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 .
Priority
A date of 05/12/2023 was used for priority.
Information Disclosure Statement
No information disclosure statement has been provided.
Drawings
The drawings are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
Claim Interpretation
Claim 1 is a compound claim and thus the manner in which the compound is produced does not limit the claim.
Claim Objections
Claim 1 is objected to because of the following informalities: Figure 0.1Formula I should have a space between Figure 0.1 Formula I and it is recommended to remove the label Figure 0.1 and just leave the label Formula I Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the commas in the first and second lines make it unclear if the compound is required to be a compound of claim 1.The applicant is suggested to amend the claim to read: …the compound of claim 1, in the form of an inhaled liquid,… 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 1-2 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 is rejected because the scope of formula I is indefinite. Formula I is unclear on how the Eugenol and Lidocaine portion of the molecule are interacting. It is unclear if a bond is drawn between the -OH or if it is a negative symbol.
A higher resolution image with more clarity on how the -OH group is interacting with the N+ atom would help overcome this rejection.
Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “bouncing” in claim 1 is used by the claim to mean “reacting,” while the accepted meaning is “to cause to rebound or be reflected.” (Merriam-Webster 2025) The term is indefinite because the specification does not clearly redefine the term.
Claims 2 provide for the use of the compounds of claim 1, but, since the claims do not set forth any steps involved in the method/process, it is unclear what method/process Applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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.
Claims 2 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966).
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.
Claim(s) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ninkov (Ninkov, Dusan, US-20030176364-A1, 2003-09-18).
The reference Ninkov teaches “This disclosure provides antimicrobial therapeutic compositions that are believed to have enhanced broad based antimicrobial activity and to be effective and useful for treating infections, especially in humans, though the compositions are also thought to be effective for use in other animals. The combination of an organic phenolic compound with either a local anesthetic, sympathomimetic, or an analgesic compound provides novel compositions that have strong antimicrobial activity and that also reduce pain and/or irritation associated with the administration of organic phenolic compounds. The organic phenolic components are typically the natural agents carvacrol and thymol, that can be isolated from the volatile essential oils of plant species that are members of the Lamiaceae, Labiatae, and Verbenaceae families. The organic phenolic compound and pharmacological base agent are combined either in a chemical reaction, or in mixtures”[0015] and “The essential oils of numerous plant species of the Lamiaceae, Labiatae and/or Verbenacae families also contain organic acids, alcohols, aldehydes, ketones, esters, other phenols, phenol esters, and many more complex organic compounds, many of which possess antimicrobial or other pharmacological activities … They also include, but are not limited to phenol esters anethol, eugenol, and safrol, as well as other more complex compounds. Each of these compounds may be combined or reacted with procaine, lidocaine, and ephedrine, or other like anesthetic, sympathomimetic compound, or analgesic, to produce novel antimicrobial therapeutic compounds” [0067]. This helps to teach claims 1 and 2.
The reference Ninkov teaches “The therapeutic pharmaceutical compositions of the present invention can be used to treat a variety of internal and external infections in subjects including humans and other animals, for example, infections caused by Escherichia spp. including E coli, Salmonella spp. Pasteurella spp., Staphyloccocus spp., Streptoccocus spp., Corinebacterium spp., Bacillus spp., including Bacillus anthracis, Clostridium spp., Spherophorus spp., Candida spp., Trychophyton spp., Microsporum spp., Micobacterium spp., Yibrio spp., Cryptosporidia spp., Microsporidia spp., Listeria monocytogenes, Lawsonia intracellularis, Treponema desynteriae, Enteroccocus spp., Heamophylus spp., Campylobacter spp., Chlamydia spp., Brucella spp., and other pathogenic bacterial species” [0089] and “ Examples of the types of illnesses caused by microbial infections that can be treated in subjects using the pharmaceutical composition of the invention include internal infections, such as infections of the lungs (for example, pneumonia), kidneys, joints, throat, muscles, and other internal organs, such as the heart, liver, pancreas, tonsils, among others”[0092]. The reference also teaches “The nature and purpose of the preparation will determine the ultimate route of delivery”[0075] and “Pharmaceutically acceptable carriers for parenteral preparations include distilled water; aqueous carriers such as sodium chloride injection, ringer's injection, dextrose injection, dextrose and sodium chloride injection, and lactated ringer's injection; water-miscible carriers such as ethyl alcohol, polyethylene glycol and propylene glycol; and nonaqueous carriers such as fixed oils. Ideally the fixed oil is of vegetable origin because such fixed oils tend to be metabolized, are a liquid at room temperature, and do not become rancid rapidly. The oils most commonly used are corn oil, cottonseed oil, peanut oil, and sesame oil; however, any vegetable oil that fits the above parameters may be used” [0077]. This helps to teach claim 2.
The reference Ninkov teaches “It is well known that phenol, as well as alcohols, contain an OH group. In the case of alcohols, the OH group is most often bound to an alkali group while with phenol the OH group is directly bound to the aromatic core. This is the case with carvacrol and thymol, which each have a benzene core that is similar in chemical properties to phenol. Due to the possibility of stabilizing the phenol union, the OH group is easily ionized, i.e., it easily releases the H<+> (proton), which makes phenol group containing molecules weak acids. This acid feature of the phenol moiety may be balanced by adding an organic base, or related compound.
In Table 1, representative pharmacological organic bases that may be combined with the antimicrobial phenolic acids carvacrol and thymol, are listed. One of ordinary skill in the art will appreciate that this list is not exhaustive but merely representative of the myriad of organic bases that may be used to practice embodiments of the present invention. In a preferred embodiment, the organic base is the local anesthetic procaine. In other preferred embodiments, the organic base pharmacological agent is lidocaine or ephedrine”[0057-0058] and from Figure 1A. This helps to teach claims 1 and 2.
The reference Ninkov does not teach the specific combination of instant formula I (all claims) but instead requires picking and choosing of variables.
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 Ninkov to get the instant invention because the reference teaches antimicrobial phenolic acids, including eugenol, reacted with pharmacological acceptable organic bases, including a preferred embodiment of lidocaine, to treat microbial infections. One would have a reasonable expectation of success because Ninkov teaches the chemistry behind the acid base reaction between the phenol compounds and the bases [0057-0058 and Figure 1A]. One would have been motivated to do so to treat microbial infections and because it is obvious to substitute known equivalents of acids and bases suggested for treating microbial infections for the same purpose of treating microbial infections. The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
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 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,037,302 in view of over Ninkov (Ninkov, Dusan, US-20030176364-A1, 2003-09-18).
The patent ‘302 claims:
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This helps to teach claims 1-2.
The patent ‘302 does not teach the compound formed from Eugenol and Lidocaine (instant claims 1-2).
The reference Ninkov further teaches that all needed changes would be obvious as outlined in the 103 rejection (which is incorporated herein by reference).
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 patent ‘302 with the reference Ninkov to get the instant invention because it is obvious to substitute equivalents (antimicrobial phenols) for the same purpose of forming an antimicrobial treatment (e.g., Pasteurella spp.). The reference teaches antimicrobial phenolic acids, including eugenol, reacted with pharmacological acceptable organic bases, including a preferred embodiment of lidocaine, to treat microbial infections. One would have a reasonable expectation of success because Ninkov teaches the chemistry behind the acid base reaction between the phenol compounds and the bases [0057-0058 and Figure 1A]. One would have been motivated to do so to treat microbial infections and because it is obvious to substitute known equivalents of acids and bases suggested for treating microbial infections for the same purpose of treating microbial infections. The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Conclusion
Claims 1-2 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR SALAMATIAN 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.S./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627