DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
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Information Disclosure Statement
No information disclosure statement (IDS) has been filed in the instant application. Applicants are reminded of their duty to disclose all information known to them to be material to patentability as defined in 37 CFR 1.56.
Status of Claims
Currently, claims 1, 5 and 17 are pending in the instant application and under consideration herein.
Claim Rejections 35 U.S.C. 102
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim 1 is rejected under 35 U.S.C. 102(b) as being anticipated by Nelson et al. (WO 2004/091513).
Nelson et al. teach the 9-substituted minocycline, and its hydrochloride salt, pharmaceutical composition comprising the same and method of using the same for treating bacterial infection, such as S. aureus, including those resistant to other tetracycline compounds. See, particularly, the abstract, compound of formula III at pages 3 bridging to page 4 page 6, lines 3-10; page 26, lines 13-22; page 33, lines 1-8; page 35, compound OH and the claims. Oral administration, such as in tablet, and intravenous administration, in a liquid composition, for the compound are disclosed. See, particularly, page 29, line 25 to page 30, line 14. Since the prior art teaches all required limitation, the claims are anticipated.
Claim Rejections 35 U.S.C. 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 5 and 17 is rejected under 35 U.S.C. 103(a) as being unpatentable over Nelson et al. (WO 2004/091513).
Nelson et al. teach the 9-substituted minocycline, and its pharmaceutical acceptable salts, such as hydrochloride p-toluenesulfonate (tosylate), pharmaceutical composition comprising the same and method of using the same for treating bacterial infection, such as S. aureus, including those resistant to other tetracycline compounds. See, particularly, the abstract, compound of formula III at pages 3 bridging to page 4, page 6, lines 3-10; page 26, lines 13-22; page 27, lines 18-30; page 33, lines 1-8; page 35, compound OH and the claims. Note, without further disclosure, the S. aureus would read on both MSSA and MRSA. The drug may be formulated for oral administration, such as in tablet, and intravenous administration, in a liquid composition, for the compound are disclosed. See, particularly, page 29, line 25 to page 30, line 14. In general, the compound can be administered to a subject in dosages used in prior tetracycline therapies, but within the range of 0.1 to 50 mg/ kg of body weight. See, particularly, page 31, lines 7-15.
Nelson et al. do not teach expressly the particular amount of the compound in the composition, or particular salt employed herein.
However, it would have been prima facie obvious to a person of ordinary skill in the art, at the time the claimed the invention was made, to use the particular amounts herein for making a pharmaceutical composition and to use the same for treating the bacterial infection.
A person of ordinary skill in the art would have been motivated to use the particular amounts herein for making a pharmaceutical composition and to use the same for treating the bacterial infection because it is a matter of optimization of result affecting parameters to find an optimal amounts of the therapeutical compounds. The optimization of a result effective parameter, e.g., dosage, is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. Further, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, treatment of patients infected or susceptible to the infection due to any injury or wound would have been within the purview of ordinary skill in the art. Accordingly, it would have been routine and obvious to discover the optimum or workable ranges by routine experimentation, which would have been obvious.
Double Patenting Rejections
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 17 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 10 of prior U.S. Patent No. 9,265,740. This is a statutory double patenting rejection.
In particular, the rejected claim is rejected as claiming an identical scope as the patented claim of the same number. Since the claim recites a scope which is identical to that already patented, a statutory double patenting rejection is appropriate.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 5 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 9,265,740. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘740 patent claims a method of treating complicated skin and skin structure infection comprising administering the patient the compound herein, wherein the infection include those caused by Staphylococcus aureus, such as MRSA or MSSA.
Claims 1, 5 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,724,358. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘358 patent claims a method of treating complicated skin and skin structure infection comprising administering the patient the compound herein, wherein the infection include those caused by Staphylococcus aureus, such as MRSA or MSSA.
Claims 1, 5 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,124,014. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘014 patent claims a method of treating complicated skin and skin structure infection comprising administering the patient the compound herein, wherein the infection include those caused by Staphylococcus aureus, such as MRSA or MSSA.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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