DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group I and the species where the oligofluorinated additive is a compound of formula 4 and the base polymer is a polyamide in the reply filed on December 10, 2025 is acknowledged. The traversal is on the grounds that the search is not burdensome because the claims do not recite a genus of compounds. The applicant also argues that they instead have 7 oligofluorinated compounds and notes 37 CFR 141(a) as support for this argument of their number of claimed compounds being reasonable to search in totality. This is not found persuasive because the claims embrace many more than 7 oligofluorinated compounds and the claims do not fulfill the requirement for Unity of Invention that governs their restriction. 37 CFR 141(a) permits “more than one species of an invention, not to exceed a reasonable number, may be specifically claimed in different claims in one national application, provided the application also includes an allowable claim generic to all the claimed species”. The applicant is correct in noting that the claims do not recite individual species that specify a particular oligofluorinated compound. Instead the most narrow of the generic claims, in regard to the oligofluorinated compound, recite generic chemical structures for the required oligofluorinated additive, where one of structure’s variable groups has more than twenty recited options. These compounds also have polyfluoroorganic groups in different number and positions across the different generic structures. The number of claimed articles embraced by the scope of these oligofluorinated additives and base polymers clearly includes many more then 7 oligofluorinated compounds and provides numerous combinations with the various embraced base polymers. Moreover, the applicant has not refuted the indication of lack of unity amongst the inventions and species based upon Santerre et al. (previously cited) as indicated in the restriction requirement mailed June 10, 2025. Thus the position held by the examiner as noted in the restriction requirement is maintained.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim.
Due to additional species encountered during the search of prior art, the scope of examination has been expanded to include polyurethane base polymers as well as polyamide or polyurethane base polymers with compound 5 as well as with other additional compounds of formula (I), where FT is -(CH2)2(CF2)5CF3, B is a urethane segment derived from 4,4′-methylene bis(cyclohexyl isocyanate) reacted with the hydroxy terminal group of a diol of A and alcohol FT source compound, and A is a triblock copolymer of poly(ethylene oxide)-b-poly(propylene oxide)-b-poly(ethylene oxide).
Specification
The disclosure is objected to because of the following: The label “Compound 2” and “Compound 3” are followed by a blank space and do not show a chemical structure for either compounds. The chemical structure shown for “compound 6” is not legible. The applicant is reminded that any sources relied upon to support a corrective amendment should provide legible versions of the compounds.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims recite an article comprising “a low friction surface” that comprises “an oligofluorinated additive admixed with a base polymer; wherein a coefficient of friction of said low friction surface is reduced by at least 30% compared to a surface of the base polymer without said oligofluorinated additive”. The functional recitation of a lowered surface friction lacks adequate description of the corresponding structure. The specification suggests that “[t]he utility of the additives of the invention versus other known macromolecular additives, lies in 1) the molecular arrangement of the amphipathic segments in the SMM chain, i.e. two w fluoro-tails, one at each end, with the central portion between them; and 2) the molecular weight of the fluorine tails relative to that of the central portions“ (see page 4 lines 11-15). The specification discusses the change in frictional properties of a collection of base polymers due to the addition of oligofluorinated additives that are disclosed. While not fully legible, compound 6 can be seen to have a straight backbone with a polyfluoroorgano group on each end. In a silicone polymer, its presence reduces the coefficient of friction by more than 80% while in a polyethyl block amide or polyurethane it has little impact (see figure 1, 2, and 5). Compound 7 has a branched four-armed core with two arms on one end terminated by polyfluoroorgano groups, while compound 8 is also branched with four arms where they are all terminated by polyfluoroorgano groups. Compound 7 reduces the coefficient of friction of polyurethane by more than 50% while neither compound 6 nor compound 8 yield a reduction. Compound 4 is a straight backbone with a polyfluoroorgano group on each end like compound 6, but unlike compound 6, it is able to reduce the coefficient of friction of both polyurethane and polyethyl block amide (see figures 1 and 3). It is not clear which structural features are required for any particular oligofluorinated additive to reduce the coefficient of friction for any particular base polymer to the degree that is instantly recited. The applicant has shown that some pairings yield the claimed reduction, while others do not. No extensible structural correlation is provided to determine which pairings of base polymer and oligofluorinated additive will also carry the claimed functionality, beyond those tested and perhaps those with the same constituent units present at different molecular weights or relative amounts. Therefore the artisan of ordinary skill would no have deemed he applicant to be in possession of the invention as claimed.
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 2 and 13 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 2 recites a particular method of measuring the coefficient of friction of the surface of the claimed article. It is not clear which structural differences are conferred by the method of assessing the frictional properties of a combination of oligofluorinated additive and base polymer. As a result the difference in scope between claims 1 and 2 is not clear.
Claim 13 recites a Markush grouping of options for the A component of Formula (I). However, this listing is not recited as a closed listing as required (see MPEP 2117(I)). Therefore the scope is unclear due to the unbounded genus that is recited.
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 1-4 and 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Steedman et al. (US PGPub No. 2019/0143217).
Steedman et al. teach a glucose sensor that includes an interface film composed of a base polymer and biostabilizing additive (see abstract; instant claim 4). The film is located such that its surface is external and/or internal to the sensor (see paragraph 7; instant claims 6-7). The base polymer is exemplified as a polyurethane and is also envisioned as a polyamide (see paragraph 14 and example 9; instant claims 9-10 and 14). The biostabilizing additive is taught to have the formula FT-[B-A)]n-B-FT, where B includes a urethane, A includes polypropylene oxide, polyethylene oxide, or polytetramethylene oxide, FT is a fluoroorgano group, and n is an integer from 1 to 10 (see paragraphs 132-137). An example is provided in compound 40 shown below:
PNG
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384
1229
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Greyscale
where n = 1, FT is -(CH2)2(CF2)5CF3 and forms a urethane linkage with 4,4′-methylene bis(cyclohexyl isocyanate as the B segment on one end and urethane linkage with a poly(ethylene oxide)-b-poly(propylene oxide)-b-poly(ethylene oxide) diol that forms A on the other (see figure 30). Steedman et al. exemplify this polymer blended with two different polyurethane polymers at 2 wt% that are coated onto a surface and dried into a film (see example 9 and paragraph 336; instant claim 8). The resulting surface of the film is an outer surface (see instant claims 1-2, 6, 9-10, 12-14). The films are also hydrated (see example 9 paragraph 341; instant claim 3). Presuming the compounds 2 and 3 of the instant specification are the compounds as disclosed in the priority document filed instantly in PCT/CA2021/051331 which generated the instant application under 35 USC 371, the choice of polymers in the A portion, urethane generating segment of B, and fluoroorganic group for FT has resulted in reducing the coefficient of friction of a polyurethane by more than 50% (see instant figure 3). The ratio of polyethylene glycol (PEG) to polypropylene glycol (PPG) in compounds 2 and 3 has more of PEG in compound 2 and more of PPG in compound 3 while the proportion of PEG in the whole compound varies between compounds 2 and 3. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Thus it is the position of the examiner that the exemplified material of Steedman et al. would have the recited functionality of reducing the coefficient of friction of the polymer in which it is blended (base polymer), absent evidence to the contrary. As a polymer, the poly(ethylene oxide)-b-poly(propylene oxide)-b-poly(ethylene oxide) must have at least two units of PEG in each of its blocks and at least two units of PPG in its block. This generates a span of possible compositions for this polymer that embrace those of instant compounds 2 and 3. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). The use of the exemplified polyurethane supplemented with these biostabilizing additives as part of the glucose sensor as envisioned would then follow.
In an additional embodiment, the A portion of the biostabilizing additives are envisioned to vary in molecular weight from 500 to 2000 Daltons when envisioned as polypropylene oxide, polyethylene oxide, or polytetramethylene oxide (see paragraphs 144-149). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a poly(ethylene oxide) for the poly(ethylene oxide)-b-poly(propylene oxide)-b-poly(ethylene oxide) as the A component in a biostabilizing additive structured like compound 40 because it is one of three envisioned homopolymer options for this portion of the compound. The taught molecular weight of 500 to 2000 Daltons for the A segment corresponds to approximately 11 to 44 repeat units which provide an overlapping range whose end points are n ≈ 46 and n ≈ 9, as recited in instant compounds 4 and 5, respectively (as calculated by the examiner based on an approximately 44 g/mol repeat unit). Their use in a polyurethane film of the sensor or in a polyamide film of the sensor would then follow and render obvious the claimed number of repeat units due to the overlap between the Steedman et al. teachings and the claimed values (see MPEP 2144.05). Therefore claims 1-4 and 6-14 are obvious over Steedman et al.
Claims 1-2, 4-7, and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Santerre et al.
Santerre et al. teach polyurethane admixtures with a fluorinated additive that are formed into blood dwelling medical devices such as catheters (see abstract). The fluorinated additive is taught to repel oil and water as well as to impart hemocompatibility (see column 1 lines 26-31). It additionally is taught as G-[B-A]n-B-G (see column 1 lines 49-62). The A is a soft segment selected from a grouping that includes polyethylene oxide, B is a hard segment that includes a urethane, G is a fluoroorgano group of the form -(CH2)2(CF2)rCF3 where r is 2 to 20, and n is an integer from 1 to 15 (see column 1 line 63-column 2 line 15). They teach the soft segment to have a molecular weight of 400 to 3000 Daltons and a diisocyanate to form the urethane selected from a grouping that includes methylene bis(p-cyclohexyl isocyanate) which provides the urethane containing segment of the elected oligofluorinated additive (see column 2 lines 23-34). Santerre et al. further teach the soft segment to be more narrowly selected from diols of polypropylene oxide, polyethylene oxide, or polytetramethylene oxide (see claims 1, 3, and 5). The fluoroorganic group is exemplified as -(CH2)2(CF2)5CF3 and n is exemplified as 1 (see column 5 lines 50-51 and compound of formulation 1).
While instant compounds 4 and 5 are not explicitly exemplified, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the catheters of Santerre et al. with a fluorinated additive composed of G as -(CH2)2(CF2)5CF3, B as produced by methylene bis(p-cyclohexyl isocyanate), polyethylene glycol as A, and n = 1. The choice of G would have been obvious because it is one of the few options that are recited and exemplified. The A is one of three narrowed choices and the B diisocyanate is one of a finite recited listing that is envisioned. The A molecular weight being 400 to 3000 Daltons would then follow because it is desired by Santerre et al. This molecular weight range corresponds to approximately 9 to 68 repeat units which provides an overlapping range that embraces n ≈ 46 and n ≈ 9, as recited in instant compounds 4 and 5, respectively (as calculated by the examiner based on an approximately 44 g/mol repeat unit). The overlap between the range of Santerre et al. and the claimed number of repeat units renders the claimed number of repeats obvious (see MPE 2144.05). The choice of n is also obvious because it is one of the few recited and exemplified options. The result is compounds that meet the limitations of instant compounds 4 or 5 admixed in polyurethane and formed into a catheter that has an inner and outer surface. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Thus it is the position of the examiner that the compounds rendered obvious by Santerre et al. would have the recited functionality of reducing the coefficient of friction of the polymer in which it they blended (base polymer), absent evidence to the contrary. Therefore claims 1-2, 4-7, and 9-14 are obvious over Santerre et al.
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 1-2, 4-7, and 9-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 8,603,070 in view of Santerre et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a catheter made of polyurethane and an oligofluorinated additive which is called a polymer with polyfluoro-oligomeric groups in the patented claims. The additive is present at 1.5 to 2.5 wt% in the device. Catheters have an inner and outer surface. The instantly claimed oligofluorinated compounds are not explicitly recited.
Santerre et al. teach polyurethane admixtures with a fluorinated additive that are formed into blood dwelling medical devices such as catheters (see abstract). The fluorinated additive is taught to repel oil and water as well as to impart hemocompatibility (see column 1 lines 26-31). It additionally is taught as G-[B-A]n-B-G (see column 1 lines 49-62). The A is a soft segment selected from a grouping that includes polyethylene oxide, B is a hard segment that includes a urethane, G is a fluoroorgano group of the form -(CH2)2(CF2)rCF3 where r is 2 to 20, and n is an integer from 1 to 15 (see column 1 line 63-column 2 line 15). They teach the soft segment to have a molecular weight of 400 to 3000 Daltons and a diisocyanate to form the urethane selected from a grouping that includes methylene bis(p-cyclohexyl isocyanate) which provides the urethane containing segment of the elected oligofluorinated additive (see column 2 lines 23-34). Santerre et al. further teach the soft segment to be more narrowly selected from diols of polypropylene oxide, polyethylene oxide, or polytetramethylene oxide (see claims 1, 3, and 5). The fluoroorganic group is exemplified as -(CH2)2(CF2)5CF3 and n is exemplified as 1 (see column 5 lines 50-51 and compound of formulation 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the catheters of the patented claims with an oligofluorinated additive of Santerre et al. as the polymer with polyfluoro-oligomeric groups. This choice would have been obvious because Santerre et al. teach these compounds in catheters to be beneficial for repellency of water and oil as well as conferring hemocompatibility. Amongst the compounds of Santerre et la. it would have been obvious to choose the variety G as -(CH2)2(CF2)5CF3, B as produced by methylene bis(p-cyclohexyl isocyanate), polyethylene glycol as A, and n = 1. The choice of G would have been obvious because it is one of the few options that are recited and exemplified. The A is one of three narrowed choices and the B diisocyanate is one of a finite recited listing that is envisioned. The A molecular weight being 400 to 3000 Daltons would then follow because it is desired by Santerre et al. This molecular weight range corresponds to approximately 9 to 68 repeat units which provides an overlapping range that embraces n ≈ 46 and n ≈ 9, as recited in instant compounds 4 and 5, respectively (as calculated by the examiner based on an approximately 44 g/mol repeat unit). The overlap between the range of Santerre et al. and the claimed number of repeat units renders the claimed number of repeats obvious (see MPE 2144.05). The choice of n is also obvious because it is one of the few recited and exemplified options. The result is compounds that meet the limitations of instant compounds 4 or 5 admixed in polyurethane and formed into a catheter that has an inner and outer surface. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Thus it is the position of the examiner that the compounds rendered obvious by Santerre et al. would have the recited functionality of reducing the coefficient of friction of the polymer in which it they blended (base polymer), absent evidence to the contrary. Therefore claims 1-2, 4-7, and 9-14 are obvious over claims 1-13 of U.S. Patent No. 8,603,070 in view of Santerre et al.
Claims 1-2, 4-7, and 9-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8,784,402 in view of Santerre et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a catheter made of polyurethane and an oligofluorinated additive which is called a polymer with terminal polyfluoro-oligomeric groups in the patented claims. The additive is present at up to 40 wt% in the device. Catheters have an inner and outer surface. The instantly claimed oligofluorinated compounds are not explicitly recited.
Santerre et al. teach polyurethane admixtures with a fluorinated additive that are formed into blood dwelling medical devices such as catheters (see abstract). The fluorinated additive is taught to repel oil and water as well as to impart hemocompatibility (see column 1 lines 26-31). It additionally is taught as G-[B-A]n-B-G (see column 1 lines 49-62). The A is a soft segment selected from a grouping that includes polyethylene oxide, B is a hard segment that includes a urethane, G is a fluoroorgano group of the form -(CH2)2(CF2)rCF3 where r is 2 to 20, and n is an integer from 1 to 15 (see column 1 line 63-column 2 line 15). They teach the soft segment to have a molecular weight of 400 to 3000 Daltons and a diisocyanate to form the urethane selected from a grouping that includes methylene bis(p-cyclohexyl isocyanate) which provides the urethane containing segment of the elected oligofluorinated additive (see column 2 lines 23-34). Santerre et al. further teach the soft segment to be more narrowly selected from diols of polypropylene oxide, polyethylene oxide, or polytetramethylene oxide (see claims 1, 3, and 5). The fluoroorganic group is exemplified as -(CH2)2(CF2)5CF3 and n is exemplified as 1 (see column 5 lines 50-51 and compound of formulation 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the catheters of the patented claims with an oligofluorinated additive of Santerre et al. as the polymer with terminal polyfluoro-oligomeric groups. This choice would have been obvious because Santerre et al. teach these compounds in catheters to be beneficial for repellency of water and oil as well as conferring hemocompatibility. Amongst the compounds of Santerre et la. it would have been obvious to choose the variety G as -(CH2)2(CF2)5CF3, B as produced by methylene bis(p-cyclohexyl isocyanate), polyethylene glycol as A, and n = 1. The choice of G would have been obvious because it is one of the few options that are recited and exemplified. The A is one of three narrowed choices and the B diisocyanate is one of a finite recited listing that is envisioned. The A molecular weight being 400 to 3000 Daltons would then follow because it is desired by Santerre et al. This molecular weight range corresponds to approximately 9 to 68 repeat units which provides an overlapping range that embraces n ≈ 46 and n ≈ 9, as recited in instant compounds 4 and 5, respectively (as calculated by the examiner based on an approximately 44 g/mol repeat unit). The overlap between the range of Santerre et al. and the claimed number of repeat units renders the claimed number of repeats obvious (see MPE 2144.05). The choice of n is also obvious because it is one of the few recited and exemplified options. The result is compounds that meet the limitations of instant compounds 4 or 5 admixed in polyurethane and formed into a catheter that has an inner and outer surface. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Thus it is the position of the examiner that the compounds rendered obvious by Santerre et al. would have the recited functionality of reducing the coefficient of friction of the polymer in which it they blended (base polymer), absent evidence to the contrary. Therefore claims 1-2, 4-7, and 9-14 are obvious over claims 1-8 of U.S. Patent No. 8,784,402 in view of Santerre et al.
Claims 1-2, 4-7, and 9-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 8,876,797 in view of Santerre et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a catheter made of polyurethane and an oligofluorinated additive which is called a polymer with terminal polyfluoro-oligomeric groups in the patented claims. The additive is present at up to 44 wt% in the device. Catheters have an inner and outer surface. The instantly claimed oligofluorinated compounds are not explicitly recited.
Santerre et al. teach polyurethane admixtures with a fluorinated additive that are formed into blood dwelling medical devices such as catheters (see abstract). The fluorinated additive is taught to repel oil and water as well as to impart hemocompatibility (see column 1 lines 26-31). It additionally is taught as G-[B-A]n-B-G (see column 1 lines 49-62). The A is a soft segment selected from a grouping that includes polyethylene oxide, B is a hard segment that includes a urethane, G is a fluoroorgano group of the form -(CH2)2(CF2)rCF3 where r is 2 to 20, and n is an integer from 1 to 15 (see column 1 line 63-column 2 line 15). They teach the soft segment to have a molecular weight of 400 to 3000 Daltons and a diisocyanate to form the urethane selected from a grouping that includes methylene bis(p-cyclohexyl isocyanate) which provides the urethane containing segment of the elected oligofluorinated additive (see column 2 lines 23-34). Santerre et al. further teach the soft segment to be more narrowly selected from diols of polypropylene oxide, polyethylene oxide, or polytetramethylene oxide (see claims 1, 3, and 5). The fluoroorganic group is exemplified as -(CH2)2(CF2)5CF3 and n is exemplified as 1 (see column 5 lines 50-51 and compound of formulation 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the catheters of the patented claims with an oligofluorinated additive of Santerre et al. as the polymer with terminal polyfluoro-oligomeric groups. This choice would have been obvious because Santerre et al. teach these compounds in catheters to be beneficial for repellency of water and oil as well as conferring hemocompatibility. Amongst the compounds of Santerre et la. it would have been obvious to choose the variety G as -(CH2)2(CF2)5CF3, B as produced by methylene bis(p-cyclohexyl isocyanate), polyethylene glycol as A, and n = 1. The choice of G would have been obvious because it is one of the few options that are recited and exemplified. The A is one of three narrowed choices and the B diisocyanate is one of a finite recited listing that is envisioned. The A molecular weight being 400 to 3000 Daltons would then follow because it is desired by Santerre et al. This molecular weight range corresponds to approximately 9 to 68 repeat units which provides an overlapping range that embraces n ≈ 46 and n ≈ 9, as recited in instant compounds 4 and 5, respectively (as calculated by the examiner based on an approximately 44 g/mol repeat unit). The overlap between the range of Santerre et al. and the claimed number of repeat units renders the claimed number of repeats obvious (see MPE 2144.05). The choice of n is also obvious because it is one of the few recited and exemplified options. The result is compounds that meet the limitations of instant compounds 4 or 5 admixed in polyurethane and formed into a catheter that has an inner and outer surface. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Thus it is the position of the examiner that the compounds rendered obvious by Santerre et al. would have the recited functionality of reducing the coefficient of friction of the polymer in which it they blended (base polymer), absent evidence to the contrary. Therefore claims 1-2, 4-7, and 9-14 are obvious over claims 1-10 of U.S. Patent No. 8,876,797 in view of Santerre et al.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4-7, and 9-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-12, 14, 28-29, 40, 43, 79-80, and 82 of copending Application No. 17/056415 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a medical device that can be a drainage catheter composed of a base polymer recited as polyurethane mixed with an additive compound. The additive compound recited as SMM 15 in the patented claims has a structure of instant claim 13 where component A is poly(ethylene oxide), B is the reaction product of 4,4′-methylene bis(cyclohexyl isocyanate) with a poly(ethylene oxide) diol with a 500 to 3000 Dalton molecular weight, G is a fluoroorganic group envisioned as -(CH2)2(CF2)5CF3, and n = 1 to 10. While not explicitly exemplified, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make instant compound 4 or compound 5 because of the narrowness and overlap in teachings of the copending claims and their subject matter. Therefore claims 1-2, 4-7, and 9-14 are obvious over claims 1, 10-12, 14, 28-29, 40, 43, 79-80, and 82 of copending Application No. 17/056415.
Claims 1-2, 4, 6-7, and 9-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 12, and 18 of copending Application No. 16/618140 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a medical device composed of a base polymer recited as polyurethane mixed with an oligofluorinated additive compound. The instantly claimed oligofluorinated compounds are not explicitly recited.
Santerre et al. teach polyurethane admixtures with a fluorinated additive that are formed into blood dwelling medical devices such as catheters (see abstract). The fluorinated additive is taught to repel oil and water as well as to impart hemocompatibility (see column 1 lines 26-31). It additionally is taught as G-[B-A]n-B-G (see column 1 lines 49-62). The A is a soft segment selected from a grouping that includes polyethylene oxide, B is a hard segment that includes a urethane, G is a fluoroorgano group of the form -(CH2)2(CF2)rCF3 where r is 2 to 20, and n is an integer from 1 to 15 (see column 1 line 63-column 2 line 15). They teach the soft segment to have a molecular weight of 400 to 3000 Daltons and a diisocyanate to form the urethane selected from a grouping that includes methylene bis(p-cyclohexyl isocyanate) which provides the urethane containing segment of the elected oligofluorinated additive (see column 2 lines 23-34). Santerre et al. further teach the soft segment to be more narrowly selected from diols of polypropylene oxide, polyethylene oxide, or polytetramethylene oxide (see claims 1, 3, and 5). The fluoroorganic group is exemplified as -(CH2)2(CF2)5CF3 and n is exemplified as 1 (see column 5 lines 50-51 and compound of formulation 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the devices of the copending claims with an oligofluorinated additive of Santerre et al. as the polymer with terminal polyfluoro-oligomeric groups. This choice would have been obvious because Santerre et al. teach these compounds in catheters to be beneficial for repellency of water and oil as well as conferring hemocompatibility. Amongst the compounds of Santerre et la. it would have been obvious to choose the variety G as -(CH2)2(CF2)5CF3, B as produced by methylene bis(p-cyclohexyl isocyanate), polyethylene glycol as A, and n = 1. The choice of G would have been obvious because it is one of the few options that are recited and exemplified. The A is one of three narrowed choices and the B diisocyanate is one of a finite recited listing that is envisioned. The A molecular weight being 400 to 3000 Daltons would then follow because it is desired by Santerre et al. This molecular weight range corresponds to approximately 9 to 68 repeat units which provides an overlapping range that embraces n ≈ 46 and n ≈ 9, as recited in instant compounds 4 and 5, respectively (as calculated by the examiner based on an approximately 44 g/mol repeat unit). The overlap between the range of Santerre et al. and the claimed number of repeat units renders the claimed number of repeats obvious (see MPE 2144.05). The choice of n is also obvious because it is one of the few recited and exemplified options. The result is compounds that meet the limitations of instant compounds 4 or 5 admixed in polyurethane and formed into a catheter that has an inner and outer surface. According to MPEP 2112.01, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” This treatment results from In re Spada, which states that, “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Thus it is the position of the examiner that the compounds rendered obvious by Santerre et al. would have the recited functionality of reducing the coefficient of friction of the polymer in which it they blended (base polymer), absent evidence to the contrary. Therefore claims 1-2, 4, 6-7, and 9-14 are obvious over 1-10, 12, and 18 of copending Application No. 16/618140 in view of Santerre et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/Examiner, Art Unit 1615