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 .
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 September 2025 has been entered.
Claim Interpretation
Attention is directed to MPEP 904.01 [R-08.2012].
The breadth of the claims in the application should always be carefully noted; that is, the examiner should be fully aware of what the claims do not call for, as well as what they do require. During patent examination, the claims are given the broadest reasonable interpretation consistent with the specification. See In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed. Cir. 1997). See MPEP § 2111 - § 2116.01 for case law pertinent to claim analysis.
It is noted with particularity that narrowing limitations found in the specification cannot be inferred in the claims where the elements not set forth in the claims are linchpin of patentability. In re Philips Industries v. State Stove & Mfg. Co, Inc., 186 USPQ 458 (CA6 1975). While the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into the claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992). In added support of this position, attention is directed to MPEP 2111 [R-11.2013], where, citing In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969), is stated:
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.
Additionally, attention is directed to MPEP 2111.01 [R-01.2024], wherein is stated:
II. IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION
“Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004).
Attention is also directed to MPEP 2111.02 II [R-07.2022]. As stated herein:
II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE
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The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation")… (Emphasis added)
Attention is directed to MPEP 2111 [R-10.2019]. As stated therein:
During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1). (Emphasis added).
Claim Rejections - 35 USC § 112, (b) / Second Paragraph
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.
Standard for Definiteness.
Attention is directed to MPEP 2171 [R-11.2013]:
Two separate requirements are set forth in 35 U.S.C. 112(b) and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the inventor or a joint inventor for a patent regards as his or her invention. Note that although pre-AIA 35 U.S.C. 112, second paragraph, uses the phrase "which applicant regards as his invention," pre-AIA 37 CFR 1.41(a) provides that a patent is applied for in the name or names of the actual inventor or inventors.
The second requirement is an objective one because it is not dependent on the views of the inventor or any particular individual, but is evaluated in the context of whether the claim is definite — i.e., whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of skill in the pertinent art.
Attention is directed to MPEP 2173.02 I [R-07.2022]:
During prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc). As the Federal Circuit stated in Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008):
“We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.”
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During examination, after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear, the claim is indefinite and should be rejected. Packard, 751 F.3d at 1310 (“[W]hen the USPTO has initially issued a well-grounded rejection that identifies ways in which language in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention, and thereafter the applicant fails to provide a satisfactory response, the USPTO can properly reject the claim as failing to meet the statutory requirements of § 112(b).”); Zletz, 893 F.2d at 322, 13 USPQ2d at 1322.
Attention is also directed to MPEP 2173.02 III B, which states in part:
To comply with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, applicants are required to make the terms that are used to define the invention clear and precise, so that the metes and bounds of the subject matter that will be protected by the patent grant can be ascertained. See MPEP § 2173.05(a), subsection I. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02, subsection II (citing Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed. Cir. 1993)); see also Halliburton Energy Servs., 514 F.3d at 1249, 85 USPQ2d at 1658 (“Otherwise, competitors cannot avoid infringement, defeating the public notice function of patent claims.”). Examiners should bear in mind that “[a]n essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.” Zletz, 893 F.2d at 322, 13 USPQ2d at 1322 [Fed. Cir. 1989]. (Emphasis added)
Attention is also directed to MPEP 2173.04 [R-10.2019], which states in part:
A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. But a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. For example, a genus claim that covers multiple species is broad, but is not indefinite because of its breadth, which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim). (Emphasis added)
Holding and Rationale
Claims 5-7, 9, 10, 12, and 16 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 1 is indefinite with respect to just which form(s) of “assaying” is/are encompassed by the claim.
Claim 1 is confusing as to just how recent and for how many generations did the human live in Africa in order to qualify as being “of African descent”. In support of this position it is noted that all of humanity is of African descent. In support of this position attention is directed to “An Evolutionary Timeline of Homo Sapiens”, Brian Handwerk, Science, February 2, 2021, which teaches at pages 2-3:
These lines of evidence increasingly indicate that H. sapiens originated in Africa,
although not necessarily in a single time and place. Instead it seems diverse
groups of human ancestors lived in habitable regions around Africa, evolving
physically and culturally in relative isolation, until climate driven changes to
African landscapes spurred them to intermittently mix and swap everything
from genes to tool techniques. Eventually, this process gave rise to the unique
genetic makeup of modern humans. (Emphasis added)
"East Africa was a setting in foment - one conducive to migrations across Africa
during the period when Homo sapiens arose," says Rick Potts, director of the
Smithsonian's Human Origins Program. "It seems to have been an ideal setting
for the mixing of genes from migrating populations widely spread across the
continent. The implicit is noted that all of modern human cation is that the human genome arose in Africa. Everyone is African, and yet not from any one part of Africa." (Emphasis added)
In view of the above showing, it is less than clear as to just which portion(s) of humanity is/are to be excluded from the group that is to undergo the claimed method of testing for if everyone is of African descent, then no one would be excluded.
Claims 6, 7, 9, 10, 12, and 16, which depend from claim 5, fails to overcome the above identified issue and are similarly rejected.
The term “increasing” in claim 12 is a relative term which renders the claim indefinite. The term “increasing” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
As presently worded, claim 1 recites the limitation “an LSAMP gene (SEQ ID NO: 2) and a CHD1 gene (SEQ ID NO: 3)”; claim 7 recites the limitation “a PTEN gene (SEQ ID NO: 25)”; claim 9 recites the limitation “a ZBTB20 gene (SEQ ID NO: 5 or SEQ ID NO: 7) and the LSAMP gene”; claim 10 recites the limitation “a ZBTB20 gene (SEQ ID NO: 5 or SEQ ID NO: 7) and the LSAMP gene”; and claim 16 recites the limitation “a PTEN gene (SEQ ID NO: 25)”. It is recognized that there are variants in sequences of a given gene. Said claims are indefinite with respect to whether the metes and bounds of the claims encompass all variants of a given gene or whether the metes and bounds are limited to a specified SEQ ID No of a given gene of interest.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Standard for Obviousness.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Attention is directed to In re Jung, 98 USPQ2d 1174, 1178 (Fed. Cir. 2011) wherein is stated:
There has never been a requirement for an examiner to make an on-the-record claim construction of every term in every rejected claim and to explain every possible difference between the prior art and the claimed invention in order to make out a prima facie rejection. This court declines to create such a burdensome and unnecessary requirement. “[Section 132] does not mandate that in order to establish prima facie anticipation, the PTO must explicitly preempt every possible response to a section 102 rejection. Section 132 merely ensures that an applicant at least be informed of the broad statutory basis for the rejection of his claims, so that he may determine what the issues are on which he can or should produce evidence.” Chester, 906 F.2d at 1578 (internal citation omitted). As discussed above, all that is required of the office to meet its prima facie burden of production is to set forth the statutory basis of the rejection and the reference or references relied upon in a sufficiently articulate and informative manner as to meet the notice requirement of § 132. As the statute itself instructs, the examiner must “notify the applicant,” “stating the reasons for such rejection,” “together with such information and references as may be useful in judging the propriety of continuing prosecution of his application.” 35 U.S.C. § 132.
Attention is directed to the decision in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007):
When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
It is further noted that prior art is not limited to the four corners of the documentary prior art being applied. Prior art includes both the specialized understanding of one of ordinary skill in the art, and the common understanding of the layman. It includes “background knowledge possessed by a person having ordinary skill in the art. . . [A] court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1396.
Suggestion, teaching or motivation does not have to be explicit and “may be found in any number of sources, including common knowledge, the prior art as a whole or the nature of the problem itself’” Pfizer, Inc. v. Apotex, Inc. 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007) citing Dystar Textilfarben GMBH v. C. H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006).
Holding and Rationale
Claim(s) 5-7, 9, 10, 12, and 16 are is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0326595 A1 (Srivastava et al.) in view of Huang et al., (“Recurrent deletion of CHD1 in prostate cancer with relevance to cell invasiveness”, Oncogene (2012) 31, 4164-4170) and US 2006/0110759 A1 (Paris et al.).
For convenience, claim 5, the sole independent claim pending, is reproduced below.
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The aspect of there being a “deletion” of a given gene has been construed as encompassing a deletion of any size or any portion of a given gene.
It is recognized that there are variants of genes and given such, said claims have been construed as encompassing variants of the specified genes and, therefore, are not limited to a specific nucleotide sequence identified via a SEQ ID NO. In further support of this interpretation it is noted that claim 5, the only independent claim pending, employs the term “comprising” in identifying the claimed method.
Srivastava et al., in the abstract, teach:
The present disclosure provides genomic arrangements of the chromosome 3q13 region that are associated with prostate cancer, such as rearrangements between the ZBTB20 and LSAMP genes, including gene fusions between the ZBTB20 gene and the LSAMP gene and deletions spanning both genes. The ZBTB20/LSAMP genomic rearrangement serves as a biomarker for prostate cancer and can be used to stratify prostate cancer based on ethnicity or the severity or aggressiveness of prostate cancer and/or identify a patient for prostate cancer treatment. Another aspect involves discovering that deletions of the PTEN gene are observed predominately in prostate cancer from subjects of Caucasian descent. (Emphasis added)3
Srivastava et al., at paragraphs [0009], [0011], [0012], [0020], [0046], [0075], [0150] and [0151] teach:
[0009] The present disclosure provides a genomic arrangement that occurs in chromosome region 3q13 and involves a ZBTB20 gene and an LSAMP gene and methods of diagnosing and prognosing prostate cancer based on the detection of the ZBTB20/LSAMP genomic arrangement in a biological sample comprising prostate cells. The ZBTB20/LSAMP genomic arrangement can be a gene fusion between the ZBTB20 gene and the LSAMP gene, a gene inversion, a gene deletion, or a gene duplication. (Emphasis added)
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[0011] In one embodiment, prostate cancer from the subject does not express a gene fusion between ERG and an androgen regulated gene, such as TMPRSS2. In another embodiment, the subject is of African descent. In this way, the ZBTB20/LSAMP genomic rearrangement can be used to prognose the severity of prostate cancer within a particular ethnic group, as the examples show that subjects of African descent who possess the ZBTB20/LSAMP genomic rearrangement in prostate cells, but not the TMPRSS2/ERG fusion, consistently develop an aggressive form of prostate cancer. (Emphasis added)
[0012] Given the prognostic value of the ZBTB20/LSAMP genomic rearrangement, the methods may further comprise a step of selecting a treatment regimen for the subject based on the detection of the ZBTB20/LSAMP genomic rearrangement or of treating the subject if the genomic rearrangement is detected in the biological sample obtained from the subject. Alternatively, the methods may further comprise a step of increasing the frequency of monitoring the subject for the development of prostate cancer or a more aggressive form of prostate cancer. (Emphasis added)
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[0020] Another genomic rearrangement of interest that is associated with prostate cancer is the PTEN deletion… Understanding the stratification of cancer-related genomic rearrangements, such as the PTEN deletion, between different patient populations provides important information to instruct treatment options for prostate cancer patients. (Emphasis added)
[0021] Accordingly, one aspect is directed to a method of selecting a targeted prostate cancer treatment for a patient of African descent, wherein the method comprises (a) excluding prostate cancer therapy that targets the PI3K/PTEN/Akt/mTOR pathway as a treatment option; and selecting an appropriate prostate cancer treatment. In one embodiment, the method further comprises a step of testing a biological sample from the patient, wherein the biological sample comprises prostate cells to confirm that the prostate cells to do not contain a PTEN gene deletion. (Emphasis added)
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[0075] Detecting a nucleic acid of interest generally involves hybridization between a target (e.g. mRNA, cDNA, or genomic DNA) and a probe. One of skill in the art can readily design hybridization probes for detecting the genomic rearrangement of the ZBTB20 and LSAMP genes or deletion of the PTEN gene. See e.g., Sambrook et al., Molecular Cloning: A Laboratory Manual, 4.sup.th Ed., Cold Spring Harbor Press, Cold Spring Harbor, N.Y., 2012. Each probe should be substantially specific for its target, to avoid any cross-hybridization and false positives. An alternative to using specific probes is to use specific reagents when deriving materials from transcripts (e.g., during cDNA production, or using target-specific primers during amplification). In both cases specificity can be achieved by hybridization to portions of the targets that are substantially unique within the group of genes being analyzed, e.g. hybridization to the polyA tail would not provide specificity. If a target has multiple splice variants, it is possible to design a hybridization reagent that recognizes a region common to each variant and/or to use more than one reagent, each of which may recognize one or more variants. (Emphasis added)
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[0150] 28 samples were sent to Illumina Inc. (UK) for sequencing. Sequences from tumor samples were mapped to the reference genome using Illumina's ELAND alignment algorithm. Sequencing reported good coverage (average 37). Variant calling for single nucleotide polymorphisms (SNPs), small insertions and deletions (InDels), copy number variants (CNVs), and structural variants (SVs) was performed concurrently using the Strelka algorithm. All established CaP mutations (TMPRSS2/ERG, SPOP, CHD1, and PTEN) were identified at expected frequencies in this cohort. A genome sequence coverage summary of the 14 patients is presented in Table 2. (Emphasis added)
[0151] Thirty one genes (including known mutations) with SNP, CNV or InDel somatic mutations in at least two of 14 patients were identified: AC091435.2; APC; ASMTL; ASMTL-AS1; CDC73; CHD1; CSF2RA; EYS; FRG1; FRG1B; HK2; IL3RA; KLLN; LIPF; LOC100293744; MT-ATP6; MT-BD4; MT-CO1; MT-CYB: MT-ND2; MT-ND3; MUC16; MUC6; NOX3; PDHA2; PTEN; SLC25A6; SLC9B1; SPOP; TRAV20; and USH2A. The top SVs and CNVs (highest confidence) present in at least 2 of 14 patients are set forth in Table 3:
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(Emphasis added)
As evidenced above, Srivastava et al., in paragraph [0021], teach not only treatment of a patient of African descent with prostate cancer, but also, and prior to, testing a sample from the patient for the presence/absence of certain mutations, including that of the PTEN gene. Such is deemed to fairly suggest limitations of claim 5 and 7.
The aspect of using multiple reagents that allow for the detection of multiple variants is deemed to fairly suggest assaying for different genes.
Srivastava et al., do not teach that CHD1 is being deleted.
Huang et al., teach that the deletion of CHD1 is a recurrent event in prostate cancer. Huang et al., at page 4169, right column first full paragraph, teach:
In our study, deletion of CHD1 was far more common than DNA sequence mutation, perhaps reflecting the relatively low rate of DNA mutation in prostate compared with other cancers (Taylor et al., 2010; Berger et al., 2011).
In view of the teachings of Huang et al., it would have been quite obvious to screen for the deletion of the CHD1 gene.
Paris et al., at paragraph [0149], teach:
Additionally, the tumor suppressor PTEN maps to the BAC identified at 10q23.1 in the exploratory biomarker analysis shown in FIG. 5B. Prostate-specific deletion of the murine Pten tumor suppressor gene has been shown to lead to metastatic prostate cancer (Wang, S., Gao, J., Lei, Q., Rozengurt, N., Pritchard, C., Jiao, J., Thomas, G. V., Li, G., Roy-Burman, P., Nelson, P. S. et al. (2003) Prostate-specific deletion of the murine Pten tumor suppressor gene leads to metastatic prostate cancer. Cancer Cell, 4:209-221). (Emphasis added)
In view of the above showing, it would have been obvious to one of ordinary skill in the art at the time of the invention to have tested human prostate cells of a subject of African descent for genomic rearrangements in LSAMP and CHD1 genes, and to also test for genomic rearrangements between the ZBTB20 and LSAMP genes, and to also determine if the subject has suffered a deletion of the PTEN gene.
In view of the detailed teachings in the prior art and the desire to identify the risks a patient may have for developing prostate cancer, said ordinary artisan would have been quite motivated to have applied such known procedures to achieve such a goal and would have had a most reasonable expectation of success.
In view of the above presentation and in the absence of convincing evidence to the contrary, claims 5-7, 9, 10, 12, and 16 are is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0326595 A1 (Srivastava et al.) in view of Huang et al., (“Recurrent deletion of CHD1 in prostate cancer with relevance to cell invasiveness”, Oncogene (2012) 31, 4164-4170) and US 2006/0110759 A1 (Paris et al.).
Response to argument
At pages 5-9 of the response of 26 September 2025, hereinafter the response, applicant’s representative traverses the rejection of claims under 35 USC 103(a). As seen at page 8 of the response traversal is based on Srivastava et al., not teaching that the CHD1 gene was being deleted. This argument has been considered. As evidenced above, this aspect of the claimed method is deemed to be fairly disclosed by Huang et al. So while Srivastava et al., does teach assaying for the CHD1 gene, it was known in the art at the time of the invention that this very gene is frequently deleted in prostate cancer cases.
In view of the above presentation and the well-developed state of the art at the time of the invention, claims 5-7, 9, 10, 12, and 16 are is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0326595 A1 (Srivastava et al.) in view of Huang et al., (“Recurrent deletion of CHD1 in prostate cancer with relevance to cell invasiveness”, Oncogene (2012) 31, 4164-4170) and US 2006/0110759 A1 (Paris et al.).
Conclusion
Objections and/or rejections which appeared in the prior Office action and which have not been repeated hereinabove have been withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradley L. Sisson whose telephone number is (571)272-0751. The examiner can normally be reached Monday to Thursday, from 6:30 AM to 5 PM..
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, 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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/Bradley L. Sisson/Primary Examiner, Art Unit 1682