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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/22/2025 has been entered.
Status of claims
Claims 14-34 are pending.
Claims 21, 26-30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim.
Claims 14-20, 22-25, and 31-34 and under examination in this Office Action.
Response to Amendment
Independent claim 14 is amended to recite composition comprising specific linear and branched SFA in combination, CF3-(CF2)5-CH(CH3)-(CH2)5-CH3 and CF3-(CF2)5-(CH2)7-CH3, or CF3-(CF2)3- CH(CH3)-(CH2)2-CH3 and CF3-(CF2)3-(CH2)4-CH3.
Claims 14-20, 22-25, and 31-34 are now rejected under 35 U.S.C.§ 103 as being unpatentable over Gunther et al. (WO 2014/041055 A1, Gunther’ 055), in view of Meinert and Steven, and on the ground of non-statutory double patenting.
Applicant's Remarks filed 09/22/2025 have been fully considered, Please see the response regarding the individual reference in following 35 U.S.C. 103 section.
Priority
The instant application filed on 06/17/2021 is a continuation of U.S. Application No. 15/280,411 filed September 29, 2016 (now US 11154513 B2), which claims priority to European Patent Application Nos. 15187760.2 filed September 30, 2015, and 15192429.7 filed October 30, 2015.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of foreign Application No. EP 15187760.2 and 15192429.7 are filed on 06/30/2021.
Information Disclosure Statement
The information disclosure statement submitted on 11/13/2025 is in compliance with the provisions of 37 CFR1.97. Accordingly, the reference listed in IDS are being considered by the Examiner. Reference written in foreign language is considered to the degree of English abstract or patent family of foreign patent by examiner.
Claim Interpretation
Claims 14, 15 19 and 22 are amended to recite combination of compounds CF3-(CF2)5-CH(CH3)-(CH2)5-CH3 and CF3-(CF2)5-(CH2)7-CH3, or CF3-(CF2)3- CH(CH3)-(CH2)2-CH3 and CF3-(CF2)3-(CH2)4-CH3.
The compound CF3-(CF2)5-CH(CH3)-(CH2)5-CH3 having following structure (CAS# 2089686-13-3) is entered in STN database on April 13, 2017)(See STN search note).
PNG
media_image1.png
102
315
media_image1.png
Greyscale
According to SFA nomenclature taught by prior art Gunther’ 055: semi-fluorinated alkanes (SFA) are linear or branched alkanes some of whose hydrogen atoms have been replaced by fluorine, and preferred embodiments which have at least one non-fluorinated hydrocarbon segment attached to one perfluorinated hydrocarbon segment. According to the general formula F(CF2)n(CH2)mH which is alternative referred to as FnHm wherein F means a perfluorated hydrocarbon segment, H means a nonfluorinated segment, and n, m is the number of carbon atoms of the respective segment (See page 10, lines 30-35; page 11, lines 1-14). For example , F(CF2)6(CH2)8H is referred to as F6H8 when n is 6 and m is 8 (See Tables 1 and 2).
Instantly claimed linear compound CF3-(CF2)5-(CH2)7-CH3 ( C14H17F13), i.e. F(CF2)6(CH2)8H, is F6H8 (linear) ; CF3-(CF2)5-CH(CH3)-(CH2)5-CH3 ( C14H17F13) is considered as branched F6H8.
The linear compound CF3-(CF2)3-(CH2)4-CH3 , i.e. F(CF2)4(CH2)5H, is F4H5 (linear). CF3-(CF2)3- CH(CH3)-(CH2)2-CH3, i. e. F(CF2)4 CHCH3(CH2)3H, is considered as branched F4H5.
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.
Claims 14, 16-20, 22, 24-25 and 31-33 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.
Claims 14 is amended to recite a composition comprising compounds CF3-(CF2)5-CH(CH3)-(CH2)5-CH3 and CF3-(CF2)5-(CH2)7-CH3, or CF3-(CF2)3- CH(CH3)-(CH2)2-CH3 and CF3-(CF2)3-(CH2)4-CH3.
or comprising the compounds CF3-(CF2)5-CH(CH3)-(CH2)5-CH3 and CF3-(CF2)5-(CH2)7-CH3, or CF3-(CF2)3- CH(CH3)-(CH2)2-CH3 and CF3-(CF2)3-(CH2)4-CH3, and one or more lipophilic constituents in an amount up to 25 wt% or up to 97%.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, combination of compounds without lipophilic constituents are the broad recitation and the claim also recites combination of compounds and lipophilic constituents which is the narrower statement of limitation. The limitation “up to 97%” is broad recitation of range while “up to 25 wt%” is narrow range. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language, lipophilic constituents is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 16-20, 22, 24-25 and 31-33 are also rejected due to their dependency on claim 14.
Claim 17 recites “wherein the composition comprises at least 1 wt% and/or up to 25 wt% of the compounds” are confusing and indefinite. If "at least" only modifies 1 wt%, that portion includes 1-25% and up to 25%. If the range is at least 1 wt% or up to 25 wt%, then “at least 1 wt%” is broader range than “up to 25 wt%”. It’ not clear what’s the amount of the compounds.
Claim 22 recites limitation “one or more lipophilic constituents in an amount up to 25 wt% or up to 97%”. The limitation “up to 97%” is broad recitation of range while “up to 25 wt%” is narrow range. The claim(s) are considered indefinite. It’ not clear what’s the amount of the lipophilic constituents.
Claim 19 recites “The composition according to claim 15, wherein the composition consists essentially of the compounds CF3-(CF2)5-CH(CH3)-(CH2)5-CH3 and CF3-(CF2)5-(CH2)7-CH3, or CF3-(CF2)3-CH(CH3)-(CH2)2-CH3 and CF3-(CF2)3-(CH2)4-CH3, and the one or more lipophilic constituents”. Claim 19 depends on claim 15. Claim 15 does not recite “one or more lipophilic constituents” . There is insufficient antecedent basis for limitation “the one or more lipophilic constituents” in claim 19.
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.
Claims 19 are 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 (necessitated by amendment).
Claim 19 recites “The composition according to claim 15, wherein the composition consists essentially of the compounds CF3-(CF2)5-CH(CH3)-(CH2)5-CH3 and CF3-(CF2)5-(CH2)7-CH3, or CF3-(CF2)3-CH(CH3)-(CH2)2-CH3 and CF3-(CF2)3-(CH2)4-CH3, and the one or more lipophilic constituents”.
Claim 19 depends on claim 15 which recites “The composition according to claim 14, wherein the composition comprises CF3-(CF2)5-CH(CH3)-(CH2)5-CH3 and CF3-(CF2)5-(CH2)7-CH3, or CF3-(CF2)3-CH(CH3)-(CH2)2-CH3 and CF3-(CF2)3-(CH2)4-CH3”. Claim 15 does not recite “one or more lipophilic constituents” . As such, claim 19 reciting lipophilic constituents is improper dependent of claim 15.
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
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 14-20, 22-25, and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Gunther et al. (WO 2014/041055 A1, Gunther’ 055), in view of Meinert (Eur. J. Ophthalmol. 2000, 10:189–197, Applicant’s IDS dated 10/28/2021, “Semifluorinated alkanes—a new class of compounds with outstanding properties for use in ophthalmology”) and Steven et al. (Journal of Ocular Pharmacology and Therapeutics, 2015, 31(8):498-503, Epub 2015 Aug 21, doi: 10.1089/jop.2015.0048, Applicant’s IDS dated 10/28/2021, "Semifluorinated Alkane Eye Drops for Treatment of Dry Eye Disease - A Prospective, Multicenter Noninterventional Study").
Gunther’ 055 discloses liquid ophthalmic compositions comprising two or more semi-fluorinated alkane (SFA) that are topically administered to ophthalmic tissue (or an eye) for treating ophthalmic disorders (dry eye, etc.)(See abstract; page 8, lines 24-33; claims 1-15).
Regarding the semi-fluorinated alkanes, Gunther’ 055 teaches semi-fluorinated alkanes (SFA) are linear or branched alkanes some of whose hydrogen atoms have been replaced by fluorine, and preferred embodiments which have at least one non-fluorinated hydrocarbon segment attached to one perfluorinated hydrocarbon segment, according to the general formula F(CF2)n(CH2)mH which is alternative referred to as FnHm wherein F means a perfluorated hydrocarbon segment, H means a nonfluorinated segment, and n, m is the number of carbon atoms of the respective segment (See page 10, lines 30-35; page 11, lines 1-14). For example , F(CF2)6(CH2)8H is referred to as F6H8 when n is 6 and m is 8 (See Tables 1 and 2).
Gunther’ 055 teaches semi-fluorinated alkanes of the formula
PNG
media_image2.png
32
148
media_image2.png
Greyscale
and embodiments comprising a first semi-fluorinated alkane wherein n is an integer from the range of 3 to 8 and m is an integer from the range of 3 to 10 that are liquid (See page 11, lines 33-35; page 12, lines 3; claim 1). Gunther’ 055 teaches embodiments wherein a first semi-fluorinated alkane is selected from a group consisting of F(CF2)4(CH2)5H, F(CF2)4(CH2)6H, F(CF2)6(CH2)6H, F(CF2)6(CH2)8H, for example, F4H5, F6H8 (See page 19, lines 9-10; Tables 1 and 2; Figure 1, claim 3). It’s noted the instant claimed SFA, e.g. elected species F6H8, 2-perfluorohexyloctane, CF3(CF2)5CHCH3(CH2)5CH3. (n=5, m=5) is considered under BRI as branched semi-fluorinated alkanes (SFA) F6H8 encompassed by Gunther’ 055. CF3-(CF2)3- CH(CH3)-(CH2)2-CH3, i. e. F(CF2)4 CHCH3(CH2)3H, is considered as branched F4H5.
Regarding combination of two SFA, Gunther’ 055 teaches composition comprises at least two SFAs selected from F(CF2)4(CH2)5H (i.e. F4H5), F(CF2)4(CH2)6H, F(CF2)6(CH2)4H, F(CF2)6(CH2)6H, F(CF2)6(CH2)8H (i.e. F6H8), and F(CF2)6(CH2)10H and at least one of F(CF2)s(CH2)10H and F(CF2)10(CH2)12H, wherein the weight ratio of the first semifluorinated alkane to the second semifluorinated alkane is at least about 3:1 (See page 13, lines 23-35Gunther’ 055 further teaches embodiments comprising at least two semifluorinated alkanes, wherein at least one semifluorinated alkane of formula F(CF2)n(CH2)mH wherein n is an integer from the range of 6 to 20 and m is an integer from the range of 10 to 20 is dissolved or miscible in at least one semifluorinated alkane of formula F(CF2)n(CH2)mH, wherein n is an integer from the range of 3 to 8 and m is an integer from the range of 3 to 10. (See page 14, lines 7-24) (which also reads on SFA as lipophilic constituents recited in instant claim 20).
Gunther’ 055 teaches compositions comprising at least two SFAs can exhibit surprisingly enhanced spreading behaviour compared to SFAs alone or SFAs in combination with non-fluorinated or fluorinated organic solvents. For example, when a 50-μL droplet of a solution of F(CF2)10 (CH2)12H in F(CF2)4(CH2)5H was administered to a glass surface, an almost two-fold increase in the spread area of the droplet, compared to F(CF2)4(CH2)5H alone, was observed (Table 2) (See page 18, lines 27-33). It’s noted F(CF2)4(CH2)5H (i.e. F4H5) is instant claimed CF3-(CF2)3-(CH2)4-CH3.
PNG
media_image3.png
446
646
media_image3.png
Greyscale
Gunther’ 055 further teaches the enhanced spreading behaviour and stable film properties of such combinations of SFAs are particularly advantageous for ophthalmic compositions in general and for ophthalmic compositions aimed at treating the dry eye condition. A droplet administered to the surface of the eye may lead to rapid spreading of the SFA mixture compositions over the corneal surface and the formation of a film. Efficient spreading would allow for a more effective distribution over the ocular surface. A stable film that does not immediately break up would also provide a longer-lasting lubricating effect on the ocular surface(See page 19, ; page 20, lines 5-8).
Gunther’ 055 teaches embodiments comprising neat F6H8 and mixtures of F6H8 with F10H10, F10H12, wherein the isotherms of the mixtures of F6H8/F10H10 and F6H8/F10H12 show a significantly detectable transition of an LE phase to the more ordered LC phase compared with neat F6H8 , and mono layer collapse occurs only at higher pressure values (See page 26, Example 1, Figure 1).
Regarding lipophilic constituents limitation of instant claim 14, 19, 20 and 34, Gunther’ 055 teaches composition comprising SFA may further comprise lipophilic vitamin derivatives, polyunsaturated fatty acids etc. (See page 22, lines 14-35). Gunther’ 055 teaches composition comprising SFA may further comprise other excipients e.g. lipid and oily excipients selected from triglycerides, oily fatty acid/alcohol/esters, etc. or any oily substance which is physiologically tolerated by the eye (See page 23, lines 22-34; page 24-25; claims 2 and 5).
Regarding claim 16, Gunther’ 055 teaches compositions may be formulated as a liquid solution (See page 25, line 27; claim 7).
Regarding the concentration limitation of instant claim 17, Gunther’ 055 teaches combination of two semi-fluorinated alkane compounds wherein weight ratios between the two being 3:1, 10:1, 50:1, etc. (See page 13, last paragraph; page 14, lines 1-2). Gunther’ 055 also teaches SFAs at concentration of 27mg/mL ( See Table 2).
Regarding limitation recited in instant claim 18, Gunther’ 055 teaches embodiments comprising semi-fluorinated alkane SFAs have bacteriostatic properties and do not support microbial growth and it is possible to formulate preservative-free ophthalmic compositions which are better tolerable for many patients, e.g. keratoconjunctivitis sicca ( See pages 20-21, bridging paragraph).
Regarding the refractive index of instant claim 24, Gunther’ 055 teaches SFAs exhibit a refractive index much better compatible with minimally affected vision, SFAs have refractive indices close to water and embodiments wherein SFA has refractive index from 1.29 to 1.35, and in particular from about 1.30 to about 1.35 at 20°C. (See page 15, lines 21-25; Table 1).
Regarding the kit limitation recited in instant claims 31-33, Gunther’ 055 explicitly teaches a pharmaceutical kit comprising such a composition in a container which has dispensing means adapted for topical administration of the composition to the eye or ophthalmic tissue. (See page 9, lines 10-12; page 25-26, bridging paragraph; claim 15): “Furthermore, the invention provides a pharmaceutical kit comprising the composition as described above and a container holding the composition. Preferably, the container which contains the composition has a dispensing means such as a dropping device adapted for topically administering the composition to the eye of a patient”. Gunther’ 055 teaches liquid droplet of combined SFA at size of 50uL (See Table 2).
Gunther’ 055 teaches benefit/advantage of SFA due to their unique properties in terms of wettability and/or spreading ability, for example, F4H5 or F6H8 exhibit excellent wetting of various surfaces, and enhanced spreading behaviors and stable film properties of combinations of SFAs are particularly advantageous for ophthalmic compositions in treating the dry eye condition)(See page 18, lines 19-30; bridging paragraph, page 19-20).
Gunther’ 055 collectively disclosed liquid ophthalmic compositions comprising combination of two or more semi-fluorinated alkane (SFA) (e.g. F6H8/F10H10 and F6H8/F10H12) with advantages(e.g. enhanced spreading behavior,) for treating ophthalmic disorders (dry eyes), compared with single SFA compound alone.
Regarding the viscosity limitation, Gunther’ 055 teaches composition comprising more than one
SFA can be mixed for optimally adjusted residence time after administration, i.e. the viscosity and evaporation behavior which provides additional means to optimize the ophthalmic composition for a more effective residence time in the eye (See page 20, lines 15-19).
Gunther’ 055 is silent about the specific viscosity value of instant claim 25. However, viscosity is the property of composition once the ophthalmic composition is formulated and measured by a skilled artisan, hence, the characterization and measurement of viscosity value do not necessarily contribute to the structural limitation of ophthalmic compositions.
Meinert teaches liquid semifluorinated alkanes, RFRH, having a perfluorocarbon and a hydrocarbon segment in the molecule, are physically, chemically and physiologically inert, colorless, laser stable liquids with substantially reduced densities and very low surface and interface tensions that can be used as solvents or solubilizers for drugs and medicaments, and excellent candidates for use in the ophthalmic field (See abstract, conclusions).
Meinert teaches semifluorinated alkanes, RFRH have the general formula of
PNG
media_image4.png
38
225
media_image4.png
Greyscale
(n= 3-20 and m = 3-20), and can be linear or branched (See page 191, left column). Meinert also teaches nomenclature of semifluorinated alkanes, for example, F6H8(See Figure 1).
Meinert teaches semifluorinated alkanes are not soluble in water, but soluble or miscible in other lipophilic solvent, e.g. n-decan, perfluoro decalin (F Decalin)(See Table III). Meinert teaches composition comprising various concentration of F6H8 in perfluorodecalin (F Decalin)(See page 195, Figures 5 and 6, Table V). Meinert teaches properties of semifluorinated alkanes, e.g. viscosity, surface tension, etc. and explicitly teaches F6H8 has a viscosity of 2.5m Pas at 25° C (See Table IV).
Steven teaches prospective observational study of perfluorohexyloctane (F6H8, NovaTears®) in patients with dry eye disease (DED) (NCT 02111928) and confirm F6H8 (NovaTears) as safe and effective treatment of mild to moderate hyperevaporative DED (See Abstract/Conclusions). Steven teaches NovaTears was CE marked in July 2013 after conformity assessment procedure according to the European Medical Device Directive (See page 499, left column).
Consistent with Gunther’ 055, Steven teaches perfluorohexyloctane (F6H8, NovaTears®) from the family of semifluorinated alkanes (SFAs), is nonblurring wetting agent for the ocular surface that does not need to be combined with a preservative, since it is a completely nonaqueous liquid, and therefore, microbial growth is not possible(See page 499, left column). Steven teaches F6H8, NovaTears® is water-free tear substitute that demonstrates strong spreading properties due to an extremely low surface tension leading to smaller drop sizes (See page 501, left column).
Gunther’ 055 explicitly teaches combination of at least two SFA compounds provide advantage/ benefit, e.g. enhanced spreading behavior compared to SFAs alone. Gunther’ 055 teaches semi-fluorinated alkanes (SFA) are linear or branched alkanes. It would be prima facie obvious to an ordinary skilled in the art to explore more SFA combination comprising linear SFA and branched SFA based on collective teaching of Gunther’ 055, Meinert and Steven and further explore the variables of ophthalmic solution based on the general knowledge of ophthalmic composition and SFA. As stated in MPEP 2144.06: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846,850, 205 USPQ 1069, 1072 {CCPA 1980)
It would be prima facie obvious to an ordinary skilled in the art to explore SFA combination comprising linear F6H8 and branched F6H8 and reasonably expect combination of linear F6H8 and branched F6H8 would exhibit advantage/ benefit, ( e.g. enhanced spreading behavior or significantly detectable transition of an LE phase to the more ordered LC phase) , compared to linear F6H8 alone. A skilled artisan would be motivated to explore combination of linear F6H8 and branched F6H8 because F6H8 is preferred SFA as taught by Gunther’ 055 and Gunther’ 055 explicitly teaches combination comprising F6H8 with other SFA exhibit better property/benefit compared to F6H8 alone. F6H8 is the component of NovaTears® for treating dry eye disease as taught by Steven. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to further explore the variables of active and inactive ingredients of the ophthalmic composition comprising F6H8 and excipients taught by Gunther’ 055. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05. The collective teachings of Gunther’ 055, and further experimentation and optimization based on general knowledge of ophthalmic composition and SFA (e.g. F6H8) would produce an ophthalmic composition comprising combination of linear F6H8 and branched F6H8 with desired viscosity and wetting/spreading properties that can be easily applied for treating dry eye.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on combined teaching of prior art, together with general knowledge of semi-fluorinated alkanes (SFA) and ophthalmic composition for treating dry eyes. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments regarding rejections under 35 U.S.C. § 103 filed 09/22/2025 have been fully considered, but they are NOT persuasive.
Applicant argues “None of Gunther '055, Gunther '071, Meinert, or Steven, teaches or suggests Applicant's claimed composition comprising CF3-(CF2)s-CH(CH3)-(CH2)s-CH3 and CF3-(CF2)s- (CH2)7-CH3, or CF3-(CF2)3-CH(CH3)-(CH2)2-CH3 and CF3-(CF2)3-(CH2)4-CH3. None of the SFA's taught in Gunther '055, Gunther '071, Meinert, or Steven are branched SFAs. All of the specific semifluorinated alkanes disclosed in Gunther '055, Gunther '071, and Meinert, are linear semifluorinated alkanes, and the word "branched" only appears a single time in each reference... None of Gunther '055, Gunther '071, Meinert, or Steven, specifically teach or suggest combining a single linear SFA with a single branched SFA, much less Applicant's particular combinations of SFAs as claimed”(Remarks, page 10).
RESPONSE: As explained in last office action mailed on 04/21/2025, instantly claimed “branched F6H8” and “linear F6H8” have the same formula C14H17F13, the difference between instantly claimed “branched F6H8” and “linear F6H8” is branched CHCH3 vs linear CH2 as illustrated by structures. Gunther '055 explicitly teach semi-fluorinated alkanes (SFA) are linear or branched alkanes some of whose hydrogen atoms have been replaced by fluorine, and preferred embodiments which have at least one non-fluorinated hydrocarbon segment attached to one perfluorinated hydrocarbon segment. Even though Gunther '055 didn’t specifically teach the “branched F6H8”, an ordinary skilled in the art would have known “branched F6H8” is embodiment/species of semi-fluorinated alkanes (SFA) in general as taught by prior art. In the alternative, even if instantly claimed branched SFA (e.g. branched F6H8) are chemically different from linear SFA species, the branched SFA and linear SFA are isomers , the nomenclature of SFA (linear or branched) and their close structural similarity would have been considered as equivalent and obvious to an ordinary skilled in the art within the meaning of 35 U.S.C. § 103. According to M.P.E.P. § 2144.09 II, “compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). An ordinary skilled in the art would have reasonably expected the branched SFA( e.g. F6H8) exhibit similar property as their linear SFA counterpart in the context of their use in composition for treating dry eyes.
Regarding combination of two SFAs, Gunther’ 055 teaches composition comprises at least two SFAs selected from F(CF2)4(CH2)5H (i.e. F4H5), F(CF2)4(CH2)6H, F(CF2)6(CH2)4H, F(CF2)6(CH2)6H, F(CF2)6(CH2)8H (i.e. F6H8), and F(CF2)6(CH2)10H, which exhibit surprisingly enhanced spreading behavior compared to SFAs alone or SFAs in combination with non-fluorinated or fluorinated organic solvents. Gunther’ 055 teaches embodiments comprising combination of F6H8 exhibit advantages compared to F6H8 alone. F6H8 is the component of NovaTears® for treating dry eye disease as taught by Steven. The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to further explore the variables of the ophthalmic solution comprising F6H8. It would be prima facie obvious to an ordinary skilled in the art to explore more SFA combination comprising F6H8 for treating dry eyes. Gunther’ 055 teaches semi-fluorinated alkanes (SFA) are linear or branched alkanes. It would be prima facie obvious to an ordinary skilled in the art to explore combination of linear F6H8 and branched F6H8 and reasonably expect combination of linear F6H8 and branched F6H8 would exhibit advantage/ benefit, ( e.g. enhanced spreading behavior or significantly detectable transition of an LE phase to the more ordered LC phase) , compared to linear F6H8 alone.
Non-Statutory 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 14-17, 19-20, 22-23, and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,154,513 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to an ophthalmic composition comprising a combination of
PNG
media_image5.png
35
420
media_image5.png
Greyscale
, which explicitly read on instant claim 1.
Reference claims 3-4, 6-8, 10 are directed to clear liquid solution comprising fluorinated compound at 1%-5% based on the total weight of the composition, and optionally one or more lipophilic liquid constituents that read on instant claims. Reference claim 11 is directed to a kit comprising ophthalmic composition of semi fluorinated compound and a container for holding the composition wherein said container comprises a dropper which dispenses droplets having a volume of 8 to 15 uL topically to a lacrimaal sac, lower eyelid, eye surface or other ophthalmic tissue that read on instant claims 31-33.
Reference claims reciting the same combination of compounds and similar limitation of compositions that read on instant claims, thus anticipate instant claimed invention.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is continuation of reference patent on the record and no 35 USC 121 shield exists.
Claims 14-20, 23-25, and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,357,738 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to an ophthalmic composition comprising combination of compounds that’s instantly claimed combination.
PNG
media_image6.png
97
471
media_image6.png
Greyscale
Reference claims recite the composition consists essentially of CF3(CF2)5(CH2)7CH3 and up to 3 wt. % CF3—(CF2)5—CH(CH3)—(CH2)5—CH3.
Reference claim 5 recites liquid solution which read on instant claim 16.
Reference claim 7 recites dynamic viscosity of not more than 10m Pas (which reads on instant claim 25).
Reference claim 14 recites refractive index from about 1.30 to about 1.35 at 20 ° C. (which reads on instant claim 24).
Reference claim 15-18 recites a kit comprising ophthalmic composition of semi fluorinated compound and a container for holding the composition wherein said container comprises a dropper which dispenses droplets having a volume of 8 to 15 uL topically to a lacrimaal sac, lower eyelid, eye surface or other ophthalmic tissue that read on instant claims 31-33.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to reference patent on the record and no 35 USC 121 shield exists.
Claims 14-17 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-8, 11-12 of U.S. Patent No. 10,682,315 B2 . Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to method of treating eye disease with ophthalmic composition consisting essentially of CF3(CF2)5(CH2)7CH3 and CF3—(CF2)5—CH(CH3)—(CH2)5—CH3, wherein the CF3—(CF2)5—CH(CH3)—(CH2)5—CH3 is present in an amount up to 25 wt %, which read on instant claimed composition.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to reference patent on the record and no 35 USC 121 shield exists.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached on (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.M./Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628