DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 5/26/2026 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-11 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without further specifying traverse of a single species in the reply filed on 5/26/2026 is also acknowledged.
Based on Applicant’s response, the elected antiseptic composition is understood to be an antiseptic composition obtained by mixing a sodium chlorite composition and an activating buffer having a pH of 5 or less, wherein:
the sodium chlorite composition comprises 2% PURITE® stock comprising sodium chlorite, sodium chloride, sodium hydrogen carbonate, sodium formate, methanol, sodium chlorate, and water; and
the activating buffer comprises sodium phosphate monobasic monohydrate and citric acid monohydrate;
wherein the antiseptic composition (Composition 10) comprises sodium chlorite, sodium phosphate monobasic monohydrate and citric acid monohydrate.
Applicant is requested to confirm that the above is, indeed, the elected composition.
The elected species read upon claims 12-17.
Expansion of Election of Species Requirement
As indicated above, the elected species reads upon claims 12-17. The elected species has been searched and is deemed to be free of the prior art and non-obvious. Accordingly, the search has been expanded as called for under current Office Markush practice to include at least a single additional species (M.P.E.P. § 803.02), and claims 12-17 are rejected based thereon.
Allowable Subject Matter
The following independent claim would be ALLOWABLE:
“An antiseptic composition obtained by mixing a sodium chlorite composition and an activating buffer having a pH of 5 or less, wherein:
the sodium chlorite composition comprises sodium chlorite, sodium chloride, sodium hydrogen carbonate, sodium formate, methanol, sodium chlorate, and water;
the activating buffer comprises sodium phosphate monobasic monohydrate and citric acid monohydrate; and
the antiseptic composition comprises sodium chlorite in an amount ranging from 800 ppm to 8000 ppm, sodium phosphate monobasic monohydrate and citric acid monohydrate, wherein sodium chlorite is the sole active agent in the antiseptic composition.”
The proposed claim would be ALLOWABLE because:
The prior art is replete with antiseptic compositions comprising sodium chlorite and buffer(s). For example, Earland et al (Textile Research Journal, Pages 591-598, 1952) teach compositions comprising 20% sodium chlorite (i.e., about 200,000 ppm) in a citrate-phosphate buffer solution having a pH of 1, 1.5, 2, 3 and 5 (Page 593, Table II).
However, it would not have been obvious to formulate the compositions of Earland et al by mixing the sodium chlorite composition and activating buffer as claimed, to arrive at the antiseptic composition as claimed, comprising sodium chlorite in an amount ranging from 800 ppm to 8000 ppm, sodium phosphate monobasic monohydrate and citric acid monohydrate, wherein sodium chlorite is the sole active agent in the antiseptic composition.
Claim Rejections - 35 USC § 102
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.
Claims 12-13 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Earland et al (Textile Research Journal, Pages 591-598, 1952).
Claim 12 is drawn to an antiseptic for disinfecting and preparing an ocular treatment site for intraocular injection, wherein the antiseptic composition is obtained by mixing a sodium chlorite composition and an activating buffer having a pH of 5 or less, and wherein the antiseptic composition provides bacterial kill efficacy without the ocular toxicity associated with 5% povidone iodine.
Earland et al teach compositions comprising “20% sodium chlorite” (i.e., about 200,000 ppm) in a citrate-phosphate buffer solution having a pH of 1, 1.5, 2, 3 and 5 (Page 593, Table II).
As to the recitation that the antiseptic is “for disinfecting and preparing an ocular treatment site for intraocular injection”, Applicant is advised that use limitations within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the aqueous solution of Earland et al would be capable of disinfecting and preparing an ocular treatment site for intraocular injection as claimed.
As to the recitation that “the antiseptic composition is obtained by mixing...” and so on, Applicant is further advised that product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (MPEP 2113). As stated by the court in In re Thorpe (777 F.2d 695 (Fed. Cir. 1985), “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claims is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process".
And finally, as to the recitation that “the antiseptic composition provides bacterial kill efficacy without the ocular toxicity associated with 5% povidone iodine”, Applicant is also advised that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent Applicant may present previously unmeasured characteristics. When, as here, the prior art appears to contain the exact same elements as those instantly claimed, the burden is properly shifted to Applicant to show otherwise. As stated in In re Best, Bolton, and Shaw, “[w]here… the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product" 562 F2d 1252 (CCPA 1977). In the instant case, the claimed and prior art products are substantially identical. As such, absent evidence to the contrary, it is asserted that the aqueous solution of Earland et al would necessarily provide a bacterial kill efficacy without the ocular toxicity associated with 5% povidone iodine. See also In re Fitzgerald 619 F2d 67 (CCPA 1980): the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on.”
Accordingly, claim 12 is anticipated.
Claim 13 is drawn to the antiseptic composition of claim 12, wherein the antiseptic composition comprises sodium chlorite in an amount of 800 ppm or greater.
As discussed above, Earland et al teach “[a] 0.2 M phosphate buffer solution adjusted to pH=4 was prepared” and “[t]o 50 mL of pH=4 buffer solution 0.5 g of sodium chlorite solid was added” (Paragraph 0045) – which is calculated to comprise about 10,000 ppm sodium chlorite.
Accordingly, claim 13 is also anticipated.
Claim 16 is drawn to the antiseptic composition of claim 12, wherein the composition is surfactant-free.
The composition of Earland et al does not contain a surfactant.
Accordingly, claim 16 is also anticipated.
Claim 17 is drawn to the antiseptic composition of claim 12, wherein sodium chlorite is the sole active agent in the antiseptic composition.
The composition of Earland et al does not contain any additional active agent(s).
Accordingly, claim 17 is also anticipated.
Claims 12-13 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Doona et al (US 2016/0068393).
Claim 12 is drawn to an antiseptic for disinfecting and preparing an ocular treatment site for intraocular injection, wherein the antiseptic composition is obtained by mixing a sodium chlorite composition and an activating buffer having a pH of 5 or less, and wherein the antiseptic composition provides bacterial kill efficacy without the ocular toxicity associated with 5% povidone iodine.
Doona et al teach “[a] 0.2 M phosphate buffer solution adjusted to pH=4 was prepared” (Paragraph 0045; more specifically, “0.2 M sodium dihydrogen phosphate buffer solution made from 28.0 g of NaH2PO4*H2O, adjusted with 1.7 mL of 1 M H2SO4, and diluted in water to 1 L final volume” (Paragraph 0060) and “[t]o 50 mL of pH=4 buffer solution 0.5 g of sodium chlorite solid was added” (Paragraph 0045).
As to the recitation that the antiseptic is “for disinfecting and preparing an ocular treatment site for intraocular injection”, Applicant is advised that use limitations within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the aqueous solution of Doona et al would be capable of disinfecting and preparing an ocular treatment site for intraocular injection as claimed.
As to the recitation that “the antiseptic composition is obtained by mixing...” and so on, Applicant is further advised that product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (MPEP 2113). As stated by the court in In re Thorpe (777 F.2d 695 (Fed. Cir. 1985), “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claims is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process".
And finally, as to the recitation that “the antiseptic composition provides bacterial kill efficacy without the ocular toxicity associated with 5% povidone iodine”, Applicant is also advised that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent Applicant may present previously unmeasured characteristics. When, as here, the prior art appears to contain the exact same elements as those instantly claimed, the burden is properly shifted to Applicant to show otherwise. As stated in In re Best, Bolton, and Shaw, “[w]here… the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product" 562 F2d 1252 (CCPA 1977). In the instant case, the claimed and prior art products are substantially identical. As such, absent evidence to the contrary, it is asserted that the aqueous solution of Doona et al would necessarily provide a bacterial kill efficacy without the ocular toxicity associated with 5% povidone iodine. See also In re Fitzgerald 619 F2d 67 (CCPA 1980): the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on.”
Accordingly, claim 12 is anticipated.
Claim 13 is drawn to the antiseptic composition of claim 12, wherein the antiseptic composition comprises sodium chlorite in an amount of 800 ppm or greater.
As discussed above, Doona et al teach “[a] 0.2 M phosphate buffer solution adjusted to pH=4 was prepared” and “[t]o 50 mL of pH=4 buffer solution 0.5 g of sodium chlorite solid was added” (Paragraph 0045) – which is calculated to comprise about 10,000 ppm sodium chlorite.
Accordingly, claim 13 is also anticipated.
Claim 16 is drawn to the antiseptic composition of claim 12, wherein the composition is surfactant-free.
The composition of Doona et al does not contain a surfactant.
Accordingly, claim 16 is also anticipated.
Claim 17 is drawn to the antiseptic composition of claim 12, wherein sodium chlorite is the sole active agent in the antiseptic composition.
The composition of Doona et al does not contain any additional active agent(s).
Accordingly, claim 17 is also anticipated.
Claims 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alliger (US 4,084,747).
Claim 12 is drawn to an antiseptic for disinfecting and preparing an ocular treatment site for intraocular injection, wherein the antiseptic composition is obtained by mixing a sodium chlorite composition and an activating buffer having a pH of 5 or less, and wherein the antiseptic composition provides bacterial kill efficacy without the ocular toxicity associated with 5% povidone iodine.
Alliger teaches “an aqueous solution of sodium chlorite containing 3,000 ppm sodium chlorite” to which “is added sufficient [amount] of an aqueous lactic acid solution to reduce the PH of the resultant solution to about three” (Column 7, Lines 19-22) exhibiting “germ killing effects... against (a) S. aureus (b) S. albus (c) Pseudomonas (d) E. coli (e) Proteus Pyogenes” and so on (Column 7, Lines 25-35).
As to the recitation that the antiseptic is “for disinfecting and preparing an ocular treatment site for intraocular injection”, Applicant is advised that use limitations within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the aqueous solution of Alliger would be capable of disinfecting and preparing an ocular treatment site for intraocular injection as claimed.
As to the recitation that “the antiseptic composition is obtained by mixing...” and so on, Applicant is further advised that product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (MPEP 2113). As stated by the court in In re Thorpe (777 F.2d 695 (Fed. Cir. 1985), “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claims is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process".
And finally, as to the recitation that “the antiseptic composition provides bacterial kill efficacy without the ocular toxicity associated with 5% povidone iodine”, Applicant is also advised that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent Applicant may present previously unmeasured characteristics. When, as here, the prior art appears to contain the exact same elements as those instantly claimed, the burden is properly shifted to Applicant to show otherwise. As stated in In re Best, Bolton, and Shaw, “[w]here… the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product" 562 F2d 1252 (CCPA 1977). In the instant case, the claimed and prior art products are substantially identical. As such, absent evidence to the contrary, it is asserted that the aqueous solution of Alliger would necessarily provide a bacterial kill efficacy without the ocular toxicity associated with 5% povidone iodine. See also In re Fitzgerald 619 F2d 67 (CCPA 1980): the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on.”
Accordingly, claim 12 is anticipated.
Claims 13-14 are drawn to the antiseptic composition of claim 12, wherein the antiseptic composition comprises sodium chlorite in an amount of 800 ppm or greater (claim 12), more specifically in an amount ranging from 800 ppm to 8000 ppm (claim 13).
As discussed above, Alliger teaches “an aqueous solution of sodium chlorite containing 3,000 ppm sodium chlorite” to which “is added sufficient [amount] of an aqueous lactic acid solution to reduce the PH of the resultant solution to about three” (Column 7, Lines 19-22).
Accordingly, claims 13-14 are also anticipated.
Claim 16 is drawn to the antiseptic composition of claim 12, wherein the composition is surfactant-free.
The composition of Alliger does not contain a surfactant.
Accordingly, claim 16 is also anticipated.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 12-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11.096,958.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘958 claims are similarly drawn to an antiseptic composition consisting of a sodium chlorite stock solution and an activating buffer, wherein the amount of sodium chlorite in the antiseptic composition is from 800 ppm to 8000 ppm and wherein the pH is < 5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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