DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 2/11/16 has been entered in full. Claims 16-22 are canceled. New claims 23-26 are added. Claims 1-15 and 23-26 are pending.
Election/Restrictions
Applicants' election without traverse of Group VIII, drawn to a method of administering an IL-27 polypeptide, in the reply filed on 2/11/16 is acknowledged. Applicants indicate that claims 6-8, 25 and 26 encompass the elected invention; the Examiner agrees as new claim 27 is directed to the elected invention in the alternative; and claims 6-8 and claim 26 are linking claims that will be examined together with the elected invention. Claims 1-5, 9-15 and 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 6-8, 25 and 26 are under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities:
---The title of the invention is not descriptive, because (1) it is directed in part to a composition, but the elected invention is directed to a method of use; and (2) it is directed in part to any method for controlling heat generation, but the elected invention is directed to use of IL-27 for controlling heat generation. A new title is required that is clearly indicative of the invention to which the claims are directed. The following title is suggested: “Method for Controlling Heat Generation within an Organism using IL-27”.
---In the current title, “Within Organism” should be “Within an Organism”, and the concluding “And Use” is redundant with “Method for…” and should be removed.
Appropriate correction is required.
Claim Objections
Claims 6-8 and 25-26 are objected to because of the following informalities:
In claim 6, line 3, there should be a comma after “pathway”; i.e., “pathway,”
In claim 8, line 1, “is in vitro tissue or cell” should be “is an in vitro tissue or cell”.
In claim 25, line 3, “up regulation” should be “up-regulation” or “upregulation”.
In claim 26, line 2, “nuclear acid” should be “nucleic acid”.
In claim 26, line 2, “mRNA, virus or plasmid DNA” should be “mRNA, virus DNA or plasmid DNA”.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 6-8, 25 and 26 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 pre-AIA the applicant regards as the invention.
Independent claim 6 is indefinite because it is unclear whether the recitation “…wherein a molecule for adjusting …. is applied to the organism” is a continuation of the preamble of the claim or is a method step. The claim first recites “for controlling heat generation within an organism”, which is considered a preamble that states the intended use for the method; i.e., to control heat generation. This is followed by a lengthy “wherein” clause that constitutes the remainder of the claim, and this can be read as simply a continuation of the stated intended use of the preamble because it is not formulated as an active step that is part of the method. Compare with withdrawn claim 9, which states, “A method for screening a candidate compound capable of controlling heat generation within an organism, comprising a step of …” In this regard, claim 6 would be rendered indefinite if amended to use language similar to claim 9; e.g., “A method for controlling heat generation within an organism, comprising a step of administering to the organism a molecule for adjusting…”
In claim 26, use of the term “like” in line 2 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention, analogous to the use of “for example” or “such as”. See MPEP § 2173.05(d).
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.-Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 8 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Per MPEP 608.01(n).III, “If the dependent claim does not comply with the requirements of 35 U.S.C. 112(d), the examiner should reject the dependent claim under 35 U.S.C. 112(d) rather than objecting to the claim” and “a dependent claim must be rejected under 35 U.S.C. 112(d) if it omits an element from the claim upon which it depends or it fails to add a limitation to the claim upon which it depends”.
Claim 7 limits the method of claim 6 to one wherein “the organism” comprises “a human subject or tissue or cell thereof, a mammal or tissue or cell thereof, or a microorganism”. The art-accepted definition of an organism does not encompass a “tissue or cell” derived from an human or mammal. As such, claim 7 is broader than parent claim 6, because claim 6 is limited to an organism but claim 7 encompasses derived cells or tissues. Claim 8 is also broader than parent claim 6 because it further limits the “tissue or cell” to an “in vitro tissue or cell”. Therefore, dependent claims 7 and 8 are each of improper dependent form for failing to further limit the subject matter of parent claim 6.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a), written description
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 6-8, 25 and 26 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Per MPEP 2163, 35 U.S.C. 112(a) requires, “separate and distinct from the enablement requirement”, that the “specification shall contain a written description of the invention…” (Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1355 (Fed. Cir. 2010)). In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112(a), it is necessary to understand what Applicants are claiming and what Applicants have possession of.
The instant claims are directed to a method with the intended use of controlling heat generation within an organism. The method asserts to achieve this goal through application of a molecule “for adjusting binding of EBI-3 and p28 or binding of dimers of EBI-3 and p28 and receptors thereof, or a downstream signal pathway”. The “controlling heat generation” includes both “improving a body temperature” by “promotion or enhancement of the binding” (as recited in dependent claim 25) or “reducing a body temperature” by “inhibition or reduction of the binding” (dependent claim 23). The elected invention under consideration is directed to use of IL-27 polypeptide as the applied molecule for improving body temperature by “promotion or enhancement of the binding of EBI-3 and p28”, “the dimers of EBI-3 and p28 and the receptors thereof”, or up-regulation “of the downstream signal pathway”.
The specification teaches that the cytokine IL-27, which is formed from a heterodimer of the subunits EBI-3 and p28, “directly acts on adipocytes, activates the p38 MAPK-PGC1 signals and stimulates generation of UCP1 [uncoupling protein 1]” (¶ 75, published application). The specification includes a working example including results demonstrating that the “IL-27 signal is indispensable for the full adaptive heat generation”. The results described in the specification are supported by the post-filing date publication of Wang et al (2021. Nature. 600: 314-318; cited on the 3/3/26 IDS).
While the working example supports the description of the IL-27 polypeptide, as well a nucleic acid encoding IL-27 polypeptide, as an example of a molecule that can improve the heat generation of an organism, the claims are not limited to administration of the IL-27 polypeptide, but instead encompass administration of any “molecule” having the requisite functional activity, i.e., adjusting binding of EBI-3 and p28, or binding of EBI-3 and p28 and receptors thereof, or a downstream signal pathway. The specification envisions that the molecule employed in the claimed method can also be another type of “biological macromolecule”, which includes other polypeptides, nucleic acids, antibodies, or a “small molecule” (¶ 6, 8). The specification also refers to “a modifier thereof” of IL-27 and/or a nucleic acid encoding such, where such modifier is otherwise structurally unspecified (¶ 8). Thus, the claims are genus claims because they are directed to use of a genus of molecules having the requisite functional activity.
While the claims are directed to a method of a product (i.e., antibody) rather than claiming a product per se, practicing said method requires a written description of the product to be used in the method. The product of the broadest claims, a “molecule”, is only defined functionally, i.e., as being able to adjusting binding of EBI-3 and p28, or binding of EBI-3 and p28 and receptors thereof, or a downstream signal pathway. However, a product defined by function is not in and of itself sufficient to describe the product because it is only an indication of what the product does, rather than what it is; i.e., the specific structure of the product. It is only a definition of a useful result rather than a definition of what achieves that result. Per MPEP 2124, "describing a composition by its function alone typically will not suffice to sufficiently describe the composition". Furthermore, in the instant case the specification does not establish a correlation between structure and function; e.g., the structure of one molecule having the required activity does not provide predictability regarding the range of other structures having the same functionality. Furthermore, the decision of the Federal Circuit in Amgen v. Sanofi, 872 F.3d 1367 (Fed. Circ. 2017) held that a claim directed to an antibody requires written description of the antibody itself rather than being satisfied solely by a written description of the antigen to which it binds (the so-called "newly characterized antigen" test). Thus, a description of the target protein (e.g. IL-27) is not in and of itself sufficient to provide a description of molecules promoting the functionality of IL-27
Written description for a genus may also be satisfied through sufficient description of a relevant number of species. This is dependent on whether one of skill in the art would recognize necessary common attributes or features possessed by the members of the genus. Generally, in an unpredictable art, adequate description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Also, “[w]hen a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" (Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005)). “[A] sufficient description of a genus … requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus” (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69).
In the instant case, other than the IL-27 protein, or a nucleic acid encoding such, the specification does not provide any examples of a molecule having the functional activity required for the claims. A description of just one is not representative of the genus of molecules to be used in the claimed methods. Per MPEP 2163, "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. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.")
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed” (pg 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed” (pg 1116).
Therefore, only a method for promoting heat generation in an organism, comprising administering a recombinant IL-27 protein, but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112(a). Applicants are reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (pg 1115).
Note on Prior Art Rejection(s)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 6-8, 25 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lei et al, 2019. Journal of Molecular Endocrinology. 63: 215-226; 12 pages as printed. The earliest date to which the instant application claims priority is 5/11/26.
In claim 6, the recitation of “for controlling heat generation within an organism” has been considered in the context of the entire claim, and is interpreted as an intended use for the method because it does not result in a manipulative difference between the method as defined by the steps and a prior art method teaching the same steps. See MPEP 2111.02. As such, this intended use does not distinguish the claimed method from a prior art method comprising the same step(s). Thus, claim 6 encompasses a method comprising a step of applying a molecule for adjusting binding of EBI-1 and p28 to an organism. Said molecule encompasses IL-27 protein as recited in dependent claim 26 in the alternative. As such, claim 6 encompasses a method comprising a step of applying IL-27 to an organism.
Lei teaches administration of IL-27 protein administration to “high-fat diet-induced obese and diabetic mice” (page 4 as printed). As such, the teachings of Lei anticipate claim 1.
Claim 7 encompasses a method of claim 6 wherein the organism is a mammal. In the teachings of Lei set forth above, the organism is a mouse, which is a mammal. As such, the teachings of Lei also anticipate claim 7.
Claim 8 encompasses a method of claim 6 wherein the organism is an in vitro cell. Lei also teaches treatment of STC-1 cells with IL-27 (page 5), and teaches that the STC-1 cells are an intestinal secretin tumor cell line (page 3), and thus are mammalian cells. As such, the teachings of Lei also anticipate claim 8.
Claim 25 encompasses a method of claim 6 wherein “the adjusting” refers to “promotion or enhancement of the binding of EBI-3 and p28”, and “the controlling refers to promotion of the heat generation”, “thereby improving a body temperature of the organism”. The recitation directed to “the adjusting” further limits the molecule of claim 6, but still encompasses the “IL-27 protein” as recited in dependent claim 26. The recitation directed to “the controlling” is directed to solely to the preamble of claim 6, and is interpreted as an intended use for the same reasons (see above). The concluding “thereby” clause has been fully considered in context of the entire claim, but does not render the claimed method patentably distinct from a method taught by the prior art because it simply expresses the intended result of a process step positively recited. See MPEP 2111.04, which states that a "whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited" (Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Specifically, in claims 25, the claim simply express the intended result (improving body temperature) of a process step positively recited (administering the molecule). As such, claim 25 also encompasses a method of a method comprising a step of applying a molecule for adjusting binding of EBI-1 and p28 to an organism, wherein the molecule is IL-27 protein. Therefore, claim 25 is anticipated by the teachings of Lei for the same reasons as for claim 6 set forth above.
Claim 26 encompasses a method of claim 25 wherein the molecule comprises IL-27 protein. As such, claim 26 also encompasses a method of a method comprising a step of applying a molecule for adjusting binding of EBI-1 and p28 to an organism, wherein the molecule is IL-27 protein. Therefore, claim 26 is anticipated by the teachings of Lei for the same reasons as for claims 6 and 25 set forth above.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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