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 .
Detailed Action
Summary
This is the Non-Final Office action based on the 18/286075 claims filed 05/31/2024 and telephonic election dated 05/21/2026 and 08/18/2026.
Claims 1-2, 6, 12, 15, 20-21, 31-32, 38, 40, 45-46, 56-58 & 61-62 were elected, along with the below noted species and have been fully considered.
Claims 69 and 76 have been withdrawn.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-2, 6, 12, 15, 20-21, 31-32, 38, 40, 45-46, 56-58, 61, drawn to a method for prognosing the risk for ER positive breast cancer.
Group II, claim(s) 69 & 76, drawn to a kit and panel for prognosing the risk of ER positive breast cancer.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
There is lack unity of invention because even though the inventions of these groups require the technical feature of one of the biomarkers listed in Table 1 or Table 2, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Meng in Keratin 18 attenuates estrogen receptor α-mediated signaling by sequestering LRP16 in cytoplasm, 2009.
Meng discloses a relationship between decrease in KRT18 and increase in proliferative activity of breast cancer cells ("Results from cell-culture experiments and clinicopathological parameter analyses have also revealed a relationship between decreased amounts of K18 in the cytoplasm and increased proliferative activity of breast cancer cells", Background, para. 3). Meng does not explicitly disclose KRT9. However, Meng discloses KRT9 and KRT18 belongs to the same class of keratin Type I (acidic, KRT9 through KRT20; Background, para. 3). It would have been obvious to one of ordinary skill in the art to have tried utilizing KRT9 as potential biomarker with a reasonable expectation of success as KRT9 belongs to the same class of keratin as KRT18 of Meng.
This application further contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
All of the claimed markers of claims 15 & 40.
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic:
No generic claims are identified.
During a telephone conversation with Jill Mello on 05/21/2026 a provisional election was made without traverse to prosecute the invention of Group I claims 1-2, 6, 12, 15, 20-21, 31-32, 38, 40, 45-46, 56-58, 61-62. During a phone call with Miao Yu on 08/18/2026, the species of ALDOA (aldose fructose biphosphate A) was elected without traverse.
Claims 69 & 76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the response on 05/21/2026.
Affirmation of this election must be made by applicant in replying to this Office action. Claims 69 & 76 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 101
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.
Claims 1-2, 6, 12, 15, 20-21, 31-32, 38, 40, 45-46, 56-58 & 61-62 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and law of nature (natural correlation) without significantly more.
Step 1: Independent Claims 1, 31, 56 & 61 are directed towards methods.
Step 2A, Prong One: Claims 1, 31, 56 & 61 recite natural correlations. These claims follow a classic diagnostic analysis and “diagnosing” is actually claimed in Claim 31. The natural correlation is the level of marker and its association with ER positive breast cancer. This is similar to the claims in Example 29 of the USPTO subject matter eligibility example which were found inelligible.
The independent claims also recite a comparison of a detected level to a threshold level. This comparison is an abstract idea judicial exception as it is a mental process.
Even further for Claim 61, the “identifying,” in the claim preamble and claim body, and the “determining,” all also read as abstract ideas since are mental processes.
See MPEP 2106.04.
Step 2A, Prong Two: These judicial exceptions are not integrated into a practical application in Claims 1, 31, 56 & 61 because upon comparison, nothing further is done.
Further the claimed detecting/measuring is done just as a data pull to use the judicial exception so is insignificant extra solution activity.
See MPEP 2106.05 (g).
Step 2B: In addition to the judicial exceptions, Claims 1, 31, 56 & 61 recite the additional elements of “detecting,” the levels of the markers is in all the claims, detecting at a second later time in Claim 56, and contacting a cell with a test compound in Claim 61.
Detecting, even multiple times and though not claimed by using routine techniques like mass spectrometry are well understood routine and conventional (WURC) in the art. This also applies to contacting of a cell and test compound.
Things that are WURC are not significantly more than the judicial exception.
See MPEP 2106.05(d).
This is evidenced by OSSOVSKAYA in WO 2009/100159.
OSSOVSKAYA teaches of obtaining numerous samples from an individual over a period of time and testing them to either verify earlier results or identify an alteration/progression of a result over time (paragraph 0071, 0085-0086), which reads on the instantly claimed first and second measurements over time to determine if there is a change in the condition (cancer presence) or not. OSSOVSKAYA teaches of detection with NMR or mass spectrometry or with ELISA (paragraph 0111-0113, 0129, 0116). OSSOVSKAYA even further teaches of contacting the sample which is a cell (paragraph 0015, 0052), with a treatment/inhibitor/modulator/test compound (paragraph 0061) and determining the treatments that are successful in modulating the cancer (paragraph 0057-0059).
Claims 2, 6, 12, 15, 20-21, 32, 38, 40, 45-46, 57-58 & 62 recite elements directed towards further limiting elements of the independent claim however none of this practically applies the judicial exceptions above at step 2 A/2, not adds significantly more at step 2B.
Claims 2, 6, 32 indicate a known or unknow diagnostic stats of the patient. These are both part of either a natural correlation/diagnostic status or a mental entity, status which is a mental process, so both part of judicial exceptions themselves.
Claims 12, 38, 57, 62 indicate what kind of sample is used. However the sample used is still for data gathering so does not practically apply and these samples are also WURC so do not add significantly more.
Claims 15, 40, indicate what the markers can be and if they are increased or decreased in comparison to threshold, however none of this changes the judicial exceptions above and this information remains part of the judicial exceptions themselves.
Claims 20, 45, specify general detection options. Detecting, using routine techniques like mass spectrometry and the other claimed techniques are well understood routine and conventional (WURC) in the art. This also applies to contacting of a cell and test compound.
Things that are WURC are not significantly more than the judicial exception.
See MPEP 2106.05(d).
Claim 21, 46, claims that another sample can be taken, which amounts to sampling a second time and measuring multiple times. Detecting multiple times and though not claimed by using routine techniques like mass spectrometry are well understood routine and conventional (WURC) in the art. This also applies to contacting of a cell and test compound.
Things that are WURC are not significantly more than the judicial exception.
Further- the claimed “selecting,” a treatment, and “monitoring,” in claims 21 & 46 and monitoring in Claim 58, are abstract idea judicial exceptions themselves.
See MPEP 2106.05(d).
Claim Rejections - 35 USC § 112
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 2 & 32 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.
With respect to Claim 2, in step (b) it is unclear what the “concurrently,” is concurrently with. For steps ( c ) and (d) it is unclear what “not yet,” means as it seems to be projecting a future diagnosis, that is not within the claim boundaries so the claim scope is unclear. This applies to the similar limitation in Claim 32, step (f).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 6, 12, 15, 20-21, 31-32, 38, 40, 45-46, 56-58 & 61-62 are rejected under U.S.C. 103 as being obvious by OSSOVSKAYA in WO 2009/100159 in view of CONDEELIS in US 20140314786.
With respect to Claim 1, OSSOVSKAYA teaches of a method of identifying and treating a disease (abstract).
OSSOVSKAYA further teaches of prognosing/predicting a risk and staging the disease, along with disease diagnosis and cancer detection (paragraph 0010) and of selecting a treatment based on the prognosis (paragraph 0142), and even further that the cancer can be breast cancer (paragraph 0015, 0026). OSSOVSKAYA further teaches of detection in a biological sample from a subject (paragraph 0014, 0018) and that differentially expressed genes in the subject including ALDOA, which is a biomarker from Table 1 or 2, are detected (paragraph 0011, 0057-0059), and that the level of the marker/s are detected and compared to a reference sample/predetermined threshold value (paragraphs 0024, 0023, 0029). OSSOVSKAYA further teaches that the expression levels of the genes in comparison to a reference sample, and wherein an increase in comparison to the reference level indicates disease (paragraph 0029, 0019, 0024).
OSSOVSKAYA does not teach of the subject being/having ER positive breast cancer.
CONDEELIS is used to remedy this and teaches of methods for determining if a subject having a tumor is (i) at risk of metastasis of the tumor, or (ii) at risk of recurrence of the tumor after treatment (abstract) and further that ALDOA is marker of such metastatic tumors (paragraphs 0007, 0009, 0010). CONDEELIS further teaches of the tumor being a breast cancer tumor for estrogen receptor positive or estrogen receptor negative breast cancer (paragraph 0039, 0055).
It would have been obvious to one of ordinary skill in the art to diagnose estrogen receptor positive breast cancer as is done in CONDEELIS in the method of OSSOVSKAYA due to the technical challenges with working with ER positive cells and therefore the need in the art for better methods to diagnose the conditions associated with them and in particular with respect to metastatic cascades associated with them (CONDEELIS, paragraph 0088, 0055, 0039, 0005).
With respect to Claim 2, OSSOVSKAYA teaches of the claims as shown above, but does not teach of the claimed diagnosis of ER positive cancer.
CONDEELIS teaches of diagnosis of ER positive breast cancer (table 4, paragraph 0039). See reason for combination from Claim 1.
With respect to Claim 6, OSSOVSKAYA teaches of the above, but does not teach of the subject being/having ER positive breast cancer which is metastatic.
CONDEELIS is used to remedy this and teaches of methods for determining if a subject having a tumor is (i) at risk of metastasis of the tumor, or (ii) at risk of recurrence of the tumor after treatment (abstract) and further that ALDOA is marker of such metastatic tumors of this cancer (paragraphs 0007, 0009, 0010). CONDEELIS further teaches of the tumor being a breast cancer tumor for estrogen receptor positive or estrogen receptor negative breast cancer (paragraph 0039, 0055). See reason for combination from Claim 1.
With respect to Claim 12, OSSOVSKAYA teaches that the sample can be a tissue sample or fluid sample including breast tissue (paragraph 0018, 0038, 0040, 0061, 0380). CONDEELIS also teaches of using ductal fluid (paragraph 0060, Table 4).
With respect to Claim 15, OSSOVSKAYA teaches of detection in a biological sample from a subject (paragraph 0014, 0018) and that differentially expressed genes in the subject including ALDOA are detected (paragraph 0011, 0057-0059), and that the level of the marker/s are detected and compared to a reference sample/predetermined threshold value (paragraphs 0024, 0023, 0029). OSSOVSKAYA further teaches that the expression levels of the genes in comparison to a reference sample, and wherein an increase in comparison to the reference level indicates disease (paragraph 0029, 0019, 0024). OSSOVSKAYA also teaches that the biomarkers/genes can be upregulated for breast cancer (paragraph 0104, 0138).
With respect to Claim 20, OSSOVSKAYA teaches of detection with NMR or mass spectrometry or with ELISA (paragraph 0111-0113, 0129, 0116).
With respect to Claim 21, OSSOVSKAYA teaches of using chemotherapy and hormone therapy and radiation (paragraph 0313, 0276, 0296, 0312), and of monitoring disease progression (paragraph 0071, 0084).
With respect to Claim 31, OSSOVSKAYA teaches of a method of identifying and treating a disease (abstract).
OSSOVSKAYA further teaches of prognosing/predicting risk and staging the disease along with disease diagnosis and cancer detection (paragraph 0010) and of selecting a treatment based on the prognosis (paragraph0141- 0142), and even further that the cancer can be breast cancer (paragraph 0015, 0026). OSSOVSKAYA further teaches of detection in a biological sample from a subject (paragraph 0014, 0018) and that differentially expressed genes in the subject including ALDOA, which is a biomarker from Table 1 or 2, are detected (paragraph 0011, 0057-0059), and that the level of the marker/s are detected and compared to a reference sample/predetermined threshold value (paragraphs 0024, 0023, 0029). OSSOVSKAYA further teaches that the expression levels of the genes in comparison to a reference sample, and wherein an increase in comparison to the reference level indicates disease (paragraph 0029, 0019, 0024) and of monitoring disease progression (paragraph 0071, 0084).
OSSOVSKAYA does not teach of the subject being/having ER positive breast cancer.
CONDEELIS is used to remedy this and teaches of methods for determining if a subject having a tumor is (i) at risk of metastasis of the tumor, or (ii) at risk of recurrence of the tumor after treatment (abstract) and further that ALDOA is marker of such metastatic tumors (paragraphs 0007, 0009, 0010). CONDEELIS further teaches of the tumor being a breast cancer tumor for estrogen receptor positive or estrogen receptor negative breast cancer (paragraph 0039, 0055).
It would have been obvious to one of ordinary skill in the art to diagnose estrogen receptor positive breast cancer as is done in CONDEELIS in the method of OSSOVSKAYA due to the technical challenges with working with ER positive cells and therefore the need in the art for better methods to diagnose the conditions associated with them and in particular with respect to metastatic cascades associated with them (CONDEELIS, paragraph 0088, 0055, 0039, 0005).
With respect to Claim 32, OSSOVSKAYA teaches of the above, but does not teach of the subject being/having ER positive breast cancer which is metastatic.
CONDEELIS is used to remedy this and teaches of methods for determining if a subject having a tumor is (i) at risk of metastasis of the tumor, or (ii) at risk of recurrence of the tumor after treatment (abstract) and further that ALDOA is marker of such metastatic tumors of this cancer (paragraphs 0007, 0009, 0010). CONDEELIS further teaches of the tumor being a breast cancer tumor for estrogen receptor positive or estrogen receptor negative breast cancer (paragraph 0039, 0055). See reason for combination from Claim 31.
With respect to Claim 38, OSSOVSKAYA teaches that the sample can be a tissue sample or fluid sample including breast tissue (paragraph 0018, 0038, 0040, 0061, 0380). CONDEELIS also teaches of using ductal fluid (paragraph 0060, Table 4).
With respect to Claim 40, OSSOVSKAYA teaches of detection in a biological sample from a subject (paragraph 0014, 0018) and that differentially expressed genes in the subject including ALDOA are detected (paragraph 0011, 0057-0059), and that the level of the marker/s are detected and compared to a reference sample/predetermined threshold value (paragraphs 0024, 0023, 0029). OSSOVSKAYA further teaches that the expression levels of the genes in comparison to a reference sample, and wherein an increase in comparison to the reference level indicates disease (paragraph 0029, 0019, 0024). OSSOVSKAYA also teaches that the biomarkers/genes can be upregulated for breast cancer (paragraph 0104, 0138).
With respect to Claim 45, OSSOVSKAYA teaches of detection with NMR or mass spectrometry or with ELISA (paragraph 0111-0113, 0129, 0116).
With respect to Claim 46, OSSOVSKAYA teaches of using chemotherapy and hormone therapy and radiation (paragraph 0313, 0276, 0296, 0312), and of monitoring disease progression (paragraph 0071, 0084).
With respect to Claim 56, OSSOVSKAYA teaches of a method of identifying and treating a disease (abstract).
OSSOVSKAYA further teaches of prognosing and staging the disease and cancer detection (paragraph 0010) and of selecting a treatment based on the prognosis (paragraph 0142), and even further that the cancer can be breast cancer (paragraph 0015, 0026). OSSOVSKAYA further teaches of detection in a biological sample from a subject (paragraph 0014, 0018) and that differentially expressed genes in the subject including ALDOA are detected (paragraph 0011, 0057-0059), and that the level of the marker/s are detected and compared to a reference sample/predetermined threshold value (paragraphs 0024, 0023, 0029). OSSOVSKAYA further teaches that the expression levels of the genes in comparison to a reference sample, and wherein an increase in comparison to the reference level indicates disease (paragraph 0029, 0019, 0024).
OSSOVSKAYA further teaches of obtaining numerous samples from an individual over a period of time and testing them to either verify earlier results or identify an alteration/progression of a result over time (paragraph 0071, 0085-0086), which reads on the instantly claimed first and second measurements over time to determine if there is a change in the condition (cancer presence) or not.
OSSOVSKAYA does not teach of the subject being/having ER positive breast cancer.
CONDEELIS is used to remedy this and teaches of methods for determining if a subject having a tumor is (i) at risk of metastasis of the tumor, or (ii) at risk of recurrence of the tumor after treatment (abstract) and further that ALDOA is marker of such metastatic tumors (paragraphs 0007, 0009, 0010). CONDEELIS further teaches of the tumor being a breast cancer tumor for estrogen receptor positive or estrogen receptor negative breast cancer (paragraph 0039, 0055) and of analyzing tumor progression (paragraph 0084).
It would have been obvious to one of ordinary skill in the art to diagnose estrogen receptor positive breast cancer and monitor tumor progression as is done in CONDEELIS in the method of OSSOVSKAYA due to the technical challenges with working with ER positive cells and therefore the need in the art for better methods to diagnose the conditions associated with them and in particular with respect to metastatic cascades associated with them (CONDEELIS, paragraph 0088, 0055, 0039, 0005).
With respect to Claim 57, OSSOVSKAYA teaches that the sample can be a tissue sample or fluid sample including breast tissue (paragraph 0018, 0038, 0040, 0061, 0380). CONDEELIS also teaches of using ductal fluid (paragraph 0060, Table 4).
With respect to Claim 58, OSSOVSKAYA further teaches of obtaining numerous samples from an individual over a period of time and testing them to either verify earlier results or identify an alteration/progression of a result over time (paragraph 0071, 0085-0086), which reads on the instantly claimed first and second measurements over time to determine if there is a change in the condition (cancer presence) or not. OSSOVSKAYA further teaches determining change of stat of the disease/cancer (paragraph 0085).
OSSOVSKAYA does not teach of the subject being/having ER positive breast cancer.
CONDEELIS is used to remedy this and teaches of methods for determining if a subject having a tumor is (i) at risk of metastasis of the tumor, or (ii) at risk of recurrence of the tumor after treatment (abstract) and further that ALDOA is marker of such metastatic tumors (paragraphs 0007, 0009, 0010). CONDEELIS further teaches of the tumor being a breast cancer tumor for estrogen receptor positive or estrogen receptor negative breast cancer (paragraph 0039, 0055) and of analyzing tumor progression (paragraph 0084). See reason for combination from Claim 56.
With respect to Claim 61, OSSOVSKAYA teaches of a method of identifying and treating a disease and further of identifying modulators/modulating agents for the disease (abstract).
OSSOVSKAYA further teaches of prognosing and staging the disease and cancer detection (paragraph 0010) and of selecting a treatment based on the prognosis (paragraph 0142), and even further that the cancer can be breast cancer (paragraph 0015, 0026). OSSOVSKAYA further teaches of detection in a biological sample from a subject (paragraph 0014, 0018) and that differentially expressed genes in the subject including ALDOA are detected (paragraph 0011, 0057-0059), and that the level of the marker/s are detected and compared to a reference sample/predetermined threshold value (paragraphs 0024, 0023, 0029). OSSOVSKAYA further teaches that the expression levels of the genes in comparison to a reference sample, and wherein an increase in comparison to the reference level indicates disease (paragraph 0029, 0019, 0024).
OSSOVSKAYA further teaches of obtaining numerous samples from an individual over a period of time and testing them to either verify earlier results or identify an alteration/progression of a result over time (paragraph 0071, 0085-0086), which reads on the instantly claimed first and second measurements over time to determine if there is a change in the condition (cancer presence) or not.
OSSOVSKAYA even further teaches of contacting the sample which is a cell (paragraph 0015, 0052), with a treatment/inhibitor/modulator/test compound (paragraph 0061) and determining the treatments that are successful in modulating the cancer (paragraph 0057-0059).
OSSOVSKAYA does not teach of the subject being/having ER positive breast cancer.
CONDEELIS is used to remedy this and teaches of methods for determining if a subject having a tumor is (i) at risk of metastasis of the tumor, or (ii) at risk of recurrence of the tumor after treatment (abstract) and further that ALDOA is marker of such metastatic tumors (paragraphs 0007, 0009, 0010). CONDEELIS further teaches of the tumor being a breast cancer tumor for estrogen receptor positive or estrogen receptor negative breast cancer (paragraph 0039, 0055) and of analyzing tumor progression (paragraph 0084).
CONDEELIS further teaches of using cells (paragraph 0005, 0008) and treating the cancer and determining risk of reoccurrence after the cancer (abstract, paragraph 0009, 0013, 0049, 0098, 0099).
It would have been obvious to one of ordinary skill in the art to diagnose estrogen receptor positive breast cancer and monitor tumor progression as is done in CONDEELIS in the method of OSSOVSKAYA due to the technical challenges with working with ER positive cells and therefore the need in the art for better methods to diagnose the conditions associated with them and in particular with respect to metastatic cascades associated with them (CONDEELIS, paragraph 0088, 0055, 0039, 0005). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to treat estrogen receptor positive breast cancer as is done in CONDEELIS in the method of OSSOVSKAYA due to the need for treatment of metastatic stages to better treat cancer as compared to just treating cancer as a whole (CONDEELIS, paragraph 0004).
With respect to Claim 62, OSSOVSKAYA teaches of the invention as shown above but does not teach of using specifically breast cancer cells. CONDEELIS is used to remedy this and teaches of using breast cancer cells (paragraph 0081, 0087).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to diagnose estrogen receptor positive breast cancer using breast cancer cells as is done in CONDEELIS in the method of OSSOVSKAYA due to the technical challenges with working with ER positive cells and therefore the need in the art for better methods to diagnose the conditions associated with them and in particular with respect to metastatic cascades associated with them (CONDEELIS, paragraph 0088, 0055, 0039, 0005) and due to the need in the art to better test and analyze cancer cells as not all cells are migratory and invasive and the need in the art to better understand tumor cell properties(CONDEELIS, paragraph 0005, 0008).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WILLIAMS in US 20210199660
WILLIAMS teaches of methods for determining cancer by analytes in a sample (abstract). WILLIAMS further teaches of detecting ALDOA (paragraph 0007, 0009, 0025), and of detecting that the breast cancer is an estrogen receptor positive breast cancer (paragraph 0024).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization wherehis application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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