DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ response to the Requirement for Restriction, filed 18 May 2026, in the matter of Application N° 18/550,874. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No additions, amendments, or cancellations have been made to the claims previously filed on 3 April 2024. No new matter has been added.
Applicants’ election of Group II (claims 1, 2, 5, 7, 9, 10, 17-19, 21, 25, and 26), without traverse, is acknowledged.
Applicants’ election is made FINAL. The claims of Groups: I and III-VI not at issue in the elected group (claims 8, 15, 22, 32, 40, 43, 48, 51, and 52) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. Applicants timely traversed the restriction requirement between the compositions and methods.
Thus, claims 1, 2, 5, 7, 9, 10, 17-19, 21, 25, and 26 are presented and represent all claims currently under consideration.
Information Disclosure Statement
One Information Disclosure Statement (IDS) filed 15 September 2023 is acknowledged and has been considered.
Claim Objections
Claims 2 and 5 are objected to because of the following informalities: each claim recites comprising “one or more active agents” and “a first active agent,” respectively.
Appropriate correction is required. The Examiner suggests amending each claim to recite “further comprises” in each claim.
Drawings
The drawings are objected to because Figure 5 is not labeled on its x-axis. 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.
Claim Rejections - 35 USC §112
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 5, 7, 9, 10, 17, and 25 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.
Claim 5 recites the limitation “the second group” in lines 3 and 4 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the first and/or second active agent” in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 9 and 10 are also rejected owing to their dependency from claim 7.
Regarding claim 17, the phrase “-based” renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by “-based”), thereby rendering the scope of the claim(s) unascertainable. See MPEP §2173.05(d).
Claim 25 is rejected as being indefinite since it is unclear exactly what components are being recited in combination.
Herein, for the purposes of consideration on the merits, the Examiner broadly and reasonably interprets claim 25 as reciting that the mixture comprises a fatty acid and a second component selected from a second fatty acid, a fatty alcohol, a fatty amine, or an active agent, or other agent.
The Examiner further submits that the claim is rendered indefinite by the recitation of “other agent,” since it is unclear what the compositional limitations of such an agent are.
Claim Rejections - 35 USC §102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 18, 19, 21, and 25 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Mattei (USPN 4,201,216; of record).
The limitations of the instantly elected invention are directed to a suture thread comprising two or more “eutectic-forming” components selected from an acid, a fatty acid, a fatty amine, a fatty alcohol, or any combination of two or more thereof that are capable of forming, in situ, at least one eutectic mixture in or on at least one polymer.
Herein, the instantly claimed composition is broadly and reasonably interpreted as being directed to a suture thread comprising a polymer and a mixture of any two or more of the aforementioned components. Where said components are disclosed in the art, so too will they be considered to meet the recited “eutectic” mixture.
Mattei discloses a synthetic, absorbable, multifilament suture comprising a coating composition comprising a mixture of a substantially water-insoluble absorbable salt of a C6 or higher fatty acid and an absorbable, film-forming polymer (see e.g., claim 1). Claim 3 discloses that the higher fatty acid is selected from the group consisting of C12 to C22 fatty acids and mixtures thereof.
Fatty acids defined by the reference as being encompassed by the foregoing range include: capric (C10), lauric (C12), and oleic acids (see col. 4, lines 8-14 and Example 8).
The limitations of instant claim 18 recite wherein the two or more eutectic forming components generate eutectic oils in situ within a polymer device. Here, the Examiner submits that the composition recited by instant claim 1 has been expressly met and as such, provides the person of ordinary skill in the art with a reasonable expectation of also meeting the recited property. See MPEP §2112.01(I) wherein it states that “[w]here 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.”
The reference is thus considered to anticipate the instantly claimed invention.
Claims 1, 2, 5, 7, 9, 10, 18, 19, and 21 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Stopek et al. (US Pre-Grant Publication Nº 2008/0058869 A1).
The limitations of the instantly elected invention are directed to a suture thread comprising two or more “eutectic-forming” components selected from an acid, a fatty acid, a fatty amine, a fatty alcohol, or any combination of two or more thereof that are capable of forming, in situ, at least one eutectic mixture in or on at least one polymer.
Herein, the instantly claimed composition is broadly and reasonably interpreted as being directed to a suture thread comprising a polymer and a mixture of any two or more of the aforementioned components. Where said components are disclosed in the art, so too will they be considered to meet the recited “eutectic” mixture.
Stopek discloses a surgical suture comprising an elongated body comprising at least one filament and an effective amount of a bioactive agent disposed thereon (see e.g., claim 1). Claims 16 and 17 discloses that the suture composition further comprises a coating comprising a degradable polymer. Polymers disclosed that are used in the coating of the suture include trimethylene carbonate, caprolactone, dioxanone, glycolic acid, lactic acid, glycolide, lactide, polyesters, homopolymers, copolymers, and combinations thereof (see e.g., claim 18).
Claim 20 discloses that the coating further comprises one or more fatty acid components selected from the group consisting of fatty acids, fatty acid salts, and salts of fatty acid esters. Paragraph [0052] further defines the fatty acids as being selected from butyric (C4), caproic, caprylic, capric, lauric, myristic, palmitic, palmitoleic, stearic, oleic, linoleic (C18), linolenic (C18), etc., thereby meeting the limitations of instant claims 19 and 21.
Claim 2 discloses that the one or more active agents are selected from biocidal agents, antimicrobial agents, anesthetics, anti-inflammatory agents, and combinations thereof.
The reference is thus considered to meet each of the instantly claimed compositional and structural limitations. The Examiner acknowledges that the reference does not disclose the practiced coating composition as being a “eutectic” mixture, and also acknowledges the definition for the term provided in the instant specification (see e.g., pg. 12, sixth paragraph). Despite this, the Examiner submits that the reference expressly discloses the instantly recited components that Applicants set forth as their defining composition. As such, absent a clear showing of evidence to the contrary, the Examiner submits that the claimed composition is anticipated.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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, 5, 7, 9, 10, 18, 19, 21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Mattei (USPN 4,201,216).
The limitations of claims 1, 18, 19, 21, and 25 are discussed above. Claim 2 further limits the composition of claim 1 reciting that the components further comprise one or more active agents. Claim 5 recites a multitude of combinations of the components already recited in claims 1 and 2. The claim adds a second active agent as an option, but it is not required. Claims 7 and 9 recite limitations for the active agent(s). Claim 10 recites limitations to the polymer component.
Mattei discloses a synthetic, absorbable, multifilament suture comprising a coating composition comprising a mixture of a substantially water-insoluble absorbable salt of a C6 or higher fatty acid and an absorbable, film-forming polymer (see e.g., claim 1). Claim 3 discloses that the higher fatty acid is selected from the group consisting of C12 to C22 fatty acids and mixtures thereof.
Fatty acids defined by the reference as being encompassed by the foregoing range include: capric (C10), lauric (C12), and oleic acids (see col. 4, lines 8-14 and Example 8).
The limitations of instant claim 18 recite wherein the two or more eutectic forming components generate eutectic oils in situ within a polymer device. Here, the Examiner submits that the composition recited by instant claim 1 has been expressly met and as such, provides the person of ordinary skill in the art with a reasonable expectation of also meeting the recited property. See MPEP §2112.01(I) wherein it states that “[w]here 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.”
Mattei additionally discloses that the coating may also contain other components other than those expressly disclosed for other useful purposes including antibiotics, antiseptics, anesthetics, and anti-inflammatory agents (see col. 4, lines 57-60). The foregoing is considered to meet the limitations recited by instant claims 2, 5, 7, and 9.
The film forming polymer limitations recited by instant claim 10 are disclosed by the reference (see e.g., claim 6). Polymers disclosed as embodying the film-forming polymer include homo- and copolymers of poly(p-dioxanone), lactide and glycolide, ethylene oxide polymers, and mixtures thereof.
Based on the combined teachings of the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Claims 1, 2, 5, 7, 9, 10, 17-19, 21, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Stopek et al. (US Pre-Grant Publication Nº 2008/0058869 A1).
The limitations of instant claims 1, 2, 5, 7, 9, 10, 18, 19, 21, and 25 are discussed above.
Claim 17 recites that the mixture comprises a non-antibiotic antimicrobial and a non-steroidal antiinflammatory. Claim 26 recites that the mixture of claim 1 comprises an antibiotic, or metronidazole, or a non-antibiotic antimicrobial, or triclosan, or a combination of metronidazole and ibuprofen, or a combination of triclosan and ibuprofen.
Stopek discloses a surgical suture comprising an elongated body comprising at least one filament and an effective amount of a bioactive agent disposed thereon (see e.g., claim 1). Claims 2-5, 12, and 13 disclose different active agents that may be incorporated into the drug-loaded polymeric composition coated onto the suture. Included therein are such drugs as triclosan (e.g., claim 4), metronidazole (e.g., claim 5), and ibuprofen (e.g., claim 13). Claims 16 and 17 discloses that the suture composition further comprises a coating comprising a degradable polymer. Polymers disclosed that are used in the coating of the suture include trimethylene carbonate, caprolactone, dioxanone, glycolic acid, lactic acid, glycolide, lactide, polyesters, homopolymers, copolymers, and combinations thereof (see e.g., claim 18).
Claim 20 discloses that the coating further comprises one or more fatty acid components selected from the group consisting of fatty acids, fatty acid salts, and salts of fatty acid esters. Paragraph [0052] further defines the fatty acids as being selected from butyric (C4), caproic, caprylic, capric, lauric, myristic, palmitic, palmitoleic, stearic, oleic, linoleic (C18), linolenic (C18), etc., thereby meeting the limitations of instant claims 19 and 21.
Claim 2 discloses that the one or more active agents are selected from biocidal agents, antimicrobial agents, anesthetics, anti-inflammatory agents, and combinations thereof.
The reference is thus considered to meet each of the instantly claimed compositional and structural limitations. The Examiner acknowledges that the reference does not disclose the practiced coating composition as being a “eutectic” mixture, and also acknowledges the definition for the term provided in the instant specification (see e.g., pg. 12, sixth paragraph). Despite this, the Examiner submits that the reference discloses the instantly recited components that Applicants set forth as their defining composition. As such, absent a clear showing of evidence to the contrary, the Examiner submits that the claimed composition is taught by the reference.
Based on the combined teachings of the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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