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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Such limitations are:
“discharge means” in claim 1. This limitation is interpreted to mean a plurality of nozzles, and functional equivalents thereof, as shown in the figures (see element 70) and paragraph 32 of the published application.
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.
Claim(s) 1-5 and 7-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rucinski (US 20110097372) in view of Dicosmo (US 20170290789).
Regarding claim 1, Rucinski discloses a method for irrigating a wound (paragraph 2) comprising the steps of:
(a) providing a non-sterile or sterile wound irrigation solution in a wound irrigation device comprising a reservoir housing (paragraph 57 discloses providing a reservoir housing containing a solution), wherein the wound irrigation device comprises a discharge means that directs a pressurized stream of the wound irrigation solution when the reservoir housing is pressurized (this limitation is interpreted to mean a nozzle, as discussed above; paragraph 65 discloses nozzles which direct the solution out of the device when pressure is applied to the reservoir), and wherein the wound irrigation solution comprises (i) sterile water, purified water, or water for pharmaceutical purposes (paragraph 18 discloses the solution can contain “sterile water”); (ii) a chlorhexidine (paragraph 13 discloses that the active agent in the solution is chlorhexidine);
(b) directing the discharge means and the reservoir housing so as to discharge the wound irrigation solution toward the wound (paragraph 58 discloses directing towards the wound); and
(c) discharging a stream of the wound irrigation solution from the reservoir housing and through the discharge means directed at the wound (paragraph 58 discloses expelling/discharging the solution).
While Rucinski discloses a range of chlorhexidine concentrations (paragraph 50 discloses a concentration less than 4%), Rucinski does not explicitly teach or disclose the concentration is between about 100 ug/mL to about 5 mg/mL. Additionally, Rucinski does not teach or disclose the solution comprises octenidine (OCT) or a pharmaceutically acceptable salt thereof at a concentration that is between about 1 ug/mL to about 100 ug/mL.
Dicosmo is directed towards aqueous solutions for wound irrigation (paragraph 2) which can comprise both chlorhexidine and octenidine (paragraph 21 discloses a list of potential antimicrobial agents which comprises chlorhexidine and octenidine and “any combinations thereof”). Dicosmo further teaches that the concentration of the antimicrobial agent can range from 10 ug/mL to 5 mg/mL, so that the range taught by Dicosmo overlaps both claimed ranges (paragraph 72 and claim 3 discloses 0.001%-0.5% w/v which equates to 10 ug/mL to 5 mg/mL).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the irrigation solution of Rucinski to include octenidine in addition to chlorhexidine, as taught by Dicosmo, since Dicosmo teaches that this is a known antimicrobial combination useful in irrigating wounds.
Additionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the solution of Rucinski to have a concentration of chlorhexidine between about 100 ug/mL to about 5 mg/mL and concentration of octenidine between about 1 ug/mL to about 100 ug/mL, as applicant appears to have placed no criticality on the claimed ranges (see paragraphs 103 and 105 of the published application which discloses a much broader range of concentrations for both chlorhexidine and octenidine and that “Wound irrigation solutions of methods and devices described herein can contain any concentration of chlorhexidine/octenidine”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 2, in the modified method of Rucinski, Rucinski discloses the wound irrigation solution consists of (i) sterile water, purified water, or water for pharmaceutical purposes; (ii) the chlorhexidine at a concentration that is between about 100 ug/mL to about 5 mg/mL; and (iii) the octenidine (OCT) or the pharmaceutically acceptable salt thereof at a concentration that is between about 1 ug/mL to about 100 ug/mL (paragraph 31 discloses that the solution “may” have other components in addition to water the chlorhexidine but that an embodiment is contemplated in which the solution only has water and chlorhexidine; Rucinski was modified with Dicosmo to only further comprise octenidine so that the solution would consist of water, chlorhexidine, and octenidine).
Regarding claim 3, in the modified method of Rucinski, Rucinski discloses the chlorhexidine is in the form of chlorhexidine gluconate (paragraph 13).
Regarding claim 4, modified Rucinski teaches all of the claimed limitations set forth in claim 1, as discussed above. Dicosmo discloses the concentration of the antimicrobial agent, which includes chlorhexidine, can range from 10 ug/mL to 5 mg/mL, so that the range taught by Dicosmo overlaps the claimed range (paragraph 72 and claim 3 discloses 0.001%-0.5% w/v which equates to 10 ug/mL to 5 mg/mL).
However, modified Rucinski does not explicitly teach or disclose the chlorhexidine is between about 200 ug/mL to about 1 mg/mL or about 100 ug/mL to about 500 ug/mL.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the solution of Rucinski to have a concentration of chlorhexidine between about 200 ug/mL to about 1 mg/mL or about 100 ug/mL to about 500 ug/mL, as applicant appears to have placed no criticality on the claimed ranges (see paragraphs 103 of the published application which discloses a much broader range of concentrations for chlorhexidine and that “Wound irrigation solutions of methods and devices described herein can contain any concentration of chlorhexidine”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 5, modified Rucinski teaches all of the claimed limitations set forth in claim 1, as discussed above. Dicosmo discloses the concentration of the antimicrobial agent, which includes chlorhexidine, can range from 10 ug/mL to 5 mg/mL, so that the range taught by Dicosmo overlaps the claimed range (paragraph 72 and claim 3 discloses 0.001%-0.5% w/v which equates to 10 ug/mL to 5 mg/mL; the examiner notes that the term “about” implies a range in that the concentration is above/below 500 ug/mL, as set forth in paragraph 111 of the published application).
However, modified Rucinski does not explicitly teach or disclose the chlorhexidine is between about 500 ug/mL.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the solution of Rucinski to have a concentration of chlorhexidine between about 500 ug/mL, as applicant appears to have placed no criticality on the claimed ranges (see paragraphs 103 of the published application which discloses a much broader range of concentrations for chlorhexidine and that “Wound irrigation solutions of methods and devices described herein can contain any concentration of chlorhexidine”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 7, modified Rucinski teaches all of the claimed limitations set forth in claim 1, as discussed above. Dicosmo discloses the concentration of the antimicrobial agent, which includes octenidine, can range from 10 ug/mL to 5 mg/mL, so that the range taught by Dicosmo overlaps the claimed range (paragraph 72 and claim 3 discloses 0.001%-0.5% w/v which equates to 10 ug/mL to 5 mg/mL).
However, modified Rucinski does not explicitly teach or disclose the octenidine is between about 1 ug/mL to about 20 ug/mL.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the solution of Rucinski to have a concentration of octenidine between about 1 ug/mL to about 20 ug/mL, as applicant appears to have placed no criticality on the claimed ranges (see paragraphs 105 of the published application which discloses a much broader range of concentrations for octenidine and that “Wound irrigation solutions of methods and devices described herein can contain any concentration of octenidine”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 8, modified Rucinski teaches all of the claimed limitations set forth in claim 1, as discussed above. Dicosmo discloses the concentration of the antimicrobial agent, which includes octenidine, can range from 10 ug/mL to 5 mg/mL, so that the range taught by Dicosmo partially overlaps the second claimed range (paragraph 72 and claim 3 discloses 0.001%-0.5% w/v which equates to 10 ug/mL to 5 mg/mL).
However, modified Rucinski does not explicitly teach or disclose the octenidine is between about 2 ug/mL to about 10 ug/mL.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the solution of Rucinski to have a concentration of octenidine between about 2 ug/mL to about 10 ug/mL, as applicant appears to have placed no criticality on the claimed ranges (see paragraphs 105 of the published application which discloses a much broader range of concentrations for octenidine and that “Wound irrigation solutions of methods and devices described herein can contain any concentration of octenidine”) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 9, modified Rucinski teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not explicitly teach or disclose the concentration of the octenidine (OCT) or the pharmaceutically acceptable salt thereof is about 1.875 ug/mL or about 3.75 ug/mL.
Dicosmo teaches that the concentration of the active agent can be derived through “routine experimentation” and would be chosen to “provide the desired therapeutic effect” (paragraph 69), indicating that concentration of octenidine is a result effective variable in that changing the concentration provides a different therapeutic effect. Further it appears that PHOSITA would had a reasonable expectation of success in modifying the modified method of Rucinski to have an octenidine concentration within the claimed range. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify solution of modified Rucinski to comprise the claimed octenidine concentration as a matter of routine optimization since it has been held that “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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 10, the limitation “an amount of irrigation time required to reduce a bacterial burden of the wound or a fungal burden of the wound by about 100-fold compared to an analogous method using an alternative irrigation solution comprising the same concentration of chlorhexidine without an additional antiseptic agent is reduced by about 50%” recites the result or effect of the method. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Although modified Rucinski does not discuss that the time is reduced as claimed, this result is inherently met since the method steps are disclosed.
Regarding claim 11, in the modified method of Rucinski, Rucinski discloses the irrigation solution comprises a combination of the chlorhexidine and the octenidine (OCT) or the pharmaceutically acceptable salt thereof that is synergistically microbiocidal or microbiostatic to a fungus or a bacterium (paragraphs 10 and 35).
Regarding claim 12, in the modified method of Rucinski, Rucinski discloses the fungus or the bacterium is selected from Candida species, E. coli, Staphylococcus species, Ralstonia species, Pseudomonas species, or a combination thereof (paragraph 35).
Regarding claim 13, in the modified method of Rucinski, Rucinski discloses the fungus or the bacterium is E. coli (paragraph 35).
Regarding claim 14, in the modified method of Rucinski, Rucinski discloses the amount of irrigation time required is within 15 minutes (paragraph 18 discloses within 5 minutes).
Regarding claim 15, in the modified method of Rucinski, Rucinski discloses about 10 ml to about 1000 ml of wound irrigation solution is applied to the wound (paragraph 65 discloses 200-300 ml).
Regarding claim 16, in the modified method of Rucinski, Rucinski discloses the method used to kill a microorganism selected from the group consisting of Candida species, E. coli, Staphylococcus species, Ralstonia species, Pseudomonas species, and a combination thereof (paragraph 35).
Regarding claim 17, in the modified method of Rucinski, Rucinski discloses the method used to kill C. albicans, E. coli, methicillin-resistant Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis, Ralstonia pickettii, P. aeruginosa, or a combination thereof (paragraph 35).
Regarding claim 18, in the modified method of Rucinski, Rucinski discloses the wound is a human skin wound and the method is used to treat the human skin wound (paragraph 18).
Regarding claim 19, in the modified method of Rucinski, Rucinski discloses the wound is selected from the group consisting of cuts, scrapes, surgical wounds, punctures, and abrasions (paragraph 68).
Regarding claim 20, the limitation “a property of wound healing is improved compared to irrigation of the wound using an analogous method, wherein an alternative wound irrigation solution either (i) consists of a saline solution, or (ii) consists of the same chlorhexidine concentration without an additional antiseptic agent, wherein the property of wound healing is wound bed scoring, exudate, wound microorganism burden, or a combination thereof” recites the result or effect of the method. Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency. Ex Parte Novitski, 26 USPQ2d 1389, 1390-91 (BdPatApp & Inter 1993). Although modified Rucinski does not discuss that a property of wound healing is improved as claimed, this result is inherently met since the method steps are disclosed.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rucinski in view of Dicosmo, as applied to claim 1 above, and further in view of Magallon (US 20080108674).
Regarding claim 6, modified Rucinski teaches all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the octenidine (OCT) or the pharmaceutically acceptable salt thereof is octenidine dihydrochloride.
Magallon is directed towards a solution for treating a skin condition (paragraph 12 discloses an “aqueous antiseptic solution”) containing octenidine dihydrochloride (paragraph 12). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the octenidine of modified Rucinski to be octenidine dihydrochloride, as taught by Magallon, as Magallon teaches this is an acceptable antiseptic agent to treat wounds.
Conclusion
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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