DETAILED ACTION
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 .
Status of the Claims
Claims 1-11 are pending and are examined on their merits.
Claim Objections
Claims 1-3, 5, 7, 8, and 11 are objected to because of the following informalities:
In claims 1-3, 5, 7, 8, and 11 the term “nandralone” is misspelled. It should be nandrolone.
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 and its dependent claims 2-11 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.
Claim 1 applicant purports to have invented a method for preventing an inflammation attack on a breast gene, comprising: administering an effective amount of a mixture of anabolic steroids consisting of stanozolol and nandrolone.
Claim 1 and each of the dependent claims are indefinite for reciting the phrase “preventing an inflammation attack on a breast gene” with a “mixture” of anabolic steroids.
One of ordinary skill in the art cannot reasonably determine the metes and bounds of the limitation as described by the applicant as preventing an attack or inflammation on a breast gene. Breast cancer is a complex disease involving a dozen genes or more that are identified as high-risk genes like BRCA1and BRCA2 and other genes that contribute to the development of breast cancer. How does a gene become inflamed? Further, the “mixture” of anabolic steroids the applicant purports to have invented suggests more than simply the combination of two anabolic steroids and may include other anabolic steroids in some sort of cocktail of treatment.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 6, and 8 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Lichten, US Patent No. 9,713,621 B2, issued July 25, 2017, (hereinafter ‘621).
Claim 1 is drawn to a method for preventing an inflammation attack on a breast gene, comprising: administering an effective amount of a mixture of anabolic steroids consisting of stanozolol and nandrolone.
The method is anticipated by ‘621 of using both anabolic steroids stanozolol and nandrolone to treating endometriosis using both stanozolol orally as a tablet and the nandrolone as an injection (as in claim 1 of ‘621). Although the conditions being treated are different; namely endometriosis (of ‘621) and breast cancer (of the instant application), they both use of the same steroid combination. See MPEP 2112.01:
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
Claims 2- 4 further limits claim 1 wherein each of the stanozolol and nandrolone steroids is administered as a suspension thereof (as in claim 2) and claim 3 (that depends from claim 2) wherein the method wherein nandrolone is suspended in benzyl alcohol and an oil selected from the group consisting of peanut oil, grape seed oil and sesame oil; and the stanozolol is suspended in a mixture of paraffin water, benzyl alcohol and sesame oil and claim and the method of claim 3 wherein: the mixture of steroid suspensions is administered as an injection (as in claim 4).
Claim 3 of ‘621 describes the method for treating endometriosis, comprising: injecting an effective amount of a mixture of anabolic steroids consisting essentially of a suspension of stanozolol and a suspension of nandrolone, the stanozolol being suspended in a mixture of paraffin water, benzyl alcohol and sesame oil and the nandrolone being suspended in a mixture of benzyl alcohol and an oil selected from the group consistent of peanut oil, grape seed oil and sesame oil. Therefore, ‘612 anticipates the use of the same steroids in a mixture of suspensions, designed for injection, and the identical excipients utilized for each of the steroids in the claimed invention.
Claim 5 further limits claim 4 wherein the suspension comprises: from about 0.5: 1 to about 2.0: 1 weight ratio of nandrolone to stanozolol, the suspension containing from about 20 mg to about 40 mg of nandrolone per one ml of liquid and from about 15 mg to about 30mg of stanozolol per one ml of liquid.
Claim 4 of ‘621 depends from the method of claim 3 of ‘621 wherein the suspension comprises: from about 0.5: 1 to about 2.0: 1 weight ratio of nandrolone to stanozolol, the suspension containing from about 20mg to about 40 mg of nandrolone per one ml of liquid and from about 15 mg to about 30 mg of stanozolol per one ml of liquid. Therefore, ‘621 anticipates each and every limitation of claim 5 of the instant application.
Claim 6 further limits claim 4 wherein: the injections are administered over a period of seven to fourteen days and from once to twice weekly.
Claim 5 of ‘621 identifies the method of claim 3 wherein: the injections are administered over a period of seven to fourteen days. Although the instant claim identifies the administration from once to twice daily; ‘621 identifies the same period of administration and does not identify a twice daily regimen. Therefore, ‘621 anticipates the same administration period of both steroids.
Claim 8 depends from claim 7 wherein: on a weekly basis from about 20 mg to about 50 mg of stanozolol is orally ingested and from about 20 mg to about 40 mg of nandrolone in a one ml suspension of benzyl alcohol and an oil selected from the group consisting of peanut oil, grape seed oil and sesame oil is injected as a liquid suspension once per week and the oxandrolone is administered daily.
Claim 2 of ‘621 depends from claim 1 wherein: on a weekly basis from about 20 mg to about 50 mg of stanozolol is orally ingested and from about 20 mg to about 40 mg of nandrolone in a one ml suspension of benzyl alcohol and an oil selected from the group consisting of peanut oil, grape seed oil and sesame oil is injected as a liquid suspension once per week. Although ‘621 does not include a dose of oxandrolone, it does anticipate the weekly basis from about 20 mg to about 50 mg of stanozolol is orally ingested and from about 20 mg to about 40 mg of nandrolone in a one ml suspension of benzyl alcohol and an oil selected from the group consisting of peanut oil, grape seed oil and sesame oil is injected as a liquid suspension once per week.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,713,621 B2, issued July 25, 2017, (hereinafter ‘621). Although the claims at issue are not identical, they are not patentably distinct from each other.
Although ‘621 describes the treatment for endometriosis and the instant application is drawn to the treatment of breast cancer, the use of both anabolic steroids consisting of stanozolol and nandrolone are in common with both ‘621 and the instant application. As described in the 102 rejections to claims 1-5, 6, and 8 above, ‘621 teaches all of the applicant’s claim limitations in exacting detail, with the exception of the condition being treated. As noted, MPEP 2112.01 details, in short, products of identical chemical composition cannot have mutually exclusive properties. ‘621 and the instant application both share the same two steroids stanozolol and nandrolone, in a suspension with the same suspension medium, available as an injection, and the same suspension weight ratios/amounts/durations.
Allowable Subject Matter
Claims 7, and 9-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-11 are rejected.
No Claims are allowed.
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/P.R.G./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
