DETAILED OFFICIAL 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 .
Examiner Note
It is noted that all references hereinafter to Applicant’s specification (“spec”) are to the published application US 2021/0102019, unless stated otherwise. Further, any italicized text utilized hereinafter is to be interpreted as emphasis placed thereupon.
Response to Amendment
The Amendment filed 05 December 2025 in response to the Non-Final Rejection dated 05 August 2025 (hereinafter “NFOA”) has been entered. Claims 1, 3, and 15-16 have been amended; claims 8-14 (previously withdrawn as a result of restriction) have been canceled; new claim 21 has been added. As such, claims 1-7 and 15-21 remain pending and are under consideration on the merits.
The amendments to claims 3 and 16 have overcome the rejection of claims 3 and 16 under 35 U.S.C. 112(b) [NFOA, ¶9-15]. As such, the 112(b) rejection has been withdrawn, and the Examiner thanks Applicant for correction of the issues in accordance with the suggested amendments.
The amendments to the claims have overcome the grounds of rejection under 35 U.S.C. 103 previously set forth in the NFOA [¶20-52]. As such, the grounds of rejection under 103 have been withdrawn.
In view of the foregoing, it is noted that new grounds of rejection are set forth herein, necessitated by the amendments to the claims.
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 1-7 and 15-21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claims 1 and 15, the limitation “the medical device exhibiting an initial sliding resistance at a first temperature and an increased sliding resistance at a second temperature, with the second temperature being greater than the first temperature” renders each claim indefinite.
The surface of the medical device upon which the sliding resistance (at first and second temperatures) is determined is unclear – in other words, it is unclear if the initial and increased sliding resistances are determined for/exhibited by a surface of the coating layer (i.e. defined by the hydrophilic copolymer), or the surface of the base material layer opposite the (claimed) surface upon which the coating layer is formed (i.e. defined by the base material layer). Additionally, the term “the medical device” in (independent) claim 15 lacks sufficient antecedent basis, as there is no prior introduction/recitation of said term in the claim, such that it is unclear what element/aspect of the hydrophilic copolymer is being limited by the aforesaid limitation regarding the initial/increased sliding resistance.
Further (pertaining to both claims 1 and 15), the parameters (measurement method) for determination of the initial (first temp.) and increased (second, greater temp.) sliding resistance are unclear – the claims do not define how the sliding resistance is determined, that is, do not define, e.g. surface of the medical device subject to measurement, object/surface and material thereof (hereinafter “counter-surface”) with which the medical device is contacted, quantity (weight) of the load which is applied to the medical device surface by the counter-surface, distance over which the resistance is determined, and the rate (speed) at which the medical device (or counter-surface) is slid relative to the counter-surface (or medical device).
As such, one of ordinary skill in the art would not be able to readily determine or envisage the metes and bounds of the scope of the claimed medical, and the public would not be informed of the boundaries of what constitutes infringement upon the claimed medical device for which patent protection is sought. See MPEP 2173, MPEP 2111, and MPEP 2111.01(II) – it is respectfully noted that during examination, it is important not to import limitations into a claim, from the specification, which are not part of the claim (MPEP 2111.01(II)), wherein claims are given the broadest reasonable interpretation in light of the specification and must be consistent with the interpretation that one of ordinary skill in the art would reach (MPEP 2111). In the instant case, the claimed “sliding resistance” does not have or correspond to an explicit definition in the spec, and one of ordinary skill in the art readily recognizes that the sliding resistance value reported for any material is dependent upon each of the parameters identified above.
As such, claims 1 and 15 are interpreted for examination on the merits wherein the claimed sliding resistance may be determined under any parameters. In order to overcome the indefiniteness issue, it is respectfully suggested to amend claims 1 and 15 – in view of ¶11 above – to include (all of) the measurement parameters/steps utilized to determine the sliding resistance as set forth in the spec [0109]. Additionally, in an effort to facilitate compact/expedient prosecution, it is respectfully suggested to also define the temperature, or temperature range, corresponding to each of the initial sliding resistance (first temperature) and increased sliding resistance (second temperature) set forth in claim 1 and claim 15 (see claim 21).
Claims 2-7 and claims 16-21, respectively, are indefinite and rejected under 35 U.S.C. 112(b) as they are directly dependent upon claim 1 and claim 15, respectively and therefore include, and do not remedy or fully remedy the indefiniteness issues identified above.
Appropriate action is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7 and 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Hyuugaji et al. (US 2018/0217294; “Hyuugaji”), in view of Sandhu et al. (US 2012/0059111; “Sandhu”) (both references previously cited). US 7,459,489 to Lewandowski et al. (“Lewandowski”) (previously cited) is cited by, and incorporated into, Sandhu by reference and is relied upon herein as an evidentiary reference in accordance with the disclosure of Sandhu.
Regarding claim 1, Hyuugaji discloses a medical device, e.g. catheter, balloon, or contact lens having a hydrophilic coating layer formed on a surface thereof and imparting lubricity to the device [Abstract; 0001-0002, 0013, 0041-0042, 0044, 0056-0057]. The layer is formed from a copolymer exhibiting a lower critical solution temperature (LCST) [0046], said copolymer formed from repeat units, i.e. monomeric structural units (A) and (B), optionally (C), and optionally (D) [0060-0065, 0170-0171, 0193-0194, 0224-0225, 0236, 0241]. The copolymer exhibits a weight average molecular weight (Mw) of 3,000-5,000,000, preferably 10,000-2,000,000, and number average molecular weight (Mn) of 2,000-10,000,000, preferably 10,000-500,000 [0237-0240].
Structural unit (A) may be, inter alia a combination of unit (A-3) and unit (A-6), or a combination of unit (A-3) and unit (A-7) [0065, 0110, 0131, 0144, 0165-0167]. Unit (A-3) is, inter alia N-isopropyl acrylamide [0110-0111, 0116] (MPEP 2131.02(II), MPEP 2144.07). Unit (A-6) is, inter alia N-(meth)acryloyloxyethyl-N,N-dimethylammonium-α-N-propylsulfobetaine, whose counterion may be a sodium ion or hydride ion [0131-0133, 0139, 0142]. Unit (A-7) is, inter alia 2-acrylamido-2-methylpropane sulfonic acid (AMPS) (or salt thereof, such as sodium) [0144, 0147-0149].
Relative to the 100% by mass of all structural units forming the copolymer, unit (A) may range from 2.5-95% by mass [0168]. Further, through calculation based on the exemplary embodiment(s) [0286-0287] disclosed (Copolymer (N-3), utilizing DMAA as (A-3) and GLBT as (A-6)), Hyuugaji reasonably teaches one of ordinary skill in the art a relative mass ratio of (A-3) to (A-6) of 34:1, i.e. about 97% by mass (A-3) and about 3% by mass (A-6) relative to 100% by mass total of (A-3) and (A-6).
As such, Hyuugaji therefore reasonably teaches that unit (A) may define up to 95% by mass of the copolymer (all structural units), and unit (A-3) may define up to about 97% by mass of the total of unit (A) – through calculation, unit (A-3) may therefore define up to about 92% by mass of the copolymer, and (A-6) and/or (A-7) may define up to about 3% by mass of the copolymer.
In view of the foregoing teachings, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to utilize/apply the aforesaid mass ratio of (A-3) to (A-6) to other embodiments of the copolymer(s) encompassed within the broad disclosure (MPEP 2131(I) and (II)) of Hyuugaji, such as the embodiment set forth/cited above wherein (A-7) may be utilized in place of (A-6), and/or wherein (A-3), (A-6), and (A-7) are the monomers identified above, as the first/most-logical attempt to achieve the disclosed benefits including increased/high lubricity.
Hyuugaji discloses that structural unit (D) may contain a functional group such as, inter alia a ketone group to allow for crosslinking of the copolymer and thereby increased resistance to detachment from the surface of the medical device; unit (D) is suitably a monomer including the ketone group [0224-0230].
Hyuugaji discloses that the copolymer may be formed via radical polymerization of the structural units present in a solution, wherein the initiator for said polymerization may be a photopolymerization initiator such as, inter alia a benzophenone compound [0243, 0245-0250, 0268-0271].
With respect to the difference(s) relative to the invention defined by claim 1, Hyuugaji is silent regarding the structural unit (D) (e.g. ketone group-containing unit) comprising a photoreactive group (i.e. an aryl ketone).
It is noted that Applicant’s spec [0048] states: “Here, the photoreactive group refers to a group capable of generating reactive species such as radicals, nitrenes, and carbenes by irradiation with active energy rays and reaction with the base material layer so as to form a chemical bond”. Further, the spec [0049] states: “Examples of the photoreactive group include an azide group, a diazo group, a diazirine group, a ketone group, and a quinone group”, and furthermore, at [0053] states: “Examples of the ketone group include groups having a structure such as acetophenone, benzophenone, anthrone, xanthine, and thioxanthone”.
Sandhu is directed to/teaches hydrophilic, lubricious and durable coatings for medical devices, e.g. catheters and medical balloons, said coatings formed from a copolymer including monomeric units of N-vinyl pyrrolidone (NVP); monomeric units which may be based on additional/other monomers (non-NVP), such as AMPS, sulfobetaines, and N-alkyl substituted acrylamides [Sandhu, 0017-0018; Lewandowski, col. 10 ln. 6-23]; and monomeric units based on aryl ketone (polymerizable) derivatives [Abstract; Fig. 1A; 0002-0003, 0012, 0014-0015, 0027-0034, 0062, 0070]. Sandhu also discloses embodiments of the copolymer which do not require NVP as a monomeric unit [0066, 0068]
Sandhu teaches that the aryl ketone may be a benzophenone (diaryl ketone), and preferably is 4-benzoylphenyl methacrylate, i.e. 4-methacryloyloxy benzophenone [Fig. 1A; 0014-0016, 0027-0032]. The use of the aforesaid benzophenone as a monomeric unit forming the copolymer facilitates/promotes crosslinking of the copolymer, while also allowing for the crosslinking reaction to be activated by light (i.e. photoactivated) [0032, 0062].
Hyuugaji and Sandhu each constitute prior art which is directly analogous to the claimed invention. In view of the combined teachings of the foregoing prior art, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the copolymer of Hyuugaji by utilizing 4-methacryloyloxy benzophenone as the reactive functional group-containing, e.g. ketone group-containing monomer of structural unit (D), as the aforesaid benzophenone would have been well recognized as suitable for provision of the reactive ketone group functional to crosslink the copolymer, while also allowing for photoactivation of the crosslinking reaction in the absence of a photoinitiator separately included in the solution (the photoactivable group capable of initiating crosslinking after exposure to one or more forms of light would be pendent to the polymer backbone, rather as a separate component in the solution). See MPEP 2144.06(I) and (II); MPEP 2144.07.
In accordance with the modification above, the copolymer of Hyuugaji, coated on the surface of a medical device, would have comprised all of the elements/features set forth above, wherein unit (D) would have been formed 4-methacryloyloxy benzophenone. That is, the disclosure of Hyuugaji taken in view of the teachings of Sandhu (hereinafter “modified Hyuugaji”) reasonably encompasses the following copolymer formed from at least structural units (A), (B), and (D):
Unit (A) would have been a combination of (A-3), and (A-6) and/or (A-7), wherein (A-3) would have been N-isopropyl acrylamide (NIPAAm), (A-6) would have been N-(meth)acryloyloxyethyl-N,N-dimethylammonium-α-N-propylsulfobetaine, and (A-7) would have been AMPS;
Unit (A-3) (NIPAAm) would have defined up to about 92% by mass of the overall mass of the copolymer (the total mass of all structural units which form the copolymer) [¶20-22 above], with unit (A) defining up to 95% by mass of the copolymer;
Unit (A-7) (AMPS) would have defined up to about 3% by mass (about 2.85% max) of the overall mass of the copolymer [¶20-22 above]; alternatively, unit (A-6) (N-(meth)acryloyloxyethyl-N,N-dimethylammonium-α-N-propylsulfobetaine), or unit (A-6) and (A-7) would have defined up to said about 3% by mass;
Unit (B), a (poly)oxyalkylene (meth)acrylate, would have defined as low as 2.5% by mass of the overall mass of the copolymer [Hyuugaji, 0170-0173, 0191]; and
Unit (D) would have been 4-methacryloyloxy benzophenone, and would have defined up to 50% by mass of the copolymer, preferably 1% to 20% by mass, and more preferably 2% to 10% by mass of the copolymer [Hyuugaji, 0235; Sandhu, 0015-0016].
Unit (A-3) formed from NIPAAm reads on the claimed structural unit derived from monomer (A), wherein 92% by mass is necessarily within the claimed range of more than 50 mol% of (A), as evidenced by Production Examples 1 and 2 of the spec [0125-0126; Table 1] – the copolymer of Ex. 1 comprises 94 mol% NIPAAm corresponding to about 82% by mass, and the copolymer of Ex. 2 comprises 90 mol% NIPAAm corresponding to about 71% by mass (each determined through calculation). As such, 92% by mass must necessarily be within the claimed range of more than 50 mol%. Further evidenced by the spec [0026], N-isopropyl acrylamide (homopolymer formed therefrom) exhibits a LCST (of about 32° C).
Unit (A-7) formed from AMPS, and/or unit (A-6) formed from N-(meth)acryloyloxyethyl-N,N-dimethylammonium-α-N-propylsulfobetaine, read(s) on the claimed structural unit derived from monomer (B) having at least one selected from sulfonic acid group, sulfate group, sulfurous acid group, and salts of the foregoing.
Unit (D) formed from 4-methacryloyloxy benzophenone reads on the claimed structural unit derived from monomer (C) having a photoreactive group.
In view of the totality of the foregoing – and in view of the information set forth in [¶37-39] below which is incorporated herein by reference (not repeated) – the medical device, e.g. medical balloon, catheter, contact lens of modified Hyuugaji, having the copolymer (set forth/cited above – see at least [¶30-33]) coated on the surface thereof (base material layer that possess a surface), would have been substantially identical, or identical, to the claimed and disclosed medical device in terms of the following (in relation to copolymer):
(1) species of monomer (A) (NIPAAm), species of monomer (B) (e.g. AMPS), and species of monomer (C) (4-methacryloyloxy benzophenone);
(2) the amount of monomer (A) (NIPAAm) being within the range of greater than 50 mol%, and corresponding to/encompassing the mass amount of (A) relative to 100 mass% total monomeric units forming the copolymer [spec, 0028, 0125-0126; Table 1];
(3) the aforesaid species and amount of monomer (A) (NIPAAm) being directly attributed in Applicant’s specification to the temperature-dependent, variable sliding resistance, i.e. higher sliding resistance/lower sliding property upon heating, and vice versa [spec, 0021, 0028];
(4) the molar and/or mass amounts of monomer (B) (e.g. AMPS), mass being up to about 3% relative to overall copolymer mass [spec, 0046-0047, 0125-0126; Table 1];
(5) the molar ratio of monomers (A):(B), i.e. (NIPAAM):(AMPS) being within the range of 70:30 to 99.5:0.5 [spec, 0047; claim 20] – additionally see [¶49] below;
(6) the molar and/or mass amount of monomer (C) (4-methacryloyloxy benzophenone), mass being up to 50%, such as 2-20% by mass relative to overall copolymer mass [spec, 0058-0059]; and
(7) the Mw of the copolymer being from 10,000-2,000,000 [spec, 0065].
Given substantially identical or identical elements (1)-(7) above, it stands to reason, and there is a strong expectation that the copolymer coated on the surface of the medical device of modified Hyuugaji would have necessarily exhibited an initial sliding resistance at a first temperature and necessarily exhibited an increased sliding resistance (relative to initial) at a second temperature which is greater than said first temperature, absent a showing of factually supported objective evidence to the contrary. See MPEP 2112(IV) and (V), MPEP 2112.01(I) and (II), MPEP 2144.05(I), MPEP 2145, and MPEP 2145(I).
Regarding claim 2, the rejection of claim 1 above reads on the device defined by claim 2 – the medical device of modified Hyuugaji is suitably a balloon or catheter, inter alia.
Regarding claim 3, as set forth in the rejection of claim 1 above, the copolymer of modified Hyuugaji is suitably formed from NIPAAm (A-3) (monomer (A)) and AMPS (A-7) (monomer (B)) as unit (A), wherein unit (A) may define from 2.5% to 95% by mass of the copolymer [Hyuugaji, 0168], with (A-3) defining up to 92% by mass and (A-7) defining up to about 3% by mass, each relative to overall mass of the copolymer [¶24-26 above]. Unit (B) may define as little as 2.5% by mass of the copolymer, and unit (D) formed from 4-methacryloyloxy benzophenone (monomer (C)) may define up to 50% by mass of the copolymer, e.g. 2-20% by mass.
Further, the spec indicates that Prod. Ex. 1 is formed from (mass) about 82% NIPAAm, about 14% AMPS, and about 4% monomer (C), which is specifically 4-methacryloyloxy benzophenone (MBP) [0125; Table 1]. The spec also indicates that Prod. Ex. 2 is formed from (mass) about 71% NIPAAm, about 25% AMPS, and about 4% MBP [0126; Table 1], wherein Prod. Ex. 1 and 2 each exhibit an LCST within the range of 40° C to 70° C [0149]. The spec also indicates that the amount of monomer (B) may be as low as 0.5 mol%, up to 30 mol% [0046] (encompasses mass amount of unit (A-7)).
In view of the foregoing, further in view of elements (1)-(7) identified in the rejection of claim 1 above, and given that Hyuugaji suggests that the LCST of the copolymer, at normal pressure, is within the range of 30° C to 80° C [0046-0050], it stands to reason – and there is a strong expectation – that the copolymer of modified Hyuugaji would have necessarily exhibited a LCST of from 40° C to 70° C, absent a showing factually supported objective evidence to the contrary. See MPEP 2112(IV) and (V), MPEP 2112.01(I) and (II), MPEP 2144.05(I), MPEP 2145, and MPEP 2145(I).
Regarding claim 4, the rejection of claim 1 above reads on the device defined by claim 4 – (A-3) of unit (A) of the copolymer is formed from, inter alia NIPAAm (monomer (A) is N-isopropyl acrylamide).
Regarding claim 5, the rejection of claim 1 above reads on the device defined by claim 5 – (A-7) of unit (A) of the copolymer is formed from, inter alia AMPS (monomer (B), represented by Formula (2)). See spec [0030-0031, 0034; Table 1].
Regarding claim 6, the rejection of claim 1 above reads on the device defined by claim 6 – unit (D) of the copolymer is formed from 4-methacryloyloxy benzophenone (MBP) (monomer (C)), i.e. a polymerizable monomer whose photoreactive group (diaryl ketone) is a benzophenone structure (monomer (C) has a benzophenone structure).
Regarding claim 7, in view of the rejection of claim 1 above, Hyuugaji discloses that the material forming the medical device and surface thereof, upon which the coating layer of the hydrophilic copolymer is formed, is suitably a polymeric material [0042, 0056-0057, 0172] (base material layer is made of a polymer material).
Regarding claim 15, the rejection of claim 1 above is incorporated herein by reference (not repeated for sake of brevity) and reads on the hydrophilic copolymer defined by each and every limitation of claim 15.
Regarding claim 16, in view of the rejection of claim 15 above, the rejection of claim 3 above is incorporated herein by reference and reads on the hydrophilic copolymer defined by claim 16.
Regarding claim 17, in view of the rejection of claim 15 above, the rejection of claim 4 above is incorporated herein by reference and reads on the hydrophilic copolymer defined by claim 17.
Regarding claim 18, in view of the rejection of claim 15 above, the rejection of claim 5 above is incorporated herein by reference and reads on the hydrophilic copolymer defined by claim 18.
Regarding claim 19, in view of the rejection of claim 15 above, the rejection of claim 6 above is incorporated herein by reference and reads on the hydrophilic copolymer defined by claim 19.
Regarding claim 20, in view of the rejection of claim 15 above, the hydrophilic copolymer of modified Hyuugaji is suitably formed from (based on mass) up to 95% unit (A) defined by the combination of (A-3) (monomer (A)) and (A-7) (monomer (B)), wherein relative to the total mass amount of (A-3) and (A-7), (A-3) may define about 97% and (A-7) may define about 3%, i.e. a “mass ratio” of 97:3 [¶20-22 above]. In view of said mass ratio, based on the repeat unit molecular weights of NIPAAm (113.16 g/mol) and AMPS (207.24 g/mol), and assuming for calculation total mass of 100 parts (100 g), the molar ratio of (A-3):(A-7) of the aforesaid copolymer determined as about 98.4:1.6, which is within the claimed molar ratio range (A:B) of 70:30 to 99.5:0.5. See MPEP 2131.03; MPEP 2144.05(I).
Regarding claim 21, the rejection of claim 1 above reads on the medical device defined by claim 21. See [¶34-35] above – it stands to reason, and there is a strong expectation, that the copolymer of modified Hyuugaji would have necessarily exhibited a sliding resistance at 25° C of 20 gf or less and a sliding resistance at 60° C of 25 gf or more, absent a showing of factually supported objective evidence to the contrary. See MPEP 2112(IV) and (V), MPEP 2112.01(I) and (II), MPEP 2144.05(I), MPEP 2145, and MPEP 2145(I).
Response to Arguments
Applicant’s arguments presented in the Remarks filed 05 December 2025, pp. 10-14 have been fully considered but not found persuasive. On p. 10 and pp. 12-13, Applicant asserts that a stark distinction exists between the claimed invention and that of modified Hyuugaji – Hyuugaji is directed to the copolymer exhibiting excellent hydrophilicity and lubricity sustained over time, i.e. Hyuugaji seeks “to achieve low sliding properties (e.g., lubricity) in all environments, including high temperature environments”. In contrast, the claimed device, in view of the amendments to claims 1 and 15 and newly added claim 21, exhibits increased high sliding property (low sliding resistance) at a first/lower/steady-environment temperature, e.g. 25° C and a low sliding property (high sliding resistance) at a second temperature which is greater than said first temperature. Applicant supports said position by citation to Hyuugaji [Table 2], asserting that lubricity is generally consistent at both low and high temperatures.
However, it is first noted that Table 2 is not directed to the lubricity of the copolymers of Hyuugaji determined at lower and higher temperatures, as asserted. Rather, Table 2 is directed to measurement of lubricity of the copolymer (medical devices having copolymer coating formed thereon) after having been subject to increased temperature specified in the “Temperature treatment” column, e.g. 35° C, e.g. 120° C and thereafter rinsed with three times with pure water for 10 seconds, the lubricity value determined by human touch with a dry finger [Hyuugaji, 0357, 0365-0373 – “Lubricity Test”], or thereafter rinsed ten times with a commercially available content lens cleaning solution followed by three washes with phosphate buffered saline [Hyuugaji, 0374-0382 – “Test on Lubricity after Scrubbing”]. As such, the lubricity values reported in Table 2 in accordance with the aforesaid tests are determined after the copolymer coating (medical device) has, presumably, cooled down to or near room temperature as a result of the 3x10 s water wash, or 10x contact solution rinse followed by 3x saline wash. Even if the aforesaid presumption were inaccurate to a degree, it may then be said definitively that the temperature of the copolymer at which the lubricity or lubricity after scrubbing is measured by Hyuugaji cannot be clearly/specifically determined from the aforecited paragraphs and Table 2. Therefore, it is clear that Table 2 of Hyuugaji does not support Applicant’s assertion.
Nevertheless, it is noted that the argument(s) [Remarks, p. 10, pp. 12-13] identified/addressed above have not been made in relation to the prima facie case of obviousness established in the rejection under 103 over Hyuugaji in view of Sandhu previously set forth [NFOA, ¶20-52]. In other words, Applicant does not explicitly or implicitly rely upon the above-identified arguments to rebut the previously-established prima facie case of obviousness, i.e. does not rely upon the above-identified arguments to assert the nonobviousness of the combination of Hyuugaji and Sandhu and the copolymer/coated medical device resultant from said combination.
For these reasons, Applicant’s arguments identified above are not found persuasive.
Further, on pp. 13-14 of the Remarks, Applicant does rely upon the above-identified arguments to support the assertion that the copolymer of modified Hyuugaji would not have necessarily exhibited the claimed temperature-dependent, variable sliding resistance as amended into claim 1 and claim 15. However, as stated above the data presented in Table 2 of Hyuugaji does not, and cannot be relied upon to, support Applicant’s assertion. Furthermore – while the Examiner does not concede to the disclosure of Hyuugaji being directed to “achieving low sliding properties in all environments, including high temperature environments” as asserted – it is noted that the fact that Hyuugaji seeks to achieve high lubricity and high hydrophilicity, for sustained periods of time, is (1) not germane to whether or not the copolymer of modified Hyuugaji would have inherently exhibited the claimed temp-dependent variable sliding resistance, (2) does not rebut the prima facie case of obviousness previously established in the NFOA and substantially maintained in a similar manner hereinabove, and (3) does not constitute a showing/provision of factually supported objective evidence necessary to rebut the prima facie case of ‘inherency’. See MPEP 2112(V) – The PTO can require an applicant prove that the prior art product does not necessarily or inherently possess the characteristics of the claimed product. See MPEP 2112.01(I) – When the PTO shows a sound basis for believing that the products of the Applicant and the prior art are the same, the Applicant has the burden of showing that they are not. The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product.
For these reasons above, Applicant’s additional argument is not found persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Michael C. Romanowski whose telephone number is (571)270-1387. The Examiner can normally be reached M-F, 09:30-17:30.
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, Aaron Austin can be reached at (571) 272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL C. ROMANOWSKI/Primary Examiner, Art Unit 1782