies, the following applies:
Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010) states that “...a generic claim may define the boundaries of a vast genus of chemical compounds...the question may still remain whether the specification, including the original claim language, demonstrates that the applicant invented species sufficient to support a claim to a genus”. See page 1171.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
See also Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species.
Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) states that “it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it”.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or structural features common to the members of the genus, which features constitute a substantial portion of the genus, so that one of skill in the art can “visualize or recognize” the members of the genus (Emphasis added). Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(i), the court states, "An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention."
Courts have stated that “[i]n claims involving [non-genetic] chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). (emphasis added).
There is no such specificity here, nor could one skilled in the art identify antibodies encompassed by the claim. Specifically, Applicant fails to disclose any antibodies, as characterized by SEQ ID NO’s, and nonetheless, any disclosed species do not represent the substantial variety covered by the genus of anti-EphA2 antibodies.
The Examiner acknowledges that a working example or exemplified embodiment is not necessarily a requirement for description. However, where a generic claim term is present in a claim, as in the present application, and defined only by functional characteristics, the specification must convey enough information, e.g., via sufficient representative examples, to indicate invention of species sufficient to constitute the genus. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 967 2 (Fed. Cir. 2002). The written description requirement “requires a description of an invention, not an indication of a result that one might achieve if one made that invention.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997); see also Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1350 (Fed. Cir. 2013) (“A patent...‘is not a reward for the search, but compensation for its successful conclusion.’ ... For that reason, the written description requirement prohibits a patentee from ‘leaving it to the ... industry to complete an unfinished invention.’” (citations omitted)).
2) The recited functional definition of the anti-EphA2 antibodies does not describe the claimed invention.
Here, the genus of peptides cannot be adequately described by functional characteristics of preferential binding, even where there is disclosed or known correlations between structure and function.
The Examiner recognizes that the target, EphA2, may be fully characterized. Previously, disclosing a bonding target, such as EphA2 satisfied the written description requirement for a claim to an antibody or protein that binds a target. The Federal Circuit's decisions in Enzo Biochem v. Gen-Probe, Inc., 323 F.3d 956, 964 (Fed. Cir. 2002) and Noelle v. Lederman, 355 F. 3d 1341 (Fed. Cir. 2004) which purportedly set forth what has been called the "newly characterized antigen" test. Also, the PTO's Written Description Training Materials Revision dated March 25, 2008, provide an example (Example 13) embodying the test set forth in Enzo and Noelle.
However, reliance on Enzo and Noelle is misplaced. While the court in Noelle did discuss what is referred to as the "newly characterized antigen" test, the Federal Circuit has recently rejected such a test. Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378-79 (Fed. Cir. 2017). At issue in Amgen was the district court's jury instruction which read:
In the case of a claim to antibodies, the correlation between structure and function may also be satisfied by the disclosure of a newly characterized antigen by its structure, formula, chemical name, or physical properties if you find that the level of skill and knowledge in the art of antibodies at the time of filing was such that the production of antibodies against such an antigen was conventional and routine.
Id. at 1376. The Federal Circuit concluded that the instruction was "not legally sound and [was] not based on any binding precedent." Id. In reaching its conclusion the Federal Circuit reviewed the cases which purported to set forth the newly characterized antigen test including Noelle. Id. at 1376-77. The court concluded that in each of the prior cases the reference to the newly characterized antigen test was dicta and not binding precedent. Id.
The Federal Circuit went on to find that the newly characterized antigen test ran afoul of the Federal Circuit's precedent in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane). Id. at 1378. The court noted that the focus of the inquiry is whether the written description contains enough information about the claimed products. Id. The court held that describing the antigens, which was not the claimed invention, did not satisfy the written description requirement when (“it has been, at the least, hotly disputed that knowledge of the chemical structure of an antigen gives the required kind of structure-identifying information about the corresponding antibodies. See, e.g., J.A. 1241 (549:5-16) (Appellants' expert Dr. Eck testifying that knowing "that an antibody binds to a particular amino acid... does not tell you anything at all about the structure of the antibody [emphasis applied]"); J.A. 1314 (836:9-11) (Appellees' expert Dr. Petsko being informed of Dr. Eck's testimony and responding that "[m]y opinion is that [he's] right"); Centocor, 636 F.3d at 1352 (analogizing the antibody antigen relationship as searching for a key "on a ring with a million keys on it") (internal citations and quotation marks omitted).
In a memo issued in February 2018, USPTO, Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, Feb. 22, 2018 (available at https://www.usnto.gov/sites/defauH/files/documents/amgen 22feb2018.pdf) the PTO issued a clarification regarding the law of written description as it applies to antibodies stating:
In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.
The Memo goes on to state that
"Examples in the 2008 Written Description Training Materials Are Outdated." and should NOT be relied upon as reflecting the current state of the law. Id. at 2. The Memo explains that
USPTO personnel should continue to follow the guidance in the MPEP regarding written description (see, e.g., MPEP 2161.01 and 2163 ), except insofar as MPEP 2163 indicates that disclosure of a fully characterized antigen may provide written descriptive support of an antibody to that antigen.
Id.
The instant claims present the same deficiency as the claims in Amgen where there is no evidence that knowledge of the chemical structure of EphA2 gives the required kind of structure-identifying information about the corresponding antibodies that it binds. As in Amgen, the instant claims attempt to describe EphA2-binding antibodies by describing the target to which the peptides bind. Moreover, there is nothing else in the disclosure that describes the antibodies as required by the test set forth in Ariad.
Moreover, regard to the functional definition an anti-EphA2 antibody, the specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116) because the specification contains almost no information by which a person of ordinary skill in the art would understand that the inventors possessed the all of the recited compounds. At best, it simply indicates that one should test an inordinate number of antibodies to see if the compounds can perform the required binding of EphA2. In this connection, the specification contains no structural or specific functional characteristics of those antibodies which bind EphA2, see In re ’318 Patent Infringement Litigation, 583 F.3d 1317, 1327 (Fed. Cir. 2009) (“[A]t the end of the day, the specification, even read in light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient.”).
Accordingly, the specification lacks adequate written description for the recited human EphA2 antibody selectively binding to an extracellular domain or a cytoplasm domain of EphA2.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “elevated EphA2 level” is a term of degree, the criteria of which is not defined by the specification. Although the specification may give examples of “elevated EphA2 level”, it is impermissible to import specific embodiments of the specification into a generic term in the claims. Therefore, the Applicant’s intended meaning of “elevated EphA2 level” is unclear.
In claims 2 and 5, the method steps required by “using an EphA2 immunohistochemistry (HC) staining assay” are not defined by the claims.
In claim 6, the intended structure of the human EphA2 antibody AF3035 is unclear. The specification and claims do not define the antibody by appropriate SEQ ID’s. Even if the antibody is known, it is unclear what fragments, portion or forms (single chain, variable domain, etc.) Applicant intends to cover by the “human EphA2 antibody AF3035”. Therefore, the intended structure of the antibody is unclear.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 7-9 recite a broad recitation of an H-score of 15 or more, and the claims also recite narrower embodiments of the same range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression, Clinical Trial NCT04180371, 2019, downloaded 5 January 2026 from https://clinicaltrials.gov/study/NCT04180371 (Clinical Trials).
Claim 1: Clinical Trials discloses the inclusion criteria for patients to be selected for clinical trials with BT5528; i.e. expression of EphA2 in tumor tissues (see inclusion criteria).
Claims 2 and 3: Metastatic recurrent histologically confirmed malignant solid tumors historically known for high EphA2 tumor expression.
Claim 4: Participants with metastatic recurrent disease histologically confirmed to be non-small cell lung cancer, ovarian cancer, triple-negative breast cancer (TNBC), gastric/upper gastrointestinal (GI) cancer, head and neck (H&N) cancer, urothelial cancer are eligible and must have failed or are ineligible for all appropriate treatment options per local guidelines and must have evidence of radiographic progression on the most recent line of therapy
Patients with urothelial cancer who have previously received treatment with enfortumab vedotin (EV) are eligible to the study. Patients who received EV and showed disease progression within 6 months of treatment start are planned for less than 50% of total patients enrolled in the cohort.
See Inclusion criteria:
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Clinical Trials therefore anticipates the subject-matter of claims 1-4 within the meaning of section 102.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by WO 2017/161069 (WO 069).
Claims 1-4: WO 069 discloses a method for treating disease conditions (i.e. cancer) which is based on the use of EphA2-targeting drugs that comprises identifying/selecting patients having overexpression of EphA2 in tumor tissues by immunohistochemistry/ immunostaining, see claims:
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Claim 5: The assays use liposomes targeted with anti-EphA2 scFv, see pages 12+.
Claim 6 does not require that the EphA2 antibody selectively binds to the extracellular domain (ECD) of EphA2, only that the IHC staining is an EphA2 antibody binds to the ECD or cytoplasm domain of EphA2 and that that EphA2 antibody that binds to the ECD. of EphA2 is AF3035. Therefore, the reference anticipates this claim since it teaches antibodies that bind to either the ECD or cytoplasm domain of EphA2.
In this way, claims 1-5 are anticipated by WO 069 within the meaning of section 102.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by WO 2008/157490 (WO 490).
Claims 1-6: WO 490 discloses a method for treating disease conditions (i.e. cancer) which is based on the use of EphA2-targeting antibodies that comprises identifying/selecting patients having overexpression of EphA2 in tumor tissues by immunohistochemistry/ immunostaining, see pages 86-87.
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Claim 6 does not require that the EphA2 antibody selectively binds to the extracellular domain (ECD) of EphA2, only that the IHC staining is an EphA2 antibody binds to the ECD or cytoplasm domain of EphA2 and that that EphA2 antibody that binds to the ECD. of EphA2 is AF3035. Therefore, the reference anticipates this claim since it teaches antibodies that bind to either the ECD or cytoplasm domain of EphA2.
In this way, claims 1-6 are anticipated by WO 490 within the meaning of section 102.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trials, WO 069 or WO 490.
The applied references may fail to explicitly H-score values defined in claims 7-9. However, the references teach a score for classifying/staging immune-stained tissues is a measure that falls within the customary practice in this technical field. The instant application does not provide data showing that the particular selection of the H-score values defined in claims 7-9 as cut-off values for identifying EphA2+ tumor cells result in any particular (unexpected) technical effect. As indicated in paragraph [124], these selections may provide an effect depending on the kind of tumor which may be useful for guiding the selection of patients for clinical trials with BT5528, but this is a merely speculative statement that is not supported by any concrete data shown in the application.
Moreover, the references substantially teach the EphA2 immunohistochemistry/ immunostaining assay required by the rejected claims. In this manner, any observed expression of EphA2 as expressed by H-score would have been a necessary aspect of these assays, see MPEP 2112.01 (“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's acting supervisor, Gregory Emch, can be reached at telephone number (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646