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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/6/2026 has been entered.
Status of Claims
Claims 1-7 are pending in the instant application.
Previous Objections/Rejections
Any rejections or objections stated of record in the office action mailed on 10/23/2025 that are not explicitly addressed herein below, are hereby withdrawn in light of applicant's arguments and/or amendments filed 3/6/2026.
Status of Rejections
35 USC § 112 (b)
The rejection of 1, 2, and 4-7 is maintained.
Applicant’s amendments and arguments, see Remarks, filed 3/6/2026, with respect to the Office Action mailed 10/23/2025 have been fully considered but are not found fully persuasive.
To reiterate the rejection of record, amended claim 1 recites the variable “R1” (see end of claim 1). With respect to “R1”, the formula I does not encompass this variable or any of the definitions within. Are Applicants suggesting variable “R1” or something else? Thus the claim and claims dependent on it which do not rectify the issue are indefinite. The examiner notes that this part of the rejection was not addressed by Applicant and thus the rejection is maintained. Correction is required.
35 USC § 103
The rejection of 1, 2, and 4-7 is maintained.
Applicant’s amendments and arguments, see Remarks, filed 3/6/2026, with respect to the Office Action mailed 10/23/2025 have been fully considered but are not found fully persuasive.
To reiterate the rejection of record, claims 1,2 and 4-7 are rejected under 35 U.S.C.103(a) as being unpatentable over CN107468694A-mentioned in IDS in view of Graham et al. The Prostate. 2022;82:S37–S44.
The claims may be drawn to the following chemical species used for the treatment of certain cancers such as colon cancer:
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wherein R1 = H and R2-4 is selected from methyl or -CH2(CH(OH))3OPH2O3.
CN107468694A discloses that riboflavin and derivatives thereof (see page 8, Figure 5 for compounds and description for use) are drugs used for treating various cancers such as colon, gastric cancer, endometrial cancer, small cell lung cancer, ovarian cancer, and skin cancer, wherein some are cancers of the instant invention to be treated (see page 23, lines 1-10 of the instant specification). The document specifically teaches the following species at Figure 5:
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wherein R1 = H and R2-4 is selected from methyl or -CH2(CH(OH))4OPH2O3. The difference between these compounds stemming from variable R2 (-CH2(CH(OH))3OPH2O3 versus -CH2(CH(OH))4OPH2O3; i.e. q = 3 versus q = 4). However the document teaches that the (-CHOH) repeating unit in these derivatives are equivalent and interchangeable (see Figure 5 again):
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Thus the claimed compound and method of use for treating these cancers and/or subsequently verifying the anticancer properties using specific cell lines would have been considered obvious to one skilled in the art. Dependent claims reciting other functional language related to the compound (e.g. claim 5 and even claims 6-7) do not tip the scales towards patentability since the prior art compound would have been expected to inherently possess these said properties. Also due to the prior art teaching that these compounds were effective in reducing cell viability of cancer cells (e.g. colon); the inherency argument is further supported.
CN107468694A taught what was described above wherein the document does not specifically recite “prostate cancer” as one of the cancers to be treated. However the document does not limit the types of cancers to only colon, gastric cancer, endometrial cancer, small cell lung cancer, ovarian cancer, and skin cancer as stated in the description; but include other cancers that are mismatch repair deficient.
However Graham et al. The Prostate. 2022;82:S37–S44 cures this deficiency by stating that castration-resistant prostate cancer (a form of prostate cancer) is a mismatch repair deficient cancer (see abstract). Thus, this particular cancer is also included in the particular types of cancers taught in CN107468694A to be treated by riboflavin and derivatives and one skilled in the art would have a reasonable expectation of success in treating colon cancer as well.
Applicants argue several points of contention which include 1) no motivation to arrive at the claimed species and 2) unpredictability regarding state of the art. The examiner respectfully disagrees. In reference to arriving at the claimed species; Applicants are reminded that the difference between these compounds stemming from variable R2 (-CH2(CH(OH))3OPH2O3 versus -CH2(CH(OH))4OPH2O3; i.e. q = 3 versus q = 4). However the document teaches that the (-CHOH) repeating unit in these derivatives are equivalent and interchangeable (see Figure 5 again):
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The compounds disclosed in the document consist of Riboflavin and derivatives thereof. The claimed species in the instant application also fits this definition as a derivative of Riboflavin itself. It is clear to one of skill that the repeating hydroxyl group may vary in linkage as described in the document. This teaching in itself provides the motivation for one of ordinary skill to access derivatives of similar structure varying in chain length.
Lastly in regard to unpredictability of the compounds to be used as anticancer agents all there is needed is a reasonable expectation of success and not absolute predictability. Obviousness only requires a reasonable expectation of success not absolute predictability as set forth in In re O'Farrell 7 USPQ 2d 1673. Applicants are reminded that CN107468694A discloses that riboflavin and derivatives thereof (see page 8, Figure 5 for compounds and description for use) are drugs used for treating various cancers such as colon, gastric cancer, endometrial cancer, small cell lung cancer, ovarian cancer, and skin cancer. Additionally the prior art compounds biological activity was indeed successfully tested at Figure 5 and thus a reasonable expectation of success would be expected for treating a variety of cancers employing said compounds.
New Objections
Claim Objections
Claims 2-3 are objected to for the following informalities:
In claim 2, the following embodiment should show a point of attachment via squiggly line or something similar to clearly articulate the point of attachment:
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. Correction is required.
Before the last compound in claim 3, the word “and” should be inserted.
Conclusion
Claims 1, 2, and 4-7 are rejected. Claim 3 is objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E MCDOWELL whose telephone number is (571)270-5755. The examiner can normally be reached on 8:30-6 MF.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E MCDOWELL/ Primary Examiner, Art Unit 1624