DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 30 September 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 .
Claims 1, 5, 7-10, 15, 17, 19, 21, 22, 25, 26, 32, 40, 43, 48, 51, and 52 are pending, where claims 8, 15, 22, 32, 40, 43, 48, 51, and 52 remain withdrawn from consideration.
Claims 2 and 18 have been canceled and their limitations added to independent claim 1.
Claims 1, 5, 7, 10, and 25 have been amended. Claim 1 is additionally amended to remove the “capable” language. Claim 5 is amended to remove the same language. The remaining claims are amended to remove the previously rejected indefinite language.
No claims have been added. No new matter has been added.
Thus, claims 1, 5, 9, 10, 17, 19, 21, 25, and 26 now represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Withdrawn Objection/Rejections
Objection to the Drawings
Applicants’ remark clarifying the drawing of Figure 5 is sufficient in overcoming the previously raised objection. Said objection is withdrawn.
Rejection under 35 USC 102
Applicants’ amendment adding the limitations of unrejected claim 2 to independent claim 1 is sufficient in overcoming the previously raised anticipation rejection. Said rejection is withdrawn.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 1 June 2026 since the art that was previously cited continues to read on the amended and previously recited limitations.
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, 5, 7, 9, 10, 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). [emphasis added to reflect canceled claims]
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 form, in situ, at least one eutectic mixture in or on at least one polymer, wherein the two or more eutectic forming components generate eutectic oils in situ within the suture thread, wherein the two or more eutectic forming components further comprises one or more active agents.
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.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 5, 7, 9, 10, 19, and 21 under pre-AIA 35 USC 102(a)(1)/(a)(2) as being anticipated by Stopek et al. have been fully considered, but are not persuasive.
Applicants initially traverse the rejection arguing that the Office “assumes that the presence of the components leads to a eutectic mixture without taking into account the relative proportions of the components, the method and extent of mixing, the kinetics of molecular diffusion, and whether sufficient interaction/reaction occurs during preparation” and that “Stopek provides no statement as it pertains to a ‘eutectic’ mixture.”
It is Applicants’ conclusion that the Office has not identified an embodiment of Stopek in which the disclosed components necessarily form a eutectic mixture or generate a eutectic oil in situ within the suture thread.
The Examiner, in response, respectfully disagrees and maintains, not only the foregoing broadest reasonable interpretation of the instantly claimed “eutectic” mixture, but also that Stopek discloses said limitations despite not expressly using the term “eutectic.”
In response to Applicants’ argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicants rely (i.e., relative proportions of the components, the method and extent of mixing, the kinetics of molecular diffusion, and whether sufficient interaction/reaction occurs during preparation) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Acknowledging the definitions for the term “eutectic” in the originally filed specification (see pg. 12, last two paragraphs), the Examiner submits that Applicants’ traversal is not commensurate in scope with the claimed composition. Therein, the claimed composition, though being styled as “eutectic” remains defined by its constituents, as are presented in the teachings of Stopek.
Applicants’ second argument asserts that Stopek discusses depositing bioactive agent compositions onto a pre-existing suture body whereas the claim recites the property that eutectic the two or more eutectic components generate eutectic oils in situ within the suture thread.
The Examiner respectfully finds this unpersuasive as Applicants’ remarks directed to the manner in which the composition is produced rather than the composition that is at issue. See MPEP §2113, regarding product-by-process limitations.
Applicants lastly assert that Stopek’s separate disclosures of broad bioactive-agent classes, fatty-acid coating components, and polymers do not disclose that a bioactive agent is one of the components capable of forming a eutectic mixture. Nor does the reference disclose the relative proportions or processing conditions needed to produce the claimed eutectic state.
Regarding the second of Applicants’ remarks first, the Examiner again maintains as stated above, that such limitations as “proportions” and “processing conditions” are not part of the claimed invention. The former is a compositional limitation that is simply not recited.
Secondly, the Examiner maintains that the reference does disclose Applicants’ generically recited components, and then relies on the additional “separate” disclosures (i.e., definitions) to further define the later-recited species.
Thus, for these reasons, Applicants’ arguments are found unpersuasive. The above rejection is hereby maintained.
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, 5, 7, 9, 10, 19, 21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Mattei (USPN 4,201,216). [emphasis added to reflect canceled claims]
The limitations of claims 1, 18, 19, 21, and 25 are discussed above. Claim 5 recites a multitude of combinations of the components already recited in claim 1. 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 1 recite wherein the two or more eutectic forming components generate eutectic oils in situ within a polymer device. Here, the Examiner submits that the compositional limitations of instant claim 1 have been met and as such, provide 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 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 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.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 5, 7, 9, 10, 19, 21, and 25 under 35 USC 103(a) as being unpatentable over the teachings of Mattei et al. have been fully considered, but they are not persuasive.
Applicants traverse the rejection on same grounds as discussed earlier with respect to Stopek, namely that “Mattei does not discuss creating or using a eutectic mixture” because “eutectic mixtures are identified not only by the components, but rather by a specific thermodynamic and structural state reached by said components”.
Applicants additionally assert that the instantly claimed composition “requires two or more eutectic forming compounds plus the polymer, whereas Mattei only states one component plus the polymer.”
The Examiner respectfully disagrees with this position noting that while the instantly claimed mixture does require two or more components as argued by Applicants, the claim also recites that said mixture may be formed of “any combination of two or more thereof”. Claim 5 of Mattei, for instance, expressly meets this limitation.
Applicants’ remark about the active agent not being required is also not persuasive as the reference teaches and suggests it as an ingredient in the practiced suture, as discussed above.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
Claims 1, 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). [emphasis added to reflect canceled claims]
The limitations of instant claims 1, 5, 7, 9, 10, 19, 21, and 25 are discussed above.
Claim 17 recites that the mixture comprises a non-antibiotic antimicrobial and a non-steroidal anti-inflammatory. 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.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 5, 7, 9, 10, 17, 19, 21, 25, and 26 under 35 USC 103(a) as being unpatentable over the teachings of Stopek et al. have been fully considered, but they are not persuasive.
Applicants traverse the rejection on the same grounds as discussed above with respect to the anticipation rejection.
The Examiner, in response, again considers these remarks as unpersuasive and maintains the rejection for the reasons already of record.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
