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 .
DETAILED ACTION
2. Claims 197-216 are pending in the application and are currently subject to the following restriction and election requirement.
This application contains claims directed to the following patentably distinct species of SEQ ID NOs. Applicant is required to select one species of SEQ ID NOs from SEQ ID NOs: 1-57 and 67-73.
3. The species are independent or distinct because each species is a materially and manipulatively distinct process comprising the use of structurally and/or functionally different products. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
Because each member of SEQ ID NO is structurally and/or functionally different from the others, the use of each different species of the invention is a materially and manipulatively different process. In addition, these species are not obvious variants of each other based on the current record. Accordingly, the examination of claims directed to any one species of invention would require a unique search that is not required for examination of any of the other species of invention, because the search of any one member of SEQ ID NO will not provide adequate information regarding any other. Moreover, the search necessary to examine claims directed to any one species of invention is not the same, nor is it coextensive with the search necessary to examine claims directed to any other. Since having to perform more than one search would constitute a serious burden, it is proper to restrict these species of invention and require Applicant to elect only one. See MPEP § 809.
4. Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or a grouping of patentably indistinct species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them 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 species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
5. During a telephone conversation with Mr. Blake Torrance on 08/26/2026, a provisional election was made without traverse to prosecute the invention of species SEQ ID NO: 49. Affirmation of this election must be made by applicant in replying to this Office action.
6. Claims 197-216 are pending in the application. Claims 204-211 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/26/2026.
7. Claims 197-203 and 212-216 are currently under prosecution.
Priority
8. Applicant’s claim under 35 U.S.C. §§ 119(e) and/or 120 for benefit of the earlier filing date of applications, is acknowledged.
Improper Markush Grouping Rejection
9. Claims 197-198 and 201-202 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 706.03(y).
The Markush grouping of the nanobody or the small peptide (SEQ ID NOs: 1-57 and 67-73) recited in claims 197-198 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: because the nanobody or the small peptide (SEQ ID NOs: 1-57 and 67-73) do not share a “single structural similarity”.
The Markush grouping of the animal allergens: Fel d1, Fel d2, Fel d3, Fel d4, Can f1, Can f2, Can f4, Can f7, Ory C1, Mus M1, and Bla G2 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: because the alternatives are not all members of the same recognized physical or chemical class or the same art-recognized class, nor do the alternative animal allergens share both a substantial structural feature and a common use that flows from the substantial structural feature.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
10. 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.
11. 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.
12. Claims 199, 213 and 215-216 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.
Claims 199, 213 and 215-216 are indefinite because the claims recite “about”.
M.P.E.P. § 2173.05(b) III. A. states:
In determining the range encompassed by the term "about", one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007). InW.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), the court held that a limitation defining the stretch rate of a plastic as "exceeding about 10% per second" is definite because infringement could clearly be assessed through the use of a stopwatch. However, in another case, the court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term "about." Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).
In this case, there is nothing in the specification to provide any indication as to what range of specific activity is covered by the term "about."
13. The following is a quotation 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.
14. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
15. Claims 197-203 and 212-216 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.
This is a “written description” rejection.
The considerations that are made in determining whether a claimed invention is supported by an adequate written description are outlined by the published Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, para. 1, ``Written Description'' Requirement (Federal Register; Vol. 66, No. 4, January 5, 2001; The 2015 Written Description Workshop materials; hereinafter “Guidelines”).
These guidelines state that rejection of a claim for lack of written description, where the claim recites the language of an original claim should be rare. Nevertheless, these guidelines further state, “the issue of a lack of written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant has possession of the claimed invention” (Id. at 1105). The “Guidelines” continue:
The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art. This problem may arise where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process.
With further regard to the proposition that, as original claims, the claims themselves provide in haec verba support sufficient to satisfy the written description requirement, the Federal Circuit has explained that in ipsis verbis support for the claims in the specification does not per se establish compliance with the written description requirement:
Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). See also: University of Rochester v. G.D. Searle & Co., 69 USPQ2d 1886 1892 (CA FC 2004).
Thus, an original claim may provide written description for itself, but it must still be an adequate written description, which establishes that the inventor was in possession of the invention.
In this instance, claims 197-198 and 203 are drawn to a nanobody or a small peptide has at least 80%, 85%, 90%, 95%, 97%, or 99% sequence identity to a sequence selected from the group consisting of SEQ ID NOs: 1-57 and 67-73.
Thus, the claims are drawn to a genus of nanobody, or small peptide has at least 80%, 85%, 90%, 95%, 97%, or 99% sequence identity to a sequence selected from the group consisting of SEQ ID NOs: 1-57 and 67-73.
Although the specification teaches the SEQ ID NOs: 1-57 and 67-73 (see Tables 3, 6, 10, 13, 18, 20 and 22); however, the specification does not teach the claimed nanobody, or small peptide has at least 80%, 85%, 90%, 95%, 97%, or 99% sequence identity to a sequence selected from the group consisting of SEQ ID NOs: 1-57 and 67-73 would have or retain the activity or function of the SEQ ID NOs: 1-57 and 67-73.
Given the fact that the claims are drawn to a genus of nanobody, or small peptide has at least 80%, 85%, 90%, 95%, 97%, or 99% sequence identity to a sequence selected from the group consisting of SEQ ID NOs: 1-57 and 67-73, which have no particular function or activity, there is no correlation between any one particularly identifying structural feature and any one particularly identifying functional feature. Consequently, it is submitted that the skilled artisan could not immediately envision, recognize or distinguish at least a substantial number of a nanobody, or a small peptide has at least 80%, 85%, 90%, 95%, 97%, or 99% sequence identity to a sequence selected from the group consisting of SEQ ID NOs: 1-57 and 67-73, to which the claims are directed.
Although the specification teaches the SEQ ID NOs: 1-57 and 67-73, the SEQ ID NOs are not reasonably representative of the plurality of a nanobody, or a small peptide has at least 80%, 85%, 90%, 95%, 97%, or 99% sequence identity to a sequence selected from the group consisting of SEQ ID NOs: 1-57 and 67-73. This is largely because each nanobody, or small peptide has at least 80%, 85%, 90%, 95%, 97%, or 99% sequence identity to a sequence selected from the group consisting of SEQ ID NOs: 1-57 and 67-73 has substantially varying structure and need not have any particular function or activity.
Guidelines states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was ‘ready for patenting’ such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” (Id. at 1104). “Guidelines” further states, “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus” (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. Moreover, because the claims encompass a genus of nanobody, or small peptide has at least 80%, 85%, 90%, 95%, 97%, or 99% sequence identity to a sequence selected from the group consisting of SEQ ID NOs: 1-57 and 67-73, which vary both structurally and functionally, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. In this instance, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; Applicant has not shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; and Applicant has not described distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention at the time the application was filed.
Thus, it is submitted that the instant claims, and the disclosure describing the claimed subject matter, fails to satisfy the written description requirement set forth under 35 U.S.C. § 112, first paragraph.
Conclusion
16. No claims are allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YAN XIAO whose telephone number is (571)270-3578. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YAN XIAO/Primary Examiner, Art Unit 1642
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