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
Claims 1-6 are pending and examined on the merits herein.
Priority
This application claims the following priority:
PNG
media_image1.png
122
653
media_image1.png
Greyscale
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 216 and 218 in Figure 2, and 340a in Figure 4A. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 340 and 370 as described in [0040] of the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0004] states that the electronic copy of the Sequence Listing is 278 bytes in size. However, the correct file size of the electronic copy of the Sequence Listing is 283711 bytes.
Appropriate correction is required.
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.
Claims 1-6 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.
-In claim 1, line 5, the phrase, “the gene inhibitor CPI203” renders the claim indefinite. It is not clear if the “a gene inhibitor” recited in line 2 of the claim is CPI203 as indicated in line 5 of the claim, or if “a gene inhibitor,” in line 2, is any “gene inhibitor.”
Additionally, claim 4, which depends from claim 1, refers to the pre-operative treatment of “the gene inhibitor CPI203,” however claim 1 recites “treating. . .with a gene inhibitor pre-operatively,” and does not specify the pre-operative gene inhibitor as CPI203, rendering claim 4 indefinite for lacking antecedent basis.
In view of compact prosecution, “a gene inhibitor,” in claim 1, is interpreted as “a CPI203 gene inhibitor.”
The rejection over claims 1 and 4 can be overcome by adding the term “CPI203” between “a” and “gene.”
-In claim 3, the phrase “said particular gene comprises BCL2A1” renders the claim indefinite. Since BCL2A1 is a single, whole gene, and since the phrase “a particular gene” connotes a single gene, it is not clear how the particular gene comprises a specific gene, since comprises is an open-ended transition phrase that does not exclude additional components. Thus, it is not clear if the phrase “said particular gene comprises BCL2A1” means that the particular gene is more than one gene, i.e., is BCL2A1 and another/other gene(s), or if this means that BCL2A1 is modified chemically or otherwise to comprise the BCL2A1 gene and additional modifications. The specification does not further define “a particular gene comprising BCL2A1.” As such, the metes and bounds of this phrase are unclear.
This rejection can be overcome by substituting “comprises” with - -is- -.
-In claim 6, the phrase “applying cold plasma at a power setting of 15 Watts” renders the claim indefinite. Since cold plasma is an ionized gas, it is not clear how the cold plasma powers itself at 15 Watts. It is not clear if the cold plasma itself has a power setting or if the cold plasma is applied by a device that has a power setting of 15 Watts.
This rejection can be overcome in claim 6, by inserting the phrase - -by a cold plasma device- -, following the phrase “comprises applying cold plasma.” See [0044] of the instant specification for support.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 12,048,704 (PTO-892) in view of Perez-Salvia (Bromodomain inhibitors and cancer therapy: From structures to application, published 2016, PTO-892).
‘704 claims:
PNG
media_image2.png
235
718
media_image2.png
Greyscale
‘704 differs from that of the instant claims in that it does not specifically teach CPI203 as the gene inhibitor.
Perez-Salvia teaches (2S)-4-(4-chlorophenyl)-2,3,9-trimethyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine6-acetamide, instant CPI203, as a BET bromodomain inhibitor, wherein the inhibitor causes down regulation of gene activity, for the treatment of cancer (abstract; pgs. 324-325 “BET bromodomains”; pg. 327, Figure 3; pg. 328, Table 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select CPI203 as the gene inhibitor of ‘704, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘704 claims its methods for the treatment of cancer and claims the administration of a gene inhibitor within its methods, and
-Perez-Salvia teaches CPI203 as a gene inhibitor useful for the treatment of cancer.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method that successfully treats cancer by combining surgery with further inhibition of tumor growth and/or spread.
Regarding claims 2 and 3, while Perez-Salvia does not explicitly teach CPI203 for the treatment of triple negative breast cancer, it does teach other BET bromodomain inhibitors for the treatment of triple negative breast cancer (pg. 328, Table 1). As such, an ordinary skilled artisan would have been motivated to select the CPI203 to treat triple negative breast cancer, since Perez-Salvia teaches BET bromodomain inhibitors as useful and effective in the treatment of triple negative breast cancer; thus, an ordinary skilled artisan would reasonably expect CPI203 to also treat triple negative breast cancer.
Specifically regarding claim 3, since BCL2A1 is upregulated in triple-negative breast cancer, an ordinary skilled artisan would readily expect the treatment of triple negative breast cancer with CPI203 to inhibit the upregulation of BCL2A1. See MPEP 2112.02, Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.
Moreover, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Since the combination of ‘704 and Perez-Salvia teaches a method of treating triple negative breast cancer by administering CPI203, the method would necessarily inhibit the upregulation of BCL2A1.
Claims 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,957,399 (PTO-892) in view of Perez-Salvia (Bromodomain inhibitors and cancer therapy: From structures to application, published 2016, PTO-892).
‘399 claims:
PNG
media_image3.png
313
721
media_image3.png
Greyscale
‘399 differs from that of the instant claims in that it does not specifically teach CPI203 as the chemotherapy.
Perez-Salvia is applied as discussed above and incorporated herein.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select CPI203 as the chemotherapy of ‘399, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘399 claims its methods for the treatment of cancer and claims within its methods, the administration of a gene inhibitor, and
-Perez-Salvia teaches CPI203 as a gene inhibitor useful for the treatment of cancer.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a method that successfully treats cancer by combining surgery with further inhibition of tumor growth and/or spread.
Regarding claims 2 and 3, while Perez-Salvia does not explicitly teach CPI203 for the treatment of triple negative breast cancer, it does teach BET bromodomain inhibitors for the treatment of triple negative breast cancer (pg. 328, Table 1). As such, an ordinary skilled artisan would have been motivated to select the CPI203 to treat triple negative breast cancer, since Perez-Salvia teaches BET bromodomain inhibitors as useful and effective in the treatment of triple negative breast cancer; thus, an ordinary skilled artisan would reasonably expect CPI203 to also treat triple negative breast cancer.
Specifically regarding claim 3, since BCL2A1 is upregulated in triple-negative breast cancer, an ordinary skilled artisan would readily expect, the treatment of triple negative breast cancer with CPI203 would inhibit the upregulation of BCL2A1. See MPEP 2112.02, Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.
Moreover, MPEP 2111.04 states, a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). Since the combination of ‘704 and Perez-Salvia teaches a method of treating triple negative breast cancer by administering CPI203, the method would necessarily inhibit the upregulation of BCL2A1.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAUREN WELLS/Primary Examiner, Art Unit 1622
Prosecution Insights