Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 20, 2026 has been entered.
DETAILED ACTION
The amendment filed August 20, 2026 in response to the Office Action of May 21, 2026 is acknowledged and has been entered.
Claims 1 and 3 have been amended.
Claims 2, 4-10, 16, and 18-22 have been cancelled.
Claims 1, 3, 11-15, and 17 are pending and under consideration.
Claim Objections
The amendment to the claims filed on August 20, 2026 does not comply with the requirements of 37 CFR 1.121(c) because the amended claims fails to include all previously presented claims in the claim listing (completely omitting claims 8, 9, 10). Appropriate correction is required.
MAINTAINED/MODIFIED REJECTIONS
Claim Rejections - 35 USC § 112(a)
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, 3, 11-15, and 17 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.
Claim 1 is drawn to “a method of diagnosing and treating uveal melanoma in a patient, the method comprising: a) obtaining a vitreous sample from an eye of the patient; b) measuring levels of expression of stem cell growth factor receptor Kit (SCFR/KIT) and kallikrein 7 (KLK7); c) determining that the subject has increased levels of expression of SCFR/KIT and decreased levels of expression of KLK7 compared to reference value ranges for the levels of expression of the biomarkers in a vitreous sample from a control subject, wherein the increased levels of expression of the SCFR/KIT and the decreased levels of expression of the KLK7 indicate that the patient has uveal melanoma; and d) treating the patient diagnosed with the uveal melanoma with a treatment for the uveal melanoma”. Claim 3 further recites “measuring levels of expression of hepatocyte growth factor receptor (c-MET/HGFR) and hepatocyte growth factor (HGF) in the vitreous sample and determining that the subject has increased levels of expression of the c- MET/HGFR and HGF compared to reference value ranges for the levels of expression of the biomarkers in a vitreous sample from a control subject, wherein the increased levels of expression of the c-MET/HGFR and HGF indicate that the patient has uveal melanoma”.
Examples of the specification described proteomic data based on very limited samples from eight uveal melanoma patients and three controls. Based on proteomic data, specification identified several potential biomarkers whose expressions are associated with uveal melanoma in the training data set. Since the study analyzed a limited number of samples, additional studies are necessary to validate these findings. However, the specification does not verify any of the genes in real diagnosis setting. It is unclear what is the sensitivity, specificity, positive predictive value, negative predictive value, discrimination power of the claimed method using the these claimed biomarker(s). Thus, the specification fails to show the inventor actually conceived or possessed the functional correlation at the time of filing.
Vas-Gath, Inc. v" Mahurkar, 19 USPQ2d 1111, makes clear that "to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed".
Regarding the SCFR/C-kit, KLK7, MET/HGFR and HGF for diagnosing uveal melanoma, even the instant specification acknowledges: “The limited number of samples and high number of measurements can introduce bias and false positives in the training set.” (see paragraph [0211] of the instant publication US 2023/0152322). The specification just has a general description about the validation design (paragraph [0211] and Fig. 6), the performance of the biomarkers in the validation study is not fully disclosed. Skeie (Skeie et al., PLOS ONE 10(5): e0127567, Publication Date: 05/28/2015, of record) teaches vitreous is a complex extracellular tissue where proteins originated from local hyalocyte and tissues, some of which are local and others are outside of the eye. The vitreous proteome becomes drastically altered as a result of systemic disease. In addition, All-Ericsson (US 2006/0111363 A1, Publication Date: 05/25/2006, cited in IDS of 11/09/2022, of record) shows that gene expression can vary significantly even among uveal melanoma samples. For example, among 134 uveal melanoma samples, 50 have no c-Kit positive cells, 18 have < 10% c-Kit positive cells, 18 have 10%-50% c-Kit positive cells, and 48 have >50% c-Kit positive cells (Example 2, [0032]). It is noted that c-Kit expression in uveal melanoma is highly variable and unpredictable. Thus, the biomarkers, which are identified based on limited number of vitreous samples, may be false positives or false negatives in diagnosing uveal melanoma.
Consistent with this complexity, Velez (Velez et al., Molecular Cancer, 2021, 20:39 including suppl., Publication Year: 2021, of record. It is noted that the inventors of the instant application are also the co-author of the article. In addition, the training dataset in the article appears the same as the dataset described in the instant application) shows that the performance of the biomarkers in the validation dataset (using 11 uveal melanoma vitreous samples and 11 controls, see Table S6) is neither consistent nor predictable. Gene expression patterns change significantly between the training data set and the validation dataset. For example, in the training dataset, FABP1 protein level is significantly decreased in uveal melanoma samples (Fig 5A of the instant specification; and Fig. S1A of Velez). However, in the verification study, FABP1 protein levels are higher in uveal melanoma samples (Fig. S2A of Velez). Even for the genes recited by the amended claims, HGF is categorized as non-Trending Markers (see Fig. S2-D). There is no difference between control and uveal melanoma samples for HGF. For KLK7, the level of expression in uveal melanoma samples largely overlap with the value range for the levels of expression in control samples (see Fig. S2-A). Some uveal melanoma samples even have a higher expression of KLK7 than in the controls (see Fig. S2-A). For HGFR/c-MET, the level of expression in uveal melanoma samples largely overlap with the value range for the levels of expression in control samples (see Fig. S2-B). The difference between control and Class I uveal melanoma is not significant. Furthermore, the gene expression levels of HGFR/c-MET vary a lot between the training population and validation population, even for controls (comparing Fig. S1-J to Fig. S2-B for HGFR/c-MET). Because both data sets share similar limitations, including limited sample number, high number of measurements, and intra-tumor heterogeneity, further verification in a larger cohort is required (also acknowledged by Velez, see page 4, col. 2, para. 1). Additionally, the specification does not provide essential information for a diagnostic biomarker(s), such as the portion of cases that test positive, the portion of controls that test negative, portion of test-positive patients who actually have uveal melanoma, portion of test-negative patients who truly do not have uveal melanoma, how well the marker(s) distinguishes cases from controls.
Taken together, limited disclosed data in the specification would not be sufficient to establish a reliable association between the expression levels of the SCFR/C-KIT and KLK7 combination (or the SCFR/C-KIT, KLK7, c-MET/HGFR and HGF combination) of the amended claims and a positive diagnosis of uveal melanoma as claimed. Thus, the specification lacks written description support for the claimed method.
Claims 11-15 and 17 encompass the same genus of biomarker selections as claim 1 which lacks written description support as set forth above. Thus, the specification fails to provide sufficient written description support for these claims.
Response to Arguments
For the WRITTEN DESCRIPTION rejection of claims 1, 3, 11-15, and 17 under 35 U.S.C. 112(a), Applicant argues:
Independent claim 1, as amended, recites the biomarkers that were identified as indicative of UM and confirmed in validation study: see FIG. 5C and FIG. 5G. KLK7 and SCF R were significantly differentially expressed between control samples and UM patients vitreous samples (see Table 2, FIG. 3A, FIG. 3B)….
Thus, the specification describes the means for further validating the prognostic proteins identified in the application as filed. As noted by the Examiner, the results from this validation study are published in Velez et al., Molecular Cancer, 2021, 20:39; of record). This validation study confirmed that of this list of biomarkers, KLK7, SCFR/c-Kit, HGFR/cMET, and HGF are highly correlated with UM. The enclosed claims 1 and 3 recite these validated biomarkers.
Applicant’s arguments have been considered but have not been found persuasive. As set forth above, even though the amended claim 1 cites a specific 2-gene combination at the diagnosing step and the amended claim 3 cites a specific 4-gene combination at the diagnosing step, the specification has not established the expression levels of these biomarkers correlate with the uveal melanoma. The biomarker genes were identified through very limited data set and performance of these marker genes were not validated. The data in the prior art and Velez demonstrated that the expression levels of these genes vary significantly between different populations, and these genes can’t reliably diagnose uveal melanoma. In particular, for SCFR/c-KIT, prior art (All-Ericsson) teaches that among 134 uveal melanoma samples, 50 have no c-Kit positive cells, 18 have < 10% c-Kit positive cells, 18 have 10%-50% c-Kit positive cells, and 48 have >50% c-Kit positive cells. HGF is recognized as a non-trending marker by Velez (see Fig. S2-D of Velez). The level of expression of KLK7 in uveal melanoma samples largely overlap with the value range for the levels of expression in control samples (see Fig. S2-A of Velez). Some uveal melanoma samples even have a higher expression of KLK7 than in the controls (see Fig. S2-A of Velez). For HGFR/c-MET, the level of expression in uveal melanoma samples largely overlap with the value range for the levels of expression in control samples (see Fig. S2-B of Velez). The difference between control and Class I uveal melanoma is not significant. Furthermore, the gene expression levels of HGFR/c-MET vary a lot between the training population and validation population, even for controls (comparing Fig. S1-J to Fig. S2-B for HGFR/c-MET of Velez). Additionally, the specification does not provide essential information for a diagnostic biomarker(s), such as the portion of cases that test positive, the portion of controls that test negative, portion of test-positive patients who actually have uveal melanoma, portion of test-negative patients who truly do not have uveal melanoma, how well the marker(s) distinguishes cases from controls. Thus, the data in the instant specification and prior art would not allow a person of ordinary skill in the art to recognize that the inventor possessed the claimed diagnostic steps and correlations.
Applicant further argues that the specification teaches validation method. However, executing a validation protocol for a candidate biomarker(s) does not guarantee that the biomarker(s) is successfully validated. It looks like a mere “plan” or hypothesis to find a correlation rather than an actual invention.
Thus, the rejection is maintained for reasons of record.
Claims 1, 3, 11-15, and 17 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Examples of the specification described proteomic data based on very limited samples from eight uveal melanoma patients and three controls. Based on proteomic data, specification identified several potential biomarkers whose expressions are associated with uveal melanoma in the training data set. Since the study analyzed a limited number of samples, additional studies are necessary to validate these findings. However, the specification does not verify any of the genes in real diagnosis setting. It is unclear what is the sensitivity, specificity, positive predictive value, negative predictive value, discrimination power of the claimed method using the these claimed biomarker(s). Thus, the performance of these biomarkers in evaluating/classifying uveal melanoma status is unpredictable and unreliable. To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir.,1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547, the court recited eight factors to consider when assessing whether or not a disclosure would require undue experimentation. These factors are:
1) the quantity of experimentation necessary, 2) the amount of direction or guidance provided, 3) the presence or absence of working examples, 4) the nature of the invention 5) the state of the art, 6) the relative skill of those in the art, 7) the predictability of the art and 8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108,427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
Nature of invention and breadth of the claims:
Claim 1 is drawn to “a method of diagnosing and treating uveal melanoma in a patient, the method comprising: a) obtaining a vitreous sample from an eye of the patient; b) measuring levels of expression of stem cell growth factor receptor Kit (SCFR/KIT) and kallikrein 7 (KLK7); c) determining that the subject has increased levels of expression of SCFR/KIT and decreased levels of expression of KLK7 compared to reference value ranges for the levels of expression of the biomarkers in a vitreous sample from a control subject, wherein the increased levels of expression of the SCFR/KIT and the decreased levels of expression of the KLK7 indicate that the patient has uveal melanoma; and d) treating the patient diagnosed with the uveal melanoma with a treatment for the uveal melanoma”. Claim 3 further recites “measuring levels of expression of hepatocyte growth factor receptor (c-MET/HGFR) and hepatocyte growth factor (HGF) in the vitreous sample and determining that the subject has increased levels of expression of the c- MET/HGFR and HGF compared to reference value ranges for the levels of expression of the biomarkers in a vitreous sample from a control subject, wherein the increased levels of expression of the c-MET/HGFR and HGF indicate that the patient has uveal melanoma”.
Relative skill in the art:
The relative skill of those in the art is high with an MD or a PhD.
Level of unpredictability in the art and State of the prior art:
Regarding the SCFR/C-kit, KLK7, MET/HGFR and HGF for diagnosing uveal melanoma, even the instant specification acknowledges: “The limited number of samples and high number of measurements can introduce bias and false positives in the training set.” (see paragraph [0211] of the instant publication US 2023/0152322). The specification just has a general description about the validation design (paragraph [0211] and Fig. 6), the performance of the biomarkers in the validation study is not fully disclosed. Skeie (Skeie et al., PLOS ONE 10(5): e0127567, Publication Date: 05/28/2015, of record) teaches vitreous is a complex extracellular tissue where proteins originated from local hyalocyte and tissues, some of which are local and others are outside of the eye. The vitreous proteome becomes drastically altered as a result of systemic disease. In addition, All-Ericsson (US 2006/0111363 A1, Publication Date: 05/25/2006, cited in IDS of 11/09/2022, of record) shows that gene expression can vary significantly even among uveal melanoma samples. For example, among 134 uveal melanoma samples, 50 have no c-Kit positive cells, 18 have < 10% c-Kit positive cells, 18 have 10%-50% c-Kit positive cells, and 48 have >50% c-Kit positive cells (Example 2, [0032]). It is noted that c-Kit expression in uveal melanoma is highly variable and unpredictable. Thus, the biomarkers, which are identified based on limited number of vitreous samples, may be false positives or false negatives in diagnosing uveal melanoma.
Consistent with this complexity, Velez (Velez et al., Molecular Cancer, 2021, 20:39 including suppl., Publication Year: 2021, of record. It is noted that the inventors of the instant application are also the co-author of the article. In addition, the training dataset in the article appears the same as the dataset described in the instant application) shows that the performance of the biomarkers in the validation dataset (using 11 uveal melanoma vitreous samples and 11 controls, see Table S6) is neither consistent nor predictable. Gene expression patterns change significantly between the training data set and the validation dataset. For example, in the training dataset, FABP1 protein level is significantly decreased in uveal melanoma samples (Fig 5A of the instant specification; and Fig. S1A of Velez). However, in the verification study, FABP1 protein levels are higher in uveal melanoma samples (Fig. S2A of Velez). Even for the genes recited by the amended claims, HGF is categorized as a non-trending marker (see Fig. S2-D). There is no difference between control and uveal melanoma samples. For KLK7, the level of expression in uveal melanoma samples largely overlap with the value range for the levels of expression in control samples (see Fig. S2-A). Some uveal melanoma samples even have a higher expression of KLK7 than in the controls (see Fig. S2-A). For HGFR/c-MET, the level of expression in uveal melanoma samples largely overlap with the value range for the levels of expression in control samples (see Fig. S2-B). The difference between control and Class I uveal melanoma is not significant. Furthermore, the gene expression levels of HGFR/c-MET vary a lot between the training population and validation population, even for controls (comparing Fig. S1-J to Fig. S2-B for HGFR/c-MET). Because both data sets share similar limitations, including limited sample number, high number of measurements, and intra-tumor heterogeneity, further verification in a larger cohort is required (also acknowledged by Velez, see page 4, col. 2, para. 1). Additionally, the specification does not provide essential information for a diagnostic biomarker(s), such as the portion of cases that test positive, the portion of controls that test negative, portion of test-positive patients who actually have uveal melanoma, portion of test-negative patients who truly do not have uveal melanoma, how well the marker(s) distinguishes cases from controls.
Thus, the performance of these biomarkers in evaluating/classifying uveal melanoma status is unpredictable and unreliable.
Direction or guidance and working examples:
MPEP § 608.01 (p) provided that within the specification, "specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims.
However, in view of above, the specification does not provide adequate direction or guidance for the claimed methods. As set forth above, Examples of the instant specification disclosed a few potential biomarkers in vitreous samples based on very limited proteomic data. The performance of these biomarkers was not validated. The claimed methods have not been evaluated. For example, the specification does not provide essential information for a diagnostic biomarker(s), such as the portion of cases that test positive, the portion of controls that test negative, portion of test-positive patients who actually have uveal melanoma, portion of test-negative patients who truly do not have uveal melanoma, how well the marker(s) distinguishes cases from controls.
Based on prior art, the associations between expression levels of the claimed biomarkers and uveal melanoma cannot be established. Based on the data disclosed in the instant specification and prior art, one of ordinary skilled in the art would not be able to confidently diagnose a uveal melanoma based on the expression levels of the claimed biomarkers (e.g. a combination of SCFR/c-Kit + KLK7 or a combination of SCFR/c-Kit + KLK7 + c-MET/HGFR + HGF).
The quantity of experimentation needed:
The factors outlined in In Re Wands' mentioned above apply here, and in particular as per the MPEP 2164.01 (a): "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)." It is very clear that one could not make/use this very broad invention that has no working examples in this unpredictable art without undue experimentation. Genetech Inc vs Nova Nordisk 42 USPQ 2d 1001 "A patent is not a hunting license. It is not a reward for search but compensation for its successful conclusion and patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable."
Applicant is reminded that MPEP 2164.03 teaches “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability of the art. In re Fisher, 428 F.2d 833, 166 USPQ 18, 24 (CCPA 1970) the amount of guidance or direction refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly state in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as how to make and use the invention in order for it to be enabling. Given only lack of guidance in the specification and prior art, no one skilled in the art would accept the assertion that the claimed invention would function as contemplated or as claimed based only on the information in the specification and prior art and that known in the art at the time the invention was made.
The specification and prior art provide insufficient guidance regarding these issues and provides sufficient working examples which would provide guidance to one skilled in the art and no evidence has been provided which would allow one of skill in the art to predict that the invention will function as contemplated or claimed with a reasonable expectation of success. For the above reasons, it appears that undue trial-and-error experimentation would be required to practice the claimed invention.
Response to Arguments
For the Enablement rejection of claims 1, 3, 11-15, and 17 under 35 U.S.C. 112(a), Applicant argues:
Therefore, independent claim 1, as amended, is directed to the biomarkers that were identified in the application as significantly correlated with presence of UM and further validated in Velez et al., Molecular Cancer, 2021, 20:39.
The specification describes how to measure levels of biomarkers in a vitreous sample (see specification, e.g., at paragraphs [0074]-[0076], [00114]- 00122], and [00163]-[00165]) and how vitreous samples can be obtained from a patient (see specification, e.g., at paragraphs [0064], [0093], and [00162]). As such, a person of ordinary skill in the art can practice the claimed method without undue experimentation.
Applicant’s arguments have been considered but have not been found persuasive. As set forth above, limited disclosed data in the specification would not be sufficient to establish a reliable association between the expression levels of the SCFR/C-KIT and KLK7 combination (or the SCFR/C-KIT, KLK7, c-MET/HGFR and HGF combination) of the amended claims and a positive diagnosis of uveal melanoma as claimed. Thus, a person of ordinary skill in the art would need to engage in extensive, trial-and-error experimentation (undue experimentation) to figure out the diagnostic thresholds, baseline levels, or predictive weights of the biomarkers.
Thus, the rejection is maintained for reasons of record.
NEW REJECTION
Claim Rejections - 35 USC § 112(b)
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.
Claim 3 is 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 3, which depends on claim 1, recites “wherein the increased levels of expression of the c-MET/HGFR and HGF indicate that the patient has uveal melanoma” (condition B). Claim 1 recites “wherein the increased levels of expression of the SCFR/KIT and the decreased levels of expression of the KLK7 indicate that the patient has uveal melanoma” (condition A). It is unclear whether a call of uveal melanoma needs to meet both condition A and condition B. For example, if a patient meets condition A, but not condition B, it is unclear whether this patient should be considered as having uveal melanoma or not.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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/CHENG LU/Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/ Supervisory Patent Examiner, Art Unit 1642
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