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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5 May 2026 has been entered.
Application Status
This action is written in response to applicant’s correspondence received 5 May 2026.
Claims 1-6, 8, 10, and 12 are currently pending. Accordingly, claims 1-6, 8, 10, and 12 are examined herein.
Any rejection or objection not reiterated herein has been overcome by amendment.
Applicant' s amendments have been thoroughly reviewed, but are not persuasive to place the
claims in condition for allowance for the reasons that follow.
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 1-6, 8, 10, and 12 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 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. This rejection is maintained.
Regarding claims 1 and 3, the claims are directed towards a panel and method that require, at least, a marker of African ethnicity wherein the marker is an ancestry informative marker or a SNP. Accordingly, the claims are interpreted as reciting a genus of markers, wherein the markers are an ancestry informative marker or a SNP, that possess the claimed function of identifying a subject ethnicity as African. Thus, claims 1 and 3 are interpreted as being directed towards a method that can utilize a genus of markers, wherein the markers are an ancestry informative marker or a SNP, such that a subject’s African ethnicity may be ascertained via the markers.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would leave one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP 2163. A claimed genus may be satisfied through sufficient descriptions of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with known or disclosed correlation between function and structure. MPEP 2163(3)a(II). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure, and (d) representative number of samples.
As the claims currently recite, as described above, the claims are directed towards a genus of markers, wherein the markers are an ancestry informative marker or a SNP, that are able to determine if a subject’s ethnicity is African. While claiming a structure by a function is not prohibited, there must be sufficient structure-function relationship described in the specification such that the claimed genus was represented by a representative number of species or the teachings of the specification, or, the prior art can be used support a well-known structure-function relationship.
In the instant case, the instant specification does not support the claimed structure-function relationship that utilizing markers would predictably result in the determination of a subject’s African ethnicity. Further, the prior art does not support a clear, well-defined, and predictable structure-function relationship between markers, wherein the markers are an ancestry informative marker or a SNP, of African ethnicity, as defined by the specification, and having the function of determining a subject’s African ethnicity without further required experimentation and analysis.
Prior Art
Prior to the effective filing date of the claimed invention, the prior art provides evidence that determining a subject’s ethnicity is not able to be accomplished through the use of genetic markers because “ethnicity” describes cultural aspects of a subject’s culture including traditions, lifestyle, diet, and values. The prior art teaches that these aspects of a subject’s culture depends on how a subject was raised and is not dependent on genetic markers, whereas markers of ancestry are genetic in nature.
Mersha ("Self-reported race/ethnicity in the age of genomic research: its potential impact on understanding health disparities." Human genomics 9.1 (2015): 1) is drawn towards a review concerned with the limitations of self-reported race, ethnicity, and genetic ancestry in biomedical research (Abstract). Mersha teaches that in the field of biomedical research ethnicity refers to communality in cultural heritage, language, social practice, traditions, and geopolitical factors (Abstract). Mersha teaches that genetic ancestry is inferred using ancestry informative markers (AIMs) is based on genetic/genomic data (Abstract). Mersha teaches that ancestry is estimated using ancestry informative markers (AIMs), which are a set of genetic variations for a particular DNA sequence that appear in different frequencies in populations from different regions of the world (pg. 4). However, Mersha teaches that ethnicity is a complex multidimensional construct that reflects biological factors, geographical origins, historical influences, as well as shared customs, beliefs, and traditions among populations that may or may not have a common genetic origin (pg. 2).
Thus, the closest prior art teaches that it was neither predictable nor well-known that markers, wherein the markers are an ancestry informative marker or a SNP, of African ethnicity possessed the function of identifying a subject as African. Rather, the closet prior art shows that ethnicity refers to a subject’s cultural upbringing, which is different from a subject’s ancestry. Further, the prior art demonstrates that there are no known genetic markers of ethnicity, as currently claimed. Therefore, the prior art does not support a clear, well-defined, and predictable structure-function relationship between markers, wherein the markers are an ancestry informative marker or a SNP, of African ethnicity and the function of identifying a subject as African.
Working Examples
With regard to working examples, the specification provides little evidence on the possession of a sufficient number of species which are encompassed by the claimed genus and possess the claimed function. The instant specification identifies 5 species of markers: ancestry informative markers (i.e., AIMs), autosomal SNPs, Y-SNPs, mitochondrial SNPs, and X-SNPs (see Example 1). However, the 5 species of markers in the instant specification do are not utilized to determine a subject’s ethnicity, only ancestry. The markers in the instant specification were not utilized to determine ethnicity that reflects biological factors, geographical origins, historical influences, as well as shared customs, beliefs, and traditions among populations. Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would recognize that the 5 species of general markers of ancestry is not a representative number of species that fall within the claimed genus of markers of African ethnicity.
Thus, the instant specification does not provide written description for the entirety of the claimed genus of “marker[s] African ethnicity […] wherein the markers is an ancestry informative marker or a SNP,” as recited in claims 1 and 3.
Conclusion
The specification does not identify a structure-function relationship between a marker, wherein the marker is an ancestry informative marker or a SNP, of ethnicity and the function of identifying a subject’s African ethnicity sufficient to show the applicant was in possession of the claimed genus. Further, the closet prior art shows that prior to the effective filing date of the claimed invention that ethnicity is a complex multidimensional construct that reflects biological factors, geographical origins, historical influences, as well as shared customs, beliefs, and traditions among populations that cannot be defined by genetic markers. Taken together, the skilled artisan would not have reasonably concluded at the time of the invention that applicant was in possession of the invention as claimed. Thus, claims 1 and 3 are rejected under 35 U.S.C. 112(a).
Regarding claims 2 and 4-6, 8, 10, and 12, as they are ultimately dependent on claims 1 and 3, and do not rectify the written description rejection described above, the claims are also rejected under U.S.C. 112(a).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6, 8, 10, and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE T REGA whose telephone number is (571)272-2073. The examiner can normally be reached M-R 8:30-4:30, every other F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE T REGA/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636
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