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 .
Application Status
This action is written in response to applicant’s correspondence received 19 December 2025. Claims 1-6, 8, 10, and 12 are pending. Claims 1, 3, 10 and 12 are amended. Accordingly, claims 1-6, 8, 10, and 12 are currently under examination.
Applicant’s amendments, filed 19 December 2025 have been fully considered but are not deemed persuasive for the reasons outlined below.
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 American 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 as African American. 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 American 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, of African American ethnicity that are able to determine if a subject is African American. 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 American 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 American ethnicity, as defined by the specification, and having the function of determining a subject’s African American 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 biochemical markers of African American ethnicity were neither predictable nor well-known and that further experimentation and analysis is required.
Phillips (Forensic Science International: Genetics 1.3-4 (2007): 273-280) is drawn to a study concerned with ancestry-informative markers (Abstract). Phillips teaches the use of an SNP assay that, with negligible error, was able to identify different ethnicities (Abstract). Phillips teaches that African-American samples analyzed did not show markedly different allele frequency distributions when compared to African populations and were therefore classified as an African population (pg. 279). Phillips teaches that the SNP assay was able to successfully distinguish individuals in the African population from Europeans or East Asians (pg. 279).
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 American ethnicity possessed the function of identifying a subject as African American. Rather, the closet prior art shows that African American samples analyzed did not show markedly different allele frequency distributions when compared to African populations and were therefore classified as an African population. 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 American ethnicity and the function of identifying a subject as African American.
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 of ethnicity: ancestry informative markers (i.e., AIMs), autosomal SNPs, Y-SNPs, mitochondrial SNPs, and X-SNPs (see Example 1). However, the 5 species of markers of ethnicity as described in the specification are broadly drawn towards general markers of ethnicity and do not specifically describe or teach the use of markers of that can identify a subject as African American. 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 ethnicity is not a representative number of species that fall within the claimed genus of markers of African American ethnicity.
Thus, the instant specification does not provide written description for the entirety of the claimed genus of “marker[s] African American of 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 American 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 markers of African American ethnicity did not did not show markedly different allele frequency distributions when compared to African populations and were therefore classified as an African population. 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).
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 1-6, 8, 10, and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that they fail to point out what is included or excluded by the claim language. This rejection is maintained.
Regarding claims 1 and 3, the claims recite limitations requiring that a particular subject is “African American” and the use of “markers of African American ethnicity […] , wherein the marker is an ancestry informative marker or a SNP.”
However, it is not clear what it means to be “African American.” For example, it is not clear whether it enough for an American subject, a subject's parents, or any ancestor to have lived at one point in time in Africa to be considered "African American". Alternatively, it is not clear whether it necessary that the subject must have been born in Africa or is it sufficient that a subject is born elsewhere so long as the parents of the subject were born in Africa. Further, it is not clear whether it is referring to a subject that was born and raised in America, but from parents whose ancestral history is strictly African, for example, is the subject “African American”. Furthermore, if such ancestral information about a subject or a subject’s origin is unavailable, the specification does not set forth criteria for determining whether a subject is “African American” or not. Alternatively, it is unclear whether or not "African American” requires that the subject has certain skin complexion. If so, the specification does not set forth criteria for evaluating whether a given subject’s skin color is “African American” or not. The specification does not define nor is there a generally accepted criteria in the art for determining if a subject is “African American.” Therefore, the claims are indefinite.
Regarding claims 2 and 4-6, 8, 10, and 12, the claims are ultimately dependent on claims 1 and 3 and do not rectify the 35 U.S.C. 112(b) issue described above. Accordingly, the claims are also rejected under 35 U.S.C. 112(b).
Response to Arguments
Applicant’s amendments and arguments, filed 19 December 2025, have been fully considered but are deemed unpersuasive for the reasons outlined below.
Applicant alleges that the rejection under 35 USC 112(a) is improper because the newly amended claims recite a genus of markers of African and African Americans, which Phillip teaches were particularly distinguishable from markers of other ethnicities. Applicant alleges that the inventor were aware that African Americans are identifiable by the proportion of their ancestry that comes from the continent of Africa (i.e., citing to paragraph [0150]-[0151] of US Patent App. Pub. No 2021/0215701 A1) and, accordingly, the amended claims comply with the written description requirement.
This argument is not found persuasive because Phillips provides evidence that markers were not able to be utilized to identify a subject as African American. Further, the cited portion of the instant specification teaches the following:
“Markers of ethnicity are known in the art and are described, for example, 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. The use of AIMs compares an individual's polymorphisms at these markers with previously analyzed genomic reference sets from people whose ancestral history is fairly well known. AIMs are used to estimate the geographical origins of an individual's ancestors, typically expressed as proportions of one's ancestry that comes from different continental regions” (paragraph [0150] of US Patent App. Pub. No 2021/0215701 A1).
“Availability of genetic markers that are ancestry informative and newly developed statistical methods may overcome concerns regarding race/ethnicity categorization. There is evidence that measures of genetic ancestry can improve clinical care for people of mixed race. For example, physicians assessing ovarian cancer can make more accurate diagnoses when they use a reference standard from the patients' actual genetic ancestry than self-reported race or ethnicity. Genetic markers used to infer ancestry include autosomal SNPs, Y-SNPs, mitochondrial SNPs, and X-SNPs” (paragraph [0151] of US Patent App. Pub. No 2021/0215701 A1).
However, the 5 species of markers of ancestry as described in the specification are broadly drawn towards general markers of ancestry and do not specifically describe or teach the use of markers of that can identify a subject as African American. 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 American ethnicity, as described above in the currently pending 35 USC 112(a) rejection of the claims. Applicant has not pointed to a disclosure in the specification that provides adequate support under 35 USC 112(a) that sets forth markers that can determine whether a subject is “African American” or not.
Applicant alleges that the rejection under 35 USC 112(b) is improper because Phillips “is just one of many studies in the field that have successfully distinguished Africans or African Americans from other groups using markers.” Applicant alleges that the term African American is not indefinite in view of Phillips.
These arguments are not persuasive because, as an initial matter, it is noted that Phillips provides evidence that markers were not able to be utilized to identify a subject as African American. Further, Applicant has not provided any specific argument pertaining to the previously pending 35 USC rejection under 112(b) other than pointing to a prior art reference that teaches that markers were not able to be utilized to identify a subject as African American. Applicant has not pointed to a disclosure in the specification that sets forth criteria for determining whether a subject is “African American” or not. Accordingly, these arguments are not persuasive and it is unclear what it means to be “African American”.
Conclusion
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.
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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/KYLE T REGA/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636