DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's election with traverse of Group I in the replies filed on October 31, 2025 and January 20, 2026 is acknowledged.
Applicant's election with traverse of MYO7A in the reply filed on October 31, 2025 and MYO7A, CDH23, and CLRN1 in the reply filed on January 20, 2026 is acknowledged.
Regarding the requirement to elect and invention, the traversal is on the ground(s) that the Examiner's search burden is not increased by searching and examining all the claims together, particularly, given the overlap in claim scope between the detecting mutations in hereditary hearing loss related genes and the kit for detecting mutations in hereditary hearing loss related genes. In particular, Applicant contests that a serious search burden is imposed on the patent examiner in searching each classification of invention. Regarding the requirement to elect a species, the traversal is on the ground(s) that the various species do not require a different field of search (including without limitation distinct classes/subclasses) that would require the Examiner to conduct more than one electronic search or employ different search strategies.
This argument has been fully considered but is not persuasive. It is maintained that there is a serious search burden because a different field of search is required. For instance, a finding that, for example, the method of invention I is anticipated or obvious over the prior art would not necessarily extend to a finding that the product invention II is also anticipated or obvious over the prior art. Similarly, a finding that the method of invention I is novel and unobvious over the prior art would not necessarily extend to a finding that the product of invention II is also novel and unobvious over the prior art. Further there is a serious examination burden because the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112 (a). Likewise a finding that, for example, one species is anticipated or obvious over the prior art would not necessarily extend to a finding that the other species are also anticipated or obvious over the prior art. Similarly, a finding that one species is novel and unobvious over the prior art would not necessarily extend to a finding that the other species are also novel and unobvious over the prior art. The requirements to elect and invention and species are still deemed proper and are therefore made FINAL.
3. Claims 1-22 are currently pending.
Claims 2, 10, 12, and 20-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter (a non-elected invention or non-elected species), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on replies filed on October 31, 2025 and January 20, 2026.
The claims have been examined to the extent that the claims read on the elected combination of genes (CDH23, CLRN1, and MYO7A). The additionally recited genes have been withdrawn from consideration as being directed to non-elected subject matter. Prior to allowance of the claim, any non-elected subject matter that is not rejoined with any allowed elected subject matter will be required to be removed from the claims.
Claim Rejections - 35 USC § 101
4. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more. The claims recite a judicial exception that is not integrated into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim analysis is set forth below.
Step 1: The claims are directed to the statutory category of a process.
Step 2A, prong one: Evaluate Whether the Claim Recites a Judicial Exception
The instant claims recite a law of nature. The claims states that “detecting at least one mutation in at least one of the plurality of bait captured gene sequences indicates an increased susceptibility to hereditary hearing loss in the patient”. Here the claims recite a correlation between a mutation and risk of hereditary hearing loss. This type of correlation is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo.
Step 2A, prong two: Evaluate Whether the Judicial Exception Is Integrated Into a Practical Application
The claims do NOT recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological
environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
In addition to the judicial exception the claims recite steps of a) extracting genomic DNA from a biological sample obtained from a patient, b) generating a library comprising a plurality of bait-captured gene sequences corresponding to CDH23, CLRN1, and MYO7A, and c) detecting at least one mutation in at least one of the plurality of bait-captured gene sequences.
These steps are NOT considered to integrate the judicial exception into a practical application because they merely add insignificant extra-solution activity (data gathering) to the judicial exception.
Step 2B: Evaluate Whether the Claim Provides an Inventive Concept
In addition to the judicial exception the claims recite steps of a) extracting genomic DNA from a biological sample obtained from a patient, b) generating a library comprising a plurality of bait-captured gene sequences corresponding to CDH23, CLRN1, and MYO7A, and c) detecting at least one mutation in at least one of the plurality of bait-captured gene sequences.
These steps do NOT amount to significantly more because they simply append well understood, routine, and conventional activities previously known in the art, specified at a high level of generality, to the judicial exceptions.
The teachings in the specification demonstrate the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known or commercially available. For example the specification teaches the following:
[0082] In some embodiments, the library is prepared using Agilent's SureSelect XT HS2 kit and sequenced on an Illumina platform (e.g. NextSeq 550Dx). In some embodiments, high throughput massive parallel sequencing is performed using pyrosequencing, reversible dye-terminator sequencing, SOLiD sequencing, Ion semiconductor sequencing, Helioscope single molecule sequencing, sequencing by synthesis, sequencing by ligation, or SMRT™ sequencing.
The prior art also demonstrates the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known or commercially available. For example Krawitz (Molecular Genetics & Genomic Medicine 2014 2(5) 393-401) teaches a method of screening for mutations in genes associated with Usher syndrome using targeted gene enrichment and deep sequencing. Krawitz teaches that 42 unrelated European patients and two affected sisters with Usher syndrome were included in their study. Krawitz teaches that DNA was extracted from blood. Krawitz teaches that they designed a customized SureSelect oligonucleotide library (Agilent, Santa Clara, CA) for the targeted enrichment of known exons of the Usher genes including CDH23,CLRN1, and MYO7A. After enrichment the exons were sequences on a HiSeq 2500 (Illumina) sequencer (page 394, col 1). The mutations that were detected are reported in Table 1. Table 1 discloses a single mutation in CDH23 and three mutations in MYO7A.
Further it is noted that the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity.
Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014)
For the reasons set forth above the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112(b)
5. 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 9, 11, 13-15, and 17 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 is drawn to a method for generating a library for the detection of at least one mutation in a plurality of hereditary hearing loss-related genes in a biological sample, wherein the library comprises a plurality of bait-captured gene sequences corresponding to the plurality of hereditary hearing loss-related genes, wherein the plurality of hereditary hearing loss-related genes comprises CDH23, CLRN1, and MYO7A. Claim 9 is considered indefinite because it attempts to claim a process without setting forth any active process steps.
Claims 11, 13-15, and 17 are drawn to a method for detecting at least one mutation in a plurality of hereditary hearing loss-related genes in a biological sample, wherein the plurality of hereditary hearing loss-related genes comprises CDH23, CLRN1, and MYO7A. The claims are considered indefinite because they attempt to claim a process without setting forth any active process steps.
Claim Rejections - 35 USC § 112(a)
6. 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.
Claim 6 is 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.
Claim 6 recites the following limitation “wherein detecting at least one mutation in at least one of the plurality of bait captured gene sequences indicates an increased susceptibility to hereditary hearing loss in the patient”
The claims do not define the mutations in CDH23, CLRN1, and MYO7A that are associated with increased susceptibility to hereditary hearing loss in terms of sufficient relevant identifying characteristics.
The size of the genus is further expanded by the fact that the claims encompass mutations correlated with ANY type of hereditary hearing loss (i.e., Usher, Pendred, Waardenburg, Branchio-Oto-Renal, Stickler, etc.). The mutations that are associated with one type of hereditary hearing loss (i.e., Usher) are expected to be different than the mutations that are associated with other types of hereditary hearing loss (i.e., Pendred, Waardenburg, Branchio-Oto-Renal, Stickler, etc.).
The specification (para 0105, Figure 3A) discloses a mutation in the CLRN1 gene (c.567T>G p.(Tyr189*) that was found in an affected Usher Syndrome patient.
The specification (para 0107, Figure 3B) discloses a mutation in the CDH23 gene (c.193delC p.(Leu65Trpfs*49) that was found in a Usher Syndrome carrier.
The specification provides written description for these two mutations. However, the specification does not describe any other species within the claimed genus to show possession of those species.
Regarding the genus of skin age biomarkers, the specification does not describe any structural features of the c.567T>G mutation in the CLRN1 gene or the c.193delC mutation in the CDH23 gene that would have been expected to be shared by members of the claimed genus. The specification does not describe any physical and/or chemical characteristics of the disclosed the c.567T>G mutation in the CLRN1 gene or the c.193delC mutation in the CDH23 gene that would be expected to be shared by members of the claimed genus. All members of the genus have the same function, i.e., they are associated hereditary hearing loss, but no correlation between their structure and this common function is disclosed. The level of knowledge and skill in the art does not allow those skilled in the art to structurally envisage or recognize additional members of the claimed genus. Because the structure of the species within the claimed genus is expected to vary unpredictably from the structure of the c.567T>G mutation in the CLRN1 gene or the c.193delC mutation in the CDH23 gene disclosed in the specification, the disclosed mutations are not a “representative number” of species within the claimed genus.
Because the c.567T>G mutation in the CLRN1 gene or the c.193delC mutation in the CDH23 gene are not representative of the entire claimed genus, and the specification does not disclose structural features shared by members of the genus, the description of the c.567T>G mutation in the CLRN1 gene or the c.193delC mutation in the CDH23 gene would not have put the applicant in possession of common structural attributes or features shared by members of the genus that structurally distinguish the members of the genus from non-members of the genus at the time of filing. Thus the description of the c.567T>G mutation in the CLRN1 gene or the c.193delC mutation in the CDH23 gene is not sufficient to describe the claimed genus of mutations indicative of hereditary hearing loss. Accordingly, the specification does not provide a representative number of species or sufficient common structural features to show that the applicant would have been in possession at the claimed genus as a whole at the time of filing.
Claim Rejections - 35 USC § 102
7. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 4, 6, 9, 11, 15, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Krawitz (Molecular Genetics & Genomic Medicine 2014 2(5) 393-401).
Regarding Claim 1 Krawitz teaches a method of screening for mutations in genes associated with Usher syndrome using targeted gene enrichment and deep sequencing. Krawitz teaches that 42 unrelated European patients and two affected sisters with Usher syndrome were included in their study. Krawitz teaches that DNA was extracted from blood. Krawitz teaches that they designed a customized SureSelect oligonucleotide library (Agilent, Santa Clara, CA) for the targeted enrichment of known exons of the Usher genes including CDH23,CLRN1, and MYO7A. After enrichment the exons were sequences on a HiSeq 2500 (Illumina) sequencer (page 394, col 1). The mutations that were detected are reported in Table 1. Table 1 discloses a single mutation in CDH23 and three mutations in MYO7A. Thus Krawitz teaches a method for detecting at least one mutation in a plurality of hereditary hearing loss-related genes in a biological sample, the method comprising: a) extracting genomic DNA from a biological sample obtained from a patient, b) generating a library comprising a plurality of bait-captured gene sequences corresponding to a plurality of hereditary hearing loss-related genes (the SureSelect library), wherein the plurality of hereditary hearing loss-related genes comprises CDH23, CLRN1, and MYO7A, and c) detecting at least one mutation in at least one of the plurality of bait-captured gene sequences.
Regarding Claim 3 Krawitz teaches a method wherein the detecting step is performed using high throughput massive parallel sequencing (HiSeq 2500) (page 394).
Regarding Claim 4 Krawitz teaches a method wherein the biological sample is whole blood (page 394).
Regarding 6 Krawitz the mutations disclosed in Table 1 in the CDH23 and MYO7A genes were all detected in subjects with hearing loss (Usher’s syndrome). Thus it is reasonable to conclude that the presence of these specific mutations are indicative of an increased susceptibility to hereditary hearing loss.
Regarding Claim 9 Krawitz teaches a method of screening for mutations in genes associated with Usher syndrome using targeted gene enrichment and deep sequencing. Krawitz teaches that 42 unrelated European patients and two affected sisters with Usher syndrome were included in their study. Krawitz teaches that DNA was extracted from blood. Krawitz teaches that they designed a customized SureSelect oligonucleotide library (Agilent, Santa Clara, CA) for the targeted enrichment of known exons of the Usher genes including CDH23,CLRN1, and MYO7A. After enrichment the exons were sequences on a HiSeq 2500 (Illumina) sequencer (page 394, col 1). The mutations that were detected are reported in Table 1. Table 1 discloses a single mutation in CDH23 and three mutations in MYO7A. Thus Krawitz teaches a method for generating a library for the detection of at least one mutation in a plurality of hereditary hearing loss-related genes in a biological sample, wherein the library comprises a plurality of bait-captured gene sequences corresponding to the plurality of hereditary hearing loss-related genes, wherein the plurality of hereditary hearing loss-related genes comprises CDH23, CLRN1, and MYO7A.
Regarding Claim 11 Krawitz teaches a method of screening for mutations in genes associated with Usher syndrome using targeted gene enrichment and deep sequencing. Krawitz teaches that 42 unrelated European patients and two affected sisters with Usher syndrome were included in their study. Krawitz teaches that DNA was extracted from blood. Krawitz teaches that they designed a customized SureSelect oligonucleotide library (Agilent, Santa Clara, CA) for the targeted enrichment of known exons of the Usher genes including CDH23,CLRN1, and MYO7A. After enrichment the exons were sequences on a HiSeq 2500 (Illumina) sequencer (page 394, col 1). The mutations that were detected are reported in Table 1. Table 1 discloses a single mutation in CDH23 and three mutations in MYO7A. Thus Krawitz teaches a method for detecting at least one mutation in a plurality of hereditary hearing loss-related genes in a biological sample, wherein the plurality of hereditary hearing loss-related genes comprises CDH23, CLRN1, and MYO7A.
Regarding Claim 15 Krawitz teaches a method wherein the biological sample is whole blood (page 394).
Regarding Claim 16 Krawitz teaches that they designed a customized SureSelect oligonucleotide library (Agilent, Santa Clara, CA) for the targeted enrichment of known exons of the Usher genes including CDH23,CLRN1, and MYO7A (page 394, col 1). Thus Krawitz teaches a method further comprising generating a library comprising a plurality of bait-captured gene sequences corresponding to a plurality of hereditary hearing loss-related genes.
Regarding Claim 17 Krawitz teaches a method wherein the detecting step is performed using high throughput massive parallel sequencing (HiSeq 2500) (page 394).
Claim Rejections - 35 USC § 103
8. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
9. Claims 5, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Krawitz (Molecular Genetics & Genomic Medicine 2014 2(5) 393-401) in view of Kimberling (Genetics in Medicine Nol 12 No 8 August 2010).
The teachings of Krawitz are presented above.
Krawitz does not teach a method wherein the biological sample is from a from an infant patient, the infant patient having or suspected of having a hereditary hearing loss disorder (clm 5, 13). Krawitz does not teach a method wherein the hereditary hearing loss disorder is Usher syndrome, Pendred syndrome, Jervell syndrome, or Lange-Nielsen syndrome (clm 14).
However Kimberling teaches that in the context of most newborn hearing screening programs, the appropriate time for DNA screening is at the time of follow-up verification of the HL, which occurs between 3 and 12 months of age (page 515). Kimberling discloses a proposed paradigm for screening D/HOH children for Usher syndrome (see Fig 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Krawitz by obtaining a biological sample from an infant suspected of having a hereditary hearing loss disorder as suggested by Kimberling. One of skill in the art would have been motivated to screen infants suspected of having Usher syndrome because Kimberling teaches that for Usher syndrome, early diagnosis has many immediate and several long-term advantages to patients and their families including the election of cochlear implantation and the potential for future treatments to delay the progression of RP (page 515).
10. Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Krawitz (Molecular Genetics & Genomic Medicine 2014 2(5) 393-401) in view of Hess (Biotechnology Advances 41 (2020) 107537).
The teachings of Krawitz are presented above.
Krawitz does not teach a method wherein an adaptor sequence is ligated to at least one end of the plurality of bait-captured gene sequences (clm 7). Krawitz does not teach a method wherein an adaptor sequence is ligated to both ends of the plurality of bait-captured gene sequences (clm 8).
However Hess teaches that NGS can be roughly divided into the process elements of sample preprocessing, library preparation, sequencing itself and bioinformatics (Fig. 1). Regardless of the underlying principles of the respective sequencing method, all modern sequencing technologies require dedicated sample preparation to yield the sequencing library loaded onto the instrument (Goodwin et al., 2016; Metzker, 2010). Sequencing libraries consist of DNA fragments of a defined length distribution with oligomer adapters at the 5′ and 3′ end for barcoding, as well as the actual sequencing process. After sequencing, the generated data is analyzed using bioinformatics (page 1).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Krawitz by putting adapters on both ends of the bait captured sequences as suggested by Hess. In the instant case Hess teaches that the use of adapters is standard in NGS. One of skill in the art would have been motivated to add adapters at both ends of the captured sequences to render the sequences compatible with the applied sequencing technique.
11. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Krawitz (Molecular Genetics & Genomic Medicine 2014 2(5) 393-401) in view of Lipson (US 11,118,213 Issued 9/14/2021)
The teachings of Krawitz are presented above.
Krawitz does not teach a method further comprising the use of at least 5,000 nucleic acid probes.
However Lipson teaches a method of using bait sequences to capture targets for nucleic acid sequencing. Lipson teaches that the bait set is greater than 5000 probes (Col 58, lines 28-32).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Krawitz by using at least 5000 nucleic acid bait probes as suggested by Lipson. In the instant case Lipson teaches that any number of bait probes can be used. It would have been obvious to use 5000 probes for the benefit of being able to capture a larger number of target genes for sequencing.
12. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Krawitz (Molecular Genetics & Genomic Medicine 2014 2(5) 393-401) in view of Lipson (US 11,118,213 Issued 9/14/2021) and Rosenthal (US 2022/0275457 Filed 1/18/2022).
The teachings of Krawitz and Lipson are presented above.
The combined references do not teach a method wherein at least one of the 5,000 nucleic acid probes comprises a region of complementarity to at least one of the plurality of hereditary hearing loss-related genes, the region of complementarity comprising a coding region and 10 bases of an untranslated region (UTR) of the at least one of the plurality of hereditary hearing loss-related genes.
However Rosenthal teaches NGS using baits to capture desired targets for sequencing. Rosenthal teaches that the baits were designed to capture all coding exons and exons/intron boundaries of hereditary cancer genes (para 0082).
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Krawitz and Rosenthal by using nucleic acid bait probes that are complementary to a coding region and 10 bases of an untranslated region (UTR) of the at least one of the plurality of hereditary hearing loss-related genes as suggested by Rosenthal. It would have been obvious to use bait probes complementary to the exon/intron boundaries for the benefit of being able to detect mutations at splice sites which can cause exon skipping or intron retention leading to nonfunctional proteins and to ensure higher quality coverage of the coding sequences.
Improper Markush Grouping Rejection
13. Claims 1, 3-9, 11, and 13-19 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 § 2117.
The claims recite the following Markush group:
wherein the plurality of hereditary hearing loss-related genes comprises three or more of ABHD12, ADGRV1, ARSG, CDH23, CEP250, CEP78, CIB2, CLRN1, ESPN, FOX11, GJB2, GJB6, HARS2, KCNE1, KCNJ10, KCNQ1, MYO7A, PCDH15, PDZD7, SLC26A4, USH1C, USH1G, USH2A, and WHRN (claims 1, 9, and 11)
The Markush grouping 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:
MPEP 2117(II) states that “A Markush claim may be rejected under judicially approved “improper Markush grouping” principles when the claim contains an improper grouping of alternatively useable members. A Markush claim contains an “improper Markush grouping” if either: (1) the members of the Markush group do not share a “single structural similarity” or (2) the members do not share a common use. Supplementary Guidelines at 7166 (citing In re Harnisch, 631 F.2d 716, 721-22, 206 USPQ 300, 305 (CCPA 1980)).
MPEP 2117(II) further state that alternatives (1) share a “single structural similarity” when they belong to the same recognized physical or chemical class or to the same art-recognized class and (2) share a common function or use when they are disclosed in the specification or known in the art to be functionally equivalent in the context of the claimed invention.
MPEP § 2117(II)(A) states that “A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein “there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved”. Herein the members of the Markush grouping are all genes. These do not belong to the same recognized physical or chemical class or to the same art-recognized class because there is no expectation from the art that each of the recited genes would function in the same way in the claimed method. It is only in the context of this specification that it was disclosed that all members of this group may behave in the same way in the context of the claimed invention.
MPEP § 2117(II)(B) states that “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 explained in subsection IIA above, the members of the Markush grouping may still be considered to be proper where the alternatives share a substantial structure feature that is essential to a common use. Again the members of the Markush grouping are all genes. While they are all made up of nucleic acids or amino acids, the structure of comprising nucleic acids or amino acids is not essential to any asserted common use.
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.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682