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 .
Drawings
The drawings are objected to because the key for figure 5 is unclear due to the gray scale being too similar in color and figure 6 is illegible due to poor image resolution. 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 it contains an embedded hyperlink (http://n2t.net/addgenc:26161 (page 28)) and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the term GraphPad Prism (pages 2 and 29), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 3 is objected to because of the following informalities: the last three lines of the claim have poor resolution. Appropriate correction is required.
Claims 5-15 and 17-22 are objected to because of the following informalities: the last two lines of claim 5 have poor resolution, the citation of claim 5 in claim 10 has poor resolution, the citation of claim 10 in claim 17 and compounds 30-41 have poor resolution, the amendments in claims 19-20 have poor resolution Appropriate correction is required.
Claim 2 is objected to because of the following informalities: there should be commas between the chemical structures. Appropriate correction is required.
Claim 1-2 are objected to because of the following informalities: the “or” in claim 1 should be lower case. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: the wedge bond next to the double bond should be in the plane of the page because of the double bond. Appropriate correction is required.
Claims 20-22 are objected to because of the following informalities: period in the middle of claim 20. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 2-3, 8-10 and 14 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.
Claims 2-3 and 9 are rejected because the scope of the claims are indefinite due to an open ended Markush grouping. Claim 2 is indefinite in scope because it states, “the formula comprises” and then list several specific compounds. It is unclear if it also then includes different compounds including derivatives of these compounds as well. Claim 3 is indefinite because it states, “R4 comprises” it is unclear what other alternative R4s are intended to be included by the claim. Claim 9 is indefinite in scope because it states a derivative comprising a compound of one of three formula and what other alternatives the formulas are intended to be is unclear. A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (each independent claim recites "a selection from the group comprising a person, an animal, an animated character, a creature, an alien, a toy, a structure, a vegetable, and a fruit." … (emphasis added). "Given the breadth of variation among the specified alternatives and the use of the open-ended word ’comprising’ to define the scope of the list, we affirm the Board's conclusion that the pending claims recite improper Markush language and are indefinite under § 112(b).").
The parentheses in claims 8 and 14 renders the claims 8 and 14 indefinite because it is unclear whether the limitations within the parentheses are a required part of the claimed invention. See MPEP § 2173.05(d).
Claim 10 recites the limitation "the gram-positive bacteria" in last two lines. There is insufficient antecedent basis for this limitation in the claim. The gram-positive bacteria lacks antecedent basis because the claim states a bacteria in the first line. It is unclear if this bacteria is limited to gram-positive bacteria and thus the claim is indefinite. Additionally, if it were interpreted as limited to gram-positive bacteria than claim 11 would not be further limiting. Thus the broadest reasonable interpretation is a bacteria is meant to mean any bacteria.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 20 improperly broaden claim 17 from which it depends by including (+) Puupehenone as an option for the compound. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
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.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Claim 3 recites a compound of Formula III:
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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 claim 3 is drawn to a composition of matter, in this case a compound. 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 compound of formula III, this includes (+)-Puupehenone(see instant Figure 1, natural products).
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 claim 3, the answer is no.
There is not a practical application of the law of nature.
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.
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) 5-6, 8, 10-12, 14, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SELF(SELF et al., US10314813B2, 2019-06-11) as evidenced by Lawson (Lawson et al., Reclassification of Clostridium difficile as Clostridioides difficile (Hall and O'Toole 1935) Prévot 1938, Anaerobe, 2016 Aug:40:95-9. doi: 10.1016/j.anaerobe.2016.06.008. Epub 2016 Jun 28, abstract).
The reference SELF teaches “Clostridium is a genus of rod-shaped Gram-positive bacteria capable of producing endospores. The methods set forth herein can be used to treat the vegetative as well as the spore form of any Clostridium infection. Several Clostridium species are responsible for disease in humans. These include, but are not limited to, Clostridium difficile (C. difficile ), Clostridium botulinum (C. botulinum ), Clostridium perfingens (C. perfingens ), Clostridium tetani (C. tetani ) and Clostridium sordelli (C. sordelli ). The reference Lawson provides evidence that Clostridium difficile is another name for Clostridioides difficile(title).
The reference SELF teaches “It has now been discovered that Puupehenone, or derivatives thereof, and compositions containing same have remarkable antimicrobial activity. Specifically, it has been shown that Puupehenone has a potent antimicrobial activity on strains of C. difficile . Accordingly, certain embodiments herein relate to killing, inhibiting growth, or reducing a population of C. difficile bacteria involving subjecting the one or more C. difficile bacteria to a composition comprising puupehenone, or a derivative thereof at an effective amount to effect such killing, growth inhibition or reduction of the population. The term population includes one or more microbes. Alternatively, puupehenol is used as the active agent. Other embodiments relate to a composition comprising a pharmaceutically acceptable carrier and an effective amount of a puupehenone compound. The term “puupehenone compound” as used herein refers to puupehenone or a derivative thereof, as well as a salt form of any of the foregoing”[0016-0017]. This anticipates claims 5-6, 10-12 and 20.
The reference SELF teaches “The composition could be formulated for non-patient uses (e.g. treating surfaces) or could be formulated with a carrier that is suitable for use on or in a patient. The composition could be administered parenterally, orally, intrarectally, topically, or other suitable modes of administration”[0024] and “The term patient or subject includes human and veterinary subjects”[0036]. This anticipates claims 8 and 14-15.
Claim(s) 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bourguet-Kondracki (Bourguet-Kondracki et al., Methanol Adduct of Puupehenone, a Biologically Active Derivative from the Marine Sponge Hyrtios Species, J. Nat. Prod. 1999, 62, 1304-1305, IDS).
The reference Bourguet-Kondracki teaches compound 1(page 1), wherein R4=H.
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This anticipates claim 3.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PubChem(PubChem CID, 10765719, 15alpha-Methoxypuupenhol diasetate", 2006-10-26, IDS).
The reference PubChem teaches the following compound (section 1.1), wherein R3=Me, R1=R2=Ac. This anticipates claims 1-2.
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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) 5-7, 9-10, 13, 17-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over SELF(SELF et al., US10314813B2, 2019-06-11) as evidenced by Lawson (Lawson et al., Reclassification of Clostridium difficile as Clostridioides difficile (Hall and O'Toole 1935) Prévot 1938, Anaerobe, 2016 Aug:40:95-9. doi: 10.1016/j.anaerobe.2016.06.008. Epub 2016 Jun 28, abstract) further in view of PubChem(PubChem CID, 10765719, 15alpha-Methoxypuupenhol diasetate", 2006-10-26, IDS) .
The reference SELF teaches “Clostridium is a genus of rod-shaped Gram-positive bacteria capable of producing endospores. The methods set forth herein can be used to treat the vegetative as well as the spore form of any Clostridium infection. Several Clostridium species are responsible for disease in humans. These include, but are not limited to, Clostridium difficile (C. difficile ), Clostridium botulinum (C. botulinum ), Clostridium perfingens (C. perfingens ), Clostridium tetani (C. tetani ) and Clostridium sordelli (C. sordelli ). The reference Lawson provides evidence that Clostridium difficile is another name for Clostridioides difficile(title).
The reference SELF teaches “It has now been discovered that Puupehenone, or derivatives thereof, and compositions containing same have remarkable antimicrobial activity. Specifically, it has been shown that Puupehenone has a potent antimicrobial activity on strains of C. difficile . Accordingly, certain embodiments herein relate to killing, inhibiting growth, or reducing a population of C. difficile bacteria involving subjecting the one or more C. difficile bacteria to a composition comprising puupehenone, or a derivative thereof at an effective amount to effect such killing, growth inhibition or reduction of the population. The term population includes one or more microbes. Alternatively, puupehenol is used as the active agent. Other embodiments relate to a composition comprising a pharmaceutically acceptable carrier and an effective amount of a puupehenone compound. The term “puupehenone compound” as used herein refers to puupehenone or a derivative thereof, as well as a salt form of any of the foregoing”[0016-0017].
The reference SELF teaches “The composition could be formulated for non-patient uses (e.g. treating surfaces) or could be formulated with a carrier that is suitable for use on or in a patient. The composition could be administered parenterally, orally, intrarectally, topically, or other suitable modes of administration”[0024] and “The term patient or subject includes human and veterinary subjects”[0036].
The reference SELF teaches “Due to the both the emergence of antibiotic resistance and more virulent pathogens, there is a growing need for new antibacterial agents for use in clinical settings. Antibiotic resistance occurs in both gram-positive and gram-negative pathogens and generally arises within a hospital setting but can then spread to the general community. Multi-drug resistant and pandrug resistant gram-negative bacteria including Acinetobacter baumanii, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa pose the threat of untreatable infections. Current figures show that the number of deaths caused by methicillin-resistant Staphylococcus aureus (MRSA) infections is greater than that of HIV and tuberculosis combined and this has led to an increase in health-care costs due to MRSA which is estimated to be $3 billion to $4 billion per year. Clostridium difficile , a nosocomial pathogen is the etiologic agent for pseudomembranous colitis and can be fatal if not properly treated. Extension of hospitalization due to C. difficile infection has estimated costs of as much as 3.2 billion dollars per year. The virulence of C. difficile is on the rise and with rising numbers of infections in hospitals and long-term care facilities this organism has become one of the major public health threats of the 21st century. The emergence of resistance coupled with the emergence of new, more virulent, pathogens demands the discovery of novel antibiotics”[0001]. This helps to teach claims 7 and 13.
The reference SELF does not specifically teach a composition for treating bacteria with drug resistant properties(claims 7 and 13), or a derivative of the formula I-III(claim 9) or specific compounds of claims 17-18 or 22.
The reference PubChem teaches the following compound (section 1.1), wherein R3=Me, R1=R2=Ac. This helps to teach claims 9, 17-18, 20 and 22.
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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 SELF to treat bacteria that are resistant to other types of drugs with the new antibiotics described in the reference. One would be motivated to do so because bacteria may not be resistant to the new antibiotics and one would have a reasonable expectation of success because if they are new the bacteria likely would not have evolved to be resistant.
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 SELF with PubChem because SELF teaches that Puupehenone, or derivatives thereof have remarkable antimicrobial activity and PubChem teaches a puupehenone derivative. One would be motivated to use the puupehenone derivative of PubChem because it may be a new antimicrobial that would be good against drug resistant bacteria. One would have a reasonable expectation of success because it is a puupehenone derivative and SELF teaches such compounds have remarkable antimicrobial activity.
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 SELF with PubChem to achieve compound 20 because the only difference between the PubChem compound and compound 20 is the Ac group instead of the methyl group. One would have a reasonable expectation of success because it is clear from the PubChem compound that it is obvious to protect O atoms of a puupehenone derivative with Ac groups. One would have motivation to do so to potentially produce new antimicrobial compounds.
Claim(s) 5, 10, 17, 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over SELF(SELF et al., US10314813B2, 2019-06-11) as evidenced by Lawson (Lawson et al., Reclassification of Clostridium difficile as Clostridioides difficile (Hall and O'Toole 1935) Prévot 1938, Anaerobe, 2016 Aug:40:95-9. doi: 10.1016/j.anaerobe.2016.06.008. Epub 2016 Jun 28, abstract) further in view of STN(STN, CAS REGISTRY 2087916-81-0 , Entered STN: 21 Mar 2017).
The references SELF and Lawson have been discussed supra and do not disclose a compound of claim 21.
The reference STN teaches the following compound which is the same as instant compound 30 (see page 13 of the instant specification). This helps to teach claims 20-21.
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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 SELF with STN because SELF teaches that Puupehenone, or derivatives thereof have remarkable antimicrobial activity and STN teaches a puupehenone derivative. One would be motivated to use the puupehenone derivative of STN because it may be a new antimicrobial that would be good against drug resistant bacteria. One would have a reasonable expectation of success because it is a puupehenone derivative and SELF teaches such compounds have remarkable antimicrobial activity.
Claim(s) 5-7, 9-10, 13, 17, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over SELF(SELF et al., US10314813B2, 2019-06-11) as evidenced by Lawson (Lawson et al., Reclassification of Clostridium difficile as Clostridioides difficile (Hall and O'Toole 1935) Prévot 1938, Anaerobe, 2016 Aug:40:95-9. doi: 10.1016/j.anaerobe.2016.06.008. Epub 2016 Jun 28, abstract) further in view of PubChem(PubChem CID, 10765719, 15alpha-Methoxypuupenhol diasetate", 2006-10-26, IDS) further in view of Felix (Felix et al., Selective Killing of Dormant Mycobacterium tuberculosis by Marine Natural Products, Experimental Therapeutics August 2017 Volume 61 Issue 8 10.1128/aac.00743-17).
The references SELF, Lawson and PubChem have been discussed supra and do not disclose mycobacterium tuberculosis(claim 19).
The reference Felix teaches “In this study, we isolated two terpene quinones with high selectivity against dormant M. tuberculosis from a sponge in the Petrosia (formerly Strongylophora) genus. Terpene quinones, including puupehenone metabolites, have been extensively studied for their antimicrobial and cytotoxic properties (32, 48–52). Nonetheless, this is the first report demonstrating that they selectively inhibit dormant drug-tolerant M. tuberculosis. The puupehenone derivatives identified here showed antituberculosis activity similar to that previously reported for puupehenone itself (26). The MICD of 15-α-methoxypuupehenol, 0.5 μg/ml, was more than 20-fold lower than its MICR of 11.5 μg/ml (Fig. 4 and Table 2). Furthermore, bactericidal activity was observed for this compound against dormant, but not replicating, M. tuberculosis at only 2-fold the MICD (Fig. 5). The methanol adduct of puupehenone had been previously isolated from the sponge Hyrtios sp. (32). Another analog, puupehedione, was isolated from the same organism. Consistent with previous studies, this compound had minor activity against replicating M. tuberculosis (26). However, a 6-fold selectivity for dormant M. tuberculosis was still observed with puupehedione (Table 2)”(page 10) and “Selective Killing of Dormant Mycobacterium tuberculosis by Marine Natural Products”(title). This helps to teach claim 19.
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 SELF and PubChem with Felix because SELF teaches that Puupehenone, or derivatives thereof have remarkable antimicrobial activity and Felix teaches a puupehenone derivative are useful for treating bacteria infection of Mycobacterium tuberculosis . One would be motivated to use the new puupehenone derivative because it may be a new antimicrobial that would be good against drug resistant bacteria such as Mycobacterium tuberculosis. One would have a reasonable expectation of success because it is a puupehenone derivative and SELF and Felix teaches such compounds have remarkable antimicrobial activity.
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 3, 5-6, 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10314813 B2 as evidenced by Lawson (Lawson et al., Reclassification of Clostridium difficile as Clostridioides difficile (Hall and O'Toole 1935) Prévot 1938, Anaerobe, 2016 Aug:40:95-9. doi: 10.1016/j.anaerobe.2016.06.008. Epub 2016 Jun 28, abstract). Although the claims at issue are not identical, they are not patentably distinct from each other because reference claim 1 teaches puupehenone and instant claim 3 claims the same compound.
Additionally, puupehenol (reference claim 2) is a derivative of puupehenone and ethanol (reference claim 6) is a pharmaceutical acceptable carrier.
Patent ‘813 claims:
“1. A method for killing, inhibiting growth, or reducing a population of Clostridium bacteria, the method comprising subjecting the population to a composition comprising puupehenone or puupehenol, or salt form thereof, at an effective amount to effect such killing, growth inhibition or reduction of the population”
“3. The method of claim 1, wherein the composition comprises a carrier”
“6. The method of claim 5, wherein the alcohol is selected from the group consisting of methanol, ethanol, n-propanol, isopropanol, n-butanol, isobutanol, n-pentanol, isopentanol, hexanol, heptanol, or isoamyl alcohol and a combination thereof”
“13. The method of claim 11, wherein the Clostridum infection is a C. perfingens infection, C. difficile infection, C. tetani infection or a C. botulinum infection”.
The reference Lawson provides evidence that Clostridium difficile is another name for Clostridioides difficile(title).
This anticipates claims 5-6, 10-12.
Claims 5-10, 13-15 and 17-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10314813 B2 in view of U.S. Patent No. 10314813 B2 ( whole document as prior art) as evidenced by Lawson (Lawson et al., Reclassification of Clostridium difficile as Clostridioides difficile (Hall and O'Toole 1935) Prévot 1938, Anaerobe, 2016 Aug:40:95-9. doi: 10.1016/j.anaerobe.2016.06.008. Epub 2016 Jun 28, abstract) further in view of PubChem(PubChem CID, 10765719, 15alpha-Methoxypuupenhol diasetate", 2006-10-26, IDS) further in view of STN(STN, CAS REGISTRY 2087916-81-0 , Entered STN: 21 Mar 2017) further in view of Felix (Felix et al., Selective Killing of Dormant Mycobacterium tuberculosis by Marine Natural Products, Experimental Therapeutics August 2017 Volume 61 Issue 8 10.1128/aac.00743-17).
The patent ‘813 claims:
“1. A method for killing, inhibiting growth, or reducing a population of Clostridium bacteria, the method comprising subjecting the population to a composition comprising puupehenone or puupehenol, or salt form thereof, at an effective amount to effect such killing, growth inhibition or reduction of the population”
“3. The method of claim 1, wherein the composition comprises a carrier”
“6. The method of claim 5, wherein the alcohol is selected from the group consisting of methanol, ethanol, n-propanol, isopropanol, n-butanol, isobutanol, n-pentanol, isopentanol, hexanol, heptanol, or isoamyl alcohol and a combination thereof”
“13. The method of claim 11, wherein the Clostridum infection is a C. perfingens infection, C. difficile infection, C. tetani infection or a C. botulinum infection”.
The patent ‘813 does not teach drug resistant bacteria (claims 7 and 13), methods of administration (claims 8 and 14), a compound of formula I-III that is a derivative (claim 9), where the subject is human (claim 15), a compound or specific bacteria of claims 17-22.
The secondary references further teach that all needed changes would be obvious as outlined in the 103 rejections (which are incorporated herein by reference).
It would have been prima facie obvious to one of ordinary skill in the art to have modified patent ‘813 with SELF to treat bacteria that are resistant to other types of drugs with the new antibiotics methods described in the reference because both teach the same method for treating bacterial infections. One would be motivated to do so because bacteria may not be resistant to the new antibiotics and one would have a reasonable expectation of success because if they are new the bacteria likely would not have evolved to be resistant.
It would have been prima facie obvious to one of ordinary skill in the art to have modified patent ‘813 with SELF with PubChem because SELF teaches that Puupehenone, or derivatives thereof have remarkable antimicrobial activity and PubChem teaches a puupehenone derivative. One would be motivated to use the puupehenone derivative of PubChem because it may be a new antimicrobial that would be good against drug resistant bacteria. One would have a reasonable expectation of success because it is a puupehenone derivative and SELF teaches such compounds have remarkable antimicrobial activity.
It would have been prima facie obvious to one of ordinary skill in the art to have modified patent ‘813 with SELF with PubChem to achieve compound 20 because the only difference between the PubChem compound and compound 20 is the Ac group instead of the methyl group. One would have a reasonable expectation of success because it is clear from the PubChem compound that it is obvious to protect O atoms of a puupehenone derivative with Ac groups. One would have motivation to do so to potentially produce new antimicrobial compounds.
It would have been prima facie obvious to one of ordinary skill in the art to have modified patent ‘813 with SELF with STN because SELF teaches that Puupehenone, or derivatives thereof have remarkable antimicrobial activity and STN teaches a puupehenone derivative. One would be motivated to use the puupehenone derivative of STN because it may be a new antimicrobial that would be good against drug resistant bacteria. One would have a reasonable expectation of success because it is a puupehenone derivative and SELF teaches such compounds have remarkable antimicrobial activity.
It would have been prima facie obvious to one of ordinary skill in the art to have modified patent ‘813 with SELF and PubChem with Felix because SELF teaches that Puupehenone, or derivatives thereof have remarkable antimicrobial activity and Felix teaches a puupehenone derivative are useful for treating bacteria infection of Mycobacterium tuberculosis . One would be motivated to use the new puupehenone derivative because it may be a new antimicrobial that would be good against drug resistant bacteria such as Mycobacterium tuberculosis. One would have a reasonable expectation of success because it is a puupehenone derivative and SELF and Felix teaches such compounds have remarkable antimicrobial activity.
Conclusion
Claims 1-3, 5-15 and 17-22 are rejected.
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/ALISON AZAR HASTINGS/ Examiner, Art Unit 1627
