DETAILED ACTION
This Office Action is responsive to the amendment filed on 1/5/2026.
The objections and rejections not addressed below are deemed withdrawn.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
The present application is being examined under the pre-AIA first to invent provisions.
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/5/2026 has been entered.
Response to Amendment
The amendment to the claims filed on 1/5/2026 does not comply with the requirements of 37 CFR 1.121(c) because it improperly labels claims 18 and 19 as (Previously Presented). Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c) which states:
(c) Claims. Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn) (emphasis added), (Previously presented), (New), and (Not entered).
In the response to a restriction requirement submitted on 12/20/2024, applicant elected the invention of Group II for examination on the merits. As a result, claims 18 and 19 were withdrawn from consideration as being drawn to a nonelected invention; see paragraph 4 of the Office Action mailed on 2/7/2025. Claims 18 and 19 therefore should be identified as (Withdrawn) in any future claims listing.
Claim Rejections - 35 USC § 112
Claims 2, 3, and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 depends from claim 10, and states that the flexible blocks are polyether blocks and/or polyether and polyester blocks. As amended, however, claim 10 requires that the flexible blocks are 100% by weight polyethylene glycol. The instant claim’s recitation that the flexible block is polyether-which reads on ether structures other than polyethylene glycol- or a combination of polyether and polyester blocks broadens the scope of the claimed invention to include block copolymers wherein the flexible blocks are not 100 wt% polyethylene glycol.
Claim 3 depends from claim 10, and states that the flexible blocks are derived from polyethylene glycol or comprise polyethylene glycol blocks and blocks derived from another polyether. The first recited embodiment that the flexible blocks are derived from polyethylene glycol does not further limit the scope of the parent claim, as claim 10 already requires that the flexible blocks are 100 wt% polyethylene glycol. With regards to the second recited embodiment, the limitation that the flexible blocks comprise additional blocks derived from another polyether broadens the scope of the parent claim to read on structures wherein the flexible blocks are not 100 wt% polyethylene glycol.
Claim 8 depends from claim 10 and states that the copolymer can be
a copolymer containing polyamide 11 blocks and blocks derived from polyethylene glycol and blocks derived from polytetrahydrofuran (lines 3-4),
a copolymer containing polyamide 12 blocks and blocks derived from polyethylene glycol and blocks derived from polytetrahydrofuran (lines 5-6), or
a copolymer containing copolyamide 6/11 blocks and blocks derived from polyethylene glycol and blocks derived from polytetrahydrofuran (lines 8-9),
Per applicant’s specification (see page 11: line 20 to page 12: line 4), polytetrahydrofuran is a flexible block. As amended, however, independent claim 10 requires that the flexible blocks of the copolymer are 100 wt% polyethylene glycol. Claim 8’s recitation of the above species therefore impermissibly broadens the scope of the parent claim to include copolymers wherein the flexible blocks are not 100 wt% polyethylene glycol.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
Claim 2-5, 8-10, 12-14, 16, 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Steenblock et al, US5703161.
Steenblock discloses film, corresponding to the claimed membrane (for claim 10) made from a polymer mixture comprising a first polyether block amide (PEBA), a second PEBA, and an ethylene/vinyl acetate/maleic anhydride terpolymer (abstract).
Regarding the claimed block copolymer: Steenblock’s first PEBA comprises 40 to 70 wt%, overlapping the claimed range (for claims 6, 10) of a soft polyethylene glycol block. Note that Steenblock does not teach the inclusion of any other comonomers/polymers in said soft block but rather specifically refers to this block as a polyethylene glycol block; the prior art soft block therefore comprises 100 wt% polyethylene glycol (for claims 7, 8, 10), corresponding to the claimed flexible block which is a polyether (for claims 2, 3, 10). The first polyether block amide comprises 30 to 60 wt%, overlapping the claimed range (for claims 6, 10), of a rigid polyamide block which may be polyamide 12 or polyamide 11 (for claims 5, 8)-i.e., the mean carbon content of the repeating unit is either 11 or 12 (for claims 4, 10) (Column 2: lines 21-31).
Regarding claim 13: The prior art film has a thickness less than 150 µm (Column 3: lines 47-49), overlapping the claimed range.
Regarding claim 14: The prior art film further comprises a second polyether block amide comprising rigid polyamide blocks and soft polyethylene glycol blocks and an ethylene/vinyl acetate/maleic anhydride terpolymer (Column 2: lines 32-39), corresponding to the at least one polymer(s).
Regarding claim 20: As disclosed by Steenblock, the prior art first PEBA does not contain any blocks other than the polyamide blocks, corresponding to the claimed rigid polyamide block, and the polyethylene glycol block, corresponding to the claimed flexible block (Column 2: lines 28-31).
Steenblock does not specifically disclose the production of a film wherein the first polyether block amide comprises 60 to 90 wt% of the soft block and 10 to 40 wt% of the rigid block.
It has been held that in the case where the claimed ranges overlap or lie inside ranges disclosed in the prior art, a prima facie case of obviousness exists; see 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) (MPEP § 2144.05). The prior art ranges overlap the claimed ranges. Barring a showing of evidence demonstrating unexpected results, it therefore would have been obvious at the time the invention was effectively filed to prepare a film wherein the first polyether block amide had the content of the soft blocks and rigid blocks within the required ranges in view of the teachings of Steenblock.
Regarding the properties of selectivity (for claim 10), elongation at break (for claim 9), and permeability to water vapor (for claim 12):“[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency under 35 U.S.C. 102, on prima facie obviousness under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…" as that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (MPEP § 2112).
As discussed above, the prior art discloses a film prepared from a composition that comprises a first polyether block amide which has the same structure as the block copolymer recited in the instant claims. Furthermore, the prior art film is required to comprise said first polyether block amide in an amount in the range of 50 to 85 wt% (Column 2: line 28). Note that applicant’s specification teaches that the claimed membrane should comprise at least 50 wt% of the recited copolymer and not more than 50 wt% of additional polymer(s) (specification page 18: lines 33-36). The film of Steenblock therefore comprises the same polymer components combined in the same amounts as applicant’s disclosed membrane. As the prior art film appears to be identical to the claimed membrane, an ordinary artisan would reasonably expect that its properties would be the same as those of the claimed invention. The burden is therefore shifted to the applicant to provide evidence that the properties used to define the claimed membrane would not be present in the film rendered obvious by Steenblock (for claims 9, 10, 12).
Regarding the claimed process steps (for claims 16, 17): "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP § 2113). As discussed above, PEBAX® MX1074 has the same structure comprising rigid polyamide blocks and soft polyethylene glycol blocks combined in the same amounts as the claimed copolymer. As the prior art copolymer appears to be identical to the claimed copolymer, the burden is shifted to applicant to provide evidence that the recited process steps result in an unobvious difference between the claimed invention and the prior art (for claims 16, 17).
Response to Arguments
Applicant's arguments filed 1/5/2026 have been fully considered but they are not persuasive with respect to the rejection over Steenblock.
Regarding the rejection over Steenblock: Applicant argues that Steenblock discloses polyether block amides (PEBAs) in which the soft blocks are derived from polyether glycols generally, including poly(tetramethylene glycol) (PTMG), polypropylene glycol, and mixtures thereof. Applicant therefore argues that Steenblock does not teach the claimed PEBA in which the soft block is 100 wt% polyethylene glycol as recited in the amended independent claim 10.
In response Steenblock discloses the following with regards to the first PEBA (abstract; Column 2: lines 27—31).
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As shown in the cited text, Steenblock explicitly teaches that the first PEBA consists of polyamide blocks chosen from the recited species and polyethylene glycol blocks; the prior art does not generically disclose the use of polyethers as alleged by applicant. Furthermore, no reference to the use of polypropylene glycol as a flexible block is found within the disclosure of Steenblock. With regards to PTMG, Steenblock only refers to this compound in its discussion of the technical background of the art, noting that PTMG was a preferable monomer in the polymers of EP0459862 (Column 1: lines 34-41). Significantly, Steenblock specifically states that such polymers are not suitable for use in the invention of US5703161 due to their low hydrophilicity (Column 1: lines 41-43). Contrary to applicant’s argument, Steenblock does teach that the flexible blocks are 100 wt% polyethylene glycol as required by the instant claims.
Applicant argues that the Steenblock does not disclose the claimed properties of being waterproof breathable and having a selectivity, defined as the ratio of its permeability to carbon dioxide to its permeability to dioxygen, greater than or equal to 10.
As noted in text cited in paragraph 27 of this Action, the first PEBA of Steenblock is a copolymer consisting of polyamide blocks and polyethylene glycol blocks; note that said polyamide blocks have a mean carbon content of the repeating unit of 11 (polyamide 11) or 12 (polyamide 12 and polyamide 12,12). Furthermore, the amounts for the polyamide and polyethylene glycol blocks of the first PEBA overlap the claimed ranges for the amounts of hard blocks and flexible blocks, respectively. The first PEBA of Steenblock therefore corresponds to the copolymer comprising rigid polyamide blocks and soft blocks that are 100 wt% polyethylene glycol as recited in independent claim 10.
Furthermore, Steenblock teaches that the prior art composition is required to comprise at least 50 to 85 wt% of the first PEBA (abstract; Column 2: lines 27—31). Note that applicant’s specification teaches that composition used to prepare the disclosed membrane is required to comprise at least 50 wt% of the recited copolymer (specification page 18, lines 33-35); Steenblock’s composition therefore comprises the first PEBA in an amount within the range disclosed by applicant.
Finally, the additional polymer components of the composition of Steenblock are a second PEBA comprising hard polyamide blocks and soft polyethylene glycol blocks and an ethylene/vinyl acetate/maleic anhydride copolymer (abstract; Column 2: lines 25-42). Applicants specification teaches that the composition used to prepare the disclosed membrane may comprise one or more additional polymers (specification page 18, lines 13-14 and 32: see the phrases “at least one additional polymer” and “and mixtures thereof”), and that those additional polymers may be a copolymer comprising rigid polyamide blocks and soft polyether blocks and ethylene/vinyl acetate/maleic anhydride copolymers (specification page 18, lines 13-32). Applicant’s specification therefore teaches that the disclosed membrane may comprise the same additional polymer components as are present in the composition of Steenblock.
As noted earlier in this Office Action, “[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on inherency under 35 U.S.C. 102, on prima facie obviousness under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same…" as that required with respect to product-by-process claims; In re Fitzgerald (MPEP § 2112). As discussed in the previous paragraphs, Steenblock renders obvious the production of a membrane comprising the same polymer components combined in the same ratio as the claimed invention. It is therefore reasonably expected that its properties would not be materially different from those of the claimed invention. The burden is therefore shifted to applicant to provide evidence demonstrating an unobvious difference between the claimed invention and the prior art.
Applicant argues that the claimed invention yields unexpected results, citing Membranes 6 and 7 from the specification.
As discussed in the Office Action mailed on 8/12/2025, Membrane 6 cited by applicant from the specification is reported to have rigid blocks which are polyamide 6; one of ordinary skill in the art will recognize that the term “polyamide 6” refers to a polyamide wherein the repeating unit contains 6 carbon atoms. Note, however, that the claimed invention requires that the mean carbon content of the repeating unit of the rigid polyamide block is greater than or equal to 7. Membrane 6 therefore does fall within the scope of the claimed invention, and any data obtained from it cannot be used as evidence that the claimed invention yields unexpected results.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979) (MPEP § 716.02(d)).
Applicant cites a single example-Membrane 7-as evidence that the claimed invention yields unexpected results. As reported in the specification, Membrane 7 is made from a block copolymer wherein the flexible blocks are polyethylene glycol and the rigid polyamide blocks are polyamide 11. In contrast, the claimed invention recites a block copolymer wherein the rigid blocks can be any polyamide wherein the repeating unit has a mean carbon content of 7 or more. Applicant’s citation of a single example wherein polyamide 11 does not demonstrate that the allegedly unexpected results may be obtained from all other species within the scope of the recited copolymer.
Furthermore, to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range; see In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960) (MPEP 716.02(d)(II)). The block copolymer as recited in the instant claims may comprise flexible blocks in any amount in the range of 60 to 90 wt% and rigid blocks in any amount in the range of 10 to 40 wt%. In contrast, applicant cites a single block copolymer comprising 60 wt% flexible blocks and 40 wt% rigid blocks. No evidence has been provided to demonstrate that the allegedly unexpected results may be obtained when the amounts of rigid and flexible blocks are any values other than 40 wt% and 60 wt%, respectively. The cited evidence therefore is not commensurate in scope with the claimed invention with regards to either the ranges for the amounts of each component or the broad range of polymers that can be used as the rigid blocks of the recited block copolymer. Applicant’s argument that the claimed invention yields unexpected results therefore is not persuasive. The rejection over Steenblock is therefore maintained.
Regarding claim 20, applicant argues that the prior art third polymer component-i.e., the ethylene/vinyl acetate/maleic anhydride copolymer- is outside the scope of the instant claims and therefore renders the claimed invention non-obvious over the prior art.
In response, claim 20 depends from independent claim 10 and states that the copolymer (emphasis added) consists essentially of the rigid polyamide blocks and the flexible blocks; however, the claimed invention is not a copolymer. As defined by independent claim 10, the claimed invention is a membrane comprising the recited copolymer.
The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (MPEP § 2111.03(I)). Contrary to applicant’s arguments, the ethylene/vinyl acetate/maleic anhydride terpolymer taught by Steenblock is not a part of the prior art first PEBA; rather, it is a separate copolymer that is combined with the prior art first and second PEBAs to form the composition used to make the film of Steenblock. As the claimed membrane comprises the recited copolymer, it is not persuasive to argue that the prior art composition contains additional polymer(s). So long as the composition taught by Steenblock includes a copolymer that falls within the scope of the recited copolymer, the prior art meets the claims regardless of whether it contains additional, unrecited polymer components.
As discussed in paragraph 27 of this Action, Steenblock specifically states that the first PEBA consists of the polyamide blocks and polyethylene glycol blocks. The prior art first PEBA does not contain any additional components that would be prohibited by the transitional phrase “consists essentially of” and therefore falls within the scope of the recited copolymer. Steenblock therefore renders the claimed invention obvious as discussed earlier in this Action.
Regarding the rejection over Goldfinger, WO03/050159: Goldfinger discloses a block copolymer, corresponding to the claimed copolymer (for claim 10), having the structure shown below wherein -C(O)-A-C(O)- is a polyamide
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segment and -O-G-O- is a polyether segment. The prior art block copolymer is used in the production of films. Note that Goldfinger teaches that said polyether segment may comprise polyethylene glycol in an amount up to 60 wt% (Page 9: lines 26-28). Goldfinger does not teach the production of a block copolymer wherein the soft block is 100 wt% polyethylene glycol as required by the amended independent claim 10. The rejection over Goldfinger is therefore withdrawn in view of the amendment to claim 10 requiring that the flexible block is 100 wt% polyethylene glycol.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY S LENIHAN whose telephone number is (571)270-5452. The examiner can normally be reached Mon.-Fri. 5:30-2:00PM.
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/JEFFREY S LENIHAN/Primary Examiner, Art Unit 1765