DETAILED ACTION
Claims 1-16 are currently pending and under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
Examiner’s Note
Applicant's amendments and arguments filed 11/25/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 11/25/2025, it is noted that claim 1 has been amended and no new matter or claims have been added.
New Rejections:
The following rejections are newly applied based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112 (b)
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 1-16 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 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: implanting into a human or animal individual. The instant claims are directed to a method for treating antimicrobial resistance of microorganisms in a human or animal individual, however the active steps require coating of a medical device prior to implantation and being configured for implantation into a human or animal individual but do not require the actual implantation step. The essential step of implantation is therefor omitted. It is unclear how the treating antimicrobial resistance of microorganisms in a human or animal by increasing the sensitivity of microorganisms and the required decrease of between 1 and 5 log reduction in colony forming units as compared to a non-coated medical device is accomplished when the implant is not required to be implanted. Additionally application of an antimicrobial step is not required. Claims 2-16 are additionally rejected as not curing the deficiency of claim 1.
Claim 2 recites the limitation "the antimicrobial". There is insufficient antecedent basis for this limitation in the claim. Instant claim 1 recites “antimicrobial compounds”. It is unclear if the antimicrobial is referring back to antimicrobial compounds, and if it is directed to a single antimicrobial or allows for more than 1 as is present in instant claim 1.
Claim 6 has unclear metes and bounds is used to coat a medical device or implant before implantation or a wound before dressing or closing. Instant claim 1 requires coating a medical device prior to implantation. Claim 6 allows for coating of a wound before dressing or closing, wherein a wound is not a medical device and therefore leads to unclear metes and bounds of the instant claim as to what is required to be coated.
Claim Rejections - 35 USC § 112 (d)
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 6 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 6 is directed to wherein the fibrinogen is used to coat a medical device or implant before implantation or a wound before dressing or closing. Instant claim 1 requires the coating on a medical device prior to implantation. Claim 6 is thus broader than claim 1 as it allows for coating both a medical device, implant or a wound. 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.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
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.
Claim(s) 1-4, 6, 9-11, 13 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0171285 (previously applied) and US 2007/0254833 (previously applied).
Regarding claims 1, the limitation of a method for treating or preventing antimicrobial resistance of microorganism in a human or animal individual by increasing sensitivity of the microorganism to antimicrobial compounds comprising administering a composition comprising fibrinogen to a human or animal individual and the coating increases sensitivity of microorganism or antimicrobial compounds by decrease of between 1 and 5 log reduction in colony forming units as compared to a non-coated medical device is met by the ‘285 publication teaching fibrinogen and fibrinogen derived products with reduced binding to bacterial (abstract) wherein the modified fibrinogen (Fg) coated to medical devices administered to patients with medical conditions ([0010], [0019]) wherein are coated onto medical devices that are in contact with human blood or fluids and for use in humans [0037]. The ‘285 publication teaches the active step of coating the composition comprising fibrinogen to a human or animal individual (patient) on a medical device, and is capable of the intended use of implantation, and thus would meet the instant claim limitation. The limitation of preventing antimicrobial resistance of the microorganism and increasing the sensitivity of microorganisms to antimicrobial compounds by decease of between 1 and 5 log reduction in colony forming units as compared to a non-coated medical device would inherently be present, as the active step of coating the claimed composition on a medical device is taught and thus necessarily prevent antimicrobial resisting of microorganism if implanted as is the intended use.
Regarding claims 2-3, 10-11 and 16, the limitation of wherein the antimicrobial is an antibacterial agent, wherein the microorganisms are in a biofilm and the composition is for increasing antimicrobial susceptibly of the biofilm is met by the ‘285 publication teaching the use of modified fibrinogen will prevent colonization from bacterial ad can be used to prevent bacterial attachment or even treat infections caused by staphylococcal species, including S. aureus. It is known that the binding between bacteria and fibrinogen is of importance for the virulence mechanisms of the pathogens, the modified fibrinogen and product thereof described herein can reduce bacterial binding and hence also the resulting virulence caused by a number of different bacterial pathogens may also be reduced ([0036]-[0037]). The active step of coating of an implant with fibrinogen is taught and the intended use of administration to a patient is taught wherein biofilm is taught be prevent or have reduced virulence, thus meeting the instant claim limitations.
Regarding claim 4, the limitation of wherein the biofilm is on a medical device is met by the ‘285 publication teaching a medical device [0036].
Regarding claims 6 and 13, the limitation of wherein the fibrinogen used to coat a medical device or implant before implantation is met by the ‘285 publication teaching administration of coated medical devices [0010].
Regarding claim 9, the limitation of wherein the fibrinogen in the composition is produced recombinantly is met by the ‘285 publication teaching recombinant variant fibrinogen [0011].
The ‘285 publication does not specifically teach coating a medical device prior to implantation with 0.1-1mL composition comprising fibrinogen per cm2 coating surface of the medical device (claim 1).
The ‘833 publication teaches implants provided for treating disease wherein the device includes a specific coating (abstract). Implant devices are taught wherein the implant [0010]. The fibrosising agent in the coating is taught to include fibrinogen ([0019]-[0020], [0101]). The exact dosing of the therapeutic agent on the implant is taught to be varied based on configurations, forms and sizes, the exact does of the therapeutic implant and portions of the implant to be coated [0180]. Hemostatic agents are taught to be applied as a polymer coating on the implant wherein the implant is taught to be coated with 0.2 to 25 ml. The implant is in the range of 0.5 to 15ml, wherein the range of 0.01ml/cm2 to 0.5 ml/cm2 of surface area coated ([0185]-[0186], [0354]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use know amounts of fibrinogen on an implant as taught by the ‘833 publication for the fibrinogen coated implant taught by the ‘285 publication. One of ordinary skill in the art before the fling date of the claimed invention would have a reasonable expectation of success as the ‘285 publication and the ‘833 publication are both directed to fibrinogen coated on implantable devices. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the amount of fibrinogen on the implantable device as the ‘833 publication teaches reasons to optimize the coating such as being varied based on configurations, forms and sizes, the exact does of the therapeutic implant and portions of the implant to be coated. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Claim(s) 1-6, 8-11, 13-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0171285 (previously applied) in view of Ganesh (previously applied), McDevitt (previously applied) and US 2007/0254833 (previously applied).
Regarding claims 1, the limitation of a method for treating or preventing antimicrobial resistance of microorganism in a human or animal individual by increasing sensitivity of the microorganism to antimicrobial compounds comprising administering a composition comprising fibrinogen to a human or animal individual and the coating increases sensitivity of microorganism or antimicrobial compounds by decrease of between 1 and 5 log reduction in colony forming units as compared to a non-coated medical device is met by the ‘285 publication teaching fibrinogen and fibrinogen derived products with reduced binding to bacterial (abstract) wherein the modified fibrinogen (Fg) coated to medical devices administered to patients with medical conditions ([0010], [0019]) wherein are coated onto medical devices that are in contact with human blood or fluids and for use in humans [0037]. The ‘285 publication teaches the active step of coating the composition comprising fibrinogen to a human or animal individual (patient) on a medical device, and is capable of the intended use of implantation, and thus would meet the instant claim limitation. The limitation of preventing antimicrobial resistance of the microorganism and increasing the sensitivity of microorganisms to antimicrobial compounds by decease of between 1 and 5 log reduction in colony forming units as compared to a non-coated medical device would inherently be present, as the active step of coating the claimed composition on a medical device is taught and thus necessarily prevent antimicrobial resisting of microorganism if implanted as is the intended use.
Regarding claims 2-3 and 10-11, the limitation of wherein the antimicrobial is an antibacterial agent, wherein the microorganisms are in a biofilm and the composition is for increasing antimicrobial susceptibly of the biofilm is met by the ‘285 publication teaching the use of modified fibrinogen will prevent colonization from bacterial and can be used to prevent bacterial attachment or even treat infections caused by staphylococcal species, including S. aureus. It is known that the binding between bacteria and fibrinogen is of importance for the virulence mechanisms of the pathogens, the modified fibrinogen and product thereof described herein can reduce bacterial binding and hance also the resulting virulence caused by a number of different bacterial pathogens may also be reduced ([0036]-[0037]). The active step of coating of an implant with fibrinogen is taught and the intended use of administration to a patient is taught wherein biofilm is taught be prevent or have reduced virulence, thus meeting the instant claim limitations.
Regarding claim 4, the limitation of wherein the biofilm is on a medical device is met by the ‘285 publication teaching a medical device [0036].
Regarding claims 6 and 13, the limitation of wherein the fibrinogen used to coat a medical device or implant before implantation is met by the ‘285 publication teaching administration of coated medical devices [0010].
Regarding claim 8, the limitation of wherein the method further comprises supplying an antimicrobial agent is met by the ‘285 publication teaching the antimicrobial agent (claim 17).
Regarding claim 9, the limitation of wherein the fibrinogen in the composition is produced recombinantly is met by the ‘285 publication teaching recombinant variant fibrinogen [0011].
The ‘285 publication does not specifically teach coating a medical device prior to implantation with 0.1-1mL composition comprising fibrinogen per cm2 coating surface of the medical device (claim 1).
The ‘285 publication does not specifically teach the composition comprises plasma fibrinogen, wild type fibrinogen, fibrinogen gamma prime, fibrinogen alpha extended variant or fibrinogen alpha truncated variant (claim 5 and 14).
Ganesh et al. teaches that clumping factor A (ClfA) from Staphylococcus aureus interacts with the C-terminal region of the fibrinogen (Fg) γ-chain (Abstract). Ganesh further teaches that staphylococcal virulence factors such as the MSCRAMM (microbial surface components recognizing adhesive matrix molecules) clumping factor A (ClfA) is the major staphylococcal fibrinogen (Fg) binding protein and is responsible for the observed clumping of S. aureus in blood plasma (p. 1, col. 1, 2nd para. Line 1-7). Ganesh et al. teaches that deletions of 2 or 4 residues from the C-terminal end of the gamma chain abolished binding to ClfA (p. 2, col. 2, 4th para., line 15-17) and that when fibrinogen that lacks the C-terminal residues AGDV in the y-chain (corresponding to residues 14–17 in the peptide) or a fibrinogen-variant that replaces the last four y-chain residues with 20 amino acids lacks the ability to bind recombinant ClfA221–550 and induce S. aureus clumping (p. 3, col. 1, line 1-4). Ganesh concludes that the study is important in developing novel anti-staphylococcal therapeutic agents (p. 7, col. 2, line 26-27).
Mcdevvit teaches that the binding site in fibrinogen for the recently identified S. aureus fibrinogen-binding protein clumping factor (ClfA) is within the C-terminus of the fibrinogen γ-chain (Abstract). McDevitt further teaches that there was an interaction of ClfA with the fibrinogen C-terminal domain of the γ-chain and that an altered y-chain C-terminal does not support adherence of S. aureus cells and are not recognized by recombinant ClfA (p. 417, col. 1, 4th para. Line 1-6). Mcdevvit teaches that the C-terminal 4 amino acids of the y chain (AGDV) were replaced by 20 amino acids (VRPEHPAETEYDSLYPEDDL), (p. 417, col. 2, 3RD para. line 8-10), forming a fibrinogen gamma chain identical to the instant SEQ ID NO: 3. Mcdevvit discloses that in their experiment, the wild type fibrinogen (α2β2y2) and the fibrinogen variant where the 4 C-terminal amino acids have been replaced by the 20mer, VRPEHPAETEYDSLYPEDDL (α2β2 Ɣ’2), ClfA+ cells adhered in increasing numbers onto microtitre wells coated with increasing amounts of (α2β2Ɣ2), but failed to adhere to microtitre wells coated with the fibrinogen variant (α2β2 Ɣ’2) (p. 419, col. 2, results section, line 17-20, Fig 1, reading on claim 5 and 14). Mcdevvit further concludes that the site in fibrinogen that supports the adherence of CIfA+ S. aureus cells is located at the C-terminus of the y chain, a domain that previously has been shown to be involved in fibrinogen-dependent staphylococcal clumping (p. 420, col. 1, line 3-7).
The ‘833 publication teaches implants provided for treating disease wherein the device includes a specific coating (abstract). Implant devices are taught wherein the implant [0010]. The fibrosising agent in the coating is taught to include fibrinogen ([0019]-[0020], [0101]). The exact dosing of the therapeutic agent on the implant is taught to be varied based on configurations, forms and sizes, the exact does of the therapeutic implant and portions of the implant to be coated [0180]. Hemostatic agents are taught to be applied as a polymer coating on the implant wherein the implant is taught to be coated with 0.2 to 25 ml. The implant is in the range of 0.5 to 15ml, wherein the range of 0.01ml/cm2 to 0.5 ml/cm2 of surface area coated ([0185]-[0186], [0354]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the fibrinogen taught by McDevvit for the fibrinogen taught by the ‘285 publication because McDevvit teaches fibrinogen variant being modified at the site of which was previously identified to be involved in fibrinogen dependent staphylococcal dumping wherein the ‘285 publication teaches the desire to prevent adherence of staphycoccal on a medical device using fibrinogen. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use modified fibrinogen taught by McDevvit in order to prevent clumping or adherence of staphylococcal on medical devices as is taught as desirable by the ‘285 publication because the ‘285 publication teaches the use of modified fibrinogen and McDevvit teaches a specifically modified fibrinogen which is modified on the gamma chain and wherein Ganesh teaches modification of the gamma chain in order to prevent staphylococcal virulence.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use know amounts of fibrinogen on an implant as taught by the ‘833 publication for the fibrinogen coated implant taught by the ‘285 publication. One of ordinary skill in the art before the fling date of the claimed invention would have a reasonable expectation of success as the ‘285 publication and the ‘833 publication are both directed to fibrinogen coated on implantable devices. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize the amount of fibrinogen on the implantable device as the ‘833 publication teaches reasons to optimize the coating such as being varied based on configurations, forms and sizes, the exact does of the therapeutic implant and portions of the implant to be coated. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Claim(s) 12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0171285, Ganesh, McDevitt and US 2007/0254833 as applied to claims 1-6, 8-11, 13-14 and 16 above, and further in view of US 2007/0282247 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1-6, 8-11, 13-14 and 16 are taught by the combination of the ‘285 publication, Ganesh and McDevitt.
The combination of references does not teach wherein the compristion is a spray, paste or gel (claim 12).
The combination of references does not specifically teach wherein the medical device is a stent (claim 15).
The ‘247 publication teaches various medical devices (abstract) wherein the prevention of biofilm formation and infection of indwelling catheter and implants such as stent is taught [0003]. The infections are often the result of biofilms forming at the insertion site of the medical implant [0004]. Fibrinogen and/or fibrin is taught as coated on medical devise ([0008], [0228]). The administration is taught via spray, powder, gels or as coatings within or attached to bandage materials [0147].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to coat a medical device such as a stent with fibrinogen taught by the combination of references as the ‘285 publication teaches fibrinogen as a medical device coating and the ‘247 publication teaches specifically coating medical device such as stents with fibrinogen. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated and have an expectation of success in using to the coating taught by the ‘285 publication on a specifically names medical device known to be coated with fibrinogen.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the fibrinogen taught by the ‘285 publication in different forms including gels and sprays as the ‘247 publication teaches administration in the form of a spray and the ‘285 publication teaches the use of fibrinogen in the form of spray, thus rendering spray form of fibrinogen administration obvious to one of ordinary skill in the art as multiple uses for coatings of medical devices and administration in the form of a spray are taught by the ‘247 publication and the ‘285 publication.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0171285, Ganesh, McDevitt and US 2007/0254833 as applied to claims 1-6, 8-11 and 13-14 above, and further in view of US 6,013,099 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1-6, 8-11, 13-14 and 16 are taught by the combination of the ‘285 publication, Ganesh, McDevitt and the ‘833 publication.
The combination of references does not specifically teach the composition further comprising thrombin, batroxobin or reptilase (claim 7).
The ‘099 patent teaches fibrin with fibrin incorporated into pores, which can be the only layer of polymeric material on the medical device (e.g. stent) (abstract). Fibrinogen is converted to fibrin through proteolysis by a fibrinogen-coagulating protein such as thrombin, reptilase or ancrod (column 9, lines 1-5). Fibrinogen solution preferably includes a fibrinogen-coagulating protein such as thrombin which can be applied (column 9, lines 35-45). The polyurethane stents were taught as suspended in fibrinogen-thrombin solution (column 12, lines 1-6).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use thrombin in the fibrinogen coating taught by the ‘285 publication because the ‘099 patent teaches that it was known as the time of the invention to use thrombin in combination with fibrinogen on a stent coating and the ‘285 publication teaches fibrinogen coating on medical devices. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘099 and the ‘285 publication both teach fibrinogen coatings on stents. One of ordinary skill in the art before the effective filing date of the claimed invention would be motivated to include thrombin in the coating of the ‘285 publication as the ‘099 patent teaches the use of thrombin solution to enhance mechanical properties and biostability of the device (column 9, lines 35-45).
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: The ‘285 publication (Hook) in view of the ‘833 publication (Hunter)
Applicant argues because the ‘285 publication alone and in combination with the ‘833 publication fails to teach or suggest the coating increases sensitivity of microorganisms to antimicrobial compounds by a decrease of between 1 and 5 log reduction in CFUs as compared to a non-coated medica device is now claimed. There is not teaching the ‘285 publication when used to coated a medical device of increasing sensitivity of microorganisms to antimicrobial compounds by a decrease of between 1 and 5 log reduction in CFUs.
In response, the ‘285 publication teaches the active step of coating the composition comprising fibrinogen to a human or animal individual (patient) on a medical device, and is capable of the intended use of implantation, and thus would meet the instant claim limitation. The limitation of preventing antimicrobial resistance of the microorganism and increasing the sensitivity of microorganisms to antimicrobial compounds by decease of between 1 and 5 log reduction in colony forming units as compared to a non-coated medical device would inherently be present, as the active step of coating the claimed composition on a medical device is taught and thus necessarily prevent antimicrobial resisting of microorganism if implanted as is the intended use. As is noted in the above 112(b) rejection the instant claims do not require the implantation of the device and therefore the method steps of coating the device and being capable of implantation are taught by the ‘285 publication.
103: The ‘285 publication (Hook) in view of Ganesh, McDevitt and the ‘833 publication (Hunter)
Applicant argues because the ‘285 publication alone and in combination with the ‘833 publication fails to teach or suggest the coating increases sensitivity of microorganisms to antimicrobial compounds by a decrease of between 1 and 5 log reduction in CFUs as compared to a non-coated medica device is now claimed. There is not teaching the ‘285 publication when used to coated a medical device of increasing sensitivity of microorganisms to antimicrobial compounds by a decrease of between 1 and 5 log reduction in CFUs.
In response, the ‘285 publication teaches the active step of coating the composition comprising fibrinogen to a human or animal individual (patient) on a medical device, and is capable of the intended use of implantation, and thus would meet the instant claim limitation. The limitation of preventing antimicrobial resistance of the microorganism and increasing the sensitivity of microorganisms to antimicrobial compounds by decease of between 1 and 5 log reduction in colony forming units as compared to a non-coated medical device would inherently be present, as the active step of coating the claimed composition on a medical device is taught and thus necessarily prevent antimicrobial resisting of microorganism if implanted as is the intended use. As is noted in the above 112(b) rejection the instant claims do not require the implantation of the device and therefore the method steps of coating the device and being capable of implantation are taught by the ‘285 publication.
Conclusion
No claims are allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
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