DETAILED ACTION
The office action on date 01/22/2026 has been withdrawn.
Election/Restrictions
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions, which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Claims 1, 4, 6, 9-10, 12-13, drawn to a method for treating age-related macular degeneration in individual in need thereof comprising:
Determining by an assay a level of (RBP4) in a sample from the individual and b) administering RBP4 inhibitor to the individual, whereby the level of RBP4 is at least 25 µg/ml. If this group is elected, a further election of a single disclosed species is also required.
Claims 48-52, 54, 56, drawn to a method for treating age-related macular degeneration in individual in need thereof comprising:
Determining by an assay the presence of one or more genemic variants. b) calculating a risk score for age-related macular degeneration using the presence of the one or more genemic variants. c) administering RBP4 inhibitor to treat age-related macular degeneration in the individual. If this group is elected, a further election of a single disclosed species is also required.
Claims 58-59, 61, 64-66, drawn to a method for treating age-related macular degeneration in individual in need thereof comprising:
Extracting a protein fraction from a blood sample obtained from the individual. b) extracting a nucleic acid fraction from the blood sample. c) determining by a first assay a level of RBP4 from the protein fraction. d) determining by a second assay an allele frequency of one or more genomic variants. e) assessing the likelihood of age-related macular degeneration based on the level of RBP4 . If this group is elected, a further election of a single disclosed species is also required.
The inventions listed as Groups I-III do not relate to a single general inventive concept under 35 USC 121 or PCT Rule 13.1 because:
PCT Rule 13.1 states that the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”).
PCT Rule 13.2 states that the unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features.
Annex B, Part 1(a), indicates that the application should relate to only one invention, of if there is more than one invention, inclusion is permitted if they are so linked to form a single general inventive concept.
Annex B Part 1(b), indicates that “special technical features” means those features that as a whole define a contribution over the prior art.
Annex B Part 1(c), further defines independent and dependent claims. Unity of invention only is concerned in relation to independent claims. Dependent claims are defined as a claim that contains all the features of another claim and is in the same category as the other claim. The category of a claim refers to the classification of claims according to subject matter e.g. product, process, use, apparatus, means, etc.
Annex B Part 1(e), indicates that the permissible combinations of different categories of claims. Part 1(e)I, states that inclusion of an independent claim for a given product, an independent claim for a process specially adapted for the manufacture of the said product, and an independent claim for a use of the said product is permissible.
Annex B, Part 1(f), indicates the “Markush practice” of alternatives in a single claim. Part 1(f)I, indicates the technical relationship and the same or corresponding special technical feature is considered to be met when (A) all alternatives have a common property or activity, and (B) a common structure is present or al alternatives belong to a recognized class of chemical compounds. Further defining (B), Annex B, Part 1(f)(I-iii), the common structure must; a) occupy a large portion of their structure, or b) the common structure constitutes a structurally distinctive portion, or c) where the structures are equivalent and therefore a recognized class of chemical compounds, each member could be substituted for one another with the same intended result. That is, with a common or equivalent structure, there is an expectation relationship and the corresponding special technical feature result from a common (or equivalent) structure that is responsible for the common activity (or property). Part 1(f) iv, indicates that when all alternatives of a Markush grouping can be differently classified, it shall no, take alone, be considered justification for finding a lack of unity. Part 1(f)v, indicates that “When dealing with alternatives, if it can be shown that at least one Markush alternative is not novel over the prior art, the question of unity of invention shall be reconsidered by the examiner”
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve 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 restriction 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 invention.
If claims are added after the election, applicant must indicate which of these 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(a) of the other invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
There is an examination and search burden for these patentably distinct species due to their mutually exclusive characteristics. The species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Niloofar Rahmani whose telephone number is 571-272-4329. The Examiner can normally be reached Monday through Friday from 8:30 to 6:00 EST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Renee Claytor can be reached at 571-272-8394. The fax number for the organization where this application 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) toll-free at 866-217-9197. If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Niloofar Rahmani/
01/26/2026
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