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 Amendment
Acknowledge is made of the receipt and entry of amendment filed on 06/29/2026, wherein claims 15 and 21 are cancelled, 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.
Rejection of claims 14, 16-20, 22, 24-25 and 31-33 under 35 U.S.C. 112(b) is withdrawn in light of amendment.
Rejection of claims 19 under 35 U.S.C. 112(d) is withdrawn in light of amendment.
Election/Restrictions
Applicant elected, without traverse, Group I and species of F6H8 in the reply on 07/22/2024.
Claims 26-30 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected election.
Status of claims
Claims 14, 16-20, 22-34 are pending.
Claims 26-30 remain withdrawn.
Claims 14, 16-20, 22-25, and 31-34 and under examination in this Office Action.
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.
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).
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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prior art Gunther’ 055: semi-fluorinated alkanes (SFA) are linear or branched alkanes some of whose hydrogen atoms have been replaced by fluorine, and preferred embodiments which have at least one non-fluorinated hydrocarbon segment attached to one perfluorinated hydrocarbon segment.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. Instant composition is drawn to combination of linear F6H8 and 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.
Action Summary
Applicant’s Remarks filed 06/29/2026 have been fully considered. Any objection and rejection found in the previous Office Action and not repeated herein has been withdrawn in view of amendment and Applicant’s remarks .The text of those sections of Title 35 U.S. Code not included in this action can be found in a prior Office action.
Applicant's argument filed 06/29/2026 have been fully considered, but NOT persuasive to overcome rejections of claims 14,16-20, 22-25, and 31-34 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. Please see response to arguments in following sections.
Maintained/Modified Rejections
As Necessitated By Amendment
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, 16-20, 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")(reapplied as necessitated by amendment).
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
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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 23-35). Gunther’ 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 CF3-(CF2)3-(CH2)4-CH3 recited in previous claim set dated 09/22/2025.
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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 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 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 lipophilic constituent limitation of instant claim 22 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 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, 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
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(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 repeatedly argues that none of the SFA's taught in Gunther '055, Meinert, or Steven are branched SFAs...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 7).
RESPONSE: As explained in previous office actions, Gunther '055 and Meinert explicitly teach semi-fluorinated alkanes (SFA) are linear or branched alkanes and preferred embodiments which have at least one non-fluorinated hydrocarbon segment attached to one perfluorinated hydrocarbon segment. Even though Gunther '055 and Meinert 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, instantly claimed “branched F6H8” and “linear F6H8” having the same formula C14H17F13 are isomers, wherein “branched F6H8” is branched CHCH3 vs linear CH2 in “linear F6H8” . 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) exhibits similar property as their linear SFA counterpart in the context of their use in composition for treating dry eyes.
Applicant repeatedly argues about the combination “ why a skilled artisan would have selected the claimed combination and reasonably expected the desired outcome”.
RESPONSE: As explained in previous office action, F6H8 is the component of NovaTears® for treating dry eye disease as taught by Steven. Gunther’ 055 teaches embodiments comprising combination of F6H8 exhibit advantages compared to F6H8 alone. A skilled artisan would be motivated to explore more SFA combinations based on optimization of F6H8 and combination thereof and reasonably expect the combination of linear F6H8 and branched F6H8 would exhibit advantage/ benefit compared to linear F6H8 alone. Applicant has not provided any evidence showing unexpected result to the contrary.
Applicant cites Stepan and Apotex cases and argues “there are an infinite number of branched semifluorinated alkanes that might be conceived of, but neither Gunther '055, Meinert, nor Steven demonstrates the structure, synthesis, or properties of any branched semifluorinated alkane” Nor do any of these references provide any guidance about how to synthesize any branched SFAs (Remarks, page 8-9).
RESPONSE: Applicant’s argument is fully considered, but NOT persuasive. Although Gunther '055 and Meinert didn’t specifically teach the “branched F6H8” and how to modify the linear F6H8, Gunther '055 and Meinert teach semi-fluorinated alkanes (SFA) are linear or branched alkanes which have at least one non-fluorinated hydrocarbon segment attached to one perfluorinated hydrocarbon segment. As explained above, F6H8 is the component of NovaTears® for treating dry eye disease and preferred embodiment/ working example of combination taught by Gunther’ 055. Isomerization and homologation are common practices that’s within the general knowledge of a skilled artisan in the art of pharmaceutical chemistry. When looking at the structure of linear F6H8, CF3-(CF2)5-(CH2)7-CH3, a skilled artisan would have known there are seven non-fluorinated carbon in CF3-(CF2)5-(CH2)7-CH3 that could be “branched” for isomerization. Thus, instant claimed branched isomer, CF3-(CF2)5-CH(CH3)-(CH2)5-CH3, wherein branched carbon is closely attached to the perfluorinated hydrocarbon segment is considered as experimentation/optimization within the general knowledge of skilled in the art. Regarding the synthesis of SFAs, SFA has been used commercially for a long time and the preparation of SFAs is considered as general knowledge to a skilled artisan, See Rabolt (1984).
Applicant argues Examiner’s comments about the difference between instantly claimed 'branched F6H8' and 'linear F6H8' is branched CHCH3 vs linear CH2 is hindsight (Remarks, page 9).
In RESPONSE to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
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, 16-17, 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 (reapplied as necessitated by amendment).
Reference claims are drawn to an ophthalmic composition comprising a combination of
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Reference composition is considered as combination of branched F4H5 and linear F4H5.
Reference claims 3-4, 6-8, 10 are directed to clear liquid solution comprising semifluorinated 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 combination of semifluorinated compounds F4H5 and similar limitation of compositions that are very similar to instant claims. Reference F4H5 and F6H8 are considered as homologs. 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).
Further, instant application is continuation of reference patent on the record and reference patent disclosed instant claimed combination of linear F6H8 and branched F6H8 in the disclosure.
Claims 14, 16-18, 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.
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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, 16-17 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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/LIYUAN MOU/Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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