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 .
DETAILED ACTION
Response to Election/Restriction filed on August 2, 2026 is acknowledged. Claims 9-16, 19-22, 24, 26-30, 32-33 are pending in the instant application.
Election/Restrictions
Applicant elected without traverse Group 1 (claims 9-16, 19-22 and 24) and without traverse PC-tuftsin (formula I); alginic acid from List II and HPMC from List III in the reply filed August 2, 2026.
The restriction is deemed proper and is made FINAL in this office action. Claims 26-30, 32-33 are withdrawn in view of being drawn to a non-elected invention.
Claims 9-16, 19-22, 24 are examined on the merits of this office action.
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 11, 21-22 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 11 is rejected as Indefinite. The resuscitation of “benzalkonium (BAK),including any salt thereof” renders it unclear whether benzalkonium itself satisfies the limitation or whether a salt of the benzalkonium is required. Applicant is required to clarify the intended scope of the resuscitation. The suggested amendment to clarify could be “benzalkonium or a salt thereof”.
Claim 21 is indefinite because the claim recites a closed Markush group ending in gelatin followed by the recitation of “including any salt any copolymer or any combination thereof”. It is unclear whether a salt, copolymer or combination thereof is required and whether such salts copolymers and combinations are intended to constitute additional members of the closed Markush group or merely optional forms of the expressly recited members. Thus, the scope of the claimed ionic mucoadhesive polymer is unclear
Claim 22 is rejected as being indefinite because it is unclear whether the resuscitation that the viscosity answer comprises the list materials joined by and requires the viscosity enhancer to comprise all the recitative materials or merely one or more thereof. Additionally the resuscitation of including any salt and copolymer or any combination thereof renders it unclear whether a salt copolymer combination thereof is required or whether such forms are merely optional. Thus, the metes and bounds of the claim viscosity enhancer cannot be determined with reasonable certainty.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9 claims “An ophthalmic composition comprising an aqueous solution, comprising (i) a pharmaceutically effective amount of a phosphorylcholine-tuftsin conjugate (PC), (ii) between 0.1 and 5% weight per weight (w/w) of a viscosity enhancer, and(iii) between 0.1 and 5% w/w of a mucoadhesive polymer”. As defined in paragraph 00045, Applicant specification states “As used herein, the term “tuftsin” refers to a tetra-peptide (threonine-lysine-proline-arginine, TKPR; SEQ ID NO: 1). Tuftsin may be synthesized chemically. Tuftsin is known for its phagocytosis-stimulating activity and augmentation of antigen presenting capacity of macrophages in-vitro and in-vivo. According to some embodiments, tuftsin may be considered as an immunomodulatory molecule”. Thus, Tuftsin does not encompass tuftsin derivatives or variants of tuftsin nor doe phosphorylcholine encompass derivatives. Claim 16 claims “The ophthalmic composition of claim 9, wherein said phosphorylcholine-tuftsin conjugate comprises at least one phosphorylcholine moiety or a derivative thereof and tuftsin or a derivative thereof covalently linked via a spacer; wherein said spacer comprises at least two amino acids; and wherein said phosphorylcholine moiety or a derivative thereof is covalently linked to said spacer via a diazo group.” The limitation of “derivatives thereof” regarding tuftsin and phosphorylcholine broadens the scope of instant claim 9. Please note that claim 19 is ok given that Applicants allow for spacers (such as Gly-Tyr) connecting the tuftsin and Phosphorylcholine (see PgPUB, paragraph 0052).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 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.
The factual inquiries 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9, 14, 16, 19-22, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Langford (WO2019087192) in view of Mandal (International Journal of Pharmaceutical Investigation | April 2012 | Vol 2 | Issue 2) and Kesavan (DARU 2010 18 (4) 237 -246).
Langford teaches of a method of treating ocular inflammation in a subject in need thereof comprising administering to an eye a pharmaceutical formulation comprising phosphorylcholine-tuftsin conjugate comprising at least one phosphorylcholine moiety or a derivative thereof and tuftsin or a derivative thereof (see claim 1). Langford teaches wherein the formulation is aqueous pharmaceutical formulation (see paragraph 0036); a viscosity enhancer (see paragraph 0038-0039, claim 19); including “hydroxy methyl cellulose, hydroxy ethyl cellulose, sodium carboxy methyl cellulose, hydroxypropyl methyl cellulose and polyalcohol” (see paragraph 0039); and a mucoadhesive polymer (see paragraph 0036, alginic acid). Langford teaches including benzalkonium chloride (see paragraph 0040) and also preservatives generally (see paragraph 0040). Langford teaches various concentrations of PC tuftsin up to 0.05% (see Figure 1A).
Langford is silent to the amounts of the viscosity enhancer and mucoadhesive polymer.
However, Mandal teaches an aqueous optimal formulation containing sodium alginate as a gel forming muco-adhesive polymer and HPMC as a viscosity enhancer. Specifically the abstract states sodium alginate a novel ophthalmic gel forming mucoadhesive polymer... was used as the gelling agent. Hydroxypropyl methylcellulose HPMC is a mucoadhesive polymer used as a viscosity enhancer.” Mandal further teaches the actual concentrations of these polymers Table 1 “formulation design of in situ gelling system”, discloses sodium alginate at 0.5, 1.0, in 1.5g, with distilled water up to 100, and HPMC E50 LV at 1.5g or HPM CK4M at 0.5g, with distilled water up to 100 (see Table 1). Mandal further teaches that sodium alginate converts to a gel in the presence of divalent calcium ions in lacrimal fluid (Mandal, Results and Discussion) and concludes that the formulation provides longer corneal residence time in sustained drug release (see conclusion).
Kesavan further teaches ophthalmic mucoadhesive in situ gelling systems comprising gellan in combination with sodium alginate to enhance gel bioadhesion (see abstract). Kesavan expressly identifies sodium alginate as a muco adhesive polymer and discloses sodium alginate at point .4, .6 and 0.8% weight to volume in formulations GM1 to GM3 (see table 1) which falls within the claimed range.
It would have been obvious before the effective filing date of the claim invention to employ the amounts of sodium alginate and HPMC (viscosity enhancer and mucoadhesive polymer) as taught by Mandal and Kesavan in the ophthalmic formulation of Langford in order to obtain the known ophthalmically useful properties taught by Mandal including suitable viscosity in situ gel formation increase corneal residence time in sustained drug release. There is a reasonable expectation of success given that Mandal teaches these formulations suitable for the eye and for use in treating the eye to release a desired drug.
Regarding claim 14, Mendel teaches sodium alginate together with HPMC in the same ophthalmic formulation (see table 1). For example F3 contains 1.5 grams of sodium alginate and 1.5g HPMC providing A numerical relationship of 1 to 1 corresponding to the lower endpoint of the claimed range.
Regarding claims 16, 19, Langford teaches “according to some embodiments the phosphorylcholine or a derivative thereof and the tuftsin or derivative thereof are separated by a spacer, according to some embodiments the spacer is at least two amino acids and according to some embodiments the spacer is glycine tyrosine” (see paragraph 0009).
Regarding claim 20, Mandal expressly described sodium alginate (ionic polymer) as an ophthalmic gel forming mucoadhesive polymer (see abstract, results and discussion). Kesavan teaches that sodium alginate was selected as a mucus adhesive polymer due to its better mucus adhesive capacity(see introduction) and Table 1 provides experimental mucoadhesive force measurements for sodium alginate containing formulations ( see Table 1).
Regarding claim 21, Mandal teaches sodium alginate as the gel forming muco adhesive polymer(see Table 1). Kesavan likewise teaches sodium alginate as a buco adhesive polymer and discloses point 4.6 and 0.8% weight to volume sodium alginate (see table 1). Sodium alginate is the sodium salt corresponding to the claimed alginic acid salt species.
Regarding claim 22, Mandal expressly teaches HPMC as a muco adhesive polymer used as a viscosity enhancer (see abstract). Mandal's Table 1 specifically teaches HPM CE50 LV and HPMC K4M in the ophthalmic formulations thus Mandal directly teaches the HPMC viscosity enhancer species recited by claim 22.
Regarding claim 24, Kesavan teaches a tonicity regular in an ophthalmic formulation. Specifically, Kesavan states that mannitol was used as an isotonicity agent (see preparation and formulation) and the Table 1 footnote states that the formulations contained 5% mannitol as isotonic agent. Kesavan further describes the formulations as liquid ophthalmic preparations that are instilled as drops into the eye and undergo a sol to gel transition (see Abstract). Mandal additionally teaches 0.9 grams sodium chloride in each ophthalmic formulation and states that the formulations were evaluated for isotonicity (see Table 1, Abstract). Thus the references teach that use of tonicity adjusting components in ophthalmic eye drop formulations.
Claim(s) 10-13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langford (WO2019087192, cited in Applicant’s IDS) in view of Mandal (International Journal of Pharmaceutical Investigation | April 2012 | Vol 2 | Issue 2) and Kesavan (DARU 2010 18 (4) 237 -246), as applied to claims 9, 14, 16, 19-22, 24 above, in further view of Pereira (Applied and Environmental Microbiology, 2019, volume 85, issue 13, pages 00377-19, cited in Applicant’ IDS).
The combined references of Langford, Mandal and Kesavan are silent to BAK at an amount of 0.01-0.18 BAK and 0.01 to 10% PC tuftsin conjugate and ratios thereof.
Langford does teach various concentrations up to 0.05% (see Figure 1A) of the PC-tuftsin conjugate.
Mandal teaches benzalkonium chloride (BAK) in the ophthalmic formulation. Table 1 identifies benzalkonium chloride at 0.02g in each of the formulation F1 to F6 with distilled water up to 100 (see table 1).
Pereira teaches that BAK concentrations of 0.003 to 0.02% in ophthalmological solutions (see table 1). This percentage corresponds to approximately 0.03 to 0.20 milligram per ml and overlaps the presently claimed range of 0.01 to 0.18 milligram per ml. Thus the prior art teaches ophthalmological BAK concentrations substantially overlapping the presently claimed range. It would have been obvious before the effect of filing date of the claim invention to select BAK concentration within the known ophthalmological range including concentrations falling within the overlapping claimed range for use of the BAK preservative taught by Mandal and Kesavan. Furthermore it would have been obvious to optimize to achieve optimal therapeutic effectiveness given the amount of BAK is considered a result effective variable (see MPEP 2144.05).
Regarding claim 10, Langford does teach preservatives generally and specifically teaches BAK(see paragraph 0040). Mandal likewise teaches BAK in each ophthalmic formulation (see Table 1). Furthermore, the reduced preservative effective concentration of BAK is considered inherent to the PC containing composition as the preservative activity necessarily results from the composition and its constituents regardless of whether the prior recognized that property.
Regarding claim 11, Mandal teaches benzalkonium chloride in the ophthalmic formulation. Table 1 identifies benzalkonium chloride at 0.02g in each of the formulation F1 to F6 with distilled water up to 100 (see table 1). The combination of Mandal in view of Pereira render obvious the claimed BAK range. As stated above, it would have been obvious to optimize to achieve optimal therapeutic effectiveness given the amount of benzalkonium chloride is considered a result effective variable (see MPEP 2144.05).
Regarding claim 12, Mandal teaches benzalkonium chloride at 0.02g per 100 mil which corresponds to 0.20 mg/mL right outside the range of instant claim 12. The combination of Mandal in view of Pereira render obvious the claimed BAK range. As stated above, it would have been obvious to optimize to achieve optimal therapeutic effectiveness given the amount of benzalkonium chloride is considered a result effective variable (see MPEP 2144.05).
Regarding claim 13, The claimed PC to BAK weight ratio would have been obvious because the prior art teaches the respective components and amounts and the resulting ratio falls within the claimed range (for example PC Tuftsin conjugate at 0.05% and BAK at 0.003% taught by Pereira) . The claimed ratio is therefore a result of combining the known amounts of PC and BAK taught by the very art.
Regarding claim 15, It would have been obvious before the effect of filing date of the claim invention to select BAK and PC-tuftsin conjugate concentration within the known ophthalmological range including concentrations falling within the overlapping claimed range for use as the benzalkonium preservative taught by Mandal and Kesavan and PC-tuftsin as a ocular therapeutic for reducing inflammation as taught by Langford. Furthermore it would have been obvious to optimize to achieve optimal therapeutic effectiveness given the amount of BAK and PC-tuftsin are considered a result effective variables (see MPEP 2144.05).
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 9-16, 19-22, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 5, 13-14, 17 of copending Application No. 18711977 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “An ophthalmic composition comprising an aqueous solution, comprising (i) a pharmaceutically effective amount of a phosphorylcholine-tuftsin conjugate (PC), (ii) between 0.1 and 5% weight per weight (w/w) of a viscosity enhancer, and(iii) between 0.1 and 5% w/w of a mucoadhesive polymer” (claim 9). The instant application further claims a quaternary ammonium cation at a preservative effective concentration below a preservative effective concentration of the quaternary ammonium cation within a similar composition devoid of said PC (claim 10); BAK (CLAIM 11); dose of 0.01-.18 mg/ml cation (claim 12); ratio of PC and cation of 1000:1-1:1 (claim 13); Mucoadhesive polymer and viscosity cancer ratio 1:1 and 10:1; 0.01 to 10% way to way of conjugate; a spacer with two amino acids (claim 16); Formula One as the conjugate (claim 19); ionic mucoadhesive polymer such as alginic acid (claim 21); a viscosity enhancer such as hydroxy methyl cellulose(claim 22); comprising up to 5% tonicity regulator in an eye drop formulation (claim 24).
The co-pending Application claims a PC tuftsin conjugate for formula I (claim 1); in a pharmaceutical formulation with a carrier (claim 5); varying concentrations including up to 2% (Claims 6 and 8); and 10% (claim 11); An aqueous composition comprising 0.1 and 5% weight of viscosity hand center in between 0.1 and 5% w/w mucoadhesive polymer (claim 13); To weight to weight ratio of the polymer to viscosity answer of 1:1 and 10:1 (see claim 14); wherein said polymer is alginic acid and or and where said viscosity enhancer is hydroxy methyl cellulose (see claim 14); The composition further comprising 10% weight-to-weight of tonicity regulator and the composition is formulated for ocular administration (claim 17).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9-16, 19-22, 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 19-38 of copending Application No. 19/311182 in view of Mandal (International Journal of Pharmaceutical Investigation | April 2012 | Vol 2 | Issue 2) , Kesavan (DARU 2010 18 (4) 237 -246) and Pereira (Applied and Environmental Microbiology, 2019, volume 85, issue 13, pages 00377-19, cited in Applicant’ IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “An ophthalmic composition comprising an aqueous solution, comprising (i) a pharmaceutically effective amount of a phosphorylcholine-tuftsin conjugate (PC), (ii) between 0.1 and 5% weight per weight (w/w) of a viscosity enhancer, and(iii) between 0.1 and 5% w/w of a mucoadhesive polymer” (claim 9). The instant application further claims a quaternary ammonium cation at a preservative effective concentration below a preservative effective concentration of the quaternary ammonium cation within a similar composition devoid of said PC (claim 10); BAK (CLAIM 11); dose of 0.01-.18 mg/ml cation (claim 12); ratio of PC and cation of 1000:1-1:1 (claim 13); Mucoadhesive polymer and viscosity cancer ratio 1:1 and 10:1; 0.01 to 10% way to way of conjugate; a spacer with two amino acids (claim 16); Formula One as the conjugate (claim 19); ionic mucoadhesive polymer such as alginic acid (claim 21); a viscosity enhancer such as hydroxy methyl cellulose(claim 22); comprising up to 5% tonicity regulator in an eye drop formulation (claim 24).
The Co-pending Application 19/311182 claims treating ocular inflammation comprising administering a PC tuftsin conjugate with a peptide spacer (claim 19); in a pharmaceutical formulation with a carrier for ocular administration (claims 28-29); a viscosity enhancer (claim 29). Co-pending Application 19/311182 is silent to mucoadhesive polymer, BAK, concentrations thereof of the polymer, BAK or enhancer; tonicity regulator and amount.
However, Mandal teaches an aqueous optimal formulation containing sodium alginate as a gel forming muco adhesive polymer and HPMC as a viscosity answer. Specifically the abstract states sodium alginate a novel ophthalmic gel forming muco adhesive polymer... Was used as the gelling agent. Hydroxypropyl methylcellulose HPMC is a mucoadhesive polymer used as a viscosity enhancer.” Mandal further teaches the actual concentrations of these polymers Table 1 “formulation design of in situ gelling system”, discloses sodium alginate at 0.5, 1.0, in 1.5g, with distilled water up to 100, and HPMC E50 LV at 1.5g or HPM CK4M at 0.5g, with distilled water up to 100 (see Table 1). Mandal further teaches that sodium alginate converts to a gel in the presence of divalent calcium ions in lacrimal fluid (Mandal, Results and Discussion) and concludes that the formulation provides longer precordial residence time in sustained drug release (see conclusion).
Kesavan further teaches ophthalmic mucoadhesive in situ gelling systems comprising gellan in combination with sodium alginate to enhance gel bioadhesion (see abstract). Kesavan expressly identifies sodium alginate as a mucoadhesive polymer and discloses sodium alginate at point 4.6 and 0.8% weight to volume in formulations GM1 to GM3 (see table 1) which falls within the claimed range.
It would have been obvious before the effective filing date of the claim invention to employ the amounts of sodium alginate and HPMC (viscosity enhancer and mucoadhesive polymer) as taught by Mandal and Kesavan in the ophthalmic formulation of AN19/31182 in order to obtain the known ophthalmically useful properties taught by Mandal including suitable viscosity in situ gel formation increase pre corneal resonance is sustained drug release. There is a reasonable expectation of success given that Mandal teaches these formulations suitable for the eye and for use in treating the eye to release a desired drug.
Pereira teaches that Benzocaine chloride concentrations of 0.003 to 0.02% in ophthalmological solutions (see table 1) as a preservative. This percentage corresponds to approximately 0.03 to 0.20 milligram per ml and overlaps the presently claimed range of 0.01 to 0.18 milligram per ml. Thus the prior art teaches ophthalmological benzalkonium chloride concentrations substantially overlapping the presently claimed range. It would have been obvious before the effect of filing date of the claim invention to select benzalkonium chloride concentration with the known ophthalmological range including concentrations falling within the overlapping claimed range for use as the benzocaine chloride preservative taught by Mandal and Kesavan. Furthermore it would have been obvious to optimize to achieve optimal therapeutic effectiveness given the amount of benzalkonium chloride is considered a result effective variable (see MPEP 2144.05).
The claimed PC to BAK weight ratio would have been obvious because the prior art teaches the respective components and amounts and the resulting ratio falls within the claimed range (for example PC Tuftsin conjugate at 0.05% and BAK at 0.003% taught by Pereira) . The claimed ratio is therefore a result of combining the known amounts of PC and BAK taught by the very art. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
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