DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 11, 2025 has been entered.
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 .
Application Priority
This application filed 4/22/2020, is a PRO 62/836,901 filed on 04/22/2019.
Information Disclosure Statement
No New information disclosure statement(s) (IDS) have been filed.
Response to Arguments
The arguments over the rejections of claims 1, 4-27 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite are moot in view of the amendments made to the claims herein.
The arguments over the rejections of claims 1, 4-27 under 35 U.S.C. 103(a) as being unpatentable over Zhang et al. (US20140228312A1) are not persuasive. The rejection is herewith maintained. Upon further consideration, the Examiner points out, while the limitation of the claims are deleted, the comprising language of formula (I) does not necessarily exclude the use of a second carbon-carbon double bond.
Applicants’ argument regarding the ODP rejection over 17916368 is that the application herein is filed earlier and the ODP rejection should be withdrawn. The Examiner points out the MPEP states “If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.”
Claim Status
Claims 1, 4-27 are pending.
Claims 1, 4-27 are herein acted on the merits.
The following rejections are made:
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 4-6, 8-10, 12-24, 26-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gawande et al. (WO2014134701A1).
Gawande et al. teaches a composition for inhibiting growth or biofilm formation in bacteria associated with wound infections selected from the group comprising:
(a) one or more chelating; (b) a zinc salt; and further comprising an anti-infective compound selected from cis-2-decenoic acid. The composition is for use against one or more infection- associated bacteria or yeasts selected from the group consisting of Salmonella (See claims 1 and 15 and [0014] – reads on inhibition, prevention, and inhibition of expression) The wound infection comprises topical or non- topical use of the composition (See claims 16) A variety of carriers and excipients can be used to formulate an embodiment of this invention and are well known. Such pharmaceutically acceptable vehicles include, but are not limited to, water, ethanol, humectants such as polypropylene glycol, glycerol and sorbitol, gelling agents such as cellulose derivatives, polyoxypropylene/polyoxyethylene block copolymers, carboxy methyl cellulose, pluronic F-127, sodium alginate, polyethylene glycol, thickening agents such as Carbopol™ 934. [0083] Also, the composition comprises one or two chelating agents (EDTA and sodium citrate) and a metal ion salt (zinc chloride or zinc sulfate or zinc lactate) has GRAS (Generally Recognized as Safe) status and all these ingredients are food as well as feed additives. [0086] Also included are other pharmaceutically acceptable vehicles, diluents, and additives such as antioxidants, antiinflammatory compounds, vitamins, tissue degrading enzymes, buffers and solutes that render the formulation isotonic in the intended recipient; and aqueous and non-aqueous sterile suspensions which may include suspending agents, surfactants and thickening agents. [0079] The term "subject" refers to a living vertebrate such as mammal (preferably human and pet animals) in need of treatment. [0060]
While the reference teaches the same compound of the claims to treat a bacterial infection, the prior art fails to exemplify the method, or the mM or milligram amount of the active in the composition or dosage form.
However, Gawande et al. teaches term "therapeutically effective amount" refers to a quantity of a composition high enough to provide a significant positive modification of the subject's condition(s) to be treated. [0061]
It would have been obvious to one of ordinary skill in the art at the time of filing prevent, alleviate or ameliorate symptoms of bacterial infection or prolong the survival of the subject being treated with cis-2-decenoic acid. The motivation to use (cis-2-decenoic acid and modify the amounts is because Gawande et al. teaches a compound that reads on the claimed compound, and the therapeutically effective amount is high enough to provide a significant positive modification of the subject's condition(s) to be treated. Hence a skilled artisan would have had reasonable expectation of success in achieving treatment. In the absence of showing the criticality, of the amounts of each component are deemed to be manipulatable parameters practiced by an artisan to obtain the best possible pharmaceutical results.
Claims 1, 4-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Zhang et al. (US20130131172A1).
Zhang et al. teaches the use of a therapeutically effective amount of a fatty acid represented by formula (I), or a tautomer, geometrical isomer, enantiomer, diastereomer, racemate form, pharmaceutically acceptable salt or prodrug thereof. [abstract]. The prior art specifically teaches the fatty acid represented by formula
PNG
media_image1.png
90
386
media_image1.png
Greyscale
wherein X is a carbon or heteroatom;
R1, R2 and R3 are each independently selected from the group consisting of hydrogen, unsubstituted or substituted C1-C10 alkyl, unsubstituted or substituted C1-C10 alkenyl, unsubstituted or substituted C1-C10 alkynyl, unsubstituted or substituted C3-C8 cycloalkyl, unsubstituted or substituted C1-C10 alkoxy, unsubstituted or substituted C3-C8 cycloalkoxy, unsubstituted or substituted C6-C14 aryl, an unsubstituted or substituted 5- to 10-membered heteroaryl wherein 1 to 4 ring atoms are independently selected from nitrogen, oxygen or sulfur, an unsubstituted or substituted 5- to 10-membered heteroalicyclic ring wherein 1 to 3 ring atoms are independently nitrogen, oxygen or sulfur, —C(O)R , —C(O)OR , 'C(O)NRR′, —NRR′, —S(O)2R, —S(O)2OR, and —S(O)2NRR′, R and R′ are independently selected from the group consisting of hydrogen and unsubstituted or substituted C1-C10 alkyl, unsubstituted or substituted C1-C10 alkenyl, unsubstituted or substituted C1-C10 alkynyl; or a tautomer, geometrical isomer, enantiomer, diastereomer, racemate form, pharmaceutically acceptable salt or prodrug thereof. (Claims 1, 4, 6-7). The compounds of and used in the invention are inclusive of all possible stereo-isomers of the respective compounds, including tautomers, geometric isomers, e.g. Z and E isomers (cis and trans isomers), and optical isomers, e.g. diastereomers and enantiomers. [0048]. The preferred routes of administration are oral and parenteral. [0076]. For oral administration, the present compositions may be formulated by combining the active compounds with pharmaceutically acceptable carriers well known in the art. Such carriers enable the compounds of the invention to be formulated as tablets, pills, lozenges, dragees, capsules, liquids, gels, syrups, slurries, suspensions and the like, for oral ingestion by a patient. [0081]. Present pharmaceutical compositions may be manufactured by processes well known in the art, for example, by means of conventional mixing, dissolving, granulating, drageemaking, levigating, emulsifying, encapsulating, entrapping or lyophilizing processes. [0078] The composition is used for treating or preventing a bacterial infection in a subject or an organism– (reads on inhibition, prevention, and inhibition of expression). The bacterial infection may, for example, be caused by bacteria of the genus Acinetobacter, Actinomyces, Aeromonas, Bordetella, Borrelia, Brucella, Burkholderia, Campylobacter, Chlamydia, Clostridium, Corynebacterium, Enterococcus, Erwinia, Escherichia, Francisella, Haemophilus, Helicobacter, Klebsiella, Legionella, Leptospira, Listeria, Mycobacterium, Mycoplasma, Neisseria, Pseudomonas, Rickettsia, Salmonella, Shigella, Staphylococcus, Streptococccus, Treponema, Veillonella, Vibrio or Yersinia. (claim 18)
While the reference teaches the same compound as claimed in a therapeutically effective amount to treat a bacterial infection, the prior art fails to exemplify the method, or the mM or milligram amount of the active in the composition or dosage form.
However, Zhang et al. teaches the terms "effective amount" means a therapeutically effective amount means an amount of the composition effective to prevent, alleviate or ameliorate symptoms of bacterial infection or prolong the survival of the subject being treated. Determination of a therapeutically effective amount is well within the capability of those skilled in the art, especially in light of the detailed disclosure provided herein. [0098]-[0099]. Dosage amount and interval may be adjusted individually to provide plasma levels of the active species which are sufficient to maintain the anti-bacterial effect. These plasma levels are referred to as minimal effective concentrations (MECs).Dosages necessary to achieve the MEC will depend on individual characteristics and route of administration. HPLC assays or bioassays can be used to determine plasma concentrations. Dosage intervals can also be determined using MEC value. Compounds should be administered using a regimen that maintains plasma levels above the MEC for 10-90% of the time, preferably between 30-90% and most preferably between 50-90%. In cases of local administration or selective uptake, the effective local concentration of the drug may not be related to plasma concentration and other procedures known in the art may be employed to determine the correct dosage amount and interval. The amount of a pharmaceutical composition administered may, of course, be dependent on the subject being treated, the severity of the affliction, the manner of administration, the judgment of the prescribing physician, etc. [0102]- [0103]
It would have been obvious to one of ordinary skill in the art at the time of filing prevent, alleviate or ameliorate symptoms of bacterial infection or prolong the survival of the subject being treated with (Z)-hexadec-2-enoic acid. The motivation to use (Z)-hexadec-2-enoic acid and modify the amounts is because Zhang et al. teaches a compound that reads on the claimed compound, and the amount of a pharmaceutical composition administered may, of course, be dependent on the subject being treated, the severity of the affliction, the manner of administration, the judgment of the prescribing physician. Hence a skilled artisan would have had reasonable expectation of success in achieving desirable prevention, alleviation or ameliorate of symptoms of bacterial infection or prolong the survival of the subject being treated. In the absence of showing the criticality, of the amounts of each component are deemed to be manipulatable parameters practiced by an artisan to obtain the best possible pharmaceutical results.
Claims 11 and 25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gawande et al. (WO2014134701A1), as applied to claims 1, 4-6, 8-10, 12-24, 26-27 above, and further in view of Zhang et al. (US20130131172A1).
Gawande et al. is as discussed above.
While Gawande et al. describes topical or non- topical use of the composition (See claims 16) and all these ingredients are food as well as feed additives [0086], the reference fails to teach the capsule.
Zhang et al. teaches the use of a therapeutically effective amount of a fatty acid represented by formula (I), or a tautomer, geometrical isomer, enantiomer, diastereomer, racemate form, pharmaceutically acceptable salt or prodrug thereof. [abstract]. For oral administration, the present compositions may be formulated by combining the active compounds with pharmaceutically acceptable carriers well known in the art. Such carriers enable the compounds of the invention to be formulated as tablets, pills, lozenges, dragees, capsules, liquids, gels, syrups, slurries, suspensions and the like, for oral ingestion by a patient. [0081].
It would have been obvious to one of ordinary skill in the art at the time of filing to interchange between carriers. The motivation to use capsules is because Gawande et al. describes topical or non- topical use of the composition (See claims 16) and all these ingredients are food as well as feed additives [0086]; and Zhang et al. teaches a fatty acid represented by formula (I), or a tautomer, geometrical isomer, enantiomer, diastereomer, racemate form, pharmaceutically acceptable salt or prodrug thereof. [abstract] used in tablets, pills, lozenges, dragees, capsules, liquids, gels, syrups, slurries, suspensions and the like, for oral ingestion by a patient. Hence a skilled artisan would have had reasonable expectation of success in using a capsule.
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, 4-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 17916368 (reference application) in view of Zhang et al. (US20140228312A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the identical fatty acid is taught but the type of infection to treat is Salmonella herein, while the copending claims are drawn to treating Vibrio infection.
Zhang et al. teaches the fatty acid represented by formula I
PNG
media_image2.png
100
272
media_image2.png
Greyscale
. The aliphatic group is unsaturated and R1 is an alkenyl group, preferably R1 is a C5-C20 alkenyl group and the C5-C20 alkenyl group comprises at least one double bond and wherein the C5-C20 alkenyl group comprises at least one double bond at the carbon-2 position of the fatty acid. (Claims 1, 4, 6-7). The bacterial infection may, for example, be caused by bacteria of the genus Acinetobacter, Actinomyces, Aeromonas, Bordetella, Borrelia, Brucella, Burkholderia, Campylobacter, Chlamydia, Clostridium, Corynebacterium, Enterococcus, Erwinia, Escherichia, Francisella, Haemophilus, Helicobacter, Klebsiella, Legionella, Leptospira, Listeria, Mycobacterium, Mycoplasma, Neisseria, Pseudomonas, Rickettsia, Salmonella, Shigella, Staphylococcus, Streptococccus, Treponema, Veillonella, Vibrio or Yersinia.
It would have been obvious to one of ordinary skill in the art at the time of filing to treat Vibrio infection. The motivation to treat Vibrio infection is because Zhang et al. teaches a compound that reads on the claimed compound, and the bacteria infection to treat include Acinetobacter, Actinomyces, Aeromonas, Bordetella, Borrelia, Brucella, Burkholderia, Campylobacter, Chlamydia, Clostridium, Corynebacterium, Enterococcus, Erwinia, Escherichia, Francisella, Haemophilus, Helicobacter, Klebsiella, Legionella, Leptospira, Listeria, Mycobacterium, Mycoplasma, Neisseria, Pseudomonas, Rickettsia, Salmonella, Shigella, Staphylococcus, Streptococccus, Treponema, Veillonella, Vibrio or Yersinia. Hence a skilled artisan would have had reasonable expectation of successfully treating Vibrio and Salmonella.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference of relevance:
Barker et al. (Components of royal jelly, 10-Hydroxy-trans-2-decenoic acid. Tetrahedron (1962), 18, 177-81).
Gudaityte et al. (Distribution and chemical polymorphism of the essential oils of Achillea cartilaginea growing wild in Lithuania. Natural Product Research (2012), 26(8), 722-73). 2-Pentadecenoic acid.
Romm et al. (CHAPTER 9 - Urinary Complaints. Botanical Medicine for Women's Health. 2010. Pages 290).
US 4215144 A.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM EST.
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 Henry 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.
/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622