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 .
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a control unit” in claim 1, line 9;
“a sensing unit” in claim 6, line 2.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The specification in paragraph 0009 and claim 1 states that “a control unit” is a component that is used to control the negative pressure supply pump and the irrigation fluid pump. The language in claim 1 will be interpreted as requiring the disclosed structure in paragraph 0009 or equivalents thereof. The specification in paragraph 0013 and claim 1 states that “a sensing unit” is a component that is used to measure the number of bacteria. The language in claim 6 will be interpreted as requiring the disclosed structure in paragraph 0013 or equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
Claims 6-7 and 11 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 6 recites the limitation "the number of bacteria” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the number of washings” in line 2 and "the number of bacteria” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the shape” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. US 2021/0045927 A1), hereby referred to as “Locke ‘927”, in view of Rice et al. (Publication No. US 2021/0113748 A1).
Regarding claim 1, Locke ‘927 teaches a wound treatment device (therapy system 100; Figure 1; Paragraph 0042) characterized by comprising:
a wound portion covering body (dressing 102; Paragraph 0042; Figure 25) including a porous member and a watertight cover member (dressing 102 has a porous tissue interface 108 and a cover 106 providing a fluid seal and is a film material; Paragraph 0060-0062 and 0064; Figure 1),
a negative pressure supply pump for supplying negative pressure to the porous member side (negative pressure source 104 to supply negative pressure to the tissue interface 108; Paragraph 0044; Figure 1),
an irrigation fluid pump for supplying an irrigation fluid to the porous member side and discharging the irrigation fluid from the porous member side (instillation regulator 118 supplies solution from source 114 to dressing’s tissue interface 108 and is fluidly coupled to negative pressure source 104 to discharge solution from the tissue interface 108; Figure 1; Paragraph 0047),
a canister for intaking the discharged irrigation fluid (container 112 intakes solution/fluid; Paragraph 0049 and 0051; Figure 1), and
a control unit for controlling the negative pressure supply pump and the irrigation fluid pump (controller 110 controls negative-pressure source 104 and instillation regulator 118; Paragraphs 0046-0047; Figure 1),
wherein subjecting the wound portion covered on the porous member side by the wound portion covering body to negative pressure wound therapy and irrigation (irrigation and suction is delivered to dressing 102 with tissue interface 108; Figure 1; Paragraph 0046-0047). Locke does not teach the wound portion covering body constituted from a flexible laminate including the porous member and the watertight cover member laminated on the porous member.
However, Rice teaches the wound portion covering body constituted from a flexible laminate including the porous member and the watertight cover member laminated on the porous member (laminate of film layer 130 and porous wound interface layer 110 and is made of elastic material, thus flexible; Figure 3B; Paragraphs 0074-0077 and 0082).
Locke ‘927 and Rice are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘927 to incorporate the teachings of Rice to have the porous member and the watertight cover member of Locke ‘927 to be laminated, as taught by Rice. This would allow for the wound interface to be stabilized structurally (Rice; Paragraph 0082).
Regarding claim 2, Locke ‘927 in view of Rice teaches the device of claim 1. Locke ‘927 further teaches wherein the porous member has a number of convex portions on the surface opposite the cover member (tissue interface 108 has convex bubbles facing the tissue site on the surface opposite the cover 106; Paragraph 0131-0133; Figure 25).
Regarding claim 3, Locke ‘927 in view of Rice teaches the device of claim 1. Locke ‘927 further teaches wherein the wound portion covering body is pad-shaped, approximately cylindrical, approximately bag- shaped or approximately shoe-shaped (dressing 102 is pad shaped; Figure 25; Paragraph 0131).
Regarding claim 4, Locke ‘927 in view of Rice teaches the device of claim 1. Locke ‘927 further teaches wherein the irrigation fluid is a liquid or a gas (solution source 114 can be saline, a liquid; Paragraph 0047; Figure 1).
Regarding claim 9, Locke ‘927 teaches a wound portion covering body (dressing 102; Paragraph 0042; Figure 25) characterized by: including a porous member and a watertight cover member (dressing 102 has a porous tissue interface 108 and a cover 106 providing a fluid seal and is a film material; Paragraph 0060-0062 and 0064; Figure 1), and used for subjecting the wound portion covered on the porous member side to negative pressure wound therapy and irrigation (irrigation and suction is delivered to dressing 102 with tissue interface 108; Figure 1; Paragraph 0046-0047). Locke ‘927 does not teach the wound portion covering body characterized by: constituted from a flexible laminate including the porous member and the watertight cover member laminated on the porous member.
However, Rice teaches teach the wound portion covering body characterized by: constituted from a flexible laminate including the porous member and the watertight cover member laminated on the porous member (laminate of film layer 130 and porous wound interface layer 110 and is made of elastic material, thus flexible; Figure 3B; Paragraphs 0074-0077 and 0082).
Locke ‘927 and Rice are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘927 to incorporate the teachings of Rice to have the porous member and the watertight cover member of Locke ‘927 to be laminated, as taught by Rice. This would allow for the wound interface to be stabilized structurally (Rice; Paragraph 0082).
Regarding claim 10, Locke ‘927 in view of Rice teaches the wound portion covering body of claim 9. Locke ‘927 further teaches wherein the porous member has a number of convex portions on the surface opposite the cover member (tissue interface 108 has convex bubbles facing the tissue site on the surface opposite the cover 106; Paragraph 0131-0133; Figure 25).
Regarding claim 11, Locke ‘927 in view of Rice teaches the wound portion covering body of claim 9. Locke ‘927 further teaches wherein the shape is pad-shaped, approximately cylindrical, approximately bag-shaped or approximately shoe-shaped (dressing 102 is pad shaped; Figure 25; Paragraph 0131).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. US 2021/0045927 A1) in view of Rice et al. (Publication No. US 2021/0113748 A1), as applied to claim 4 above, and further in view of Ingram et al. (Publication No. US 2017/0182230 A1) and Kitano et al. (Publication No. US 2017/0172149 A1).
Regarding claim 5, Locke ‘927 in view of Rice teaches the device of claim 4. The combination of Locke ‘927 in view of Rice does not teach wherein the liquid contains an aqueous solution of peroxynitric acid.
However, Ingram teaches wherein the liquid contains an aqueous solution of antibacterial solution for delivery to the tissue site (Abstract; Paragraph 0008 and 0064).
Locke ‘927 in view of Rice and Ingram are both considered to be analogous to the claimed invention because they are in the same field of negative pressure wound therapy devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘927 in view of Rice to incorporate the teachings of Ingram to have the antibacterial solution of Ingram to be the irrigation fluid of Locke ‘927 in view of Rice. This would allow for the antibacterial liquid to kill bacteria on the tissue site and reduce bacterial infections (Ingram; Paragraph 0064). The combination of Locke ‘927 in view of Rice and Ingram does not teach wherein the liquid contains an aqueous solution of peroxynitric acid.
However, Kitano teaches wherein the liquid contains an aqueous solution of peroxynitric acid (Abstract; Paragraph 0013-0016).
Locke ‘927 in view of Rice and Ingram and Kitano are both considered to be analogous to the claimed invention because they are in the same field of antibacterial solutions. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘927 in view of Rice and Ingram to incorporate the teachings of Kitano to have the antibacterial solution of Locke ‘927 in view of Rice and Ingram to be an aqueous solution of peroxynitric acid, as taught by Kitano. This would allow for the sterilization treatment to kill bacteria with the equivalent power of plasma-treated solution (Kitano; Paragraph 0013-0016).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. US 2021/0045927 A1) in view of Rice et al. (Publication No. US 2021/0113748 A1), as applied to claim 1 above, and further in view of Bayon (Publication No. US 2017/0281064 A1).
Regarding claim 6, Locke ‘927 in view of Rice teaches the device of claim 1. The combination of Locke ‘927 in view of Rice does not teach wherein the canister is equipped with a sensing unit that measures the number of bacteria in the irrigation fluid.
However, Bayon teaches wherein the canister is equipped with a sensing unit that measures the number of bacteria in the irrigation fluid (sensor system 104 on container 101 is a sensor that measures the concentration/number of bacteria in the fluid; Paragraph 0036; Figure 1).
Locke ‘927 in view of Rice and Bayon are both considered to be analogous to the claimed invention because they are in the same field of drainage apparatus. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘927 in view of Rice to incorporate the teachings of Bayon to have the sensing unit of Bayon on the canister of Locke ‘927 in view of Rice. This would allow for the sensor to detect if a bacterial infection is occurring on the tissue site (Bayon; Paragraph 0036; Figure 1).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. US 2021/0045927 A1) in view of Rice et al. (Publication No. US 2021/0113748 A1), as applied to claim 1 above, and further in view of Bayon (Publication No. US 2017/0281064 A1) and Rubin et al. (Publication No. US 2018/0110499 A1).
Regarding claim 6, Locke ‘927 in view of Rice teaches the device of claim 1. The combination of Locke ‘927 in view of Rice does not teach wherein the control unit is capable of adjusting the number of washings depending on the number of bacteria.
However, Bayon teaches a sensing unit that measures the number of bacteria in the irrigation fluid (sensor system 104 on container 101 is a sensor that measures the concentration/number of bacteria in the fluid; Paragraph 0036; Figure 1).
Locke ‘927 in view of Rice and Bayon are both considered to be analogous to the claimed invention because they are in the same field of drainage apparatus. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘927 in view of Rice to incorporate the teachings of Bayon to have the sensing unit of Bayon on the canister of Locke ‘927 in view of Rice and connected to the control unit of Locke ‘927 in view of Rice for bacterial measurements. This would allow for the sensor to detect if a bacterial infection is occurring on the tissue site (Bayon; Paragraph 0036; Figure 1).
The combination of Locke ‘927 in view of Rice and Bayon does not teach wherein the control unit is capable of adjusting the number of washings depending on the number of bacteria.
However, Rubin teaches wherein the control unit is capable of adjusting the number of washings depending on the number of bacteria (device has a detection member 20 that can detect bacteria and provide a continuous rinse with clean washing to drain contaminated waste solution; Paragraph 0005, 0008, 0024, and 0053).
Locke ‘927 in view of Rice and Bayon and Rubin are both considered to be analogous to the claimed invention because they are in the same field of bacterial treatment apparatus. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘927 in view of Rice and Bayon to incorporate the teachings of Rubin to have the control unit of Locke ‘927 in view of Rice and Bayon to detect and determine the amount of irrigating the site, as taught by Rubin, in response to the bacterial measurement of Locke ‘927 in view of Rice and Bayon, and to irrigate the target site based on the determination, as taught by Rubin. This would allow for the device to rinse microbes to cleanse the target site while collection fluid samples for bacterial testing (Rubin; Paragraph 0005, 0008, 0024, and 0053).
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Locke et al. (Publication No. US 2021/0045927 A1) in view of Rice et al. (Publication No. US 2021/0113748 A1), as applied to claim 1 above, and further in view of Locke et al. (Publication No. US 2011/0178481 A1), hereby referred to as “Locke ‘481”.
Regarding claim 8, Locke ‘927 in view of Rice teaches the device of claim 1. The combination of Locke ‘927 in view of Rice does not teach characterized in that the negative pressure supply pump or the irrigation fluid pump is separable from the wound treatment device.
However, Locke ‘481 teaches characterized in that the negative pressure supply pump or the irrigation fluid pump is separable from the wound treatment device (fluid source 50, such as a fluid pump, is separable form the wound dressing device 10 through tee-fitting connector 58; Figure 1; Paragraph 0052 and 0080).
Locke ‘927 in view of Rice and Locke ‘481 are both considered to be analogous to the claimed invention because they are in the same field of drainage apparatus. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Locke ‘927 in view of Rice to incorporate the teachings of Locke ‘481 to have the irrigation fluid pump of Locke ‘927 in view of Rice be separable with a connector, as taught by Locke ‘481. This would allow for the fluid source to be removably connected from the system when negative pressure treatment only is desired or a fluid instillation treatment only is desired (Locke ‘481; Paragraph 0052 and 0071).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Robinson et al. (Publication No. US 2020/0139025 A1) discusses a wound treatment device that delivers negative pressure and irrigation to a wound site and comprising convex portions on the surface opposite to the cover member;
Olson et al. (Patent No. US 8,057,441 B2) discusses a wound treatment device that delivers negative pressure to a wound site and comprising convex portions on the surface opposite to the cover member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE-PH M PHAM whose telephone number is (571)272-0468. The examiner can normally be reached Mon-Fri, 8AM to 5PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE-PH MINH PHAM/Examiner, Art Unit 3781
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