Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-8 and 12), in the reply filed on 4/23/26 is acknowledged.
Claims 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/23/26.
The examiner withdraws the additional Species election imposed in the 2/3/26 Requirement for Restriction.
Claim Rejections - 35 USC § 112
Claims 1-8 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “a molecule represented by the formula W(X)-NHR1 where W is a linear or branched molecule…”, and the claim also recites “including polyethylene, …“ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For purposes of examination the narrower language is interpreted as at least inclusive of being merely exemplary.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “a molecule represented by the formula W(X)-NHR4 where W is a molecule comprising an aromatic structure…”, and the claim also recites “including 4-aminophenol, …” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For purposes of examination the narrower language is interpreted as at least inclusive of being merely exemplary.
The limitation “said reagent substance is optionally dissolved in a solvent and said silicon elastomer surface is placed…” in claim 1 renders the claim indefinite as it is uncertain as to which portions of this limitation “optionally” applies. For example does the “optionally” only applied the act of dissolution of the reagent substance in a solvent, or does it also extend to the entire remaining portion of the limitation, or only to a partial portion thereof. Thus one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination this limitation will be interpreted as at least inclusive of any such scenarios.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “oxidizing agent”, and the claim also recites “including ozone…” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For purposes of examination the narrower language is interpreted as at least inclusive of being merely exemplary.
Claims 3 and 12: The term “strong alkali” in claims 3 and 12 is a relative term which renders the claims indefinite. The term “strong” is not defined by the claim (there is no distinct threshold (such a pH, concentration, etc) to allow determination as what materials are included or excluded by usage of this term), the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination, the limitation will be interpreted as at least inclusive of any such scenario).
Claims 3 and 12: Regarding claims 3 and 12; the phrase "such as" renders these claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of examination the limitations following are interpreted as at least inclusive of exemplary species.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “a crosslinker”, and the claim also recites “preferably selected from…” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For purposes of examination the narrower language is interpreted as at least inclusive of being merely exemplary.
The other dependent claims do not cure the defects of the claims from which they depend.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baldvinsdottir (“Optimization of antimicrobial chitosan coating for silicone” Master’s Thesis, University of Iceland, May 2021; hereafter Baldvinsdottir.
Claim 1: Baldvinsdottir teaches a method of modifying a silicone solid surface to introduce amino groups to said surface for making it amendable to further modification (See, for example, abstract). The method comprising treating the silicone elastomer surface with a reagent substance of ethanolamine (See, for example, abstract, section 4.5).
Claim 2-3 and 12: Baldvinsdottir further teaches the surface is not pretreated with oxidizing agent or strong alkali (See, for example, abstract, section 4.5).
Claim 4: Baldvinsdottir has further taught the reagent is dissolved in a solvent (10% solution of ethanolamine), and the silicone surface is placed in said solvent / dissolved reagent (see, for example, Section 4.5).
Claim(s) 1-3, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karthauser (US 2006/0148985: hereafter Karthauser.
Claim 1: Karthauser teaches a method of modifying a silicone solid surface to introduce amino groups to said surface for making it amendable to further modification (See, for example, [0124], treatment with ethanolamine). The method comprising treating the silicone elastomer surface with a reagent substance of ethanolamine (See, for example, [0124]).
Claim 2-3 and 12: Karthauser further teaches the surface is not pretreated with oxidizing agent or strong alkali (See, for example, [0124], [0083]).
Claim Rejections - 35 USC § 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 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.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baldvinsdottir as applied to claim 1 above and further in view of Rodriguez et al (ES 2455441; hereafter Rodriguez).
Claim 5-6: Baldvinsdottir teaches the method of claim 1 above, directed to activation, including via ethanolamine to provide amino functionalization, and further functionalization of silicone surfaces for improvement in biocompatibility and bioactivity (see, for example, abstract, section 1.1.1, section 4.3-4.5). But Baldvinsdottir does not explicitly teach treating the silicone surface with a azide-transfer reagent, further of one claimed, to convert at least some of said introduced amino groups to azide group. Rodriguez teaches a method applicable to the biocompatibilization and bioactivation of solid implants (See, for example, [0002]). Rodriguez further teaches wherein such bioactivation can be achieved by functionalization of the surface with azide groups, particularly with TfN3 (triflyl azide), which acts as a nucleophlic reagent providing substitution of amino groups with azide groups (See, for example, Fig 1, [0050], [0088]). Rodriguez further teaches wherein such functionalization will provide the implant with biocompatibility and bioactivity allowing it to adapt better to surrounding tissue, and for better contact and adhesion (See, for example, [0052-0059]). Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated treating the silicone surface with an azide-transfer reagent, further triflyl azide, to convert at least some of said introduced amino groups to azide group as such treatment would predictably enhance the surfaces biocompatibility and bioactivity allowing it to adapt better to surrounding tissue, and for better contact and adhesion.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baldvinsdottir.
Claim 7: Baldvinsdottir teaches the method of claim 1 (above) and further teaches treating an ATPMS treated silicone surface with a crosslinker (further glutaraldehyde) (See, for example, section 4.3, 5.3). Although Baldvinsdottir does not explicitly teach treating an ethanolamine treated silicone surface with such a crosslinker, it does explicitly state that “next steps should be to find out if EA treatment of the silicone surface could be used with crosslinker to make chitosan coating”. Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated a step of treating the silicon surface with a crosslinker since the art explicitly directs such a step should be attempted as such treatment has been demonstrated to react with amino groups on silicone surfaces to enhance attachment of chitosan.
Claim 8: Baldvinsdottir teaches the method of claim 1 (above) and further teaches treating an ATPMS treated silicone surface with a crosslinker (further glutaraldehyde) and chitosan (See, for example, section 4.3-4.4 and 5.3-5.4). Although Baldvinsdottir does not explicitly teach treating an ethanolamine treated silicone surface with such a crosslinker, it does explicitly state that “next steps should be to find out if EA treatment of the silicone surface could be used with crosslinker to make chitosan coating”. Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated a step of treating the silicon surface with a crosslinker and chitosan since the art explicitly directs such a step should be attempted as such treatment has been demonstrated to react with amino groups on silicone surfaces to enhance attachment of chitosan.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karthauser in view of DOW (“DOW Monoethanolamine Technical Data Sheet”, available at least as early as 9/18/2019; hereafter DOW).
Claim 4: Karthauser teaches the method of claim 1 above, further wherein the silicone surface is placed in said reagent, but is silent as to purity / concentration of ethanolamine used, so it does not explicitly teach the reagent is dissolved in a solvent and the silicone surface is placed in said solvent / dissolved reagent. DOW teaches wherein various grades of ethanolamine are available, and further wherein dissolved aqueous forms allow for easier handling and avoidance of freezing (See, for example, entirety) Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated ethanolamine as aqueous ethanolamine since such a form is commercially available, well know, provides for easier handling and avoidance of freezing and since when a primary reference is silent as to a certain detail, one of ordinary skill would be motivated to consult a secondary reference which satisfies the deficiencies of the primary reference.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karthauser in view of Lv et al (“A one-step tannic acid coating to improve cell adhesion and proliferation on polydimethylsiloxane” New J. Chem. 2020, 44, 15140; hereafter Lv).
Claim 7: Karthauser teaches the method of claim 1 (above) and further teaches modification of silicone surfaces for applications of membranes, further for gas separation (See, for example, [0076], [0125]). But it does not explicitly teach treating the silicone surface with a crosslinker. Lv teaches a method of modifying silicone surfaces used in applications including gas permeability (See, for example, abstract, pg 15140). Lv further teaches wherein the silicone surface is treated with a crosslinker, further a combination of tannic acid and Fecl3, to improve cell adhesion, spreading, and long-term culture (see, for example, abstract, Scheme 1, Fig 8, pg 15141-15143, conclusion), Therefore it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to have incorporated a step of treating the silicon surface with a crosslinker, further tannic acid / Fecl3 mixture, since such treatment would predictably improve cell adhesion, spreading, and long-term culture.
Claim 8: Karthauser in view of Lv teaches the method of claim 7 above, and Lv further teaches treating the silicone surface with a bioactive molecule, further a protein (such as BSA) (See, for example, pg 15145, Fig 8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN H EMPIE whose telephone number is (571)270-1886. The examiner can normally be reached Monday-Thursday 5:30AM - 4 PM.
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, Michael Cleveland can be reached at 571-272-1418. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATHAN H EMPIE/Primary Examiner, Art Unit 1712
Prosecution Insights