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 .
Claim Rejections - 35 USC § 101- Updated Due to Amendments
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 16-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Claim 16 recites:
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The remaining claims do not add significantly more because they only further limit by which formula, adding asymmetric carbons, or specifying a large range of wt% of the compound in an agent, or adding an excipient.
In accordance with the 2019 Revised Patent Subject Mater Eligibility Guidance (aka 2019 PEG), the following revised flowchart found in MPEP §2106(III), is used when considering whether or not a claimed invention recites eligible subject matter:
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The invention recited in claims 16-28 are drawn to a composition of matter, in this case a composition comprising a compound of formula 1-4. Step 1 is satisfied.
Step 2 has now been broken out into a two-prong analysis:
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Step 2A first asks whether or not the claimed invention is directed to a judicial exception such as a natural phenomenon (e.g., product of nature). Here, the answer is yes, since the only compositional requirement set forth in the composition comprises a composition comprising at least two compounds of formula 1-4. The reference Koyama et al., Discovery of new hazimycin congeners from Kitasatospora sp. P07101, Acta Pharmaceutica Sinica B 2015;5(6):564–568 provides evidence that “In an analytical study of microbial broths, the actinomycete strain Kitasatospora sp. P07101 was found to produce three new congeners, which were designated hazimycins B (1), C (2), and D (3), together with the previously reported hazimycin (renamed hazimycin A (4))”(abstract) which have the following structures (1-4, figure 1) and are natural products found together in nature that fall under the instantly claimed formula 1-4. Additionally, page 566 states that all structures have the S configuration.
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The second leg of the analysis evaluates whether the claim recites additional elements that integrate the established judicial exception into a practical application of the exception. Based on the recitations provided in claims 16-28, the answer is no. There is not a practical application of the law of nature. These claims do not recite further steps. These claims recite further ingredients that may be naturally occurring (e.g., oils, waxes, and resins as excipients ).
Lastly, step 2B asks if the claim recites additional elements that amount to “significantly more” than the judicial exception. Asked another way, do the claims recite anything additional demonstrating that the recited composition provides an inventive concept? Here, again, the answer is no because the claims simply do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from a natural product. Reciting the intended use of a natural product (i.e., a copper chelating agent, anticancer agent) does not amount to significantly more than the judicial exception. The composition contains naturally occurring ingredients that do not have markedly different characteristics from what occurs in nature. Even though the claimed subject matter recites specific amounts or ratios, the claims are still patent ineligible because each naturally occurring product would still be structurally identical to what exists in nature. The recitation of the (wt%) amounts of ingredients do not arrive at any change in the characteristics (structural or functional) of the naturally occurring ingredients. In the instant case, the claim encompass ingredients that exist in nature thus the composition is formed of naturally occurring ingredients. It does not have markedly different characteristics from any naturally occurring counterpart(s) in their natural state. For example, gunpowder comprising a finely ground mixture of 75 % potassium nitrate, 15 % charcoal and 10 % sulfur. The three counterparts occur naturally in nature. None of them are explosive in nature. When the substances are finely ground and intimately nixed in the claimed ratio, the claimed combination is explosive upon ignition. The explosive property of the claimed combination is markedly different from the non-explosive properties of the substances by themselves in nature and thus the claimed combination has markedly different characteristics. In the instant case, there is no evidence that the combination has any markedly different characteristics. There is no indication that the claimed ingredients has any characteristics (structure, functional or otherwise) that are different from the naturally occurring ingredients. As such, the claims fail to recite subject matter that is patent eligible, and thus the claims do not amount to significantly more than the judicial exception.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 16-19 and 26-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koyama (Koyama et al., Discovery of new hazimycin congeners from Kitasatospora sp. P07101, Acta Pharmaceutica Sinica B 2015;5(6):564–568).
Koyama teaches “In an analytical study of microbial broths, the actinomycete strain Kitasatospora sp. P07101 was found to produce three new congeners, which were designated hazimycins B (1), C (2), and D (3), together with the previously reported hazimycin (renamed hazimycin A (4))”(abstract) which have the following structures (1-4, figure 1) and are natural products found together in nature that fall under the instantly claimed formula 1-4. Additionally, page 566 states that all structures have the S configuration. The reference also taught “We examined antimicrobial activity against 7 test microorganisms using the paper disk method 8.As shown in Table 3, compounds 1–3 and dityrosine did not inhibit the growth of these microorganisms; only compound 4 exhibited antimicrobial activity against Mycobacteriums megmatis, Bacillus subtilis, Staphylococcus aureus, Micro coccusluteus, and Candida albicans with inhibition zones of 19,14, 23, 26 and 20mm, respectively”(page 566). This anticipates claims 16-19 and 26-28.
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Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16 and 20-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koyama (Koyama et al., Discovery of new hazimycin congeners from Kitasatospora sp. P07101, Acta Pharmaceutica Sinica B 2015;5(6):564–568) in view of Chaudhari (Chaudhari et al., Pharmaceutical Excipients: A review, IJAPBC – Vol. 1(1), Jan- Mar, 2012).
The reference Koyama has been discussed supra and does not disclose wherein a content of the at least one compound is 0.0001 wt% to 90 wt% (claims 20 and 25), or the composition with the excipient(claim 21-24).
The reference Chaudhari teaches “Excipients play an important role in formulating a dosage form. These are the ingredients which along with Active Pharmaceutical Ingredients make up the dosage forms. Excipients act as protective agents, bulking agents and can also be used to improve bioavailability of drugs in some instances”(abstract). This helps to teach claim 21-25.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Koyama to get the specific wt% of the instant claims because "[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.). One would be motivated to try new compositions with new wt% as potential antibiotic solutions and one would have a reasonable expectation of success because 0.0001 wt% to 90 wt% is a very large range and so is easy to fall within.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Koyama with Chaudhari because the four compounds are tested for antimicrobial activity and Chaudhari teaches it is common place to add excipients to drugs. One would be motivated to add excipients to potential antimicrobial agents to improve drug characteristics. While only one of the 4 showed activity one of ordinary skill in the art would be motivated to explore antimicrobial activity versus other microorganisms and thus would be motivated to add excipients. One would have a reasonable expectation of success because one would not use serious toxic excipients when determining biological activity.
Response to Arguments
Applicant’s arguments with respect to claims 16-28 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Claims 16-28 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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