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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
Receipt of the Information Disclosure Statements filed on 3/19/2024, 6/5/2024, and 7/15/2025 is acknowledged. A signed copy is attached to this office action.
Drawings
The drawings are objected to because the text and numbers, particularly in figures 1A, 2B, 9B, and 9C, are not clearly legible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0052] “herteroalkoxy” is a typographical error.
[0052, 0078, 0083, 0085, 0087, 0091, 0108, 0116, 0121, 0127, 0131, 0138] “herteroalkenyl” is a typographical error.
Appropriate correction is required.
The use of the terms CarboSil, Tecoflex, Tecophilic, Tecophillic, and ELAST-EON, which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 3, 10, 25, and 32 are objected to because of the following informalities: “herteroalkenyl” is a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 31 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. Claim 31 as written depends upon itself and is therefore improper. 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. For examination purposes, claim 31 has been interpreted to be dependent upon claim 30.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 13, 30, 31, and 32 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.
Regarding claim 9, the meaning of “a residue of S-nitroso-N-acetyl-penicillamine, S-nitroso-3-N-acetyl cysteine, S-nitroso-N-acetyl cysteamine, S-nitrosoglutathione, methyl S-nitrosothioglycolate, and a derivative thereof” is indefinite. It is unclear if this is intended to be a residue of all of these compounds and derivatives thereof, a residue of one of the listed compounds and a derivative thereof, or a residue of one of these compounds or derivatives thereof.
Regarding claim 13, the scope of “the nitric oxide releasing polysiloxane is produced the method” is unclear and indefinite.
Regarding claim 30, the scope of “the nitric oxide releasing polysiloxane is produced the method” is unclear and indefinite. Dependent claim 32 is similarly rejected by its dependence on indefinite claim 30. Based on the examiner’s assumption that improper dependent claim 31 was intended to depend upon claim 30, claim 31 is similarly rejected by its presumed dependence on indefinite claim 30.
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.
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 1-4, 8-10, 13, 25-26, 28, 30-33, 35, 39-40, and 51-52 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Handa et al (US 20210268156 A1).
Regarding claim 1, Handa discloses a nitric oxide-releasing material including a polymer matrix, which includes a plurality of nitric oxide-donating crosslinking moieties that covalently crosslink polysiloxanes in the plurality of polysiloxanes [0007]. While the instant application does not disclose crosslinking, it does not teach away or disclose a lack of crosslinks. Thus, Handa’s disclosure reads on claim 1.
Regarding claim 2, Handa further discloses that the plurality of polysiloxanes may be selected from the group consisting of polydimethylsiloxane, polydiethylsiloxane, polydipropylsiloxane, and polydiphenylsiloxane [0063]. "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). See MPEP 2131.02. In the instant case, the species of polydimethylsiloxane and others anticipates the genus of dialkyl polysiloxanes.
Regarding claims 3 and 4, Handa discloses moieties of the formula shown below (page 8 [0008]), where
R1 is a substituted or unsubstituted C1-C20 alkyl, a substituted or unsubstituted C1-C20 heteroalkyl, a substituted or unsubstituted C2-C20 alkenyl, a substituted or unsubstituted C2-C20 herteroalkenyl, a substituted or unsubstituted C1-C20 alkoxy, or a substituted or unsubstituted C1-C20 heteroalkoxy; and
where each occurrence of R2 is independently a substituted or unsubstituted C1-C20 alkyl, a substituted or unsubstituted C1-C20 heteroalkyl, a substituted or unsubstituted C2-C20 alkenyl, a substituted or unsubstituted C2-C20 herteroalkenyl, a substituted or unsubstituted C1-C20 alkoxy, or a substituted or unsubstituted C1-C20 heteroalkoxy, or a bond to a polysiloxane in the plurality of polysiloxanes when at least two occurrences of R2 are a bond to a polysiloxane in the plurality of polysiloxanes; and
where A is a nitric oxide donor [0009].
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A prima facie case of obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05(I). Since R1 of the instant application may be a heteroalkyl group, the amide functionality attached to the nitric oxide-donating moiety disclosed by Handa's formula on page 8 reads on applicant's structure I.
Regarding claims 8 and 9, Handa discloses that the nitric oxide donor is particularly an S-nitrosothiol which may be S-nitroso-N-acetyl-penicillamine, S-nitroso-N-acetyl cysteine, S-nitroso-N-acetyl cysteamine, S-nitrosoglutathione, methyl S-nitrosothioglycolate, and a derivative thereof [0059-0060].
Regarding claim 10, Handa particularly discloses a plurality of polysiloxanes [0007], which reads on applicant’s claimed copolymer. The limitations of Handa’s disclosed R1 and R2 are set forth above with respect to claims 3 and 4. Handa discloses both polysiloxanes and nitric oxide-releasing polysiloxanes [0007], which read on applicant’s structure II. Moreover, applicant’s own disclosure dictates that the term “alkyl”, as applied to instant R3, encompasses “both "unsubstituted alkyls" and "substituted alkyls", the latter of which refers to alkyl moieties having one or more substituents replacing a hydrogen on one or more carbons of the hydrocarbon backbone. Such substituents include, but are not limited to, halogen, hydroxyl, carbonyl (such as a carboxyl, alkoxycarbonyl, formyl, or an acyl), thiocarbonyl (such as a thioester, a thioacetate, or a thioformate), alkoxyl, phosphoryl, phosphate, phosphonate, a phosphinate, amino, amido, amidine, imine, cyano, nitro, azido, sulfhydryl, alkylthio, sulfate, sulfonate, sulfamoyl, sulfonamido, sulfonyl, heterocyclyl, aralkyl, or an aromatic or heteroaromatic moiety” [0049]. In this way, Handa’s disclosed structure (page 8, [0008]) reads on structure II.
Regarding claim 13, Handa further discloses a method of making a nitric oxide-releasing material prepared by reacting thiolactone with an amine pendant on a polysiloxane backbone to produce a thiol-functionalized polymer matrix, followed by nitrosating a thiol on the thiol-functionalized polymer matrix to produce the nitric oxide-releasing material [0069].
Regarding claims 25, 26, and 28, Handa particularly disclose S-nitrosothiols as nitric oxide donors as set forth with respect to claims 8 and 9 above. The limitations of Handa’s disclosed R1 and R2 are set forth above with respect to claims 3 and 4. A S-nitrosothiol-based nitric oxide-donating moiety coupled with an amide-terminated heteroalkyl group for R1 reads on applicant’s structure IV.
Regarding claim 30, Handa discloses a method of making a nitric oxide-releasing material prepared by reacting thiolactone with an amine pendant on a polysiloxane backbone to produce a thiol-functionalized polymer matrix, followed by nitrosating a thiol on the thiol-functionalized polymer matrix to produce the nitric oxide-releasing material [0069], as set forth with respect to claim 13 above.
Regarding claim 31, assuming it was applicant’s intent for claim 31 to be dependent on claim 30, Handa further discloses that the plurality of polysiloxanes may be selected from the group consisting of polydimethylsiloxane, polydiethylsiloxane, polydipropylsiloxane, and polydiphenylsiloxane [0063] as set forth in the above rejection with respect to claim 2. "A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989). See MPEP 2131.02. In the instant case, the species of polydimethylsiloxane and others anticipates the genus of dialkyl polysiloxanes.
Regarding claim 32, 33, and 35, Handa further discloses thiol-functionalized polysiloxane polymer matrices [0009], which read on structure V in combination with the limitations of Handa’s R1 and R2, as set forth in the above rejection with respect to claims 3 and 4.
Regarding claims 39 and 40, Handa further discloses a device having at least one surface wherein the surface comprises said composition [0065] and discloses a device prepared from said composition which is a component of a hemodialysis device [0066].
Regarding claims 51 and 52, Handa further discloses use of their nitric oxide-releasing polymer composition in antibacterial [0115] and anti-biofilm applications [0068].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 8-10, 13, 25-26, 28, 30-33, 35, 39-40, and 51-52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 5, and 7 of copending Application No. 18/264,094 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application recites a composition comprising a nitric oxide-releasing material comprising (a) a nitric oxide releasing material comprising a (i) a polysiloxane network and (ii) a plurality of nitric oxide-donating moieties covalently bonded to the polysiloxane network; and (b) a silicone oil. Disclosed nitrogen oxide-donating moieties include residues of S-nitroso-N-acetyl-penicillamine, S-nitroso-N-acetyl cysteine, S-nitroso- N-acetyl cysteamine, S-nitrosoglutathione, methyl S-nitrosothioglycolate, and a derivative thereof. While the instant application does not specify inclusion of a silicone oil, it does not teach away its inclusion. The copending application also recites crosslinked polysiloxanes, which the instant application does not specifically include or teach away.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 8, 9, 39, 40, 51, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 8, 9, 15, 16, 17, and 20 of copending Application No. 18/485,737 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application recites a nitric oxide releasing material comprising (i) a polysiloxane network and (ii) a plurality of nitric oxide-donating moieties covalently bonded to the polysiloxane network. The copending claims recite the same nitric oxide-donating moieties and polysiloxanes as the instant claims. The copending claims also recite use of the composition to coat at least one surface of an article, use of the composition as part of an article, an article comprising one or more components fabricated with the composition, and use of the composition to prevent bacterial growth or biofilm formation.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 8, 9, 13, 30, 31, and 52 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34, 43, 46, 47, and 68 of copending Application No. 17/259,817 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application discloses a nitric oxide releasing material comprising a polymer matrix, wherein the polymer matrix comprises a plurality of polysiloxanes covalently crosslinked with a plurality of nitric oxide-donating crosslinking moieties, and wherein the polysiloxanes are selected from the group consisting of polydimethylsiloxane, polydiethylsiloxane, polydipropylsiloxane, and polydiphenylsiloxane. The copending application also discloses use of the composition to reduce biofilm formation. The copending application further discloses a method of crosslinking a plurality of polysiloxanes with a plurality of amine-functionalized crosslinking moieties to produce a crosslinked polymer matrix; covalently attaching a thiolactone to an amine in the amine-functionalized crosslinking moieties to produce a thiol-functionalized crosslinked polymer matrix; and nitrosating the thiol in the thiol-functionalized crosslinked polymer matrix in the presence of an organic acid to produce the nitric oxide-releasing material. While the instant application does not teach the presence of an organic acid, it does not specifically exclude its presence. The copending application also recites crosslinked polysiloxanes, which the instant application does not specifically include or teach away.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pepe et al (US 3959327 A) discloses organofunctional silicon compounds formed by a reaction of a thiolactone and an amino-functionalized polysiloxane, resulting in an amide-functionalized polysiloxane which may be substituted with a plurality of alkyl groups.
Frost et al (WO 2014046671 A1, attached) discloses nitric oxide-releasing polysiloxanes and uses thereof, which may be synthesized by reacting a primary amine with a thiolactone to create a thiol-substituted polysiloxane. Frost discloses S-nitrosothiols as nitric oxide donors, including S-nitroso-N-acetyl-D-penicillamine and others. Frost also discloses polydimethylsiloxane or polydiethylsiloxane, among others, as suitably polysiloxanes for further reactions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Savannah G Phillips whose telephone number is (571)270-0822. The examiner can normally be reached M-Th 8-6 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Del Sole can be reached at (571)272-1130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVANNAH G. PHILLIPS/Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
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