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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 17, 2026 has been entered.
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 1-4, 6-16, and 18-20 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/require reacting an aldehyde with the hydrocarbon groups of poly(aryl ether ketone) comprised in the surface of an untreated article to form a hydroxyalkyl and/or hydroxyaryl group or “contacting one or more poly(aryl ether ketone) (PAEK) with formaldehyde, the formaldehyde reacting with the hydrocarbon groups of the one or more poly(aryl ether ketone)(s) (PAEKs) on the at least one portion of the surface of the article to form a hydroxymethyl group”. The disclosure discusses and exemplifies applying formaldehyde to a PAEK and states that the result is hydroxyalkyl and/or hydroxyaryl group formation. There is no mention of any other reactants or catalysts involved in the reaction or being employed in the instant process nor any analysis verifying the chemical composition of the PAEK surface after contact with the aldehyde. Hydroxyalkylation/hydroxyarylation due to reaction between aldehydes and aromatic compounds is known to occur. However, the reaction was known to require the presence of a base, acid, and/or catalyst. A discussion by de Angelis (previously cited) details the acid catalyzed hydroxyalkylation reaction producing a carbonium ion from the aldehyde that is then ready for reaction with an aromatic (hydrocarbon) compound (see page 1169 first column, scheme 1, and table 1). They additionally teach that the resulting hydroxyalkylated product tends to further react and produce a diaryl product (see page 11669 first column). Ciganek (previously cited) details catalyzed reactions between alkene compounds and aldehydes yielding hydroxyalkylation where a diazobicyclo[2.2.2]octane, amines, phosphines, and transition metal complexes are employed as the catalyst (see pages 203-205 and 209-211). They detail that the reaction can be very slow, on the order of days to weeks at room temperature, even when catalyzed, while the instant specification details that contact/reaction temperature play a minor role and that contact/reaction times of 10-60 minutes are sufficient for reaction (see page 204; instant specification page 7). Narang et al. (previously cited) detail a poly(arylene ether ketone) polymer in solution treated with formaldehyde and a base which results in the formation of hydroxymethyl groups on one or more aromatic rings (see column 29 line 20-column 30 line 65, column 32 lines 37-46, and column 35 line 63-column 36 lines 43). Similarly, Aini et al.(previously cited) teach a process of modifying aromatic rings with hydroxymethyl groups due to reaction with formaldehyde, again in the presence of a base (see page 5 second full paragraph and figure 1). Melzner et al. teach a solution of formaldehyde in aqueous acid for the treatment of aromatic polymer containing surfaces so as to hydroxymethylate the aromatic groups in the surface (see WO 92/01735 – English translation relied upon for citations; abstract, paragraphs 14 and 22-25). The instant claims do not recite a catalyst, base, or acid being included in the reaction. While an adherent coating was ultimately obtained in instant example 1, which treats a poly(ether ether ketone) (PEEK) article with a formaldehyde solution, there is no indication in the example that hydroxyalkyl or hydroxyaryl groups are present on its surface due to treatment for the detailed thirty minutes. As a result the artisan of ordinary skill would not have deemed the instant applicant to be in possession of the claimed hydroxymethylation result and reaction as instantly claimed.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is 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. The claim recites the biological material or biomolecules of the parent claim to be selected from options where natural and artificial are recited. All biological material or biomolecules are embraced by these two groupings. 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
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 1-2, 6-11, 14, 16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Melzner et al. as evidenced by Häuselmann et al. (US Patent No. 5,658,343) and Ward et al. (US PGPub No. 2011/0060578)
Melzner et al. teach the treatment of the surface of articles composed of polymers that have aromatic groups in order to confer hydrophilicity via applied functional groups (see abstract and paragraph 14). Envisioned polymers include polyetherketone (PEK) (see paragraph 15; Häuselmann et al. claim 14; instant claims 1-2 and 18-20). Melzner et al. contemplate porous membranes as the articles of interest (see paragraph 4). They teach surface treatment by immersion of the article in an acidified solution of a compound comprising a carbonyl group that is envisioned as formaldehyde (see paragraphs 22 and 24; instant claims 1 and 6). When formaldehyde is employed, Melzner et al. teach its solution concentration to range from 30 to 36 wt% (see paragraph 22).They go on to teach of the resulting hydroxymethylation of the aromatic moieties of the polymer as a consequence of treatment with a formaldehyde compound (see paragraph 25; instant claims 1, 8, and 16). Melzner et al. also teach the formation of methylene bridges between the newly formed hydroxyl groups that crosslink the surface polymer as well as the preferable post-treatment (immersion followed by removal – dip coating) in a solution hydrogen peroxide (biomolecule; low molecular weight compound) or with another compound that reacts with the hydroxyl groups (see paragraphs 25 and 31, and 39; Ward et al. paragraph 93; instant claims 7-11, 14, and 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow the guidance of Melzner et al. concerning choices of components for their taught method and apply a solution of formaldehyde to a polyetherketone article because both are explicitly envisioned amongst a small set of named composition materials for the article and surface treatment compounds, respectively. Post-treatment as taught by Melzner et al. would follow because they suggest to do so. The envisioned membrane articles of Melzner et al. could be employed in a biotechnological application or as a scaffold for cell culture (see instant claims 19-20). Therefore claims 1-2, 6-11, 14, 16, and 18-20 are obvious over Melzner et al. as evidenced by Häuselmann et al. and Ward et al.
Claims 1-2, 6-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Melzner et al. as evidenced by Häuselmann et al. and Ward et al. as applied to claims 1-2, 6-11, 14, 16, and 18-20, and further in view of Stevens et al. (Biotechnology and Bioengineering 1998 57:26-34) and Coelfen et al. (US PGPub No 2018/0236132).
Melzner et al. as evidenced by Häuselmann et al. and Ward et al. render obvious the limitations of instant claims 1-2, 6-11, 14, 16, and 18-20. Melzner et al. envision the article as an ultrafiltration membrane conferred with hydrophilicity due to surface modification (see paragraphs 4 and 5). While further modification of the surface hydroxyl groups via binding to additional compounds is taught, gelatin is not explicitly named as such a modifying compound.
Stevens et al. teach of the improved flux and selectivity of ultrafiltration membranes for protein filtration when provided with a covalently bound coating of a hydrolyzed gelatin (see abstract, page 28 second column and page 33 second column first full paragraph).
Coelfen et al. teach coating the surface of a hydroxy modified poly(ether ether ketone) (PEEK) with gelatin by covalent attachment via a linker to the amino groups of the gelatin (see examples 2-3 and 6, claims 1 and 7; instant claims 11-13). The activators responsible for the covalent attachment also can crosslink the carboxyl and amino groups within the gelatin (see paragraph 120; instant claim 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply a gelatin coating to the PEK membrane of Melzer et al. as evidenced by Häuselmann et al. and Ward et al. in light of Stevens et al. via the technique of Coelfen et al. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement and the combination of prior art elements via known techniques to yield a predictable outcome. Given the presence of gelatin crosslinking agents in process Coelfen et al., it is the position of the examiner that some degree of crosslinking would occur amongst gelatin chains. MPEP 2144.04IVC highlights In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946), noting that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. Here there is no indication of the criticality of the order of steps and no evidence of unexpected result due to the selection of the claimed ordering (e.g. crosslinking after gelatin binding to the surface vs. simultaneous crosslinking of gelatin and binding to the surface). Therefore claims 1-2, 6-16, and 18-20 are obvious over Melzer et al. in view of Stevens et al. and Coelfen et al. as evidenced by Häuselmann et al. and Ward et al.
Claims 1-2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Küpper et al. (EP 0776669) in view of Hennebert et al. (US Patent No. 4,637,916).
Küpper et al. teach a test pack (device) for testing/verifying the efficiency of sterilizers during sterilization runs (see abstract). Steam or chemical sterilant gas, envisioned as formaldehyde gas, are taught in a sterilization chamber in which the test pack is located for the duration of a sterilization cycle (see column 5 lines 29-34; instant clami1 and 6). The device has a body which defines an internal enclosure/cavity in which a sensor of the sterilant is located (see column 5 lines 29-55; instant claim 1). The body is envisioned as a material that has a low thermal capacity and both PEEK and poly(ether ketone ether ketone ketone) (PEKEKK) are envision amongst seven named options (see column 6 lines 41-56; instant claims 1-2). Figures 1-2 and 7 depict the body as component 2, the enclosure as component 4, an endcap as component 3, the sensor as component 8, and a porous material as component 7 (see column 5 lines 45-55 and column 10 line 54-column 11 line 18). Figure 2, shown below, depicts the configuration of the components:
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The surface of the outside of the body and the enclosure are composed of the polymer and therefore exposed to sterilant during sterilization runs. A particular sterilizer is not detailed.
Hennebert et al. teach a sterilization chamber that employs formaldehyde as the gaseous sterilant (see abstract and examples). They further detail verifying the efficacy of the sterilization run, where a 20.3 wt% solution of formaldehyde is employed to generate a 17.35 mg/L atmosphere of gaseous formaldehyde in the chamber for 20 minutes (see example 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the device of Küpper et al. for its intended use in a sterilization chamber employing formaldehyde gas for sterilization because they detail this use. It additionally would have been obvious to select PEEK or PEKEKK as the body material of the test pack because they are two of a small number of explicitly envisioned options for this component. As a known formaldehyde gas sterilization chamber, it would have been obvious to employ the test pack in the exemplified chamber of Hennebert et al. The result of this choice would be the contacting of a PEEK or PEKEKK surface of the provided article with formaldehyde gas for 20 minutes. While silent in regard to the formation of hydroxymethyl groups as a consequence of this contacting, the practice of the claimed steps with the claimed components is rendered obvious. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus, absent evidence to the contrary, the claimed function/result, namely hydroxyl methylation to some degree, would also be present. Therefore claims 1-2 and 6 are obvious over Küpper et al. in view of Hennebert et al.
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Endo et al. (US PGPub No. 2007/093848) in view of Colgan et al. (US Patent No. 6,264,689) and Hennebert et al.
Endo et al. teach medical instruments composed of a composite of carbon nanotubes/fibers in a polymer matrix (see abstract and paragraphs 22 and 62-63; instant claims 3-4). A catheter composed of the material is envisioned and exemplified (see paragraphs 44 and 64). Endo et al. go on to teach polymers envisioned as the polymer matrix and name PEEK (see paragraph 36; instant claims 1-2). They further detail sterilizing the catheter embodiment via treatment of gaseous formaldehyde prior to use (see paragraph 81; instant claim 6). A particular sterilization regimen is not detailed.
Colgan et al. teach PEEK as a preferred compositional material for catheters (see column 6 lines 30-35).
Hennebert et al. teach a sterilization chamber that employs formaldehyde as the gaseous sterilant (see abstract and examples). They further detail verifying the efficacy of the sterilization run, where a 20.3 wt% solution of formaldehyde is employed to generate a 17.35 mg/L atmosphere of gaseous formaldehyde in the chamber for 20 minutes (see example 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select PEEK as the polymer matrix of Endo et al. because they explicitly name it as an envisioned polymer and it was a known preferred polymer for catheters as detail by Colgan et al. It additionally would have been obvious to perform the taught formaldehyde sterilization in the exemplified chamber of Hennebert et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. The result of this choice would be the contacting of a PEEK surface of the provided article with formaldehyde gas for 20 minutes. While silent in regard to the formation of hydroxymethyl groups as a consequence of this contacting, the practice of the claimed steps with the claimed components is rendered obvious. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Thus, absent evidence to the contrary, the claimed function/result, namely hydroxyl methylation to some degree, would also be present. Therefore claims 1-4 and 6 are obvious over Endo et al. in view of Colgan et al. and Hennebert et al.
Declaration
The declaration under 37 CFR 1.132 filed December 19, 2017 is insufficient to overcome the rejection of claims 1-4, 6-16, and 18-20 under 35 USC 112(a) as set forth in the last Office action because: the evidence in support of the declarant’s statement is not legible. The declarant provided a Fourier Transform Infrared (FTIR)analysis of carbon fiber reinforced poly(ether ether ketone) incubated in 37% aqueous formaldehyde for 20 minutes and blotted dry as well as of the same material that had not undergone this treatment. While reference is made to colored lines in the results showing the signals of the two materials, only a black and white version is visible to the examiner. The lines are not discernable from one another in the region highlighted by the declarant as demonstrative of a hydroxy group present on the formaldehyde treated surface and absent on the untreated surface. As a result, the evidence of record does not clearly support the remarks provided by the declarant which renders the declaration unpersuasive and insufficient to overcome the rejection of record.
Response to Arguments
Applicant's arguments filed March 17, 2026 have been fully considered. In light of the amendment to the claims, the previous grounds of rejections, with the exception of that under 35 USC 112(a) are hereby withdrawn. The arguments directed toward the remaining rejection reiterate the declaration and are unpersuasive as indicated in the Declaration section above. New grounds of rejection are detailed to address the new claim limitations
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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