FINAL 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 .
Status of Claims
Receipt is acknowledged of the claim amendments filed on 21 October 2025.
Claim 1 has been amended.
Claims 2, 15, 18 and 22 are cancelled.
Claims 26-31 remains withdrawn from consideration.
Claims 32-35 have been added.
Consequently, claims 1, 3-14, 16-17, 19-21, 23-25 and 32-35 are presented for examination herein.
Priority
Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statements (IDSs) filed 10/202025, 11/19/2025 and 12/29/2025 have been considered by the Examiner. A signed and initialed copy of the IDS is included with the instant Office Action.
Rejections Maintained and Modified as Necessitated by the Claim Amendments
Claim Rejections - 35 USC § 103
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 of this title, 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.
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 35 U.S.C. 103 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.
Claims 1, 3-14, 16-17, 19-21, 23-25 and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over RAAD (US 2010/0055086 A1, publication date of 4 March 2010) in view of ROSENBLATT (US 2010/0087788 A1, publication date of 8 April 2010).
Raad is primarily directed towards antimicrobial solutions that comprise at least on alcohol, at least one antimicrobial agent and at least one chelator and/or anticoagulant (abstract).
Regarding claims 1, 3 and 32-35, Raad discloses antimicrobial solutions comprising at least one alcohol, at least one antimicrobial agent, and at least one chelator and/or anticoagulant (paragraph [0011]). Raad discloses that the antimicrobial agent includes chlorhexidine (paragraph [0028]). Raad discloses that the chelator agent includes EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid) (paragraph [0034] and TABLE 1). Raad discloses that the alcohol includes ethanol and isopropanol (paragraph [0036]). Raad discloses that solution is including a locking solution for filling and/or flushing a medical indwelling device including a catheter (paragraph [0049]). Raad discloses that EDTA enhances the antimicrobial activity of other antimicrobial agents (paragraph [0069]). Raad discloses including alcohol diluted with distilled water (e.g., aqueous solution) (paragraph [091]). Raad discloses an antimicrobial solution comprising ethanol, chlorhexidine and EDTA (claim 18 of Raad). Raad discloses that the concentration of alcohol is more preferably in the range of 10% to 50% (v/v) (paragraph [0083]). Raad discloses a total volume of including 3 ml of ready to use preparation (paragraph [0090]). A 3 ml solution with 50% v/v of ethanol contains about 44.10% by weight of ethanol (calculation: [1.1835 g (mass of 50% v/v ethanol in 3 ml)/ 2.6835 g (total mass of ethanol and water in 50% v/v ethanol in 3 ml)] x 100 ~ 44.10%). A 3 ml solution with 10% v/v of ethanol contains about 8.02% by weight of ethanol (calculation: [0.2355 g (mass of 10% v/v ethanol in 3 ml)/ 2.9355 g (total mass of ethanol and water in 10% v/v ethanol in 3 ml)] x 100 ~ 8.02%). Thus, the range of 10% to 50% v/v of ethanol (e.g., about 8.02% by weight to about 44.10%) overlaps the range of “10.0 wt% to about 20.0 wt%” and “about 2.0 wt% to about 50.0 wt%”, recited in claims 1, 32 and 34, respectively. Thus, the amount of ethanol is rendered prima facie obvious. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also MPEP 2144.05. Radd discloses that the concentration of EDTA is in the range of 10-100 mg/ml (paragraph [0038]). A 3 ml solution with 100 mg/ml of EDTA contains about 10.05% by weight of EDTA (calculation: [300 mg (EDTA) / 2983.5 mg (total mass of 3ml solution with 50% v/v ethanol)] x 100 ~ 10.05%). A 3 ml solution with 10 mg/ml of EDTA contains about 1.105% by weight of EDTA (calculation: [30 mg (EDTA) / 2713.5 mg (total mass of 3ml solution with 50% v/v ethanol)] x 100 ~ 1.105%). Thus, the amount of 10-100 mg/ml of EDTA in including a 3ml solution of 50% v/v ethanol (e.g., about 1.105 wt% to about 10.05 wt%) overlaps the range of “about 1.0 wt% to about 4.0 wt%” and “about 0.05 wt% to about 10.0 wt%”, recited in claims 1, 32 and 33, respectively. Thus, the amount of EDTA is rendered prima facie obvious. See MPEP 2144.05 (quoted supra).
Raad does not specifically teach that the amount of the chlorhexidine of about 0.015 µg/mL to about 100.0 µg/mL. The deficiency is made up for by the teachings of Rosenblatt.
Rosenblatt is primarily directed towards implantable catheters treated with chlorhexidine and methods for disinfecting the catheters with alcohol (abstract).
Regarding claims 1 and 11-12, Rosenblatt teaches a synergistic relationship between chlorhexidine and alcohol to combat infection of implantable medical devices such as catheters with reduced risk of toxicity (paragraph [0011]). Rosenblatt teaches synergy of ethanol and chlorhexidine by showing that chlorhexidine when present with ethanol at a % including 5.6% for E.(e.g., gram-positive), 9.6% for S. aureus (e.g., gram-positive), and 8% for E. coli (e.g., gram-negative) that is 80% of MIC (minimum inhibitory concentration) for ethanol, the MBC (minimum bacteriocidal) of chlorhexidine drops about 50% to including 4 µg/ml for E. faecalis, 1 µg/ml for S. aureus, and 2 µg/ml for E. coli which shows that potency is increased (paragraph [0034] and TABLE 2).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce a solution in a volume of including 3 ml that comprises ethanol, chlorhexidine and EDTA; wherein the amount of ethanol is in a range of 10% to 50% v/v (e.g., about 8.02% by weight to about 44.10% by weight); wherein the amount of the chlorhexidine is including at a minimum of 4 µg/ml; and wherein the amount of EDTA is 10-100 mg/ml (e.g., about 1.105 wt% to about 10.05 wt%). The person of ordinary skill in the art would have been motivated to make those modifications because the potency of chlorhexidine is increased and the toxicity of chlorhexidine is reduced in the presence of ethanol by having a lower minimum bacteriocidal concentration of including a concentration of 4 µg/ml that is about a 50% drop when combined with ethanol in an amount that is only 80% of the minimum inhibitory concentration for ethanol. The person of ordinary skill in the art would have reasonably expected success because Raad discloses antimicrobial solutions comprising at least one alcohol, at least one antimicrobial agent, and at least one chelator and/or anticoagulant (paragraph [0011]). Raad discloses that solution is including a locking solution for filling and/or flushing a medical indwelling device including a catheter (paragraph [0049]). Raad discloses an antimicrobial solution comprising ethanol, chlorhexidine and EDTA (claim 18 of Raad). Raad discloses that the concentration of alcohol is more preferably in the range of 10% to 50% (v/v) (paragraph [0083]). Raad discloses a total volume of including 3 ml of ready to use preparation (paragraph [0090]). Radd discloses that the concentration of EDTA is in the range of 10-100 mg/ml (paragraph [0038]). Rosenblatt teaches a synergistic relationship between chlorhexidine and alcohol to combat infection of implantable medical devices such as catheters with reduced risk of toxicity (paragraph [0011]). Rosenblatt teaches synergy of ethanol and chlorhexidine by showing that chlorhexidine when present with ethanol at a % including 5.6% for E.(e.g., gram-positive), 9.6% for S. aureus (e.g., gram-positive), and 8% for E. coli (e.g., gram-negative) that is 80% of MIC (minimum inhibitory concentration) for ethanol, the MBC (minimum bacteriocidal) of chlorhexidine drops about 50% to including 4 µg/ml for E. faecalis, 1 µg/ml for S. aureus, and 2 µg/ml for E. coli which shows that potency is increased (paragraph [0034] and TABLE 2).
Regarding claims 4-14, 16-17, 19-21, and 23-25, although the combination of Raad and Rosenblatt do not specifically teach the composition eliminates more than 99% planktonic cells, eliminates more than 99% biofilm cells, wherein the biofilm comprise bacterial or fungal cells, eliminates more than 99% of sessile cells, eliminates biofilm cells comprising Gram-positive cells, Gram-negative cells, or a combination thereof, provides equivalent MBEC values of single test antimicrobials at substantially lower concentrations of antimicrobials, eliminates a 48 hour old biofilm after a 2-hour exposure, provides a substantial reduction in biofilm cells within a 30-minute contact time, eliminates ≥ 99% of strains of planktonic cells, eliminates ≥ 99% of strains of biofilm cells, and eliminates ≥ 99% biofilms following 24 hours of treatment or exposure; the claimed composition of a composition comprising (a) about 0.05 wt% to about 10.0 wt% of ethylenediaminetetraacetic acid, a salt thereof, a chelating agent, or a combination thereof;(b) about 2.0 wt% to about 50.0 wt% of ethanol (ET), isopropyl alcohol, or a combination thereof; and,(c) about 0.015 µg/mL to about 100.0 µg/mL of chlorhexidine (CH), a salt thereof, or a combination thereof (paragraphs [0011] , [0038], [0083], [0090] and claim 18 of Raad; paragraphs [0011], [0034] and TABLE 2 of Rosenblatt) appears to be the same as the prior art, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 4-14, 16-17, 19-21, 23-25 and 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of copending Application No. 18/112,625 (reference application, cited as Pub. No. US 2023/0263757 A1 in IDS filed 02/20/2024, hereafter ‘625) in view of ROSENBLATT (US 2010/0087788 A1, publication date of 8 April 2010).
Regarding instant claim 1 and 32-35, claim 1 of ‘625 recites a second composition comprising 1.0-15% (w/v) of tetrasodium EDTA, ethanol, and chlorhexidine. Claim 5 of ‘625 recites that the second composition comprises 10-60% (w/v) of ethanol.
The claims of ‘625 do not specifically recite that the amount of the chlorhexidine is about 0.015 µg/mL to about 100.0 µg/mL. The deficiency is made up for by the teachings of Rosenblatt.
Rosenblatt is primarily directed towards implantable catheters treated with chlorhexidine and methods for disinfecting the catheters with alcohol (abstract).
Regarding claims 1 and 11-12, Rosenblatt teaches a synergistic relationship between chlorhexidine and alcohol to combat infection of implantable medical devices such as catheters with reduced risk of toxicity (paragraph [0011]). Rosenblatt teaches synergy of ethanol and chlorhexidine by showing that chlorhexidine when present with ethanol at a % including 5.6% for E.(e.g., gram-positive), 9.6% for S. aureus (e.g., gram-positive), and 8% for E. coli (e.g., gram-negative) that is 80% of MIC (minimum inhibitory concentration) for ethanol, the MBC (minimum bacteriocidal) of chlorhexidine drops about 50% to including 4 µg/ml for E. faecalis, 1 µg/ml for S. aureus, and 2 µg/ml for E. coli which shows that potency is increased (paragraph [0034] and TABLE 2).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce comprising ethanol, chlorhexidine and tetrasodium EDTA; wherein the amount of the tetrasodium EDTA IS 1.0-15% (w/v); wherein the amount of ethanol is in a range of 10% to 60% w/v; and wherein the amount of the chlorhexidine is including at least of 4 µg/ml. The person of ordinary skill in the art would have been motivated to make those modifications because the potency of chlorhexidine is increased and the toxicity of chlorhexidine is reduced in the presence of ethanol by having a lower minimum bacteriocidal concentration of including a concentration of 4 µg/ml that is about a 50% drop when combined with ethanol in an amount that is only 80% of the minimum inhibitory concentration for ethanol. The person of ordinary skill in the art would have reasonably expected success because Rosenblatt teaches a synergistic relationship between chlorhexidine and alcohol to combat infection of implantable medical devices such as catheters with reduced risk of toxicity (paragraph [0011]). Rosenblatt teaches synergy of ethanol and chlorhexidine by showing that chlorhexidine when present with ethanol at a % including 5.6% for E.(e.g., gram-positive), 9.6% for S. aureus (e.g., gram-positive), and 8% for E. coli (e.g., gram-negative) that is 80% of MIC (minimum inhibitory concentration) for ethanol, the MBC (minimum bacteriocidal) of chlorhexidine drops about 50% to including 4 µg/ml for E. faecalis, 1 µg/ml for S. aureus, and 2 µg/ml for E. coli which shows that potency is increased (paragraph [0034] and TABLE 2).
Regarding claims 4-14, 16-17, 19-21 and 23-25, although the combination of the claims of ‘625 and Rosenblatt do not specifically teach the composition eliminates more than 99% planktonic cells, eliminates more than 99% biofilm cells, wherein the biofilm comprise bacterial or fungal cells, eliminates more than 99% of sessile cells, eliminates biofilm cells comprising Gram-positive cells, Gram-negative cells, or a combination thereof, provides equivalent MBEC values of single test antimicrobials at substantially lower concentrations of antimicrobials, eliminates a 48 hour old biofilm after a 2-hour exposure, provides a substantial reduction in biofilm cells within a 30-minute contact time, eliminates ≥ 99% of strains of planktonic cells, eliminates ≥ 99% of strains of biofilm cells, and eliminates ≥ 99% biofilms following 24 hours of treatment or exposure; the claimed composition of a composition comprising (a) about 0.05 wt% to about 10.0 wt% of ethylenediaminetetraacetic acid, a salt thereof, a chelating agent, or a combination thereof;(b) about 2.0 wt% to about 50.0 wt% of ethanol (ET), isopropyl alcohol, or a combination thereof; and,(c) about 0.015 µg/mL to about 100.0 µg/mL of chlorhexidine (CH), a salt thereof, or a combination thereof (claims 1 and 5 of ‘625; paragraphs [0011], [0034] and TABLE 2 of Rosenblatt) appears to be the same as the composition recited in the claims of ‘625 in view of Rosenblatt, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
This is a provisional nonstatutory double patenting rejection.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of ‘625 in view of Rosenblatt as applied to claims 1, 4-14, 16-17, 19-21, 23-25 and 32-35, and further in view of RAAD (US 2010/0055086 A1, publication date of 4 March 2010).
Regarding claim 3, the composition of claim 1 is described above in section 10.
The claims of ‘625 do not recite and Rosenblatt does not teach that the composition is and aqueous solution. The deficiency is made up for by the teachings of Raad.
Raad is primarily directed towards antimicrobial solutions that comprise at least on alcohol, at least one antimicrobial agent and at least one chelator and/or anticoagulant (abstract).
Regarding claim 3, Raad discloses antimicrobial solutions comprising at least one alcohol, at least one antimicrobial agent, and at least one chelator and/or anticoagulant (paragraph [0011]). Raad discloses that EDTA enhances the antimicrobial activity of other antimicrobial agents (paragraph [0069]). Raad discloses including alcohol diluted with distilled water (e.g., aqueous solution) (paragraph [091]). Raad discloses an antimicrobial solution comprising ethanol, chlorhexidine and EDTA (claim 18 of Raad).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce comprising ethanol, chlorhexidine and tetrasodium EDTA; wherein the amount of the tetrasodium EDTA IS 1.0-15% (w/v); wherein the amount of ethanol is in a range of 10% to 60% w/v; wherein the amount of the chlorhexidine is including at least of 4 µg/ml; and wherein the composition is a solution with the alcohol diluted in distilled water (e.g. aqueous solution). The person of ordinary skill in the art would have been motivated to make those modifications because to obtain the amount of ethanol the composition can be diluted with including distilled water to obtain the desired concentration of ethanol and would necessarily also be a solution because they are substantially the same. The person of ordinary skill in the art would have reasonably expected success because Raad discloses antimicrobial solutions comprising at least one alcohol, at least one antimicrobial agent, and at least one chelator and/or anticoagulant (paragraph [0011]). Raad discloses that EDTA enhances the antimicrobial activity of other antimicrobial agents (paragraph [0069]). Raad discloses including alcohol diluted with distilled water (e.g., aqueous solution) (paragraph [091]). Raad discloses an antimicrobial solution comprising ethanol, chlorhexidine and EDTA (claim 18 of Raad).
Claims 1, 4-14, 16-17, 19-21, 23-25 and 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of copending Application No. 18/112,648 (reference application, cited as Pub. No. US 2023/0263758 A1 in IDS filed 02/20/2024, hereafter ‘648).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 1 and 32-35, claim 1 of ‘648 recites a first composition comprising EDTA having a concentration of at least about 1% w/v. Claim 4 of ‘648 recites that the first composition further comprises chlorhexidine or a pharmaceutically acceptable salt thereof. Claim 5 of ‘648 recites that the amount of the chlorhexidine is from about 0.1 µg/mL to ab out 100 µg/mL. Claim 6 of ‘648 recites that the first composition further comprises ethanol. Claim 7 of ‘648 recites that the concentration of ethanol in the first composition is from about 0.1% w/v to about 70% w/v.
Regarding claims 4-14, 16-17, 19-21 and 23-25, although the claims of ‘625 do not specifically recite that the composition eliminates more than 99% planktonic cells, eliminates more than 99% biofilm cells, wherein the biofilm comprise bacterial or fungal cells, eliminates more than 99% of sessile cells, eliminates biofilm cells comprising Gram-positive cells, Gram-negative cells, or a combination thereof, provides equivalent MBEC values of single test antimicrobials at substantially lower concentrations of antimicrobials, eliminates a 48 hour old biofilm after a 2-hour exposure, provides a substantial reduction in biofilm cells within a 30-minute contact time, eliminates ≥ 99% of strains of planktonic cells, eliminates ≥ 99% of strains of biofilm cells, and eliminates ≥ 99% biofilms following 24 hours of treatment or exposure; the claimed composition of a composition comprising (a) about 0.05 wt% to about 10.0 wt% of ethylenediaminetetraacetic acid, a salt thereof, a chelating agent, or a combination thereof;(b) about 2.0 wt% to about 50.0 wt% of ethanol (ET), isopropyl alcohol, or a combination thereof; and,(c) about 0.015 µg/mL to about 100.0 µg/mL of chlorhexidine (CH), a salt thereof, or a combination thereof (claims 1 and 4-7 of ‘648) appears to be the same as the composition recited in the claims of ‘648, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-7 of ‘648 as applied to claims 1, 4-14, 16-17, 19-21, 23-25 and 32-35 above, and further in view of RAAD (US 2010/0055086 A1, publication date of 4 March 2010).
The claims of ‘648 do not recite that the EDTA IS tetrasodium EDTA. The claims of ‘648 do not recite that the composition is and aqueous solution. The deficiencies are made up for by the teachings of Raad.
Raad is primarily directed towards antimicrobial solutions that comprise at least on alcohol, at least one antimicrobial agent and at least one chelator and/or anticoagulant (abstract).
Regarding claim 3, Raad discloses antimicrobial solutions comprising at least one alcohol, at least one antimicrobial agent, and at least one chelator and/or anticoagulant (paragraph [0011]). Raad discloses that the chelator agent includes EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid) (paragraph [0034] and TABLE 1). Raad discloses that EDTA enhances the antimicrobial activity of other antimicrobial agents (paragraph [0069]). Raad discloses including alcohol diluted with distilled water (e.g., aqueous solution) (paragraph [091]). Raad discloses an antimicrobial solution comprising ethanol, chlorhexidine and EDTA (claim 18 of Raad).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce comprising ethanol, chlorhexidine and EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid); wherein the amount of the EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid) is at least about 1% w/v; wherein the amount of ethanol is from about 0.1% w/v to about 70% w/v; wherein the amount of the chlorhexidine is from about 0.1 µg/mL to ab out 100 µg/mL; and wherein the composition is a solution with the alcohol diluted in distilled water (e.g. aqueous solution). The person of ordinary skill in the art would have been motivated to make those modifications because suitable EDTA for the same use includes EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid), and to obtain the amount of ethanol the composition can be diluted with including distilled water to obtain the desired concentration of ethanol and would necessarily also be a solution because they are substantially the same. The person of ordinary skill in the art would have reasonably expected success because Raad discloses antimicrobial solutions comprising at least one alcohol, at least one antimicrobial agent, and at least one chelator and/or anticoagulant (paragraph [0011]). Raad discloses that the chelator agent includes EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid) (paragraph [0034] and TABLE 1). Raad discloses that EDTA enhances the antimicrobial activity of other antimicrobial agents (paragraph [0069]). Raad discloses including alcohol diluted with distilled water (e.g., aqueous solution) (paragraph [091]). Raad discloses an antimicrobial solution comprising ethanol, chlorhexidine and EDTA (claim 18 of Raad).
Claims 1, 4-14, 16-17, 19-21, 23-25 and 32-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 and 8-10 of copending Application No. 18/112,674 (reference application, cited as Pub. No. US 2023/0263758 A1 in IDS filed 02/20/2024, hereafter ‘674).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 1 and 32-35, claim 1 of ‘674 recites a composition comprising, a salt of ethylene diamine tetraacetic acid (EDTA) in solution, wherein the salt of EDTA comprises including tetra-sodium EDTA, wherein the EDTA has a concentration in the composition from about 1% (w/v) to about 15% (w/v). Claim 6 of ‘674 recites that the composition further comprises chlorhexidine or a pharmaceutically acceptable salt thereof. Claim 8 of ‘674 recites that the concentration of chlorhexidine in the composition is from about 0.1 µg/mL to about 100 µg/mL. Claim 9 of ‘674 recites that the composition further comprises ethanol. Claim 10 of ‘674 recites that the amount of ethanol in the composition is from about 0.1% (w/v) to about 70% (w/v).
Regarding claims 4-14, 16-17, 19-21, 23-25, although the claims of ‘674 do not specifically recite that the composition eliminates more than 99% planktonic cells, eliminates more than 99% biofilm cells, wherein the biofilm comprise bacterial or fungal cells, eliminates more than 99% of sessile cells, eliminates biofilm cells comprising Gram-positive cells, Gram-negative cells, or a combination thereof, provides equivalent MBEC values of single test antimicrobials at substantially lower concentrations of antimicrobials, eliminates a 48 hour old biofilm after a 2-hour exposure, provides a substantial reduction in biofilm cells within a 30-minute contact time, eliminates ≥ 99% of strains of planktonic cells, eliminates ≥ 99% of strains of biofilm cells, and eliminates ≥ 99% biofilms following 24 hours of treatment or exposure; the claimed composition of a composition comprising (a) about 0.05 wt% to about 10.0 wt% of ethylenediaminetetraacetic acid, a salt thereof, a chelating agent, or a combination thereof;(b) about 2.0 wt% to about 50.0 wt% of ethanol (ET), isopropyl alcohol, or a combination thereof; and,(c) about 0.015 µg/mL to about 100.0 µg/mL of chlorhexidine (CH), a salt thereof, or a combination thereof (claims 1, 6 and 8-10 of ‘674) appears to be the same as the composition recited in the claims of ‘674, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 and 8-10 of ‘674 as applied to claims 1, 4-14, 16-17, 19-21, 23-25 and 32-35 above, and further in view of RAAD (US 2010/0055086 A1, publication date of 4 March 2010).
The claims of ‘674 do not recite that the composition is and aqueous solution. The deficiency are made up for by the teachings of Raad.
Raad is primarily directed towards antimicrobial solutions that comprise at least on alcohol, at least one antimicrobial agent and at least one chelator and/or anticoagulant (abstract).
Regarding claim 3, Raad discloses antimicrobial solutions comprising at least one alcohol, at least one antimicrobial agent, and at least one chelator and/or anticoagulant (paragraph [0011]). Raad discloses that the chelator agent includes EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid) (paragraph [0034] and TABLE 1). Raad discloses that EDTA enhances the antimicrobial activity of other antimicrobial agents (paragraph [0069]). Raad discloses including alcohol diluted with distilled water (e.g., aqueous solution) (paragraph [091]). Raad discloses an antimicrobial solution comprising ethanol, chlorhexidine and EDTA (claim 18 of Raad).
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to produce comprising ethanol, chlorhexidine and tetra-sodium EDTA; wherein the amount of the tetra-sodium EDTA is from about 1% (w/v) to about 15% (w/v); wherein the amount of ethanol is from about 0.1% (w/v) to about 70% (w/v); wherein the amount of the chlorhexidine is from about 0.1 µg/mL to about 100 µg/mL; and wherein the composition is a solution with the alcohol diluted in distilled water (e.g. aqueous solution). The person of ordinary skill in the art would have been motivated to make those modifications because to obtain the amount of ethanol the composition can be diluted with including distilled water to obtain the desired concentration of ethanol and would necessarily also be a solution because they are substantially the same. The person of ordinary skill in the art would have reasonably expected success because Raad discloses antimicrobial solutions comprising at least one alcohol, at least one antimicrobial agent, and at least one chelator and/or anticoagulant (paragraph [0011]). Raad discloses that EDTA enhances the antimicrobial activity of other antimicrobial agents (paragraph [0069]). Raad discloses including alcohol diluted with distilled water (e.g., aqueous solution) (paragraph [091]). Raad discloses an antimicrobial solution comprising ethanol, chlorhexidine and EDTA (claim 18 of Raad).
Response to Arguments
Applicant argues on page 7 as shown in the examples, triple combination of tetrasodium EDTA, ethanol and chlorhexidine showed a superior ability to kill planktonic and biofilm cells off various bacterial and fungal species. Applicant argues that triple combinations of either 3% tetrasodium EDTA with 10% ethanol and 5.0 µg/mL chlorhexidine HCI or of 3% tetrasodium EDTA with 20% ethanol and 2.5 µg/mL chlorhexidine HCI completely eradicated 48 hour old biofilms of all of the test organisms following a 2 hour exposure. Applicant points to paragraph [0068] of the instant specification. Applicant argues that Figures 4 and 5 of the instant application show comparison between triple combinations with compositions including only a single agent from tetrasodium EDTA, ethanol, and chlorhexidine, combinations of tetrasodium EDTA and ethanol, combinations of tetrasodium EDTA and chlorhexidine, as well as triple combinations using other concentrations of ingredients, wherein the combinations falling within the concentration ranges of amended claim 1 showed a clear benefit over the other compositions, which highlight the criticality of the claimed compositions over a wide range of bacterial and fungal species. Applicant argues that the synergistic effects between tetrasodium EDTA, ethanol, and chlorhexidine are neither taught nor suggested in the cited art.
Applicant's arguments filed on 21 October 2025 have been fully considered but they are not persuasive. In response, Raad discloses that a composition comprising antimicrobial agent (e.g., chlorhexidine), chelator/anticoagulant (e.g., EDTA )and alcohol solution (e.g., ethanol) provides rapid reduction or eradication of microorganisms embedded in a biofilm (paragraph [0064]). Raad discloses that their composition has an unexpected and surprising efficacy not provided by compositions that comprise only alcohol solutions, or compositions that comprise combinations of antimicrobials with chelators/anticoagulants (paragraph [0065]). Thus, in light of the teachings of Raad, one of ordinary skill in the art expects that a composition comprising antimicrobial agent including chlorhexidine, EDTA including EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid) and alcohol solution including ethanol at concentration of preferably 10% to 50% v/v (e.g., about 8.02% by weight to about 44.10%) provides better efficacy than compositions that comprise only alcohol solutions, or compositions that comprise combinations of antimicrobials with chelators/anticoagulants.
Applicant argues in the paragraph bridging pages 7 and 8 that the synergistic effects between tetrasodium EDTA, ethanol, and chlorhexidine are neither taught nor suggested in the cited art. Applicant argues that the use of the tetrasodium salt of EDTA in combination with the claimed compositions is not taught in the art, that tetrasodium EDTA have a higher pH compared to other salts, as well as better solubility and a stronger chelating ability. Applicant argues that nothing in Raad specifically teaches or suggests the use of tetrasodium EDTA, only that tetrasodium EDTA could be used among any other salt or free acid of EDTA. Applicant argues that results of the experiments in the instant specification also show that the triple combination recited in claim 1 is superior to including other triple combinations of tetrasodium EDTA, ethanol and chlorhexidine having different amounts of the three ingredients.
Applicant's arguments filed on 21 October 2025 have been fully considered but they are not persuasive. In response, antimicrobial agent including chlorhexidine, EDTA including EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid) and alcohol solution including ethanol at concentration of preferably 10% to 50% v/v (e.g., about 8.02% by weight to about 44.10%) provides better efficacy than compositions that comprise only alcohol solutions, or compositions that comprise combinations of antimicrobials with chelators/anticoagulants. Raad discloses that the chelator agent includes EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid) (paragraph [0034] and TABLE 1). Therefore, it would have been prima facie obvious to select EDTA 4Na (e.g., tetrasodium ethylenediaminetetraacetic acid) as the chelators/anticoagulants as each and every one of the species of chelators/anticoagulants disclosed by Raad would have been equally obvious.
Additionally, Applicant has not provided any evidence of unexpected results of selecting tetrasodium EDTA and not selecting other EDTA or other chelators/anticoagulants in a composition comprising antimicrobial agent including chlorhexidine, chelators/anticoagulants including EDTA and alcohol solution including ethanol at concentration of preferably 10% to 50% v/v (e.g., about 8.02% by weight to about 44.10%).
Applicant argues, regarding the double patenting rejections, that none of the claims of the reference applications or the cited art motivate a person having ordinary skill in the art to arrive at the specific concentrations of tetrasodium EDTA, ethanol and chlorhexidine recited in claim 1, which provide a superior ability to eradicate biofilm and planktonic cells of a broad range of bacterial and fungal species.
Applicant's arguments filed on 21 October 2025 have been fully considered but they are not persuasive. In response, the claims of the reference applications teach a composition containing tetrasodium EDTA, ethanol and chlorhexidine and/or Raad discloses that a composition comprising antimicrobial agent (e.g., chlorhexidine), chelator/anticoagulant (e.g., EDTA )and alcohol solution (e.g., ethanol) provides rapid reduction or eradication of microorganisms embedded in a biofilm (paragraph [0064]). Raad discloses that their composition has an unexpected and surprising efficacy not provided by compositions that comprise only alcohol solutions, or compositions that comprise combinations of antimicrobials with chelators/anticoagulants (paragraph [0065]). Thus, the claims of the reference applications and/or the teachings of Raad, teaches a composition comprising antimicrobial agent including chlorhexidine, EDTA including EDTA 4Na at substantially the same amounts and Raad teaches that the three ingredients together provides better efficacy than compositions that comprise only alcohol solutions, or compositions that comprise combinations of antimicrobials with chelators/anticoagulants.
Thus, for the reasons of record and for the reasons presented above claims 1, 3-14, 16-17, 19-21, 23-25 and 32-35 are rejected under 35 U.S.C. 103(a) and on the ground of nonstatutory double patenting.
Conclusion and Correspondence
No claims are allowed.
THIS ACTION IS MADE FINAL.
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 extension fee 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 date of this final action.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600