| PTO Form 1957 (Rev 9/2005) |
| OMB No. 0651-0050 (Exp. 07/31/2017) |
| Input Field |
Entered |
|---|---|
| SERIAL NUMBER | 85794477 |
| LAW OFFICE ASSIGNED | LAW OFFICE 115 |
| MARK SECTION | |
| MARK | http://tess2.gov.uspto.report/ImageAgent/ImageAgentProxy?getImage=85794477 |
| LITERAL ELEMENT | G3 |
| STANDARD CHARACTERS | YES |
| USPTO-GENERATED IMAGE | YES |
| MARK STATEMENT | The mark consists of standard characters, without claim to any particular font style, size or color. |
| ARGUMENT(S) | |
|
Response to 2(d) Refusal
The Examiner has refused registration of Applicant’s G3 mark on the grounds that it is merely descriptive. In particular, she notes that “[t]he designation ‘G3’ is commonly used to identify a particular stage of prostate cancer where the cells of the tumor are poorly differentiated.” She concludes that the mark is descriptive based on the assumption that Applicant’s goods are used to determine “whether the tumor cells are Grade 3.”
Applicant respectfully disagrees with the refusal. In fact, “G3” is no longer a commonly used designation to identify a particular grade of prostate cancer and will not be understood to stand for “Grade 3” by the intended audience. Applicant directs the Examiner’s attention to the Wikipedia entry on “Prostate Cancer Staging” which explains that the histologic grading of prostate cancer as GX, G1, G2, G3, and G4 is generally outdated:
Usually, the grade of the cancer (how different the tissue is from normal tissue) is evaluated separately from the stage; however, for prostate cancer, grade information is used in conjunction with TNM status to group cases into four overall stages.
GX: cannot assess grade G1: the tumor closely resembles normal tissue (Gleason 2–4) G2: the tumor somewhat resembles normal tissue (Gleason 5–6) G3–4: the tumor resembles normal tissue barely or not at all (Gleason 7–10)
Of note, this system of describing tumors as "well-", "moderately-", and "poorly-" differentiated based on Gleason score of 2-4, 5-6, and 7-10, respectively, persists in SEER and other databases but is generally outdated.
See Wikipedia entry attached as Exhibit A (emphasis added). The Wikipedia page goes on to explain that the more contemporary method of categorizing tumors under the Gleason grade is as follows:
A more contemporary consideration of Gleason grade is: Gleason 3+3: tumor is low grade (favorable prognosis) Gleason 3+4 / 3+5: tumor is mostly low grade with some high grade Gleason 4+3 / 5+3: tumor is mostly high grade with some low grade Gleason 4+4 / 4+5 / 5+4 / 5+5: tumor is all high grade
Id. Rather than Grade 3, a tumor today would be categorized as Gleason 3+3 or Gleason 3+4 under the Gleason Scoring System. This Gleason Scoring System is the most widely adopted pathologic predictor for prostate outcome in North America and was endorsed by the World Health Organization in 2003 as the standard for prostate evaluation. Attached as Exhibit B is an article from the Prostate Cancer Research Institute entitled “Gleason Grade Migration: Changes in Prostate Cancer Grade in the Contemporary Era” that gives a history of the Gleason Scoring System and explains its components. The article goes on to explain that, in recent years, there are little to no lower grade cancers that are diagnosed with a Gleason Score of less than 6. As such, Applicant’s intended audience will not see the number “3” in Applicant’s mark as the overall stage or grade of prostate cancer.
Applicant notes that the Examiner found some general-interest references that still refer to “Grade 3” tumors. Applicant’s intended consumers, however, are highly specialized oncologists and laboratory researchers that will be using the most up-to-date, discriminating grading systems. These professionals will know that Applicant’s cutting edge G3 diagnostic test is not referring to an outdated system of categorizing tumors simply as “Grade 3.”
In addition, contrary to the Examiner’s assumption, Applicant’s tests do not determine whether tumor cells are Grade 3 (because this grading system is outdated), but instead conduct a much more sophisticated analysis to predict the patient’s Gleason Score. The Gleason Score, otherwise known as “GS,” is typically determined from tumor patterns assessed by a pathologist in interpreting a biopsy specimen under a microscope. Applicant’s G3 test is a state-of-the-art innovation in that it will be able to predict the GS Score based on certain patient biomarkers and genomes. In the context of assessing the GS score, Applicant’s specialized and sophisticated audience will not understand G3 as referring to a single, specific grade of tumor. Rather, it will appear to them as a coined term in connection with a Gleason Scoring test.
Applicant coined the term to suggest the 3 G’s involved in the testing, “Gleason,” “Genomes,” and “Grading.” In light of the above, G3 is at most a suggestive term, and does not immediately describe the function of the Applicant’s test.
The Examiner’s Request for Information
Applicant’s does not yet have materials specifically addressing its G3 goods and services. Applicant provides printouts from its website to give the Examiner similar documentation for its services of the same type. See website printouts attached as Exhibit C. These materials illustrate for the Examiner that Applicant is not providing outdated prostate testing and assessment, but is offering cutting-edge testing that conducts a sophisticated analysis of the gene activity in tumors. The results of these tests are not simplistic Grade 1, Grade 2 or Grade 3 categorizations but are a much more complex assessment of the tumors. As Applicant’s website states, the “conventional tools fall short of being able to accurately identify who is truly at risk and who is not” and so Applicant is developing more effective and accurate tools for classifying patients.
Further, as the Examiner can see from these materials, Applicant’s prospective customers are select physicians and researchers that are using the most state-of-the-art technologies on their patients. In response to the Examiner’s specific questions: Applicant’s testing services are not used to determine the Grade 1-10 stage of cancer or to make a simple determination of the level of differentiation of the cells of a prostate cancer tumor. Rather, Applicant’s testing services perform a much more sophisticated analysis that employs high-resolution, whole-genome analysis and proprietary bioinformatics to profile the patient’s cancer and provide a direct measure of the true biological risk of metastatic prostate cancer. |
|
| EVIDENCE SECTION | |
| EVIDENCE FILE NAME(S) | |
| ORIGINAL PDF FILE | evi_12146203101-172116040_._G3.pdf |
| CONVERTED PDF FILE(S) (15 pages) |
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| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0003.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0004.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0005.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0006.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0007.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0008.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0009.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0010.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0011.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0012.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0013.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0014.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0015.JPG | |
| \\TICRS\EXPORT16\IMAGEOUT16\857\944\85794477\xml5\ROA0016.JPG | |
| DESCRIPTION OF EVIDENCE FILE | Information on tumor analysis and Applicant's services |
| SIGNATURE SECTION | |
| RESPONSE SIGNATURE | /ChelseaaBush/ |
| SIGNATORY'S NAME | Chelseaa Bush |
| SIGNATORY'S POSITION | Attorney for Applicant, CA bar member |
| SIGNATORY'S PHONE NUMBER | 650-815-2600 |
| DATE SIGNED | 05/06/2013 |
| AUTHORIZED SIGNATORY | YES |
| FILING INFORMATION SECTION | |
| SUBMIT DATE | Mon May 06 17:33:04 EDT 2013 |
| TEAS STAMP | USPTO/ROA-XX.XXX.XXX.XXX- 20130506173304060968-8579 4477-500a2cf62aa8a7f2e5e9 670d2f429cd4bcea6fe1dd32b ce84aad089d0f67bb6f9bb-N/ A-N/A-2013050617211604075 0 |
| PTO Form 1957 (Rev 9/2005) |
| OMB No. 0651-0050 (Exp. 07/31/2017) |
Response to 2(d) Refusal
The Examiner has refused registration of Applicant’s G3 mark on the grounds that it is merely descriptive. In particular, she notes that “[t]he designation ‘G3’ is commonly used to identify a particular stage of prostate cancer where the cells of the tumor are poorly differentiated.” She concludes that the mark is descriptive based on the assumption that Applicant’s goods are used to determine “whether the tumor cells are Grade 3.”
Applicant respectfully disagrees with the refusal. In fact, “G3” is no longer a commonly used designation to identify a particular grade of prostate cancer and will not be understood to stand for “Grade 3” by the intended audience. Applicant directs the Examiner’s attention to the Wikipedia entry on “Prostate Cancer Staging” which explains that the histologic grading of prostate cancer as GX, G1, G2, G3, and G4 is generally outdated:
Usually, the grade of the cancer (how different the tissue is from normal tissue) is evaluated separately from the stage; however, for prostate cancer, grade information is used in conjunction with TNM status to group cases into four overall stages.
GX: cannot assess grade
G1: the tumor closely resembles normal tissue (Gleason 2–4)
G2: the tumor somewhat resembles normal tissue (Gleason 5–6)
G3–4: the tumor resembles normal tissue barely or not at all (Gleason 7–10)
Of note, this system of describing tumors as "well-", "moderately-", and "poorly-" differentiated based on Gleason score of 2-4, 5-6, and 7-10, respectively, persists in SEER and other databases but is generally outdated.
See Wikipedia entry attached as Exhibit A (emphasis added). The Wikipedia page goes on to explain that the more contemporary method of categorizing tumors under the Gleason grade is as follows:
A more contemporary consideration of Gleason grade is:
Gleason 3+3: tumor is low grade (favorable prognosis)
Gleason 3+4 / 3+5: tumor is mostly low grade with some high grade
Gleason 4+3 / 5+3: tumor is mostly high grade with some low grade
Gleason 4+4 / 4+5 / 5+4 / 5+5: tumor is all high grade
Id. Rather than Grade 3, a tumor today would be categorized as Gleason 3+3 or Gleason 3+4 under the Gleason Scoring System. This Gleason Scoring System is the most widely adopted pathologic predictor for prostate outcome in North America and was endorsed by the World Health Organization in 2003 as the standard for prostate evaluation. Attached as Exhibit B is an article from the Prostate Cancer Research Institute entitled “Gleason Grade Migration: Changes in Prostate Cancer Grade in the Contemporary Era” that gives a history of the Gleason Scoring System and explains its components. The article goes on to explain that, in recent years, there are little to no lower grade cancers that are diagnosed with a Gleason Score of less than 6. As such, Applicant’s intended audience will not see the number “3” in Applicant’s mark as the overall stage or grade of prostate cancer.
Applicant notes that the Examiner found some general-interest references that still refer to “Grade 3” tumors. Applicant’s intended consumers, however, are highly specialized oncologists and laboratory researchers that will be using the most up-to-date, discriminating grading systems. These professionals will know that Applicant’s cutting edge G3 diagnostic test is not referring to an outdated system of categorizing tumors simply as “Grade 3.”
In addition, contrary to the Examiner’s assumption, Applicant’s tests do not determine whether tumor cells are Grade 3 (because this grading system is outdated), but instead conduct a much more sophisticated analysis to predict the patient’s Gleason Score. The Gleason Score, otherwise known as “GS,” is typically determined from tumor patterns assessed by a pathologist in interpreting a biopsy specimen under a microscope. Applicant’s G3 test is a state-of-the-art innovation in that it will be able to predict the GS Score based on certain patient biomarkers and genomes. In the context of assessing the GS score, Applicant’s specialized and sophisticated audience will not understand G3 as referring to a single, specific grade of tumor. Rather, it will appear to them as a coined term in connection with a Gleason Scoring test.
Applicant coined the term to suggest the 3 G’s involved in the testing, “Gleason,” “Genomes,” and “Grading.” In light of the above, G3 is at most a suggestive term, and does not immediately describe the function of the Applicant’s test.
The Examiner’s Request for Information
Applicant’s does not yet have materials specifically addressing its G3 goods and services. Applicant provides printouts from its website to give the Examiner similar documentation for its services of the same type. See website printouts attached as Exhibit C. These materials illustrate for the Examiner that Applicant is not providing outdated prostate testing and assessment, but is offering cutting-edge testing that conducts a sophisticated analysis of the gene activity in tumors. The results of these tests are not simplistic Grade 1, Grade 2 or Grade 3 categorizations but are a much more complex assessment of the tumors. As Applicant’s website states, the “conventional tools fall short of being able to accurately identify who is truly at risk and who is not” and so Applicant is developing more effective and accurate tools for classifying patients.
Further, as the Examiner can see from these materials, Applicant’s prospective customers are select physicians and researchers that are using the most state-of-the-art technologies on their patients.
In response to the Examiner’s specific questions: Applicant’s testing services are not used to determine the Grade 1-10 stage of cancer or to make a simple determination of the level of differentiation of the cells of a prostate cancer tumor. Rather, Applicant’s testing services perform a much more sophisticated analysis that employs high-resolution, whole-genome analysis and proprietary bioinformatics to profile the patient’s cancer and provide a direct measure of the true biological risk of metastatic prostate cancer.
