DETAILED ACTION
This Office Action is in response to the Amendment filed on 7/3/2025. Claims 19-20 were cancelled and claims 21-22 have been added. Claims 1-18 and 21-22 are now pending in the application. Claims 14-15 are withdrawn due to a previous restriction requirement.
The previous objections of claims 1 and 10 and the previous 35 USC 112 rejections of claim 16 are withdrawn in light of Applicant’s amendment and remarks.
Election/Restrictions
Newly submitted claim 22 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 22 comprises different properties and newly required amounts for the components that are not required by claim 1.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 22 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
Claim 21 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. Instant specification is silent regarding said semi crystalline polymer consisting of ethylene and at least one of CTFE and TFE. For purposes of examination, the claim will be interpreted as reciting “consisting essentially of” (instead of consisting of) since instant specification supports this limitation [0038].
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 1-4, 7-9, 11-13, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over WO2016128315 to Carella (hereinafter as Carella ‘315, as found on the IDS dated 4/8/2022) as evidenced by WO 2016046300 to Carella (herein after Carella ‘300 as found on the IDS dated 4/8/2022).
Regarding Claim 1, 12, 17 and 18, Carella ‘315 discloses a pipe [0067] i.e., a fluid system component; comprising a meltable polymer [0025] (thermoplastic polymeric composition) comprising 25 - 48.5 mole % ethylene [0028], 53% to 62% chlorotrifluoroethylene and/or tetrafluoroethylene [0026] having a preferred heat of fusion of about 18.6 J/g [0023] thereby reading on the claimed less than 35 J/g.
Carella ‘315 do not particularly teach the meltable polymer comprising one or more semi crystalline polymers.
Nevertheless, Carella ‘300 teaches a semi-crystalline polymer is a polymer having a detectable melting point [0067] and that it is well known in the art that ECTFE or ETFE copolymers show crystallinity [0068] thereby reading on the semi-crystalline as required by the instant claim. Thereby, the meltable polymer comprising chlorotrifluoroethylene and/or tetrafluoroethylene [0026] as taught by Carella ‘315 comprises one or more semi crystalline polymers as evidenced by Carella ‘300.
Carella ‘315 does not particularly teach an extraction test having leaching of less than 50 ppb for each of Ca, Fe, K, Na, Zn, Ti, Sn, Ce, Cu, Zr, Bi, Si, Al, Sb.
However, extraction in a leaching process is a function of the chemical composition and the test conditions of the leaching process. Carella ‘315 teaches the same composition comprising a polymer comprising the claimed amounts of ethylene and chlorotrifluoroethylene as set forth in the rejection above. Therefore, the amount of extraction in a leaching process for the composition of Carella ‘315 will be the same leaching as required by the instant claims. Case law has held that claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The courts have stated that 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. In re Spada, 911 F.2d 705, 15 USPQ2d 1655, (Fed. Cir. 1990). See also In re Best, 562 F.2d 1252, 195 USPQ 430, (CCPA 1977). "Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." Further, if it is the applicant's position that this would not be the case, evidence would need to be provided to support the applicant's position. In the alternative that the above disclosure is insufficient to anticipate the above listed claims, it would have nonetheless been obvious to the skilled artisan to produce the claimed composition, as the reference teaches each of the claimed ingredients within the claimed proportions for the same utility.
Regarding Claim 2 and 16, Carella ‘315 teaches the fluid system component according to claim 1, wherein the article is made only using compressed polymer [0102] i.e., 100% semi crystalline polymer (A).
Regarding Claim 3, Carella ‘315 teaches the fluid system component according to claim 1, wherein in a preferred embodiment, polymer (P) comprises 58 to 60 mole % CTFE and 31.5 to 40.8 mole % ethylene [0030], therefore comprising a minimum of 89.5 mole % derived from ethylene, CTFE and TFE.
Regarding Claim 4, Carella ‘315 teaches the fluid system component according to claim 1, wherein in a more preferred embodiment, polymer (P) comprises 31.5 to 40.8 mole % ethylene [0030] i.e., less than 50 mole %.
Regarding Claim 7, Carella ‘315 teaches the fluid system component according to claim 5, wherein the hydrogenated comonomer is found at 0% therefore not required to be included as (meth)acrylic monomers.
Regarding Claim 8, Carella ‘315 teaches the fluid system component according to claim 1, wherein the thermoplastic polymeric composition has a melting temperature of at least 150°C and at most 220°C [0025].
Regarding Claim 9, Carella ‘315 teaches the fluid system component according to claim 1, wherein the thermoplastic polymeric composition has a melt flow rate of 0.01 to 30 g/10 min [0024] thereby encompassing the claimed melt flow rate of 1 g/10 min.
Regarding Claim 11, Carella ‘315 teaches the fluid system component according to claim 1, wherein the thermoplastic polymeric composition is free from UV filters, antioxidants, acid scavangers, metal oxides, and salts.
Regarding Claim 13, Carella ‘315 teaches the fluid system component according to claim 1, wherein the article is made only using compressed polymer [0102] i.e., 100% semi crystalline polymer (A). Therefore all surfaces, including the fluid contacting surface of the article are made from the thermoplastic polymeric composition.
Claims 5, 6, 10, and 21 is rejected under 35 U.S.C. 103 as being unpatentable over WO2016128315 to Carella ‘315 (as found on the IDS dated 4/8/2022) as evidenced by WO 2016046300 to Carella ‘300 (as found on the IDS dated 4/8/2022).
Regarding Claim 5 and 6, Carella ‘315 teaches the fluid system component according to claim 1, wherein in a preferred embodiment, polymer (P) comprises 58 to 60 mole % CTFE (reading on 52-70 mole%), 31.5 to 40.8 mole % ethylene (reading on 30-48 mole%), and 1.2-8.5 mole% acrylic acid (reading on 0-5 mole% hydrogenated comonomer) [0030] reading on the claimed ranged wherein acrylic acid is a hydrogenated comonomer selected from the group of (meth)acrylic monomers as taught in instant application [instant specification, 0025]
Though the prior art hydrogenated comonomer range is not identical to the claimed range, it does overlap. It has been held that, 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 USPG 90 (CCPA 1976) (MPEP 2144.05)
Regarding Claim 10, Carella ‘315 teaches the fluid system component according to claim 1 as set forth above and incorporated herein by reference.
Carella ‘315 does not teach the TOC (total organic carbon) of the polymeric composition. Consequently, the Office recognizes that all of the claimed effects or physical properties are not positively stated by the reference(s).
However, Carella ‘315, when modified in the manner proposed above, teaches a product prepared from all of the claimed ingredients in the claimed amounts by a substantially similar process. Therefore, the claimed effects and physical properties - i.e. TOC - would implicitly be achieved in a product prepared from all of the claimed ingredients in the claimed amounts by a substantially similar process. See In Re Spada, 911, F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) and MPEP 2111.01 (I)(II). If it is applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant’s position and (2) it would be the Office’s position that the application contains inadequate disclosure as to how to obtain the claimed properties in a product prepared from all of the claimed ingredients in the claimed amounts by a substantially similar process.
Regarding Claim 21, Carella ‘315 discloses a pipe [0067] i.e., a fluid system component; comprising a polymer [0025] (thermoplastic polymeric composition) consisting of ethylene [0014], chlorotrifluoroethylene and/or tetrafluoroethylene [0014], and 0.5-10 mole% acrylic acid [0014] having a preferred heat of fusion of about 18.6 J/g [0023] thereby reading on the claimed less than 35 J/g. Instant specification defines “consisting essentially of” as minor amounts of monomer in an amount lower than 1 mole% [0041] thereby the prior art range of 0.5-10 mole% acrylic acid reads on consisting essentially of ethylene and at least one of CTFE and TFE.
Though the prior art range of minor amounts of monomer is not identical to the claimed range, it does overlap. It has been held that, 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 USPG 90 (CCPA 1976) (MPEP 2144.05)
Carella ‘315 do not particularly teach the meltable polymer comprising one or more semi crystalline polymers.
Nevertheless, Carella ‘300 teaches a semi-crystalline polymer is a polymer having a detectable melting point [0067] and that it is well known in the art that ECTFE or ETFE copolymers show crystallinity [0068] thereby reading on the semi-crystalline as required by the instant claim. Thereby, the meltable polymer comprising chlorotrifluoroethylene and/or tetrafluoroethylene [0026] as taught by Carella ‘315 comprises one or more semi crystalline polymers as evidenced by Carella ‘300.
Carella ‘315 does not particularly teach an extraction test having leaching of less than 50 ppb for each of Ca, Fe, K, Na, Zn, Ti, Sn, Ce, Cu, Zr, Bi, Si, Al, Sb.
However, extraction in a leaching process is a function of the chemical composition and the test conditions of the leaching process. Carella ‘315 teaches the same composition comprising a polymer comprising the claimed amounts of ethylene and chlorotrifluoroethylene as set forth in the rejection above. Therefore, the amount of extraction in a leaching process for the composition of Carella ‘315 will be the same leaching as required by the instant claims. Case law has held that claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The courts have stated that 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. In re Spada, 911 F.2d 705, 15 USPQ2d 1655, (Fed. Cir. 1990). See also In re Best, 562 F.2d 1252, 195 USPQ 430, (CCPA 1977). "Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established." Further, if it is the applicant's position that this would not be the case, evidence would need to be provided to support the applicant's position. In the alternative that the above disclosure is insufficient to anticipate the above listed claims, it would have nonetheless been obvious to the skilled artisan to produce the claimed composition, as the reference teaches each of the claimed ingredients within the claimed proportions for the same utility.
Response to Arguments
Applicant's arguments filed 7/3/2025 have been fully considered but they are not persuasive.
Applicant states that Carella ‘315 comprises acrylic acid monomers, that Acrylic acid groups are known to react with cations such as those claimed in instant claim 1, and that Carella ‘315 would not have the claimed amount of leaching.
In response, attention is drawn to instant specification wherein polymeric composition 2 which is a comparative example [0077] and comprises acrylic acid copolymer metal salts [0078] that has 4.5ppb Ca, 15ppb Fe, 16ppb K, 3.2ppb Na, and 1.1 ppb Zn [table 1], therefore having a leaching of 39.8ppb which is within the instant claimed range. Based on this data the argument that acrylic acid monomers in Carellas ‘315 composition is not found persuasive.
(3) Applicant states the amount of acrylic acid found in Carella ‘315 is a limiting or minimizing amount in claim 5.
In response, it is noted in the rejection of claim 5 and 6 that though the prior art range is not identical to the claimed range, it does overlap. It has been held that, 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 USPG 90 (CCPA 1976) (MPEP 2144.05)
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 DEVIN MITCHELL DARLING whose telephone number is (703)756-5411. The examiner can normally be reached Monday - Friday 7:30am - 5:00pm.
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/DEVIN MITCHELL DARLING/Examiner, Art Unit 1764
/ARRIE L REUTHER/Supervisory Primary Examiner, Art Unit 1764