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 .
The rejection under section 112(d) is moot since the rejected claims have been canceled.
The following rejection are maintained:
The rejection under section 112(a) is maintained:
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 1, 5, 6, 9-11 remain 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 claims cover a monoclonal anti-periostin antibody that recognizes the peptide sequence SEQ ID NO:1 in the fasciclin (FAS)1-1 domain of periostin.
Here, a genus of antibodies that can bind to the fasciclin (FAS)1-1 domain of periostin, or functional fragments thereof, or any % identity to fragments thereof, 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 binding to the fasciclin (FAS)1-1 domain of periostin 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 an anti-periostin antibody, 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 claims. Specifically, in view of the above, the specification does not provide adequate written description of an anti-periostin antibody. Applicant fails to properly identify disclose any anti-periostin antibody, by way of SEQ ID NO’s, and nonetheless, the limited number species in the specification do not represent the substantial variety covered by the genus of anti-periostin 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 binding the peptide sequence SEQ ID NO:1 in the fasciclin (FAS)1-1 domain of periostin does not describe the claimed invention.
Here, the genus of antibodies 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, periostin, may be fully characterized. Previously, disclosing a bonding target, such as periostin satisfied the written description requirement for a claim to an antibody or protein that binds the 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 periostin gives the required kind of structure-identifying information about the corresponding antibodies that bind it. As in Amgen, the instant claims attempt to cover an antibody by describing the target to which the antibody binds. Moreover, there is nothing else in the disclosure that describes the peptides as required by the test set forth in Ariad.
Moreover, regard to the functional definition of binding the peptide sequence SEQ ID NO:1 in the fasciclin (FAS)1-1 domain of periostin 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 antibodies. At best, it simply indicates that one should test an inordinate number of antibodies to see if the antibodies can perform the required binding of the peptide sequence SEQ ID NO:1 in the fasciclin (FAS)1-1 domain of periostin. In this connection, the specification contains no structural or specific functional characteristics of those antibodies which bind the peptide sequence SEQ ID NO:1 in the fasciclin (FAS)1-1 domain of periostin, 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 antibodies that bind the peptide sequence SEQ ID NO:1 in the fasciclin (FAS)1-1 domain of periostin.
The claims have been amended to recite that the antibody is for use as a medicament for use for treating inflammatory, fibrotic or respiratory disorders in a subject in need thereof, wherein the monoclonal anti-periostin antibody is an lgG, wherein the monoclonal anti-periostin antibody has a dissociation constant KD with SEQ ID NO: 1 inferior or equal to 50 nM.
However, these are functional limitations. As indicated above, the functional definitions still require that one should test an inordinate number of antibodies to see if the antibodies can perform the required function.
What is required is structure, see above (“[a]n adequate written description... requires a precise definition, such as by structure, formula, chemical name…not a mere wish or plan for obtaining the claimed chemical invention [emphasis applied].”).
Here, there is no teaching of what structure (whether the DNA or encoded antibody) would be a surrogate for conservation of the claimed function. In other words, there is no teaching as to residues of the in the antibody are required while still conserving the function of the encoded polypeptide.
The specification leaves it to others to discover the nature and scope of substitutions, deletions, and insertions that can be made to arrive at an antibody sequence that additionally allows for recited activity.
The applicants may attempt to use BLAST homology data to argue that a person of ordinary skill would be able to address the issue, but the evidence would be accorded little weight and characterized as an invitation to experiment.
Even though the DNA/polypeptides that could be envisioned by one of ordinary skill could be easily tested as set forth in the specification for conservation of the recited function, this is not enough to describe the structure so that one could determine beforehand whether or not a particular structure meets the functional requirements. For an antibody which is claimed by function of the expressed protein, one must be able to determine if a sequence or structure produce an antibody that can accomplish the recited function from the specification itself in order to meet the written description requirement.
However, the specification here leaves it to others to discover the nature and scope of residues, substitutions, deletions, and insertions that can be made to arrive at an antibody that additionally allows for recited activity since the specification offers no structural description of the regions of the recited antibody critical for conservation of the recited function.
Even if DNA/polypeptides could be easily tested as set forth in the specification for conservation of the recited anti-periostin function, this is not enough to describe the structure so that a person having ordinary skill in the art could determine beforehand whether or not a particular structure meets the anti-periostin functional requirements. Therefore, the rejection is maintained.
The rejection under section 112(b) is maintained in-part, below:
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, 5, 6, 9-11 remain 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 structure of an antibody that bind the peptide sequence SEQ ID NO:1 in the fasciclin (FAS)1-1 domain of periostin is still not defined in the specification or claims.
The structure of the antibody segments that Applicant considers functional fragments of the antibody are not defined.
It is still unclear what structure will confer the recited functions.
The ejection under section 103 is maintained:
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 1, 5, 6, 9-11 remain rejected under 35 U.S.C. 103 as being unpatentable over Field et al., Int J Cancer. 2016 Apr 15;138(8):1959-70 (Field).
Field teaches discloses antibodies binding to the fasciclin domain 1-1 including the antibody designated MPC5B4 which is also referred to in the present application (abstract, fig. 1-6).
The antibodies were raised in mice infected with LDV, using human POSTN conjugated to OVA (page 1961, left-hand col.). The antibodies included IgG and IgM antibodies; the antibody MPC5B4 is an IgG1 antibody (page 1962, righthand col.).
The antibodies inhibit the binding to avẞ3 integrin and inhibits migration of human endothelial colony forming cells (fig. 5). Moreover, the antibodies moreover block adhesion of melanoma cells to periostin (fig. 2). The reference suggests that targeting periostin with such antibodies as anti-tumor therapy (page 1969).
The intended uses and product-by process limitations in the various dependent claims do not further limit the recited antibodies.
Some dependent claims recite binding affinities. However, Field substantially teaches the recited antibodies, and any characteristics, such as preferential binding, would have been necessary aspects of the disclosed antibodies, 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.”).
The difference between Field and the claimed invention is that Field does not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, based on the above, Field teaches the elements of the claimed antibodies with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Applicant admits that Field teaches the same antibodies as those claimed:
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Applicant argues that the present application discloses and exemplifies a fundamentally different and non-obvious therapeutic utility for the claimed anti-POSTN antibody.
However, the intended use language does not limit the scope of the claim. Field still renders the claim obvious since the reference teaches the same anti-POSTN antibodies and is therefore capable of performing the intended use, see MPEP 2111.01.
Election/Restrictions
Newly submitted claims 12-16 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The original claims and new claims are related as an antibody and a therapeutic method of using the antibody. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the therapeutic methods can be used with fundamentally different agents, e.g., small molecules.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 12-16 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
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