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
The Amendments and Remarks filed 9/4/25 in response to the Office Action of 6/5/25 are acknowledged and have been entered.
Claims 1-2 are pending.
Claims 1-2 have been amended by Applicant.
Claims 1-2 are currently under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The following Office Action contains NEW GROUNDS of rejections Necessitated by Amendments.
Rejections Withdrawn
All previous rejections are withdrawn.
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112
Claims 1-2 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.
Claims 1-2 are rejected because claim 1 recites “…measuring viability or proliferation of the MEL-18-overexpressing HER2-positive breast cancer cell line cells in sample 1 and sample 2….” The metes-and-bounds of the claims are unclear because it is unclear which sample is “sample 1” and which sample is “sample 2”.
Claim Rejections - 35 USC § 102
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manson et al (Journal of Nutritional Biochemistry, 2015, 26: 16-23).
Manson et al teaches a method of screening drugs for reducing or overcoming resistance to HER2-targeted drugs or being co-administered with HER2-targeted drugs, the method comprising treating a first BT747 cell line sample (“a first sample of MEL-18-overexpressing HER2-positive breast cancer cell line cells”, as evidenced by Figure 2B of the instant specification) with flaxseed oil and trastuzumab (“a candidate material in the presence of a HER2-targeting drug”) and treating a second control sample of the BT747 cell line with the trastuzumab without flaxseed oil; measuring proliferation of the cell lines in the samples; and selecting flaxseed oil that increases sensitivity of the cell line cells to trastuzumab as compared to the control as an agent that enhances sensitivity (Figure 1(B), in particular).
Claim Rejections - 35 USC § 102
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Han et al (Oncotarget, 2015, 6(36): 38912-38925).
Han et al teaches a method of screening drugs for reducing or overcoming resistance to HER2-targeted drugs or being co-administered with HER2-targeted drugs, the method comprising treating a first BT747 cell line sample (“a first sample of MEL-18-overexpressing HER2-positive breast cancer cell line cells”, as evidenced by Figure 2B of the instant specification) with tunicamycin and trastuzumab (“a candidate material in the presence of a HER2-targeting drug”) and treating a second control sample of the BT747 cell line with the trastuzumab without tunicamycin; measuring survival of the cell lines in the samples measured with SRB; and selecting tunicamycin that increases sensitivity of the cell line cells to trastuzumab as compared to the control as an agent that enhances sensitivity (Figure 1(C), in particular).
Claim Rejections - 35 USC § 112
Claims 1-2 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a NEW MATTER rejection.
Claims 1-2 recite a method comprising treating a first sample of MEL-18-overexpressing HER2-positive breast cancer cell line cells with a candidate material in the presence of a HER2-targeted drug and treating a second sample of the MEL-18-overexpressing HER2-positive breast cancer cell line cells with the HER2-targeted drug without the candidate material as a controls; measuring viability of the MEL-18-overexpressing HER2-positive breast cancer cell line cells in samples; and selecting a candidate material that increases sensitivity of the MEL-18-overexpresing HER2-positive breast cancer cell line cells to the HER2-targeted drug as compared to the control. Descriptions of a method comprising treating a first sample of MEL-18-overexpressing HER2-positive breast cancer cell line cells with a candidate material in the presence of a HER2-targeted drug and treating a second sample of the MEL-18-overexpressing HER2-positive breast cancer cell line cells with the HER2-targeted drug without the candidate material as a controls; measuring viability or proliferation of the MEL-18-overexpressing HER2-positive breast cancer cell line cells in samples; and selecting a candidate material that increases sensitivity of the MEL-18-overexpresing HER2-positive breast cancer cell line cells to the HER2-targeted drug as compared to the control are not found in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the invention was filed, had possession of the claimed invention.
Further, claims 1-2 recite a method comprising treating a first sample of MEL-18-overexpressing HER2-positive breast cancer cell line cells with a candidate material in the presence of a HER2-targeted drug and treating a second sample of the MEL-18-overexpressing HER2-positive breast cancer cell line cells with the HER2-targeted drug without the candidate material as a controls; measuring proliferation of the MEL-18-overexpressing HER2-positive breast cancer cell line cells in samples; and selecting a candidate material that increases sensitivity of the MEL-18-overexpresing HER2-positive breast cancer cell line cells to the HER2-targeted drug as compared to the control. Descriptions of a method comprising treating a first sample of MEL-18-overexpressing HER2-positive breast cancer cell line cells with a candidate material in the presence of a HER2-targeted drug and treating a second sample of the MEL-18-overexpressing HER2-positive breast cancer cell line cells with the HER2-targeted drug without the candidate material as a controls; measuring viability or proliferation of the MEL-18-overexpressing HER2-positive breast cancer cell line cells in samples; and selecting a candidate material that increases sensitivity of the MEL-18-overexpresing HER2-positive breast cancer cell line cells to the HER2-targeted drug as compared to the control are not found in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the invention was filed, had possession of the claimed invention.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642