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 16 April 2026. Claims 1, 5, 9, 11, 17, 22, 26, 29, 37, 39-40, 42-43, 45, 185-191, and 194-195 are currently pending. Claims 40 and 42-43 are withdrawn from prosecution as being drawn to non-elected subject matter. Accordingly, claims 1, 5, 9, 11, 17, 22, 26, 29, 37, 39, 45, 185-191, and 194-195 are examined herein. The restriction requirement mailed 30 January 2023 is still deemed proper. Applicant's elected the species of the specific sets of genes recited in claims 19 and 41 alongside claims 24 and 39 without traverse in the reply filed 1 May 2024.
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, 5, 9, 11, 17, 22, 26, 29, 37, 39, 45, 185-191, and 194-195 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 claim 1, the claim is broadly drawn towards a method of determining the presence of diabetic nephropathy with at least 80% accuracy via the analysis of 6 genes if the subject is male and 5 genes if the subject is female. Accordingly, the claims are interpreted as claiming a method of diagnosis that is at least 80% accurate and only requires the analysis of 6 genes if the subject is male and 5 genes if the subject is female. The instant specification does not provide support for the broadly claimed gene sets being able to determine the presence of diabetic nephropathy with at least 80% accuracy and the prior art provides evidence that the determination of the presence of diabetic nephropathy via the analysis of genes is unpredictable.
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 claim is directed towards a method of determining the presence of diabetic nephropathy that is at least 80% accurate and only requires the analysis of 6 genes if the subject is male and 5 genes if the subject is female. While claiming a genus of structures (i.e., specific genes) by a function (i.e., a method of diagnosing the presence of a diabetic nephropathy with at least 80% accuracy) is not prohibited, there must be a 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 to support a well-known structure-function relationship.
In the instant case, the instant specification does not provide support that the broadly claimed genes alone are able to perform the claimed function. Further, the prior art demonstrates that the ability for diabetic nephropathy to be diagnosed through the analysis of sets of genes is unpredictable.
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 entirety of the claimed genus.
MPEP 2163 teaches that “for some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed [emphasis added].”
In the instant case, the specification teaches the use of 10 different sets of genes that can be analyzed in female subjects and 9 different sets of gens that can be analyzed in male subjects in order to determine the presence of a kidney disease with at least 80% accuracy ([0196]-[0199]; see Tables 3-6). However, the required genes present in the sets of genes that could perform the claimed function in the specification in both males and females are much larger and more specific than the instantly claimed set of genes. For females, the disclosed sets of genes that could perform the claimed function included 38, 53, 55, 59, 65, 76, 81, 89, 110, and 132, individual genes ([0196]-[0197]; see Tables 3-4). For males, the discloses set of genes that could perform the claimed function included 50, 60, 70, 74, 88, 94, 106, and 134 individual genes ([0198]-[0199]; see Tables 5-6). Thus, when taken as a whole, the set of genes present in the specification is not representative of the claimed genus as a while because the claimed genus broadly encompasses a method that can performed the claimed function only through the analysis of only 6 genes if the subject is male and only 5 genes if the subject is female. Further, MPEP 2163 teaches that “[…] an adequate description of a genus may not support claims to a subgenus or species within the genus […]”. Therefore, the instantly claimed and broader subgenus of genes present in claim 1 is not adequately described in the specification as being able to determine the presence of diabetic nephropathy with at least 80% accuracy, as claimed.
Thus, the instant specification does not provide written description for the entirety of the claimed method comprising the analysis of 6 genes if the subject is male and 5 genes if the subject is female (see Claim 1).
Prior Art
Regarding the state of the prior art, the prior art demonstrates that the structure of the genes that can be utilized to determine the presence of diabetic nephropathy can vary widely and the successful use of the genes to determine the presence of diabetic nephropathy in a subject is unpredictable and requires experimentation.
Tang (Renal Failure 37.3 (2015): 363-371) is drawn towards a review study concerned with gene and protein markers of diabetic nephropathy (i.e., “DN”) (Abstract). Tang teaches that while there are some studies pointing to specific sets of candidate genes that could be utilized in genetic linkage studies, “there has been no consistent and reproducible identification of genetic loci or candidate genes for DN risk or protection” (pg. 364).
Thus, the prior art shows that prior to the effective filing date of the claimed invention it was not predictable that a broad set of genes could be utilized to determine the presence of diabetic nephropathy with an accuracy of at least 80%. Rather, the prior art shows that a candidate set of genes that could be utilized to determine the presence of diabetic nephropathy is very specific and not predictable. Further, the prior art explicitly states that there has been no consistent and reproducible identification of genetic loci or candidate genes for the determination of diabetic nephropathy DN risk in a subject.
Conclusion
The specification does not identify a representative number of species of the broadly claimed set of genes that possess the claimed function of determining the presence of diabetic nephropathy in a subject with an accuracy of at least 80%. Further, the prior art shows that prior to the effective filing date of the claimed invention that determining genes associated with the presence of diabetic nephropathy was unpredictable and highly specific. Therefore, a person of ordinary skill in the art would not have concluded that Applicant was in possession of the invention as claimed. Thus, claim 1 is rejected under 35 U.S.C. 112(a).
Regarding claims 5, 9, 11, 17, 22, 26, 29, 37, 39, 45, and 185-192, as the claims are ultimately dependent on claim 1 and do not rectify the 35 USC 112(a) rejection above, the claims are also rejected under 35 USC 112(a).
Regarding claim 194, the claim is drawn towards a method of determining the presence of a kidney disease with at least 80% accuracy via the analysis of 10 genes if the subject is male and 8 genes if the subject is female (see Claim 194). The pertinent analysis of the claim is discussed above as applied to claim 1 because the claim broadly claims a set of genes that is not supported in the specification to be able to determine the presence of a kidney disease with at least 80% accuracy. Further, as discussed above as applied to claim 1, the prior art teaches that determining the presence of a kidney disease via the analysis of a set of genes is unpredictable. Therefore, as applied above to claim 1, the claim is rejected under 35 USC 112(a).
Regarding claims 195, as the claim is ultimately dependent on claim 194 and does not rectify the 35 USC 112(a) rejection above, the claim is also rejected under 35 USC 112(a).
Claims 1, 5, 9, 11, 17, 22, 26, 29, 37, 39, 45, 185-191, and 194-195 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 194, the claims recites a method that can determine the presence of diabetic nephropathy with at least 80% accuracy via the analysis of 6 genes if the subject is male and 5 genes if the subject is female (see Claim 1) or the analysis of 10 genes if the subject is male and 8 genes if the subject is female (see Claim 194). However, as discussed above in the written description rejection of claims 1, 5, 9, 11, 17, 22, 26, 29, 37, 39, 45, and 185-195, the specification as originally filed does not provide support for the claimed set of genes performing the claimed functions. The claimed set of genes is much broader than, and is not limited to, the specific sets of genes that were capable of performing the claimed function described in the specification.
Further, the currently pending Remarks which introduced the new matter, filed 18 September 2025, do not identify a specific paragraph from which the newly amended set of genes has support in the specification as being able to perform the claimed function.
Thus, the claims are rejected under 35 USC 112(a) for introducing new matter because the claim language was not original and the scope of the claim goes beyond what the specification describes.
Regarding claims 5, 9, 11, 17, 22, 26, 29, 37, 39, 45, 185-192, and 195, as the claims are ultimately dependent on claims 1 and 194 and do not rectify the new matter rejection above, the claims are also rejected under 35 USC 112(a).
Response to Arguments
Applicant's arguments filed 27 March 2026 have been fully considered but they are not persuasive.
Applicant alleges that Tang is inapposite for the purposes of supporting the Office’s claim rejections because it addresses genetic loci for DN risk prediction or protection, and not diagnosis of existing DN via differential mRNA expression (Remarks; pg. 11). Applicant alleges that these concepts are different and are recognized as being so in the field; therefore, to the extent the Office has relied on this understanding of Tang to formulate the instant rejection, it must fail (Remarks; pg. 11).
This argument is not found persuasive because Tang is replied upon for the assertion that the knowledge in the art surrounding the analysis of genes and the association the expression of those genes have with DN is not well-known. Utilizing Tang as a reference pointing to the state of the art with respect to the claimed method does not inherently result in the failure of the maintained 35 USC 112(a) rejection of record because Tang is merely relied upon as evidence surrounding the uncertainty of correlating any sort of gene expression products with the association of DN within a subject.
Applicant alleges that the instant specification provides direct support for the claimed 80% accuracy range when analyzing gene sets that include the specific gens recited in claims 1 and 194 (Remarks; pg. 11). Applicant directs the examiner’s attention to Tables 3-6 for evidence of the claimed genes performing the claimed function (Remarks; pg. 11).
This argument is not found persuasive because, as discussed above in the maintained 112(a) rejection of record, for females, the disclosed sets of genes that could perform the claimed function included 38, 53, 55, 59, 65, 76, 81, 89, 110, and 132, individual genes ([0196]-[0197]; see Tables 3-4). For males, the discloses set of genes that could perform the claimed function included 50, 60, 70, 74, 88, 94, 106, and 134 individual genes ([0198]-[0199]; see Tables 5-6).
The claimed genus of genes that could perform the claimed function is much broader than the gene sets shown in the instant specification to be able to perform the claimed function. Under the broadest reasonable interpretation of the claims, the claimed genus broadly encompasses a method that can performed the claimed function only through the analysis of only 6 genes if the subject is male and only 5 genes if the subject is female. The only working examples in the instant specification are much narrower than the claims and require the analysis of dozens of genes not recited in the claims. The fact that a large set of genes achieved a high diagnostic accuracy doesn't mean that the same result could be achieved with fewer genes. Rather, the use of the smaller amount of claimed genes requires testing and is unpredictable
Thus, when taken as a whole, the set of genes present in the specification is not representative of the claimed genus as a while because the claimed genus broadly encompasses a method that can performed the claimed function only through the analysis of only 6 genes if the subject is male and only 5 genes if the subject is female (see Claim 1) or the analysis of 10 genes if the subject is male and 8 genes if the subject is female (see Claim 194). Further, MPEP 2163 teaches that “[…] an adequate description of a genus may not support claims to a subgenus or species within the genus […]”. Therefore, the instantly claimed and broader subgenus of genes present in claims 1 and 194 are not adequately described in the specification as being able to determine the presence of diabetic nephropathy with at least 80% accuracy, as claimed.
Additionally, it is noted that Applicant has not provided any arguments nor amendments addressing the currently outstanding 112(a) new matter rejections of claims 1, 5, 9, 11, 17, 22, 26, 29, 37, 39, 45, 185-192, and 194-195.
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).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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